UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-K

 

x

ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended December 31, 2013

or

¨

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from                     to                     

Commission file number: 033-17264-NY

 

IMMUNOCELLULAR THERAPEUTICS, LTD.

(Exact name of registrant as specified in its charter)

 

 

Delaware

 

93-1301885

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification Number)

 

 

23622 Calabasas Road, Suite 300

Calabasas, California

 

91302

(Address of principal executive offices)

 

(Zip code)

Registrant’s telephone number, including area code: (818) 264-2300

Securities registered pursuant to Section 12(b) of the Exchange Act:

 

Title of each class

 

Name of each exchange on which registered

Common Stock, $0.0001 par value

 

NYSE MKT

Securities registered pursuant to Section 12(g) of the Exchange Act: None

 

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.     ¨   Yes     x   No

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Exchange Act.     ¨   Yes     x   No

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the past 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.     x   Yes     ¨   No

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).     x   Yes     ¨   No

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of the registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.   x

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer,” and “smaller reporting company” in Rule 12b-2 of the Exchange Act (Check one):

 

Large accelerated filer

 

¨

  

Accelerated filer

 

x

 

 

 

 

Non-accelerated filer

 

¨

  

Smaller reporting company

 

¨

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act):     ¨   Yes     x   No

The aggregate market value of the common stock held by non-affiliates of the registrant as of June 30, 2013 was approximately $103,973,710.

There were 57,565,704 shares of the registrant’s common stock outstanding on February 28, 2014 .

Documents incorporated by reference:

Portions of the registrant’s Proxy Statement for the 2014 Annual Meeting of Stockholders are incorporated herein by reference in Part III of this Annual Report on Form 10-K to the extent stated herein.  The proxy statement will be filed with the Securities and Exchange Commission within 120 days of the registrant’s fiscal year ended December 31, 2013.  

 

 

 

 

 


Table of Contents

Form 10-K

 

 

 

 

  

Page

 

 

PART I

  

 

Item 1.

 

Business

  

2

Item 1A.

 

Risk Factors

  

10

Item 1B.

 

Unresolved Staff Comments

  

22

Item 2.

 

Properties

  

22

Item 3.

 

Legal Proceedings

  

22

Item 4.

 

Mine Safety Disclosures

  

22

 

 

PART II

  

 

Item 5.

 

Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

  

23

Item 6.

 

Selected Financial Data

  

24

Item 7.

 

Management’s Discussion and Analysis of Financial Condition and Results of Operations

  

25

Item 7A.

 

Quantitative and Qualitative Disclosures About Market Risk

  

30

Item 8.

 

Financial Statements and Supplementary Data

  

30

Item 9.

 

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

  

30

Item 9A.

 

Controls and Procedures

  

30

Item 9B.

 

Other Information

  

31

 

 

PART III

  

 

Item 10.

 

Directors, Executive Officers and Corporate Governance

  

32

Item 11.

 

Executive Compensation

  

32

Item 12.

 

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

  

32

Item 13.

 

Certain Relationships and Related Transactions, and Director Independence

  

32

Item 14.

 

Principal Accounting Fees and Services

  

32

 

 

PART IV

  

 

Item 15.

 

Exhibits and Financial Statement Schedules

  

33

 

 

 

i


“SAFE HARBOR” STATEMENT

From time to time, we make oral and written statements that may constitute “forward-looking statements” (rather than historical facts) as defined in the Private Securities Litigation Reform Act of 1995 or by the Securities and Exchange Commission (the “SEC”) in its rules, regulations and releases, including Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). We desire to take advantage of the “safe harbor” provisions in the Private Securities Litigation Reform Act of 1995 for forward-looking statements made from time to time, including the forward-looking statements made in this Annual Report, as well as those made in our other filings with the SEC.

All statements in this Annual Report, including under the captions “Business,” “Risk Factors,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” other than statements of historical fact are forward-looking statements for purposes of these provisions, including statements of our current views with respect to our business strategy, business plan and research and development activities, our future financial results, and other future events. These statements include forward-looking statements both with respect to us, specifically, and the biotechnology industry, in general. In some cases, forward-looking statements can be identified by the use of terminology such as “may,” “will,” “expects,” “plans,” “anticipates,” “estimates,” “potential” or “could” or the negative thereof or other comparable terminology. Although we believe that the expectations reflected in the forward-looking statements contained herein are reasonable, there can be no assurance that such expectations or any of the forward-looking statements will prove to be correct, and actual results could differ materially from those projected or assumed in the forward-looking statements.

All forward-looking statements involve inherent risks and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated in these statements. We believe that these factors include, but are not limited to, those factors set forth in this Annual Report under the captions “Business,” “Risk Factors,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” all of which you should review carefully. If one or more of these or other risks or uncertainties materialize, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. Please consider our forward-looking statements in light of those risks as you read this Annual Report. We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise.

 

 

 

1


PART I.

Throughout this Annual Report, the terms “we,” “us,” “our,” “our company,” “Company” and “the Registrant” refer to ImmunoCellular Therapeutics, Ltd., a Delaware corporation, formerly known as Optical Molecular Imaging, Inc.

 

Item 1.

Business.

ImmunoCellular Therapeutics, Ltd. is a clinical-stage biotechnology company that is developing immune-based therapies for the treatment of cancers, such as brain and ovarian. Immunotherapy is an emerging approach to treating cancer in which a patient’s own immune system is stimulated to target tumor antigens, which are molecular signals that the immune system uses to identify foreign bodies. While some other cancer immunotherapies only target a single cancer antigen, our technology can elicit an immune response against several antigens. Our cancer immunotherapies are also distinguished by the fact that they target cancer stem cells (CSCs), which are the primary drivers of tumor growth and disease recurrence. Our most advanced product candidate, ICT-107, completed Phase II testing in December 2013, and we have a portfolio of other potential therapeutic immunotherapies using our proprietary approach to treating cancer.

ICT-107, our lead product candidate, is a dendritic cell (DC) vaccine for the treatment of newly diagnosed glioblastoma multiforme (GBM), the most common and lethal type of brain cancer. ICT-107 is designed to activate a patient’s immune system to target six different tumor-associated antigens. The recently completed Phase II testing of ICT-107 involved a clinical trial designed as a double-blind, placebo-controlled (2:1 randomized), multicenter evaluation of the safety and efficacy of ICT-107 in patients with newly diagnosed GBM. From January 2011 until September 2012, the trial enrolled 278 patients at 25 centers throughout the U.S. and 124 patients were randomized to ICT-107 or placebo. In December 2013, we reported that ICT-107 treated patients had a numerical advantage for median survival of two months more than placebo patients in the Intent to Treat (ITT) population but that the difference in survival between ICT-107 and placebo treated patients (the primary efficacy endpoint of the trial), did not reach statistical significance (p-value = 0.58; Hazard Ratio = 0.87). For Progression-Free Survival (PFS), an important secondary efficacy endpoint, we reported ICT-107 treated patients had a two-month advantage in median PFS compared with placebo patients in the ITT population.  This difference in PFS between ICT-107 and placebo treated patients reached statistical significance (p-value = 0.014; Hazard Ratio = 0.56).   ICT-107 was generally safe and well tolerated, with no imbalance in adverse events between the treated and placebo groups.  

The ICT-107 Phase II trial ended once 64 of the 124 randomized patients had died.  Once this event level was reached, the process of verifying the patient data at each trial site, addressing missing or incorrect data, and conducting the predefined statistical analysis took place.  In the course of this process, three more patients died and their survival data were included in the results announced in December 2013, bringing the event count to 67 deaths.  Because patients in the Phase II trial continue to be monitored for survival and other parameters, the Company periodically will be able to rerun important endpoint analyses including the comparison of overall survival for ICT-107 and placebo treated patients.  In addition, the Company will be able to monitor long-term survival which is thought to be a feature of cancer immunotherapies and has been periodically reported on by trial investigators for the 16 newly diagnosed GBM patients treated in the Phase I clinical trial that concluded in 2010.  Management currently plans to request an end of Phase II meeting with FDA in the second quarter of 2014 to discuss the design, conduct and results of the ICT-107 Phase II trial.  In addition, we plan to discuss next clinical steps for ICT-107, including potentially a Phase III trial.  Based on the timing of this meeting request, the FDA meeting could occur in the second or third quarters of 2014.  

In addition to ICT-107, the Company is also developing other therapeutic DC vaccines: ICT-140 for ovarian cancer and ICT-121 for recurrent GBM. ICT-140 targets seven tumor-associated antigens expressed on ovarian cancer cells. Some of the antigens utilized in ICT-140 were also used in ICT-107. We filed an investigational new drug (IND) application for ICT-140 at the end of 2012 and the IND was allowed by the FDA in January 2013. We subsequently modified the design of the trial and amended the IND to reflect this new Phase II design proposal in May 2013. This amendment was allowed by FDA later that month.  Prior to starting this Phase II trial, we are upgrading our generalized DC vaccine manufacturing process in an effort to bring it to the level of Phase III/commercial ready.  We plan to use this improved process once developed to manufacture clinical supplies for the ICT-140 trial.  We expect to begin enrolling patients for this trial in the third quarter of 2014. ICT-121 specifically targets CD133, a CSC marker that is overexpressed in a wide variety of solid tumors, including ovarian, pancreatic, and breast cancers. We began screening patients in September 2013 for a Phase I trial in recurrent GBM.  We enrolled and treated the first patient in December 2013.

Compared to other cell-based immunotherapies, such as sipuleucel-T (Provenge) from Dendreon, our DC vaccines can be manufactured at a lower expense. This is primarily due to the fact that we can make multiple doses of a patient’s vaccine from a single manufacturing run.  In addition, the vaccine is stored in liquid nitrogen making the logistics of shipping and administration to the patient easier than sipuleucel-T, which must be shipped fresh and administered to the patient within 18 hours of manufacture.  

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While the Company has a promising technology portfolio of multiple clinical-stage candidates, we do not currently anticipate that the Company will generate any revenues from either product sales or licensing in the foreseeable future. The Company has financed the majority of its prior operations through the sales of securities, including underwritten public offerings completed in January 2012 and October 2012 that generated $9.3 million and $19.3 million of net proceeds, respectively. During 2012, the Company also received approximately $3.2 million from the exercise of warrants.  During 2013, the Company received approximately $5.0 million from the additional exercise of warrants and approximately $4.9 million, net of offering expenses of $338,000, from the sales of our common stock pursuant to our Controlled Equity Offering ℠ Sales Agreement with Cantor Fitzgerald & Co.

The estimated cost of completing the development of any of the current or potential immunotherapy candidates will require the Company to raise additional capital or enter into collaboration agreements with third parties. There can be no assurances that the Company will be able to obtain any additional funding, or if such funding is available, that the terms will be favorable. In addition, collaborations with third parties may not be available to us and may require us to surrender rights to many of our products, which may reduce the potential share of returns in any licensed products. If we are unable to raise sufficient capital or secure collaborations with third parties, we will not be able to further develop our product candidates.

Company Information

We filed our original Certificate of Incorporation with the Secretary of State of Delaware on March 20, 1987 under the name Redwing Capital Corp. On June 16, 1989, we changed our name to Patco Industries, Ltd. and conducted an unrelated business under that n ame until 1994. On January 30, 2006, we amended our Certificate of Incorporation to change our name to Optical Molecular Imaging, Inc. in connection with our merger on January 31, 2006 with Spectral Molecular Imaging, Inc. The acquisition was accounted for as a reverse merger, with Spectral Molecular Imaging deemed to be the accounting acquirer and Optical Molecular Imaging deemed to be the legal acquirer.  As such, the financial statements herein reflect the historical activity of Spectral Molecular Imaging since its inception on February 25, 2004.  On November 2, 2006, we amended our Certificate of Incorporation to change our name to ImmunoCellular Therapeutics, Ltd. to reflect the disposition of our Spectral Molecular Imaging subsidiary and the acquisition of our cellular-based technology from Cedars-Sinai.

Our principal executive offices are located at 23622 Calabasas Road, Suite 300, Calabasas, California 91302 , and our telephone number at that address is (818) 264-2300.

Technology and Potential Products

The table below summarizes the status of our ICT-107, ICT-121, and ICT-140 product candidates and other technologies:

 

PRODUCT CANDIDATE

  

TARGET INDICATION

  

STATUS

Active Immunotherapies

  

 

  

 

 

 

 

 

 

ICT-107

(DC-based vaccine targeting CSCs and cancer antigens)  

  

Newly diagnosed GBM

  

Phase II completed

 

 

 

 

 

ICT-121

(DC-based vaccine targeting CD133+ CSCs)  

  

Recurrent GBM and other solid tumor cancers

  

Phase I enrolling patients

 

 

 

 

 

ICT-140

(DC-based vaccine targeting CSCs and cancer antigens)

  

Recurrent ovarian cancer

  

Phase II pending

Cancer is caused by abnormal cells that grow in an uncontrolled manner. These cells proliferate and can metastasize throughout the body causing tumors that can result in organ failure and death. Unfortunately, conventional cancer treatments, such as surgery, radiation, and chemotherapy, have limited therapeutic benefit and significant undesirable side effects. Our approach is to develop cancer therapies that activate the body’s immune system response to fight cancer. The U.S. Food and Drug Administration (FDA)-approved cancer immunotherapies, such as sipuleucel-T and ipilimumab, have been shown to improve patient survival where conventional therapies failed.

We believe our approach of targeting multiple tumor-associated antigens, as well as CSC antigen s, is critical for developing clinically effective treatments. Cancer is a complex disease often characterized by several cellular abnormalities. Targeting multiple cancer antigens not only increases the likelihood of an effective treatment, but can also prevent tumor escape mechanisms that are sometimes observed with single-antigen targeted therapies.

Solid tumors commonly consist of different types of cancer cells. CSCs are a subset of cancerous cells, typically representing less than 5% of all cells in a tumor. They are believed to be responsible for growth and recurrence of primary and metastatic tumors. Like normal stem cells, CSCs have the ability to self-renew and make differentiated daughter cells. But, unlike normal stem cells, CSCs no longer have the ability to regulate their own growth. Scientists have shown that CSCs are resistant to radiat ion and

3


chemotherapy. Thus, conventional therapies can eliminate most of the bulk tumor, but since the CSCs are not destroyed, the tumor can regrow after treatment. Complete eradication of the entire tumor mass requires elimination of the CSCs.

Active Immunotherapy

DCs are cells responsible for antigen processing and presentation to the immune system and play a central role in the body’s immune response. They act as first responders that initiate a T cell response to fight infections or foreign bodies. DCs do this by recognizing, processing and presenting foreign antigens to the T cells. Thus, they are powerful potentiators of acquired immunity through an effective presentation of the cancer antigens to T cells, which subsequently mediate the killing of ca ncer cells. The goal of DC-based vaccines is to (i) make use of and enhance the DC’s ability to trigger a T cell response and (ii) stimulate DCs to focus the T cell response to specifically target and destroy cancer cells.

DCs normally do not target malignant tumors, since they do not recognize the tumor as a foreign body that needs to be eliminated. Also, they are typically not present in sufficient numbers to permit an adequately potent immune response to fight cancer. DC therapy typically involves harve sting peripheral blood mononuclear cells (PBMCs) from a patient, culturing them and processing them in a laboratory to produce a sufficient number of highly potent DCs. The DCs are then cultured with tumor-associated antigens and injected back into the patient, where they can signal T cells to seek out and destroy cancer cells that express the tumor-associated antigens.

Sipuleucel-T was the first cell-based cancer immunotherapy to be approved by the FDA. The prostate cancer vaccine utilizes the patient’s antigen presenting cells (APCs) to target a single tumor antigen known as prostatic acid phosphatase. A randomized Phase III trial showed that sipuleucel-T was safe and extended the median overall survival of metastatic castrate-resistant prostate cancer pa tients by four months.

Manufacturing and logistical costs associated with sipuleucel-T have limited the drug’s commercial viability. Manufacturing is relatively inefficient as only about 25% of the final product actually consists of APCs. The APCs cannot be stored and must be administered within 18 hours. Also, patients must undergo three apheresis procedures every two weeks to harvest enough cells to manufacture three doses of sipuleucel-T. According to Dendreon, the margins associated with sipuleucel-T a re less than 50%, although that may improve as manufacturing becomes more efficient over time.

In contrast, our DC technology overcomes many of sipuleucel-T’s shortcomings. As much as 90% of our final manufacturing product is DCs, which can stimulate a much stronger immune response than APCs. We have optimized manufacturing to produce an average of 20 doses per patient, so patients only need to undergo a single apheresis procedure. The DCs can be stored, eliminating the need to ship the product back to patients within 18 hours. Also, DCs can be administered more conveniently by intradermal injection versus intravenous infusion for sipuleucel-T. As a result of technological improvements, the margins for our DC vaccines are expected to be better than those of sipuleucel-T.

Product Candidates

ICT-107

The American Cancer Society (ACS) estimated that about 23,130 malignant tumors of the brain and spinal cord would be diagnosed in the US in 2013. GBM is the most prevalent and aggressive form of brain cancer. Over 10,000 new patients are diagnosed with GBM in the US each year. Despite advances in surgery, radiation, and chemotherapy, recurrence is almost a certainty, occurring on average within 6.9 months. The median survival time for newly diagnosed GBM patients is only 14.6 months, and fewer than 10% of these patients live more than five years.

ICT-107 is a DC vaccine that targets six different tumor-associated antigens that are found on patients’ tumor cells; at least four of the six antigens are highly expressed on CSCs. The therapeutic vaccine is used subsequent to conventional therapy or concomitantly with chemotherapy in patients with newly diagnosed GBM. Results from a Phase I clinical trial at Cedars-Sinai Medical Center in Los Angeles showed that ICT-107 was well tolerated, with no significant adverse events reported. Of the 16 newly diagnosed patients treated with ICT-107, seven continue to survive beyond five years. Six of the 16 patients were disease free over five years.  One of these six patients later died from leukemia without recurrence of GBM, one progressed at 62 months, and four patients are still free of disease. The median PFS in the 16 newly diagnosed patients enrolled in the trial was 16.9 months, and median OS was 38.4 months—a two-year improvement compared to historical standard of care.

In January 2011, we commenced a randomized, placebo-controlled, double-blind, multicenter Phase II trial of ICT-107 in newly diagnosed GBM patients. From January 2011 until September 2012, the trial enrolled 278 patients at 25 centers throughout the U.S. and 124 patients were randomized to ICT-107 or placebo. In December 2013, we reported that ICT-107 treated patients had a numerical advantage for median survival of two months more than placebo patients in the Intent to Treat (ITT) population but that the difference in survival between ICT-107 and placebo treated patients (i.e. the primary efficacy endpoint of the trial) did not reach statistical significance

4


(p-value = 0.58; Hazard Ratio = 0.87). For Progression-Free Survival (PFS), an important secondary efficacy endpoint, we reported ICT-107 treated patients had a two-month advantage in median PFS compared with placebo patients in the ITT population.  This difference in PFS between ICT-107 and placebo treated patients reached statistical significance (p-value = 0.014; Hazard Ratio = 0.56).   ICT-107 was generally safe and well tolerated, with no imbalance in adverse events between the treated and placebo groups.  

In June 2010, ICT-107 was granted Orphan Drug status by the FDA, making the product candidate eligible, under certain circumstances, for marketing exclusivity and other potential benefits.

In September 2010, we entered into a Master Services Agreement (MSA) with Aptiv Solutions (formerly Averion International Corp.), a clinical research organization. Under the MSA, Aptiv Solutions provides us with clinical trial support services in connection w ith and over the course of our Phase II clinical trial for ICT-107, including overseeing enrollment of patients and execution. The MSA, which may be terminated by us at any time, provides for a limit of approximately $5.0 million on the fees that we will be obligated to pay if all of the planned services are actually provided.

In January 2011, we entered into a sponsored research and vaccine production agreement with the University of Pennsylvania, which had helped us to optimize the formulation of ICT-107 that we used in the Phase II trial. The University of Pennsylvania assisted us in the Good Manufacturing Practice (GMP) production of ICT-107 for the Phase II trial. In October 2011, we entered into an agreement with Progenitor Cell Therapy, LLC to serve as a second manufacturer of ICT-107 for the Phase II trial.  We are continuing our optimization efforts with third parties in order to develop a validated commercial scale manufacturing process as we plan for potential Phase III clinical studies.

In February 2014, ICT-107 was granted Orphan Drug status by the European Medicines Agency, providing us with incentives, including a 10-year period of market exclusivity, access to a centralized review process, trial design assistance and scientific advice during p roduct development, fee reductions, and tax incentives.

ICT-140

The ACS estimates that in the U.S., about 21,980 women will receive a new diagnosis of ovarian cancer and about 14,270 will die from ovarian cancer in 2014. The National Cancer Institute reports that ovarian cancer is the ninth leading cause of cancer death in the United States and the lifetime risk is approximately 1.4%. By contrast according to the most recent estimates 39% of women who inherit a harmful BRCA1 mutation and 11% to 17% of women who inherit a harmful BRCA2 mutation will develop ovarian cancer by age 70 years.

Ovarian cancer usually spreads via local shedding into the peritoneal cavity followed by implantation on the peritoneum and via local invasion of bowel and bladder. The incidence of positive nodes at primary surgery has been reported to be as much as 24% in patients with stage I disease, 50% in patients with stage II disease, 74% in patients with stage III disease and 73% in patients with stage IV disease. The five-year s urvival rate for all stages of ovarian cancer is approximately 44%. For cases where a diagnosis is made early in the disease, when the cancer is still confined to the primary site, the five-year survival rate is 92%. However, only 15% of all ovarian cancers are found at this early stage.

Many ovarian cancers are spontaneously invaded by T cells, and patients whose tumors have tumor-infiltrating T cells survive longer. Therefore, cancer immunotherapies may improve the survival rate of patients with ovarian cancer.

ICT-140 is a DC vaccine that targets seven different ovarian cancer antigens. Some of the antigens included in ICT-140 are the same as in ICT-107. We filed an investigational new drug ( IND) application for ICT-140 at the end of 2012 and the IND was allowed by the FDA in January 2013. We subsequently modified the design of the trial and amended the IND to reflect this new Phase II design proposal in May 2013. This amendment was allowed by the FDA later that month.  Prior to starting this Phase II trial, we are upgrading our generalized DC vaccine manufacturing process to bring it to the level of Phase III/commercial ready.  We will use this improved process once developed to manufacture clinical supplies for the ICT-140 trial.  We expect to begin screening patients for this trial during the second half of 2014.

ICT-121

Dr. John Yu and his research team have discovered antigen peptides that can elicit a T cell immune response against CD133, a marker that is commonly present on CSCs. CD133-positive CSCs have been identified in a number of different cancers, including gliomas, colon cancer and pancreatic cancer.

ICT-121 specifically targets CD133, a CSC marker that is overexpressed in a wide variety of solid tumors, including ovarian, pancreatic, and breast cancers. We began screening patients in September 2013 for a Phase I trial in recurrent GBM.  We enrolled and treated the first patient in this study in December 2013.

5


Other Technologies

We have other technologies that we are currently not developing.  These include several monoclonal antibodies that have shown in vitro activities in small cell lung cancer and the DIAAD (differential immunization for antigen and antibody discovery) platform for discovering monoclonal antibodies for therapeutic and diagnostic development.  The Company has entered into negotiations with a third party to license this technology.

Intellectual Property Agreements

Cedars-Sinai Agreements

In November 2006, we entered into a license agreement with Cedars-Sinai under which we acquired an exclusive, worldwide license to technology for use as cellular therapies, including DC-based vaccines for neurological disorders, which include brain tumors, neurodegenerative diso rders and other cancers. This technology is covered by a number of pending U.S. and foreign patent applications, and the term of the license will be until the last to expire of any patents that are issued covering this technology. We issued Cedars-Sinai 694,000 shares of our common stock and paid Cedars-Sinai $62,000 upon entry into the agreement. We will be required to pay to Cedars-Sinai additional specified milestone payments when we initiate patient enrollment in our first Phase III clinical trial for our first product and when we receive FDA marketing approval for our first product. If both of these milestones are met, the required milestone payments will total $1,250,000.

In June 2008, through an amendment to our original license agreement with Cedars-Sinai, we licensed an additional CSC vaccine technology in consideration for 100,000 shares of our common stock.

We have agreed to pay Cedars-Sinai a mid-single digit percentage of our gross revenues from sales of products and of all of our sublicensing income based on the licensed technology. To maintain our rights to the licensed technology, we must meet certain development and funding milestones.

In September 2010, we entered into a sponsored research agreement with Cedars-Sinai under which Cedars-Sinai provided services to us in developing the ICT-121 vaccine at a total cost of $446,142.  In September 2011, we entered into Amendment No. 1 extending the agreement to September 2012 at an incremental cost of $294,504.  In September 2012, we entered into Amendment No. 2 extending the agreement to September 2013 at an incremental cost of $329,832.  This agreement concluded in September 2013 and was extended through March 2014 at a projected incremental cost of $210,856.

Molecular Discoveries Agreement

In February 2008, we entered into an agreement with Molecular Discoveries to acquire certain mAb-related technology owned by Molecular Discoveries. In connection with this acquisition, we retained Dr. Cohava Gelber, a key inventor of the Molecular Discoveries technology, as a consultant to assist us in further developing the acquired technology. The consulting agreement with Dr. Gelber expired in August 2009.

Our acquisition under the Molecular Discoveries agreement consisted of (i) the DIAAD platform technology for the potentially rapid discovery of mAbs to detect and treat cancer and other chronic diseases and (ii) certain mAb candidates for the potential detection and treatment of multiple myeloma, small-cell lung, pancreatic and ovarian cancers. The conside ration that we paid for the acquired technology consisted of (i) the issuance of 800,000 shares of our common stock to Molecular Discoveries and (ii) our reimbursement to Molecular Discoveries or its managing member of $250,000 of previously incurred patent expenses.

University of Pennsylvania Licensing Agreement

In February 2012, we entered into a license agreement with the University of Pennsylvania, pursuant to which we acquired an exclusive, worldwide license relating to technology for the production, use and cryopreservation of high-activity DC cancer vaccines. The license covers the application of this technology to the development of therapeutics for all indications except breast cancer and ductal carcinoma in situ, and the term of the license will be until the later of the expiration or abandonment of the last patent included within the license and 10 years after the first sale of a product using the licensed technology. Pursuant to this license agreement, we paid an upfront licensing fee and will be obligated to pay annual license maintenance fees. In addition, for products covered by the license, we have agreed to make payments upon completion of specified milestones and to pay royalties of a specified percentage on net sales, subject to a specified minimum royalty, and sublicensing fees.

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The Johns Hopkins University Licensing Agreement

In February 2012, we entered into a license agreement with The Johns Hopkins University (JHU), pursuant to which we received an exclusive, worldwide license to JHU’s rights in and to certain technology related to mesothelin-specific cancer immunotherapies. The license covers the application of this technology for all mesothelin peptide-based vaccines for cancer treatment and prevention, except bacteria-based, viral vector-based and nucleic acid-based vaccines. Unless earlier terminated, the term of the license extends in each country until the later of the expiration of the last patent related to the licensed technology in that country or ten years after the effective date of the license agreement. In order to maintain our license rights under the license agreement, we are required to meet certain diligence milestones and timelines.

Pursuant to the license agreement, we paid an upfront licensing fee, in cash and shares of common stock. We are obligated to pay milestone license fees upon completion of specified milestones, customary royalties based on a specified percentage of net sales and sublicensing payments as well as annual minimum royalties. We will also be responsible for reimbursing JHU for reasonable costs associated with the preparation, filing, maintenance and prosecution of the technology subject to the license. In September 2013, we entered into Amendment No. 1 to the license agreement that updated certain milestones.

Competition

The biopharmaceutical industry is characterized by intense competition and significant technological advancements. Many companies, research institutions, and universities are conducting research and development in a number of areas similar to those that we focus on. The development of new products could compete with and be superior to our product candidates.

Many of the companies with which we compete have substantially greater financial, technical, manufacturing, marketing, distribution and other resources. A number of these companies may have or may develop technologies for products that could be superior to ours. We expect technological developm ents in the biopharmaceutical and related fields to occur at a rapid rate, and believe competition will intensify as these fields advance. Accordingly, we will be required to devote substantial resources and efforts to research and development activities in order to potentially achieve and maintain a competitive position. Products that we develop may become obsolete before we are able to market them or to recover all or any portion of our research and development expenses. We may be competing with companies that have significantly more experience in undertaking preclinical testing and human clinical trials with new or improved therapeutic products and obtaining regulatory approvals of such products. A number of these companies already market and may be in advanced phases of clinical testing of various drugs that may compete with our product candidates or any future product candidates. Competitors may develop or commercialize products more rapidly than we do, or that have significant advantages over products we develop. Therefore, our competitors may be more successful in commercializing their products, which could adversely affect our competitive position and business.

With the approvals of sipuleucel-T and ipilimumab, several major biopharmaceutical companies, including Roche/Genentech, Amgen, Merck, Novartis, GlaxoSmithKline and Bristol-Myers Squibb, in addition to smaller biotechnology companies, such as Dendreon, Oncothyreon, Galena, Bavarian Nordic and Immunovaccine, are developing cancer immunotherapies. A number of immunotherapy companies, including Northwest Biotherapeutics, Prima Biomed and DCPrime, also utilize DCs for their therapeutic cancer vaccines.

Several companies are developing immunotherapies to treat newly diagnosed GBM. For example, Celldex is conducting a Phase III clinical trial for its EGFRvIII-targeted cancer vaccine, rindopepimut. Northwest Biotherapeutics is also conducting a Phase III study with DCVax, a DC-based tumor lysate vaccine. Agenus has completed enrollment of a Phase II cli nical trial with its heat shock protein and tumor-derived peptide vaccine (HSPPC-96).

In addition to the previously mentioned companies developing cancer immunotherapies, there are also several pharmaceutical companies, including OncoMed, Verastem, Boston Biomedical (acquired by Dainippon) and Infinity Pharmaceuticals, that are pursuing drugs that target CSCs. Stemline Therapeutics is currently developing a peptide treatment, SL-701, for brain cancer.

Colleges, universities, governmental agencies and other public and private research organizations are becoming more active in seeking patent protection and licensing arrangements to collect royalties for use of technologies that they have developed, some of which may directly compete with our product candidat es or any future product candidates. Governments of a number of foreign countries are aggressively investing in cellular therapy research and promoting such research by public and private institutions within those countries. Domestic and foreign institutions and governmental agencies, along with pharmaceutical and specialized biotechnology companies, can be expected to compete with us in recruiting qualified scientific personnel.

Our competitive position will be significantly impacted by the following factors, among others:

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our ability to obtain FDA marketing approval for our product candidates on a timely basis;

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the level of acceptance of our products by physicians, compared to those of competing products or therapies;

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our ability to have our products manufactured on a commercial scale;

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the effectiveness of sales and marketing efforts on behalf of our products;

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our ability to meet demand for our products;

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our ability to secure insurance reimbursement for our products candidates;

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the price of our products relative to competing products or therapies;

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our ability to recruit and retain appropriate management and scientific personnel; and

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our ability to develop a commercial-scale research and development, manufacturing and marketing infrastructure, either on our own or with one or more future strategic partners.

Intellectual Property

The Company owns or has rights to patents and patent ap plications that include claims that cover or could cover the manufacturing, use, and antigen composition of our DC vaccines.  The U.S. Patent and Trademark Office (USPTO) has recently issued two patents covering ICT-107 and certain other aspects of our cancer vaccine technology having expiration dates between about 2024 and 2028. Our dendritic cell-based vaccine and cancer stem cell vaccine product candidates are also currently covered by five patent applications that have been filed in the United States and by patent applications that have been filed in certain foreign countries.

In addition, we have acquired exclusive worldwide ownership rights to eight granted U.S. and ten other patents for various European and Asian territories as well as several U.S. and foreign patent applications through our acquisition of the monoclonal antibody related technology from Molecular Discoveries. The issued patents relate to monoclonal antibodies targeting various cancers, including human myeloma, ovarian cancer and small cell lung cancer and have expiration dates ranging from 2019 to 2023. A third party has exercised an option to license this technology and negotiations are ongoing.

The USPTO issued patents covering ICT-107 and certain other aspects of our cancer vaccine technology which we first licensed from Cedars-Sinai in 2006. The USPTO also issued two patents covering our cancer stem cell vaccine product candidate, ICT-121. The corresponding international applications are still pending and there can be no assurance that any patent will issue in any foreign jurisdiction.  Moreover, the patents licensed from Cedars-Sinai and any patent that may issue to us in the future may be challenged, invalidated or circumvented by others.

Dr. John Yu, a co-inventor of our cellular-based therapy technology who serves as our Chairman of the Board and Chief Scientific Officer, is employed by Cedars-Sinai, which may assert that future intellectual property generated by Dr. Yu belongs to that institution rather than to us, and we may b e required to seek a license from Cedars-Sinai for any such rights.

Employees

We have three full-time employees and three part-time employees. In addition, we have a number of consulting agreements for clinical development, regulatory affairs, investor relations and business development. We outsource all of our drug discovery research, process development, manufacturing and clinical development to third parties with expertise in those areas as we believe it to be a more capital efficient solution.

Government Regulation

The United States and other developed countries extensively regulate the preclinical and clinical testing, manufacturing, labeling, storage, record-keeping, advertising, promotion, export, marketing and distribution of drugs and biologic products. The United States Food and Drug Administration, under the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act and other federal statutes and regulations, regulates pharmaceutical and biologic products.

To obtain approval of our product candidates from the FDA, we must, among other requirements, submit data supporting safety and efficacy for the intended indication as well as detailed information on the manufacture and composition of the product candidate. In most cases, this will r equire extensive laboratory tests and preclinical and clinical trials. The collection of these data, as well as the preparation of applications for review by the FDA involve significant time and expense. The FDA also may require post-marketing testing to monitor the safety and efficacy of approved products or place conditions on any approvals that could restrict the therapeutic claims and commercial applications of these products. Regulatory authorities may withdraw product approvals if we fail to comply with regulatory standards or if we encounter problems at any time following initial marketing of our products.

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The first stage of the FDA approval process for a new biologic or drug involves completion of preclinical studies and the submission of the results of these studies to the FDA. This data, together with proposed clinical protocols, manufacturing information, analytical data and other information submitted to the FDA, in an investigational new drug application (IND), must become effective before human clinical trials may commence. Preclinical studies generally involve FDA regulated laboratory evaluation of product characteristics and animal studies to assess the efficacy and safety of the product candidate.

After the IND becomes effective, a company may commence human clinical trials. These are typically conducted in three sequential phases, but the phases may overlap. Phase I trials consist of testing of the product candidate in a small number of patients or healthy volunteers, primarily for safety at one or more doses. Phase I trials in cancer are often conducted with patients who are not healthy and who have end-stage or metastatic cancer. Phase II trials, in addition to safety, evaluate the efficacy of the product candidate in a patient population somewhat larger than Phase I trials. Phase III trials typically involve additional testing for safety and clinical efficacy in an expanded population at multiple test sites. A company must submit to the FDA a clinical protocol, accompanied by the approval of the Institutional Review Boards at the institutions participating in the trials, prior to commencement of each clinical trial.

To obtain FDA marketing authorization, a company must submit to the FDA the results of the preclinical and clinical testing, together with, among other things, detailed information on the manufacture and composition of the product candidate, in the form of a new drug application (NDA) or, in the case of a biologic, like dendritic cell-based vaccines for neurological disorders, a biologics license application (BLA).

The amount of time taken by the FDA for approval of an NDA or BLA will depend upon a number of factors, including whether the product candidate has received priority review, the quality of the submission and studies presented, the potential contribution that the compound will make in improving the treatment of the disease in question, and the workload at the FDA. The FDA has committed to reviewing standard BLAs in 10 months and priority BLAs in six months, but the actual time it takes to review any BLA that we may file could be substantially longer.

The FDA may, during its review of an NDA or BLA, ask for additional test data that may require the conduct of additional clinical trials. If the FDA does ultimately approve the product candidate for marketing, it may require post-marketing testing to monitor the safety and effectiveness of the product. The FDA also may in some circumstances impose restrictions on the use of the product, which may be difficult and expensive to administer and may require prior appr oval of promotional materials.

The FDA may, in some cases, confer upon an investigational product the status of a fast track product. A fast track product is defined as a new drug or biologic intended for the treatment of a serious or life-threatening condition that demonstrates the potential to address unmet medical needs for this condition. The FDA can base approval of an NDA or BLA for a fast track product on an effect on a surrogate endpoint, or on another endpoint that is reasonably likely to predict clinical benefit. If a preliminary review of clinical data suggests that a fast track product may be effective, the FDA may initiate review of entire sections of a marketing application for a fast track product before the sponsor completes the application.

We will also be subject to a variety of regulations governing clinical trials and sales of our products outside the United States. Whether or not FDA approval has been obtained, approval of a product candidate by the comparable regulatory authorities of foreign countries and regions must be obtained prior to the commencement of marketing the product in those countries. The approval process varies from one regulatory authority to another and the time may be longer or shorter than that required for FDA appr oval. In the European Union, Canada and Australia, regulatory requirements and approval processes are similar, in principle, to those in the United States.

Before approving a BLA, the FDA will inspect the facilities at which the product is manufactured and will not approve the product unless the manufacturing facilities are in compliance with the FDA’s cGMP, which are regulations that govern the manufacture, holding and distribution of a product. Manufacturers of biologics also must comply with the FDA’s g eneral biological product standards. Following approval, the FDA periodically inspects drug and biologic manufacturing facilities to ensure continued compliance with the good manufacturing practices regulations. We must ensure that any third-party manufacturers continue to comply with those requirements. Failure to comply with these requirements subjects the manufacturer to possible legal or regulatory action, such as suspension of manufacturing or recall or seizure of product. Adverse patient experiences with the product must be reported to the FDA and could result in the imposition of marketing restrictions through labeling changes or market removal. Product approvals may be withdrawn if compliance with regulatory requirements is not maintained or if problems concerning safety or efficacy of the product occur following approval.

The labeling, advertising, promotion, marketing and distribution of a drug or biologic product also must be in compliance with FDA and Federal Trade Commission, requirements, which include, among others, standards and regulations for off-label promotion, industry sponsored scientific and educational activities, promotional activities involving the internet, and direct-to-consumer advertising. We also will be subject to a variety of federal, state and local regulations relating to the use, handling, storage and disposal of hazardous materials, including chemicals and radioactive and biological materials. In addition, we will be subject to

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various laws and regulations governing laboratory practices and the experimental use of animals. In each of these areas, as above, the FDA has broad regulatory and enforcement powers, including the ability to levy fines and civil penalties, suspend or delay issuance of product approvals, seize or recall products, and deny or withdraw approvals.

We also will be subject to federal regulation by the Occupational Safety and Health Administration and the Environmental Protection Agency and to regulation under the Toxic Substances Control Act, the Resource Conservation and Recovery Act and other federal and state regulatory statutes, and may in the future be subject to other federal, state or local regulations.

Available Information

We file electronically with the SEC our annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K pursuant to Section 13 or 15(d) of the Exchange Act. The public may read or copy any materials we file with the SEC at the SEC’s Public Reference Room at 100 F Street, NE, Washington, DC 20549. The public may obtain information on the operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330. The SEC maintains an Internet site that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC. The address of that site is www.sec.gov.

You may obtain a free copy of our annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K and amendments to those reports on the day of filing with the SEC, on our website at www.imuc.com or by contacting the Investor Relations Department at our corporate offices at (818)  264-2300. The information found on our website is not part of this or any other report filed with or furnished to the SEC.

 

Item 1A.

Risk Factors.

In evaluating our business, you should carefully consider the following risks in addition to the other information in this report. Any of the following risks could materially and adversely affect our business, results of operations, financial condition or your investment in our securities, and many are beyond our control. The risks and uncertainties described below are not the only ones facing us. Additional risks and uncertainties not presently known to us, or that we currently see as immaterial, may also adversely affect our business.

Risks Related To Our Business

We are a development-stage company subject to all of the risks and uncertainties of a biotechnology business, including the risk that we may never successfully develop any products or generate revenues.

We are a development-stage company that has only recently commenced any significant research and development activity. We may be unable to satisfactorily develop or market any of our current or proposed product candidates, those product candidates may not generate any revenues, and any revenues generated may not be sufficient for us to become profitable or thereafter maintain profitability. We have not generated any recurring revenues to date, and we do not expect to generate any such revenues for a number of years.

Our cell-based vaccine technologies are our primary platform technologies, and our commercial prospects will be heavily dependent on the outcome of any future clinical trials for our lead vaccine product candidate, ICT-107. We have only three full-time employees and three part-time employees, have limited resources and may not possess the ability to successfully overcome many of the risks and uncertainties frequently encountered by early stage companies involved in the new and rapidly evolving field of biotechnology in general and cancer immunotherapies and monoclonal antibodies in particular. You must consider that we may not be able to:

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obtain additional financial resources necessary to develop, test, manufacture and market our vaccine product candidates or any future product candidates;

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engage corporate partners to assist in developing, testing, manufacturing and marketing our vaccine product candidates or any future product candidates;

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satisfy the requirements of acceptable pre-clinical and clinical trial protocols, including timely patient enrollment;

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establish and demonstrate or satisfactorily complete the research to demonstrate at various stages the pre-clinical and clinical efficacy and safety of our vaccine product candidates or any future product candidates;

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apply for and obtain the necessary regulatory approvals from the FDA and the appropriate foreign regulatory agencies;

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market our vaccine product candidates or any future product candidates to achieve acceptance and use by the medical community and patients in general and produce revenues; and

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·

attract and retain, on acceptable terms, qualified technical, commercial and administrative staff for the continued development and growth of our business.

Our current product candidates and any future product candidates will be based on novel technologies and the development, manufacture and regulatory approval for such products are inherently risky.

We are subject to the risks of failure inherent in the development of products based on new technologies. The novel nature of our therapies creates significant challenges in regards to product development and optimization, manufacturing, government regulation, third-party reimbursement and market acceptance. For example, the FDA may have limite d experience with cancer stem cell or dendritic cell-based therapeutics and, with the exception of one dendritic cell-based vaccine for the treatment of prostate cancer, has not yet approved any of these therapeutics for marketing, and the pathway to regulatory approval for our vaccine product candidates or any future vaccine product candidates may accordingly be more uncertain, complex and lengthy than the pathway for new conventional drugs. The targeting of cancer stem cells as a potential therapy is a recent development that may not become broadly accepted by scientists, pharmaceutical companies or the FDA. In addition, the manufacture of biological products, including cancer stem cell or dendritic cell-based vaccines, could be more complex and difficult, and therefore, these potential challenges may prevent us from developing and commercializing products on a timely or profitable basis or at all.

We may elect to delay or discontinue preclinical studies or clinical trials based on unfavorable results. Any product candidate using a cellular therapeutic technology may fail to:

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survive and persist in the desired location;

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provide the intended therapeutic benefits;

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properly integrate into existing tissue in the desired manner; or

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achieve therapeutic benefits equal to or better than the standard of treatment at the time of testing.

In addition, our product candidates may cause undesirable side effects. Results of preclinical research with our vaccine product candidates or any other or future product candidates or clinical results with formulations used in earlier trials that are similar but not identical to our product candidate formulations may not be indicative of the results that will be obtained in later stages of preclinical or clinical research on our product candidates. In particular, the results generated in our recently completed Phase II trial of ICT-107 may not be indicative of the results that we might obtain in further testing of ICT-107, including potential Phase III testing.

If regulatory authorities do not approve our products or if we fail to maintain regulatory compliance, we would be unable to commercialize our products, and our business and results of operations would be harmed. Furthermore, because cancer stem cell and dendritic cell-based products represent new forms of therapy, the marketplace may not accept any products we may develop that utilize these technologies. If we do succeed in developing products, we will face many potential obstacles, such as the need to obtain regulatory approvals and to develop or obtain manufacturing, marketing and distribution capabilities. In addition, we will face substantial additional risks, such as product liability claims.

Because of the early stage of development of our vaccine product candidates, we do not know if we will be able to generate data that will support the filing of a biologics license application for these product candidates or the FDA’s approval thereof. If we experience substantial delays, we may not have the financial resources to continue development of these product candidates or the development of any of our other or future product candidates. Delays in clinical trials could reduce the commercial viabilit y of our vaccine product candidates and any other or future product candidates. Delays in patient enrollment may be caused by a number of factors, including patient reluctance to participate in blinded trials where the patient is not assured of receiving the treatment being tested in the trial. Even if we successfully develop and gain regulatory approval for our products, we still may not generate sufficient or sustainable revenues or we may not become profitable, which could have a material adverse effect on our ability to continue our marketing and distribution efforts, research and development programs and operations.

If we encounter difficulties enrolling patients in our clinical trials, our trials could be delayed or otherwise adversely affected.

Clinical trials for our product candidates may require that we identify and enroll a large number of patients with the disease under investigation. We may not be able to enroll a sufficient number of patients, or those with required or desired characteristics to achieve diversity in a study, to complete our clinical trials in a timely manner. We have in the past experienced some difficulty in enrollment in our clinical trials due to the criteria specified for eligibility for these trials, and we may encounter these difficulties in our ongoing clinical trials for our product candidates.

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Patient enrollment is affected by factors including:

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design of the trial protocol;

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the size of the patient population;

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eligibility criteria for the study in question;

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perceived risks and benefits of the product candidate under study;

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availability of competing therapies and clinical trials;

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efforts to facilitate timely enrollment in clinical trials;

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patient referral practices of physicians;

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the ability to monitor patients adequately during and after treatment; and

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proximity and availability of clinical trial sites for prospective patients.

If we have difficulty enrolling a sufficient number or diversity of patients to conduct our clinical trials as planned, we may need to delay or terminate ongoing or planned clinical trials, either of which would have a negative effect on our business.

Before we can market our vaccine product candidates or any other or future product candidates, we must obtain governmental approval for each of these product candidates, the application and receipt of which is time-consuming, costly and uncertain.

Our current product candidates and any future product candidates that we will be developing will require approval of the FDA before they can be marketed in the U.S. Although our focus at this time is primarily on the U.S. market, in the future similar approvals w ill need to be obtained from foreign regulatory agencies before we can market our current and proposed product candidates in other countries. The process for filing and obtaining FDA approval to market therapeutic products is both time-consuming and costly, with no certainty of a successful outcome. The historical failure rate for companies seeking to obtain FDA approval of therapeutic products, particularly vaccines for cancer, is high and, with the exception of Dendreon Corp.’s antigen presenting cell vaccine for the treatment of prostate cancer, no cancer stem cell or dendritic cell-based cancer vaccine has to date been approved by the FDA. This process includes conducting extensive pre-clinical research and clinical testing, which may take longer and cost more than we initially anticipate due to numerous factors, including without limitation, difficulty in securing appropriate centers to conduct trials, difficulty in enrolling patients in conformity with required protocols in a timely manner, unexpected adverse reactions by patients in the trials to our proposed product candidates and changes in the FDA’s requirements for our testing during the course of that testing.

ICT-121 has only recently begun its first testing in patients and we may encounter unexpected and adverse immune responses or other side effects in the patients whom we test with this product candidate.

The time required to obtain FDA and other approvals is unpredictable but often can exceed five years following the commencement of clinical trials, depending upon the complexity of the product and other factors.

Any analysis we perform on data from preclinical and clinical activities is subject to confirmation and interpretation by regulatory authorities, which could delay, limit or prevent regulatory approval. We may also encounter unexpected delays or increased costs due to a variety of reasons, including new government regulations from future legislation or administrative action, or from changes in FDA policy during the period of product development, clinical trials and FDA regulatory review.

Failure to timely and successfully complete clinical trials, show that our products are safe and effective and timely file and receive approval of our biologics license applications would have a material adverse effect on our business and results of operations. Even if approved, the labeling approved by the relevant regulatory authority for a product may restrict to whom we and our potential partners may market the product or in the manner in which our product may be administered, which could significantly limit the commercial opportunity for such product.

Prior to granting product approval, the FDA must determine that our third party contractors’ manufacturing facilities meet current good manufacturing practice (GMP) requirements before we can use them in the commercial manufacture of our products. We and all of our contract manufacturers are required to comply with the applicable GMP current regulations. Manufacturers of biologics must also comply with the FDA’s general biological product standards. Failure to comply with the statutory and regulatory requirements subjects the manufacturer to possible legal or regulatory action, such as suspension of manufacturing, seizure of product or voluntary recall of a product. GMP regulations require quality control and quality assurance as well as the corresponding maintenance of records and documentation sufficient to ensure the quality of the approved product.

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Certain of our current product candidates may not be eligible for Orphan Drug status.

The United States and Europe may designate drugs for relatively small patient populations as orphan drugs. Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process, but does make the product eligible for orphan drug exclusivity, reduced filing fees and specific tax credits. Generally, if a company receives the first marketing approval for a product with an orphan drug designation in the clinical indic ation for which it has such designation, the product is entitled to orphan drug exclusivity. Orphan drug exclusivity in the United States means that the FDA will not approve another application to market the same drug for the same indication, except in limited circumstances, for a period of seven years in the United States. This exclusivity, however, could block the approval of our proposed product candidates if a competitor obtains marketing approval before us. In Europe, orphan drug exclusivity means that we will have market exclusivity for ten years.  We have obtained orphan drug status in the United States and Europe for ICT-107 to treat GBM and may also seek this status for ICT-140 to treat ovarian cancer and for ICT-121 to treat recurrent GBM if we meet the eligibility criteria. However, even if we obtain orphan drug exclusivity for any of our proposed product candidates, we may not be able to maintain it. For example, if a competitive product is shown to be clinically superior to our product, any orphan drug exclusivity we have will not block the approval of such competitive product.

Fast Track designation for development of our vaccine product candidates or any other potential product candidate may not lead to a faster development or regulatory review or approval process, and it does not increase the likelihood that our product candidates will receive marketing approval.

If a drug is intended for the treatment of a serious or life-threatening condition and the drug demonstrates the potential to address unmet medical needs for this condition, the drug sponsor may apply for FDA Fast Track designation for a particular indication. Marketing applications filed by sponsors of products in Fast Track development may qualify for priority review under the polici es and procedures offered by the FDA, but the Fast Track designation does not assure any such qualification or ultimate marketing approval by the FDA. Receipt of Fast Track designation may not result in a faster development process, review or approval compared to drugs considered for approval under conventional FDA procedures. In addition, the FDA may withdraw any Fast Track designation at any time. We may seek Fast Track designation for our vaccine product candidates or any other product candidates, but the FDA may not grant this status to any of our proposed product candidates.

Because our current and our other future potential product candidates will represent novel approaches to the treatment of disease, there are many uncertainties regarding the development, manufacturing, market acceptance, third-party reimbursement coverage and commercial potential of our product candidates.

The approaches offered by our current product candidates or any future product candidates may not gain broad acceptance among doctors or patients and governmental agencies or third-party medical insurers may not be willing to provide reimbursement coverage for proposed product candidates. Moreover, we do not have internal marketing data research resources and are not certain of an d have not attempted to independently verify the potential size of the commercial markets for our current product candidates or any future product candidates. Since our current product candidates and any future product candidates will represent new approaches to treating various conditions, it may be difficult, in any event, to accurately estimate the potential revenues from these product candidates. We may spend large amounts of money trying to obtain approval for these product candidates, and never succeed in doing so. In addition, these product candidates may not demonstrate in large sets of patients the pharmacological properties ascribed to them in the laboratory studies or smaller groups of patients, and they may interact with human biological systems in unforeseen, ineffective or even harmful ways either before or after they are approved to be marketed. We have not yet manufactured our product on a commercial scale and may not be able to achieve manufacturing efficiencies relative to our competitors. We do not yet have sufficient information to reliably estimate what it will cost to commercially manufacture our current product candidates or any future product candidates, and the actual cost to manufacture these products could materially and adversely affect the commercial viability of these products. Certain of our cell-based vaccine product candidates may be formulated with cells harvested and processed from individual target patients, which could limit the total patient population for these vaccines and could require complex and costly manufacturing processes to produce these vaccines on a commercial basis. As a result, we may never succeed in developing a marketable product. If we do not successfully develop and commercialize products based upon our approach, we will not become profitable, which would materially and adversely affect the value of our common stock. Finally, in order to have commercially viable markets for our products, we will need to obtain an adequate level of reimbursement by third party payors for our products.

The commercial success of our product candidates will depend upon the degree of market acceptance by physicians, patients, healthcare payers and others in the medical community.

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Any product that we bring to market may not gain or maintain market acceptance by governmental purchasers, group purchasing organizations, physicians, patients, healthcare payors and others in the medical community. If any products that we develop do not achieve an adequate level of acceptance, we may n ot generate sufficient revenues to support continued commercialization of these products. The degree of market acceptance of our product candidates, if approved for commercial sale, will depend on a number of factors, including:

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the perceived safety and efficacy of our products;

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the prevalence and severity of any side effects;

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our ability to gain access to the entire market through distributor arrangements;

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the willingness of the target patient population to try new products and of physicians to prescribe our products;

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the effectiveness of our marketing strategy and distribution support;

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the timing of our receipt of any marketing approvals, the terms of any approvals and the countries in which approvals are obtained;

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the availability of government and third-party payor reimbursement;

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the pricing of our product candidates, particularly as compared to alternative treatments; and

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the availability of alternative effective forms of treatments, at that time, for the diseases that the product candidates we are developing are intended to treat.

Adverse publicity regarding cellular therapies could impact our business.

Although we are not utilizing embryonic stem cells, adverse publicity due to the ethical and social controversies surrounding the use of such cells or any adverse reported side effects from any stem cell, dendritic or other cell therapy clinical trials or to the failure of such trials to demonstrate that these therapies are efficacious could materially and adversely affect our ability to raise capital or recruit managerial or scientific personnel or obtain research grants.

As an early stage small company that will be competing against numerous large, established companies that have substantially greater financial, technical, manufacturing, marketing, distribution and other resources than we have, we will be at a significant competitive disadvantage.

The pharmaceutical and biopharmaceutical industry is characterized by intense competition and rapid and significant technological changes and advancements. Many companies, research institutions and universities are doing research and development work in a number of areas similar to those that we focus on that could lead to the development of new products which could compete with and be superior to our product candidates.

Most of the companies with which we compete have substantially greater financial, technical, research, manufacturing, marketing, distribution and other resources than those of ours. A number of these companies may have or may develop technologies for developing products for treating various diseases, including brain cancers, which could prove to be superior to ou rs. We expect technological developments in the pharmaceutical and biopharmaceutical and related fields to occur at a rapid rate, and we believe competition will intensify as advances in these fields are made. Accordingly, we will be required to continue to devote substantial resources and efforts to research and development activities in order to potentially achieve and maintain a competitive position in this field. Products that we develop may become obsolete before we are able to market them or to recover all or any portion of our research and development expenses. We will be competing with respect to our products with companies that have significantly more experience and expertise in undertaking preclinical testing and human clinical trials with new or improved therapeutic products and obtaining regulatory approvals of such products. A number of these companies already market and may be in advanced phases of clinical testing of various drugs that will or may compete with our current product candidates or other future potential product candidates. Our competitors may develop or commercialize products more rapidly than we do or with significant advantages over any products we develop. Our competitors may therefore be more successful in commercializing their products than us, which could adversely affect our competitive position and business.

With the approvals of sipuleucel-T and ipilimumab, several major biopharmaceutical companies, including Roche/Genentech, Amgen, Merck, Novartis, GlaxoSmithKline, and Bristol-Myers Squibb, in addition to smaller biotechnology companies, such as Dendreon, Oncothyreon, Galena, Bavarian Nordic, and Immunovaccine, are developing cancer immunotherapies. A number of immunotherapy companies, including Northwest Biotherapeutics, Prima Biomed, and DCPrime, also utilize DCs for their therapeutic cancer vaccines.

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Several companies are developing immunotherapies to treat newly diagnosed GBM. For example, Celldex is conducting a Phase III clinical trial for its EGFRvIII-targeted cancer vaccine, rindopepimut. Northwest Biotherapeutics is also conducting a Phase III study with DCVax, a DC-based tumor lysate vaccine. Agenus has completed enrollment of a Phase II clinical trial with its heat shock protein and tumor-derived peptide vaccine ( HSPPC-96).

In addition to the previously mentioned companies developing cancer immunotherapies, there are also several pharmaceutical companies, including OncoMed, Verastem, Boston Biomedical (acquired by Dainippon), and Infinity Pharmaceuticals, that are pursuing drugs that target CSCs. Stemline Therapeutics is currently developing a peptide treatment, SL-701, for brain cancer.

Colleges, universities, governmental agencies, and other public and private research organizations are becoming more active in seeking patent protection and licensing arrangements to collect royalties for use of technologies that they have developed, some of which may directly compete with our product candidates or any future product candidates. Governments of a number of foreign countries are aggressively investing in cellular therapy research and promoting such research by public and private institutions within those countries. Domestic and foreign institutions and governmental agencies, along with pharmaceutical and specialized biotechnology companies, can be expected to compete with us in recruiting qualified scientific personnel.

Our competitive position will be significantly impacted by the following factors, among others:

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our ability to obtain FDA marketing approval for our product candidates on a timely basis;

·

the level of acceptance of our products by physicians, compared to those of competing products or therapies;

·

our ability to have our products manufactured on a commercial scale;

·

the effectiveness of sales and marketing efforts on behalf of our products;

·

our ability to meet demand for our products;

·

our ability to secure insurance reimbursement for our products candidates;

·

the price of our products relative to competing products or therapies;

·

our ability to recruit and retain appropriate management and scientific personnel; and

·

our ability to develop a commercial-scale research and development, manufacturing and marketing infrastructure, either on our own or with one or more future strategic partners.

The market success of our current product candidates and any future product candidates will be dependent in part upon third-party reimbursement policies that will not be established for our product candidates until we are closer to receiving approval to market.

Our ability to successfully commercialize and penetrate the market for our current product candidates and any future product candidates is likely to depend significantly on the availability of reimbursement for our lead product candidate or any other or future product candidates from third-party payers, such as governmental agencies, private insurers and private health plans. Even if we are successful in bringing a proposed product candidate to the market, these product candidates may not be considered cost-effective, and the amount reimbursed for our products may be insufficient to allow us to sell any of our products on a competitive basis. We cannot predict whether levels of reimbursement for our product candidates, if any, will be high enough to allow the price of our product candidates to include a reasonable profit margin. Even with FDA approval, third-party payers may deny reimbursement if the payer determines that our particular product candidates are unnecessary, inappropriate or not cost effective. If patients are not entitled to receive reimbursements similar to reimbursements for competing products which currently are reimbursable, they may be unwilling to use our product candidates since they will have to pay for the unreimbursed amounts. The reimbursement status of newly approved health care products is highly uncertain. If levels of reimbursement are decreased in the future, the demand for our lead product candidate and any future product candidates could diminish or our ability to sell our products on a profitable basis could be adversely affected.

We believe that the efforts of governments and third-party payors to contain or reduce the cost of healthcare will continue to affect the business and financial condition of pharmaceutical and biopharmaceutical companies. Comprehensive health care reform legislation that was enacted in 2010 could adversely affect our business and f inancial condition. Among other provisions, the legislation provides that a biosimilar product may be approved by the FDA on the basis of analytical tests and certain clinical studies demonstrating that such product is highly similar to an existing, approved product and that switching between an existing product and the biosimilar product will not result in diminished safety or efficacy. This abbreviated regulatory approval process may result in increased competition if we are able to bring a biopharmaceutical product to market. The legislation also includes more stringent compliance programs for companies in various sectors of the life sciences industry with which we may need to comply and enhanced penalties for non-compliance with the new health care regulations. Complying with new regulations may divert management resources, and inadvertent failure to comply with new regulations may result in penalties being imposed on us.

15


A number of legislative and regulatory proposals to change the healthcare system in the United States and other major healthcare markets have been proposed at the state and federal levels in recent years. These proposals have included prescription drug benefit legislation recently enacted in the United States and healthcare reform legisl ation recently enacted by certain states. Further federal and state legislative and regulatory developments are likely, and we expect ongoing initiatives in the United States to increase pressure on drug pricing. Such reforms could have an adverse effect on anticipated revenues from any products that we may successfully develop.

We may be subject to product liability and other claims that could have a material negative effect on our operations and on our financial condition.

The development and sale of medical products in general, and vaccines in particular, expose us to the risk of significant damages from product liability and other claims. Product liability claims could delay or prevent completion of our clinical development programs. If we succeed in m arketing our current lead products candidates or any future product candidates, such claims could result in an FDA investigation of the safety and effectiveness of our products or our marketing programs, and potentially a recall of our products or more serious enforcement action, or limitations on the indications for which they may be used, or suspension or withdrawal of approval. We plan to obtain and maintain product liability insurance for coverage of our clinical trial activities and obtained this coverage for the recently completed and current clinical trials of our dendritic cell-based vaccine product candidate. We may not be able to secure such insurance in the amounts we are seeking or at all for any of the future trials for our current product candidates or any future product candidates. We intend to obtain coverage for our products when they enter the marketplace (as well as requiring the manufacturers of our products to maintain insurance), but we do not know if insurance will be available to us at acceptable costs or at all. The costs for many forms of liability insurance have risen substantially in recent years and the costs for insuring a vaccine type product may be higher than other pharmaceutical products, and such costs may continue to increase in the future, which could materially impact our costs for clinical or product liability insurance. If the cost is too high, we will have to self-insure, and we may have inadequate financial resources to pay the costs of any claims. A successful claim in excess of our product liability coverage could have a material adverse effect on our business, financial condition and results of operations.

We are dependent on our key personnel, and the loss of one or more of our key personnel would materially and adversely affect our business and prospects.

We are dependent on our officers and directors for their scientific or managerial skills, including Dr. John Yu, our Chairman of the Board and Chief Scientific Officer and Andrew Gengos, our President and Chief Executive Officer. Except for our President and Chief Executive Officer and our Senior Vice President – Strategic Resources, we do not have any full-time management personnel. We do not currently maintain key man life insurance on any of our scientific or management team. Dr. Yu or Mr. Gengos can terminate their services to us at any time. The loss of the services of Dr. Yu or Mr. Gengos would materially and adversely affect our business.

As we retain additional full-time or part-time senior personnel necessary to further our advanced development of product candidates, our expenses for salaries and related items will increase materially from current levels. Competition for such personnel is intense, and we may not be able to attract or retain qualified senior personnel and our failure to do so could have an adverse effect on our ability to implement our business plan.

Risks Relating to our Financial Position and Operations

We have a history of operating losses. We expect to continue to incur losses for the near future, and we may never become profitable.

With the exception of a one-time licensing fee payment that we previously received in connection with our entering into a research and license option agreement covering one of our monoclonal antibody product candidates with a third party who did not subsequently exercise that option, we have not generated any revenues and have incurred operating losses since our inception, and we expect to continue to incur operating losses for the foreseeable future. We do not have any products that generate revenue from c ommercial product sales. Our operating losses have resulted principally from costs incurred in pursuing our research and development programs, clinical trials, manufacturing, and general and administrative expenses in support of operations. We may be unable to develop or market products in the future that will generate revenues, and any revenues generated may not be sufficient for us to become profitable. In the event that our operating losses are greater than anticipated or continue for longer than anticipated, we will need to raise significant additional capital sooner, or in greater amounts, than otherwise anticipated in order to be able to continue development of our present or future product candidates and maintain our operations. There can be no assurances that capital will be available to us when and if we require additional capital on terms that are acceptable to us or favorable to our existing stockholders, or at all.

16


As our product candidates advance in clinical development, we will require significant additional funding, and our future access to capital is uncertain.

It is expensive to develop and commercialize cancer immunotherapy candidates. We plan to continue to simultaneously conduct clinical trials and preclinical research for a number of product candidates. Our product development efforts may not lead to commercial products, either because our product candidates fail to be found safe or effective in clinical trials or because we lack the necessary financial or other resources or relationship s to pursue our programs through commercialization. Even if commercialized, a product may not achieve revenues that exceed the costs of producing and selling it. Our capital and future cash flow may not be sufficient to support the expenses of our operations and we may need to raise additional capital depending on a number of factors, including the following:

·

the need to conduct larger, more expensive and longer clinical trials to obtain the data necessary for submission for product approval to regulatory agencies;

·

the capability to manufacture product at the scale and quantities required to meet regulatory approval requirements and the development and commercial requirements for the product;

·

the costs to obtain qualified commercial development of infrastructure and activities related to the commercialization of our products;

·

the rate of progress and cost of our research and development and clinical trial activities; and

·

the introduction into the marketplace of competing products and other adverse market developments.

Other than our Controlled Equity Offering Sales Agreement with Cantor Fitzgerald & Co., we currently do not have arrangements to obtain additional financing. Any such financing could be difficult to obtain on favorable terms or at all. If we are unable to raise additional funds, we may have to delay, reduce or eliminate some of our clinical trials and our development programs. Even if we raise additional funds by issuing equity or equity-linked securities, such financings may only be available on unattractive terms and, in such event, the market price of our common stock may decline and further dilution to our existing stockholders will result. In addition, the expectation of future dilution as a result of our offering of securities convertible into equity securities may cause our stock price to decline.

We may seek Small Business Innovation Research or other government grants to conduct a portion of our planned research and development work in addition to certain equity financing. Except for one grant awarded under a federal tax credit/grant program for pharmaceutical research and development companies in 2010 and one grant application submitted under the Orphan Drug Act that was denied, we have not yet submitted any requests for these grant s, the competition for obtaining these grants is intense and we may be unable to secure any grant funding on a timely basis or at all.

We are required to pay certain royalties under our license agreements with third party licensors, and we must meet certain milestones to maintain our license rights.

Under our license agreements with academic institutions generally, including our Cedars-Sinai license for ICT-107, we will be required to pay substantial royalties to that institution based on our revenues from sales of our products utilizing the technologies and products licensed from the institution, and these royalty payments could adversely affect the overall profitability for us of any products that we may seek to commercialize. In order to maintain our li cense rights under these license agreements, we will need to meet certain specified milestones, subject to certain cure provisions, in the development of our vaccine product candidates and in the raising of funding. In addition, many of these agreements contain diligence milestones and we may not be successful in meeting all of the milestones in the future on a timely basis or at all. We will need to outsource and rely on third parties for many aspects of the clinical development, manufacture, sales and marketing of our products covered under our license agreements, including the Cedars-Sinai license for ICT-107. Delay or failure by these third parties could adversely affect the continuation of our license agreements with their party licensors.

17


Risks Relating to Reliance on Third Parties

We outsource almost all of our operational and development activities, and if any party to which we have outsourced certain essential functions fails to perform its obligations under agreements with us, the development and commercialization of our lead product candidate and any future product candidates could be delayed or terminated.

We generally rely on third-party consultants or other vendors to manage and implement the day-to-day conduct of our operations, including conducting clinical trials and manufacturing our current product candidates or any future product candidates. Accordingly, we are and will continue to be dependent on the timeliness and effectiveness of their efforts. Our dependence on third parties includes key suppliers and third party ser vice providers supporting the development, manufacture and regulatory approval of our products as well as support for our information technology systems and other infrastructure, including our network of leukapheresis providers. While our management team oversees these vendors, failure of any of these third parties to meet their contractual, regulatory and other obligations or the development of factors that materially disrupt the performance of these third parties could have a material adverse effect on our business. For example, all of the key oversight responsibilities for the development and manufacture of ICT-107, our lead product candidate, are conducted by our management team but all activities are the responsibility of third party vendors.

If a clinical research organization, or CRO, that we utilize is unable to allocate sufficient qualified personnel to our studies in a timely manner or if the work performed by it does not fully satisfy the requirements of the FDA or other regulatory agencies, we ma y encounter substantial delays and increased costs in completing our development efforts. Any manufacturer that we select may encounter difficulties in the manufacture of new products in commercial quantities, including problems involving product yields, product stability or shelf life, quality control, adequacy of control procedures and policies, compliance with FDA regulations and the need for further FDA approval of any new manufacturing processes and facilities. The manufacture of clinical supplies for studies and commercial quantities of our current product candidates and any future product candidates are likely to be inherently more difficult and costly than typical chemical pharmaceuticals. This could delay commercialization of any of our product candidates or reduce the profitability of these candidates for us. If any of these occur, the development and commercialization of our product candidates could be delayed, curtailed or terminated because we may not have sufficient financial resources or capabilities to continue such development and commercialization on our own. If we rely on only one source for the manufacture of the clinical or commercial supplies of any of our product candidates or products, any production problems or supply constraints with that manufacturer could adversely impact the development or commercialization of that product candidate or product.

If we or our contractors or service providers fail to comply with regulatory laws and regulations, we or they could be subject to regulatory actions, which could affect our ability to develop, market and sell our product candidates and any other or future product candidates and may harm our reputation.

If we or our manufacturers or other third party contractors fail to comply with applicable federal, state or foreign laws or regulations, we could be subject to regulatory actions, which could affect our ability to develop, market and sell our current product candidates or any future product candidates under development successfully and could h arm our reputation and lead to reduced or non-acceptance of our proposed product candidates by the market. Even technical recommendations or evidence by the FDA through letters, site visits, and overall recommendations to academia or biotechnology companies may make the manufacturing of a clinical product extremely labor intensive or expensive, making the product candidate no longer viable to manufacture in a cost efficient manner. The mode of administration may make the product candidate not commercially viable. The required testing of the product candidate may make that candidate no longer commercially viable. The conduct of clinical trials may be critiqued by the FDA, or a clinical trial site’s Institutional Review Board or Institutional Biosafety Committee; which may delay or make impossible clinical testing of a product candidate. The Data Safety Monitoring Committee for a clinical trial established by us may stop a trial or deem a product candidate unsafe to continue testing. This may have a material adverse effect on the value of the product candidate and our business prospects.

We will need to outsource and rely on third parties for the clinical development and manufacture, sales and marketing of our current product candidates or any future product candidates, and our future success will be dependent on the timeliness and effectiveness of the efforts of these third parties.

We do not have the required financial and human resources to carry out on our own all the pre-clinical and clinical development for our vaccine product candidates or any other or future product candidates, and do not have the capability and resources to manufacture, market or sell our current product candidates or any future product candidates. Vaccines are often administered with o ne or more adjuvants, which if necessary we will have to procure from a third-party source. Our business model calls for the partial or full outsourcing of the clinical and other development and manufacturing, sales and marketing of our product candidates in order to reduce our capital and infrastructure costs as a means of potentially improving our financial position.

18


Risks Relating to our Intellectual Property

Our patents and maintenance of trade secrets may not protect the proprietary rights of our products, impairing our competitive position, and our business, financial condition and results of operations could be adversely affected.

Our ability to compete successfully will depend significantly on our ability to obtain patent coverage for our products throughout their product lifetimes, defend patents that may have issued, protect trade secrets and operate without infringing the proprietary rights of others or others infringing on our proprietary rights. Although Cedars-Sinai as our licensor has filed applications relative to a number of aspects of our cancer vaccine technology, we are responsible going forward to prosecute these patent applications. The patent situation in the fields of cancer vaccine technology and monoclonal antibody and stem cell technologies is highly uncertain and involves complex legal and scientific questions.

Even if we have or are subsequently able to obtain patent protection for our vaccine product candidates or any of our other or future product candidates, there is no guarantee that the coverage of these patents will be sufficiently broad to protect us from competitors with the same or similar technologies, or that we will be able to enforce our patents against potential infringement by third parties. Patent litigation is ex pensive, and we may not be able to afford the costs. We may not become aware on a timely basis that products we are developing or marketing infringe the rights of others, nor may we be able to detect unauthorized use or take appropriate and timely steps to enforce our own intellectual property rights. We may not hold or be able to obtain all of the proprietary rights to certain patents, process patents, and use patents that may be owned or controlled by third parties. As a result, we may be required to obtain additional licenses under third party patents to market certain of our potential products. If licenses are not available to us on acceptable terms, or at all, we may not be able to market these products or we may be required to delay marketing until the expiration of such patents. Protecting our intellectual property rights may also consume significant management time and resources.

Nondisclosure agreements with employees and third parties may not adequately prevent disclosure of trade secrets and other proprietary information.

In order to protect our proprietary technology and processes, we will also rely in part on nondisclosure agreements with our employees, licensing partners, consultants, agents and other organizations to which we disclose our proprietary information. These agreements may not effectively prevent disclosure of confidential information, may be limited as to their term, and may not provide an adequate remedy in the event of unauthorized disclosure of confidential information. In additi on, others may independently discover trade secrets and proprietary information, and in such cases we could not assert any trade secret rights against such party. Costly and time-consuming litigation could be necessary to enforce and determine the scope of our proprietary rights, and failure to obtain or maintain trade secret protection could adversely affect our competitive business position. Since we will rely on trade secrets and nondisclosure agreements, in addition to patents, to protect some of our intellectual property, there is a risk that third parties may obtain and improperly utilize our proprietary information to our competitive disadvantage. We may not be able to detect unauthorized use or take appropriate and timely steps to enforce our intellectual property rights.

The manufacture, offer for sale, use or sale of our current product candidates or any future product candidates may infringe on the patent rights of others, and we may be forced to take additional licenses, or litigate if an intellectual property dispute arises.

Should third parties patent specific cells, systems, receptors, antigens or other items that we are seeking to utilize in our development activities, we may be forced to license rights from these parties or abandon our development activities if we are unable to secure these rights on attractive terms or at all. In light of the large number of companies and institutions engaged in research and development in the cellular therapy field, we anticipate that many parties will be seeking patent rights for many cellular based technologies and that licensing and cross-licensing of these rights among various competitors may arise. Specifically, our dendritic cell-based vaccine product candidates utilize multiple antigens for which we may be required to obtain licenses from one or more other parties before we can commercialize them. We may not be able to obtain all of the licenses that we may need on attractive terms or at all, which could result in our having to reformulate or abandon this product candidate or delay its development or commercialization until the expiration of third party patent rights.

If we infringe or are alleged to have infringed another party’s patent rights, we may be required to defend an infringement action or challenge the validity of the patents in court. Patent litigation is costly and time consuming. We may not have sufficient resources to bring these actions to a successful conclusion. In addition, if we do not obtain a license, do not successfully defend an infringement action or are unable to have infringed patents declared invalid, we may:

·

incur substantial monetary damages;

·

encounter significant delays in marketing our current product candidates or any future product candidates; or

·

be unable to conduct or participate in the manufacture, use, offer for sale or sale of product candidates or methods of treatment requiring licenses.

19


Parties making such claims may be able to obtain injunctive relief that could effectively block our ability to further develop or commercialize our current product candidates or any future product candidates in the United States and abroad and could result in the award of substantial damages. Defense of any lawsuit or failure to obtain any such license could substantially harm us. Litigation, regardless of outcome, could result in substantial cost to and a diversio n of efforts by us.

Risks Related to our Common Stock

Our stock price may be volatile, and your investment in our common stock could decline in value.

The market prices for our common stock and the securities of other development state pharmaceutical or biotechnology companies have been highly volatile and may continue to be highly volatile in the future. Between October 1, 2013 and December 31, 2013, the stock price for our common stock has ranged from $0.65 to $4.00.  The following factors, in addition to other risk factors described in this section, may have a significant impact on the market price of our common stock:

·

the progress and success of clinical trials and preclinical activities (including studies and manufacture of materials) of our product candidates conducted by us or our collaborative partners or licensees;

·

the receipt or failure to receive the additional funding necessary to conduct our business;

·

selling by large stockholders;

·

presentations of detailed clinical trial data at medical and scientific conferences and investor perception thereof;

·

announcements of technological innovations or new commercial products by our competitors or us;

·

developments concerning proprietary rights, including patents by our competitors or us;

·

developments concerning our collaborations;

·

publicity regarding actual or potential medical results relating to products under development by our competitors or us;

·

regulatory developments in the United States and foreign countries;

·

manufacturing or supply disruptions at our contract manufacturers, or failure by our contract manufacturers to obtain or maintain approval of the FDA or comparable regulatory authorities;

·

litigation or arbitration;

·

economic and other external factors or other disaster or crisis; and

·

period-to-period fluctuations in financial results.

Furthermore, during the last few years, the stock markets have experienced extreme price and volume fluctuations and the market prices of some equity securities continue to be volatile. These fluctuations often have been unrelated or disproportionate to the operating performance of these companies. These broad market and industry fluctuations, as well as general economic, political and market conditions such as recessions, interest rate changes or international currency fluctuations, may cause the market pr ice of shares of our common stock to decline.

20


Future equity issuances or a sale of a substantial number of shares of our common stock may cause the price of our common stock to decline.

Because we will continue to need additional capital to continue to expand our business and our research and development activities, among other things, we may conduct additional equity offerings. In addition, we have an existing Controlled Equity Offering Sales Agreement, commonly referred to as an ATM facility, pursuant to which we may offer and sell, from time to time, shares of our common stock having an offering price up to an aggregate total of $25.0 million (of which only $17.0 million was initially registered for offer and sale). As of December 31, 2013, we had approximately $11.8 million available for offer and sale pursuant to our ATM facility.  If we or our stockholders sell substantial amounts of our common stock (including shares issued upon the exercise of options and warrants) in the public market, the market price of our common stock could fall. A decline in the market price of our common stock could make it more difficult for us to sell equity or equity-related securities in the future at a time and price that we deem appropriate. Furthermore, if we obtain funds through a credit facility or through the issuance of debt or preferred securities, these securities would likely have rights senior to your rights as a common stockholder, which could impair the value of our common stock.

If we fail to adhere to the strict listing requirements of the NYSE MKT LLC, we may be subject to delisting. As a result, our stock price may decline and our common stock may be delisted. If our stock were no longer listed on the NYSE MKT, the liquidity of our securities likely would be impaired.

Our common stock currently trades on the NYSE MKT under the symbol IMUC. If we fail to adhere to the NYSE MKT LLC’s strict listing criteria, our stock may be delisted. This could potentially impair the liquidity of our securities not only in the number of shares that could be bought and sold at a given price, which might be depressed by the relative illiquidity, but also through delays in the timing of transactions and the potential reduction in media covera ge. As a result, an investor might find it more difficult to dispose of our common stock. We believe that current and prospective investors would view an investment in our common stock more favorably if it continues to be listed on the NYSE MKT.

Our founder and Chairman of the Board may be able to prevent other stockholders from influencing significant corporate decisions.

As of February 28 , 2014, Dr. John Yu beneficially owned approximately 9.94% of our outstanding common stock. Dr. Yu, our founder, Chairman of the Board and Chief Scientific Officer, is entitled to serve as a director and to designate two of our other directors. Dr. Yu, through his right to name himself plus two of our directors, may be able to direct the outcome of matters presented to our board of directors and our stockholders, including the election of our directors and other corporate actions such as:

·

our merger with or into another company;

·

sale of substantially all of our assets; and

·

amendments to our certificate of incorporation.

We also may choose in the future to enter into agreements with one or more investors in which we would agree to change the size or composition of our board of directors.

The decisions of these stockholders or any investor — designated directors may conflict with our interests or those of our other stockholders.

Potential conflicts of interest could arise for certain members of our management team in the performance of their services for us.

Dr. John Yu is a full-time employee of Cedars-Sinai, which owns shares of our common stock and where we previously conducted and plan to conduct future research and development work, including clinical trials of our vaccine product candidates. Potential conflicts of interest could arise as a result, including for Dr. Yu in performing services for us and for Cedars-Sinai, in establishing the terms under which Cedars-Sinai performs work for us, and in Cedars-Sinai conducting the research. Dr. Yu and other scientists associated with Dr. Yu at Cedars-Sinai may perform research in the field of brain tumors that is sponsored by other third parties. We have no present right to acquire any interest in the intellectual property generated by this research, including several clinical trials with dendritic cell-based vaccines that have been completed or are planned to be initiated. These studies may compete for patients to be enrolled in our current or future clinical trials.

21


Substantial sales of our common stock could cause our common stock price to fall.

As of February 28 , 2014, we had 57,565,704 shares of common stock outstanding and another 20,244,314 shares of common stock issuable upon exercise of options or warrants, most of which are eligible to be publicly resold under current registration statements or pursuant to Rule 144. The possibility that substantial amounts of our common stock may be sold in the public market may adversely affect prevailing market prices for our common stock and could impair our ability to raise capital through the sale of our equity securities.

 

Item 1B.

Unresolved Staff Comments.

None.

 

Item 2.

Properties.

We currently maintain our corporate office in Calabasas , California under an operating lease through August 31, 2016 at a monthly rental rate of $8,063. We do not lease or own any other real property.

 

Item 3.

Legal Proceedings.

We are not a party to any material legal proceedings. We may occasionally become subject to legal proceedings and claims that arise in the ordinary course of our business. It is impossible for us to predict with any certainty the outcome of any disputes that may arise, and we cannot predict whether any liability arising from claims and litigation will be material in relation to our financial position or results of operations.

 

Item 4.

Mine Safety Disclosures.

Not applicable.

 

 

 

22


PART II.

 

Item 5.

Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.

Market Information

Our common stock has been traded on the NYSE MKT since May 30, 2012 under the symbol IMUC. Our common stock previously traded on the OTC Bulletin Board over-the-counter market. The following price information reflects inter-dealer prices, without retail mark-up, mark-down or commission and may not represent actual transactions:

 

Quarter Ended

  

    High    

 

  

    Low    

 

March 31, 2012

  

 

3.40

  

  

 

0.98

  

June 30, 2012

  

 

4.00

  

  

 

2.05

  

September 30, 2012

  

 

3.96

  

  

 

2.25

  

December 31, 2012

  

 

2.93

  

  

 

1.51

  

 

 

 

 

 

 

 

 

 

March 31, 2013

  

 

2.89

  

  

 

1.91

  

June 30, 2013

  

 

2.78

  

  

 

1.92

  

September 30, 2013

  

 

3.69

  

  

 

1.91

  

December 31, 2013

  

 

4.00

  

  

 

0.65

  

Stockholders

As of March 1, 201 4, there were approximately 112 holders of record of our common stock, not including any persons who hold their stock in “street name.”

Dividend Policy

We have not paid any dividends on our common stock to date and do not anticipate that we will pay dividends in the foreseeable future. Any payment of cash dividends on our common stock in the future will be dependent upon the amount of funds legally available, our earnings, if any, our financial condition, our anticipated capital requirements and other factors that the Board of Directors may think are relevant. However, we currently intend for the foreseeable future to follow a policy of retaining all of ou r earnings, if any, to finance the development and expansion of our business and, therefore, do not expect to pay any dividends on our common stock in the foreseeable future.

23


Sales of Unregistered Securities

The following table provides information about the Company’s repurchases of its common stock during the year ended December 31, 201 3.

 

Month

  

Shares
Deemed to be
Repurchased (1)

 

  

Average price
paid
per share

 

  

Total number of
shares
purchased as
part of
Publicly announced
Plans or
Programs

 

  

Maximum
Number of Shares
that May Yet be
Purchased Under
the Plans or
Maximum
Number of Shares
that May Yet be
Purchased Under
the Plans or
Programs

 

January

  

 

 

 

$

 

 

 

 

 

 

 

February

  

 

 

 

$

 

 

 

 

 

 

 

March

  

 

33,457

 

 

$

 

 

 

 

 

 

 

April

  

 

99.208

 

 

$

 

 

 

 

 

 

 

May

  

 

12,984

 

 

$

 

 

 

 

 

 

 

June

  

 

 

 

$

 

 

 

 

 

 

 

July

  

 

 

 

$

 

 

 

 

 

 

 

August

  

 

99,331

 

 

$

 

 

 

 

 

 

 

September

  

 

5,491

 

 

$

 

 

 

 

 

 

 

October

  

 

5,843

 

 

$

 

 

 

 

 

 

 

November

  

 

 

 

$

 

 

 

 

 

 

 

December

  

 

 

 

$

 

 

 

 

 

 

 

 

  

 

256,314

 

 

$

 

 

 

 

 

 

 

(1)

- These shares are deemed to be repurchased through the cashless exercise of warrants and stock options during 2013.

 

Item 6.

Selected Financial Data.

The data set forth below should be read in conjunction with Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and the financial statements and notes thereto included under Item 8 of this annual report on Form 10-K.

 

 

  

For the Years Ended December 31,

 

 

  

2013

 

 

2012

 

 

2011

 

 

2010

 

 

2009

 

Income Statement Data

  

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenue

  

$

 

 

$

 

 

$

 

 

$

  

 

$

300,000

 

Income (loss) from continuing operations

  

$

(8,800,563

)

 

 

(14,495,139

 

 

(5,719,903

 

 

(6,150,142

 

 

(2,626,205

Income (loss) from continuing operations per share

  

 

(0.16

)

 

 

(0.35

 

 

(0.21

 

 

(0.32

 

 

(0.19

Net (loss) attributable to common stockholders

  

 

(8,800,563

)

 

 

(14,495,139

 

 

(5,719,903

 

 

(8,242,642

 

 

(2,626,205

Net (loss) per share attributable to common stockholders

  

 

(0.16

)

 

 

(0.35

 

 

(0.21

 

 

(0.43

 

 

(0.19

Cash divdends declared per common share

  

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance Sheet Data (as of year end)

  

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total assets

  

 

28,940,677

 

 

 

27,019,201

  

 

 

7,150,757

  

 

 

5,365,150

  

 

 

1,472,716

  

Cash and cash equivalents

  

 

27,646,351

 

 

 

26,216,668

  

 

 

6,653,168

  

 

 

5,319,776

  

 

 

331,353

  

Long-term obligations and redeemable preferred stock

  

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

24


Item 7.

Management’s Discussion and Analysis of Financial Condition and Results of Operations.

You should read the information in this Item 7 together with our financial statements and notes thereto that appear elsewhere in this Annual Report. This Annual Report contains forward-looking statements that involve risks, uncertainties, and assumptions. Actual results may differ materially from those anticipated in these forward-looking statements as a result of var ious factors, including, but not limited to, those presented under “Risk Factors” included in Item 1.A of Part I and elsewhere in this Annual Report.

Overview and Plan of Operation

ImmunoCellular Therapeutics, Ltd. (the Company) is a development stage company that is seeking to develop and commercialize new therapeutics to fight cancer using the immune system.

The Company has been primarily engaged in the acquisition of certain intellectual property, together with development of its product candidates and the recent clinical testing activities for its vaccine product candidates, and has not generated any recurring revenues. The Company’s lead product candidate, ICT-107, completed Phase II testing in December 2013. The Company has two other product candidates, ICT-140 and ICT-121, both with investigational new drug (IND) applications active at the US Food and Drug Administration (FDA). The Company has incurred operating losses and, as of December 31, 2013, the Company had an accumulated deficit of $51,969,393. The Company expects to incur significant research, development and administrative expenses before any of its products can be launched and recurring revenues generated.

On January 31, 2006, we completed a merger pursuant to which Spectral Molecular Imaging, Inc. became our wholly owned subsidiary. At the time of the merger, we had virtually no assets or liabilities, and we had not conducted any business operations for several years. In connectio n with the merger, we changed our name from Patco Industries, Ltd. to Optical Molecular Imaging, Inc. and replaced our officers and directors with those of Spectral Molecular Imaging. Although we acquired Spectral Molecular Imaging in the merger, for accounting purposes the merger was treated as a reverse merger since the stockholders of Spectral Molecular Imaging acquired a majority of our outstanding shares of common stock and the directors and executive officers of Spectral Molecular Imaging became our directors and executive officers. Accordingly, our financial statements contained in this Report and the description of our results of operations and financial condition reflect the operations of Spectral Molecular Imaging from its inception on February 25, 2004.

For additional information about our plan of business operation, see the “Business” section of this Annual Report included in Item 1 of Part I.

Critical Accounting Policies

Management’s discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an ongoing basis, management evalu ates its estimates, including those related to impairment of long-lived assets, including finite lived intangible assets, accrued liabilities, fair value of warrant derivatives and certain expenses. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ materially from these estimates under different assumptions or conditions.

Our significant accounting policies are summarized in Note 2 of our financial statements for the period from February 25, 2004 to December 31, 2013 . We believe the following critical accounting policies affect our more significant judgments and estimates used in the preparation of our financial statements:

Development Stage Enterprise

We are a development stage enterprise as defined by FASB ASC Topic 915, “Accounting and Reporting by Development Stage Enterprises.” We are devoting substantially all of our present efforts to research and development. All losses accumulated since inception are considered as part of our development stage activities.

25


Research and Development Costs

Although we believe that our research and development activities and underlying technologies have continuing value, the amount of future benefits to be derived from them is uncertain. Research and development costs are therefore expensed as incurred rather than capitalized. During the years ended December 31, 201 3, 2012 and 2011, we recorded an expense of $5,339,716, $7,711,233 and $4,988,612, respectively, related to research and development activities. We expect our research and development expenses in 2014 will increase compared to 2013.

Stock-Based Compensation

Stock-based compensation expense is estimated as of the grant date based on the fair value of the award and is recognized as expense over the requisite service period, which generally equals the vesting period, based on the number of awards that are expected to vest. Estimating the fair value for stock options requires judgment, including the expected term of our stock options, volatility of our stock, expected dividends, risk-free intere st rates over the expected term of the options and the expected forfeiture rate. In connection with our performance based programs, we make assumptions principally related to the number of awards that are expected to vest after assessing the probability that certain performance criteria will be met.

Income Taxes

The Company accounts for federal and state income taxes under the liability method, with a deferred tax asset or liability determined based on the difference between the financial statement and tax basis of assets and liabilities, as measured by the enacted tax rates. The Company’s provision for income taxes represents the amount of taxes currently payable, if any, plus the change in the amount of net deferred tax assets or liabilities. A valuati on allowance is provided against net deferred tax assets if recoverability is uncertain on a more likely than not basis. The Company recognizes in its financial statements the impact of an uncertain tax position if the position will more likely than not be sustained upon examination by a taxing authority, based on the technical merits of the position. The Company’s policy is to recognize interest related to unrecognized tax benefits as interest expense and penalties as operating expenses. The Company is not currently under examination by any taxing authority nor has it been notified of an impending examination. The Company’s tax returns for the years ended December 31, 2013, 2012 and 2011, remain open for possible review.

Fair Value of Financial Instruments

The carrying amounts reported in the balance sheets for cash, cash equivalents, and accounts payable approximate their fair values due to their quick turnover. The fair value of warrant liability is estimated using the Binomial Lattice option valuation model.

Results of Operations

For the Years Ended December 31, 2013 and 2012

Revenues

We did not have any revenue in the years ended December 31, 2013 or 2012 and we do not expect to have any revenue in 2014.

Expenses

Research and development expenses during the year ended December  31, 2013 were $5,339,716 compared to $7,711,233 for the year ended December 31, 2012, a decrease of $2,371,517. During 2012, we enrolled 179 patients in our Phase II clinical trial for ICT-107 bringing the total number of enrolled patients to 278.  Additionally, we had two manufacturing facilities and 25 Phase II clinical sites that were operational.  Since we completed our ICT-107 patient enrollment in 2012, we did not incur certain expenses related to product manufacturing or quality control during 2013.  However, we continued to incur other trial related expenses for ICT-107 during 2013.  The decrease in the amounts expended for ICT-107 was partially offset by certain pre-clinical expenses we incurred related to ICT-121 and ICT-140 during 2013.  During 2014, we expect to enroll patients in our ICT-121 and ICT-140 clinical trials.  We will continue to incur certain ICT-107 expenses related to patient follow up and data analysis related to the Phase II trial.

Our general and administrative expenses for the years ended De cember 31, 2013 and 2012 were $3,396,391 and $3,619,291, respectively, a decrease of $222,900. During 2012, our expenses in the areas of investor relations, travel, board and professional fees increased to expand our infrastructure. During 2013, we optimized our spending in the areas of investor relations, travel and professional fees, which resulted in a decrease in expense.  These decreases were partially offset by increases in personnel related expenses as we hired additional employees and we concluded a litigation matter.

Our stock based compensation increased from $496,007 during the year ended December 31, 2012, to $724,212 during the year ended December 31, 2013. During 2013, the Company issued additional stock options to its current employees and one new hire.

26


Non-Cash Items

During the year ended December 31, 2013, we incurred $778,431 in non-cash expenses, consisting of $724,212 of stock based compensation, $3,817 loss on disposal of assets and $50,402 of depreciation expense.  These expenses were partially offset as the Company recognized a credit of $642,411 related to the revaluation of our warrant derivatives.  During the year ended December 31, 2012, we incurred $3,219,047 in non-cash expenses, consisting of $496,007 of stock based compensation, $397,294 financing expense associated with warrant repricing, $45,823 of depreciation and $2,279,923 related to the revaluation of our warrant derivatives. The value of our warrant derivative is highly influenced by the price of our Company’s common stock. As of December 31, 2013, the price of our common stock decreased to $0.93 per share compared to $1.92 at December 31, 2012.

The warrants issued as part of the February 2011 financing contained a provision whereby the exercise price of those warrants, and the number of underlying warrants, would be adjusted in the event that we subsequently sold shares of our common stock at a price that was less than the current exercise price. As part of the January and October 2012 financings, we sold shares of our common stock at a price that was less than the current exercise price and the exercise price of the February 2011 warrants was decreased from $2.25 to $1.87 and the number of warrants outstanding was increased by 563,851. We recorded a non-cash financing expense charge of $397,294 during the year ended December 31, 2012 to account for the issuance of these additional warrants. There was no comparable charge during the year ended December 31, 2013.

Net Loss

We incurred a net loss of $8,800,563 during the year ended December 31, 2013 compared to a net loss of $14,495,139 in the year ended December 31, 2012. The decrease in the net loss is primarily due to reductions in research and development expenses and a credi t of $642,411 related to the revaluation of our warrant derivatives rather than a charge of $2,279,923 as recorded in the prior year.

For the Years Ended December 31, 2012 and 2011

Revenues

We did not have any revenue in the years ended December 31, 2012 or 2011.

Expenses

Research and development expenses during the year ended December 31, 2012 were $7,711,233 compared to $4,988,612 for the year ended December 31, 2011, an increase of $2,722,621. During 2011, we began our Phase II clinical trial for ICT-107 and enrolled a total of 99 patients and during 2012, we enrolled 179 patients. Also, during 2012, we began our pre-clinical work to develop ICT-140.

Our general and administrative expenses for the years ended December 31, 2012 and 2011 were $3,619,291 and $2,446,757 , respectively. During the latter half of 2011, we incurred additional expenses in the areas of investor relations, travel, personnel, board and professional fees to expand our infrastructure. During 2012, our expenses in these areas continued to increase.

Our stock based compensation decreased from $1,190,133 during the year ended December 31, 2011, to $496,007 during the year ended December 31, 2012. During 2012, the Company issued stock options to its employees and directors with longer vesting periods. Additionally, the decrease in stock based compensation expense reflects the 2012 forfeiture of unvested stock options. There were no material stock option forfeitures in 2011.

Non-Cash Items

The warrants issued as part of the February 2011 financing contained a provision whereby the exercise price of those warrants, and the number of underlying warrants, will be adjusted in the event that we subsequently sold shares of our common stock at a price that was less than $1.55 per share. As part of the January and October 2012 financings, we sold shares of our common stock at a price that was less than $1.55 per share and the exercise price of the February 2011 warrants was decreased from $2.25 to $1.87 and the number of warrants outstanding was increased by 563,851. We recorded a non-cash financing expense charge of $397,294 during the year ended December 31, 2012 to account for the issuance of these additional warrants. There was no comparable charge during the year ended December 31, 2011.

27


During the year ended December 31, 2012, we incurred $3,219,047 in non-cash expenses, consisting of $496,007 of stock based compensation, $397,294 financing expense associated with warrant repricing, $45,823 of depreciation and $2,279,923 related to the revaluation of our warrant derivatives accounted for as a liability. The value of our warrant derivative is highly influenced by the price of our Company’s common stock. As of December 31, 2012, the price of our common stock increased to $1.92 per share comp ared to $1.36 at December 31, 2011. During the year ended December 31, 2011, we incurred $1,210,490 in non-cash expenses, consisting of $1,190,133 of stock based compensation and $20,357 of depreciation expense. Also, during 2011, we recorded a credit of $2,901,253 related to the revaluation adjustment of our warrant derivatives accounted for as a liability.

Net Loss

We incurred a net loss of $14,495,139 during the year ended December 31, 2012 compared to a net loss of $5,719,903 in the year ended December 31, 2011. The increase in the net loss reflects the expansion of our research and development activities, increased general and administrative expenses and the change in the fair value of our warrant derivatives.

Liquidity and Capital Resources

As of December 31, 201 3, we had working capital of $27,007,377, compared to working capital of $25,832,869 as of December 31, 2012.

The estimated cost of completing the development of any of our current vaccine product candidates and of obtaining all required regulatory approvals to market any of those product candidates is substantially greater than the amount of funds we currently have available. However, we believe that our existing cash balances will be sufficient to fund our operations through at least the end of 2014, although there is no assurance that such proceeds will be sufficient.

On April 18, 2013, we entered into a Controlled Equity Offering SM Sales Agreement (the Sales Agreement) with Cantor Fitzgerald & Co., as agent (Cantor), pursuant to which we may offer and sell, from time to time through Cantor, shares of our common stock having an aggregate offering price of up to $25.0 million (of which only $17.0 million was initially registered for offer and sale). Under the Sales Agreement, Cantor may sell shares by any method permitted by law and deemed to be an “at-the-market” offering as defined in Rule 415 promulgated under the Securities Act, as amended, including sales made directly on the NYSE MKT, on any other existing trading market for our common stock or to or through a market maker. We may instruct Cantor not to sell shares if the sales cannot be effected at or above the price designated by us from time to time. We are not obligated to make any sales of the shares under the Sales Agreement. The offering of shares pursuant to the Sales Agreement will terminate upon the earlier of (a) the sale of all of the shares subject to the Sales Agreement or (b) the termination of the Sales Agreement by Cantor or the Company, as permitted therein. We will pay Cantor a commission rate of 3.0% of the aggregate gross proceeds from each sale of shares and have agreed to provide Cantor with customary indemnification and contribution rights. We will also reimburse Cantor for certain specified expenses in connection with entering into the Sales Agreement. On April 22, 2013, NYSE MKT approved the listing of 10,593,220 shares of our common stock in connection with the Sales Agreement. During the year ended December 31, 2013, we issued 1,862,142 shares and received net proceeds of $4,906,078.  As of December 31, 2013, we had $11,754,071 remaining under the registration statement.  See additional discussion in Note 6 to the audited financial statements which are included in this Form 10-K.

In October 2012, we completed a $21,000,000 underwritten public offering, before commissions and costs of approximately $1.6 million, of 10 million units priced at $2.10 per unit. Each unit consisted of one share of common stock and a warrant to purchase 0.45 of a share of our common stock at an exercise price of $2.65 per share. In January 2012, we completed a $10,438,380 underwritten public offering, before commissions and costs of approximately $1.1 million, of 9,489,436 units at a price of $1.10 per unit. Each unit consists of one share of stock and a warrant to purchase 0.5 of a share of our common stock at an exercise price of $1.41 per share. In February 2011, we completed an $8,090,644 private placement, before commissions and costs of $630,000, of 5,219,768 units at a price of $1.55 per unit, with each unit consisting of one share of our common stock and a warrant to purchase 0.5 of a share of our common stock at an exercise price of $2.25 per share. In May 2010, we raised $2,716,308 (after commissions and offering expenses) from the sale of 2,490,910 shares of common stock and warrants to purchase 1,245,455 shares of common stock at an exercise price of $1.50 per share. In March 2010, we raised $1,654,686 (after commissions and offering expenses) from the sale of 1,740,000 shares of common stock and warrants to purchase 696,000 shares of common stock at an exercise price of $1.15 per share. We do not have any bank credit lines.

We may also in the future seek to obtain funding through strategic alliances with larger pharmaceutical or biomedical companies. We cannot be sure that we will be able to obtain any additional funding from either financings or alliances, or that the terms under which we may be able to obt ain such funding will be beneficial to us. If we are unsuccessful or only partly successful in our efforts to secure additional financing, we may find it necessary to suspend or terminate some or all of our product development and other activities.

28


As of December 31, 201 3, we had no long-term debt obligations, no capital lease obligations, or other similar long-term liabilities. We have various purchase commitments for sponsored research and license fees. We have no financial guarantees, debt or lease agreements or other arrangements that could trigger a requirement for an early payment or that could change the value of our assets, and we do not engage in trading activities involving non-exchange traded contracts.

Contractual Obligations

The following is a summary of our contractual obligations including those entered into subsequent to December 31, 201 3.

 

 

  

Total

 

 

Less than
1 year

 

  

1-3
years

 

  

3-5
years

 

  

More than
5 years

 

Unconditional purchase obligations

  

$

3,212,400

  

 

$

1,392,191

  

  

$

1,820,209

  

  

$

 

  

$

 

Operating lease obligation

  

$

267,061

  

 

 

97,724

  

  

 

169,337

 

  

 

 

  

 

 

 

  

$

3,479,461

  

 

$

1,489,915

  

  

$

1,989,546

  

  

$

 

  

$

 

Cash Flows

For the Year Ended December 31, 2013 and 2012

We used $8,787,217 of cash in our operations during the year ended December 31, 2013, compared to $12,380,013 during the year ended December 31, 2012. During 2012, we greatly expanded our research and development activities, expanded our investor relations program and obtained a listing on NYSE MKT.  Since we completed our ICT-107 patient enrollment in 2012, we did not incur ce rtain expenses related to product manufacturing or quality control during 2013.  During 2013, we recorded a non-cash credit of $642,411 related to the revaluation of our warrant derivatives.  In 2012, we incurred a non-cash charge of $2,279,923 related to the revaluation of our warrant derivatives. During 2013, we incurred a non-cash charge for stock based compensation of $724,212 compared to $496,007 during 2012.  Also during 2012, we incurred a non-cash charge of $397,294 related to the increase in the number of warrants outstanding that was triggered by the January and October 2012 financings.

During the year ended December 31, 2013, we used $44,372 of cash from our investing activities for the acquisition of computer equipment and a telephone system. During the year ended December 31, 2012, we used $9,828 of cash from our investing activities for the acquisition of computers.

We received $10,261,272 of cash from our financing activities during 2013, consisting of $324,519 from the exercise of stock options, $5,030,677 from the exercise of warrants and $4,906,078 in net proceeds from our controlled equity offering.  We received $31,953,341 of cash from our financing activities during 2012, consisting of $20,500 from the exercise of stock options, $3,201,918 from the exercise of warrants and $28,730,923 of net proceeds from the sale of our common stock and warrants.

For the Year Ended December 31, 2012 and 2011

We used $12,380,013 of cash in our operations during the year ended December 31, 2012, compared to $6,383,742 during the year ended December 31, 2011. During 2012, we continued the patient enrollement of ICT-107 that started in 2011 and we incurred certain expenses associated with the pre-clinical development of ICT-140. We also incurred additio nal general and administrative expenses to expand our infrastructure. During 2012, we incurred a non-cash charge of $2,279,923 related to the revaluation of our warrant derivatives. In 2011, we recorded a non-cash credit of $2,901,253 to reflect the decrease in our warrant derivative liability. During 2012, we incurred a non-cash charge for stock based compensation of $496,007 compared to $1,190,133 during 2011. Also, during 2012, we incurred a non-cash charge of $397,294 related to the increase in the number of warrants outstanding that was triggered by the January and October 2012 financings.

During the year ended December 31, 2012, we used $9,828 of cash from our investing activities for the acquisition of computers. During the year ended December 31, 2011, we used $84,392 of cash from our investing activities for the acquisition of property and equipment, primarily to support our research and development activities.

We received $31,953,341 of cash from our financing activities during 2012, consisting of $20,500 from the exercise of stock options, $3,201,918 from the exercise of warrants and $28,730,923 of net proceeds from the sale of our common stock and warrants. We received $7,801,526 of cash from our financing activities during 2011, consisting of $388,379 from the exercise of stock options, $53,018 from the repayment of a promissory note previously issued for common stock and $7,360,129 net proceeds from the sale of common stock and warrants.

29


Off-Balance Sheet Arrangements

We are not party to any off-balance sheet arrangements that have, or are reasonably likely to have, a material current or future effect on our financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources.

 

Item 7A.

Quantitative and Qualitative Disclosures About Market Risk.

Our market risk consists principally of interest rate risk on our cash and cash equivalents. Our exposure to market risk is limited primarily to interest income sensitivity, which is affected by changes in interest rates, particularly because the majority of our investments are in short-term certificates of deposit.

Our investment policy restricts our investments to high-quality investments and limits the amounts invested with any one issuer, industry, or geographic area. The goals of our investment policy are as follows: preservation of capital; assurance of liquidity needs and best available return on invested capital. Some of the securities in which we invest may be subject to market risk. This mea ns that a change in prevailing interest rates may cause the principal amount of the investment to fluctuate. For example, if we hold a security that was issued with an interest rate fixed at the then-prevailing rate and the prevailing interest rate later rises, the principal amount of our investment will probably decline. To minimize this risk, in accordance with our investment policy, we maintain our cash and cash equivalents in short-term marketable securities, including money market mutual funds and certificates of deposit. The risk associated with fluctuating interest rates is limited to our investment portfolio. Due to the short-term nature of our investment portfolio, we believe we have minimal interest rate risk arising from our investments. As of December 31, 2013 and 2012, a 10% change in interest rates would have had an immaterial effect on the value of our short-term marketable securities. We do not use derivative financial instruments in our investment portfolio. We do not hold any instruments for trading purposes.

To date, we have operated exclusively in the U.S. and have not had any material exposure to foreign currency rate fluctuations.

 

Item 8.

Financial Statements and Supplementary Data.

Our financial statements and notes thereto and the related reports of Marcum LLP are included in this Annual Report on Form 10-K beginning at page F-1 and are incorporated herein by reference.

 

Item 9.

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.

None.

 

Item 9A.

Controls and Procedures.

Evaluation of Disclosure Controls and Procedures

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in the reports that we file with the SEC under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and that such information is accumulated and communicated to our management, including our principal executive and financial officers, as appropr iate, to allow for timely decisions regarding required disclosure. As required by SEC Rule 15d-15(b), we carried out an evaluation, under the supervision and with the participation of our management, including our principal executive and financial officers, of the effectiveness of the design and operation of our disclosure controls and procedures as of December 31, 2013, which is the end of the period covered by this report. Based on the foregoing, our principal executive and financial officers concluded that our disclosure controls and procedures were effective as of December 31, 2013.

Management’s Report on Internal Control Over Financial Reporting

Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act, and for assessing the effectiveness of internal control over financial reporting.

Internal control over financial reporting is intended to provide reasonable assurance regarding the reliability of our financial reporting and the preparation of financial statements for external purposes in accordance with accounting principles generally accepted in the United States. Internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of our assets, (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with accounting principles generally accepted in the United States and that our receipts and expenditures are being made only in accordance with authorizations of our management and directors, and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisitions, use, or disposition of our assets that could have a material effect on our financial statements.

30


Management, with the participation of our principal executive and financial officers, conducted an evaluation of the effectiveness of our internal control over financial reporting, as of December 31, 201 3, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission in 1992. Based upon its evaluation, management concluded that, as of December 31, 2013, our internal control over financial reporting was effective.

Our registered independent public accounting firm, Marcum LLP, as auditors of the Company, have audited our internal controls over financial reporting as of December 31, 2013, and their report appears herein.

Changes in Internal Control Over Financial Reporting

There was no change in our internal control over financial reporting during the most recent fiscal quarter that materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

Item 9B.

Other Information.

None.

 

 

 

31


PART III.

 

Item 10.

Directors, Executive Officers and Corporate Governance.

We will file with the SEC a definitive Proxy Statement (the 201 4 Proxy Statement) , not later than 120 days after the fiscal year ended December 31, 2013.  The information required by this item is incorporated herein by reference to the information contained in the 2014 Proxy Statement.  

 

Item 11.

Executive Compensation

The information required by this item is incorporated herein by reference to the information contained in the 201 4 Proxy Statement.  

 

Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.

The information required by this item is incorporated herein by reference to the information contained in the 201 4 Proxy Statement.  

 

Item 13.

Certain Relationships and Related Transactions, and Director Independence.

The information required by this item is incorporated herein by reference to the information contained in the 201 4 Proxy Statement.  

 

Item 14.

Principal Accounting Fees and Services.

The information required by this item is incorporated herein by reference to the information contained in the 2014 Proxy Statement.  

 

 

 

 

32


PART IV.

 

Item 15.

Exhibits and Financial Statement Schedules

The company’s financial statements and related notes thereto are listed and included in this Annual Report beginning on page F-1, which information is incorporated herein by reference. The following exhibits are filed with, or are incorporated by reference into, this Annual Report.

 

Exhibit
Number

 

Description

 

 

2.1

  

Agreement and Plan of Reorganization dated as of May 5, 2005, as amended, among Patco Industries Subsidiary, Inc., William C. Patridge, and Spectral Molecular Imaging, Inc., as amended on June 30, 2005, September 26, 2005 and January 20, 2006. (1)

 

 

3.1

 

Amended and Restated Certificate of Incorporation of ImmunoCellular Therapeutics, Ltd. (2)

 

 

3.2

 

Certificate of Amendment of Amended and Restated Certificate of Incorporation of ImmunoCellular Therapeutics, Ltd. (2)

 

 

3.3

 

Certificate of Amendment of Amended and Restated Certificate of Incorporation of ImmunoCellular Therapeutics, Ltd. (3)

 

 

3.4

 

Certificate of Amendment of the Amended and Restated Certificate of Incorporation. (28)

 

 

3.5

 

Amended and Restated Bylaws of ImmunoCellular Therapeutics, Ltd. (23)

 

 

3.6

 

Amendment to the Amended and Restated Bylaws of ImmunoCellular Therapeutics, Ltd. (31)

 

 

3.7

 

Certificate of Amendment to the Amended and Restated Certificate of Incorporation of ImmunoCellular Therapeutics, Ltd. (39)

 

 

4.1

 

Form of Common Stock Certificate for ImmunoCellular Therapeutics, Ltd. (5)

 

 

4.2

 

Warrant dated December 3, 2009 issued by ImmunoCellular Therapeutics, Ltd. to Socius Capital Group, LLC d/b/a Socius Life Sciences Capital Group, LLC (20)

 

 

4.3

 

Amended Certificate of Designations of Preferences, Rights and Limitations of Series A Preferred Stock dated May 3, 2010. (21)

 

 

4.4

 

Form of Warrant issued to participants in the March 2010 private placement to purchase shares of common stock of ImmunoCellular Therapeutics, Ltd. (21)

 

 

4.5

 

Form of Warrant issued to participants in the May 2010 private placement to purchase shares of common stock of ImmunoCellular Therapeutics, Ltd. (22)

 

 

4.6

 

Warrant dated May 2, 2010 for 1,350,000 shares issued by ImmunoCellular Therapeutics, Ltd. to Socius CG II, Ltd. (21)

 

 

4.7

 

Form of Warrant issued to participants in the February 2011 private placement to purchase shares of common stock of ImmunoCellular Therapeutics, Ltd. (24)

 

 

4.8

 

Form of Warrant issued to participants in the January 13, 2012 underwritten public offering. (29)

 

 

4.9

 

Form of Specimen Preferred Stock Certificate and Form of Certificate of Designation of Preferred Stock*

 

 

4.10

 

Form of Debt Indenture, between Registrant and one or more trustees to be named (33)

 

 

4.11

 

Form of Common Stock Warrant Agreement and Warrant Certificate (33)

 

 

4.12

 

Form of Preferred Stock Warrant Agreement and Warrant Certificate (33)

 

 

4.13

 

Form of Debt Securities Warrant Agreement and Warrant Certificate (33)

 

 

10.1

 

Amended and Restated 2006 Equity Incentive Plan of ImmunoCellular Therapeutics, Ltd. (28)

 

 

10.2

 

Form of Non-Qualified Stock Option Agreement for the 2006 Equity Incentive Plan of ImmunoCellular Therapeutics, Ltd. (12)

33


Exhibit
Number

 

Description

 

 

10.3

 

Form of Incentive Stock Option Agreement for the 2006 Equity Incentive Plan of ImmunoCellular Therapeutics, Ltd. (12)

 

 

 

10.4

 

Exclusive License Agreement dated as of November 17, 2006 between Cedars-Sinai Medical Center and ImmunoCellular Therapeutics, Ltd.† (8)

 

 

10.5

 

First Amendment to Exclusive License Agreement dated as of June 16, 2008, between Cedars-Sinai Medical Center and ImmunoCellular Therapeutics, Ltd.† (9)

 

 

10.6

 

Stock Purchase Agreement dated as of November 17, 2006 between Cedars-Sinai Medical Center and ImmunoCellular Therapeutics, Ltd. (8)

 

 

10.7

 

Registration Rights Agreement dated as of November 17, 2006 between Cedars-Sinai Medical Center and ImmunoCellular Therapeutics, Ltd. (8)

 

 

10.8

 

Securities Purchase Agreement dated as of November 17, 2006 between Dr. John Yu and ImmunoCellular Therapeutics, Ltd. (8)

 

 

10.9

 

Agreement dated as of November 17, 2006 between Dr. John Yu and ImmunoCellular Therapeutics, Ltd.** (8)

 

 

10.10

 

Nonqualified Stock Option Agreement dated as of November 17, 2006 between Dr. John Yu and ImmunoCellular Therapeutics, Ltd.** (8)

 

 

10.11

 

Registration Rights Agreement dated as of November 17, 2006 between Dr. John Yu and ImmunoCellular Therapeutics, Ltd. (8)

 

 

10.12

 

Agreement dated as of February 14, 2008 between Molecular Discoveries, LLC and ImmunoCellular Therapeutics, Ltd. (11)

 

 

10.13

 

Registration Rights Agreement dated as of April 14, 2008, between Molecular Discoveries, LLC and ImmunoCellular Therapeutics, Ltd. (15)

 

 

10.14

 

Agreement dated as of August 1, 2008 between Dr. Cohava Gelber and ImmunoCellular Therapeutics, Ltd. ** (17)

 

 

10.15

 

Second Amendment dated August 1, 2009 to Exclusive License Agreement dated as of November 1, 2006 between Cedars-Sinai Medical Center and ImmunoCellular Therapeutics, Ltd. (19)

 

 

10.16

 

Preferred Stock Purchase Agreement dated as of December 3, 2009 between ImmunoCellular Therapeutics, Ltd. and Socius Capital Group, LLC d/b/a Socius Life Sciences Capital Group, LLC. (20)

 

 

10.17

 

Agreement dated March 1, 2010 between Dr. John Yu and ImmunoCellular Therapeutics, Ltd. ** (25)

 

 

10.18

 

Securities Purchase Agreement dated March 29, 2010 between participants in the March 2010 private placement and ImmunoCellular Therapeutics, Ltd. (22)

 

 

10.19

 

Form of Registration Rights Agreement dated as of March 29, 2010 between participants in the March 2010 private placement and ImmunoCellular Therapeutics, Ltd. (21)

 

 

10.20

 

Modification Agreement dated May 2, 2010 among Socius CG II, Ltd., Socius Life Sciences Capital Group, LLC and ImmunoCellular Therapeutics, Ltd. (21)

 

 

10.21

 

Third Amendment dated March 26, 2010 to Exclusive License Agreement dated as of November 1, 2006 between Cedars-Sinai Medical Center and ImmunoCellular Therapeutics, Ltd. (21)

 

 

10.22

 

Securities Purchase Agreement dated May 12, 2010 between participants in the May 2010 private placement and ImmunoCellular Therapeutics, Ltd. (22)

 

 

10.23

 

Form of Registration Rights Agreement between participants in the May 2010 private placement and ImmunoCellular Therapeutics, Ltd. (22)

 

 

10.24

 

Purchase Agreement, dated as of February 22, 2011, by and between the ImmunoCellular Therapeutics, Ltd. and each investor named therein. )24)

 

 

10.25

 

Registration Rights Agreement, dated as of February 22, 2011, by and among ImmunoCellular Therapeutics, Ltd. and the investors named therein. (24)

34


Exhibit
Number

 

Description

 

 

10.26

 

Exclusive Sublicense Agreement dated May 28, 2010 between Targepeutics, Inc. and ImmunoCellular Therapeutics, Ltd. † (26)

 

 

10.27

 

Sponsored Research and Vaccine Production Agreement dated January 1, 2011 between The Trustees of the University of Pennsylvania and ImmunoCellular Therapeutics, Ltd. † (26)

 

 

10.28

 

Placement agent agreement dated March 30, 2010 between Gilford Securities Incorporated and ImmunoCellular Therapeutics, Ltd. (26)

 

 

10.29

 

Placement agent agreement dated April 7, 2010 between Scarsdale Equities LLC and ImmunoCellular Therapeutics, Ltd. (26)

 

 

10.30

 

Consulting Agreement dated October 1, 2010 between JFS Investments and ImmunoCellular Therapeutics, Ltd. (26)

 

 

10.31

 

Advisory services agreement dated October 1, 2010 between Garden State Securities Inc. and ImmunoCellular Therapeutics, Ltd. (26)

 

 

10.32

 

Co-placement Agents Agreement dated January 31, 2011 among Summer Street Research Partners, Dawson James Securities, Inc. and ImmunoCellular Therapeutics, Ltd. (26)

 

 

10.33

 

Agreement dated as of March 1, 2011 between Dr. John Yu and ImmunoCellular Therapeutics, Ltd. ** (27)

 

 

10.34

 

Patent License Agreement, effective February 10, 2012, among The Trustees of the University of Pennsylvania and ImmunoCellular Therapeutics, Ltd.†(30)

 

 

10.35

 

Exclusive License Agreement, effective February 16, 2012, between the Johns Hopkins University and ImmunoCellular Therapeutics, Ltd.†(30)

 

 

10.36

 

Office Lease dated July 1, 2012 between Regent Business Centers and ImmunoCellular Therapeutics, Ltd. (32)

 

 

10.37

 

Form of Warrant issued to participants in the October 18, 2012 underwritten public offering.(34)

 

 

10.38

 

Employment Agreement dated December 3, 2012 between Andrew Gengos and ImmunoCellular Therapeutics, Ltd.**(35)

 

 

10.39

 

Form of Stock Option Grant Notice for the 2006 Equity Incentive Plan of ImmunoCellular Therapeutics, Ltd.(35)

 

 

10.40

 

Controlled Equity Offering SM Sales Agreement dated April 18, 2013 between ImmunoCellular Therapeutics, Ltd. and Cantor Fitzgerald & Co. (36)

 

 

10.41

 

Form of Indemnity Agreement between ImmunoCellular Therapeutics, Ltd. and each of its directors and executive officers. (37)

 

 

10.42

 

Office Lease dated May 13, 2013 between Calabasas/Sorrento Square, LLC and ImmunoCellular Therapeutics, Ltd. (38)

 

 

10.43

 

Master Services Agreement dated September 1, 2010 between Averion International Corp. and  ImmunoCellular Therapeutics, Ltd. (38)

 

 

10.44

 

Employment Agreement dated August 19, 2013 between Anthony Gringeri and ImmunoCellular Therapeutics, Ltd. **(40)

 

 

10.45

 

Amendment No. 1 to the Exclusive License Agreement between the Johns Hopkins University and ImmunoCellular Therapeutics, Ltd. † (40)

 

 

10.46

 

Amended and Restated 2006 Equity Incentive Plan of  ImmunoCellular Therapeutics, Ltd. (40)

 

 

10.47

 

Amendment No. 1 to Amended and Restated 2006  Equity Incentive Plan of ImmunoCellular Therapeutics, Ltd. (40)

 

 

10.48

 

Form of Stock Option Grant Notice for the 2006  Equity Incentive Plan of ImmunoCellular Therapeutics, Ltd. (40)

 

 

10.49

 

Master Services Agreement dated September 17, 2013 between Aptiv Solutions, Inc. and ImmunoCellular Therapeutics, Ltd. ***

 

 

23.1

 

Consent of Marcum LLP. ***

 

 

24.1

 

Power of Attorney (included in the signature page hereto)***

35


Exhibit
Number

 

Description

 

 

31.1

 

Certification of the registrant’s Principal Executive Officer under Exchange Act Rule 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.***

 

 

31.2

 

Certification of the registrant’s Principal Financial Officer under Exchange Act Rule 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.***

 

 

32.1

 

Certification of the registrant’s Principal Executive Officer under 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.***

 

 

32.2

 

Certification of the registrant’s Principal Financial Officer under 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.***

 

 

101

 

The following financial information from the Annual Report on Form 10-K of ImmunoCellular, Ltd. for the year ended December 31, 2013, formatted in XBRL (eXtensible Business Reporting Language): (1) Balance Sheets as of December 31, 2013, and 2012; (2) Statements of Operations for the years ended December 31, 2013, 2012 and 2011 and from February 25, 2004 (Inception) to December 31, 2013; (3) Statements of Stockholders’ Equity (Deficit) from February 25, 2004 (Inception) through December 31, 2013; (4) Statements of Cash Flows for the years ended December 31, 2013, 2012 and 2011and from February 25, 2004 (Inception) to December 31, 2013; and (5) Notes to Financial Statements.

Certain portions of the exhibit have been omitted based upon a request for confidential treatment filed by us with the Securities and Exchange Commission. The omitted portions of the exhibit have been separately filed by us with the Securities and Exchange Commission.

*

To be filed by amendment.

**

Indicates a management contract or compensatory plan or arrangement.

***

Filed with this Form 10-K.

(1)

Previously filed by us on January 26, 2006 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.

(2)

Previously filed by us on November 3, 2006 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.

(3)

Previously filed by us on May 9, 2007 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.

(4)

Previously filed by us on February 6, 2006 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.

(5)

Previously filed by us on February 12, 2007 as an exhibit to our Registration Statement on Form SB-2, File No. 333-140598, and incorporated herein by reference.

(6)

Previously filed by us on May 1, 2007 as an exhibit to our Registration Statement on Form SB-2, File No. 333-142480, and incorporated herein by reference.

(7)

Previously filed by us on July 12, 2007 as an exhibit to our Registration Statement on Form SB-2, File No. 333-144521, and incorporated herein by reference

(8)

Previously filed by us on November 22, 2006 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.

(9)

Previously filed by us on August 14, 2008 as an exhibit to our Quarterly Report on Form 10-Q and incorporated herein by reference.

(10)

Previously filed by us on September 14, 2007 as an exhibit to our Registration Statement on Form SB-2/A, File No. 333-144521 and incorporated herein by reference.

(11)

Previously filed by us on March 25, 2008 as an exhibit to our Annual Report on Form 10-KSB and incorporated herein by reference.

(12)

Previously filed by us on November 9, 2007 as an exhibit to our Registration Statement on Form S-8, File No. 333-147278, and incorporated herein by reference.

(13)

Previously filed by us on November 6, 2007 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.

(14)

Previously filed by us on April 2, 2007 as an exhibit to our Annual Report on Form 10-KSB and incorporated herein by reference.

(15)

Previously filed by us on April 16, 2008 as an exhibit to our Registration Statement on Form S-1, File No. 333-150277, and incorporated herein by reference.

(16)

Previously filed by us on November 13, 2008 as an exhibit to our Quarterly Report on Form 10-Q and incorporated herein by reference.

(17)

Previously filed by us on March 30, 2009 as an exhibit to our Annual Report on Form 10-K and incorporated herein by reference.

36


(18)

Previously filed by us on August 14, 2009 as an exhibit to our Quarterly Report on Form 10-Q and incorporated herein by reference.

(19)

Previously filed by us on November 13, 2009 as an exhibit to our Quarterly Report on Form 10-Q and incorporated herein by reference.

(20)

Previously filed by us on December 7, 2009 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.

(21)

Previously filed by us on May 12, 2010 as an exhibit to our Registration Statement on Form S-1 to SB-2, File No. 333-144521 and incorporated herein by reference.

(22)

Previously filed by us on May 18, 2010 as an exhibit to our Quarterly Report on Form 10-Q and incorporated herein by reference.

(23)

Previously filed by us on January 11, 2011 as an exhibit to our Registration Statement on Form S-8, File No. 333-171652 and incorporated herein by reference.

(24)

Previously filed by us on February 25, 2011 as an exhibit to our current report on Form 8-K and incorporated herein by reference.

(25)

Previously filed by us on March 31, 2010 as an exhibit to our Annual Report on Form 10-K and incorporated herein by reference.

(26)

Previously filed by us on March 31, 2011 as an exhibit to our Annual Report on Form 10-K and incorporated herein by reference.

(27)

Previously filed by us on August 18, 2011 as an exhibit to our Quarterly Report on Form 10-Q and incorporated herein by reference.

(28)

Previously filed by us on November 14, 2011 as an exhibit to our Quarterly Report on Form 10-Q and incorporated herein by reference.

(29)

Previously filed by us on January 10, 2012 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.

(30)

Previously filed by us on March 21, 2012 as an exhibit to our Annual Report on Form 10-K and incorporated herein by reference.

(31)

Previously filed by us on May 25, 2012 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.

(32)

Previously filed by us on August 14, 2012 as an exhibit to our Quarterly Report on Form 10-Q and incorporated herein by reference.

(33)

Previously filed by us on September 21, 2012 as an exhibit to our Registration Statement on Form S-3, File No. 333-184010 and incorporated herein by reference.

(34)

Previously filed by us on October 19, 2012 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.

(35)

Previously filed by us on March 11, 2013 as an exhibit to our Annual Report on Form 10-K and incorporated herein by reference.

(36)

Previously filed by us on April 18, 2013 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.

(37)

Previously filed by us on May 9, 2013 as an exhibit to our Quarterly Report on Form 10-Q and incorporated herein by reference.

(38)

Previously filed by us on August 8, 2013 as an exhibit to our Quarterly Report on Form 10-Q and incorporated herein by reference.

(39)

Previously filed by us on September 24, 2013 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.

(40)

Previously filed by us on November 7, 2013 as an exhibit to our Quarterly Report on Form 10-Q and incorporated herein by reference.

 

 

 

37


SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

 

 

IMMUNOCELLULAR THERAPEUTICS, LTD.

 

 

 

 

Date: March 14, 2014

 

By:

 

/s/ Andrew Gengos

 

 

 

 

Andrew Gengos

 

 

 

 

President and Chief Executive Officer

POWER OF ATTORNEY

KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Andrew Gengos and David Fractor or either of them, his or her attorney-in-fact, each with the power of substitution, for him or her in any and all capacities, to sign any amendments to this Annual Report on Form 10-K, and to file the same, with exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, hereby ratifying and confirming all that each of sai d attorneys-in-fact, or his or her substitute or substitutes, may do or cause to be done by virtue hereof.

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.

 

Signature

  

Title

  

Date

 

 

 

 

 

/s/ Andrew Gengos

  

President, Chief Executive Officer and Director

  

March 14, 2014

Andrew Gengos

  

 

  

 

 

 

 

 

 

/s/ David Fractor

  

Principal Financial and Accounting Officer

  

March 14, 2014

David Fractor

  

 

  

 

 

 

 

 

 

/s/ Richard Chin

  

Director

  

March 14, 2014

Richard Chin, M.D.

  

 

  

 

 

 

 

 

 

/s/ Helen S. Kim

  

Director

  

March 14, 2014

Helen S. Kim

  

 

  

 

 

 

 

 

 

/s/ Rahul Singhvi

  

Director

  

March 14, 2014

Rahul Singhvi, Sc.D.

  

 

  

 

 

 

 

 

 

/s/ Gary S. Titus

  

Director

  

March 14, 2014

Gary S. Titus

  

 

  

 

 

 

 

 

 

/s/ John S. Yu

  

Director

  

March 14, 2014

John S. Yu, M.D.

  

 

  

 

 

 

 

38


ImmunoCellular Therapeutics, Ltd.

(a Development Stage Company)

Index to Financial Statements

 

 

  

Page

Financial Statements:

  

 

 

 

 

 

 

Reports of Independent Registered Public Accounting Firm – Marcum LLP

  

F–

2

Balance Sheets as of December 31, 2013 and 2012

  

F–

4

Statements of Operations for each of the three years in the period ended December 31, 2013 and from February 25, 2004 (Inception) to December 31, 2013

  

F–

5

Statements of Shareholders Equity (Deficit) from February 25, 2004 (Inception) to December 31, 2013

  

F–

6

Statements of Cash Flows for each of the three years in the period ended December 31, 2013 and from February 25, 2004 (Inception) to December 31, 2013

  

F–

9

Notes to Financial Statements

  

F–

10

 

 

 

F-1


Report of Independent Registered Public Accounting Firm

To the Audit Committee of the

Board of Directors and Shareholders of

ImmunoCellular Therapeutics, Ltd.

 

 

We have audited the accompanying balance sheets of ImmunoCellular Therapeutics, Ltd. (a Development Stage Company) (the “Company”) as of December 31, 2013 and 2012, and the related statements of operations, shareholders’ equity (deficit) and cash flows for each of the years ended December 31, 2013, 2012 and 2011 and for the period from February 25, 2004 (inception) to December 31, 2013.  Our audits also included the financial statement schedule as of and for the years listed in the index at Item 15(a)(2).  These financial statements and financial statement schedule are the responsibility of the Company’s management.  Our responsibility is to express an opinion on these financial statements and financial statement schedule based on our audits. The accompanying financial statements of the Company for the period from February 25, 2004 (inception) to December 31, 2009 were not audited by us.  Those statements were audited by other auditors whose report, dated March 29, 2010, expressed an unqualified opinion on those financial statements.  The financial statements for the period from February 25, 2004 (inception) to December 31, 2009 reflect a net loss of $14,711,146.  Our opinion, insofar as it relates to the amounts included for such prior periods as indicated in the accompanying financial statements for such periods from February 25, 2004 (inception) to December 31, 2009, is based solely on the report of such other auditors.

 

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States).  Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement.  An audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation.  We believe that our audits provide a reasonable basis for our opinion.

 

In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of ImmunoCellular Therapeutics, Ltd. (a Development Stage Company) as of December 31, 2013 and 2012, and the results of its operations and its cash flows for the years ended December 31, 2013, 2012 and 2011 and for the period from February 25, 2004 (inception) to December 31, 2013 in conformity with accounting principles generally accepted in the United States of America.  Also, in our opinion, the related financial statement schedule, when considered in relation to the basic financial statements taken as a whole, presents fairly in all material respects the information set forth therein.

 

We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), ImmunoCellular Therapeutics, Ltd.’s (a Development Stage Company) internal control over financial reporting as of December 31, 2013, based on the criteria established in Internal Control - Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission in 1992 and our report dated March 14, 2014 expressed an unqualified opinion on the effectiveness of the Company’s internal control over financial reporting.

 

 

/s/ Marcum LLP

 

Los Angeles, CA

March 14, 2014

 

F-2


Report of Independent Registered Public Accounting Firm

on Internal Control Over Financial Reporting

To the Audit Committee of the

Board of Directors and Shareholders of

ImmunoCellular Therapeutics, Ltd.

 

 

We have audited ImmunoCellular Therapeutics, Ltd.’s (a Development Stage Company) (the “Company”) internal control over financial reporting as of December 31, 2013, based on criteria established in Internal Control - Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission in 1992. The Company's management is responsible for maintaining effective internal control over financial reporting, and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying “Management Annual Report on Internal Control over Financial Reporting . Our responsibility is to express an opinion on the Company's internal control over financial reporting based on our audit.

 

We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit of internal control over financial reporting included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk. Our audit also included performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.

 

A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company's internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.

 

Because of the inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that degree of compliance with the policies or procedures may deteriorate.  

 

In our opinion, ImmunoCellular Therapeutics, Ltd (a Development Stage Company) maintained, in all material aspects, effective internal control over financial reporting as of December 31, 2013, based on criteria established in Internal Control – Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission in 1992.

 

We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the balance sheets as of December 31, 2013 and 2012 and the related statements of operations, shareholders’ equity (deficit), and cash flows and the related financial statement schedule for each of the years ended December 31, 2013, 2012 and 2011, and for the period from February 25, 2004 (inception) to December 31, 2013 of the Company and our report dated March 14, 2014 expressed an unqualified opinion on those financial statements and financial statement schedule.

 

 

/s/ Marcum LLP

 

Los Angeles, CA

March 14, 2014

 

 

 

 

F-3


ImmunoCellular Therapeutics, Ltd.

(A Development Stage Company)

Balance Sheets

 

 

 

December 31, 2013

 

 

December 31, 2012

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

27,646,351

 

 

$

26,216,668

 

Other assets

 

 

763,299

 

 

 

714,508

 

 

 

 

 

 

 

 

 

 

Total current assets

 

 

28,409,650

 

 

 

26,931,176

 

 

 

 

 

 

 

 

 

 

Property and equipment, net

 

 

66,442

 

 

 

76,289

 

 

 

 

 

 

 

 

 

 

Other assets

 

 

464,585

 

 

 

11,736

 

 

 

 

 

 

 

 

 

 

Total assets

 

$

28,940,677

 

 

$

27,019,201

 

 

 

 

 

 

 

 

 

 

Liabilities and Shareholders’ Equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

861,026

 

 

$

732,851

 

Accrued compensation and benefits

 

 

357,265

 

 

 

309,345

 

Accrued liabilities

 

 

183,982

 

 

 

56,111

 

 

 

 

 

 

 

 

 

 

Total current liabilities

 

 

1,402,273

 

 

 

1,098,307

 

 

 

 

 

 

 

 

 

 

Warrant Liability

 

 

1,064,810

 

 

 

2,852,880

 

 

 

 

 

 

 

 

 

 

Commitments and contingencies (Note 5)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shareholders’ equity:

 

 

 

 

 

 

 

 

Common stock, $0.0001 par value; 149,000,000 shares and 99,000,000 shares authorized as of December 31, 2013 and 2012 respectively; 57,542,231 shares and 51,500,996 shares issued and outstanding as of December 31, 2013 and 2012, respectively

 

 

5,754

 

 

 

5,150

 

Additional paid-in capital

 

 

78,437,233

 

 

 

66,231,694

 

Deficit accumulated during the development stage

 

 

(51,969,393

)

 

 

(43,168,830

)

 

 

 

 

 

 

 

 

 

Total shareholders’ equity

 

 

26,473,594

 

 

 

23,068,014

 

 

 

 

 

 

 

 

 

 

Total liabilities and shareholders’ equity

 

$

28,940,677

 

 

$

27,019,201

 

 

 

 

 

 

 

 

 

 

 

 

 

The accompanying notes are an integral part of these financial statements.

 

 

 

F-4


ImmunoCellular Therapeutics, Ltd.

(A Development Stage Company)

 

Statements of Operations

For the Years Ended December 31,

 

 

 

2013

 

 

2012

 

 

2011

 

 

February 25, 2004 (Inception) to December 31, 2013

 

Revenues

 

$

-

 

 

$

-

 

 

$

-

 

 

$

300,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

5,339,716

 

 

 

7,711,233

 

 

 

4,988,612

 

 

 

23,599,829

 

Stock based compensation

 

 

724,212

 

 

 

496,007

 

 

 

1,190,133

 

 

 

9,440,224

 

General and administrative

 

 

3,396,391

 

 

 

3,619,291

 

 

 

2,446,757

 

 

 

16,081,138

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total expenses

 

 

9,460,319

 

 

 

11,826,531

 

 

 

8,625,502

 

 

 

49,121,191

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss before other income (expense)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

and income taxes

 

 

(9,460,319

)

 

 

(11,826,531

)

 

 

(8,625,502

)

 

 

(48,821,191

)

Interest income

 

 

17,345

 

 

 

8,609

 

 

 

4,346

 

 

 

365,089

 

Financing expense

 

 

-

 

 

 

(397,294

)

 

 

-

 

 

 

(397,294

)

Change in fair value of

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

warrant liability

 

 

642,411

 

 

 

(2,279,923

)

 

 

2,901,253

 

 

 

(1,023,497

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss before income taxes

 

 

(8,800,563

)

 

 

(14,495,139

)

 

 

(5,719,903

)

 

 

(49,876,893

)

Income taxes

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Net loss

 

 

(8,800,563

)

 

 

(14,495,139

)

 

 

(5,719,903

)

 

 

(49,876,893

)

Deemed dividend on redemption

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

of preferred stock

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(2,092,500

)

Net loss attributable to common stock

 

$

(8,800,563

)

 

$

(14,495,139

)

 

$

(5,719,903

)

 

$

(51,969,393

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share basic and diluted

 

$

(0.16

)

 

$

(0.35

)

 

$

(0.21

)

 

$

(2.55

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average number of shares

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

basic and diluted

 

 

54,281,189

 

 

 

41,797,048

 

 

 

27,450,559

 

 

 

20,405,284

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

The accompanying notes are an integral part of these financial statements.

 

 

F-5


ImmunoCellular Therapeutics, Ltd.

(A Development Stage Company)

Statements of Shareholders’ Equity (Deficit)

 

 

Preferred Stock

 

 

Common Stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Additional Paid-in Capital

 

 

Promissory Note

 

 

Deficit Accumulated During the Development Stage

 

 

Total

 

Initial capitalization at $0.00002 per share

 

-

 

 

$

-

 

 

 

6,256,500

 

 

$

10

 

 

$

87

 

 

$

-

 

 

$

-

 

 

$

97

 

Common stock issued for cash during 2004 at $0.00078 per share

 

-

 

 

 

-

 

 

 

193,500

 

 

 

15

 

 

 

135

 

 

 

-

 

 

 

-

 

 

 

150

 

Net loss

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(11,741

)

 

 

(11,741

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at December 31, 2004

 

-

 

 

 

-

 

 

 

6,450,000

 

 

 

25

 

 

 

222

 

 

 

-

 

 

 

(11,741

)

 

 

(11,494

)

Common stock issued for cash during 2005 at $0.19 per share

 

-

 

 

 

-

 

 

 

387,000

 

 

 

659

 

 

 

74,341

 

 

 

-

 

 

 

-

 

 

 

75,000

 

Common stock issued for cash during 2005 at $0.32 per share

 

-

 

 

 

-

 

 

 

154,800

 

 

 

16

 

 

 

49,984

 

 

 

-

 

 

 

-

 

 

 

50,000

 

Common stock issued for research and development during 2005 at $0.99 per share

 

-

 

 

 

-

 

 

 

154,800

 

 

 

15

 

 

 

152,745

 

 

 

-

 

 

 

-

 

 

 

152,760

 

Net loss

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(246,004

)

 

 

(246,004

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at December 31, 2005

 

-

 

 

 

-

 

 

 

7,146,600

 

 

 

715

 

 

 

277,292

 

 

 

-

 

 

 

(257,745

)

 

 

20,262

 

Common stock issued for services during 2006 at $0.50 per share

 

-

 

 

 

-

 

 

 

73,093

 

 

 

7

 

 

 

36,539

 

 

 

-

 

 

 

-

 

 

 

36,546

 

Common stock issued for cash during 2006 in private placements at $1.00 per share, net of redemptions

 

-

 

 

 

-

 

 

 

1,510,000

 

 

 

151

 

 

 

549,249

 

 

 

-

 

 

 

-

 

 

 

549,400

 

Common stock issued for research and development during 2006 at $1.00 per share

 

-

 

 

 

-

 

 

 

694,000

 

 

 

69

 

 

 

693,931

 

 

 

-

 

 

 

-

 

 

 

694,000

 

Shares issued in connection with reverse merger

 

-

 

 

 

-

 

 

 

825,124

 

 

 

83

 

 

 

(83

)

 

 

-

 

 

 

-

 

 

 

-

 

Shares cancelled in connection with the sale of Optical Molecular Imaging, Inc.

 

-

 

 

 

-

 

 

 

(2,059,100

)

 

 

(206

)

 

 

(64,794

)

 

 

-

 

 

 

-

 

 

 

(65,000

)

Exercise of stock options

 

-

 

 

 

-

 

 

 

10,062

 

 

 

1

 

 

 

3,521

 

 

 

-

 

 

 

-

 

 

 

3,522

 

Stock based compensation (options)

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

4,103,645

 

 

 

-

 

 

 

-

 

 

 

4,103,645

 

Net loss

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(5,152,713

)

 

 

(5,152,713

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at December 31, 2006

 

-

 

 

 

-

 

 

 

8,199,779

 

 

 

820

 

 

 

5,599,300

 

 

 

-

 

 

 

(5,410,458

)

 

 

189,662

 

Common stock issued for cash during 2007 in private placements at $1.50 per share

 

-

 

 

 

-

 

 

 

3,531,603

 

 

 

353

 

 

 

4,892,133

 

 

 

-

 

 

 

-

 

 

 

4,892,486

 

Exercise of stock options

 

-

 

 

 

-

 

 

 

51,111

 

 

 

5

 

 

 

(5

)

 

 

-

 

 

 

-

 

 

 

-

 

Reclassification of warrant derivative liability

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

2,233,600

 

 

 

-

 

 

 

-

 

 

 

2,233,600

 

Stock based compensation (options)

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

1,296,714

 

 

 

-

 

 

 

-

 

 

 

1,296,714

 

Net loss

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(3,614,753

)

 

 

(3,614,753

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at December 31, 2007

 

-

 

 

 

-

 

 

 

11,782,493

 

 

 

1,178

 

 

 

14,021,742

 

 

 

-

 

 

 

(9,025,211

)

 

 

4,997,709

 

Common stock issued for research and development during 2008 at $0.53 per share

 

-

 

 

 

-

 

 

 

800,000

 

 

 

80

 

 

 

423,920

 

 

 

-

 

 

 

-

 

 

 

424,000

 

Common stock issued for research and development during 2008 at $0.65 per share

 

-

 

 

 

-

 

 

 

100,000

 

 

 

10

 

 

 

64,990

 

 

 

-

 

 

 

-

 

 

 

65,000

 

Stock based compensation (options)

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

513,357

 

 

 

-

 

 

 

-

 

 

 

513,357

 

Net loss

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(3,059,730

)

 

 

(3,059,730

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at December 31, 2008

 

-

 

 

 

-

 

 

 

12,682,493

 

 

 

1,268

 

 

 

15,024,009

 

 

 

-

 

 

 

(12,084,941

)

 

 

2,940,336

 

Exercise of warrants

 

-

 

 

 

-

 

 

 

1,970,992

 

 

 

197

 

 

 

462,551

 

 

 

-

 

 

 

-

 

 

 

462,748

 

Exercise of stock options

 

-

 

 

 

-

 

 

 

214,357

 

 

 

22

 

 

 

64,460

 

 

 

(52,668

)

 

 

-

 

 

 

11,814

 

Stock based compensation (options)

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

308,302

 

 

 

-

 

 

 

-

 

 

 

308,302

 

Net loss

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(2,626,205

)

 

 

(2,626,205

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at December 31, 2009

 

-

 

 

 

-

 

 

 

14,867,842

 

 

 

1,487

 

 

 

15,859,322

 

 

 

(52,668

)

 

 

(14,711,146

)

 

 

1,096,995

 

F-6


 

Preferred Stock

 

 

Common Stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Additional Paid-in Capital

 

 

Promissory Note

 

 

Deficit Accumulated During the Development Stage

 

 

Total

 

Common stock and warrants issued for cash during 2010 at $1.00 per share, net of offering costs

 

-

 

 

 

-

 

 

 

4,230,910

 

 

 

423

 

 

 

3,248,315

 

 

 

-

 

 

 

-

 

 

 

3,248,738

 

Preferred stock and warrants issued for cash during 2010 at $10,000 per share, net of offering costs

 

400

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Exercise of warrants in exchange for promissory note

 

-

 

 

 

-

 

 

 

2,700,000

 

 

 

270

 

 

 

5,399,730

 

 

 

(5,400,000

)

 

 

-

 

 

 

-

 

Redemption of preferred stock for repayment of promissory note

 

(400

)

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

5,400,000

 

 

 

(2,092,500

)

 

 

3,307,500

 

Exercise of stock options

 

-

 

 

 

-

 

 

 

50,000

 

 

 

5

 

 

 

26,495

 

 

 

-

 

 

 

-

 

 

 

26,500

 

Cashless exercise of stock options

 

-

 

 

 

-

 

 

 

297,156

 

 

 

30

 

 

 

(30

)

 

 

-

 

 

 

-

 

 

 

-

 

Common stock issued for services during 2010 at $0.90 per share

 

-

 

 

 

-

 

 

 

60,000

 

 

 

6

 

 

 

53,994

 

 

 

-

 

 

 

-

 

 

 

54,000

 

Common stock issued for services during 2010 at $1.06 per share

 

-

 

 

 

-

 

 

 

7,694

 

 

 

-

 

 

 

8,156

 

 

 

-

 

 

 

-

 

 

 

8,156

 

Stock based compensation

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

745,697

 

 

 

-

 

 

 

-

 

 

 

745,697

 

Interest on promissory note

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(1,614

)

 

 

-

 

 

 

(1,614

)

Net loss

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(6,150,142

)

 

 

(6,150,142

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at December 31, 2010

 

-

 

 

 

-

 

 

 

22,213,602

 

 

 

2,221

 

 

 

25,341,679

 

 

 

(54,282

)

 

 

(22,953,788

)

 

 

2,335,830

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common stock and warrants issued for cash during 2011 at $1.55 per share, net of offering costs

 

-

 

 

 

-

 

 

 

5,219,768

 

 

 

522

 

 

 

4,982,817

 

 

 

-

 

 

 

-

 

 

 

4,983,339

 

Exercise of stock options

 

-

 

 

 

-

 

 

 

382,000

 

 

 

38

 

 

 

388,341

 

 

 

-

 

 

 

-

 

 

 

388,379

 

Cashless exercise of stock options

 

-

 

 

 

-

 

 

 

667,077

 

 

 

67

 

 

 

(67

)

 

 

-

 

 

 

-

 

 

 

-

 

Stock based compensation

 

-

 

 

 

-

 

 

 

131,537

 

 

 

13

 

 

 

1,190,120

 

 

 

-

 

 

 

-

 

 

 

1,190,133

 

Interest on promissory note

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(352

)

 

 

-

 

 

 

(352

)

Redemption of promissory note

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

54,634

 

 

 

-

 

 

 

54,634

 

Net loss

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(5,719,903

)

 

 

(5,719,903

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at December 31, 2011

 

-

 

 

 

-

 

 

 

28,613,984

 

 

 

2,861

 

 

 

31,902,890

 

 

 

-

 

 

 

(28,673,691

)

 

 

3,232,060

 

Common stock and warrants issued for cash during January 2012 at $1.10 per share, net of offering costs

 

-

 

 

 

-

 

 

 

9,489,436

 

 

 

949

 

 

 

9,270,421

 

 

 

-

 

 

 

-

 

 

 

9,271,370

 

Common stock and warrants issued for cash during October 2012 at $2.10 per share, net of offering costs

 

-

 

 

 

-

 

 

 

10,000,000

 

 

 

1,000

 

 

 

19,358,553

 

 

 

-

 

 

 

-

 

 

 

19,359,553

 

Exercise of warrants

 

-

 

 

 

-

 

 

 

2,295,334

 

 

 

230

 

 

 

3,201,690

 

 

 

-

 

 

 

-

 

 

 

3,201,920

 

Reclassification of warrant liability upon exercise

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

1,981,743

 

 

 

-

 

 

 

-

 

 

 

1,981,743

 

Cashless exercise of warrants

 

-

 

 

 

-

 

 

 

288,973

 

 

 

29

 

 

 

(29

)

 

 

-

 

 

 

-

 

 

 

-

 

Cashless exercise of stock options

 

-

 

 

 

-

 

 

 

792,018

 

 

 

79

 

 

 

(79

)

 

 

-

 

 

 

-

 

 

 

-

 

Restricted stock vested

 

-

 

 

 

-

 

 

 

1,251

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Stock based compensation

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

496,007

 

 

 

-

 

 

 

-

 

 

 

496,007

 

Exercise of stock options

 

-

 

 

 

-

 

 

 

20,000

 

 

 

2

 

 

 

20,498

 

 

 

-

 

 

 

-

 

 

 

20,500

 

Net loss

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(14,495,139

)

 

 

(14,495,139

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at December 31, 2012

 

-

 

 

 

-

 

 

 

51,500,996

 

 

 

5,150

 

 

 

66,231,694

 

 

 

-

 

 

 

(43,168,830

)

 

 

23,068,014

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exercise of warrants

 

-

 

 

 

-

 

 

 

3,441,551

 

 

 

344

 

 

 

6,175,992

 

 

 

-

 

 

 

-

 

 

 

6,176,336

 

Cashless exercise of warrants

 

-

 

 

 

-

 

 

 

31,155

 

 

 

3

 

 

 

(3

)

 

 

-

 

 

 

-

 

 

 

-

 

Exercise of stock options

 

-

 

 

 

-

 

 

 

528,702

 

 

 

53

 

 

 

324,464

 

 

 

-

 

 

 

-

 

 

 

324,517

 

Cashless exercise of stock options

 

-

 

 

 

-

 

 

 

149,385

 

 

 

15

 

 

 

(15

)

 

 

-

 

 

 

-

 

 

 

-

 

Stock based compensation

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

724,212

 

 

 

-

 

 

 

-

 

 

 

724,212

 

F-7


 

Preferred Stock

 

 

Common Stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Additional Paid-in Capital

 

 

Promissory Note

 

 

Deficit Accumulated During the Development Stage

 

 

Total

 

Common stock issued for licensing rights in January 2013 at $2.41 per share

 

-

 

 

 

-

 

 

 

28,300

 

 

 

3

 

 

 

74,997

 

 

 

-

 

 

 

-

 

 

 

75,000

 

Common stock issued through controlled equity offering during May at an average of $2.57 per share

 

-

 

 

 

-

 

 

 

172,988

 

 

 

17

 

 

 

404,174

 

 

 

-

 

 

 

-

 

 

 

404,191

 

Common stock issued through controlled equity offering during July at an average of $2.79 per share

 

-

 

 

 

-

 

 

 

770,508

 

 

 

77

 

 

 

2,013,047

 

 

 

-

 

 

 

-

 

 

 

2,013,124

 

Common stock issued through controlled equity offering during August at an average of $2.90 per share

 

-

 

 

 

-

 

 

 

642,604

 

 

 

64

 

 

 

1,752,274

 

 

 

-

 

 

 

-

 

 

 

1,752,338

 

Common stock issued through controlled equity offering during September at an average of $2.84 per share

 

-

 

 

 

-

 

 

 

276,042

 

 

 

28

 

 

 

736,397

 

 

 

-

 

 

 

-

 

 

 

736,425

 

Net loss

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(8,800,563

)

 

 

(8,800,563

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at December 31, 2013

 

-

 

 

$

-

 

 

 

57,542,231

 

 

$

5,754

 

 

$

78,437,233

 

 

$

-

 

 

$

(51,969,393

)

 

$

26,473,594

 

 

 

 

 

 

 

 

 

 

 

The accompanying notes are an integral part of these financial statements.

 

 

 

F-8


ImmunoCellular Therapeutics, Ltd.

(A Development Stage Company)

Statements of Cash Flows

For the Years Ended December 31,

 

 

 

2013

 

 

2012

 

 

2011

 

 

February 25, 2004,

(Inception) to

December 31, 2013

 

Cash flows from operating activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(8,800,563

)

 

$

(14,495,139

)

 

$

(5,719,903

)

 

$

(49,876,893

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

50,402

 

 

 

45,823

 

 

 

20,357

 

 

 

125,687

 

Interest accrued on promissory note

 

 

-

 

 

 

-

 

 

 

1,264

 

 

 

 

 

Loss on disposal of assets

 

 

3,817

 

 

 

-

 

 

 

-

 

 

 

3,817

 

Change in fair value of warrant liability

 

 

(642,411

)

 

 

2,279,923

 

 

 

(2,901,253

)

 

 

1,023,497

 

Financing expense

 

 

-

 

 

 

397,294

 

 

 

-

 

 

 

397,294

 

Stock-based compensation

 

 

724,212

 

 

 

496,007

 

 

 

1,190,133

 

 

 

9,378,068

 

Common stock issued for services

 

 

-

 

 

 

-

 

 

 

-

 

 

 

98,703

 

Common stock issued for research and development

 

 

-

 

 

 

-

 

 

 

-

 

 

 

1,335,760

 

Changes in assets and liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other assets

 

 

(426,640

)

 

 

(623,538

)

 

 

(105,581

)

 

 

(1,219,047

)

Accounts payable

 

 

128,175

 

 

 

(401,090

)

 

 

962,876

 

 

 

860,676

 

Accrued liabilities

 

 

175,791

 

 

 

(79,293

)

 

 

168,365

 

 

 

541,247

 

Net cash used in operating activities

 

 

(8,787,217

)

 

 

(12,380,013

)

 

 

(6,383,742

)

 

 

(37,331,191

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash flows from investing activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Purchase of property and equipment

 

 

(44,372

)

 

 

(9,828

)

 

 

(84,392

)

 

 

(200,064

)

Cash paid for sale of Optical Molecular Imaging, Inc.

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(25,000

)

Net cash used in investing activities

 

 

(44,372

)

 

 

(9,828

)

 

 

(84,392

)

 

 

(225,064

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash flows from financing activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Proceeds from exercise of stock options

 

 

324,517

 

 

 

20,500

 

 

 

388,379

 

 

 

775,230

 

Proceeds from exercise of warrants

 

 

5,030,677

 

 

 

3,201,918

 

 

 

-

 

 

 

8,695,343

 

Payments on promissory note receivable

 

 

-

 

 

 

-

 

 

 

53,018

 

 

 

53,018

 

Proceeds from issuance of common stock and warrants net of offering costs

 

 

4,906,078

 

 

 

28,730,923

 

 

 

7,360,129

 

 

 

51,899,857

 

Proceeds from issuance of preferred stock and warrants, net of offering costs

 

 

-

 

 

 

-

 

 

 

-

 

 

 

3,779,158

 

Net cash provided by financing activities

 

 

10,261,272

 

 

 

31,953,341

 

 

 

7,801,526

 

 

 

65,202,606

 

Increase in cash and cash equivalents

 

 

1,429,683

 

 

 

19,563,500

 

 

 

1,333,392

 

 

 

27,646,351

 

Cash and cash equivalents, beginning of period

 

 

26,216,668

 

 

 

6,653,168

 

 

 

5,319,776

 

 

 

-

 

Cash and cash equivalents, end of period

 

$

27,646,351

 

 

$

26,216,668

 

 

$

6,653,168

 

 

$

27,646,351

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Supplemental cash flows disclosures:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense paid

 

$

-

 

 

$

-

 

 

$

-

 

 

$

-

 

Income taxes paid

 

$

-

 

 

$

-

 

 

$

-

 

 

$

-

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Supplemental non-cash financing disclosures:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exercise of warrants in exchange for promissory note

 

$

-

 

 

$

-

 

 

$

-

 

 

$

3,350,000

 

Redemption of preferred stock for repayment of promissory note

 

$

-

 

 

$

-

 

 

$

-

 

 

$

3,350,000

 

Deemed dividend on redemption of preferred stock

 

$

-

 

 

$

-

 

 

$

-

 

 

$

2,092,500

 

Warrant liability converted to additional paid-in capital

 

$

1,145,659

 

 

$

1,981,745

 

 

$

-

 

 

$

3,127,404

 

Deposits used to acquire property and equipment

 

$

-

 

 

$

35,882

 

 

$

-

 

 

$

35,882

 

Deferred offering costs

 

$

-

 

 

$

-

 

 

$

182,599

 

 

$

182,599

 

Common stock issued for license rights

 

$

75,000

 

 

$

-

 

 

$

-

 

 

$

75,000

 

 

The accompanying notes are an integral part of these financial statements.

 

 

F-9


ImmunoCellular Therapeutics, Ltd.

(A Development Stage Company)

Notes to Financial Statements

 

1.

Nature of Organization and Development Stage Operations

ImmunoCellular Therapeutics, Ltd. (the Company) is a development stage company that is seeking to develop and commercialize new therapeutics to fight cancer using the immune system.

The Company has been primarily engaged in the acquisition of certain intellectual property, together with development of its product candidates and the recent clinical testing activities for one of its vaccine product candidates, and has not generated any r ecurring revenues. The Company’s lead product candidate, ICT-107, is in Phase II clinical development. The Company has two other product candidates, ICT-140 and ICT-121, both with investigational new drug (IND) applications active at the US Food and Drug Administration (FDA). The Company has incurred operating losses and, as of December 31, 2013, the Company had an accumulated deficit of $51,969,393. The Company expects to incur significant research, development and administrative expenses before any of its products can be launched and recurring revenues generated.

On January 31, 2006, we completed a merger pursuant to which Spectral Molecular Imaging, Inc. became our wholly owned subsidiary. At the time of the merger, we had virtually no assets or liabilities, and we had not conducted any business operations for several years. In connection with the merger, we changed our name from Patco Industries, Ltd. to Optical Molecular Imaging, Inc. and replaced our officers and directors with those of Spectral Molecu lar Imaging. Although we acquired Spectral Molecular Imaging in the merger, for accounting purposes the merger was treated as a reverse merger since the stockholders of Spectral Molecular Imaging acquired a majority of our outstanding shares of common stock and the directors and executive officers of Spectral Molecular Imaging became our directors and executive officers. Accordingly, our financial statements contained in this Report and the description of our results of operations and financial condition reflect the operations of Spectral Molecular Imaging from its inception on February 25, 2004.

 

2.

Summary of Significant Accounting Policies

Development Stage Enterprise —The Company is a development stage enterprise and is devoting substantially all our pre sent efforts to research and development. All losses accumulated since inception are considered part of the Company’s development stage activities.

Liquidity —As of December 31, 201 3, the Company had working capital of $27,007,377, compared to working capital of $25,832,869 as of December 31, 2012. The estimated cost of completing the development of any of our current vaccine product candidates and of obtaining all required regulatory approvals to market any of those product candidates is substantially greater than the amount of funds we currently have available. However, we believe that our existing cash balances are sufficient for our currently planned level of operations for at least the next twelve months, although there is no assurance that such proceeds will be sufficient for this purpose.

Cash and cash equivalents— The Company considers all highly liquid instruments with an original maturity of 90 days or less to be cash equivalents. As of December 31, 201 3 and December 31, 2012, the Company had $25,913,893 and $23,646,922, respectively, of certificates of deposit. The Company places its cash and cash equivalents with various banks in order to maintain FDIC insurance on all of its investments..

Property and Equipment —Property and equipment are stat ed at cost and depreciated using the straight-line methods based on the estimated useful lives (generally three to five years) of the related assets. Computer and computer equipment are depreciated over three years. Management continuously monitors and evaluates the realizability of recorded long-lived assets to determine whether their carrying values have been impaired. The Company records impairment losses on long-lived assets used in operations when events and circumstances indicate that the assets might be impaired and the nondiscounted cash flows estimated to be generated by those assets are less than the carrying amount of those assets. Any impairment loss is measured by comparing the fair value of the asset to its carrying amount. Repairs and maintenance costs are expensed as incurred.

Research and Development Expenses —Research and development expenses consist of costs incurred for direct research and development and are expensed as incurred.

Stock Based Compensation— The Company records the cost for all share-based payment transactions in the Company’s financial statements.

F-10


Stock option grants issued prior to March 31, 2011 to employees and officers and directors were valued using the Black-Scholes pricing model. Stock option grants made subsequent to March 31, 2011 were valued using the binomial lattice simulation model.

Fair value was estimated at the date of grant using the following weighted average assumptions:

 

 

  

Year

 

 

Year

 

 

Year

 

 

  

Ended

 

 

Ended

 

 

Ended

 

 

  

December 31,

 

 

December 31,

 

 

December 31,

 

 

  

2013

 

 

2012

 

 

2011

 

Risk-free interest rate

 

 

1.64

%

 

 

0.49

 

 

1.89

Expected dividend yield

 

 

None

 

 

 

None

  

 

 

None

  

Expected life

 

 

5.21 years

 

 

 

4.40 years

  

 

 

5.8 years

  

Expected volatility

 

 

90.58

%

 

 

66.1

 

 

64

Expected forfeitures

 

 

0

%

 

 

0

 

 

0

The weighted-average grant-date fair value of options granted during the year ended December 31, 2013 , 2012 and 2011 was $1.89, $1.29 and $0.98, respectively.

The risk-free interest rate used is based on the implied yield currently available in U.S. Treasury securities at maturity with an equivalent term. The Company has not declared or paid any dividends and does not currently expect to do so in the future. The expected term of options represents the period that our stock-based awards are expected to be outstanding and was determined based on projected holding periods for the remaining unexercised shares. Consideration was given to the contractual terms of our s tock-based awards, vesting schedules and expectations of future employee behavior. For the year ended December 31, 2013, the expected volatility is based upon the historical volatility of the Company’s common stock. Forfeitures have been estimated to be nil.

The Company’s stock price volatility and option lives involve management’s best estimates, both of which impact the fair value of the option calculated and, ultimately, the expense that will be recognized over the life of the option.

When options are exercised, our policy is to issue previously unissued shares of common stock to satisfy share option exercises. As of December 31, 201 3, the Company had 56,617,707 shares of authorized but unissued common stock.

No tax benefits were attributed to the stoc k-based compensation expense because a valuation allowance was maintained for all net deferred tax assets.

Income Taxes —The Company accounts for federal and state income taxes under the liability method, with a deferred tax asset or liability determined based on the difference between the financial statement and tax basis of assets and liabilities, as measured by the enact ed tax rates. The Company’s provision for income taxes represents the amount of taxes currently payable, if any, plus the change in the amount of net deferred tax assets or liabilities. A valuation allowance is provided against net deferred tax assets if recoverability is uncertain on a more likely than not basis. As of December 31, 2013 and 2012, the Company fully reserved its deferred tax assets. The Company recognizes in its financial statements the impact of an uncertain tax position if the position will more likely than not be sustained upon examination by a taxing authority, based on the technical merits of the position. The Company’s policy is to recognize interest related to unrecognized tax benefits as interest expense and penalties as operating expenses. As of December 31, 2013, the Company had no unrecognized tax benefits and as such, no liability, interest or penalties were required to be recorded.  The Company does not expect this to change significantly in the next twelve months.  The Company has determined that its main taxing jurisdictions are the United States of America and the State of California.  The Company is not currently under examination by any taxing authority nor has it been notified of a pending examination. The Company’s tax returns are generally no longer subject to examination for the years before December 31, 2009 for the state and December 31, 2010 for the federal taxing authority.

Fair Value of Financial Instruments —The carrying amounts reported in the balance sheets for cash , cash equivalents, and accounts payable approximate their fair values due to their quick turnover. The fair value of warrant liability is estimated using the Binomial Lattice option valuation model.

Fair value for financial reporting is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date.   The Company utilizes a fair value hierarchy which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The three levels of inputs that may be used to measure fair value are as follows:

Level 1 - quoted prices in active markets for identical assets or liabilities

Level 2 - quoted prices for similar assets and liabilities in active markets or inputs that are observable

F-11


Level 3 - inputs that are unobservable (for example cash flow modeling inputs based on assumptions)

Warrant liabilities represent the only financial assets or liabilities recorded at fair value by the Company. The fair value of warrant liabilities are determined based on Level 3 inputs.

Use of Estimates —The preparation o f financial statements in conformity with accounting principles generally accepted in the United States requires management to make certain estimates and assumptions about the future outcome of current transactions which may affect the reporting and disclosure of these transactions. Accordingly, actual results could differ from those estimates used in the preparation of these financial statements.

The following critical accounting policies affect the company’s more significant judgments and estimates used in the preparation of these financial statements:

Stock-Based Compensation - Stock-based compensation expense is estimated as of the grant date based on the fair value of the award and is recognized as expense over the requisite service period, which generally equals the vesting period, based on the number of awards that are expected to vest. Estimating the fair value for stock options requires judgment, including the expected term of our stock options, volatility of the company’s stock, expected dividends, risk-free interest rates over the expected term of the options and the expected forfeiture rate. In connection with performance based programs, the company makes assumptions principally related to the number of awards that are expected to vest after assessing the probability that certain performance criteria will be met.

Income Taxes - The Company accounts for federal and state income taxes under the liability method, with a deferred tax asset or liability determined based on the difference between the financial statement and tax basis of assets and liabilities, as measured by the enacted tax rates. The Company’s provision for income taxes represents the amount of taxes currently payable, if any, plus the change in the amount of net deferred tax assets or liabilities. A valuation allowance is provided against net deferred tax assets if recoverability is uncertain on a more likely than not basis. The Company recognizes in its financial statements the impact of an uncertain tax position if the position will more likely than not be sustained upon examination by a taxing authority, based on the technical merits of the position. The Company’s policy is to recognize interest related to unrecognized tax benefits as interest expense and penalties as operating expenses. The Company is not currently under examination by any taxing authority nor has it been notified of an impending examination. The Company’s tax returns for the years ended December 31, 2013, 2012 and 2011, remain open for possible review.

Warrant liability - The fair value of warrant liability is estimated using the Binomial Lattice option valuation model.  The use of the Binomial Lattice option valuation model requires estimates including the volatility of the company’s stock, risk-free rates over the expected term of warrants and early exercise of the options.

Basic and Diluted Net Loss per Common Share —Basic and diluted net loss per common share are computed based on the weighted average number of common shares outstanding. Common share equivalents (which consist of options and warrants) are excluded from the computation of diluted net loss per share for the years ended December 31, 2013, 2012 and 2011, since the effect would be antidilutive. Common share equivalents which could potentially dilute basic earnings per share in the future, and which were excluded from the computation of diluted net loss per share, totaled 26,108,984, 24,139,760 and 17,405,930 shares at December 31, 2013, 2012 and 2011, respectively.

Recently Issued Accounting Standards In June 2011, the Financial Accounting Standards Board (FASB) issued ASU No. 2011-5, which amends the Comprehensive Income Topic of the ASC. The ASU eliminates the option to present the components of other comprehensive income as part of the statement of changes in shareholders’ equity, and instead requires consecutive presentation of the statement of net income and other comprehensive income either in a continuous statement of comprehensive income or in two separate but consecutive statements. ASU No. 2011-5 became effective for interim and annual periods beginning after December 15, 2011. In February 2013, the FASB issued ASU No. 2013-02, which further amends the Comprehensive Income Topic of the ASC. This amendment requires entities to report the effect of significant reclassifications out of accumulated other comprehensive income on the respective line items in net income if the amount is being reclassified in its entirety to net income. This standard became effective for periods beginning after December 15, 2012. The adoption of these ASU’s did not have a material impact on the Company’s results of operations, financial condition or liquidity.

Other recent accounting pronouncements issued by the FASB (including its Emerging Issues Task Force), the American Institute of Certified Public Accountants, and the Securities Exchange Commission (the SEC) did not or are not believed by management to have a material impact on the Company’s present or future condensed financial statements.

 

F-12


3.

Property and Equipment

Property and equipment consist of the following:

 

 

  

December 31,

 

 

December 31,

 

 

  

2013

 

 

2012

 

Computers

 

$

67,566

 

 

$

23,192

 

Research equipment

 

 

117,809

 

 

 

128,381

 

 

 

 

185,375

 

 

 

151,573

 

Accumulated depreciation

 

 

(118,933

)

 

 

(75,284

)

 

 

$

66,442

 

 

$

76,289

 

Depreciation expense was $ 50,402, $45,823 and $20,357 for the years ended December 31, 2013, 2012 and 2011, respectively. Depreciation expense was $125,687 for the period from February 25, 2004 (date of inception) to December 31, 2013.

 

4.

Related-Party Transactions

Cedars-Sinai Medical Center License Agreement

Dr. John Yu, our Chief Scientific Officer and former interim Chief Executive Officer, is a neurosurgeon at Cedars-Sinai Medical Center (Cedars-Sinai). In November 2006, the Company entered into a license agreement with Cedars-Sinai under which the Company acquired an exclusive, worldwide licen se to its technology for use as cellular therapies, including cancer stem cell and dendritic cell-based vaccines for neurological disorders that include brain tumors and neurodegenerative disorders and other cancers. This technology is covered by a number of pending U.S. and foreign patent applications, and the term of the license will be until the last to expire of any patents that are issued covering this technology.

As an upfront licensing fee, the Company issued Cedars-Sinai 694,000 shares of its common stock and paid Cedars-Sinai $62,000. Additional specified milestone payments will be required to be paid to Cedars-Sinai when the Company initiates patient enrollment in its first Phase III clinical trial and when it receives FDA marketing approval for i ts first product.

The Company has agreed to pay Cedars-Sinai specified percentages of all of its sublicensing income and gross revenues from sales of products based on the licensed technology. To maintain its rights to the licensed technology, the Company must meet certain development and funding milestones. These milestones include, among others, commencing a Phase I clinical trial for a product candidate by March 31, 2007 and raising at least $5,000,000 in funding from equity or other sources by December  31, 2008. The Company satisfied the foregoing funding requirement in 2007 and commenced a Phase I clinical trial in May 2007, which was within the applicable cure period for the milestone requirement. Through December 31, 2009, the Company has paid Cedars-Sinai a total of $166,660 in connection with the Phase I clinical trial. The Company also was required to commence a Phase II clinical trial for a product candidate by December 31, 2008 and a waiver of this requirement was obtained from Cedars-Sinai (see Second Amendment below).

On June 16, 2008, the Company entered into a First Amendment to Exclusive License Agreement (the Amendment) with Cedars-Sinai. The Amendment amended the License Agreement to include in the Company’s exclusive license from Cedars-Sinai under that agreement an epitope to CD133 and certain related intellectual property. This technology is covered by U.S. patent applications filed by both parties. Pursuant to the Amendment, the Company issued Cedars-Sinai 100,000 shares of the Company’s common stock as an additional license fee for the licensed CD133 epitope technology, which will be subject to the royalty and other terms of the License Agreement.

On July 22, 2009, the Company entered into a Second Amendment to Exclusive License Agreement (the Second Amendment) with Cedars-Sinai to become effective August 1, 2009. The Second Amendment amended the License Agreement to revise the milestones set forth in the License Agreement that the Company must achieve in order to maintain its license rights under that agreement . The revised milestones include the replacement of a milestone that required commencement of a Phase II clinical trial for the Company’s first product candidate by no later than December 31, 2008 with milestones that require commencement of a Phase I clinical trial for the Company’s second product candidate by no later than June 30, 2010 and commencement of a Phase II clinical trial for one of the Company’s product candidates by no later than March 31, 2012.

Effective March 23, 2010, the Company entered into a Third Amendment to Exclusive License Agreement (the Third Amendment) with Cedars-Sinai. The Third Amendment amended the License Agreement to revise the milestones set forth in the License Agreement that the Company must achieve in order to maintain i ts license rights under that agreement. The revised milestones include the replacement of a milestone that required commencement of a Phase I clinical trial for the Company’s second product candidate by no later than June 30, 2010 and commencement of a Phase II clinical trial for one of the Company’s product candidates by no later than March 31, 2012 with a requirement that the Company by September 30, 2011 either commence a Phase II clinical trial

F-13


for its dendritic cell vaccine candidate or a Phase I clinical trial for its cancer stem cell vaccine candidate. The amendment also added a requirement that the Company obtain certain defined forms of equity or other funding in the amount of at least $2,500,000 by December 31, 2010 and a total of at least $5,000,000 by September 30, 2011. These funding requirements were fully satisfied as of June 30, 2011.

Effective September  20, 2010, the Company entered into a sponsored research agreement with Cedars-Sinai under which Cedars-Sinai provided services to the Company in developing the ICT-121 vaccine at a total cost of $446,142.  Effective September 20, 2011, the Company entered into Amendment No. 1 extending the agreement to September 19, 2012 at an incremental cost of $294,504.  Effective September 20, 2012, the Co mpany entered into Amendment No. 2 extending the agreement to September 19, 2013 at an incremental cost of $329,832.  This agreement concluded on September 19, 2013 but was extended through March 19, 2014 at a projected incremental cost of $210,856.

 

5.

Commitments and Contingencies

Sponsored Research Agreements

In an effort to expand the Company’s intellection property portfolio to use antigens to create personalized vaccines, the Company has entered into various intellectual property and research agreements. Those agreements are long-term in nature and are discussed below.

Aptiv Solutions

The Company has contracted with Aptiv Solutions to provide certain services related to the Company’s ICT-107 Phase II trial. The original agreement was entered into in August of 2010 and provided for estimated payments of approximately $3 million for services through September 2013. Subsequen tly, the Company and Aptiv entered into three contract amendments. Under the first amendment, effective January 20, 2011, Aptiv agreed to provide additional services in conjunction with the Phase II trial of ICT-107 for an additional fee of $469,807. The second amendment, effective February 4, 2012, extended the services to be provided by Aptiv and further increased the fees by $986,783. The second amendment also extended the term of the agreement to March 31, 2014. On January 11, 2013, the third amendment was finalized whereby the services were further extended and the fees were further increased by $608,201. The total aggregate fee pursuant to the original agreement and the three modifications is $5,078,169.

On September 17, 2013, the Company entered into a Master Services Agreement with Aptiv Solutions to provide certain services related to the Company’s ICT-140 Phase II trial.   The related Project Agreement Number 1 entered into on September 17, 2013  provided for estimated payments of approximately $2.7 million until completion of the services described therein.

As of December 31, 2013 , the Company’s remaining obligation under the existing commitments is approximately $3.1 million.

University of Pennsylvania

On February 13, 2012, the Company entered into a Patent License Agreement with The Trustees of the University of Pennsylvania under which the Company acquired an exclusive, world-wide license relating to patent technology for the production, use and cryopreservation of high-activity dendritic cell ca ncer vaccines

Pursuant to the License Agreement, the Company paid an upfront licensing fee and will be obligated to pay annual license maintenance fees. In addition, the Company has agreed to make payments upon completion of specified milestones and to pay royalties of a specified percentage on net sales, subject to a specified minimum royalty, and sublicensing fees on product sales covered by the license.

The John Hopkins University Licensing Agreement

On February 23, 2012, the Company entered into an Exclusive License Agreement, effective as of February 16, 2012, with The John Hopkins University (JHU) under which it received an exclusive, world-wide license to JHU’s rights in and to certain intellectual property related to mesothelin-specific cancer immunotherapies.

Pursuant to the License Agreement, the Company agreed to pay an upfront licensing fee, payable half in cash and half in shares of its common stock, within 30 days of the effective date of the License Agreement and upon issuance of the first U.S. patent covering the subject technology. In addition, the Company has agreed to pay milestone license fees upon completion of specified milestones, customary royalties based on a specified percentage of net sales, sublicensing payments and annual minim um royalties. Effective September 24, 2013, the Company entered into an Amendment No. 1 to the Exclusive License Agreement that updated certain milestones.

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The University of Pittsburgh Patent License Agreement

On March 20, 2012, the Company entered into an Exclusive License Agreement with the University of Pittsburgh under which the Company has licensed intellectual property surrounding EphA2, a tyrosine kinase receptor that is highly expressed by ovarian cancer and other advanced and metastatic malignanci es. The License Agreement grants a world-wide exclusive license to the intellectual property for ovarian and pancreatic cancers; and a world-wide non-exclusive license to the intellectual property for brain cancer.

Pursuant to the License Agreement, the Company agreed to pay an upfront nonrefundable and noncreditable licensing fee and nonrefundable and noncreditable maintenance fees due annually starting 12 months from the anniversary of the effective date of the License Agreement. In addition, the Company has agreed to make certain milestone payments upon completion of specified milestones and to pay customary royalties based on a specified percentage of net sales and sublicensing payments, as applicable.

Torrey Pines

On October 1, 2012, the Company entered into a Contract Services Agreement with Torrey Pines under which the Company has engaged Torrey Pines to determine the immunogenicity of certain peptides that are used in conjunction with the Company’s ICT-107 Phase II trial and in the development of I CT-140. The Company agreed to pay an upfront nonrefundable and noncreditable fee and is obligated to pay the remainder at the conclusion of the contract. On April 1, 2013, the Company and Torrey Pines expanded the scope of work to be completed by Torrey Pines under an additional Contract Services Agreement. This supplemental agreement provides for the Company to pay an upfront fee and additional fees at the conclusion of the contract.

Cedars-Sinai Medical Center

In connection with the Cedars-Sinai Medical Center License Agreement, the Company has certain commitments as described in Note 4.

Employment Agreement with Andrew Gengos

On December 3, 2012, the Company entered into an Agreement with Andrew Gengos pursuant to which Mr. Gengos serves as the Company’s President and Chief Executive Officer. The Agreement may be terminated be either party with or without cause. The Agreement provides for an annual base salary of $400,000. Additionally, beginning in 2013, Mr. Gengos was eligible for an annual dis cretionary bonus of up to 40% of his base annual salary as determined by the Company’s Board of Directors.

On December 3, 2012, Mr. Gengos was granted a seven-year option to purchase 700,000 shares of the Company’s common stock at a price of $2.13 per share vesting in one annual installment of 175,000 shares on December 2, 2013 and in 36 equal monthly installments thereafter. The vesting of the stock options will accelerate such that the stock options will be fully vested on his last day of employment. The options may be exercised during Mr. Gengos’ employment with the Company and for 90 days after termination for any reason except termination without cause by Mr. Gengos or termination for cause by the Company, provided that such exercise is within the seven-year term of the option.

In the event the Company terminates Mr. Gengos’ employment without cause, or in the event Mr. Gengos resigns for good cause, Mr. Gengos will be entitled to severance equal to one-year of Mr. Gengos’ base salary in effect at the date of termination. Additionally, the Company will pay Mr. Gengos’ COBRA premiums for a period of up to one year.

Employment Agreement with Dr. John Yu

On May 10, 2011, the Company entered into an Agreement, effective as of March 1, 2011, with Dr. John Yu pursuant to which Dr. Yu continue s to serve as the Company’s Chief Scientific Officer. The term of this Agreement automatically renews on the one-year anniversary date of the Agreement each year after March 1, 2011 for successive one-year terms unless either party terminates. Dr. Yu may also terminate the Agreement at any time upon 60 days notice. The Agreement was automatically renewed on March 1, 2012 and March 1, 2013. Under this agreement, Dr. Yu currently receives an annual salary of $125,000. Additionally, Dr. Yu is eligible for a discretionary cash bonus.

On March 1, 2011, Dr. Yu was granted a seven-year option to purchase 50,000 shares of the Company’s common stock at a price of $1.95 per share vesting in three equal annual installments beginning o n February 29, 2012.  The option may be exercised during the term that Dr. Yu provides services to the Company and for twelve months after termination for any reason except termination without cause by Dr. Yu or termination for cause by the Company, provided that such exercise is within the seven-year term of the option.  On June 14, 2013, Dr. Yu was granted a five-year option to purchase 45,000 shares of the Company’s common stock at a price of $2.19 per share vesting in equal monthly installments over a four-year term beginning on March 1, 2013.   All of the options granted to Dr. Yu will vest if his services terminate following a merger or similar corporate transaction in which the Company

F-15


is not the surviving entity and the surviving entity does not offer Dr. Yu an executive position at a compensation level at least equal to his then compensation level under the Agreement.

Employment Agreement with Anthony Gringeri

On August 19, 2013, the Company entered into an Agreement with Anthony Gringeri pursuant to which Dr. Gringeri serves as the Company’s Senior Vice President of Strategic Resources. The Agreement may be terminated be either party with or without cause. The Agreement provides for an annual base salary of $310,000. Additionally, Dr. Gringeri is eligible for an annual discretionary bonus of up to 30% of his base annual salary, prorated for 2013, as determined by the Company’s Board of Directors.

On September 20, 2013, Dr. Gringeri was granted a ten-year option to purchase 300,000 shares of the Company’s common stock at a price of $2.70 per share vesting in one annual installment of 75,000 shares on September 20, 2014 and in 36 equal monthly installments thereafter. The vesting of the stock options will accelerate such that the stock options vesting within six months of termination will be fully vested on his last day of employment. The options may be exercised during Dr. Gringeri’s employment with the Company and for 90 days after termination for any reason except termination without cause by Dr. Gringeri or termination for cause by the Company, provided that such exercise is within the ten-year term of the option.

In the event the Company terminates Dr. Gringeri’s employment without cause, or in the event Dr. Gringeri resigns for good cause, Dr. Gringeri will be entitled to severance equal to six months of Dr. Gringeri’s base salary in effect at the date of termination. Additionally, the Company will pay Dr. Gringeri’s COBRA premiums for a period of up to six months.

Employment Agreement with David Fractor

On April 4, 2011, the Company entered into an Employment Agreement with David Fractor pursuant to which Mr. Fractor serves as the Company’s Vice President of Finance and Principal Accounting Officer on a part-time basis for a three-year term, subject to termination by either party on 30 days notice. Under this agreement, Mr. Fractor currently receives an annual salary of $172,000.  Additionally, Mr. Fractor is eligible for a discretionary cash bonus.

On April 4, 2011, Mr. Fractor was granted a seven-year option to purchase 42,000 shares of the Company’s common stock at a price of $2.25 per share vesting in equal monthly installments over the three-year term of the agreement. On October 24, 2011, the Company granted Mr. Fractor a seven-year opti on to purchase 10,000 shares of the Company’s common stock at a price of $1.42 per share vesting in one annual installment of 2,500 shares on October 24, 2012 and in 36 equal monthly installments thereafter. On February 24, 2012, the Company granted Mr. Fractor a seven-year option to purchase 10,000 shares of the Company’s common stock at a price of $1.90 per share vesting over a one-year term ending February 24, 2013. On March 7, 2013, the Company granted Mr. Fractor a seven-year option to purchase 64,000 shares of the Company’s common stock at a price of $2.72 per share vesting in one annual installment of 16,000 shares on March 6, 2014 and in 36 equal monthly installments thereafter.  

Summary of Employment Agreements

The aggregate base salary payable pursuant to the above Employment Agreements is approximately $1.0 million.  Additionally during 2013, the Company issued an aggregate of 489,000 stock options to its management group at a weighted average exercise price of $2.66 that vest over a four-year term.

Operating Lease

The Company entered into a lease for new office space effective June 15, 2013 and continuing through August 31, 2016 at an initial monthly rental of $8,063. The monthly rental will increase by 3% on each anniversary date of the lease. Rent for the months of August and September 2013 was abated. Rent expense was approximately $80,000, $55,000 and $40,000 for the years ended December 31, 2013, 2012 and 2011, respectively.

Future minimum rentals under the operating lease are as follows:

 

Years ending December 31,

 

Amount

 

2014

 

$

97,724

 

2015

 

 

100,905

 

2016

 

 

68,432

 

Total

 

$

267,061

 

F-16


Contractual Obligations

The following is a summary of our contractual obligations including those entered into subsequent to December 31, 201 3.

 

 

 

  

Total

 

  

Less than
1 year

 

  

1-3
years

 

  

3-5
years

 

  

More than
5 years

 

Unconditional purchase obligations for
research and development

 

$

3,212,400

 

 

$

1,392,191

 

 

$

1,820,209

 

 

$

 

 

$

 

Operating lease obligation

 

$

267,061

 

 

 

97,724

 

 

 

169,337

 

 

 

 

 

 

 

 

 

$

3,479,461

 

 

$

1,489,915

 

 

$

1,989,546

 

 

$

 

 

$

 

 

 

6.

Shareholders’ Equity

Common Stock

In March 2010, the Company raised $1,654,686 (after commissions and offering expenses) from the sale of 1,740,000 shares of common stock and warrants to purchase 696,000 shares of common stock at an exercise price of $1.15 per share, to various investors in a private placement. (See “Warrants and Warrant Liabilities” below.)

In May 2010, the Company raised $2,716,308 (after commissions and offering expenses) from the sale of 2,490,910 shares of common stock and warrants to purchase 1,245,455 shares of common stock at an exercise price of $1.50 per share, to various investors in a private placement. (See “Warrants and Warrant Liabilities” below)

In February 2011, the Company raised $7,460,129 (after commissions and offering expenses) from the sale of 5,219,768 shares of common stock and warrants to purchase 2,609,898 shares of common stock at an exercise price of $2.25 per share, to various investors in a private placement . The warrants contain a provision whereby the warrant exercise price would be decreased in the event that certain future common stock issuances are made at a price less than $1.55. The January and October 2012 underwritten public offerings (see below) provided for the issuance of shares at prices that were less than $1.55. Accordingly, the exercise price of these warrants was adjusted to $1.87 and the number of warrants was proportionately increased to 2,823,696 net of exercises. (See “Warrants and Warrant Liabilities” below)

In January 2012, the Company raised $9,271,370 in an underwritten public offering, net of offering expenses of approximately $1.1 million, from the sale of 9,489,436 shares of common stock and warrants to purchase 4,744,718 shares of common stock at an exercise price of $1.41 per share, to various investors in an underwritten public offering. The warrants have a term of 60 months from the date of issuance. The warrants do not contain any features (such as net cash settlement or anti-di lution features) that would preclude the Company from accounting for these warrants as equity. Accordingly, the warrants are accounted for as equity.

In October 2012, the Company raised $19,359,553 in an underwritten public offering, net of offering expenses of approximately $1.6 million, from the sale of 10,000,000 shares of common stock and warrants to purchase 4,500,000 shares of common stock at an exercise price of $2.65 per share, to various investors in an underwritten public offering. The warrants h ave a term of 60 months from the date of issuance. The warrants do not contain any features (such as net cash settlement or anti-dilution features) that would preclude the Company from accounting for these warrants as equity. Accordingly, the warrants are accounted for as equity.

Controlled Equity Offering

On April 18, 2013, the Company entered into a Controlled Equity Offering SM Sales Agreement (the Sales Agreement) with Cantor Fitzgerald & Co., as agent (Cantor), pursuant to which the Company may offer from time to time through Cantor, shares of our common stock having an aggregate offering price of up to $25.0 million (of which only $17.0 million is currently registered for offer and sale). Under the Sales Agreement, Cantor may sell shares by any method permitted by law and deemed to be an “at-the-market” offering as defined in Rule 415 promulgated under the Securities Act, as amended, including sales made directly on the NYSE MKT, on any other existing trading market for our common stock or to or through a market maker. The Company may instruct Cantor not to sell shares if the sales cannot be effected at or above the price designated by us from time to time. The Company is not obligated to make any sales of the shares under the Sales Agreement. The offering of shares pursuant to the Sales Agreement will terminate upon the earlier of (a) the sale of all of the shares subject to the Sales Agreement or (b) the termination of the Sales Agreement by Cantor or the Company, as permitted therein. Cantor will receive a commission rate of 3.0% of the aggregate gross proceeds from each sale of shares and the Company has agreed to provide Cantor with customary indemnification and contribution rights. The Company will also reimburse Cantor for certain specified expenses in connection with entering into the Sales Agreement. On April 22, 2013, NYSE MKT approved the listing of 10,593,220 shares of our common stock in connection with the Sales Agreement. Through December 31, 2013, we sold 1,862,142 shares of our common stock under the Sales Agreement that resulted in proceeds to the Company of approximately $4,906,078, less offering expenses of approximately $338,000. As of December 31, 2013, aggregate gross sales for additional common stock of approximately $11,754,071 remained available under the Sales Agreement .

F-17


Stock Options

In February 2005, the Company adopted an Equity Incentive Plan (Plan). Pursuant to the Plan, a committee appointed by the Board of Directors may grant, at its discretion, qualified or nonqualified stock options, stock appreciation rights and may grant or sell restricted stock to key individuals, including employees, nonemployee directors, consultants and advisors. Option prices for qualified incentive stock options (which may only be granted to emplo yees) issued under the plan may not be less than 100% of the fair market value of the common stock on the date the option is granted (unless the option is granted to a person who, at the time of grant, owns more than 10% of the total combined voting power of all classes of stock of the Company; in which case the option price may not be less than 110% of the fair market value of the common stock on the date the option is granted). Option prices for nonqualified stock options issued under the Plan are at the discretion of the committee and may be equal to, greater or less than fair market value of the common stock on the date the option is granted. The options vest over periods determined by the Board of Directors and are exercisable no later than ten years from date of grant (unless they are qualified incentive stock options granted to a person owning more than 10% of the total combined voting power of all classes of stock of the Company, in which case the options are exercisable no later than five years from date of grant). Initially, the Company reserved 6,000,000 shares of common stock for issuance under the Plan. On October 24, 2011, the Company’s shareholders voted to increase the number of authorized shares reserved for the Plan to 8,000,000 shares. On September 20, 2013, the Company’s shareholders voted to increase the number of authorized shares reserved for the Plan to 12,000,000 shares. Options to purchase 3,433,270 common shares have been granted under the Plan and are outstanding as of December 31, 2013.   As of December 31, 2013, there were 5,662,274 options available for issuance under the Plan.

The following is a summary of stock option grants issued outside the Plan:

In January 2007, the Company granted an option to purchase 1,500,000 shares of its common stock at an exercise price of $1.10 per share to the Chairman of the Company’s Scientific Advisory Board.

In November 2006, the Company granted an option to purchase 300,000 shares of its common stock at an exercise price of $1.00 per share to an affiliate of the Company’s then Chairman of the Board .

In November 2006, the Company granted an option to purchase 5,933,424 shares of its common stock at an exercise price of $1.00 per share to a Board member in connection with the Cedars-Sinai license acquisition .

The following table summarizes stock option activity for the Company during the three years ended December 31, 2013:

 

 

  

 

 

 

Weighted

 

  

Weighted

 

  

 

 

 

  

 

 

 

Average

 

  

Average

 

  

Aggregate

 

 

  

 

 

 

Exercise

 

  

Contractual

 

  

Intrinsic

 

 

  

Options

 

 

Price

 

  

Term

 

  

Value

 

Outstanding December 31, 2010

 

 

11,094,845

 

 

$

0.92

 

 

 

-

 

 

 

 

 

Granted

 

 

1,077,000

 

 

$

0.91

 

 

 

 

 

 

 

 

 

Exercised

 

 

(1,269,767

)

 

$

0.39

 

 

 

 

 

 

 

 

 

Forfeited or expired

 

 

(128,000

)

 

$

1.04

 

 

 

 

 

 

 

 

 

Outstanding December 31, 2011

 

 

10,774,078

 

 

$

1.07

 

 

 

 

 

 

 

 

 

Granted

 

 

1,292,500

 

 

$

2.50

 

 

 

 

 

 

 

 

 

Exercised

 

 

(1,285,384

)

 

$

0.95

 

 

 

 

 

 

 

 

 

Forfeited or expired

 

 

(200,000

)

 

$

2.25

 

 

 

 

 

 

 

 

 

Outstanding December 31, 2012

 

 

10,581,194

 

 

$

1.16

 

 

 

 

 

 

 

 

 

Granted

 

 

862,287

 

 

$

2.67

 

 

 

 

 

 

 

 

 

Exercised

 

 

(829,702

)

 

$

0.92

 

 

 

 

 

 

 

 

 

Forfeited or expired

 

 

(147,084

)

 

$

1.81

 

 

 

 

 

 

 

 

 

Outstanding December 31, 2013

 

 

10,466,695

 

 

$

1.37

 

 

 

3.61

 

 

$

49,938

 

 

Vested or expected to vest at December 31, 2013

 

 

8,710,260

 

 

$

2.67

 

 

 

2.76

 

 

$

49,938

 

As of December 31, 2013, the total unrecognized compensation cost related to unvested stock options amounted to $4,188,162, which will be amortized over the weighted-average remaining requisite service period of approximately 21 months.

Warrants

In connection with the March 2010 common stock private placement, the Company issued to the investors warrants to purchase 696,000 shares of the Company’s common stock at $1.15 per share. The warrants had a term of 26 months from the date of issuance. As of December 31, 2013, these warrants have been fully exercised.

F-18


In connection with the May 2010 common stock private placement, the Company issued to the investors warrants to purchase 1,245,455 shares of the Company’s common stock at $1.50 per share. The warrants have a term of 36 months from the date of issuance. As of December 31, 2013 these warrants have been fully exercised, exc ept for warrants to purchase 4,000 shares of the Company’s common stock that expired. (see Warrant Liabilities below)

In connection with the sale of Preferred Stock in May 2010, the Company issued warrants to purchase 1,350,000 shares of common stock at an exercise price of $2.50. The warrants have a term of five-years from the date of issuance. As of December 31, 2013, warrants to purchase 1,290,996 shares of the Company’s common stock at $2.50 were outstanding related to this private placement. (See “War rant Liability” below.)

In connection with the February 2011 common stock private placement, the Company issued to the investors warrants to purchase 2,818,675 shares of the Company’s common stock at $2.25 per share. The warrants have a five-year term from the date of issuance and contain a provision that provides for an adjustment to the exercise price in the event the Company completes an equity financing at a per share price of its common stock that is less than the adjusted exercise price. As a result of the January and October 2012 financings, the exercise price of the warrants was adjusted to $1.87 and the number of warrants was proportionately increased to 2,823,670 net of exercises. As of December 31, 2013, warrants to purchase 2,823,670 shares of the Company’s common stock were outstanding related to this private placement. (See “Warrant Liability” below.)

In connection with the January 2012 underwritten public offering, the Company issued to the investors warrants to purchase 4,744,718 shares of the Company’s common stock at $1.41 per share. The warrants have a five-year term from the date of issuance. These warrants qualify for equity treatment since they do not have any provisions that would require the Company to redeem them for cash or that wou ld result in an adjustment to the number of warrants. As of December 31, 2013, warrants to purchase 1,418,575 shares of the Company’s common stock remain outstanding relating to this public offering.

In connection with the October 2012 underwritten public offering, the Company issued to the investors warrants to purchase 4,500,000 shares of the Company’s common stock at $2.65 per share. The warrants have a five-year term from the date of issuance. These warrants qualify for equity treatment since they do n ot have any provisions that would require the Company to redeem them for cash or that would result in an adjustment to the number of warrants. As of December 31, 2013, warrants to purchase 4,446,775 shares of the Company’s common stock remain outstanding relating to this public offering.

Warrant Liability

The Company’s warrant liability is adjusted to fair value each reporting period and is influenced by several factors including the price of the Company’s common stock as of the balance sheet date. On December 31, 2013, the price per share of Company’s common stock was $0.93 per share compared to $1.92 per share at December 31, 2012 and $1.36 per share at December 31, 2011.

In connection with the March 2010 common stock private placement, the Company issued to the investors warrants to purchase 696,000 shares of the Company’s common stock at $1.15 per share. Of the total proceeds from the March 2010 common stock private placement, $257,520 was allocated to the freestanding warrants associated with the unit s based upon the fair value of the warrants determined under the Black Scholes option pricing model. The warrants contain a provision whereby the warrant exercise price would be decreased in the event that future common stock issuances are made at a price less than $1.00. Due to the potential variability of their exercise price, these warrants do not qualify for equity treatment, and therefore are recognized as a liability. The warrant liability was adjusted to fair value each reporting period, and any change in value is recognized in the statement of operations. Prior to 2011, the Company had concluded that Black-Scholes method of valuing the price adjustment feature does not materially differ from the valuation of such warrants using the lattice simulation model, and therefore, the use of the Black-Scholes valuation model was considered a reasonable method to value the warrants. The assumptions used in the Black Scholes model for determining the initial fair value of the warrants were as follows: (i) dividend yield of 0%; (ii) expected volatility of 102%, (iii) risk-free interest rate of 1.00%, and (iv) contractual life of 26 months. During the year ended December 31, 2011, the Company determined that it was more appropriate to value the warrants using a binomial lattice simulation model. During 2012, the remaining warrants were fully exercised; however, the Company recorded a charge to other expense of $745,500 as the Company revalued the warrants through the date of exercise.

In connection with the May 2010 common stock private placement, the Company issued to the investors warrants to purchase 1,245,455 shares of the Company’s common stock at $1.50 per share. Of the total proceeds from the May 2010 common stock private placement, $834,455 was allocated to the freestanding warrants associated with the units based upon the fair value of the warrants determined under the Black Scholes option pricing model. The warrants contain a provision whereby the warrant exercise price would be decreased in the event that future common stock issuances are made at a price less than $1.00. Due to the potential variability of their exercise price, these warrants do not qualify for equity treatment, and therefore are recognized as a liability. The warrant liability is adjusted to fair value each reporting period, and any change in value is recognized in the statement of operations. Prior to 2011, the Company concluded that the Black-Scholes method of valuing the price adjustment feature does not materially differ from the valuation of such warrants using the binomial lattice simulation models, and therefore, the use of the Black-Scholes valuation model

F-19


was considered a reasonable method to value the warrants. The assumptions used in the Black Scholes model for determining the initial fair value of the warrants were as follows: (i) dividend yield of 0%; (ii) expected volatility of 102%, (iii) risk-free interest rate of 1.375%, and (iv) contractual life of 36 months. Effective January 1, 2011 the Company determined that it was more appropriate to value the warrants using a binomial lattice simulation model. The binomial lattice simulation model used by the Company at December 31, 2012, assumed (i) dividend yield of 0%; (ii) expected volatility of 78%; (iii) risk free rate of 0.08% and (iv) expected term of 0.42 years. Based upon this model, the Company recorded a charge to other expense of $357,808 during the year ended December 31, 2012. During 2013, the remaining warrants were fully exercised; however, the Company recorded a charge to other expense of $583,134 as the Company revalued the warrants through the date of exercise.

In connection with the sale of Preferred Stock in 2010, the Company vested warrants to purchase 1,350,000 shares of the Company’s common stock at an exercise price of $2.50 per share. Of the total proceeds from the May 2010 preferred stock sale, $5,710,500 was allocated to the freestanding warrants associated with the units based upon the fair value of these warrants determined under the Black Scholes option pric ing model. The warrants contain a provision whereby the warrant may be settled for cash in connection with a change of control with a private company. Due to the potential variability of their exercise price, these warrants do not qualify for equity treatment, and therefore are recognized as a liability. The warrant liability is adjusted to fair value each reporting period and any change in value is recognized in the statement of operations. Prior to 2011, the Company concluded that the Black-Scholes method of valuing the price adjustment feature does not materially differ from the valuation of such warrants using the Monte Carlo or binomial lattice simulation models, and therefore, the use of the Black-Scholes valuation model was considered a reasonable method to value the warrants. The assumptions used in the Black Scholes model for determining the initial fair value of the warrants were as follows: (i) dividend yield of 0%; (ii) expected volatility of 102%, (iii) risk-free interest rate of 2.50%, and (iv) contractual life of 60 months. Effective January 1, 2011, the Company determined that it was more appropriate to value the warrants using a binomial lattice simulation model. The lattice simulation model used by the Company at December 31, 2012, assumed (i) dividend yield of 0%; (ii) expected volatility of 67%; (iii) risk free rate of 0.30% and (iv) expected term of 2.42 years. Based upon this model, the Company recorded a charge to other expense of $128,344 for the year ended December 31, 2012.  As of December 31, 2013, the Company revalued the warrants using the binomial lattice simulation model assuming (i) dividend yield of 0%; (ii) expected volatility of 123%; (iii) risk free rate of 0.21% and (iv) expected term of 1.34 years. For the year ended December 31, 2013, the Company recorded a credit to other expense of $320,167. As of December 31, 2013, the carrying value of the warrant liability is $268,528.

In connection with the February 2011 common stock private placement, the Company issued to the investors warrants to purchase 2,818,675 shares of the Company’s common stock at $2.25 per share. Of the total proceeds from the February 2011 common stock private placement, $2,476,790 was allocated to the freestanding warrants associated with the units based u pon the fair value of the warrants determined under the Binomial lattice model. The warrants contain a provision whereby the warrant exercise price would be decreased in the event that certain future common stock issuances are made at a price less than $1.55. Due to the potential variability of their exercise price, these warrants do not qualify for equity treatment, and therefore are recognized as a liability. As a result of the January and October 2012 financings, the exercise price of the warrants was adjusted to $1.87 and the number of warrants was proportionately increased to 2,823,696 net of exercises. The Company recorded a charge to financing expense of $397,294 to reflect the issuance of the additional warrants. The warrant liability is adjusted to fair value each reporting period, and any change in value is recognized in the statement of operations. The Company initially valued these warrants using a binomial lattice simulation model assuming (i) dividend yield of 0%; (ii) expected volatility of 146%; (iii) risk free rate of 1.96% and (iv) expected term of 5 years. Based upon those calculations, the Company calculated the initial valuation of the warrants to be $2,476,790. The lattice simulation model used by the Company at December 31, 2012 assumed (i) dividend yield of 0%; (ii) expected volatility of 67%; (iii) risk free rate of 0.39% and (iv) expected term of 3.15 years. For the year ended December 31, 2012, the Company recorded a charge to other expense of $1,048,271. As of December 31, 2013, the Company revalued the warrants using the binomial lattice simulation model assuming (i) dividend yield of 0%; (ii) expected volatility of 111%; (iii) risk free rate of 0.44% and (iv) expected term of 2.14 years. For the year ended December 31, 2013, the Company recorded a credit to other expense of $905,377. As of December 31, 2013, the carrying value of the warrant liability is $796,282.

The below table summarizes the warrant liability activity for the years ended December 31, 2013, 2011 and 2010. The loss included in earnings is reflective of several factors including the increase in the Company’s stock during the years ended December 31, 2013, 2011 and 2010.

 

 

  

2013

 

 

2012

 

 

2011

 

Beginning Balance, January 1

 

$

2,852,880

 

 

$

2,157,408

 

 

$

2,581,871

 

Issuance of warrants and effect of repricing

 

 

 

 

 

397,294

 

 

 

 

Exercise of warrants

 

 

(1,145,659

)

 

 

(1,981,745

)

 

 

2,476,790

 

(Gain) or loss included in earnings

 

 

(642,411

)

 

 

2,279,923

 

 

 

(2,901,253

)

Transfers in and/or out of Level 3

 

 

 

 

 

 

 

 

 

Ending Balance, December 31

 

$

1,064,810

 

 

$

2,852,880

 

 

$

2,157,408

 

 

 

F-20


7.

401(k) Profit Sharing Plan

During 2011, the Company adopted a Profit Sharing Plan that qualifies under Section 401(k) of the Internal Revenue Code. Contributions to the plan are at the Company’s discretion. The Company did not make any matching contributions during the years ended December 31, 201 3 and 2012.

 

8.

Income Taxes

Deferred taxes represent the net tax effects of the temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes. Temporary differences result primarily from the recording of tax benefits of net operating loss carry forwards and stock-based compensation.

As of December 31, 2013 , the Company has an insufficient history to support the likelihood of ultimate realization of the benefit associated with the deferred tax asset. Accordingly, a valuation allowance has been established for the full amount of the net deferred tax asset.

The Company’s effective income tax rate differs from the amount computed by applying the federal statutory income tax rate to loss before income taxes as follows:

 

 

  

2013

 

 

2012

 

 

2011

 

Income tax benefit at the federal statutory rate

 

 

-34

%

 

 

-34

%

 

 

-34

%

State income tax benefit, net of federal tax benefit

 

 

-6

%

 

 

-6

%

 

 

-6

%

Change in fair value of warrant liability

 

 

-3

%

 

 

-6

%

 

 

20

%

Change in valuation allowance for deferred tax assets

 

 

43

%

 

 

46

%

 

 

20

%

Total

 

 

0

%

 

 

0

%

 

 

0

%

Deferred taxes consisted of the following:

 

 

  

December 31,
2013

 

 

December 31,
2012

 

Net operating loss carryforwards

 

$

15,759,274

 

 

$

12,821,749

 

Stock-based compensation

 

 

2,020,987

 

 

 

1,796,954

 

Less valuation allowance

 

 

(17,780,261

)

 

 

(14,618,703

)

Net deferred tax asset

 

$

 

 

$

 

As of December 31, 2013 , the Company had federal and California income tax net operating loss carryforwards of approximately $40.8 million. These net operating losses will begin to expire in 2022 and 2016, respectively, unless previously utilized.

Section 382 of the Internal Revenue Code can limit the amount of net operating losses which may be utilized if certain changes to a company’s ownership occur. While the Company underwent an ownership change in 2012 as defined by Section 382 of the Internal Revenue Code, management estimated that the Company has not incurred any limitations on its ability to utilize its net operating losses under Section 382 of the Internal Revenue Code during 2013. The Company may incur limitations in the future if there are additional changes in ownership.

 

9.

Supplementary Financial Information

Summary of Quarterly Results (Unaudited)

 

 

 

  

Quarter Ended

 

 

  

March

 

 

June

 

 

September

 

 

December

 

 

Fiscal Year

 

Fiscal 2013

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenues

 

$

 

 

$

 

 

$

 

 

$

 

 

$

 

Net income (loss)

 

 

(4,973,791

)

 

 

(150,329

)

 

 

(3,793,441

)

 

 

116,998

 

 

 

(8,800,563

)

Net income (loss) per common share

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

(0.10

)

 

$

(0.00

)

 

$

(0.07

)

 

$

(0.00

)

 

$

(0.16

)

Diluted

 

$

(0.10

)

 

$

(0.00

)

 

$

(0.07

)

 

$

(0.00

)

 

$

(0.16

)

Fiscal 2012

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenues

 

$

 

 

$

 

 

$

 

 

$

 

 

$

 

Net income (loss)

 

 

(7,889,435

)

 

 

(6,451,817

)

 

 

(637,627

)

 

 

483,740

 

 

 

(14,495,139

)

Net income (loss) per common share

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

F-21


 

  

Quarter Ended

 

 

  

March

 

 

June

 

 

September

 

 

December

 

 

Fiscal Year

 

Basic

 

$

(0.21

)

 

$

(0.16

)

 

$

(0.02

)

 

$

0.01

 

 

$

(0.35

)

Diluted

 

$

(0.21

)

 

$

(0.16

)

 

$

(0.02

)

 

$

0.01

 

 

$

(0.35

)

 

 

10.

Subsequent Events

Warrant Exercises

Subsequent to December 31, 2013 , the Company issued 23,473 shares of common stock upon the cashless exercise of options to purchase 75,000 shares of common stock.

Stock Option Grants

The Company’s Board of Directors approved the granting of 330,000 stock options to certain officers and employees on March 7, 2014. These options have an exercise price equal to the closing stock price on March 7, 2014 of $1.34 and will vest over a period of four years.


F-22


IMMUNOCELLULAR THERAPEUTICS, LTD .

Schedule II - Valuation and Qualifying Accounts

 

 

Additions

 

 

Beginning
Balance

 

Charged to
Costs &
Expenses

 

Other
Amounts

 

Deductions

 

Ending
Balance

2013

 

 

 

 

 

 

 

 

 

 

 

 

 

Deferred Tax Asset Valuation Account

 

$

14,618,703

 

$

3,161,558

 

 

 

 

 

$

17,780,261

2012

 

 

 

 

 

 

 

 

 

 

 

 

 

Deferred Tax Asset Valuation Account

 

$

11,004,790

 

$

3,613,913

 

 

 

 

 

$

14,618,703

2011

 

 

 

 

 

 

 

 

 

 

 

 

 

Deferred Tax Asset Valuation Account

 

$

7,429,620

 

$

3,575,170

 

 

 

 

 

$

11,004,790

 

 

 

 

F-23


Exhibit Index

 

Exhibit
Number

  

Description

 

 

2.1

  

Agreement and Plan of Reorganization dated as of May 5, 2005, as amended, among Patco Industries Subsidiary, Inc., William C. Patridge, and Spectral Molecular Imaging, Inc., as amended on June 30, 2005, September 26, 2005 and January 20, 2006. (1)

 

 

3.1

  

Amended and Restated Certificate of Incorporation of ImmunoCellular Therapeutics, Ltd. (2)

 

 

3.2

  

Certificate of Amendment of Amended and Restated Certificate of Incorporation of ImmunoCellular Therapeutics, Ltd. (2)

 

 

3.3

  

Certificate of Amendment of Amended and Restated Certificate of Incorporation of ImmunoCellular Therapeutics, Ltd. (3)

 

 

3.4

  

Certificate of Amendment of the Amended and Restated Certificate of Incorporation. (28)

 

 

3.5

  

Amended and Restated Bylaws of ImmunoCellular Therapeutics, Ltd. (23)

 

 

3.6

  

Amendment to the Amended and Restated Bylaws of ImmunoCellular Therapeutics, Ltd. (31)

 

 

3.7

  

Certificate of Amendment to the Amended and Restated Certificate of Incorporation of ImmunoCellular Therapeutics, Ltd. (39)

 

 

4.1

  

Form of Common Stock Certificate for ImmunoCellular Therapeutics, Ltd. (5)

 

 

4.2

  

Warrant dated December 3, 2009 issued by ImmunoCellular Therapeutics, Ltd. to Socius Capital Group, LLC d/b/a Socius Life Sciences Capital Group, LLC (20)

 

 

4.3

  

Amended Certificate of Designations of Preferences, Rights and Limitations of Series A Preferred Stock dated May 3, 2010. (21)

 

 

4.4

  

Form of Warrant issued to participants in the March 2010 private placement to purchase shares of common stock of ImmunoCellular Therapeutics, Ltd. (21)

 

 

4.5

  

Form of Warrant issued to participants in the May 2010 private placement to purchase shares of common stock of ImmunoCellular Therapeutics, Ltd. (22)

 

 

4.6

  

Warrant dated May 2, 2010 for 1,350,000 shares issued by ImmunoCellular Therapeutics, Ltd. to Socius CG II, Ltd. (21)

 

 

4.7

  

Form of Warrant issued to participants in the February 2011 private placement to purchase shares of common stock of ImmunoCellular Therapeutics, Ltd. (24)

 

 

4.8

  

Form of Warrant issued to participants in the January 13, 2012 underwritten public offering. (29)

 

 

4.9

  

Form of Specimen Preferred Stock Certificate and Form of Certificate of Designation of Preferred Stock*

 

 

4.10

  

Form of Debt Indenture, between Registrant and one or more trustees to be named (33)

 

 

4.11

  

Form of Common Stock Warrant Agreement and Warrant Certificate (33)

 

 

4.12

  

Form of Preferred Stock Warrant Agreement and Warrant Certificate (33)

 

 

4.13

  

Form of Debt Securities Warrant Agreement and Warrant Certificate (33)

 

 

10.1

  

Amended and Restated 2006 Equity Incentive Plan of ImmunoCellular Therapeutics, Ltd. (28)

 

 

10.2

  

Form of Non-Qualified Stock Option Agreement for the 2006 Equity Incentive Plan of ImmunoCellular Therapeutics, Ltd. (12)

 

 

10.3

  

Form of Incentive Stock Option Agreement for the 2006 Equity Incentive Plan of ImmunoCellular Therapeutics, Ltd. (12)

 

 

10.4

  

Exclusive License Agreement dated as of November 17, 2006 between Cedars-Sinai Medical Center and ImmunoCellular Therapeutics, Ltd.† (8)

 

 

10.5

  

First Amendment to Exclusive License Agreement dated as of June 16, 2008, between Cedars-Sinai Medical Center and ImmunoCellular Therapeutics, Ltd.† (9)

Ex-1


Exhibit
Number

  

Description

 

 

10.6

  

Stock Purchase Agreement dated as of November 17, 2006 between Cedars-Sinai Medical Center and ImmunoCellular Therapeutics, Ltd. (8)

 

 

10.7

  

Registration Rights Agreement dated as of November 17, 2006 between Cedars-Sinai Medical Center and ImmunoCellular Therapeutics, Ltd. (8)

 

 

10.8

  

Securities Purchase Agreement dated as of November 17, 2006 between Dr. John Yu and ImmunoCellular Therapeutics, Ltd. (8)

 

 

10.9

  

Agreement dated as of November 17, 2006 between Dr. John Yu and ImmunoCellular Therapeutics, Ltd.** (8)

 

 

10.10

  

Nonqualified Stock Option Agreement dated as of November 17, 2006 between Dr. John Yu and ImmunoCellular Therapeutics, Ltd.** (8)

 

 

10.11

  

Registration Rights Agreement dated as of November 17, 2006 between Dr. John Yu and ImmunoCellular Therapeutics, Ltd. (8)

 

 

10.12

  

Agreement dated as of February 14, 2008 between Molecular Discoveries, LLC and ImmunoCellular Therapeutics, Ltd. (11)

 

 

10.13

  

Registration Rights Agreement dated as of April 14, 2008, between Molecular Discoveries, LLC and ImmunoCellular Therapeutics, Ltd. (15)

 

 

10.14

  

Agreement dated as of August 1, 2008 between Dr. Cohava Gelber and ImmunoCellular Therapeutics, Ltd. ** (17)

 

 

10.15

  

Second Amendment dated August 1, 2009 to Exclusive License Agreement dated as of November 1, 2006 between Cedars-Sinai Medical Center and ImmunoCellular Therapeutics, Ltd. (19)

 

 

10.16

  

Preferred Stock Purchase Agreement dated as of December 3, 2009 between ImmunoCellular Therapeutics, Ltd. and Socius Capital Group, LLC d/b/a Socius Life Sciences Capital Group, LLC. (20)

 

 

10.17

  

Agreement dated March 1, 2010 between Dr. John Yu and ImmunoCellular Therapeutics, Ltd. ** (25)

 

 

10.18

  

Securities Purchase Agreement dated March 29, 2010 between participants in the March 2010 private placement and ImmunoCellular Therapeutics, Ltd. (22)

 

 

10.19

  

Form of Registration Rights Agreement dated as of March 29, 2010 between participants in the March 2010 private placement and ImmunoCellular Therapeutics, Ltd. 21)

 

 

10.20

  

Modification Agreement dated May 2, 2010 among Socius CG II, Ltd., Socius Life Sciences Capital Group, LLC and ImmunoCellular Therapeutics, Ltd. (21)

 

 

10.21

  

Third Amendment dated March 26, 2010 to Exclusive License Agreement dated as of November 1, 2006 between Cedars-Sinai Medical Center and ImmunoCellular Therapeutics, Ltd. (21)

 

 

10.22

  

Securities Purchase Agreement dated May 12, 2010 between participants in the May 2010 private placement and ImmunoCellular Therapeutics, Ltd. (22)

 

 

10.23

  

Form of Registration Rights Agreement between participants in the May 2010 private placement and ImmunoCellular Therapeutics, Ltd. (22)

 

 

10.24

  

Purchase Agreement, dated as of February 22, 2011, by and between the ImmunoCellular Therapeutics, Ltd. and each investor named therein. (24)

 

 

10.25

  

Registration Rights Agreement, dated as of February 22, 2011, by and among ImmunoCellular Therapeutics, Ltd. and the investors named therein. (24)

 

 

10.26

  

Exclusive Sublicense Agreement dated May 28, 2010 between Targepeutics, Inc. and ImmunoCellular Therapeutics, Ltd. † (26)

 

 

10.27

  

Sponsored Research and Vaccine Production Agreement dated January 1, 2011 between The Trustees of the University of Pennsylvania and ImmunoCellular Therapeutics, Ltd. † (26)

 

 

10.28

  

Placement agent agreement dated March 30, 2010 between Gilford Securities Incorporated and ImmunoCellular Therapeutics, Ltd. (26)

 

 

Ex-2


Exhibit
Number

  

Description

10.29

  

Placement agent agreement dated April 7, 2010 between Scarsdale Equities LLC and ImmunoCellular Therapeutics, Ltd. (26)

 

 

10.30

  

Consulting Agreement dated October 1, 2010 between JFS Investments and ImmunoCellular Therapeutics, Ltd. (26)

 

 

10.31

  

Advisory services agreement dated October 1, 2010 between Garden State Securities Inc. and ImmunoCellular Therapeutics, Ltd. (26)

 

 

10.32

  

Co-placement Agents Agreement dated January 31, 2011 among Summer Street Research Partners, Dawson James Securities, Inc. and ImmunoCellular Therapeutics, Ltd. (26)

 

 

10.33

  

Agreement dated as of March 1, 2011 between Dr. John Yu and ImmunoCellular Therapeutics, Ltd. ** (27)

 

 

10.34

  

Patent License Agreement, effective February 10, 2012, among The Trustees of the University of Pennsylvania and ImmunoCellular Therapeutics, Ltd.†(30)

 

 

10.35

  

Exclusive License Agreement, effective February 16, 2012, between the Johns Hopkins University and ImmunoCellular Therapeutics, Ltd.†*(30)

 

 

10.36

  

Office Lease dated July 1, 2012 between Regent Business Centers and ImmunoCellular Therapeutics, Ltd. (32)

 

 

10.37

  

Form of Warrant issued to participants in the October 18, 2012 underwritten public offering.(34)

 

 

10.38

  

Employment Agreement dated December 3, 2012 between Andrew Gengos and ImmunoCellular Therapeutics, Ltd.** (35)

 

 

10.39

  

Form of Stock Option Grant Notice for the 2006 Equity Incentive Plan of ImmunoCellular Therapeutics, Ltd.(35)

 

 

10.40

 

Controlled Equity Offering SM Sales Agreement dated April 18, 2013 between ImmunoCellular Therapeutics, Ltd. and Cantor Fitzgerald & Co. (36)

 

 

10.41

 

Form of Indemnity Agreement between ImmunoCellular Therapeutics, Ltd. and each of its directors and executive officers. (37)

 

 

10.42

 

Office Lease dated May 13, 2013 between Calabasas/Sorrento Square, LLC and ImmunoCellular Therapeutics, Ltd. (38)

 

 

10.43

 

Master Services Agreement dated September 1, 2010 between Averion International Corp. and  ImmunoCellular Therapeutics, Ltd. (38)

 

 

10.44

 

Employment Agreement dated August 19, 2013 between Anthony Gringeri and ImmunoCellular Therapeutics, Ltd. **(40)

 

 

10.45

 

Amendment No. 1 to the Exclusive License Agreement between the Johns Hopkins University and ImmunoCellular Therapeutics, Ltd. † (40)

 

 

10.46

 

Amended and Restated 2006 Equity Incentive Plan of  ImmunoCellular Therapeutics, Ltd. (40)

 

 

10.47

 

Amendment No. 1 to Amended and Restated 2006  Equity Incentive Plan of ImmunoCellular Therapeutics, Ltd. (40)

 

 

10.48

 

Form of Stock Option Grant Notice for the 2006  Equity Incentive Plan of ImmunoCellular Therapeutics, Ltd. (40)

 

 

10.49

 

Master Services Agreement dated September 17, 2013 between Aptiv Solutions, Inc. and ImmunoCellular Therapeutics, Ltd. ***

 

 

23.1

  

Consent of Marcum LLP. ***

 

 

24.1

  

Power of Attorney (included in the signature page hereto)***

 

 

31.1

  

Certification of the registrant’s Principal Executive Officer under Exchange Act Rule 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.***

 

 

31.2

  

Certification of the registrant’s Principal Financial Officer under Exchange Act Rule 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.***

 

 

32.1

  

Certification of the registrant’s Principal Executive Officer under 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.***

 

 

32.2

  

Certification of the registrant’s Principal Financial Officer under 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.***

Ex-3


Exhibit
Number

  

Description

 

 

101

  

The following financial information from the Annual Report on Form 10-K of ImmunoCellular, Ltd. for the year ended December 31, 2012, formatted in XBRL (eXtensible Business Reporting Language): (1) Balance Sheets as of December 31, 2012, and 2011; (2) Statements of Operations for the years ended December 31, 2012, 2011 and 2010 and from February 25, 2004 (Inception) to December 31, 2012; (3) Statements of Stockholders’ Equity (Deficit) from February 25, 2004 (Inception) through December 31, 2012; (4) Statements of Cash Flows for the years ended December 31, 2012, 2011 and 2010 and from February 25, 2004 (Inception) to December 31, 2012; and (5) Notes to Financial Statements.

Certain portions of the exhibit have been omitted based upon a request for confidential treatment filed by us with the Securities and Exchange Commission. The omitted portions of the exhibit have been separately filed by us with the Securities and Exchange Commission.

*

To be filed by amendment.

**

Indicates a management contract or compensatory plan or arrangement.

***

Filed with this Form 10-K.

(1)

Previously filed by us on January 26, 2006 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.

(2)

Previously filed by us on November 3, 2006 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.

(3)

Previously filed by us on May 9, 2007 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.

(4)

Previously filed by us on February 6, 2006 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.

(5)

Previously filed by us on February 12, 2007 as an exhibit to our Registration Statement on Form SB-2, File No. 333-140598, and incorporated herein by reference.

(6)

Previously filed by us on May 1, 2007 as an exhibit to our Registration Statement on Form SB-2, File No. 333-142480, and incorporated herein by reference.

(7)

Previously filed by us on July 12, 2007 as an exhibit to our Registration Statement on Form SB-2, File No. 333-144521, and incorporated herein by reference

(8)

Previously filed by us on November 22, 2006 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.

(9)

Previously filed by us on August 14, 2008 as an exhibit to our Quarterly Report on Form 10-Q and incorporated herein by reference.

(10)

Previously filed by us on September 14, 2007 as an exhibit to our Registration Statement on Form SB-2/A, File No. 333-144521 and incorporated herein by reference.

(11)

Previously filed by us on March 25, 2008 as an exhibit to our Annual Report on Form 10-KSB and incorporated herein by reference.

(12)

Previously filed by us on November 9, 2007 as an exhibit to our Registration Statement on Form S-8, File No. 333-147278, and incorporated herein by reference.

(13)

Previously filed by us on November 6, 2007 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.

(14)

Previously filed by us on April 2, 2007 as an exhibit to our Annual Report on Form 10-KSB and incorporated herein by reference.

(15)

Previously filed by us on April 16, 2008 as an exhibit to our Registration Statement on Form S-1, File No. 333-150277, and incorporated herein by reference.

(16)

Previously filed by us on November 13, 2008 as an exhibit to our Quarterly Report on Form 10-Q and incorporated herein by reference.

(17)

Previously filed by us on March 30, 2009 as an exhibit to our Annual Report on Form 10-K and incorporated herein by reference.

(18)

Previously filed by us on August 14, 2009 as an exhibit to our Quarterly Report on Form 10-Q and incorporated herein by reference.

(19)

Previously filed by us on November 13, 2009 as an exhibit to our Quarterly Report on Form 10-Q and incorporated herein by reference.

(20)

Previously filed by us on December 7, 2009 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.

(21)

Previously filed by us on May 12, 2010 as an exhibit to our Registration Statement on Form S-1 to SB-2, File No. 333-144521 and incorporated herein by reference.

(22)

Previously filed by us on May 18, 2010 as an exhibit to our Quarterly Report on Form 10-Q and incorporated herein by reference.

(23)

Previously filed by us on January 11, 2011 as an exhibit to our Registration Statement on Form S-8, File No. 333-171652 and incorporated herein by reference.

Ex-4


(24)

Previously filed by us on February 25, 2011 as an exhibit to our current report on Form 8-K and incorporated herein by reference.

(25)

Previously filed by us on March 31, 2010 as an exhibit to our Annual Report on Form 10-K and incorporated herein by reference.

(26)

Previously filed by us on March 31, 2011 as an exhibit to our Annual Report on Form 10-K and incorporated herein by reference.

(27)

Previously filed by us on August 18, 2011 as an exhibit to our Quarterly Report on Form 10-Q and incorporated herein by reference.

(28)

Previously filed by us on November 14, 2011 as an exhibit to our Quarterly Report on Form 10-Q and incorporated herein by reference.

(29)

Previously filed by us on January 10, 2012 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.

(30)

Previously filed by us on March 21, 2012 as an exhibit to our Annual Report on Form 10-K and incorporated herein by reference.

(31)

Previously filed by us on May 25, 2012 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.

(32)

Previously filed by us on August 14, 2012 as an exhibit to our Quarterly Report on Form 10-Q and incorporated herein by reference.

(33)

Previously filed by us on September 21, 2012 as an exhibit to our Registration Statement on Form S-3, File No. 333-184010 and incorporated herein by reference.

(34)

Previously filed by us on October 19, 2012 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.

(35)

Previously filed by us on March 11, 2013 as an exhibit to our Annual Report on Form 10-K and incorporated herein by reference.

(36)

Previously filed by us on April 18, 2013 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.

(37)

Previously filed by us on May 9, 2013 as an exhibit to our Quarterly Report on Form 10-Q and incorporated herein by reference.

(38)

Previously filed by us on August 8, 2013 as an exhibit to our Quarterly Report on Form 10-Q and incorporated herein by reference.

(39)

Previously filed by us on September 24, 2013 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.

(40)

Previously filed by us on November 7, 2013 as an exhibit to our Quarterly Report on Form 10-Q and incorporated herein by reference.

Ex-5

Exhibit 10.49

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Master Services Agreement

This Master Services Agreement (the “Agreement”) is made and entered into on February 19, 2014, (the “Effective Date”), by and between ImmunoCellular Therapeutics, Ltd. , a California corporation, with offices at 23622 Calabasas Road, Suite 300, Calabasas, CA 91302 (hereinafter referred to as “Client”) and Aptiv Solutions, Inc. , together with its Affiliates, with offices at 1925 Isaac Newton Square, Suite 100, Reston, Virginia 20190 (hereinafter referred to as “Aptiv Solutions”), both hereinafter referred as a “Party” or collectively as the "Parties".

Aptiv Solutions is engaged in the business of providing services related to the implementation and management of clinical development programs for the pharmaceutical, biotechnology and medical device industries; and

Client desires to engage Aptiv Solutions to perform such services in connection with certain pharmaceutical products under development by or under control of Client;

Therefore, in consideration of the premises and mutual promises and undertakings herein, the receipt and sufficiency of which are hereby acknowledged, the Parties intending to be legally bound do hereby agree as follows:

1.0

Definitions

a.

Affiliates :  With respect to either Party, an Affiliate is any entity that is controlled by, controls, or is under common control with the Party named above.

b.

Amendment :  A written specification of changes to a Project Agreement that is agreed to by the Parties and authorized by signature of each Party’s authorized representative(s), in a format substantially similar to Exhibit B attached hereto.

c.

Budget for Services : A component of a Project Agreement that delineates the estimated cost of the Services based upon the Project Specifications.

d.

Institutional Review Board (“IRB”) :  Any board, committee, or other group formally designated by an institution to review, to approve the initiation of, and to conduct periodic review of, biomedical research involving human subjects.  The primary purpose of such review is to assure the protection of the rights and welfare of human subjects.  The term has the same meaning as the phrase institutional review committee, independent ethics committee or ethics committee.

e.

GCP or Good Clinical Practice : The standard defined in the ICH Harmonised Tripartite Guideline For Good Clinical Practice E6(R1) Current Step 4 version dated 10 June 1996 (including the Post Step 4 corrections) together with, for Services performed in the European Union, such other Good Clinical Practice requirements as are specified in Directive 2001/20/EC of the European Parliament and the Council of 4 April 2001 relating to medicinal products for human use and in guidance published by the European Commission pursuant to such Directive; and for Services performed in other jurisdictions, any analogous laws and/or regulations.

f.

Institution : Any public or private entity or agency or medical or dental facility where clinical trials are conducted.

g.

Investigator(s) : A person or persons responsible for the conduct of the clinical trial at a Trial Site. If a trial is conducted by a team of individuals at a Trial Site, the Investigator is the responsible leader of the team and may be called the principal investigator.

h.

Milestone :  An event associated with a specific date, for which a payment will be due, as set out in the Payment Schedule of any Project Agreement.

 

 

 


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i.

Pass-Through Budget : A component of a Project Agreement that outlines the estimated costs of Pass Through Expenses for goods and services incurred by Aptiv Solutions on behalf of Client, in connection with the performance of the Services.

j.

Payment Schedule :  A component of a Project Agreement that describes the timing of payments due to be made for Services delivered and Pass Through Expenses incurred.

k.

Aptiv Solutions Project Manager : The Aptiv Solutions representative assigned to lead the Aptiv Solutions project team, act as the principal liaison between Aptiv Solutions and Client, and provide general oversight in the delivery of Services with regard to a specific Project Agreement.

l .

Project Agreement : A written specification of Services to be performed by Aptiv Solutions under this Agreement, including the Project Specifications, Project Schedule, Contact Information, Budget for Services, Pass-Through Budget, and Payment Schedule

m.

Project Schedule : A component of a Project Agreement that outlines the project milestones, estimated timelines and completion date for the Services based upon the Project Specifications.

n.

Project Specifications : A component of a Project Agreement that outlines the specific Services to be provided, assumptions used in preparing the Budget for Services, Pass-Through Budget and Project Schedule, and assignment of project-related responsibilities between the Parties.

o.

Services : The services to be provided by Aptiv Solutions and its Subcontractors (if applicable) under this Agreement as specifically outlined in a Project Agreement or otherwise authorized by Client.

p.

Study : A clinical trial performed at one or more investigative sites under the supervision of one or more Investigator(s) pursuant to a study protocol.

q.

Subcontractor : An individual or company engaged by Aptiv Solutions to conduct some elements of a Project Agreement, including without limitation, clinical laboratories, patient recruitment services, interactive voice recognition systems and other services.  

r.

Trial Site(s) : The location(s) where trial-related activities are actually conducted.

2.0

Services

Aptiv Solutions, itself or through one of its Affiliates or Subcontractors (if applicable), will perform the Services as specified in this Agreement and any associated Project Agreement(s), in accordance with the terms and conditions of this Agreement.  Aptiv Solutions will use reasonable efforts to perform the Services described in any Project Agreement issued hereunder and to meet all obligations and deadlines described in such Project Agreements.  The Parties will agree on all Services to be provided and the performance of those Services will be authorized in writing through the execution of a Project Agreement.  Aptiv Solutions will not begin work on any Services without an agreement in writing.

Client will have the overall responsibility for the studies at all times and will manage all study related tasks which have not been specifically delegated to Aptiv Solutions as described in each Project Agreement.  Client will, at its expense and as applicable, supply the drug for the timely completion of the clinical studies described in each Project Agreement.  Client agrees to keep Aptiv Solutions fully informed at all times of relevant information known to Client which might influence the conduct of the study and the provision of Services.

Client acknowledges that Aptiv Solutions will require documents, drug supplies, data, records and cooperation by Client, investigators, and/or third party suppliers in order to properly perform the Services, and that Aptiv Solutions will not be liable for the failure of Client or any third party involved in a Study to supply such information or data to Aptiv Solutions.

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All responsibility for the conduct of the study will remain with Client as defined in 21 CFR 312.52 or Directive 2001/20/EC, as applicable.

2.1

Project Agreements

Aptiv Solutions will provide Services as specified in one or more Project Agreements, which will be prepared in a format substantially similar to the Form of Project Agreement, attached hereto as Exhibit A.  Each Project Agreement will include detailed information with respect to a specific project, including Project Specifications, Project Schedule, Budget for Services, Pass-Through Budget, and Payment Schedule.  Project Agreements will become effective when signed by an authorized representative or representatives of both Parties as directed by the Project Agreements.

2.2

Amendments

Any changes to a Project Agreement, including but not limited to changes to the Project Specifications, Project Schedule, Budget for Services or Pass-Through Budget, will be agreed upon by the Parties and documented in an Amendment to the Project Agreement in a form substantially similar to that attached hereto as Exhibit B.  Client agrees that Aptiv Solutions will not perform any out-of-scope work described in an Amendment until it is approved in writing by both Parties.  

a.

Unanticipated Changes .  Client agrees that some changes in costs associated with clinical research resulting from, for example, changes to Project Specifications resulting from modifications to the study protocol, delays in receipt of study drugs from Client, changes in amounts charged by third party suppliers or poor subject enrollment due to changes in clinical practices, cannot be reasonably anticipated in advance. Upon identification by either Party of changes to the project assumptions or other unanticipated changes to the Project Specifications, the Parties will negotiate in good faith an Amendment to accommodate increases or decreases to the Project Budget, Project Schedule or Payment Schedule that are reasonably associated with any such adjustments.  Amendments will be documented in accordance with the terms of this Section 2.2.   Such unanticipated changes may include, but are not limited to, any of the following:

i.

delays in receiving from Client technical information or Client's acceptance of documents submitted by Aptiv Solutions in the performance of its duties under this Agreement or any Project Agreement, or any other delay on the part of Client;

ii.

delay in receipt of regulatory approval from a regulatory agency, IRB or Ethics Committee;

iii.

delay in performance by a Subcontractor not selected by Aptiv Solutions;

iv.

delay in shipment of study drug, clinical samples and/or clinical supplies;

v.

delay due to changes in standard of care imposed by law, regulation or changes in medical practice affecting participating sites;

vi.

delay by reason of force majeure as defined herein;

vii.

Client requested additional services or changes to the Services or protocol;

viii.

delays due to questions received by either Party from regulatory agencies or ethics committees regarding submission materials that relate to characteristics of the study drug or protocol design;

ix.

delays due to any changes in applicable law or regulatory environment; or

x.

changes for any other reason agreed upon in writing by Client.

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2.3

Project Staffing

In performing the Services, Aptiv Solutions will assign personnel who are adequately trained, qualified and experienced to conduct the work as specified in a Project Agreement.  Client may make reasonable requests for replacement of assigned personnel for cause, such as unsatisfactory performance or interpersonal conflicts.  Aptiv Solutions will promptly respond to any such request and make reasonable efforts to correct the situation in order to improve performance, or to provide a replacement, at its own expense, within a mutually agreeable timeframe.  Aptiv Solutions will assign personnel at its sole discretion from one or more of its or its Affiliates offices located worldwide, as needed to perform the Services in accordance with the Project Agreement.

a.

Use of Contract Employees .  Aptiv Solutions may, at its own discretion, assign some elements of the Services to contract employees.  Aptiv Solutions agrees that any contract employees used to perform the Services will be adequately qualified, experienced and trained as required to perform the Services in the same manner as Aptiv Solutions qualifies and trains its own employees.  Aptiv Solutions will remain responsible for satisfactory performance of all Services performed by contract employees.

2.4

Use of Subcontractors

Aptiv Solutions may use Subcontractors to conduct some elements of a Project Agreement.  Aptiv Solutions will notify Client in advance of its use of Subcontractors.  In the event that Client objects, for reasonable cause, to any such Aptiv Solutions Subcontractors, Aptiv Solutions will replace the Subcontractor within a mutually agreeable timeframe.

a.

Client-Selected Subcontractors .  In the event that Client requires Aptiv Solutions to use a specific Subcontractor (hereinafter “Client Subcontractor”), Aptiv Solutions will not be responsible for the performance of the Client Subcontractor, and Client will manage the performance of the Client Subcontractor and be responsible for any delays or changes to the Project Schedule or Project Budget that result from the performance of the Subcontractor.  Aptiv Solutions will notify Client promptly of any performance issues arising out of the use of any such Client Subcontractors.  If Client engages a Client Subcontractor, but requires that Aptiv Solutions manage or oversee the performance of the Client Subcontractor, then Client will supply Aptiv Solutions with a copy of the relevant contract with the Client Subcontractor. If Client requires that Aptiv Solutions contract with the Client Subcontractor, then Client hereby authorizes Aptiv Solutions to do so as agent on behalf of Client.  Client remains responsible for any delays or changes to the Project Schedule or Project Budget that result from the performance of the Client engaged Client Subcontractor.

b.

Aptiv Solutions-Selected Subcontractors .  For Subcontractors selected and contracted directly by Aptiv Solutions, Aptiv Solutions will be responsible for the performance and agrees to manage the performance of the Subcontractor.  

2.5

Applicable Standards

The Parties agree that Aptiv Solutions will provide the operational systems, processes and standard operating procedures to be used in performance of the Services unless specified otherwise in the Project Specifications.  All Services will be conducted in accordance with GCP and applicable laws and regulations, including but not limited to all relevant personal data protection legislation.

2.6

Client-Provided Systems

In the event that Client requires Aptiv Solutions to use Client’s information systems and associated processes, Client will be responsible for all costs associated with installation and operation of the systems, including costs for hardware and software licenses, and for training of Aptiv Solutions personnel assigned to the project in the use of Client system(s).

3.0

PAYMENT  

The Parties agree that the fees and other reimbursements that Aptiv Solutions will receive for performing the Services hereunder will be outlined in each Project Agreement and are subject to the following terms and conditions.  

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3.1

Compensation for Services

For Services provided, Client will pay Aptiv Solutions in accordance with the terms in this section of the Agreement and each applicable Project Agreement.  Each Project Agreement will include a Budget for the Services to be performed by Aptiv Solutions and will include the costs related to the Services to be provided. Aptiv Solutions will not exceed the total cost outlined in the Budget for Services without the prior approval of Client, unless specifically authorized by an Amendment, as set out in Section 2.2 above. Client agrees that the Budget for Services presented in each Project Agreement is an estimate based upon the Project Specifications and Project Schedule.  

3.2

Pass-Through Budget

a.

Pass-Through Expenses .  Pass Through Expenses, include, but are not limited to investigator fees and grants, central labs, packaging and distribution of medication, printing and distribution of Case Report Forms, Institutional Review Board submission fees, incurred by Aptiv Solutions in the conduct and performance of the Services will be passed on to Client for payment.  

b.

In order to provide funding for Pass Through Expenses, exclusive of investigator grants described below, Client will make an advance payment to Aptiv Solutions of an amount described in the Project Agreement, at such time as shall be delineated in the Project Agreement.  Aptiv Solutions will submit to Client monthly invoices for amounts incurred during the relevant billing period.  The advance payment will be retained by Aptiv Solutions until the completion of the Services, at which time a reconciliation of expenses will be done to ensure that Client pays for only those expenses actually incurred. The advance payment, if any, will then be applied to the final invoice, if unpaid, and any remaining advance payment will be refunded to Client within thirty (30) days from the date of the agreed final reconciliation.

c.

Client will reimburse all travel expenses in accordance with Aptiv Solutions’ applicable Travel and Expense Policy (to be provided upon request), as shown on monthly invoices.  Each invoice will include, as necessary, a summary of all Pass Through Expenses.

3.3

Payments to Institutions and Investigators

a.

In order to provide for timely payments to Institutions and Investigators, Client will make an advance payment to Aptiv Solutions of such amounts as are delineated in the Project Agreement. Aptiv Solutions will submit to Client monthly invoices in advance for estimated amounts to be paid to Investigators to be incurred in the upcoming quarter to ensure that adequate funds are available to pay such expenses.  Client agrees that Aptiv Solutions will not make payments to Institutions or Investigators without sufficient funds available.  The advance payment will be retained by Aptiv Solutions until the completion of the Services, at which time a reconciliation of expenses will be done to ensure that Client pays for only those expenses actually incurred. The advance payment, if any, will then be applied to the final invoice, if unpaid, and any remaining advance payment will be refunded to Client within thirty (30) days from the date of the agreed final reconciliation.

b.

Financial Reports of Payments to Institutions and Investigators .    At Client’s request, Aptiv Solutions will prepare and submit a financial report, documenting amounts paid to Investigators pursuant to a particular Project Agreement.   Aptiv Solutions will comply with regulatory requirements for the reporting of any fees and other expenditures paid to Institutions and Investigators on Client’s behalf, which requirements have been provided in advance. Aptiv Solutions acknowledges that Client may be required to disclose to relevant governmental authorities the payments made by or on behalf of Client by Aptiv Solutions under such a Project Agreement, as well as the purpose and nature of such payments. Client acknowledges that it shall be responsible for filing such information with governmental or regulatory agencies.

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3.4

Invoices

a.

Invoices for Services and Pass Through Expenses will be submitted in accordance with the Payment Schedule associated with the relevant Project Agreement and will be prepared monthly, or as frequently as necessary.  Any final payments specified in the Project Agreement will be invoiced upon completion of the project and delivery to Client of any final study databases, reports or other deliverables as specified in the Project Specifications.  

b.

All invoices under this Agreement will be forwarded to the Client representative designated in the relevant Project Agreement.

c.

All payments under this Agreement will be remitted to the Aptiv Solutions Affiliate named in the Project Agreement, to the address and in the manner set forth in the Payment Schedule of the applicable Project Agreement.

3.5

Payment Terms

Client agrees to pay for Services and Pass Through Expenses in accordance with the Payment Schedule outlined in each Project Agreement or associated Amendment.  Client will pay for all Services, Pass Through Expenses and other correctly invoiced items within thirty (30) days of date of invoice.  All payments will be made in the currency noted in the Payment Schedule of the Project Agreement.  All fees for Services and Pass Through Expenses are exclusive of VAT (including non-refundable VAT), local taxes, charges or remittance fees, which Client will pay when applicable.  In the event that undisputed invoiced amounts are not paid within the Payment Terms, Aptiv Solutions reserves the right, at its sole discretion to (i) charge interest against any unpaid overdue balance at a rate of one percent (1.0%) per month; and/or (ii) suspend performance of the Services until such time that the overdue amounts are paid. Additionally Aptiv Solutions reserves the right to suspend work in the event that any disputed invoices have not been resolved within 30 days of the notification of the dispute.

3.6

Exchange Rate Fluctuation

The parties acknowledge that some projects may be executed in more than one country, and that the currencies used by those countries may vary, and may fluctuate in value during the term of this Agreement.  Any such Project Agreements will contain a notation of the Base Exchange Rate for all currencies other than US Dollars in which costs for Services will be incurred.   If at any time during the term of a Project Agreement the Base Exchange Rate for Services specified in a foreign currency has fluctuated more than 3%, plus or minus, Aptiv Solutions will calculate a foreign currency exchange adjustment for those Services. The adjustment will be calculated by comparing the Base Exchange Rate with the Oanda.com foreign currency exchange spot rate on the last business Friday before each invoice is issued. Any resulting decrease in costs will be credited to Client and any resulting increase in costs will be invoiced to Client.   In the event Aptiv Solutions incurs a pass through cost in a currency other than U.S. Dollars, the Parties shall determine the amount payable based on the relevant conversion rate as reported on Oanda.com on the invoice date.  

3.7

Long Term Fee for Service Studies

In cases where hourly fees for services are charged for a project with a duration which exceeds twelve (12) months, Aptiv Solutions reserves the right on each anniversary of a project’s starting point to increase  the hourly rates by up to five percent (5%) to reflect the changes in the salaries paid to its employees and other cost increases. This potential increase shall be applied to all invoices and subsequent payments occurring after the notice of the increase.  For clarity, project budgets which are unit based and which have a duration which exceed twelve (12) months will have commensurate increases automatically included in the Budget for Services.

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4.0

Term and Termination

4.1

Term

Unless earlier terminated according to Section 4.2, 4.3, or 4.4 below, this Agreement will remain in effect for an initial term of two (2) years from the Effective Date, and thereafter will renew automatically unless either Party notifies the other Party of termination of the Agreement no later than sixty (60) days prior to renewal hereof.  In the event of non-renewal by either Party, the term of this Agreement applicable under any outstanding Project Agreement will continue until completion of the Services described in such Project Agreement or termination of the Project Agreement.  

4.2

Termination without Cause

The Client may terminate the Agreement or any Project Agreement issued hereunder for any reason upon sixty (60) days written notice to Aptiv Solutions. Should Client terminate this Agreement or a Project Agreement without cause, the termination process and associated fees will be as follows:

a.

Client and Aptiv Solutions will meet within thirty (30) days of Aptiv Solutions’ receipt of such termination notice to develop a plan for (a) closing down administration of this Agreement or (b) closing down the Study which is the subject of the terminated Project Agreement, which will include transferring any remaining tasks or other responsibilities to Client or its designee.

b.

Client will pay to Aptiv Solutions the actual costs incurred in providing the Services and the Pass Through Expenses incurred in the performance of the terminated Project Agreement, as well as the actual costs and the pass-through expenses incurred in the course of winding down or closing out the terminated Project Agreement.

4.3

Termination by Client for Cause

Failure of Aptiv Solutions to comply with any of the material terms or conditions of this Agreement or any Project Agreement will entitle Client to give written notice of default via certified/return receipt mail or overnight courier to ensure receipt by Aptiv Solutions.  If Aptiv Solutions does not cure the default within sixty (60) days of receipt of notice (or for such reasonable amount of time thereafter, if the default is not susceptible of cure within sixty (60) days), this Agreement may be terminated by Client.  Client will pay Aptiv Solutions for all Services properly rendered and Pass Through Expenses incurred.  As soon as practicable following receipt of notice of termination under this Section 4.3, Aptiv Solutions will submit an itemized accounting of Pass Through Expenses and costs incurred, costs anticipated, and payments received in order to determine a balance to be paid by either Party to the other.  Such balance will be paid by Client within thirty (30) days of completion of work.

4.4

Termination by Aptiv Solutions for Cause

Failure of Client to comply with any of the material terms or conditions of this Agreement or to respond to Aptiv Solutions’ inquiries or requests for information will entitle Aptiv Solutions to give written notice of default via certified/return receipt mail or overnight courier to ensure receipt by Client.  If Client does not cure the default within sixty (60) days of receipt of notice (or for such reasonable amount of time thereafter, if the default is not susceptible of cure within sixty (60) days), this Agreement may be terminated by Aptiv Solutions, which will cease performance of Services.  The cessation of Services in accordance with this Section will not be a default of performance obligations by Aptiv Solutions, nor will it be a breach of this Agreement or any Project Agreement.  Client will pay to Aptiv Solutions all amounts due and owing for Services performed, Pass Through Expenses incurred, costs associated with winding up activities, as well as any late fees which may be due, pursuant to Section 3.5 above.

If in the reasonable assessment of Aptiv Solutions, its continued performance of the Services contemplated by this Agreement or any Project Agreement could constitute a potential or actual violation of legal, regulatory, ethical or scientific standards, then Aptiv Solutions may terminate this Agreement or any Project Agreement by giving written notice stating the effective date (which may not be less than sixty [60] days from the notice date) of such termination.  The parties shall use all reasonable efforts to rectify the alleged violation prior to the end of the sixty (60) day notice period.

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4.5

Termination for Other Reasons

Either Party may terminate this Agreement and all Project Agreements hereunder, effective immediately upon written notice to the other Party, if the other Party: (i) files a voluntary petition in bankruptcy or has an involuntary bankruptcy petition filed against it, which is not dismissed within thirty (30) days after its institution, (ii) is adjudged as bankrupt, (iii) becomes insolvent, (iv) has a receiver, trustee, conservator or liquidator appointed for all or a substantial part of its assets, (v) ceases to do business, (vi) commences any dissolution, liquidation or winding up, or (vii) makes an assignment of its assets for the benefit of its creditors.

4.6

Survival

Expiration or termination of this Agreement will not relieve the Parties of any obligation accruing prior to such expiration or termination.  In addition, the Sections on Payment, Term and Termination, Representations and Warranties, Debarment Certification, Disposition of Computer Files and Study Materials, Ownership and Confidentiality, Indemnification, and Employees as well as any other sections which by their nature should survive, will survive expiration or termination of this Agreement indefinitely, or for the period of time noted in the specific clause.

5.0

Representations and Warranties

5.1

Acknowledgments

Client acknowledges and agrees that the results of the Services to be provided hereunder are inherently uncertain and that, accordingly, there can be no assurance, representation or warranty by Aptiv Solutions that the drug, compound, device or other material which is the subject of research covered by this Agreement or any Project Agreement issued hereunder can, either during the term of this Agreement or thereafter, will be successfully developed or, if so developed, will receive the required approval by any regulatory authority.  

5.2

Mutual Representations

Each of the Parties represents, warrants and covenants to the other that: (a) it is a corporation duly incorporated, validly existing and in good standing; (b) it has taken all necessary actions on its part to authorize the execution, delivery and performance of the obligations undertaken in this Agreement, and no other corporate actions are necessary with respect thereto; (c) it is not a party to any agreement or understanding and knows of no law or regulation that would prohibit it from entering into and performing this Agreement; (d) when executed and delivered by it, this Agreement will constitute a legal, valid and binding obligation of it, enforceable against it in accordance with this Agreement’s terms; (e) it is duly licensed, authorized or qualified to do business and is in good standing in every jurisdiction in which a license, authorization or qualification is required for it to perform its obligations under this Agreement; and (f) it will not enter into any other agreements which would interfere or prevent performance of the obligations described herein.

5.3

Representations and Warranties of Client

a.

Client represents and warrants that it has the right, title and interest in the drug, compound, device or other material which is the subject of research covered by this Agreement or any Project Agreement (whether such right, title and interest is held solely by Client or jointly with others) and that it has the legal right, authority and power to enter into this Agreement, and to perform any clinical trial which is the subject of a Project Agreement issued hereunder.

b.

Client further represents and warrants that the services required of Aptiv Solutions hereunder will not violate the rights of any third party including but not limited to intellectual property rights.

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c.

If Client requires Aptiv Solutions to use MedDRA to code, analyze or report data for a Study, Client represents and warrants that it has a current and valid license agreement with the Maintenance and Support Services Organization (“MSSO”) to use MedDRA.  Furthermore, if Aptiv Solutions is required to use WHO Drug, WHO Herbal or WHO ART for coding of data, Client warrants and represents that it has a current and valid license agreement with The Uppsala Monitoring Centre for the dictionaries which Aptiv Solutions will be required to use.  If Client does not currently have such licenses, it represents and warrants that such licenses will be in place prior to the delivery of data by Aptiv Solutions which is coded using these dictionaries. Aptiv Solutions will not be liable to Client for use of data coded without proper licensing, and Client will hold Aptiv Solutions harmless in these occasions.  In the event Client requests that Aptiv Solutions perform services which require Aptiv Solutions to distribute MedDRA terminology or WHODrug dictionary to third parties, CLIENT shall be responsible for ensuring that all such third parties possess the necessary MedDRA and/or Uppsala Monitoring Centre product licenses.

5.4

Representations and Warranties of Aptiv Solutions

a.

Aptiv Solutions represents and warrants that the personnel assigned to perform Services rendered under this Agreement will be capable professionally.

b.

Aptiv Solutions further represents and warrants that it will make available to Client or to the responsible regulatory authority relevant records, programs, and data as may be reasonably requested by Client for purposes related to filing and prosecution of Client's related new drug applications; provided such request is consistent with all applicable laws that protect confidentiality of personal data.

c.

Aptiv Solutions’ sole obligation for material breach of a representation and warranty set out in this Section will be to correct or replace that portion of the Services that fails to materially conform thereto.  

5.5

No Other Warranties

The parties’ warranties and representations contained in this Agreement are in lieu of all other warranties expressed or implied.

6.0

Debarment Certification

a.

Aptiv Solutions certifies that it has not been debarred under Section 306 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §335a(a) or (b) or any equivalent local law or regulation.  In the event that Aptiv Solutions becomes debarred, Aptiv Solutions agrees to notify Client immediately.

b.

Aptiv Solutions certifies that it has not and will not use in any capacity the services of any individual, corporation, partnership, or association which has been debarred under Section 306 of the Federal Food, Drug and Cosmetic Act, 21 U.S.C §335a (a) or (b) or any equivalent local law or regulation.  In the event that Aptiv Solutions becomes aware of or receives notice of the debarment of any individual, corporation, partnership, or association providing services to Aptiv Solutions, which relate to the Services being provided under this Agreement, Aptiv Solutions agrees to notify Client immediately.

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7.0

Audit and Inspections

7.1

Audit by Client

a.

Routine Audits .  During the term of this Agreement, Aptiv Solutions will permit representatives of Client who are not competitors of Aptiv Solutions to examine, at a reasonable time during normal business hours and subject to at least ten (10) business days prior written notice to Aptiv Solutions: (i) the facilities where the Services are being, will be or have been conducted; (ii) related study documentation.  The purpose of such audit will be to enable the Client to confirm that the Services are being or will be or have been conducted in conformance with applicable standard operating procedures, a specific Project Agreement, this Agreement and in compliance with applicable laws and regulations.  Client shall pay the reasonable costs of any such audits, including the costs of time spent by Aptiv Solutions employees in preparation and attendance at the audit.  Routine audits will be limited to one per calendar year.  Aptiv Solutions will provide copies of any materials reasonably requested by Client during, but not before such audit.  Aptiv Solutions will implement all modifications that prove necessary subsequent to the findings of the audit made by or on behalf of Client.  

b.

“For cause” audits .  During the term of this Agreement, Client shall have the right to conduct “for cause” audits in the event of a reasonable suspicion that Aptiv Solutions is not performing the Services correctly or in conformity with applicable standard operating procedures, a specific Project Agreement, this Agreement or applicable laws and regulations.   Client will only pay the costs of time spent by Aptiv Solutions employees in preparation and attendance at the audit if the audit does not result in a finding that Aptiv Solutions performance was materially deficient and that corrective action is required.  Aptiv Solutions will cooperate fully in such audit, and will provide copies of any materials reasonably requested by Client during such audit.

7.2

Inspection by Regulatory Authorities

During the term of this Agreement, each Party will permit regulatory authorities to examine, (i) the facilities where the Services are being conducted; (ii) study documentation; and (iii) any other relevant information, including information that may be designated by one or both of the Parties as confidential, reasonably necessary for regulatory authorities to confirm that the Services are being conducted in compliance with applicable laws and regulations.  Each Party will immediately notify the other if any regulatory authority schedules, or without scheduling, begins an inspection that relates to the Services or the Parties’ respective obligations hereunder.

Aptiv Solutions shall provide Client with a copy of any inspection report related to the Services pursuant to this Agreement. Client shall be responsible for all costs and expenses related to Aptiv Solutions’ obligations hereunder if not otherwise included in the Project Agreement or Change Order.

7.3

Audit of Trial Site(s) by Aptiv Solutions

In connection with Aptiv Solutions’ provision of Services as specified in this Agreement and any associated Project Agreement, Aptiv Solutions may conduct monitoring visits and/or audits of Trial Sites.  Based on Aptiv Solutions’ observations during such Trial Site visits and audits, Aptiv Solutions may decide: i) that enrollment should be suspended at the Trial Site; ii) that a Trial Site’s non-compliance needs to be reported to Client and/or regulatory authorities; and/or (iii) Trial Site’s participation in a Study needs to be terminated.  Upon such a determination, Aptiv Solutions will present to Client a basis for its decision. If Client disagrees with the basis for Aptiv Solutions’ decision, Aptiv Solutions will assign its contract with the Trial Site to Client and Client agrees to accept such assignment and to be responsible for all contractual duties and obligations to the Trial Site.

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8.0

Disposition of Computer Files and Study Materials

Aptiv Solutions will take reasonable and customary precautions, including periodic backup of computer files, to prevent the loss or alteration of Client's study data, documentation, and correspondence.  Upon termination of this Agreement, Aptiv Solutions will dispose of Client computer-stored files and study materials according to Aptiv Solutions’ internal standard operating procedures. Client may communicate any special request for the disposition of materials in writing to Aptiv Solutions.  Client will bear all costs incurred by Aptiv Solutions in complying with any such written instructions furnished by Client.  Aptiv Solutions will provide a written estimate to Client, and Client will provide written approval, of all such costs prior to any action by Aptiv Solutions.

9.0

Ownership of data and intellectual property

9.1

Client Data

All data (including without limitation, written, printed, graphic, video and audio material, and information contained in any computer database or computer readable form) generated by Aptiv Solutions in the course of conducting the Services (the “Data”) and related to the Services will be Client’s property.  Any copyrightable work created in connection with performance of the Services and contained in the Data will be considered work made for hire, whether published or unpublished, and all rights therein will be the property of Client as employer, author and owner of copyright in such work.

9.2

Client’s Intellectual Property Rights  

The underlying rights to the intellectual property and materials that are the subject of each Project Agreement, including, without limitation, all intellectual property rights in Client’s drug candidates or products, are owned solely by Client.  Neither Aptiv Solutions, its Affiliates nor any of their respective Subcontractors will acquire any rights of any kind whatsoever with respect to Client’s drug candidates or products as a result of conducting Services hereunder.  All rights to any know-how, trade secrets, developments, discoveries, inventions or improvements (whether or not patentable) conceived or reduced to practice in the performance of work conducted under this Agreement by Aptiv Solutions’ or its Affiliates’ employees, or independent contractors, either solely or jointly with employees, agents, consultants or other representatives of Client (the “Intellectual Property”), will be owned solely by Client.  Aptiv Solutions, its Affiliates and their respective employees and Subcontractors will sign and deliver to Client all writings and do all such things as may be necessary or appropriate to vest in Client all right, title and interest in and to such Intellectual Property.  Aptiv Solutions will promptly disclose to Client any such Intellectual Property arising under this Agreement.  Client may, in its sole discretion, file and prosecute in its name and at its expense, patent applications on any patentable inventions within the Intellectual Property.  Upon the request of Client, and at the sole expense of Client, Aptiv Solutions will execute and deliver any and all instruments necessary to transfer its ownership of such patent applications to Client and to enable Client to file and prosecute such patent applications in any country.

9.3

Aptiv Solutions’ Intellectual Property Rights  

Notwithstanding the foregoing, Client agrees that Aptiv Solutions possesses or may in the future possess analytical methods, computer technical expertise and software, which have been independently developed by Aptiv Solutions (“Technology”) and which will remain the sole and exclusive property of Aptiv Solutions, except to the extent that improvements or modifications include, incorporate or are based upon Client's information. Improvements or enhancements made to Aptiv Solutions’ Technology which are independently developed incidental to the provision of Services hereunder will remain the sole property of Aptiv Solutions. Aptiv Solutions grants Client a non-exclusive, irrevocable, perpetual, worldwide, royalty-free license for this information and Technology free of charge for interpretation purposes or regulatory authorities’ purposes or for any purposes required for the achievement of the scope and objectives of a Project Agreement and use of any deliverables further to the Project Agreement. Any improvement on information of Client will remain the sole property of Client.

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10.0

Confidential Information

10.1

Client Confidential Information

a.

Client may disclose confidential information to Aptiv Solutions during the course of this Agreement.  All information provided by or on behalf of Client or data collected by Aptiv Solutions during the performance of the Services is deemed to be the confidential information of Client and is hereinafter referred to as “Client Information”.  Aptiv Solutions will not disclose Client Information to any person other than its Affiliates and its and their respective employees, agents, Investigators, Trial Sites and independent contractors involved in the Services or use any such information for any purpose other than the performance of Services without the prior written consent of Client, except that Aptiv Solutions may share Client Information with Client’s Affiliates, if requested.

b.

Aptiv Solutions will ensure that it and its Affiliates’ employees, agents, and independent contractors involved in the Services will comply with terms substantively similar to the confidentiality provisions of this Agreement.  Contracts with Trial Sites will include provisions no less restrictive than these terms.  Aptiv Solutions will disclose the Client Information only to those of Aptiv Solutions’ of Client’s Affiliates, and their employees, agents, Investigators, Trial Sites and independent contractors who reasonably need to know the Client Information for the purposes of carrying out a Project Agreement.

c.

Aptiv Solutions will exercise due care to prevent the unauthorized disclosure and use of Client Information associated with the Services.

d.

This confidentiality, nondisclosure and nonuse provision will not apply to Client Information that Aptiv Solutions can demonstrate by competent evidence:

i.

was known by Aptiv Solutions before initiation of the Services or which is independently discovered, after the initiation of the Services, without the aid, application or use of Client Information, as evidenced by written records;

ii.

was in the public domain at the initiation of the Services or subsequently became publicly available through no fault or action of Aptiv Solutions; or

iii.

was disclosed to Aptiv Solutions on a non-confidential basis by a third party authorized to disclose it.

e.

In no event will either Party be prohibited from disclosing confidential information of the other Party to the extent required by law to be disclosed, provided that the disclosing Party provides the non-disclosing Party with written notice thereof, prior to disclosure, to the extent reasonably practicable, discloses only what is required to be disclosed by law or regulation, and, at the non-disclosing Party’s request and expense, cooperates with the non-disclosing Party’s efforts to obtain a protective order or other confidential treatment of the confidential information required to be disclosed.

10.2

Aptiv Solutions Confidential Information

Client agrees that all business processes, contract terms, prices, procedures, policies, methodologies, systems, computer programs, software, applications, databases, proposals and other documentation generally used by Aptiv Solutions and not developed solely for Client are the exclusive proprietary and confidential property of Aptiv Solutions (hereinafter “Aptiv Solutions Information”).  Client agrees that all Aptiv Solutions Information, along with any improvement, alteration or enhancement made thereto during the course of the Services, will be the exclusive proprietary and confidential property of Aptiv Solutions, and will be subject to the same degree of protection as is required of Aptiv Solutions to protect Client Information.

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10.3

Return or Destruction of Information   

At the conclusion of a Study, Aptiv Solutions will deliver to Client all Client Information in its possession unless Client directs otherwise.  Upon the written request of the Client, Aptiv Solutions shall either destroy or return to the Client the Client Information.  Provided, however, that Aptiv Solutions shall be entitled to retain in confidence under this Agreement, including without limitation: (i) one (1) archived copy of Client Information and all materials created by Aptiv Solutions and containing Client Information, including without limitation notes and memoranda, solely for the purpose of administering Aptiv Solutions’ obligations under this Agreement; and (ii) Client Information contained in Aptiv Solutions’ electronic back-up files that are created in the normal course of business pursuant to Aptiv Solutions’ standard protocol for preserving its electronic records.

10.4

Data Protection

To the extent applicable, Client and Aptiv Solutions will comply with all applicable national and international laws, regulations and guidelines relating to protection of the personal information of study subjects, including the European Commission Directive 95/46/IC as it relates to the protection of the personal information of EU/EEA  study subjects, and the Standards for Privacy of Individually Identifiable Health Information (Privacy Rule) under the Health Insurance Portability and Accountability Act of 1996 (HIPAA).  

11.0

Publicity

Client may use, refer to and disseminate reprints of scientific, medical and other published articles which disclose the name of Aptiv Solutions consistent with applicable international copyright laws, provided such use does not constitute an endorsement of any commercial product or service by Aptiv Solutions.  Neither Party will disclose publicly or utilize in any advertising or promotional materials or media the existence of this Agreement or its association with the other except to the party’s Affiliates, or use of the other Party’s name or the name of any of the other Party’s Affiliates, divisions, subsidiaries, products or investigations without the prior written permission of the other Party, provided however, that Aptiv Solutions may use the name of Client in its list of customers and may use Client’s logo or trademarks on proposals and presentation specifically prepared for Client.  Further, either Party may make such public disclosures as it determines, based on advice of counsel, and are reasonably necessary to comply with laws or regulations.

12.0

Indemnification

12.1

Client’s Agreement

a.

Client will indemnify, defend and hold harmless Aptiv Solutions, its Affiliates, and their officers, directors, agents, employees, and independent contractors approved by Client (each an “Indemnitee”) against any claim, suit, action, proceeding, arbitration or investigation, pending by a third party (each a “Claim”) against Indemnitees arising from the performance of the Services conducted under this Agreement, including but not limited to court costs, legal fees, awards or settlements, except to the extent that such Claim arose as a result of Aptiv Solutions’ negligence, recklessness, intentional misconduct or material breach of this Agreement or any Project Agreement hereunder.  Under such circumstances Aptiv Solutions will repay to Client all reasonable defense costs incurred by Client on its behalf.  

b.

Aptiv Solutions will promptly notify Client upon receipt of notice of any Claim (provided that the failure to give such notice will not relieve Client of its obligations under this Section except to the extent, if at all, it is prejudiced thereby) and will permit Client's attorneys and personnel, at Client's discretion and cost, to handle and control the defense of any such Claim.  In the event that representation of Aptiv Solutions and Client by the same counsel is a conflict of interest for such counsel, Aptiv Solutions may select its own independent counsel, at its own expense, without relieving Client of its obligations under this Section. Under no circumstances, however, will Client accept liability, settle or otherwise compromise any Claims without prior written consent of Aptiv Solutions.  Aptiv Solutions will fully cooperate and aid in any such defense.

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12.2

Aptiv Solutions’ Agreement

a.

Aptiv Solutions will indemnify, defend and hold harmless Client and its employees, officers, agents, principals and directors against any and all Claims including but not limited to reasonable to court costs, legal fees, awards or settlements resulting from Aptiv Solutions’ negligence, recklessness, intentional misconduct, or material breach of this Agreement or any Project Agreement hereunder, except to the extent that such claim arose as a result of Client’s negligence, recklessness, intentional misconduct or material breach of this Agreement or any Project Agreement hereunder.  Under such circumstances Client will repay to Aptiv Solutions all reasonable defense costs incurred by Aptiv Solutions on its behalf.  

b.

Client will promptly notify Aptiv Solutions upon receipt of notice of any Claim for which it intends to seek indemnification hereunder, provided that the failure to give such notice will not relieve Aptiv Solutions of its obligations under this Section except to the extent, if at all, it is prejudiced thereby.  Client will permit Aptiv Solutions’ attorneys and personnel, at Aptiv Solutions’ discretion and cost, to handle and control the defense of any such Claim.  In the event that representation of Client and Aptiv Solutions by the same counsel is a conflict of interest for such counsel, Client may select its own independent counsel, at Clients’ expense, without relieving Aptiv Solutions of its obligations under this Section. Under no circumstances, however, will Aptiv Solutions accept liability, settle or otherwise compromise any Claims subject to indemnification under this Section without prior written consent of Client.  Client will fully cooperate and aid in any such defense.

12.3

Limits of Liability

Aptiv Solutions' liability for direct damages hereunder will not exceed the total fees payable by Client to Aptiv Solutions under the applicable Project Agreement.  In no event will Aptiv Solutions be liable to Client for any indirect, incidental, special, or consequential damages or lost profits arising out of or related to its provision of Services to Client, even if Aptiv Solutions has been advised of the possibility of such damages, except to the extent that such damages result from the gross negligence, recklessness or intentional misconduct of Aptiv Solutions, its employees, independent contractors or agents.

Notwithstanding anything to the contrary in this Agreement or in any Project Agreement, the Parties agree that Aptiv Solutions shall not be liable for: (1) the lack of efficacy or complications associated with any product under study outside of Aptiv Solutions control, or (2) the act of any principal investigator, sub-investigator, clinical research associate, nurse, nurse-practitioner, pharmacist, or any other employee or consultant licensed to practice medicine or employed by or under agreement with any hospital, clinic, nursing service, site management organization, or other entity which is contracted to be a Trial Site for any study conducted pursuant to this Agreement, even if Aptiv Solutions shall pay, compensate, select, train, contract with or otherwise interact with any of the foregoing.

12.4

Insurance

a.

Client Insurance.  During the term of this Agreement, and for a period of five (5) years following the termination of this Agreement or completion of each Project Agreement, Client shall maintain in full force and effect a policy or policies or self-insurance of:

i.

general liability insurance (with product liability endorsements) with limits of not less than Five Million Dollars ($5,000,000);

ii.

products liability with limits of not less than Five Million Dollars ($5,000,000); and

iii.

clinical trials insurance in compliance with local compulsory requirements. Client will extend this coverage to protect Aptiv Solutions from and against any action or actions for property damage, personal injury or death arising from activities properly undertaken, or undertaken at the express instructions of Client, within the terms of the Agreement.

Aptiv Solutions may from time to time request evidence confirming such insurance.

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b.

Aptiv Solutions Insurance.  Aptiv Solutions shall at all times during the term of this Agreement and any extended terms thereof, provide and maintain at its own expense, the following types of insurance:

i.

Professional Liability: Professional Liability covering all professional acts, errors and omissions in an amount of not less than Five Million Dollars ($5,000,000) per occurrence and in the aggregate.

ii.

General Liability: Commercial General Liability insurance against claims for bodily injury and property damage in an amount of not less than Five Million Dollars ($5,000,000) per occurrence and in the aggregate.

iii.

Workers Compensation and Employers’ Liability: To comply with the statutory requirements of the state(s) in which the Services are performed.  The policy shall include Employers’ Liability for not less than One Million Dollars ($1,000,000) per accident.

c.

General Terms

i.

All policies shall be issued by one or more insurance companies rated A- VII or better by the BEST Rating guide or its equivalent.

ii.

Such insurance may be provided on a claims-made basis (with the exception of workers compensation and employers’ liability), however, such insurance shall have a retroactive date prior to the date that any work will be performed pursuant to the Agreement, and shall be maintained (or shall have an extended reporting period) of at least five (5) years after the termination of this Agreement.

iii.

In the event that such policies are cancelled, terminated or altered, the insured Party shall endeavor to provide at least thirty (30) days prior written notice to the other Party.

iv.

It is agreed and understood that the above limits are minimum required amounts and are not limitations of liability.  

13.0

Independent Contractor Relationship

Aptiv Solutions and Client are independent contractors.  Nothing in this Agreement will be construed to create the relationship of partners, joint venturers, or employer and employee between Aptiv Solutions and Client or Aptiv Solutions' employees.  Neither Party, nor its employees, or independent contractors will have authority to act on behalf of or bind the other Party in any manner whatsoever unless otherwise authorized in this Agreement or a specific Project Agreement or in a separate writing signed by both Parties.

14.0

Employees

Neither Party, during the term of this Agreement and for twelve months thereafter, will, without the prior written consent of the other Party, directly or indirectly solicit for employment or contract, attempt to employ or contract with or assist any other entity in employing, contracting with or soliciting for employment or contract any employee or executive who is at that time employed/contracted by the other Party and who had been employed/contracted by the other Party in connection with one or more Project Agreements issued hereunder.  Provided, however, that the foregoing provision will not prevent either Party from conducting solicitation via a general advertisement for employment that is not specifically directed to any such employee or from employing any such person who responds to such solicitation.

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15.0

Notices

Except as otherwise provided, all communications and notices required under this Agreement will be mailed by first class mail or sent via nationally recognized overnight courier to the addresses set forth below, or to such other addresses as the Parties from time to time specify in writing.

 

If to Aptiv Solutions :

Aptiv Solutions, Inc.

1925 Isaac Newton Square

Suite 100

Reston, VA 20190

Attention: Chief Executive Officer

Copy to:  VP, Legal Affairs

 

If to Client:

 

16.0

Force Majeure

If the performance of this Agreement by Aptiv Solutions or Client is prevented, restricted, interfered with or delayed (either totally or in part) by reason of any cause beyond the control of the Parties (including, but not limited to, acts of God, flood, sabotage, explosion, disease, weather, war, insurrection, terrorism, civil strike, failures to obtain requested governmental visas, work permits or other authorizations, governmental laws and regulations imposed after the fact, power failures, riots or extensive power failure), the Party so affected will, upon giving notice to the other Party as soon as is practical, be excused from such performance to the extent of such prevention, restriction, interference or delay, provided that the affected Party will use reasonable efforts to avoid or remove such causes of non-performance and will continue performance whenever such causes are removed. In the event such failure continues for a period of sixty (60) days or more, either Aptiv Solutions or Client may terminate the applicable Work Order by giving written notice thereof to the other Party.

17.0

Governing Law

This Agreement will be governed by, and construed and enforced in accordance with, the laws of the State of Delaware, U.S.A. applicable to contracts made and to be performed therein, without giving effect to the principles thereof relating to the conflict of laws

18.0

Severability

If any of the provisions or a portion of any provision of this Agreement is held to be unenforceable or invalid by a court of competent jurisdiction, the validity and enforceability of the enforceable portion of any such provision and/or the remaining provisions will not be affected thereby.

19.0

Assignment

Neither Party may assign this Agreement without the prior written consent of the other Party, which consent will not be unreasonably withheld; provided, however, that either Party may assign this Agreement without consent to a successor in interest to substantially all of the business of that Party to which the subject matter of this Agreement relates upon delivery to the other Party of notice of such assignment.

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20.0

Waiver

No waiver of any term, provision or condition of this Agreement whether by conduct or otherwise in any one or more instances will be deemed to be construed as a further or continuing waiver of such term, provision or condition or of any other term, provision or condition of this Agreement.

21.0

Entire Agreement

This Agreement, including all Exhibits, Project Agreements, and associated Amendments hereto contains the full understanding of the Parties with respect to the Services and supersedes all existing Agreements and all other oral, written or other communications between the Parties concerning the subject matter hereof. This Agreement will not be modified in any way except in writing and signed by a duly authorized representative of Client and an authorized officer of Aptiv Solutions.

22.0

English Language

The Parties hereto confirm that this Agreement as well as any other documents relating hereto, including notices, have been and shall be drawn up in the English language.

23.0

Counterparts

This Agreement may be executed in several counterparts, each of which will be deemed an original but all of which will constitute one and the same instrument.  To the extent that counterparts are in a language other than English, the English language version shall control.

24.0

Arbitration

In the event a dispute relating to this Agreement or any Project Agreement arises between the Parties, the Parties will use all reasonable efforts to resolve the dispute through direct discussions for a period of thirty (30) business days. The senior management of each Party is committed to respond to any such dispute.  Subsequent to such thirty-day period either Party may, but will not be required to, resort to binding arbitration procedures.  If the dispute arises under a Project Agreement executed by Aptiv Solutions, Inc. arbitration will be conducted within the Commonwealth of Virginia.  If the dispute arises under a Project Agreement executed by one of Aptiv Solutions’ Affiliates in Europe, arbitration will be conducted in London, England.

25.0

AMBIGUITIES

Each party has participated fully in the review and revision of this Agreement.  Any rule of construction to the effect that ambiguities are to be resolved against the drafting party shall not apply in interpreting this Agreement. The language in this Agreement shall be interpreted as to its fair meaning and not strictly for or against any party.

26.0

TELECOPY EXECUTION AND DELIVERY

A facsimile, telecopy, “pdf” file or other reproduction of this Agreement may be executed by one or both Parties hereto, each of which counterpart shall be deemed an original Agreement and all of which shall constitute but one Agreement. Further, an executed copy of this Agreement may be delivered by one or both Parties hereto by facsimile or similar electronic transmission device pursuant to which the signature of or on behalf of such Party can be seen, and such execution and delivery shall be considered valid, binding and effective for all purposes.  At the request of either Party hereto, both Parties hereto agree to execute an original of this Agreement as well as any facsimile, telecopy or other reproduction hereof.

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The undersigned have executed this Agreement as of the day and year noted below.

 

APTIV SOLUTIONS, INC.

 

IMMUNOCELLULAR THERAPEUTICS, LTD.

 

 

 

Authorized Signature

 

Authorized Signature

 

 

 

Name

 

Name

 

 

 

Title

 

Title

 

 

 

Date

 

Date

LIST OF EXHIBITS

Exhibit A:   Form of Project Agreement

Exhibit B:   Form of Amendment

 

 

 

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EXHIBIT A:

FORM OF PROJECT AGREEMENT

Project Agreement Number: _____

Client Project Number: _________

This Project Agreement is made and entered into on <Month> <Day>, <Year>, the Effective Date, by and between <Client> , a corporation of _______ with offices at < Location> (hereinafter referred to as “Client”) and Aptiv Solutions, Inc., together with its Affiliates, with offices at 1925 Isaac Newton Square, Suite 100, Reston, Virginia 20190 (hereinafter referred to as “Aptiv Solutions”).

WHEREAS , Client and Aptiv Solutions have entered into that certain Master Services Agreement for dated the <day> of <month>, 201_ (hereinafter referred to as the “Agreement”); and

WHEREAS , pursuant to the Agreement, Aptiv Solutions has agreed to perform certain Services in accordance with Project Agreements from time to time entered into by the Parties, as more fully provided in Section 2 of the Agreement, and Client and Aptiv Solutions now desire to enter into such a Project Agreement.

WHEREAS , Aptiv Solutions and Client desire that Aptiv Solutions provide certain Services with respect to a __________________________, (the “Study”) for the study of the drug <device> ___________________________ (“Study Drug”) as set out in the Protocol titled: ________________, which is incorporated herein by reference.

NOW, THEREFORE , in consideration of the mutual covenants contained herein, the parties hereby agree as follows:

1.      Project Specifications.   Aptiv Solutions will perform the services described in the Project Specifications, attached hereto as Appendix A, in accordance with the Project Schedule, attached hereto as Appendix B and any other documents attached to this Project Agreement (“Services”).

2.      Compensation .  For performance of these Services, Client will pay to Aptiv Solutions the amounts described in the Budget for Services and Pass-Through Budget set forth in Appendix C, which amounts will be payable pursuant to the Payment Schedule set forth in Appendix D.  

2.1.  A payment plan inclusive of a down payment of twenty percent (20%) of the total budget estimate, inclusive of Pass Through Expenses and Investigator Payments is included in the Payment Schedule. The down payment is considered as an advance payment and shall be taken into account with the final payment(s) upon completion of the Services. Down payment invoices are due immediately upon signature of this Project Agreement.  All other payments are to be made in accordance with the Agreement and due within thirty (30) days of invoice date.

3.      Designated Contact Person.   The Aptiv Solutions Project Manager <or other designation for this project> who will oversee the Services in accordance with the Master Agreement, is:

<name>

< title>

<Address>

<Phone>

<E-mail>

4.      Term and Termination.   The term of this Project Agreement will commence upon its execution by Aptiv Solutions and Client and will continue until completion of the Services described in Appendix A, provided, however, that either Party may terminate this Project Agreement in accordance with Section 4, Term and Termination, of the Agreement.

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5.      Incorporation by Reference; Conflict.   The provisions of the Agreement are hereby expressly incorporated by reference into and made a part of this Project Agreement.   In the event of a conflict between the terms and conditions of this Project Agreement and those of the Agreement, the terms of the Agreement will take precedence and control; provided however, in event of conflicts between the Project Agreement and the Agreement, Sections 3.0 Payment, 4.0 Term and Termination, the Project Agreement shall control.

IN WITNESS WHEREOF , the parties have hereunto signed this Project Agreement effective as of the day and year first written above.

 

APTIV SOLUTIONS, INC.

 

<Client>

 

 

 

Authorized Signature

 

Authorized Signature

 

 

 

Name

 

Name

 

 

 

Title

 

Title

 

 

 

Date

 

Date

List of Appendices

Appendix A:   Project Specifications

Appendix B:   Project Schedule

Appendix C:   Budget for Services and Pass-Through Budget

Appendix D:   Payment Schedule

 

 

 

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EXHIBIT B

FORM OF AMENDMENT

AMENDMENT #__

Agreement No_____, Protocol #

THIS AMENDMENT #_ (“Amendment #_”), dated <Month> <Day>, <Year> (the “Effective Date”), is by and between <Client> , a corporation of _______ with offices at < Location> (hereinafter referred to as “Client”) and Aptiv Solutions, Inc. , together with its Affiliates, with offices at 1925 Isaac Newton Square, Suite 100, Reston, Virginia 20190 (hereinafter referred to as “Aptiv Solutions”).

W I T N E S S E T H:

WHEREAS, under the terms of a certain Master Services Agreement (the “Agreement”), dated the ___ day of _______, 201_ by and between the parties, Client agreed to retain Aptiv Solutions, and Aptiv Solutions agreed to be retained by Client, to perform the Services as more particularly described in the Agreement pursuant to the terms of Project Agreements to be issued from time to time;

WHEREAS , the Parties have entered into Project Agreement No. _ pursuant to the terms of the Agreement; and

WHEREAS, the Parties hereto have entered into certain additional agreements with respect to modification of the Project Agreement, and which they desire to memorialize in this Amendment #_;

NOW, THEREFORE, in consideration of the premises and of the following mutual promises, covenants and conditions hereinafter set forth, the parties hereto agree as follows:

1.       Project Specifications.   The Services to be provided by Aptiv Solutions pursuant to the Agreement are hereby amended by inclusion of the Services described in Amendment Appendix __, “Additional Project Specifications”, which is attached hereto and incorporated herein by reference.

2.       Project Schedule.   The Project Schedule, attached to the Agreement as Appendix __, is hereby stricken and replaced by the Amended Project Schedule, attached hereto as Amendment Appendix__, “Amended Project Schedule”, which is incorporated herein by reference.

3.       Budget and Payment Schedule.   Therefore, the following changes to the Agreement are hereby made:

a.  The Budget for Services, attached to the Agreement as Appendix _, is hereby stricken and replaced by the “Amended Budget”, attached hereto as Amendment Appendix _, which is incorporated herein by reference.

b.  The Payment Schedule, attached to the Agreement as Appendix __, is hereby stricken and replaced by the “Amended Payment Schedule”, attached hereto as Amendment Appendix __, which is incorporated herein by reference.

4.       Designated Contact Persons.   The Designated Contact Person assigned to this Study has changed.  Therefore, the Designated Contact Person , is hereby stricken and replaced by <name, title, contact> .

5.       Ratification of Balance of Agreement.   In all other respects, the terms of the Project Agreement are hereby ratified and affirmed by each of the parties hereto.

6.       Headings.   The headings in this Amendment #1 are for convenience of reference only and will not affect its interpretation.

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IN WITNESS WHEREOF , the parties hereto, each by a duly authorized representative, have executed this Amendment #_ as of the date first written above.

 

APTIV SOLUTIONS, INC.

 

<Client>

 

 

 

Authorized Signature

 

Authorized Signature

 

 

 

Name

 

Name

 

 

 

Title

 

Title

 

 

 

Date

 

Date

List of Appendices:

Amendment Appendix A: Additional Project Specifications

Amendment Appendix B: Amended Project Schedule

Amendment Appendix C: Amended Budget

Amendment Appendix D: Amended Payment Schedule

 

22

Exhibit 23.1

Independent Registered Public Accounting Firm’s Consent

We consent to the incorporation by reference in the Registration Statement of ImmunoCellular Therapeutics, Ltd. (a Development Stage Company) on Forms S-1 (File Nos. 333-178211, 333-173312, 333-167207 and 333-144521) and S-3 (File No. 333-184010) and S-8 ( File Nos. 333-192177, 333-183715, 333-171652, 333-155199, 333-151968 and 333-147278) of our report dated March 14, 2014, with respect to our audits of the financial statements of ImmunoCellular Therapeutics, Ltd. (a Development Stage Company) as of December 31, 2013 and 2012 and for the years ended December 31, 2013, 2012, and 2011 and for the period from February 25, 2004 (inception) to December 31, 2013, and our report dated March 14, 2014 with respect to our audit of the effectiveness of internal control over financial reporting of ImmunoCellular Therapeutics, Ltd. (a Development Stage Company) as of December 31, 2013, which reports are included in this Annual Report on Form 10-K of ImmunoCellular Therapeutics, Ltd. (a Development Stage Company) for the year ended December 31, 2013.

Marcum llp

Los Angeles, CA

March 14, 2014

 

Exhibit 31.1

Certification of the Principal Executive Officer Under Section 302 of the Sarbanes-Oxley Act

I, Andrew Gengos, certify that:

1.

I have reviewed this report on Form 10-K of ImmunoCellular Therapeutics, Ltd.;

2.

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4.

The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a)

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this annual report is being prepared;

(b)

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c)

Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d)

Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5.

The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

(a)

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: March 14, 2014

By:

/s/ Andrew Gengos  

 

 

Name:

Andrew Gengos

 

 

Title:

President and Chief Executive Officer

 

 

 

 

Exhibit 31.2

Certification of the Principal Financial Officer Under Section 302 of the Sarbanes-Oxley Act

I, David Fractor, certify that:

1.

I have reviewed this report on Form 10-K of ImmunoCellular Therapeutics, Ltd.;

2.

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4.

The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a)

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this annual report is being prepared;

(b)

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c)

Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d)

Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5.

The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

(a)

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: March 14, 2014

By:

/s/ David Fractor

 

 

Name:

David Fractor

 

 

Title:

Principal Financial and Accounting Officer

 

Exhibit 32.1

CERTIFICATION OF THE PRINCIPAL EXECUTIVE OFFICER

Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and Section 1350 of Chapter 63 of Title 18 of the United States Code ( 18 U.S.C. § 1350), the undersigned officer of ImmunoCellular Therapeutics, Ltd. (the “Company”) hereby certifies that, to the best of his knowledge:

1.

The Company’s Annual Report on Form 10-K for the period ended December 31, 2013 (the “Annual Report”), to which this Certification is attached as Exhibit 32.1, fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act; and

2.

The information contained in the Annual Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

Date: March 14, 2014

By:

/s/ Andrew Gengos  

 

 

Name:

Andrew Gengos

 

 

Title:

President and Chief Executive Officer

 

Exhibit 32.2

CERTIFICATION OF THE PRINCIPAL FINANCIAL OFFICER

Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. § 1350), the undersigned officer of ImmunoCellular Therapeutics, Ltd. (the “Company”) hereby certifies that, to the best of his knowledge:

1.

The Company’s Annual Report on Form 10-K for the period ended December 31, 2013 (the “Annual Report”), to which this Certification is attached as Exhibit 32.1, fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act; and

2.

The information contained in the Annual Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

Date: March 14, 2014

By:

/s/ David Fractor  

 

 

Name:

David Fractor

 

 

Title:

Principal Financial and Accounting Officer