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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Delaware
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56-2110007
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification No.)
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4233 Technology Drive
Durham, North Carolina
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27704
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(Address of principal executive offices)
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(Zip Code)
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Title of Each Class
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Name of Each Exchange on Which Registered
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Common Stock, par value $0.001 per share
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NASDAQ Global Market
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Large accelerated filer
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¨
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Accelerated filer
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Non-accelerated filer
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x
(Do not check if a smaller reporting company)
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Smaller reporting company
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PART I
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PART II
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PART III
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PART IV
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the progress and timing of our development and commercialization activities;
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the timing and conduct of our phase 3 clinical trial of AGS-003 for the treatment of metastatic renal cell carcinoma, or mRCC, and phase 2 clinical trials of AGS-003, including the timing of enrollment and completion of the trials and the period in which the results of the trials are anticipated to become available;
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the timing and conduct of our two phase 2 clinical trials of AGS-004 for the treatment of HIV, one for HIV eradication and one for long-term viral control in pediatric patients, including the timing of enrollment and the completion of the trials and the period in which results of the trials are anticipated to become available;
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our ability to obtain U.S. and foreign marketing approval for AGS-003 for the treatment of mRCC and for AGS-004 for the treatment of HIV, and the ability of these product candidates to meet existing or future regulatory standards;
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the potential benefits of our Arcelis platform and our Arcelis-based product candidates;
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our ability to build out and equip a new North American commercial manufacturing facility and supply on a commercial scale our Arcelis-based products;
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our intellectual property position and strategy;
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our expectations related to the sufficiency of our cash, cash equivalents and short-term investments;
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the accuracy of our estimates of the size and characteristics of the markets that may be addressed by our product candidates;
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our ability to establish and maintain collaborations for the development and commercialization of our product candidates;
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developments relating to our competitors and our industry; and
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the impact of government laws and regulations.
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target a patient’s disease-specific antigens, including mutated antigens, to elicit a potent immune response that is specific to the patient’s own disease;
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overcome the immune suppression that exists in cancer and infectious disease patients;
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induce memory T-cells, a specialized type of immune cell that is known to correlate with improved clinical outcomes for cancer and HIV patients;
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have minimal toxicity; and
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can be produced using a automated centralized manufacturing process at a cost that will be comparable to biologics.
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Product Candidate
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Primary Indication
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Status
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AGS-003
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mRCC (clear cell)
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Ongoing pivotal phase 3 clinical trial; completion of enrollment expected
by the end of second quarter 2015
; overall survival data expected in the second half of 2016
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mRCC (non-clear cell)
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Phase 2 investigator-initiated clinical trial expected to begin in the second half of 2015
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Early stage RCC (neoadjuvant)
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Ongoing investigator-initiated phase 2 clinical trial;
initial
data expected in 2016
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Early stage RCC (adjuvant)
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Investigator-initiated phase 2 clinical trial expected to begin mid-2015;
initial
data expected in 2016
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Advanced solid tumors
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Two investigator-initiated phase 2 clinical trials expected to begin in the second half of 2015
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AGS-004
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HIV
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Phase 2b clinical trial complete; data announced on January 9, 2015
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Ongoing first stage of investigator-initiated phase 2 clinical trial for HIV eradication; Second stage expected to begin in the second half of 2015
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Investigator-initiated phase 2 clinical trial for long-term viral control in pediatric patients planned for the second half of 2015
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complete clinical development and seek marketing approvals of AGS-003 for the treatment of mRCC;
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expand clinical development of AGS-003 in other cancers, including non-clear cell mRCC, early stage RCC and other solid tumors;
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commercialize AGS-003 in North America independently and with third parties outside North America;
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establish automated manufacturing processes based on our existing functioning prototypes of automated devices and, prior to the filing of our BLA for AGS-003, build out and equip a new North American facility for the commercial manufacture of products based on our Arcelis platform; and
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continue clinical development of AGS-004 for the treatment of HIV, potentially through government funding or other third party funding, and collaborate with third parties for commercialization on a worldwide basis;
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pursue expansion of our broad intellectual property protection for our Arcelis technology platform, product candidates and proprietary manufacturing processes through U.S. and international patent filings and maintenance of trade secret confidentiality.
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Target disease-specific antigens, including mutated antigens.
The immunotherapy should target antigens, including mutated antigens, associated with the patient’s disease. We believe that immunotherapies that target only non-mutated, or normal, tumor-associated antigens will be limited in terms of efficacy as non-mutated antigens are generally poor at stimulating immune responses. Our Arcelis platform uses messenger RNA, or mRNA, from the patient’s own cancer or virus to yield a fully personalized immunotherapy that contains the patient’s disease-specific antigens, including mutated antigens, and is designed to elicit a potent immune response specific to the patient’s own disease.
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Overcome disease-induced immune suppression.
The immunotherapy must be able to generate an effective immune response in patients whose immune systems are compromised by their disease. Both tumors and HIV are known to impair the functionality of CD4+ T helper cells, which aid their escape from CD8+ T-cell attack. Our Arcelis-based immunotherapies do not require CD4+ helper T-cells to mount an immune response with effective anti-tumor or anti- viral activity as we add the protein known as CD40 ligand, or CD40L, to provide the signaling that the CD4+ helper T-cells would otherwise provide.
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Induce memory T-cells.
The immunotherapy should be able to induce specific T-cells, such as CD8+CD28+ memory T-cells, that are known to correlate with improved clinical outcomes for cancer and HIV patients. These memory T-cells are long lived and necessary for a durable immune response. Our Arcelis process produces dendritic cells that secrete IL-12, which is necessary to induce and expand patient-specific CD8+CD28+ memory T-cells. These memory T-cells are able to seek out and kill cancer or virus-infected cells that express the antigens identical to those displayed on the surface of the dendritic cells. In addition, because these newly generated memory T-cells do not express PD-1, they are not subject to inhibition by the PD-1/PD-L1 pathway.
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Have minimal toxicity.
The immunotherapy should have minimal toxicity, which would potentially enable it to be combined with other therapies for cancer and infectious diseases. The mechanism of action of Arcelis-based products induces patient- and disease-specific memory T-cells. This target customization and specificity is less likely to impact healthy tissue and cause toxicity. Our Arcelis-based product candidates have been well tolerated in clinical trials in more than 170 patients with no serious adverse events attributed to our immunotherapies.
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A disease sample: In the case of cancer, the sample consists of tumor cells, and in the case of infectious disease, the sample consists of blood containing the virus. The disease sample is generally collected at the time of diagnosis or initial treatment.
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Monocytes: Monocytes are a type of white blood cell, which are obtained through a laboratory procedure called leukapheresis that occurs after diagnosis and at least three weeks prior to initiating treatment with our immunotherapy.
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We isolate the patient’s disease mRNA, which carries the genetic information to recreate the patient’s disease antigens, from the disease sample and amplify the mRNA so that only a small disease sample is required to manufacture the immunotherapy.
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Separately, we extract the monocytes from the leukapheresis product and culture them using a proprietary process to produce matured dendritic cells.
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We then culture the matured dendritic cells in a solution of the patient’s isolated mRNA and a proprietary synthetic CD40L RNA. We apply a brief electric pulse to the solution in a process referred to as electroporation, which enables the patient’s mRNA and the CD40L RNA to pass into, or load, the dendritic cells. The dendritic cells process the CD40L RNA into CD40L protein, enabling the dendritic cells to secrete IL-12, a cytokine required to induce and expand CD8+CD28+ memory T-cells.
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We then further culture the mRNA-loaded dendritic cells so that these cells allow for antigen expression from the patient’s mRNA and presentation in the form of peptides on the surface of the dendritic cells. These mature, loaded dendritic cells are formulated into the patient’s plasma that was collected during the leukapheresis to become the Arcelis-based product.
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After verifying the quality of the product, we then vial, freeze and ship the product to the clinic, which thaws the product and administers it to the patient by intradermal injection.
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produce several years of customized therapy for a patient from a small disease sample and a single leukapheresis from that patient;
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produce additional years of therapy for a patient at a later date without requiring an additional disease sample from the patient;
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use a centralized manufacturing facility for North America, which is possible because our Arcelis process can utilize monocytes obtained through leukapheresis within four days of the procedure, and doses of our immunotherapies can be shipped frozen in a cryoshipper that can maintain the target temperature for at least two weeks;
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cryopreserve the doses generated from the single manufacturing process for each patient in a direct injectable formulation that allows the doses to remain stable and usable for up to five years; and
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produce immunotherapies that can be administered by intradermal injection in an outpatient procedure.
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time from diagnosis to the initiation of systemic therapeutic treatment of less than one year, which is indicative of more aggressive disease. We refer to this risk factor as the less than one year to treatment risk factor;
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low levels of hemoglobin, a protein in the blood that carries oxygen;
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elevated corrected calcium levels;
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diminished overall patient performance status or physical functioning;
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elevated levels of neutrophils, a type of white blood cell; and
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elevated platelet count.
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in 157 favorable risk patients, the median overall survival was 43 months;
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in 440 intermediate risk patients, the median overall survival was 22.5 months; and
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in 252 poor risk patients, the median overall survival was 7.8 months.
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We believe that because the mechanism of action of AGS-003 is unrelated to the mechanism of action of sunitinib or the other targeted therapies, combining AGS-003 with these therapies has the potential to have an additive efficacy benefit.
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We believe that if a combination therapy with AGS-003 shows improved efficacy, the combination could be used as the standard of care for first-line treatment of mRCC in our targeted patient population.
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We believe that the lack of significant toxicity of AGS-003 will enable it to be combined with sunitinib and the other targeted therapies at a full dose for both therapies without added toxicity.
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We believe that, by following an initial cycle of sunitinib with AGS-003 in combination therapy, patients are likely to have a lower metastatic tumor burden, or at least a slowing of tumor progression, at the time of initiation of AGS-003 therapy, making it more likely that AGS-003 would have the opportunity to elicit immune responses and demonstrate an effect on the tumor.
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We believe that continued dosing of sunitinib, as well as certain of the other targeted therapies, decreases regulatory T-cells and myeloid-derived suppressor cells, both of which are immunosuppressive cells known to expand during cancer and suppress T-cell responses. As a result, by combining with these therapies, we believe that AGS-003 may be able to generate more potent T-cell responses.
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a phase 2 combination therapy clinical trial of AGS-003 in combination with sunitinib;
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a phase 1/2 monotherapy clinical trial of AGS-003; and
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a phase 1/2 monotherapy clinical trial of MB-002.
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Outcome
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(N=21)
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Median OS
(1)
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30.2 months
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Median PFS
(2)
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11.2 months
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Complete response
(3)
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0 patients
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Partial response
(4)
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9 patients
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Stable disease
(5)
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4 patients
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Immune response
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CD8+ CD28+ memory T-cells correlated with OS, PFS and reduced metastatic tumor burden; IL-2 and interferon-
g
(IFN-
g
) recovery
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(1)
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Overall survival, or OS, is the length of time from the initiation of treatment to the patient’s death.
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(2)
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Progression free survival, or PFS, is the length of time from treatment initiation to the worsening of the patient’s disease or the patient’s death.
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(3)
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Complete response is the disappearance of all measurable target lesions and non-target lesions.
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(4)
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Partial response is the overall tumor regression based on a decrease of at least 30% in the overall amount of measurable tumor mass in the body and improvement or no change in non-target lesions.
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(5)
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Stable disease is neither sufficient decrease in tumor size to qualify as a partial response nor sufficient increase in tumor size to qualify as disease progression.
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Seven patients survived for more than 4.5 years following enrollment in this trial. As of
December 31, 2014
, three of these seven patients remained alive and continued to be monitored for overall survival. Two of these patients have not progressed and continue to be dosed.
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Five poor risk patients did not receive five doses of AGS-003 due to early disease progression. Median overall survival in the 16 patients who received at least five doses of AGS-003 was 36.0 months.
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Median overall survival in the 11 intermediate risk patients was 61.9 months. Median overall survival in the 10 poor risk patients was 9.1 months.
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The following graphic shows data and follow-up as of December 31, 2014, the number of months that each patient in the phase 2 clinical trial survived from the time of enrollment in the trial. The three patients who remained alive as of December 31, 2014 are indicated by the arrows at the end of the bar. Two of these patients have continued AGS-003 for nearly six years. The five poor risk patients who did not receive five doses of AGS-003 are indicated with an “x” at the end of the bar.
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Of the nine patients who exhibited a partial response, four patients exhibited partial responses during the 24-week induction phase, including two patients who exhibited partial responses prior to initiation of treatment with AGS-003. The other three patients exhibited partial responses after prolonged dosing with AGS-003 during the booster phase. We do not believe that these late occurring partial responses have been observed in clinical trials of sunitinib alone. As a result, we believe that these late responses may relate to the immunologic effects of prolonged AGS-003 dosing and AGS-003’s effect on CD8+ CD28+ memory T-cells.
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We observed a statistically significant correlation between increased progression free survival and prolonged survival (p<0.001). Statistical significance is determined by methods that establish the p-value of the results. Typically, results are considered statistically significant if they have a p-value of 0.05 or less, meaning that there is less than a one-in-20 likelihood that the observed results occurred by chance.
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In the 14 patients in the trial who received at least five doses of AGS-003 and could be evaluated for memory T-cell response, we observed a statistically significant correlation between the increase in the number of CD8+ CD28+ memory T-cells over the initial five doses of AGS-003 and survival (p<0.002), progression free survival (p<0.031) and reduced metastatic tumor burden (p<0.045). We presented at the 2013 Annual Meeting of ASCO, Genitourinary Cancers Symposium results, as of May 14, 2012, showing the correlation with survival. The following graphics show, for each of these 14 patients, the increase in their tumor-specific memory T-cells that they exhibited as measured immediately prior to their first dose of AGS-003 and immediately following the patient’s fifth dose of AGS-003, or the absence of such increase, as compared to such patient’s survival.
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AGS-003 was found to have positive impact on immune cell function and restoration of cellular immunity in a majority of patients, including an increase in levels of IL-2 and IFN-
g
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The adverse events in this trial associated with AGS-003 were generally only mild injection site reactions, while the toxicities associated with sunitinib were consistent with those expected from treatment with sunitinib alone.
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The data that was presented in the British Journal of Cancer included data categorized by risk profile group. The number of patients in each risk profile group was presented as a percentage of a total population of 1,059 mRCC patients. Accordingly, the 455 intermediate risk and poor risk patients referenced in this table and elsewhere in this Annual Report on Form 10-K represent an approximation based on those percentages.
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Outcome
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(N=22)
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Median OS
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15.6 months
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Median PFS
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5.6 months
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Complete response
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0 patients
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Partial response
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1 patient
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Stable disease
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7 patients
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Immune response
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IL-2 and IFN-
g
recovery
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As of November 30, 2013, one patient, who subsequently was treated with AGS-003 in combination with sunitinib, was still alive nearly seven years after initiation of AGS-003. Four other patients survived for more than 40 months following enrollment in the trial.
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The following graphic shows, as of December 31, 2013, the number of months that each patient in the phase 1/2 monotherapy clinical trial survived following enrollment in the trial. All patients were deceased as of December 31, 2013, except for one patient who was subsequently treated with AGS-003 in combination with sunitinib. This subject was still alive for approximately seven years after initiation of AGS-003, as of follow-up for this subject through late 2013.
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Only three patients received a targeted therapy following treatment with AGS-003, which we believe indicates that the clinical benefit demonstrated in this trial was a result of AGS-003 treatment.
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Despite the intermediate and poor risk population, eight of the evaluable patients experienced some degree of tumor regression at one point during the induction phase of treatment with AGS-003.
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AGS-003 was found to have a positive impact on immune cell function and restoration of cellular immunity in a majority of patients, including an increase in levels of IL-2 and IFN-
g
. We did not measure CD8+CD28+ memory T-cells in this trial as, at the time this trial was conducted, the technology for monitoring CD8+CD28+ memory T-cells had not yet been developed.
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AGS-003 was well-tolerated, with adverse events limited to mild injection site reactions, transient flu-like symptoms and tenderness in the lymph nodes.
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We plan to support an investigator-initiated open label phase 2 clinical trial of AGS-003 in patients with mRCC and non-clear cell, or NCC, histology in the second half of 2015. In the trial, we plan to evaluate the safety, efficacy and immunologic effects of AGS-003 when combined with targeted therapy in approximately 30 to 40 NCC mRCC patients.
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We are supporting two investigator-initiated phase 2 clinical trials, which are designed to evaluate treatment with AGS-003 in patients with early stage RCC prior to and following nephrectomy. The initial study, which will evaluate AGS-003 prior to nephrectomy, (neoadjuvant study) is ongoing. We expect that the second trial, which will evaluate AGS-003 after standard nephrectomy (adjuvant RCC study), will begin mid-2015. We expect that between 40 and 50 patients in total will be enrolled across these two trials and that we will have initial data by 2016.
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In addition, we plan to initiate additional investigator-initiated clinical trials of AGS-003 in other advanced solid tumor types, including bladder cancer and non-small cell lung cancer during the second half of 2015.
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ART can have significant side effects. The most recent U.S. guidelines on ART treatment contain a number of tables of adverse effects of combination regimens and how to manage them. Some combinations present potentially life-threatening complications and other complications that are chronic, cumulative and overlapping, and sometimes irreversible.
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ART requires life-long daily treatment. The risks of long-term daily administration of ART remain unknown but are potentially significant. In addition, the requirement for life-long daily treatment has made strict adherence to the treatment regime difficult. Poor compliance has led to the development of drug resistant HIV variants that are ineffectively controlled by the available armamentarium of ART.
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ART cannot eradicate the virus and, therefore, does not cure HIV-infected patients. For example, up to 20% of patients receiving ART fail to achieve normal CD4+ T-cell counts, resulting in a continued weakened immune system. In addition, certain patients are not able to achieve effective control of the virus using current treatment regimens. ART cannot eradicate the virus because the virus persists in latently infected cells. These cells, which constitute the HIV latent reservoir, do not express HIV antigens and are therefore invisible to the immune system. Instead, these cells serve as the source for virus replication and viral rebound in the absence of ART. Following discontinuation of treatment with ART, HIV viral levels return to levels observed prior to treatment with ART within 12 weeks of treatment interruption.
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Potential to Eradicate HIV in Combination with Latency Reversing Drugs
. A number of companies and academic groups are evaluating drugs that can potentially activate the latently infected cells to increase viral antigen expression and make the cells vulnerable to elimination by the immune system. We believe that treating HIV-infected patients, who are being successfully treated with ART, with a combination of AGS-004 and one of these latency reversing drugs could lead to activation of antigen expression from the latently infected cells along with a potent memory T-cell response that is specific to the patient’s own unique viral antigens. We believe that this approach could potentially result in complete eradication of the patient’s virus.
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Long-Term Viral Load Control in Immunologically Healthy Patients
. We believe that AGS-004 may allow for long-term virus control and eliminate the need for life-long treatment with ART in infected patients who have minimal immune suppression but no T-cell response against their virus. We have designed AGS-004 to induce CD8+ CD28+ memory T-cells that are specific to the patient’s own unique viral antigens, do not require CD4+ T-cell help to kill viral cells and do not result in CD4+ T-cell activation which typically increases viral replication and viral load. As reported in
Clinical & Experimental Immunology
, researchers have demonstrated that elevated levels of CD8+CD28+ memory T-cells in the blood are a statistically significant predictor of long-term non-progression in HIV-infected patients not treated with ART drugs. As a result, we believe that inducing these memory T-cells may lead to viral control. Patients with minimal immune suppression and no T-cell response include pediatric patients who have been successfully treated with ART drugs since birth or shortly thereafter and have generally healthy immune systems.
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Minimal Toxicity
. AGS-004 has been well tolerated in clinical trials with no serious adverse events being attributed to it. As a result, we believe we can combine AGS-004 with other HIV therapies without additional toxicities.
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Lack of Chronic Inflammation
. We have designed AGS-004 to elicit a patient-specific and disease-specific immune response that does not cause any additional inflammation. In our clinical trials of AGS-004, AGS-004 has not induced changes in markers that are associated with chronic inflammation in HIV patients.
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a phase 2b clinical trial of AGS-004;
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a phase 2a clinical trial of AGS-004; and
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a phase 1 clinical trial of AGS-004.
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centralized manufacturing capable of delivering products to clinical sites throughout North America;
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a automated manufacturing platform that is scalable for large disease indications; and
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manufacturing with a cost of goods that we expect will be comparable to other biologics and methods that are scalable, consistent and broadly applicable across patients and indications.
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amplifying mRNA from a disease sample obtained from the patient;
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differentiating dendritic cell precursors (monocytes) isolated from the patient into immature dendritic cells;
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maturing the immature dendritic cells in culture and loading the mature dendritic cells with the amplified mRNA and CD40L protein; and
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formulating the matured, loaded dendritic cells in the patient’s plasma with cryoprotectants to protect the cells in the resulting drug product when the drug product is frozen and thawed.
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Arcelis-based compositions of matter and products;
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methods of manufacturing Arcelis-based products;
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methods of using Arcelis-based products for treatment of tumors;
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compositions that we use in the manufacture of Arcelis-based AGS-004 products; and
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equipment that we intend to use for assisting the automated manufacture of Arcelis-based products.
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five U.S. patents and one U.S. patent application that are collectively directed toward the composition of matter of Arcelis-based products (dendritic cells loaded with RNA from tumors or pathogens), methods of manufacture of these products and methods of using these products to treat tumors. Each of the five U.S. patents encompass the AGS-003 composition of matter. One of the five U.S. patents encompasses the AGS-004 composition of matter. The U.S. patents expire in 2016 and the U.S. patent application, if issued, would expire in 2016. Corresponding patents in Europe and Japan and a pending corresponding patent application in Europe, if issued, would expire in 2017.
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three U.S. patents, one U.S. patent application and corresponding patent application in Europe and patent in Japan collectively directed towards an automated apparatus for the manipulation of nucleic acids in a closed container, components thereof and related methods of use. The U.S. and Japanese patents expire in 2027, and the patent applications in the United States and Europe, if issued, would expire in 2027.
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one U.S. patent and corresponding European and Japanese patents collectively directed towards cryoconserved dendritic cells and related methods of manufacture. The U.S., European and Japanese patents expire in 2021.
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two U.S. patents and two U.S. patent applications, two corresponding European patents, two corresponding Japanese patents and a corresponding patent application in Europe collectively directed towards methods of maturing dendritic cells and the composition of matter of dendritic cells that have undergone this maturation process. The U.S. patents expire in 2026 and the U.S. applications, if issued, would expire in 2025, the European patents expire in 2025 and 2027, the Japanese patents expire in 2025 and 2027 and the patent application in Europe, if issued, would expire in 2025.
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one U.S. patent application and one U.S. reissue patent application and corresponding patent application in Europe and patent in Japan collectively directed towards methods of manufacture of dendritic cells from monocytes stored for more than six hours and up to four days without freezing and the composition of matter of dendritic cells that have been manufactured from these monocytes. The U.S. patent application, if issued, will expire in 2026, the U.S. reissue patent application, if issued, will expire in 2029, the Japanese patent will expire in 2026 and the patent application in Europe, if issued, would expire in 2026.
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two U.S. patent applications, two patent applications in Europe and one patent in Japan are collectively directed towards the composition of matter of AGS-004 and related methods of manufacture. The U.S. patent applications and the patent applications in Europe, if issued, would expire in 2025. The Japanese patent will expire in 2025.
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one U.S. patent is directed towards the composition of matter and related methods of use of some of the primers that we use in the manufacture of AGS-004. The U.S. patent will expire in 2028.
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must pay all costs of prosecution and maintenance of the licensed patent rights;
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must pay an annual minimum royalty to Duke beginning with the calendar year beginning the second January 1 after first approval of a licensed product approved by the FDA or a comparable regulatory authority in a foreign country or any sale of a licensed product that does not require regulatory approval; and
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must pay low single-digit percentage royalties, subject to reduction in specified circumstances, to Duke on net sales of licensed products, which are creditable against the annual minimum royalty.
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a $75,000 annual license fee;
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a specified milestone payment based on the achievement of a specified regulatory milestone; and
|
|
•
|
a specified dollar amount per dose of AGS-003 we sell.
|
|
•
|
completion of preclinical laboratory tests, animal studies and formulation studies in compliance with the FDA’s good laboratory practice, or GLP, regulations;
|
|
•
|
submission to the FDA of an IND which must become effective before human clinical trials may begin;
|
|
•
|
approval by an independent institutional review board, or IRB, at each clinical site before each trial may be initiated;
|
|
•
|
performance of adequate and well-controlled human clinical trials in accordance with good clinical practices, or GCP, to establish the safety and efficacy of the proposed drug or biological product for each indication;
|
|
•
|
submission to the FDA of a new drug application, or NDA, or a BLA;
|
|
•
|
satisfactory completion of an FDA advisory committee review, if applicable;
|
|
•
|
satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the product is produced to assess compliance with cGMP, and to assure that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality and purity; and
|
|
•
|
FDA review and approval of the NDA or BLA.
|
|
•
|
Phase 1: The drug or biological product is initially introduced into healthy human subjects or patients with the target disease or condition and tested for safety, dosage tolerance, absorption, metabolism, distribution, excretion and, if possible, to gain an early indication of its effectiveness.
|
|
•
|
Phase 2: The drug or biological product is administered to a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance and optimal dosage.
|
|
•
|
Phase 3: The drug or biological product is administered to an expanded patient population, generally at geographically dispersed clinical trial sites, in well-controlled clinical trials to generate enough data to statistically evaluate the efficacy and safety of the product for approval, to establish the overall risk-benefit profile of the product, and to provide adequate information for the labeling of the product.
|
|
•
|
public health concerns emerge that were unrecognized at the time of the protocol assessment;
|
|
•
|
a sponsor fails to follow a protocol that was agreed upon with the FDA;
|
|
•
|
the relevant data, assumptions, or information provided by the sponsor in a request for SPA change are found to be false statements or misstatements or are found to omit relevant facts; or
|
|
•
|
the FDA and the sponsor agree in writing to modify the trial protocol and such modification is intended to improve the study.
|
|
•
|
restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls;
|
|
•
|
fines, warning letters or holds on post-approval clinical trials;
|
|
•
|
refusal of the FDA to approve pending applications or supplements to approved applications, or suspension or revocation of product license approvals;
|
|
•
|
product seizure or detention, or refusal to permit the import or export of products; or
|
|
•
|
injunctions or the imposition of civil or criminal penalties.
|
•
|
successful completion of clinical trials, including clinical results that are statistically significant as well as clinically meaningful in the context of the indications for which we are developing our product candidates;
|
•
|
receipt of marketing approvals from the FDA and similar regulatory authorities outside the United States;
|
•
|
establishing commercial manufacturing capabilities by building out and equipping a commercial manufacturing facility for our Arcelis-based product candidates;
|
•
|
maintaining patent and trade secret protection and regulatory exclusivity for our product candidates, both in the United States and internationally;
|
•
|
launching commercial sales of the products, if and when approved, whether alone or in collaboration with others;
|
•
|
commercial acceptance of our products, if and when approved, by patients, the medical community and third party payors;
|
•
|
obtaining and maintaining healthcare coverage and adequate reimbursement;
|
•
|
effectively competing with other therapies; and
|
•
|
a continued acceptable safety profile of the products following any marketing approval.
|
•
|
be delayed in obtaining marketing approval for our product candidates;
|
•
|
not obtain marketing approval at all;
|
•
|
obtain approval for indications or patient populations that are not as broad as intended or desired;
|
•
|
obtain approval with labeling that includes significant use restrictions or safety warnings, including boxed warnings;
|
•
|
be subject to additional post-marketing testing requirements;
|
•
|
be subject to restrictions on how the product is distributed or used; or
|
•
|
have the product removed from the market after obtaining marketing approval.
|
•
|
regulators or institutional review boards may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site;
|
•
|
we may have delays in reaching or fail to reach agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites;
|
•
|
clinical trials of our product candidates may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon product development programs;
|
•
|
the number of patients required for clinical trials of our product candidates may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate or participants may drop out of these clinical trials at a higher rate than we anticipate; for example, in our phase 2b clinical trial of AGS-004, we experienced a higher dropout rate than we anticipated due to the higher than expected number of patients who did not complete the full 12 week antiretroviral treatment interruption required by the protocol for the trial;
|
•
|
our third party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;
|
•
|
we may decide, or regulators or institutional review boards may require us or our investigators to, suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements or a finding that the participants are being exposed to unacceptable health risks;
|
•
|
the cost of clinical trials of our product candidates may be greater than we anticipate; and
|
•
|
the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate.
|
•
|
severity of the disease under investigation;
|
•
|
eligibility criteria for the trial in question;
|
•
|
perceived risks and benefits of the product candidate under study;
|
•
|
efforts to facilitate timely enrollment in clinical trials;
|
•
|
patient referral practices of physicians;
|
•
|
the ability to monitor patients adequately during and after treatment; and
|
•
|
proximity and availability of clinical trial sites for prospective patients.
|
•
|
continue our ongoing phase 3 clinical trial of AGS-003 for the treatment of mRCC and initiate additional clinical trials of AGS-003 for the treatment of cancers;
|
•
|
initiate and conduct additional clinical trials of AGS-004 for the treatment of HIV;
|
•
|
seek regulatory approvals for our product candidates that successfully complete clinical trials;
|
•
|
continue to build out and equip our new commercial facility for the manufacture of our Arcelis-based products;
|
•
|
establish a sales, marketing and distribution infrastructure to commercialize products for which we may obtain regulatory approval;
|
•
|
maintain, expand and protect our intellectual property portfolio;
|
•
|
continue our other research and development efforts;
|
•
|
hire additional clinical, quality control, scientific and management personnel; and
|
•
|
add operational, financial and management information systems and personnel, including personnel to support our product development and planned commercialization efforts.
|
•
|
the progress and results of our ongoing pivotal phase 3 clinical trial of AGS-003 and other clinical trials of AGS-003 that we may conduct;
|
•
|
the progress and results of our ongoing phase 2 clinical trial of AGS-004 for HIV eradication and other clinical trials of AGS-004 that we may conduct and our ability to obtain additional funding under our NIH contract for our AGS-004 program;
|
•
|
the scope, progress, results and costs of preclinical development, laboratory testing and clinical trials for our other product candidates;
|
•
|
the costs and timing of our build-out and equipping of our new commercial manufacturing facility;
|
•
|
the costs, timing and outcome of regulatory review of our product candidates;
|
•
|
the costs of commercialization activities, including product sales, marketing, manufacturing and distribution, for any of our product candidates for which we receive regulatory approval;
|
•
|
the potential need to repay the $9.0 million loan under our license agreement with Medinet;
|
•
|
revenue, if any, received from commercial sales of our product candidates, should any of our product candidates be approved by the FDA or a similar regulatory authority outside the United States;
|
•
|
the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims;
|
•
|
the extent to which we acquire or invest in other businesses, products and technologies;
|
•
|
our ability to obtain government or other third party funding for the development of our product candidates; and
|
•
|
our ability to establish collaborations on favorable terms, if at all, particularly arrangements to develop, market and distribute AGS-003 outside North America and arrangements for the development and commercialization of our non-oncology product candidates, including AGS-004.
|
•
|
efficacy and potential advantages compared to alternative treatments;
|
•
|
the ability to offer our product candidates for sale at competitive prices;
|
|
•
|
convenience and ease of administration compared to alternative treatments;
|
•
|
the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;
|
•
|
the strength of sales, marketing and distribution support;
|
•
|
the approval of other new products for the same indications;
|
•
|
availability and amount of reimbursement from government payors, managed care plans and other third party payors;
|
•
|
adverse publicity about the product or favorable publicity about competitive products;
|
•
|
clinical indications for which the product is approved; and
|
•
|
the prevalence and severity of any side effects.
|
•
|
regulatory authorities may withdraw their approval of the product or seize the product;
|
•
|
we may be required to recall the product or change the way the product is administered;
|
•
|
additional restrictions may be imposed on the marketing of, or the manufacturing processes for, the particular product;
|
•
|
regulatory authorities may require the addition of labeling statements, such as a “black box” warning or a contraindication;
|
•
|
we may be required to create a Medication Guide outlining the risks of the previously unidentified side effects for distribution to patients;
|
•
|
additional restrictions may be imposed on the distribution or use of the product via a risk evaluation and mitigation strategy, or REMS;
|
•
|
we could be sued and held liable for harm caused to patients;
|
•
|
the product may become less competitive; and
|
•
|
our reputation may suffer.
|
•
|
our inability to recruit and retain adequate numbers of effective sales and marketing personnel;
|
•
|
the inability of sales personnel to obtain access to or persuade adequate numbers of physicians to prescribe any future products;
|
•
|
the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; and
|
•
|
unforeseen costs and expenses associated with creating an independent sales and marketing organization.
|
•
|
decreased demand for any product candidates or products that we may develop;
|
•
|
injury to our reputation and significant negative media attention;
|
•
|
withdrawal of clinical trial participants;
|
•
|
significant costs to defend the related litigation;
|
•
|
substantial monetary awards to trial participants or patients;
|
•
|
loss of revenue; and
|
•
|
the inability to commercialize any products that we may develop.
|
•
|
terminate agreements, in whole or in part, for any reason or no reason;
|
•
|
reduce or modify the government’s obligations under such agreements without the consent of the other party;
|
•
|
claim rights, including intellectual property rights, in products and data developed under such agreements;
|
•
|
impose U.S. manufacturing requirements for products that embody inventions conceived or first reduced to practice under such agreements;
|
•
|
suspend or debar the contractor or grantee from doing future business with the government or a specific government agency;
|
•
|
pursue criminal or civil remedies under the False Claims Act, False Statements Act and similar remedy provisions specific to government agreements; and
|
•
|
limit the government’s financial liability to amounts appropriated by the U.S. Congress on a fiscal-year basis, thereby leaving some uncertainty about the future availability of funding for a program even after it has been funded for an initial period.
|
•
|
specialized accounting systems unique to government contracts and grants;
|
•
|
mandatory financial audits and potential liability for price adjustments or recoupment of government funds after such funds have been spent;
|
•
|
public disclosures of certain contract and grant information, which may enable competitors to gain insights into our research program; and
|
•
|
mandatory socioeconomic compliance requirements, including labor standards, non-discrimination and affirmative action programs and environmental compliance requirements.
|
•
|
collaborators have significant discretion in determining the efforts and resources that they will apply to these collaborations;
|
•
|
collaborators may not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the collaborator’s strategic focus or available funding, or external factors such as an acquisition that diverts resources or creates competing priorities;
|
•
|
collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or, require a new formulation of a product candidate for clinical testing;
|
•
|
collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product candidates if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours;
|
•
|
a collaborator with marketing and distribution rights to one or more products may not commit sufficient resources to the marketing and distribution of such product or products;
|
•
|
collaborators may have the right to conduct clinical trials of our product candidates without our consent and could conduct trials with flawed designs that result in data that adversely affect our clinical trials, our ability to obtain marketing approval for our product candidates or market acceptance of our product candidates. Pharmstandard, Green Cross and Medinet each have this right under our license agreements with them;
|
•
|
collaborators may hold rights that could preclude us from commercializing our products in certain territories. For example, we have granted Medinet an exclusive license to manufacture in Japan AGS-003 for the treatment of mRCC and an option to acquire a non-exclusive license to sell in Japan AGS-003 for the treatment of mRCC. Even if Medinet does not exercise the option to acquire the license to sell, we will not have the right to manufacture AGS-003 in Japan for the purposes of development and commercialization of AGS-003 for the treatment of mRCC. If we and Medinet are unable to agree to the terms of a supply agreement under these circumstances, we will not be able to sell AGS-003 in Japan unless we repurchase these rights from Medinet;
|
•
|
collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our proprietary information or expose us to potential litigation;
|
•
|
disputes may arise between the collaborators and us that result in the delay or termination of the research, development or commercialization of our products or product candidates or that result in costly litigation or arbitration that diverts management attention and resources; and
|
•
|
collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates. For example, our collaboration with Kyowa Hakko Kirin Co., Ltd. with respect to AGS-003 and AGS-004 was terminated by our collaborator.
|
•
|
demonstrate that the disposable components and sterilization and packaging methods used in the manufacturing process are suitable for use in manufacturing in accordance with current good manufacturing practice, or cGMP, and current Good Tissue Practices, or cGTP;
|
•
|
build and validate processing equipment that complies with cGMP and cGTP;
|
•
|
build out and equip a suitable manufacturing facility to accommodate the automated manufacturing process;
|
•
|
perform process testing with final equipment, disposable components and reagents to demonstrate that the methods are suitable for use in cGMP and cGTP manufacturing;
|
•
|
demonstrate consistency and repeatability of the automated manufacturing processes in the production of AGS-003 in our new facility to fully validate the manufacturing and control process using the actual automated cGMP processing equipment; and
|
•
|
demonstrate comparability between AGS-003 that we produce using existing processes in our current facility and AGS-003 produced using the automated processes in our new facility.
|
•
|
failure to obtain a sufficient supply of key raw materials of suitable quality;
|
•
|
difficulties in manufacturing our product candidates for multiple patients simultaneously;
|
•
|
difficulties in obtaining adequate patient-specific material, such as tumor samples, virus samples or leukapheresis product, from physicians;
|
•
|
difficulties in completing the development and validation of the specialized assays required to ensure the consistency of our product candidates;
|
•
|
failure to ensure adequate quality control and assurances in the manufacturing process as we increase production quantities;
|
•
|
difficulties in the timely shipping of patient-specific materials to us or in the shipping of our product candidates to the treating physicians due to errors by third party carriers, transportation restrictions or other reasons;
|
•
|
destruction of, or damage to, patient-specific materials or our product candidates during the shipping process due to improper handling by third party carriers, hospitals, physicians or us;
|
•
|
destruction of, or damage to, patient-specific materials or our product candidates during storage at our facilities; and
|
•
|
destruction of, or damage to, patient-specific materials or our product candidates stored at clinical and future commercial sites due to improper handling or holding by clinicians, hospitals or physicians.
|
•
|
restrictions on such products, manufacturers or manufacturing processes;
|
•
|
restrictions on the marketing of a product;
|
•
|
restrictions on product distribution;
|
•
|
requirements to conduct post-marketing clinical trials;
|
•
|
warning or untitled letters;
|
•
|
withdrawal of the products from the market;
|
•
|
refusal to approve pending applications or supplements to approved applications that we submit;
|
•
|
recall of products;
|
•
|
fines, restitution or disgorgement of profits or revenue;
|
•
|
suspension or withdrawal of regulatory approvals;
|
•
|
refusal to permit the import or export of our products;
|
•
|
product seizure; or
|
•
|
injunctions or the imposition of civil or criminal penalties.
|
•
|
the federal healthcare anti-kickback statute prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under federal and state healthcare programs such as Medicare and Medicaid;
|
•
|
the federal False Claims Act imposes civil penalties, including civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;
|
•
|
the federal Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act, imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit program and also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;
|
•
|
the federal false statements statute prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items or services;
|
•
|
the federal transparency requirements under the Health Care Reform Law will require manufacturers of drugs, devices, biologics and medical supplies to report to the Department of Health and Human Services information related to physician payments and other transfers of value and physician ownership and investment interests; and
|
•
|
analogous state laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third party payors, including private insurers, and some state laws require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government in addition to requiring drug manufacturers to report information related to payments to physicians and other health care providers or marketing expenditures.
|
•
|
establish a classified board of directors such that not all members of the board are elected at one time;
|
•
|
allow the authorized number of our directors to be changed only by resolution of our board of directors;
|
•
|
limit the manner in which stockholders can remove directors from the board;
|
•
|
establish advance notice requirements for stockholder proposals that can be acted on at stockholder meetings and nominations to our board of directors;
|
•
|
require that stockholder actions must be effected at a duly called stockholder meeting and prohibit actions by our stockholders by written consent;
|
•
|
limit who may call stockholder meetings;
|
•
|
authorize our board of directors to issue preferred stock without stockholder approval, which could be used to institute a “poison pill” that would work to dilute the stock ownership of a potential hostile acquirer, effectively preventing acquisitions that have not been approved by our board of directors; and
|
•
|
require the approval of the holders of at least 75% of the votes that all our stockholders would be entitled to cast to amend or repeal certain provisions of our charter or bylaws.
|
•
|
results of clinical trials of our product candidates or those of our competitors;
|
•
|
the success of competitive products or technologies;
|
•
|
potential approvals of our product candidates for marketing by the FDA or equivalent foreign regulatory authorities or our failure to obtain such approvals;
|
•
|
regulatory or legal developments in the United States and other countries;
|
•
|
the results of our efforts to commercialize our product candidates;
|
•
|
developments or disputes concerning patents or other proprietary rights;
|
•
|
the recruitment or departure of key personnel;
|
•
|
the level of expenses related to any of our product candidates or clinical development programs;
|
•
|
the results of our efforts to discover, develop, acquire or in-license additional product candidates or products;
|
•
|
actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts;
|
•
|
variations in our financial results or those of companies that are perceived to be similar to us;
|
•
|
changes in the structure of healthcare payment systems;
|
•
|
market conditions in the pharmaceutical and biotechnology sectors and issuance of new or changed securities analysts’ reports or recommendations;
|
•
|
general economic, industry and market conditions; and
|
•
|
the other factors described in this “Risk Factors” section.
|
2014
|
||||||||
High
|
Low
|
|||||||
First quarter (February 7, 2014 to March 31, 2014)
|
$ | 13.74 | $ | 7.97 | ||||
Second quarter
|
$ | 10.55 | $ | 6.21 | ||||
Third quarter
|
$ | 10.80 | $ | 5.61 | ||||
Fourth quarter
|
$ | 10.28 | $ | 7.80 |
Year Ended December 31,
|
||||||||||||||||
2011
|
2012
|
2013
|
2014
|
|||||||||||||
Revenue
|
$ | 7,642,695 | $ | 7,039,010 | $ | 4,421,689 | $ | 1,974,019 | ||||||||
Operating expenses:
|
||||||||||||||||
Research and development
|
12,668,025 | 17,616,892 | 23,991,151 | 45,498,916 | ||||||||||||
General and administrative
|
3,703,813 | 6,135,581 | 4,662,317 | 8,599,359 | ||||||||||||
Operating loss
|
(8,729,143 | ) | (16,713,463 | ) | (24,231,779 | ) | (52,124,256 | ) | ||||||||
Other income (expense):
|
||||||||||||||||
Interest income
|
1,259 | 4,604 | 7,184 | 66,580 | ||||||||||||
Interest expense
|
(6,656,366 | ) | (292,496 | ) | (4,705 | ) | (1,123,579 | ) | ||||||||
Change in fair value of warrant liability
|
(4,661,811 | ) | 4,916,785 | 355,352 | — | |||||||||||
Derivative (expense) income
|
(94,668 | ) | 1,036,403 | — | — | |||||||||||
Investment tax credits
|
— | 694,331 | — | 140,556 | ||||||||||||
Other expense
|
— | (117,494 | ) | (47,615 | ) | (265,239 | ) | |||||||||
Other (expense) income, net
|
(11,411,586 | ) | 6,242,133 | 310,216 | (1,181,682 | ) | ||||||||||
Net loss
|
(20,140,729 | ) | (10,471,330 | ) | (23,921,563 | ) | (53,305,938 | ) | ||||||||
Net loss attributable to noncontrolling interest
|
(63,047 | ) | — | — | — | |||||||||||
Net loss attributable to Argos Therapeutics, Inc.
|
(20,077,682 | ) | (10,471,330 | ) | (23,921,563 | ) | (53,305,938 | ) | ||||||||
Accretion of redeemable convertible preferred stock
|
(926,542 | ) | (351,371 | ) | 4,772,991 | (863,226 | ) | |||||||||
Less: Preferred stock dividend due to exchanges of preferred shares
|
— | — | (14,726,088 | ) | — | |||||||||||
Net loss attributable to common stockholders
|
$ | (21,004,224 | ) | $ | (10,822,701 | ) | $ | (33,874,660 | ) | $ | (54,169,164 | ) | ||||
Basic and diluted net loss attributable to common stockholders per share
|
$ | (197.29 | ) | $ | (54.58 | ) | $ | (147.37 | ) | $ | (3.12 | ) | ||||
Basic and diluted weighted average shares outstanding
|
106,466 | 198,306 | 229,865 | 17,367,665 |
As of December 31,
|
||||||||||||||||
2011
|
2012
|
2013
|
2014
|
|||||||||||||
Cash, cash equivalents and short-term investments
|
$ | 2,002,814 | $ | 12,363,736 | $ | 46,957,782 | $ | 56,239,937 | ||||||||
Working (deficit) capital
|
(19,541,194 | ) | 5,741,666 | 46,365,329 | 54,220,549 | |||||||||||
Total assets
|
5,973,958 | 15,396,973 | 51,131,295 | 64,366,878 | ||||||||||||
Total long-term liabilities
|
— | 48,428 | 10,080,106 | 29,718,320 | ||||||||||||
Redeemable convertible preferred stock
|
77,722,306 | 75,800,882 | 113,664,469 | — | ||||||||||||
Total stockholders’ (deficit) equity
|
(96,355,106 | ) | (68,567,710 | ) | (75,776,593 | ) | 31,351,804 |
•
|
$215.3 million from the sale of our common stock, convertible debt, warrants and preferred stock;
|
•
|
$32.9 million from the licensing of our technology; and
|
•
|
$104.1 million from government contracts, grants and license and collaboration agreements.
|
•
|
$12.5 million from our venture loan and security agreement, or the Loan Agreement, with Horizon Technology Finance Corporation and Fortress Credit Co LLC, or the Lenders.
|
•
|
continue our ongoing phase 3 clinical trial of AGS-003 for the treatment of mRCC and initiate additional clinical trials of AGS-003 for the treatment of other cancers;
|
•
|
initiate and conduct additional clinical trials of AGS-004 for the treatment of HIV;
|
•
|
seek regulatory approvals for our product candidates that successfully complete clinical trials;
|
•
|
continue to build out and equip a new commercial facility for the manufacture of our Arcelis-based products;
|
•
|
establish a sales, marketing and distribution infrastructure to commercialize products for which we may obtain regulatory approval;
|
•
|
maintain, expand and protect our intellectual property portfolio;
|
•
|
continue our other research and development efforts;
|
•
|
hire additional clinical, quality control, scientific and management personnel; and
|
•
|
add operational, financial and management information systems and personnel, including personnel to support our product development and planned commercialization efforts.
|
|
•
|
salaries and related expenses for personnel in research and development functions;
|
|
•
|
fees paid to consultants and clinical research organizations, or CROs, including in connection with our clinical trials, and other related clinical trial fees, such as for investigator grants, patient screening, laboratory work and statistical compilation and analysis;
|
|
•
|
commercial manufacturing development consisting of costs incurred under our development agreement with Invetech under which Invetech has agreed to develop and provide prototypes of the automated production system to be used for the manufacture of our Arcelis-based products;
|
|
•
|
allocation of facility lease and maintenance costs;
|
|
•
|
costs incurred under our development agreement with Saint-Gobain to develop a range of disposables for use in the automated production system;
|
|
•
|
depreciation of leasehold improvements, laboratory equipment and computers;
|
|
•
|
costs related to production of product candidates for clinical trials;
|
|
•
|
costs related to compliance with regulatory requirements;
|
|
•
|
consulting fees paid to third parties related to non-clinical research and development;
|
|
•
|
costs related to stock options or other stock-based compensation granted to personnel in research and development functions; and
|
|
•
|
acquisition fees, license fees and milestone payments related to acquired and in-licensed technologies.
|
|
•
|
the scope, rate of progress, expense and results of our ongoing clinical trials;
|
|
•
|
the scope, rate of progress, expense and results of additional clinical trials that we may conduct;
|
|
•
|
the scope, rate of progress, expense and results of our commercial manufacturing development efforts;
|
|
•
|
other research and development activities; and
|
|
•
|
the timing of regulatory approvals.
|
|
•
|
fees paid to CROs in connection with clinical trials;
|
|
•
|
fees paid to investigative sites in connection with clinical trials;
|
|
•
|
professional service fees; and
|
|
•
|
unpaid salaries, wages and benefits.
|
|
•
|
We do not have sufficient history to estimate the volatility of our common stock price. We calculate expected volatility based on reported data for selected reasonably similar publicly traded companies for which the historical information is available. For the purpose of identifying peer companies, we consider characteristics such as industry, length of trading history, similar vesting terms and in-the-money option status. We plan to continue to use the guideline peer group volatility information until the historical volatility of our common stock is relevant to measure expected volatility for future option grants.
|
|
•
|
The assumed dividend yield is based on our expectation of not paying dividends in the foreseeable future.
|
|
•
|
The expected term represents the period that the stock-based awards are expected to be outstanding. Our historical share option exercise experience does not provide a reasonable basis upon which to estimate an expected term because of a lack of sufficient data. Therefore we estimate the expected term by using the simplified method provided by the SEC. The simplified method calculates the expected term as the average of the time-to-vesting and the contractual life of the options.
|
|
•
|
We determine the risk-free interest rate by reference to implied yields available from U.S. Treasury securities with a remaining term equal to the expected life assumed at the date of grant.
|
|
•
|
We estimate forfeitures based on our historical analysis of actual stock option forfeitures.
|
2012
|
2013
|
2014
|
||||||||||
Risk-free interest rate
|
1.20 | % | 2.12 | % | 2.26 | % | ||||||
Dividend yield
|
0 | % | 0 | % | 0 | % | ||||||
Expected option term (in years)
|
7 | 7 | 7 | |||||||||
Volatility
|
94 | % | 94 | % | 96 | % |
Year Ended
December 31,
|
$
|
%
|
Year Ended
December 31,
|
$
|
%
|
|||||||||||||||||||||||||||
2013
|
2014
|
Change
|
Change
|
2012
|
2013
|
Change
|
Change
|
|||||||||||||||||||||||||
(in thousands)
|
||||||||||||||||||||||||||||||||
Revenue
|
$
|
4,422
|
$
|
1,974
|
$
|
(2,448
|
)
|
(55.4
|
)%
|
$
|
7,039
|
$
|
4,422
|
$
|
(2,617
|
)
|
(37.2
|
)%
|
||||||||||||||
Operating expenses:
|
||||||||||||||||||||||||||||||||
Research and development
|
23,991
|
45,499
|
21,508
|
89.7
|
%
|
17,617
|
23,991
|
6,374
|
36.2
|
%
|
||||||||||||||||||||||
General and administrative
|
4,662
|
8,599
|
3,937
|
84.4
|
%
|
6,135
|
4,662
|
(1,473
|
)
|
(24.0
|
)%
|
|||||||||||||||||||||
Total operating expenses
|
28,653
|
54,098
|
25,445
|
88.8
|
%
|
23,752
|
28,653
|
4,901
|
20.6
|
%
|
||||||||||||||||||||||
Loss from operations
|
(24,231
|
)
|
(52,124
|
)
|
(27,893
|
)
|
115.1
|
%
|
(16,713
|
)
|
(24,231
|
)
|
(7,518
|
)
|
45.0
|
%
|
||||||||||||||||
Interest income
|
7
|
67
|
60
|
*
|
5
|
7
|
2
|
40.0
|
%
|
|||||||||||||||||||||||
Interest expense
|
(5
|
)
|
(1,124
|
)
|
(1,119
|
)
|
*
|
(293
|
)
|
(5
|
)
|
288
|
(98.3
|
)%
|
||||||||||||||||||
Change in fair value of warrant liability
|
355
|
—
|
(355
|
)
|
*
|
4,917
|
355
|
(4,562
|
)
|
(92.8
|
)%
|
|||||||||||||||||||||
Derivative income
|
—
|
—
|
—
|
*
|
1,036
|
—
|
(1,036
|
)
|
*
|
|||||||||||||||||||||||
Investment tax credits
|
—
|
141
|
141
|
*
|
694
|
—
|
(694
|
)
|
*
|
|||||||||||||||||||||||
Other expense
|
(48
|
)
|
(266
|
)
|
(218
|
)
|
*
|
(117
|
)
|
(48
|
)
|
69
|
(59.0
|
)%
|
||||||||||||||||||
Net loss
|
$
|
(23,922
|
)
|
$
|
(53,306
|
)
|
$
|
(29,384
|
)
|
122.8
|
%
|
$
|
(10,471
|
)
|
$
|
(23,922
|
)
|
$
|
(13,451
|
)
|
128.5
|
%
|
*
|
Not meaningful
|
Year Ended December 31,
|
||||||||||||
2012
|
2013
|
2014
|
||||||||||
(in thousands)
|
||||||||||||
Direct research and development expense by program:
|
||||||||||||
AGS-003
|
$ | 5,842 | $ | 11,301 | $ | 16,940 | ||||||
AGS-004
|
2,626 | 1,602 | 903 | |||||||||
Other
|
403 | 52 | 131 | |||||||||
Total direct research and development program expense
|
8,871 | 12,955 | 17,974 | |||||||||
Commercial manufacturing development
|
— | — | 11,588 | |||||||||
Indirect research and development expense
|
8,746 | 11,036 | 15,937 | |||||||||
Total research and development expense
|
$ | 17,617 | $ | 23,991 | $ | 45,499 |
•
|
Direct research and development expense for AGS-003 increased from $11.3 million for the year ended December 31, 2013 to $16.9 million in the year ended December 31, 2014. This increase primarily reflects increased patient enrollment in the ongoing pivotal phase 3 clinical trial of AGS-003 in combination with sunitinib in the year ended December 31, 2014 as compared with the year ended December 30, 2013; and
|
•
|
Direct research and development expense with respect to AGS-004 decreased from $1.6 million in the year ended December 31, 2013 to $0.9 million in the year ended December 31, 2014 primarily due to the decreased activity in our phase 2b clinical trial of AGS-004 as the number of patients receiving treatment in the trial declined, which decrease was partially offset by $0.2 million in costs to support stage 1 of an investigator-initiated phase 2 clinical trial of AGS-004 in adult HIV patients aimed at eradication of the virus that began in May 2014.
|
|
•
|
Direct research and development expense for AGS-003 increased from $5.8 million for the year ended December 31, 2012 to $11.3 million in the year ended December 31, 2013. This increase primarily reflects increased activity in connection with the commencement in January 2013 of the pivotal phase 3 clinical trial of AGS-003 in combination with sunitinib; and
|
|
•
|
Direct research and development expense with respect to AGS-004 decreased from $2.6 million in the year ended December 31, 2012 to $1.6 million in the year ended December 31, 2013 primarily due to the decreased activity in our phase 2b clinical trial of AGS-004 as the number of patients receiving treatment in the trial declined.
|
Issue
|
Year
|
Gross
Proceeds
|
||||
(in thousands)
|
||||||
Series A Preferred
|
2000
|
$
|
1,594
|
|||
Series B Preferred
|
2001
|
$
|
39,382
|
|||
Series B-1 Preferred
|
2004
|
$
|
5,000
|
|||
Series C Preferred
|
2008
|
$
|
33,462
|
|||
Series D Preferred
|
2012
|
$
|
9,022
|
|||
Series D-1 Preferred
|
2012
|
$
|
15,978
|
|||
Series E Preferred
|
2013
|
$
|
48,000
|
Year Ended December 31,
|
||||||||||||
2012
|
2013
|
2014
|
||||||||||
(in thousands)
|
||||||||||||
Net cash (used in) provided by:
|
||||||||||||
Operating activities
|
$ | (13,198 | ) | $ | (18,256 | ) | $ | (45,241 | ) | |||
Investing activities
|
(5,281 | ) | (10,057 | ) | (7,789 | ) | ||||||
Financing activities
|
24,871 | 53,404 | 56,966 | |||||||||
Effect of exchange rate changes on cash
|
(180 | ) | (8 | ) | (10 | ) | ||||||
Net increase (decrease) in cash and cash equivalents
|
$ | 6,212 | $ | 25,083 | $ | 3,926 |
•
|
the progress and results of our ongoing pivotal phase 3 clinical trial of AGS-003 and other clinical trials of AGS-003 that we may conduct;
|
•
|
the progress and results of our ongoing phase 2 clinical trial for HIV eradication and other clinical trials of AGS-004 that we may conduct and our ability to obtain additional funding under our NIH contract for our AGS-004 program;
|
•
|
the scope, progress, results and costs of preclinical development, laboratory testing and clinical trials for our other product candidates;
|
•
|
the costs and timing of our planned build-out and equipping of a new commercial manufacturing facility;
|
•
|
the ability to access the second tranche of our Loan Agreement;
|
•
|
the potential need to repay the $9.0 million loan under our license agreement with Medinet;
|
•
|
the costs, timing and outcome of regulatory review of our product candidates;
|
•
|
the costs of commercialization activities, including product sales, marketing, manufacturing and distribution, for any of our product candidates for which we receive regulatory approval;
|
•
|
revenue, if any, received from sales of our product candidates, should any of our product candidates be approved by the FDA or a similar regulatory authority outside the United States;
|
•
|
the costs of preparing, filing and prosecuting patent applications, maintaining, enforcing our intellectual property rights and defending intellectual property-related claims;
|
•
|
the extent to which we acquire or invest in businesses, products and technologies;
|
•
|
our ability to obtain government or other third party funding for the development of our product candidates; and
|
•
|
our ability to establish collaborations on favorable terms, if at all, particularly arrangements to develop, market and distribute AGS-003 outside North America and arrangements for the development and commercialization of our non-oncology product candidates, including AGS-004.
|
Payments Due by Period
|
||||||||||||||||||||
Total
|
Less Than
1 Year
|
1-3 Years
|
3-5 Years
|
More Than
5 Years
|
||||||||||||||||
Operating leases for existing facilities and equipment
|
$ | 909 | $ | 394 | $ | 515 | $ | — | $ | — | ||||||||||
Facility lease obligation for new facility
|
6,236 | 375 | 1,156 | 1,208 | 3,497 | |||||||||||||||
Notes payable to Horizon Technology and Fortress Credit
|
12,500 | — | 7,812 | 4,688 | — | |||||||||||||||
Final payment to Horizon Technology and Fortress Credit
|
625 | — | — | 625 | — | |||||||||||||||
Note payable to Medinet
|
9,000 | — | — | 9,000 | — | |||||||||||||||
Other notes payable
|
78 | 31 | 47 | — | — | |||||||||||||||
Amount due under development agreement with Invetech
|
3,476 | — | 3,476 | — | — | |||||||||||||||
Interest on long-term debt and development agreement with Invetech
|
5,094 | 1,177 | 2,417 | 1,500 | — | |||||||||||||||
Purchase obligation with Invetech
|
25,000 | — | 25,000 | — | — | |||||||||||||||
Total
|
$ | 62,918 | $ | 1,977 | $ | 40,423 | $ | 17,021 | $ | 3,497 |
Name
|
Age
|
Position
|
||
Jeffrey D. Abbey
|
53
|
President, Chief Executive Officer and Director
|
||
Charles A. Nicolette, Ph.D.
|
52
|
Chief Scientific Officer and Vice President of Research and Development
|
||
Frederick M. Miesowicz, Ph.D.
|
66
|
Chief Operating Officer and Vice President of Manufacturing
|
||
Douglas C. Plessinger
|
46
|
Vice President of Clinical and Medical Affairs
|
||
Lori R. Harrelson
|
45
|
Vice President of Finance
|
||
Joan Winterbottom
|
57
|
Chief Human Resources Officer
|
||
Hubert Birner, Ph.D.
(1)(3)
|
48
|
Chairman of the Board of Directors
|
||
Jean Lamarre
(1)
|
61
|
Director
|
||
Andrei Petrov
(2)(3)
|
41
|
Director
|
||
Brian J. Underdown, Ph.D.
(2)(3)
|
73
|
Director
|
||
Sander van Deventer M.D., Ph.D.
|
60
|
Director
|
||
Philippe Van Holle
(1)(2)
|
60
|
Director
|
||
Alexey Vinogradov, Ph.D.
|
41
|
Director
|
(1)
|
Member of the Audit Committee
|
(2)
|
Member of the Compensation Committee
|
(3)
|
Member of the Nominating and Corporate Governance Committee
|
|
•
|
the class I directors are Brian J. Underdown, Ph.D., Sander van Deventer, M.D., Ph.D. and Alexey Vinogradov, Ph.D., and their term expires at our annual meeting of stockholders to be held in 2015;
|
|
•
|
the class II directors are Hubert Birner, Ph.D. and Jean Lamarre, and their term expires at our annual meeting of stockholders to be held in 2016; and
|
|
•
|
the class III directors are Jeffrey D. Abbey, Andrei Petrov and Philippe Van Holle, and their term expires at our annual meeting of stockholders to be held in 2017.
|
|
•
|
chairing meetings of our board and of the independent directors in executive session;
|
|
•
|
meeting with any director who is not adequately performing his or her duties as a member of our board or any committees;
|
|
•
|
facilitating communications between other members of our board and the chief executive officer;
|
|
•
|
determining the frequency and length of board meetings and recommending when special meetings of our board should be held;
|
|
•
|
preparing or approving the agenda for each board meeting; and
|
|
•
|
reviewing and, if appropriate, recommending action to be taken with respect to written communications from stockholders submitted to our board.
|
|
•
|
increasing the independent oversight of our company and enhancing our board’s objective evaluation of our chief executive officer;
|
|
•
|
freeing the chief executive officer to focus on company operations instead of board administration;
|
|
•
|
providing the chief executive officer with an experienced sounding board;
|
|
•
|
providing greater opportunities for communication between stockholders and our board;
|
|
•
|
enhancing the independent and objective assessment of risk by our board; and
|
|
•
|
providing an independent spokesman for our company.
|
|
•
|
appointing, approving the compensation of, and assessing the independence of our registered public accounting firm;
|
|
•
|
overseeing the work of our independent registered public accounting firm, including through the receipt and consideration of reports from such firm;
|
|
•
|
reviewing and discussing with management and our independent registered public accounting firm our annual and quarterly financial statements and related disclosures;
|
|
•
|
monitoring our internal control over financial reporting, disclosure controls and procedures and code of business conduct and ethics;
|
|
•
|
overseeing our internal audit function, if any;
|
|
•
|
overseeing our risk assessment and risk management policies;
|
|
•
|
establishing policies regarding hiring employees from our independent registered public accounting firm and procedures for the receipt and retention of accounting related complaints and concerns;
|
|
•
|
meeting independently with our internal auditing staff, our independent registered public accounting firm and management;
|
|
•
|
reviewing and approving or ratifying any related person transactions; and
|
|
•
|
preparing the audit committee report required by SEC rules.
|
|
•
|
reviewing and approving, or making recommendations to our board with respect to, the compensation of our chief executive officer and our other executive officers;
|
|
•
|
overseeing an evaluation of our senior executives;
|
|
•
|
overseeing and administering our cash and equity incentive plans;
|
|
•
|
reviewing and making recommendations to our board with respect to director compensation;
|
|
•
|
reviewing and discussing annually with management our compensation disclosure required by SEC rules; and
|
|
•
|
preparing the annual compensation committee report required by SEC rules.
|
|
•
|
identifying individuals qualified to become members of our board;
|
|
•
|
recommending to our board the persons to be nominated for election as directors and to each of our board’s committees;
|
|
•
|
reviewing and making recommendations to our board with respect to our board leadership structure;
|
|
•
|
reviewing and making recommendations to our board with respect to management succession planning;
|
|
•
|
developing and recommending to our board corporate governance principles; and
|
|
•
|
overseeing a periodic evaluation of our board.
|
|
•
|
Jeffrey D. Abbey, our president and chief executive officer;
|
|
•
|
Charles A. Nicolette, Ph.D., our vice president of research and development and chief scientific officer; and
|
|
•
|
Frederick M. Miesowicz, Ph.D., our vice president of manufacturing and chief operating officer.
|
Name and Principal Position
|
Year
|
Salary
($)
|
Bonus
($)
|
Option
Awards
($)
(1)
|
All Other
Compensation
($)
(2)
|
Total ($)
|
||||||||||||||||
Jeffrey D. Abbey
(3)
President and Chief Executive Officer
|
2014
2013
|
379,788
300,000
|
163,800
136,800
|
482,991
2,112,044
|
16,632
3,136
|
1,043,211
2,551,980
|
||||||||||||||||
Charles A Nicolette, Ph.D.
Vice President of Research and Development and Chief Scientific Officer
|
2014
2013
|
294,327
250,000
|
88,200
71,250
|
202,618
891,946
|
8,117
3,033
|
593,262
1,216,229
|
||||||||||||||||
Frederick M. Miesowicz, Ph.D.
Vice President of Manufacturing and Chief Operating Officer
|
2014
2013
|
284,552
261,380
|
72,455
74,493
|
104,357
504,879
|
13,623
3,112
|
474,987
843,864
|
(1)
|
The amounts reported in the “Option Awards” column reflect the aggregate fair value of share-based compensation awarded during the year computed in accordance with the provisions of Financial Accounting Standards Board Accounting Standard Codification, or ASC, Topic 718. See Notes 2 and 12 to our consolidated financial statements appearing in “Item 8. Financial Statements and Supplementary Data” of this annual report regarding assumptions underlying the valuation of the option awards.
|
(2)
|
The amounts reported in the “All Other Compensation” column reflect, for each named executive officer, the sum of the incremental cost to us of all perquisites and other personal benefits, which are comprised of post-tax insurance earnings.
|
(3)
|
Mr. Abbey also serves as a member of our board of directors but does not receive any additional compensation for his service as a director.
|
|
•
|
base salary;
|
|
•
|
annual cash bonuses; and
|
|
•
|
equity incentive awards
|
Name
|
Grant Date
|
All Option
Awards: Number of
Securities Underlying
Options (#)
|
Exercise or Base
Price of Option
Awards ($/Sh)
|
Grant Date
Fair Value of
Option
Awards($)
(3)
|
||||||||||
Jeffrey D. Abbey
|
7/28/2014
|
58,400 | (1) | 6.09 | 291,585 | |||||||||
7/28/2014
|
87,600 | (2) | 6.09 | 191,406 | ||||||||||
Charles A Nicolette, Ph.D.
|
7/28/2014
|
18,000 | (1) | 6.09 | 89,872 | |||||||||
7/28/2014
|
27,000 | (2) | 6.09 | 71,030 | ||||||||||
Frederick M. Miesowicz, Ph.D.
|
7/28/2014
|
10,200 | (1) | 6.09 | 50,928 | |||||||||
7/28/2014
|
15,300 | (2) | 6.09 | 53,429 |
(1)
|
This option was granted on July 28, 2014 and vests as to 25% of the shares on July 1, 2015, with the remaining 75% of the shares vesting in equal amounts monthly over the three year period commencing on July 1, 2015, provided that the recipient continues to provide services to us over such period.
|
(2)
|
This option was granted on July 28, 2014 and vests based on the achievement of various individual performance and market targets at various dates through December 31, 2017, provided that the recipient continues to provide services to us through the individual target measurement date.
|
(3)
|
Amounts reported represent the grant date fair value of the stock options granted during 2014 over the entire term of the options, computed in accordance with ASC 718. The valuation assumptions used in calculating the fair value of the stock options are set forth in note 12 to our consolidated financial statements.
|
Name
|
Number of Securities
Underlying Unexercised
Options (#) Exercisable
|
Number of Securities
Underlying Unexercised
Options (#) Unexercisable
|
Option
Exercise
Price ($)
|
Option
Expiration
Date
|
||||||||||
Jeffrey D. Abbey
|
14,175 | (1) | — | 4.20 | (8) |
7/2/18
|
||||||||
5,706 | (2) | — | 4.20 | (8) |
12/5/18
|
|||||||||
50,425 | (3) | — | 4.20 | (8) |
12/10/20
|
|||||||||
58,751 | (4) | 4,701 | (4) | 4.20 | (8) |
4/10/22
|
||||||||
45,602 | (5) | — | 4.20 | (8) |
12/11/22
|
|||||||||
104,573 | (6) | 281,545 | (6) | 5.82 |
11/1/23
|
|||||||||
17,355 | (7) | 46,727 | (7) | 5.82 |
11/11/23
|
|||||||||
— | 58,400 | (9) | 6.09 |
7/27/24
|
||||||||||
— | 87,600 | (10) | 6.09 |
7/27/24
|
||||||||||
Charles A. Nicolette, Ph.D.
|
14,640 | (1) | — | 4.20 | (8) |
7/2/18
|
||||||||
5,893 | (2) | — | 4.20 | (8) |
12/5/18
|
|||||||||
14,619 | (3) | — | 4.20 | (8) |
12/10/20
|
|||||||||
29,375 | (4) | 2,351 | (4) | 4.20 | (8) |
4/10/22
|
||||||||
22,801 | (5) | — | 4.20 | (8) |
12/11/22
|
|||||||||
43,778 | (6) | 117,865 | (6) | 5.82 |
11/1/23
|
|||||||||
7,713 | (7) | 20,768 | (7) | 5.82 |
11/11/23
|
|||||||||
— | 18,000 | (9) | 6.09 |
7/27/24
|
||||||||||
— | 27,000 | (10) | 6.09 |
7/27/24
|
||||||||||
Frederick M. Miesowicz, Ph.D.
|
13,943 | (1) | — | 4.20 | (8) |
7/2/18
|
||||||||
5,612 | (2) | — | 4.20 | (8) |
12/5/18
|
|||||||||
6,809 | (3) | — | 4.20 | (8) |
12/10/20
|
|||||||||
22,031 | (4) | 1,763 | (4) | 4.20 | (8) |
4/10/22
|
||||||||
17,102 | (5) | — | 4.20 | (8) |
12/11/22
|
|||||||||
24,324 | (6) | 65,491 | (6) | 5.82 |
11/1/23
|
|||||||||
4,820 | (7) | 12,980 | (7) | 5.82 |
11/11/23
|
|||||||||
— | 10,200 | (9) | 6.09 |
7/27/24
|
||||||||||
— | 15,300 | (10) | 6.09 |
7/27/24
|
(1)
|
This option was granted on July 2, 2008 and vested as to 50% of the shares on the date of grant, with the remaining 50% of the shares vesting in equal amounts monthly over the two year period commencing on April 1, 2008.
|
(2)
|
This option was granted on December 5, 2008 and vested in specified increments over a two-year period ending on April 1, 2010.
|
(3)
|
This option was granted on December 10, 2010. This option vested in equal monthly installments over a four year period, with the first installment vesting on February 24, 2010, provided that recipient continued to provide services to us over such period.
|
(4)
|
This option was granted on April 10, 2012 and vested as to 1/3 of the shares on the date of grant, with the remaining 2/3 of the shares vesting in equal amounts monthly over the three year period commencing on April 10, 2012, provided that the recipient continues to provide services to us over such period.
|
(5)
|
This option was granted on December 11, 2012 and vested as to 50% of the shares on the date of grant, with the remaining 50% of the shares vesting in equal amounts monthly over the two year period commencing on October 31, 2012, provided that the recipient continued to provide services to us over such period.
|
(6)
|
This option was granted on November 1, 2013 and vests as to 25% on November 1, 2014, with the remaining 75% of the shares vesting in equal amounts monthly over the three year period commencing on November 1, 2014, provided that the recipient continues to provide services to us over such period.
|
(7)
|
This option was granted on November 11, 2013 and vests as to 25% on November 1, 2014, with the remaining 75% of the shares vesting in equal amounts monthly over the three year period commencing on November 1, 2014, provided that the recipient continues to provide services to us over such period.
|
(8)
|
In April 2012, our board of directors approved the repricing of stock options that had exercise prices between $10.86 and $36.66 per share, including this option, to the then estimated fair value of our common stock, determined to be an exercise price of $4.20 per share.
|
(9)
|
This option was granted on July 28, 2014 and vests as to 25% of the shares on July 1, 2015, with the remaining 75% of the shares vesting in equal amounts monthly over the three year period commencing on July 1, 2015, provided that the recipient continues to provide services to us over such period.
|
(10)
|
These options were granted on July 28, 2014 and vest based on the achievement of various individual performance and market targets at various dates through December 31, 2017, provided that the recipient continues to provide services to us through the individual target measurement date.
|
|
•
|
the number of shares of our common stock covered by options and the dates upon which the options become exercisable;
|
|
•
|
the type of options to be granted;
|
|
•
|
the duration of options, which may not be in excess of ten years;
|
|
•
|
the exercise price of options, which may not be less than the fair market value of our common stock on the date of grant of the options; and
|
|
•
|
the number of shares of our common stock subject to any stock appreciation rights, restricted stock awards, restricted stock units or other stock-based awards and the terms and conditions of such awards, including conditions for repurchase, issue price and repurchase price.
|
|
•
|
provide that all outstanding awards shall be assumed, or substantially equivalent awards shall be substituted, by the acquiring or successor corporation (or an affiliate thereof);
|
|
•
|
upon written notice to a participant, provide that all of the participant’s unexercised awards will terminate immediately prior to the consummation of such reorganization event unless exercised by the participant;
|
|
•
|
provide that outstanding awards shall become exercisable, realizable or deliverable, or restrictions applicable to an award shall lapse, in whole or in part, prior to or upon such reorganization event;
|
|
•
|
in the event of a reorganization event pursuant to which holders of shares of our common stock will receive a cash payment for each share surrendered in the reorganization event, make or provide for a cash payment to the participants with respect to each award held by a participant equal to (1) the number of shares of common stock subject to the vested portion of the award (after giving effect to any acceleration of vesting that occurs upon or immediately prior to such reorganization event) multiplied by (2) the excess, if any, of the cash payment for each share surrendered in the reorganization event over the exercise, measurement or purchase price of such award and any applicable tax withholdings, in exchange for the termination of such award; and
|
|
•
|
provide that, in connection with a liquidation or dissolution, awards shall convert into the right to receive liquidation proceeds.
|
|
•
|
providing that such awards will be assumed, or substantially equivalent awards substituted, by the acquiring or succeeding corporation or an affiliate thereof;
|
|
•
|
providing, upon notice to the participant, that all unexercised awards will terminate immediately prior to the consummation of such transaction unless exercised within a specified period of time;
|
|
•
|
providing that all or any outstanding awards will become vested or exercisable, or restrictions applicable to such awards will lapse, in full or in part, at or immediately prior to such event;
|
|
•
|
in the event of a consolidation, merger, combination, reorganization or similar transaction under the terms of which holders of our common stock will receive a cash payment per share surrendered in the transaction, making or providing for an equivalent cash payment in exchange for the termination of such equity awards; or
|
|
•
|
providing that in the event of a liquidation or dissolution awards will convert into the right to receive liquidation proceeds.
|
|
•
|
The majority of the awards granted under the 2008 stock incentive plan provide that the unvested portion of such award would become fully vested upon specified changes of control of our company.
|
|
•
|
such person is customarily employed by us or a designated subsidiary for more than 20 hours a week and for more than five months in a calendar year;
|
|
•
|
such person has been employed by us or a designated subsidiary for at least three months prior to enrolling in the 2014 ESPP; and
|
|
•
|
such person was our employee or an employee of a designated subsidiary on the first day of the applicable offering period under the 2014 ESPP.
|
|
•
|
provide that options will be assumed, or substantially equivalent options will be substituted, by the acquiring or succeeding corporation (or an affiliate thereof);
|
|
•
|
upon written notice to employees, provide that all outstanding options will be terminated immediately prior to the consummation of such reorganization event and that all such outstanding options will become exercisable to the extent of accumulated payroll deductions as of a date specified by our board of directors;
|
|
•
|
upon written notice to employees, provide that all outstanding options will be cancelled as of a date prior to the effective date of the reorganization event and that all accumulated payroll deductions will be returned to participating employees on such date;
|
|
•
|
upon the occurrence of a reorganization event in which holders of our common stock will receive a cash payment for each share surrendered in the reorganization event, change the last day of the purchase plan period to be the date of the consummation of the reorganization event and provide that participants will receive a cash payment equal to the acquisition price times the number of shares of common stock that the participant’s accumulated payroll deductions as of immediately prior to the reorganization event could purchase at the option price minus the result of multiplying such number of shares by such option price; and
|
|
•
|
provide that, in connection with a liquidation or dissolution of our company, options will convert into the right to receive liquidation proceeds (net of the option price).
|
Name
|
Fees Earned or Paid in Cash
|
Stock Awards
|
Option
Awards (1)
|
Non-Equity Incentive Plan Compensation
|
Non-
Qualified Deferred
Compensation
Earnings
|
All Other Compensation
|
Total
|
|||||||||||||||||||||
($)
|
($)
|
($)
|
($)
|
($)
|
($)
|
($)
|
||||||||||||||||||||||
Hubert Birner, Ph.D.
|
70,000 | — | — | — | — | — | 70,000 | |||||||||||||||||||||
David Gryska (2)
|
48,917 | — | — | — | — | — | 48,917 | |||||||||||||||||||||
Jean Lamarre
|
50,585 | — | — | — | — | — | 50,585 | |||||||||||||||||||||
Andrei Petrov
|
42,500 | — | — | — | — | — | 42,500 | |||||||||||||||||||||
Brian J. Underdown, Ph.D.
|
50,835 | — | — | — | — | — | 50,835 | |||||||||||||||||||||
Sander van Deventer, M.D., Ph.D.
|
35,000 | — | 99,084 | — | — | — | 134,084 | |||||||||||||||||||||
Philippe Van Holle (3)
|
5,543 | — | 73,704 | — | — | — | 79,247 | |||||||||||||||||||||
Alexey Vinogradov, Ph.D.
|
35,000 | — | 99,084 | — | — | — | 134,084 |
(1)
|
The amounts shown in this column reflect the aggregate grant date fair value of the stock awards and option awards granted to our non-employee directors computed in accordance with FASB ASC Topic 718. The assumptions made in determining the fair values of our stock awards and option awards are set forth in Notes 2 and 12 to our 2014 Consolidated Financial Statements in Part II, Item 8 of this Annual Report on Form 10-K.
|
(2)
|
David Gryska resigned from our board of directors effective October 31, 2014.
|
(3) | Philippe Van Holle joined our board of directors in November 2014. |
Name
|
Option Awards
|
|||
Hubert Birner, Ph.D.
|
11,000 | |||
Jean Lamarre
|
16,015 | |||
Andrei Petrov
|
11,000 | |||
Brian J. Underdown, Ph.D.
|
11,000 | |||
Sander van Deventer, M.D., Ph.D.
|
11,000 | |||
Philippe Van Holle
|
11,000 | |||
Alexey Vinogradov, Ph.D.
|
11,000 |
Equity Compensation Plan Information
|
|||||||||||||
Plan Category
|
Number of securities
to be issued upon
exercise of
outstanding options,
warrants and rights
|
Weighted average
exercise price of
outstanding options,
warrants and rights
|
Number of securities remaining
available for future issuance
under equity compensation
plans (excluding securities in
first column)
|
||||||||||
Equity compensation plans approved by security holders
|
2,929,878 | $ | 5.98 | 1,372,394 | (1) | ||||||||
Equity compensation plans not approved by security holders
|
— | — | — | ||||||||||
Total
|
2,929,878 | $ | 5.98 | 1,372,394 |
(1)
|
Reflects the total number of shares of our common stock available for issuance under the 2014 Plan and the 2014 – ESPP as of December 31, 2014. Our 2014 Plan contains an “evergreen” provision, which allows for an annual increase in the number of shares of our common stock available for issuance under the plan on the first day of each fiscal year starting in the 2015 fiscal year and on each subsequent anniversary through January 1, 2024, equal to the lowest of 2,309,023 shares of our common stock, 4% of the number of the Company’s outstanding shares of common stock on the first day of each such fiscal year or an amount determined by the Company’s board of directors. On January 1, 2015, 589,722 shares of our common stock were authorized for issuance under the 2014 stock incentive plan.
|
|
•
|
each of our directors;
|
|
•
|
each of our named executive officers;
|
|
•
|
all of our directors and executive officers as a group; and
|
|
•
|
each person, or group of affiliated persons, who is known by us to beneficially own more than 5% of our common stock.
|
Name and Address of Beneficial Owner
|
Number of
Shares
Beneficially
Owned
|
Percentage of Shares
Beneficially Owned
|
||||||
5% Stockholders:
|
||||||||
Pharmstandard International S.A.
(1)
|
5,983,549 | 30.41 | % | |||||
Entities affiliated with Forbion
(2)
|
2,450,144 | 12.45 | % | |||||
Wasatch Advisors, Inc.
(3)
|
2,099,767 | 10.67 | % | |||||
TVM V Life Science Ventures GmbH & Co. KG
(4)
|
1,471,091 | 7.48 | % | |||||
Entities affiliated with Lumira Capital
(5)
|
1,249,572 | 6.35 | % | |||||
Entities affiliated with Intersouth Parners
(6)
|
1,069,979 | 5.44 | % | |||||
Directors and Named Executive Officers:
|
||||||||
Andrei Petrov
(7)
|
5,987,215 | 30.42 | % | |||||
Alexey Vinogradov, Ph.D.
(7)
|
5,987,215 | 30.42 | % | |||||
Sander van Deventer, M.D., Ph.D.
(8)
|
2,453,810 | 12.47 | % | |||||
Hubert Birner, Ph.D.
(9)
|
1,474,757 | 7.49 | % | |||||
Brian J. Underdown, Ph.D.
(10)
|
1,253,238 | 6.37 | % | |||||
Jeffrey D. Abbey
(11)
|
341,385 | 1.71 | % | |||||
Frederick M. Miesowicz, Ph.D.
(12)
|
106,662 | 0.54 | % | |||||
Charles A. Nicolette, Ph.D.
(13)
|
163,814 | 0.83 | % | |||||
Philippe Van Holle
(14)
|
916 | 0.00 | % | |||||
Jean Lamarre
(15)
|
7,287 | 0.04 | % | |||||
All executive officers and directors as a group (12 persons)
(16)
|
11,938,472 | 58.38 | % |
(1)
|
The address of Pharmstandard International S.A. is 65, Boulevard Grande Duchesse Charlotte, L-1331 Luxembourg, Grand Duchy of Luxembourg. Pharmstandard International S.A. is a wholly owned subsidiary of Public Joint Stock Company “Pharmstandard.” As the parent entity, Public Joint Stock Company “Pharmstandard” has voting and investment control over the shares of the Company held by Pharmstandard International S.A.
|
(2)
|
The address of Forbion is Gooimeer 2-35 1411 DC Naarden, the Netherlands. Consists of (i) 1,254,388 shares of common stock held by Coöperatieve AAC LS U.A. and (ii) 1,195,756 shares of common stock held by Forbion Co-Investment II Coöperatief U.A. Forbion 1 Management B.V., the director of Cooperatieve AAC LS U.A, has voting and investment power over the shares held by Cooperatieve AAC LS U.A, which are exercised through Forbion 1 Management B.V.‘s investment committee, consisting of L.P.A. Bergstein, H. A. Slootweg, M. A. van Osch, G. J. Mulder and Sander van Deventer. None of the members of the investment committee has individual voting and investment power with respect to such shares, and the members disclaim beneficial ownership of such shares except to the extent of their pecuniary interests therein. Forbion 1 Co- II Management B.V., the director of Forbion Co-Investment II Cooperatief U.A., has voting and investment power over the shares held by Forbion Co-Investment II Cooperatief U.A., which are exercised through Forbion 1 Co II Management B.V.‘s investment committee, consisting of L.P.A. Bergstein, H. A. Slootweg, M. A. van Osch, G. J. Mulder and Sander van Deventer. None of the members of the investment committee has individual voting and investment power with respect to such shares, and the members disclaim beneficial ownership of such shares except to the extent of their pecuniary interests therein.
|
(3)
|
The address of Wasatch Advisors, Inc. is 505 Wakara Way, 3
rd
Floor, Salt Lake City, UT 84108.
Reference is hereby made to the Schedule 13G/A filed by Wasatch Advisors, Inc. filed on March 10, 2015 for information about the number of shares held by such reporting person and the nature of its beneficial ownership. Wasatch Advisors, Inc.'s beneficial ownership percentage was calculated using the total number of shares of common stock outstanding as of February 28, 2015.
|
(4)
|
The address of TVM V Life Science Ventures GmbH &Co. KG is Ottostr. 4, 80333 Munich, Germany. The shares represented here are directly held by TVM V Life Science Ventures GmbH & Co. KG (“TVM V”), the managing limited partner of which is TVM V Life Science Ventures Management GmbH & Co. KG (“TVM V Management”), for which Hubert Birner, Stefan Fischer, Alexandra Goll and Alex Polack, each a member of the investment committee of TVM V Management, share voting and investment authority over the shares held by TVM V. Each of TVM V Management, Hubert Birner, Stefan Fischer, Alexandra Goll and Alex Polack disclaims beneficial ownership of these shares, except to the extent of their pecuniary interest therein, if any.
|
(5)
|
The address of Lumira Capital is 141 Adelaide Street West, Suite 770, Toronto, Ontario, Canada M5H 3L5. The shares represented here are directly and/or beneficially owned by each of, LCC Legacy Holdings Inc., an Ontario corporation (“LCC”), Lumira Capital Investment Management Inc., a Canadian corporation (“LCIM”), Peter van der Velden, as a member of the Board of Directors of LCC and a member of the investment committee of LCIM, Gerald Brunk, as a member of the investment committee of LCIM, Daniel Hetu, as a member of the investment committee of LCIM, Benjamin Rovinski, as a member of the investment committee of LCIM, Brian J. Underdown, as a member of the investment committee of LCIM and Vasco Larcina, as a member of the investment committee of LCIM. Each of the foregoing is referred to as a “Reporting Person” and collectively as the “Reporting Persons.” LCC, acting as the Manager of Lumira Capital I Limited Partnership (“CI”), has voting and investment power over the securities held by CI, which is exercised by the investment committee of LCIM. Lumira Capital I (QGP) Inc., which is the general partner of Lumira Capital I Quebec Limited Partnership (“CQ”) and a wholly-owned subsidiary of LCC, has voting and investment power over the shares held by CQ; such investment and voting power is exercised based on the recommendations of the investment committee of LCIM. Voting and investment power over the securities held directly by LCC is exercised by the LCC board of directors. CI directly holds 821,016 shares; CQ directly holds 289,323 shares; LCC directly holds 139,233 shares. Each of the Reporting Persons specifically disclaims beneficial ownership of the securities reported herein that are not directly owned by such Reporting Person, except to the extent of their pecuniary interest therein. Beneficial ownership is derived from a Schedule 13D filed on February 21, 2014.
|
(6)
|
The address for Intersouth Partners is 102 City Hall Plaza, Suite 200, Durham, North Carolina 27701. The shares represented here are directly and/or beneficially owned by each of Intersouth Partners V, L.P., Intersouth Affiliates V, L.P., Intersouth Associates V LLC, Intersouth Partners IV, L.P., Intersouth Associates IV LLC, Mitch Mumma and Dennis Dougherty. Intersouth Affiliates V, L.P. directly holds 32,999 shares; (ii) Intersouth Partners V, L.P. directly holds 721,884 shares; and (iii) Intersouth Partners IV, L.P. directly holds 315,096 shares. Intersouth Associates V LLC, the general partner of each of Intersouth Partners V, L.P. and Intersouth Affiliates V, L.P., and Intersouth Associates IV LLC, the general partner of Intersouth Partners IV, L.P., may be deemed to share voting and dispositive power over the shares held by each of Intersouth Affiliates V, L.P. and Intersouth Partners V, L.P. and Intersouth Partners IV, L.P., respectively. Dennis Dougherty and Mitch Mumma are both Member Managers of Intersouth Associates V LLC, and Intersouth Associates IV LLC, and share voting and investment power over the shares held by Intersouth Affiliates V, L.P., Intersouth Partners V, L.P. and Intersouth Partners IV, L.P. Beneficial ownership is derived from a Schedule 13G filed on February 18, 2014.
|
(7)
|
Consists of (i) 5,983,549 shares of common stock beneficially owned by Pharmstandard International S.A. as described in footnote (1) above and (ii) 3,666 shares of common stock issuable upon exercise of options that are exercisable as of February 28, 2015 or will become exercisable within 60 days after such date.
|
(8)
|
Consists of (i) 2,450,144 shares of common stock beneficially owned by Forbion as described in footnote (2) above and (ii) 3,666 shares of common stock issuable upon exercise of options that are exercisable as of February 28, 2015 or will become exercisable within 60 days after such date.
|
(9)
|
Consists of (i) 1,471,091 shares of common stock beneficially owned by TVM V as described in footnote (4) above and (ii) 3,666 shares of common stock issuable upon exercise of options that are exercisable as of February 28, 2015 or will become exercisable within 60 days after such date.
|
(10)
|
Consists of (i) 1,249,572 shares of common stock beneficially owned by the Lumira entities as described in footnote 5 above and (ii) 3,666 shares of common stock issuable upon exercise of options that are exercisable as of February 28, 2015 or will become exercisable within 60 days after such date.
|
(11)
|
Consists of (i) 2,580 shares of common stock and (ii) 338,805 shares of common stock issuable upon exercise of options that are exercisable as of February 28, 2015 or will become exercisable within 60 days after such date.
|
(12)
|
Consists of (i) 1,289 shares of common stock and (ii) 105,373 shares of common stock issuable upon exercise of options that are exercisable as of February 28, 2015 or will become exercisable within 60 days after such date.
|
(13)
|
Consists of (i) 6,800 shares of common stock and (ii) 157,014 shares of common stock issuable upon exercise of options that are exercisable as of February 28, 2015 or will become exercisable within 60 days after such date.
|
(14)
|
Consists of 916 shares of common stock issuable upon exercise of options that are exercisable as of February 28, 2015 or will become exercisable within 60 days after such date.
|
(15)
|
Consists of 7,287 shares of common stock issuable upon exercise of options that are exercisable as of February 28, 2015 or will become exercisable within 60 days after such date.
|
(16)
|
Includes (i) 11,165,025 shares of common stock and (ii) 773,447 shares of common stock issuable upon exercise of options that are exercisable as of February 28, 2015 or will become exercisable within 60 days after such date.
|
Name
|
Shares of Common
Stock Purchased
in our IPO
|
Aggregate
Purchase
Price
|
||||||
Entities affiliated with Forbion
|
36,416 | $ | 291,328 | |||||
Entities affiliated with Intersouth Partners
|
28,841 | $ | 230,728 | |||||
Entities affiliated with Lumira Capital
|
40,497 | $ | 323,976 | |||||
TVM V Life Science Ventures GmbH & Co. KG
|
39,873 | $ | 318,984 | |||||
Pharmstandard International S.A.
|
1,275,000 | $ | 10,200,000 |
|
•
|
the related person’s interest in the related person transaction;
|
|
•
|
the approximate dollar value of the amount involved in the related person transaction;
|
|
•
|
the approximate dollar value of the amount of the related person’s interest in the transaction without regard to the amount of any profit or loss;
|
|
•
|
whether the transaction was undertaken in the ordinary course of our business;
|
|
•
|
whether the terms of the transaction are no less favorable to us than terms that could have been reached with an unrelated third party;
|
|
•
|
the purpose of, and the potential benefits to us of, the transaction; and
|
|
•
|
any other information regarding the related person transaction or the related person in the context of the proposed transaction that would be material to investors in light of the circumstances of the particular transaction.
|
|
•
|
interests arising solely from the related person’s position as an executive officer of another entity (whether or not the person is also a director of such entity), that is a participant in the transaction, where (a) the related person and all other related persons own in the aggregate less than a 10% equity interest in such entity, (b) the related person and his or her immediate family members are not involved in the negotiation of the terms of the transaction and do not receive any special benefits as a result of the transaction, and (c) the amount involved in the transaction equals less than the greater of $200,000 dollars or 5% of the annual gross revenues of the other entity that is a party to the transaction; and
|
|
•
|
a transaction that is specifically contemplated by provisions of our charter or bylaws.
|
2014
|
2013
|
|||||||
Audit Fees (1)
|
$ | 379,974 | $ | 639,510 | ||||
Audit-Related Fees (2)
|
— | — | ||||||
Tax Fees (3)
|
— | — | ||||||
All Other Fees (4)
|
— | — | ||||||
Total Fees for Services Provided
|
$ | 379,974 | $ | 639,510 |
(1)
|
Audit fees include fees associated with the annual audit, reviews of interim financial statements included in SEC registration statements, accounting and reporting consultations and audits conducted under OMB Circular A-133.
|
(2)
|
There were no audit-related fees for the fiscal year ended December 31, 2014 or 2013.
|
(3)
|
There were no tax fees for the fiscal years ended December 31, 2014 or 2013.
|
(4)
|
Other fees include fees billed for other services rendered not included within Audit Fees, Audit Related Fees or Tax Fees.
There were no other fees for the fiscal years ended December 31, 2014 or 2013.
|
ARGOS THERAPEUTICS, INC.
|
||
By:
|
/s/ Jeffrey D. Abbey
|
|
Name: Jeffrey D. Abbey
|
||
Title: President and Chief Executive Officer
|
Signature
|
Title
|
Date
|
||
/s/ Jeffrey D. Abbey
|
President, Chief Executive Officer and Director
|
March 31, 2015
|
||
Jeffrey D. Abbey
|
(Principal Executive Officer)
|
|||
/s/ Lori R. Harrelson
|
Vice President of Finance
|
March 31, 2015
|
||
Lori R. Harrelson
|
(Principal Financial Officer and Principal Accounting Officer)
|
|||
/s/ Hubert Birner, Ph.D.
|
Director
|
March 31, 2015
|
||
Hubert Birner, Ph.D.
|
||||
/s/ Jean Lamarre
|
Director
|
March 31, 2015
|
||
Jean Lamarre
|
||||
/s/ Andrei Petrov
|
Director
|
March 31, 2015
|
||
Andrei Petrov
|
||||
/s/ Brian J. Underdown, Ph.D.
|
Director
|
March 31, 2015
|
||
Brian J. Underdown, Ph.D.
|
||||
/s/ Sander van Deventer, M.D., Ph.D.
|
Director
|
March 31, 2015
|
||
Sander van Deventer, M.D., Ph.D.
|
||||
/s/ Philippe Van Holle
|
Director
|
March 31, 2015
|
||
Philippe Van Holle
|
||||
/s/ Alexey Vinogradov, Ph.D.
|
Director
|
March 31, 2015
|
||
Alexey Vinogradov, Ph.D.
|
EXHIBIT INDEX
|
Exhibit
Number
|
Description of Exhibit
|
|
3.1
|
Restated Certificate of Incorporation of the Registrant (filed as Exhibit 3.1 to the Registrant’s Current Report on Form 8-K (File No. 001-35443) on February 18, 2014 and incorporated herein by reference)
|
|
3.2
|
Amended and Restated Bylaws of the Registrant (filed as Exhibit 3.2 to the Registrant’s Current Report on Form 8-K (File No. 001-35443) on February 18, 2014 and incorporated herein by reference)
|
|
4.1
|
Specimen Stock Certificate evidencing the shares of common stock (filed as Exhibit 4.1 to Amendment No. 1 to the Registrant’s Registration Statement on Form S-1 (File No. 333-193137) on January 21, 2014 and incorporated herein by reference)
|
|
4.2
|
Fifth Amended and Restated Registration Rights Agreement, dated as of August 9, 2013 (filed as Exhibit 4.2 to the Registrant’s Registration Statement on Form S-1 (File No. 333-193137) on December 30, 2013 and incorporated herein by reference)
|
|
10.1+
|
1999 Stock Option Plan (filed as Exhibit 10.1 to the Registrant’s Registration Statement on Form S-1 (File No. 333-193137) on December 30, 2013 and incorporated herein by reference)
|
|
10.2+
|
2008 Stock Incentive Plan, as amended (filed as Exhibit 10.2 to the Registrant’s Registration Statement on Form S-1 (File No. 333-193137) on December 30, 2013 and incorporated herein by reference)
|
|
10.3+
|
Form of Incentive Stock Option Agreement under 2008 Stock Incentive Plan (filed as Exhibit 10.3 to the Registrant’s Registration Statement on Form S-1 (File No. 333-193137) on December 30, 2013 and incorporated herein by reference)
|
|
10.4+
|
Form of Nonstatutory Stock Option Agreement under 2008 Stock Incentive Plan (filed as Exhibit 10.4 to the Registrant’s Registration Statement on Form S-1 (File No. 333-193137) on December 30, 2013 and incorporated herein by reference)
|
|
10.5+
|
2014 Stock Incentive Plan (filed as Exhibit 10.5 to Amendment No. 1 to the Registrant’s Registration Statement on Form S-1 (File No. 333-193137) on January 21, 2014 and incorporated herein by reference)
|
|
10.6+
|
Form of Incentive Stock Option Agreement under 2014 Stock Incentive Plan (filed as Exhibit 10.6 to Amendment No. 1 to the Registrant’s Registration Statement on Form S-1 (File No. 333-193137) on January 21, 2014 and incorporated herein by reference)
|
|
10.7+
|
Form of Nonstatutory Stock Option Agreement under 2014 Stock Incentive Plan (filed as Exhibit 10.7 to Amendment No. 1 to the Registrant’s Registration Statement on Form S-1 (File No. 333-193137) on January 21, 2014 and incorporated herein by reference)
|
|
10.8
|
Lease Agreement, dated as of January 16, 2001, between the Registrant and HCP MOP, as amended (filed as Exhibit 10.8 to the Registrant’s Registration Statement on Form S-1 (File No. 333-193137) on December 30, 2013 and incorporated herein by reference)
|
|
10.9+
|
Employment Agreement between the Registrant and Jeffrey D. Abbey, dated December 9, 2013 (filed as Exhibit 10.9 to the Registrant’s Registration Statement on Form S-1 (File No. 333-193137) on December 30, 2013 and incorporated herein by reference)
|
|
10.10+
|
Employment Agreement between the Registrant and Charles A. Nicolette, dated December 9, 2013 (filed as Exhibit 10.10 to the Registrant’s Registration Statement on Form S-1 (File No. 333-193137) on December 30, 2013 and incorporated herein by reference)
|
|
10.11+
|
Employment Agreement between the Registrant and Frederick M. Miesowicz, dated December 9, 2013 (filed as Exhibit 10.11 to the Registrant’s Registration Statement on Form S-1 (File No. 333-193137) on December 30, 2013 and incorporated herein by reference)
|
|
10.12+
|
Employment Agreement between the Registrant and Lori R. Harrelson, dated December 9, 2013 (filed as Exhibit 10.12 to the Registrant’s Registration Statement on Form S-1 (File No. 333-193137) on December 30, 2013 and incorporated herein by reference)
|
|
10.13+
|
Employment Agreement between the Registrant and Douglas C. Plessinger, dated December 9, 2013 (filed as Exhibit 10.13 to the Registrant’s Registration Statement on Form S-1 (File No. 333-193137) on December 30, 2013 and incorporated herein by reference)
|
Exhibit
Number
|
Description of Exhibit
|
|
10.14
|
Form of Indemnification Agreement between the Registrant and each director and executive officer (filed as Exhibit 10.14 to the Registrant’s Registration Statement on Form S-1 (File No. 333-193137) on December 30, 2013 and incorporated herein by reference)
|
|
10.15†
|
Contract No. HHSN266200600019C, dated September 30, 2006, by and among the Registrant, the National Institutes of Health and the National Institutes of Allergy and Infectious Diseases, as amended (filed as Exhibit 10.15 to the Registrant’s Registration Statement on Form S-1 (File No. 333-193137) on December 30, 2013 and incorporated herein by reference)
|
|
10.16†
|
License Agreement, dated August 9, 2013, by and between the Registrant and Pharmstandard S.A. (filed as Exhibit 10.16 to the Registrant’s Registration Statement on Form S-1 (File No. 333-193137) on December 30, 2013 and incorporated herein by reference)
|
|
10.17†
|
License Agreement, dated July 31, 2013, by and between the Registrant and Green Cross Corp. (filed as Exhibit 10.17 to Amendment No. 1 to the Registrant’s Registration Statement on Form S-1 (File No. 333-193137) on January 21, 2014 and incorporated herein by reference)
|
|
10.18†
|
License Agreement, dated July 28, 2011, by and between the Registrant and Celldex Therapeutics, Inc. (filed as Exhibit 10.18 to the Registrant’s Registration Statement on Form S-1 (File No. 333-193137) on December 30, 2013 and incorporated herein by reference)
|
|
10.19†
|
License Agreement, dated January 10, 2000, by and between the Registrant and Duke University, as amended (filed as Exhibit 10.19 to the Registrant’s Registration Statement on Form S-1 (File No. 333-193137) on December 30, 2013 and incorporated herein by reference)
|
|
10.20
|
Acknowledgement Agreement, dated November 4, 2013, by and between the Registrant and Pharmstandard International S.A. (filed as Exhibit 10.20 to Amendment No. 1 to the Registrant’s Registration Statement on Form S-1 (File No. 333-193137) on January 21, 2014 and incorporated herein by reference)
|
|
10.21+
|
2014 Employee Stock Purchase Plan (filed as Exhibit 10.21 to Amendment No. 1 to the Registrant’s Registration Statement on Form S-1 (File No. 333-193137) on January 21, 2014 and incorporated herein by reference)
|
|
10.22
|
Lease Agreement, dated August 18, 2014, by and between by and between the Registrant and TKC LXXII, LLC (filed as Exhibit 10.1 to the Registrant’s Current Report on Form 8-K on August 22, 2014 and incorporated herein by reference)
|
|
10.23
|
Venture Loan and Security Agreement, dated September 29, 2014, by and between the Registrant and Horizon Technology Finance Corporation and Fortress Credit Co LLC (filed as Exhibit 10.1 to the Registrant’s Current Report on Form 8-K on September 30, 2014 and incorporated herein by reference)
|
|
10.24
|
Form of Warrant to Purchase Common Stock, issued to Horizon Technology Finance Corporation on September 29, 2014 (filed as Exhibit 10.2 to the Registrant’s Current Report on Form 8-K on September 30, 2014 and incorporated herein by reference)
|
|
10.25
|
Form of Warrant to Purchase Common Stock, issued to Drawbridge Special Opportunities Fund LP on September 29, 2014 (filed as Exhibit 10.3 to the Registrant’s Current Report on Form 8-K on September 30, 2014 and incorporated herein by reference)
|
|
10.26
|
Development Agreement, dated October 29, 2014, by and between the Registrant and Invetech Lty Ltd
(filed as Exhibit 10.5 to the Registrant’s Quarterly Report on Form 10-Q on November 14, 2014 and incorporated by reference)
|
|
10.27*
†
|
Development Agreement dated January 5, 2015, by and between the Registrant and Saint-Gobain Performance Plastics Corporation
|
Exhibit
Number
|
Description of Exhibit
|
|
10.28
|
Purchase and Sale Agreement, dated February 16, 2015, by and between the Registrant and TKC LXXII, LLC (filed as Exhibit 10.1 to the Registrant’s Current Report on Form 8-K on
February 20, 2015 and incorporated by reference)
|
|
10.29* † |
Novated, Amended and Restated License Agreement effective as of October 1, 2014, by and between the Registrant and MEDcell Co., Ltd.
|
|
21.1
|
Subsidiaries of the Registrant (filed as Exhibit 21.1 to the Registrant’s Registration Statement on Form S-1 on December 30, 2013 and incorporated herein by reference)
|
|
23.1*
|
Consent of PricewaterhouseCoopers, an independent registered public accounting firm | |
31.1*
|
Certification of principal executive officer pursuant to Rules 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
|
31.2*
|
Certification of principal financial officer pursuant to Rules 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
|
32.1*
|
Certifications pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of The Sarbanes-Oxley Act of 2002, by the Registrant’s principal executive officer and principal financial officer
|
|
101.INS
|
XBRL Instance Document
|
|
101.SCH
|
XBRL Taxonomy Extension Schema Document
|
|
101.CAL
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
101.DEF
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
101.LAB
|
XBRL Taxonomy Extension Label Linkbase Document
|
|
101.PRE
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
†
|
Confidential treatment requested as to portions of the exhibit. Confidential materials omitted and filed separately with the Securities and Exchange Commission.
|
+
|
Management contract or compensatory plan or arrangement required to be filed as exhibits hereto pursuant to Item 15(a) of Form 10-K.
|
Page
|
|
Consolidated Financial Statements:
|
|
Financial Statement Schedule:
|
|
December 31,
|
||||||||
2013
|
2014
|
|||||||
Assets
|
||||||||
Current assets
|
||||||||
Cash and cash equivalents
|
$ | 33,297,970 | $ | 37,223,590 | ||||
Short-term investments
|
13,659,812 | 19,016,347 | ||||||
Prepaid expenses
|
629,935 | 838,420 | ||||||
Deferred financing costs
|
1,516,424 | 309,927 | ||||||
Other receivables
|
424,501 | 129,019 | ||||||
Total current assets
|
49,528,642 | 57,517,303 | ||||||
Property and equipment, net
|
1,602,103 | 5,513,555 | ||||||
Restricted cash
|
— | 1,325,000 | ||||||
Other assets
|
550 | 11,020 | ||||||
Total assets
|
$ | 51,131,295 | $ | 64,366,878 | ||||
Liabilities, Redeemable Convertible Preferred Stock and Stockholders’ (Deficit) Equity
|
||||||||
Current liabilities
|
||||||||
Accounts payable
|
$ | 1,317,072 | $ | 1,860,491 | ||||
Other accrued expenses
|
1,800,794 | 1,405,378 | ||||||
Current portion of notes payable
|
45,447 | 30,885 | ||||||
Total current liabilities
|
3,163,313 | 3,296,754 | ||||||
Long-term portion of notes payable
|
7,014,106 | 19,796,545 | ||||||
Long-term portion of manufacturing research and development obligation
|
— | 3,475,552 | ||||||
Long-term portion of facility lease obligation
|
— | 3,380,223 | ||||||
Deferred liability
|
3,066,000 | 3,066,000 | ||||||
Commitments
|
||||||||
Series A redeemable convertible preferred stock $0.001 par value; 1,200,000 and 0 shares authorized as of December 31, 2013 and 2014; 1,040,216 and 0 shares issued and outstanding as of December 31, 2013, and 2014; liquidation preference of $332,869 as of December 31, 2013
|
332,869 | — | ||||||
Series B redeemable convertible preferred stock $0.001 par value; 18,500,000 and 0 shares authorized as of December 31, 2013 and 2014; 9,803,688 and 0 shares issued and outstanding as of December 31, 2013, and 2014; liquidation preference of $5,521,437 as of December 31, 2013
|
5,521,437 | — | ||||||
Series C redeemable convertible preferred stock, $0.001 par value; 40,000,000 and 0 shares authorized as of December 31, 2013 and 2014; 28,716,679 and 0 shares issued and outstanding as of December 31, 2013 and 2014; liquidation preference of $2,655,884 as of December 31, 2013
|
2,655,884 | — | ||||||
Series D redeemable convertible preferred stock $0.001 par value; 31,000,000 and 0 shares authorized as of December 31, 2013 and 2014; 21,040,817 and 0 shares issued and outstanding as of December 31, 2013, and 2014; liquidation preference of $41,630,624 as of December 31, 2013
|
33,262,492 | — | ||||||
Series E redeemable convertible preferred stock, $0.001 par value; 70,000,000 and 0 shares authorized as of December 31, 2013 and 2014; 56,011,258 and 0 shares issued and outstanding as of December 31, 2013, and 2014; liquidation preference of $72,945,310 as of December 31, 2013
|
71,891,787 | — | ||||||
Stockholders’ (deficit) equity
|
||||||||
Preferred stock $0.001 par value; 0 and 5,000,000 shares authorized as of December 31, 2013 and 2014; 0 shares issued and outstanding as of December 31, 2013 and 2014
|
— | — | ||||||
Common stock $0.001 par value; 120,000,000 and 200,000,000 shares authorized as of December 31, 2013 and 2014; 235,707 and 19,657,412 shares issued and outstanding as of December 31, 2013 and 2014
|
236 | 19,657 | ||||||
Accumulated other comprehensive loss
|
(102,531 | ) | (124,841 | ) | ||||
Additional paid-in capital
|
75,189,950 | 235,627,174 | ||||||
Accumulated deficit
|
(150,864,248 | ) | (204,170,186 | ) | ||||
Total stockholders’ (deficit) equity
|
(75,776,593 | ) | 31,351,804 | |||||
Total liabilities, redeemable convertible preferred stock and stockholders’ (deficit) equity
|
$ | 51,131,295 | $ | 64,366,878 |
Years Ended December 31,
|
||||||||||||
2012
|
2013
|
2014
|
||||||||||
Revenue
|
$ | 7,039,010 | $ | 4,421,689 | $ | 1,974,019 | ||||||
Operating expenses
|
||||||||||||
Research and development
|
17,616,892 | 23,991,151 | 45,498,916 | |||||||||
General and administrative
|
6,135,581 | 4,662,317 | 8,599,359 | |||||||||
Total operating expenses
|
23,752,473 | 28,653,468 | 54,098,275 | |||||||||
Operating loss
|
(16,713,463 | ) | (24,231,779 | ) | (52,124,256 | ) | ||||||
Other income (expense)
|
||||||||||||
Interest income
|
4,604 | 7,184 | 66,580 | |||||||||
Interest expense
|
(292,496 | ) | (4,705 | ) | (1,123,579 | ) | ||||||
Change in fair value of warrant liability
|
4,916,785 | 355,352 | — | |||||||||
Derivative (expense) income
|
1,036,403 | — | — | |||||||||
Investment tax credits
|
694,331 | — | 140,556 | |||||||||
Other expense
|
(117,494 | ) | (47,615 | ) | (265,239 | ) | ||||||
Other income (expense), net
|
6,242,133 | 310,216 | (1,181,682 | ) | ||||||||
Net loss
|
(10,471,330 | ) | (23,921,563 | ) | (53,305,938 | ) | ||||||
Accretion of redeemable convertible preferred stock (See Note 19)
|
(351,371 | ) | 4,772,991 | (863,226 | ) | |||||||
Less: Preferred stock dividend due to exchanges of preferred shares (See Note 19)
|
— | (14,726,088 | ) | — | ||||||||
Net loss attributable to common stockholders
|
$ | (10,822,701 | ) | $ | (33,874,660 | ) | $ | (54,169,164 | ) | |||
Net loss attributable to common stockholders per share, basic and diluted
|
$ | (54.58 | ) | $ | (147.37 | ) | $ | (3.12 | ) | |||
Weighted average shares outstanding, basic and diluted
|
198,306 | 229,865 | 17,367,665 |
Years Ended December 31,
|
||||||||||||
2012
|
2013
|
2014
|
||||||||||
Net loss
|
$ | (10,471,330 | ) | $ | (23,921,563 | ) | $ | (53,305,938 | ) | |||
Other comprehensive loss:
|
||||||||||||
Foreign currency translation (loss) gain
|
(180,049 | ) | (8,264 | ) | (10,382 | ) | ||||||
Unrealized (loss) on short-term investments
|
— | — | (11,928 | ) | ||||||||
Total comprehensive loss
|
$ | (10,651,379 | ) | $ | (23,929,827 | ) | $ | (53,328,248 | ) |
Common
Stock
Shares
|
Common
Stock
Amount
|
Additional
Paid-in Capital
|
Accumulated Other Comprehensive Income (Loss)
|
Accumulated Deficit
|
Noncontrolling Interest
|
Total Stockholders’
(Deficit)
Equity
|
||||||||||||||||||||||
Balance as of December 31, 2011
|
122,345 | $ | 122 | $ | 29,413,821 | $ | 85,782 | $ | (128,828,989 | ) | $ | 2,974,158 | $ | (96,355,106 | ) | |||||||||||||
Issuance of restricted stock
|
— | — | 14,550 | — | — | — | 14,550 | |||||||||||||||||||||
Issuance of options to nonemployees
|
— | — | 561 | — | — | — | 561 | |||||||||||||||||||||
Stock-based compensation
|
— | — | 1,042,989 | — | — | — | 1,042,989 | |||||||||||||||||||||
Conversion of preferred stock into common stock
|
104,494 | 105 | 8,067,829 | — | — | — | 8,067,934 | |||||||||||||||||||||
Accretion of preferred stock
|
— | — | (351,371 | ) | — | — | — | (351,371 | ) | |||||||||||||||||||
Capital contribution
|
— | — | 17,306,478 | — | — | — | 17,306,478 | |||||||||||||||||||||
Extinguishment of preferred shares
|
— | — | — | — | 12,357,634 | — | 12,357,634 | |||||||||||||||||||||
Purchase of noncontrolling interest’s shares
|
— | — | 2,974,158 | — | — | (2,974,158 | ) | — | ||||||||||||||||||||
Cumulative translation adjustment
|
— | — | — | (180,049 | ) | — | — | (180,049 | ) | |||||||||||||||||||
Net loss
|
— | — | — | — | (10,471,330 | ) | — | (10,471,330 | ) | |||||||||||||||||||
Balance as of December 31, 2012
|
226,839 | $ | 227 | $ | 58,469,015 | $ | (94,267 | ) | $ | (126,942,685 | ) | $ | — | $ | (68,567,710 | ) | ||||||||||||
Exercise of common stock options
|
1,379 | 2 | 5,791 | — | — | — | 5,793 | |||||||||||||||||||||
Issuance of restricted stock
|
7,571 | 7 | 16,493 | — | — | — | 16,500 | |||||||||||||||||||||
Issuance of common warrants
|
— | — | 618,155 | — | — | — | 618,155 | |||||||||||||||||||||
Distribution of shares to affiliates
|
(7 | ) | — | — | — | — | — | — | ||||||||||||||||||||
Surrender of shares
|
(75 | ) | — | — | — | — | — | — | ||||||||||||||||||||
Stock-based compensation
|
— | — | 1,053,163 | — | — | — | 1,053,163 | |||||||||||||||||||||
Reversal of prior accretion
|
— | — | 5,657,638 | — | — | — | 5,657,638 | |||||||||||||||||||||
Accretion of preferred stock
|
— | — | (884,647 | ) | — | — | — | (884,647 | ) | |||||||||||||||||||
Exchange of preferred shares
|
— | — | (14,726,088 | ) | — | — | — | (14,726,088 | ) | |||||||||||||||||||
Reduction of liquidation value
|
— | — | 24,980,430 | — | — | — | 24,980,430 | |||||||||||||||||||||
Cumulative translation adjustment
|
— | — | — | (8,264 | ) | — | — | (8,264 | ) | |||||||||||||||||||
Net loss
|
— | — | — | — | (23,921,563 | ) | — | (23,921,563 | ) | |||||||||||||||||||
Balance as of December 31, 2013
|
235,707 | $ | 236 | $ | 75,189,950 | $ | (102,531 | ) | $ | (150,864,248 | ) | $ | — | $ | (75,776,593 | ) | ||||||||||||
Issuance of common stock
|
6,228,725 | 6,229 | 49,823,571 | — | — | — | 49,829,800 | |||||||||||||||||||||
Common stock issuance costs
|
— | — | (6,391,588 | ) | — | — | — | (6,391,588 | ) | |||||||||||||||||||
Exercise of common stock options
|
3,050 | 3 | 12,807 | — | — | — | 12,810 | |||||||||||||||||||||
Conversion of warrants into common stock
|
1,679 | 1 | (1 | ) | — | — | — | — | ||||||||||||||||||||
Stock-based compensation
|
— | — | 3,013,284 | — | — | — | 3,013,284 | |||||||||||||||||||||
Accretion of preferred stock
|
— | — | (863,226 | ) | — | — | — | (863,226 | ) | |||||||||||||||||||
Conversion of preferred stock into common stock
|
13,188,251 | 13,188 | 114,514,267 | — | — | — | 114,527,455 | |||||||||||||||||||||
Issuance of warrants
|
— | — | 328,110 | — | — | — | 328,110 | |||||||||||||||||||||
Cumulative translation adjustment
|
— | — | — | (10,382 | ) | — | — | (10,382 | ) | |||||||||||||||||||
Unrealized loss on short-term investments
|
— | — | — | (11,928 | ) | — | — | (11,928 | ) | |||||||||||||||||||
Net loss
|
— | — | — | — | (53,305,938 | ) | — | (53,305,938 | ) | |||||||||||||||||||
Balance as of December 31, 2014
|
19,657,412 | $ | 19,657 | $ | 235,627,174 | $ | (124,841 | ) | $ | (204,170,186 | ) | $ | — | $ | 31,351,804 |
Years Ended December 31,
|
||||||||||||
2012
|
2013
|
2014
|
||||||||||
Cash flows from operating activities
|
||||||||||||
Net loss
|
$ | (10,471,330 | ) | $ | (23,921,563 | ) | $ | (53,305,938 | ) | |||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||||||
Depreciation and amortization
|
505,261 | 611,421 | 566,117 | |||||||||
Compensation expense related to stock options and warrants
|
1,043,550 | 1,081,186 | 3,013,283 | |||||||||
Amortization of debt issuance costs
|
— | — | 69,308 | |||||||||
Amortization of debt discount
|
— | — | 24,917 | |||||||||
Interest accrued on long-term debt
|
— | — | 693,114 | |||||||||
Write-off of deferred financing costs
|
1,785,779 | — | — | |||||||||
Derivative expense (income)
|
(1,036,403 | ) | — | — | ||||||||
Noncash interest expense
|
292,064 | 2,465 | — | |||||||||
Increase (decrease) in fair value of warrant liability
|
(4,916,785 | ) | (355,352 | ) | — | |||||||
Issuance of restricted stock recorded as consulting expense
|
14,550 | 16,500 | — | |||||||||
Loss (gain) on disposal of equipment
|
(4,774 | ) | (50,835 | ) | (1,710 | ) | ||||||
Changes in operating assets and liabilities:
|
||||||||||||
Prepaid expenses and other receivables
|
(216,332 | ) | 438,867 | 86,997 | ||||||||
Deferred financing costs
|
— | (571,327 | ) | — | ||||||||
Other assets
|
— | — | (10,471 | ) | ||||||||
Accounts payable
|
60,977 | 181,965 | 543,419 | |||||||||
Accrued expenses
|
(254,813 | ) | 1,244,940 | (395,416 | ) | |||||||
Long-term portion of manufacturing research and development obligation
|
— | — | 3,475,552 | |||||||||
Deferred liability
|
— | 3,066,000 | — | |||||||||
Net cash used in operating activities
|
(13,198,256 | ) | (18,255,733 | ) | (45,240,828 | ) | ||||||
Cash flows from investing activities
|
||||||||||||
Purchases of property and equipment
|
(1,137,533 | ) | (596,455 | ) | (1,097,798 | ) | ||||||
Proceeds from sales of fixed assets
|
5,555 | 50,835 | 2,000 | |||||||||
Purchases of short-term investments
|
(4,591,437 | ) | (13,600,941 | ) | (25,593,464 | ) | ||||||
Payment to restricted cash account securing letter of credit
|
— | — | (1,325,000 | ) | ||||||||
Proceeds from sales and maturities of short-term investments
|
442,566 | 4,090,000 | 20,225,000 | |||||||||
Net cash (used in) provided by investing activities
|
(5,280,849 | ) | (10,056,561 | ) | (7,789,262 | ) | ||||||
Cash flows from financing activities
|
||||||||||||
Proceeds from sale of common stock
|
— | — | 49,829,800 | |||||||||
Proceeds from sale of redeemable convertible preferred stock
|
25,000,000 | 47,409,867 | — | |||||||||
Proceeds from issuance of common stock warrants
|
— | 590,132 | — | |||||||||
Stock issuance costs
|
(208,934 | ) | (1,501,344 | ) | (4,875,404 | ) | ||||||
Proceeds from notes payable with detachable common stock warrants
|
95,756 | 6,934,000 | 12,500,000 | |||||||||
Debt issuance costs
|
— | — | (449,796 | ) | ||||||||
Payments on notes payable
|
(15,568 | ) | (34,934 | ) | (51,481 | ) | ||||||
Proceeds from exercise of common stock options
|
— | 5,793 | 12,810 | |||||||||
Net cash provided by financing activities
|
24,871,254 | 53,403,514 | 56,965,929 | |||||||||
Effect of exchange rates changes on cash
|
(180,098 | ) | (8,115 | ) | (10,219 | ) | ||||||
Net increase in cash and cash equivalents
|
6,212,051 | 25,083,105 | 3,925,620 | |||||||||
Cash and cash equivalents
|
||||||||||||
Beginning of period
|
2,002,814 | 8,214,865 | 33,297,970 | |||||||||
End of period
|
$ | 8,214,865 | $ | 33,297,970 | $ | 37,223,590 | ||||||
Supplemental disclosure of cash flow information
|
||||||||||||
Cash paid for interest
|
$ | 433 | $ | 512 | $ | 307,944 | ||||||
Supplemental disclosure of noncash investing and financing activities
|
||||||||||||
Conversion of notes payable and accrued interest into preferred stock
|
$ | 10,668,185 | $ | — | $ | — | ||||||
Conversion of preferred stock into common stock
|
$ | 8,067,307 | $ | — | $ | 114,527,695 | ||||||
Preferred stock accretion
|
$ | 351,371 | $ | (4,772,991 | ) | $ | 863,226 | |||||
Interest accrued on long-term debt
|
$ | — | $ | — | $ | 693,114 | ||||||
Recognition of asset and facility lease obligation related to construction of new property
|
$ | — | $ | — | $ | 3,380,223 |
Quoted Prices
in Active
Markets for
Identical Assets
(Level 1)
|
Significant
Other
Observable
Inputs
(Level 2)
|
Significant
Unobservable
Inputs
(Level 3)
|
Balance as of
December 31,
2013
|
|||||||||||||
Assets
|
||||||||||||||||
Money-market funds
|
$
|
22,891,418
|
$
|
—
|
$
|
—
|
$
|
22,891,418
|
||||||||
Corporate debt securities – short-term
|
—
|
13,659,812
|
—
|
13,659,812
|
||||||||||||
Total assets at fair value
|
$
|
22,891,418
|
$
|
13,659,812
|
$
|
—
|
$
|
36,551,230
|
Quoted Prices
in Active
Markets for
Identical Assets
(Level 1)
|
Significant
Other
Observable
Inputs
(Level 2)
|
Significant
Unobservable
Inputs
(Level 3)
|
Balance as of
December 31,
2014
|
|||||||||||||
Assets
|
||||||||||||||||
Money-market funds
|
$
|
35,541,595
|
$
|
—
|
$
|
—
|
$
|
35,541,595
|
||||||||
Corporate debt securities – short-term
|
—
|
20,266,243
|
—
|
20,266,243
|
||||||||||||
Restricted cash – long-term
|
1,325,000
|
1,325,000
|
||||||||||||||
Total assets at fair value
|
$
|
36,866,595
|
$
|
20,266,243
|
$
|
—
|
$
|
57,132,838
|
Fair Value Measurements Using Significant Unobservable
Inputs (Level 3)
|
||||||||||||||||
Beginning
Balance
|
Net Change in
Unrealized
(Gains) Losses
|
Reduction
|
Ending
Balance
|
|||||||||||||
Warrant Liability
|
$ | 6,392,652 | $ | (355,352 | ) | $ | (6,037,300 | ) | $ | — | ||||||
$ | 6,392,652 | $ | (355,352 | ) | $ | (6,037,300 | ) | $ | — |
Useful Life
(Years)
|
December 31, 2013
|
December 31, 2014
|
|||||||||
Office furniture and equipment
|
7 | $ | 528,732 | $ | 458,380 | ||||||
Computer equipment
|
3 | 712,609 | 788,563 | ||||||||
Computer software
|
3 | 540,809 | 629,948 | ||||||||
Laboratory equipment
|
7 | 5,264,952 | 5,345,786 | ||||||||
Leasehold improvements
|
5 | 2,643,023 | 2,646,891 | ||||||||
Asset related to facility lease obligation
|
— | 3,380,223 | |||||||||
Construction of manufacturing facility in progress
|
76,010 | 500,093 | |||||||||
9,766,135 | 13,749,884 | ||||||||||
Less: Accumulated depreciation and amortization
|
(8,164,032 | ) | (8,236,329 | ) | |||||||
Property and equipment, net
|
$ | 1,602,103 | $ | 5,513,555 |
Year ended December 31, 2012
|
$ | 505,261 | ||
Year ended December 31, 2013
|
611,421 | |||
Year ended December 31, 2014
|
566,117 |
December 31,
|
||||||||
2013
|
2014
|
|||||||
U.S. federal and state net operating loss carryforwards
|
$ | 41,359,722 | $ | 59,689,264 | ||||
Foreign net operating loss carryforwards
|
1,827,221 | 1,743,603 | ||||||
Contribution carryforwards
|
3,055 | 4,245 | ||||||
Research and development credits
|
4,061,844 | 5,253,055 | ||||||
Investment tax credits
|
38,175 | 35,108 | ||||||
Stock-based compensation
|
22,282 | 462,796 | ||||||
Patents and other intangibles
|
2,967 | 611 | ||||||
Other accruals
|
97,157 | 125,614 | ||||||
Deferred revenue
|
— | 372,040 | ||||||
Property and equipment
|
532,316 | 510,466 | ||||||
Total deferred tax assets
|
47,944,739 | 68,196,802 | ||||||
Valuation allowance for deferred assets
|
(47,944,739 | ) | (68,196,802 | ) | ||||
Net deferred tax assets
|
$ | — | $ | — |
December 31,
2011
|
December 31,
2012
|
December 31,
2014
|
||||||||||||||||||||||
Amount
|
Percent of
Pretax
Earnings
|
Amount
|
Percent of
Pretax
Earnings
|
Amount
|
Percent of
Pretax
Earnings
|
|||||||||||||||||||
U.S. federal tax statutory rate
|
$ | (3,560,252 | ) | 34.0 | % | $ | (8,133,331 | ) | 34.0 | % | $ | (18,124,019 | ) | 34.0 | % | |||||||||
State taxes (net of federal benefit)
|
(476,446 | ) | 4.5 | % | (789,412 | ) | 3.3 | % | (1,707,912 | ) | 3.2 | % | ||||||||||||
U.S. federal research and development tax credits
|
— | 0.0 | % | (1,262,562 | ) | 5.3 | % | (1,701,727 | ) | 3.2 | % | |||||||||||||
Nondeductible interest expense
|
(1,782,830 | ) | 17.0 | % | (132,546 | ) | 0.6 | % | — | 0.0 | % | |||||||||||||
Other nondeductible expenses
|
(210,790 | ) | 2.0 | % | 419,934 | (1.8 | %) | 658,740 | (1.1 | %) | ||||||||||||||
Expiration of capital loss carryforward
|
3,246,049 | (31.0 | %) | — | (0.0 | %) | — | 0.0 | % | |||||||||||||||
Increase in unrecognized tax benefits
|
— | 0.0 | % | 378,769 | (1.6 | %) | 510,516 | (1.0 | %) | |||||||||||||||
Change in effective state tax rate
|
— | 0.0 | % | 1,349,062 | (5.6 | %) | 1,685 | (0.0 | %) | |||||||||||||||
Expiration of NOL & contribution carryforwards
|
57,538 | (0.5 | %) | 6,630 | (0.0 | %) | 77,391 | (0.1 | %) | |||||||||||||||
Change in valuation reserves
|
2,618,552 | (25.2 | %) | 8,811,127 | (36.8 | %) | 20,252,063 | (38.1 | %) | |||||||||||||||
Deferred tax asset true-ups
|
108,179 | (0.8 | %) | (647,671 | ) | 2.6 | % | 33,263 | (0.1 | %) | ||||||||||||||
Provision for income taxes
|
$ | — | 0.0 | % | $ | — | 0.0 | % | $ | — | 0.0 | % |
2012
|
2013
|
2014
|
||||||||||
Beginning balance
|
$ | 1,272,800 | $ | 1,265,700 | $ | 1,644,500 | ||||||
Gross increase for tax positions related to current periods
|
— | 378,800 | 474,300 | |||||||||
Gross (decrease) increase for tax positions related to prior periods
|
(7,100 | ) | — | 36,200 | ||||||||
Ending balance
|
$ | 1,265,700 | $ | 1,644,500 | $ | 2,155,000 |
December 31,
2013
|
December 31,
2014
|
|||||||
Notes payable under the venture loan and security agreement
|
$ | — | $ | 12,500,000 | ||||
Less related debt discount
|
— | (373,756 | ) | |||||
Notes payable under the venture loan and security agreement, net of debt discount
|
— | 12,126,244 | ||||||
Promissory note payable to Medinet including accrued interest
|
6,936,466 | 7,623,546 | ||||||
Other notes payable
|
123,087 | 77,640 | ||||||
Total notes payable
|
7,059,553 | 19,827,430 | ||||||
Less current portion
|
(45,447 | ) | (30,885 | ) | ||||
Long-term portion of notes payable
|
$ | 7,014,106 | $ | 19,796,545 |
Series A Preferred
|
Series B Preferred
|
Series B-1
Preferred
|
Series C Preferred
|
Series D Preferred
|
Series D-1 Preferred
|
Series E Preferred
|
||||||||||||||||||||||||||||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
|||||||||||||||||||||||||||||||||||||||||||
Balance as of December 31, 2011
|
1,276,103 | $ | 1,276,103 | 24,326,574 | $ | 42,814,762 | 917,771 | $ | 1,615,276 | 112,165,271 | $ | 32,016,165 | — | $ | — | — | $ | — | — | $ | — | |||||||||||||||||||||||||||||||||||
Issuance of shares
|
— | — | — | — | — | — | — | — | 2,549,897 | 4,793,806 | 3,713,333 | 7,842,733 | — | — | ||||||||||||||||||||||||||||||||||||||||||
Conversion of bridge note
|
— | — | — | — | — | — | — | — | 3,023,661 | 5,684,483 | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||
Conversion of accrued services
|
— | — | — | — | — | — | — | — | 7,142 | 25,200 | 3,602 | 15,485 | — | — | ||||||||||||||||||||||||||||||||||||||||||
Pull through of existing preferred
|
— | — | (3,652,680 | ) | (6,428,717 | ) | — | — | (64,256,463 | ) | (18,571,283 | ) | 2,557,039 | 4,807,233 | 3,716,935 | 7,835,133 | — | — | ||||||||||||||||||||||||||||||||||||||
Stock issuance costs
|
— | — | — | — | — | — | — | — | — | (128,275 | ) | — | (80,659 | ) | — | — | ||||||||||||||||||||||||||||||||||||||||
Shares converted to common
|
(124,050 | ) | (124,050 | ) | (2,182,576 | ) | (3,841,332 | ) | (917,771 | ) | (1,615,276 | ) | (8,605,955 | ) | (2,487,276 | ) | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||
Accretion
|
— | — | — | — | — | — | — | 327,465 | — | 18,529 | — | 5,377 | — | — | ||||||||||||||||||||||||||||||||||||||||||
Balance as of December 31, 2012
|
1,152,053 | 1,152,053 | 18,491,318 | 32,544,713 | — | — | 39,302,853 | 11,285,071 | 8,137,739 | 15,200,976 | 7,433,870 | 15,618,069 | — | — | ||||||||||||||||||||||||||||||||||||||||||
Exchange of Series D-1
|
— | — | — | — | — | — | — | — | 16,151,212 | 26,887,407 | (7,433,870 | ) | (15,628,821 | ) | — | — | ||||||||||||||||||||||||||||||||||||||||
Issuance of shares
|
— | — | — | — | — | — | — | — | 6,373,782 | 11,446,143 | — | — | 36,856,922 | 47,409,867 | ||||||||||||||||||||||||||||||||||||||||||
Exchange of Series D
|
— | — | — | — | — | — | — | — | (12,607,779 | ) | (24,945,326 | ) | — | — | 19,154,336 | 24,945,326 | ||||||||||||||||||||||||||||||||||||||||
Pull through of existing preferred
|
(111,837 | ) | (35,788 | ) | (8,687,630 | ) | (4,892,873 | ) | — | — | (10,586,174 | ) | (979,070 | ) | 2,985,863 | 4,030,920 | — | — | — | — | ||||||||||||||||||||||||||||||||||||
Reduction of liquidation value
|
— | (783,396 | ) | — | (18,001,661 | ) | — | — | — | (6,195,373 | ) | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||
Stock issuance costs
|
— | — | — | — | — | — | — | — | — | (64,530 | ) | — | — | — | (556,247 | ) | ||||||||||||||||||||||||||||||||||||||||
Reversal of prior accretion
|
— | — | — | (4,128,742 | ) | — | — | — | (1,528,896 | ) | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||
Accretion
|
— | — | — | — | — | — | — | 74,152 | — | 706,902 | — | 10,752 | — | 92,841 | ||||||||||||||||||||||||||||||||||||||||||
Balance as of December 31, 2013
|
1,040,216 | 332,869 | 9,803,688 | 5,521,437 | — | — | 28,716,679 | 2,655,884 | 21,040,817 | 33,262,492 | — | — | 56,011,258 | 71,891,787 | ||||||||||||||||||||||||||||||||||||||||||
Accretion
|
— | — | — | — | — | — | — | — | — | 336,350 | — | — | — | 526,876 | ||||||||||||||||||||||||||||||||||||||||||
Shares converted to common stock
|
(1,040,216 | ) | (332,869 | ) | (9,803,688 | ) | (5,521,437 | ) | — | — | (28,716,679 | ) | (2,655,884 | ) | (21,040,817 | ) | (33,598,842 | ) | — | — | (56,011,258 | ) | (72,418,423 | ) | ||||||||||||||||||||||||||||||||
Stock issuance costs
|
— | — | — | — | — | — | — | — | — | — | — | — | — | (240 | ) | |||||||||||||||||||||||||||||||||||||||||
Balance as of December 31, 2014
|
— | $ | — | — | $ | — | — | $ | — | — | $ | — | — | $ | — | — | $ | — | — | $ | — |
Type of Warrant
|
Number of Shares
|
Exercise Price
|
Expiration
Date(s)
|
|||||||
Common
|
1 | $ | 23,894.34 |
7/13/16
|
||||||
Common
|
9,598 | $ | 6.60 |
12/20/23
|
Type of Warrant
|
Number of Shares
|
Exercise Price
|
Expiration
Date(s)
|
|||||||
Common stock
|
1 | $ | 23,894.34 |
7/13/16
|
||||||
Common stock
|
82,780 | $ | 9.06 |
9/29/21
|
Years Ended December 31,
|
||||||||||||
2012
|
2013
|
2014
|
||||||||||
Research and development
|
$ | 511,860 | $ | 524,495 | $ | 1,604,215 | ||||||
General and administrative
|
531,129 | 528,668 | 1,409,068 | |||||||||
Total stock-based compensation expense
|
$ | 1,042,989 | $ | 1,053,163 | $ | 3,013,283 |
2012
|
2013
|
2014
|
||||||||||
Risk-free interest rate
|
1.20 | % | 2.12 | % | 2.26 | % | ||||||
Expected dividend yield
|
0 | % | 0 | % | 0 | % | ||||||
Expected option term (in years)
|
7 | 7 | 7 | |||||||||
Expected volatility
|
94 | % | 94 | % | 96 | % |
Number of
Shares
|
Weighted
Average Exercise
Price
|
Weighted
Average
Contractual
Term
(in years)
|
Aggregate
Intrinsic
Value
|
|||||||||||||
Outstanding as of December 31, 2013
|
1,957,069 | $ | 5.48 | |||||||||||||
Granted
|
967,903 | $ | 6.70 | |||||||||||||
Exercised
|
(3,050 | ) | $ | 4.20 | ||||||||||||
Cancelled
|
(74,825 | ) | $ | 4.94 | ||||||||||||
Outstanding as of December 31, 2014
|
2,847,097 | $ | 5.89 | 8.65 | $ | 11,796,921 | ||||||||||
Exercisable as of December 31, 2014
|
897,294 | $ | 5.04 | 7.54 | $ | 4,509,931 | ||||||||||
Vested and expected to vest as of December 31, 2014
|
2,716,363 | $ | 5.86 | 8.62 | $ | 11,255,225 |
Exercise Price or Range of Exercise Price
|
Options Outstanding
|
Weighted Average
Contractual Life
(Years)
|
Options Exercisable
|
|||||||||||
$4.20 | 553,434 | 6.64 | 521,718 | |||||||||||
$5.82 | 1,219,689 | 8.85 | 333,785 | |||||||||||
$5.98 | to | $6.62 | 869,525 | 9.50 | — | |||||||||
$7.32 | to | $11.09 | 203,172 | 9.10 | 40,514 | |||||||||
$35.30 | to | $36.66 | 1,271 | 6.70 | 1,271 | |||||||||
$135.78 | to | $4,615.92 | 6 | 0.83 | 6 | |||||||||
2,847,097 | 8.65 | 897,294 |
|
•
|
a $75,000 annual license fee;
|
|
•
|
a specified milestone payment based on the achievement of a specified regulatory milestone; and
|
|
•
|
a specified dollar amount per dose of AGS-003 the Company sells.
|
Year ending December 31:
|
||||
2015
|
$ | 375,333 | ||
2016
|
571,445 | |||
2017
|
584,303 | |||
2018
|
597,449 | |||
2019
|
610,892 | |||
Thereafter
|
3,496,201 | |||
Total future minimum lease payments
|
$ | 6,235,623 |
2015
|
$ | 394,089 | ||
2016
|
435,359 | |||
2017
|
79,688 | |||
Total minimum lease payments
|
$ | 909,136 |
Year Ended December 31,
|
||||||||||||
2012
|
2013
|
2014
|
||||||||||
Net loss
|
$ | (10,471,330 | ) | $ | (23,921,563 | ) | $ | (53,305,938 | ) | |||
Accretion of redeemable convertible preferred stock
|
(351,371 | ) | (884,647 | ) | (863,226 | ) | ||||||
Reverse prior accretion on redeemable preferred stock due to reduction in liquidation value of Series A, B, and C
|
— | 5,657,638 | — | |||||||||
Preferred stock dividend due to exchanges of preferred shares
|
— | (14,726,088 | ) | — | ||||||||
Net loss attributable to common stockholders
|
$ | (10,822,701 | ) | $ | (33,874,660 | ) | $ | (54,169,164 | ) | |||
Weighted average common shares outstanding, basic and diluted
|
198,306 | 229,865 | 17,367,665 | |||||||||
Net loss per share attributable to common stockholders, basic and diluted
|
$ | (54.58 | ) | $ | (147.37 | ) | $ | (3.12 | ) |
Year Ended December 31,
|
||||||||||||
2012
|
2013
|
2014
|
||||||||||
Redeemable convertible preferred stock
|
2,167,143 | 6,322,747 | — | |||||||||
Stock options outstanding
|
366,389 | 767,510 | 2,847,097 | |||||||||
Warrants outstanding
|
316,184 | 424,961 | 82,781 |
Quarter Ended
|
||||||||||||||||
March 31,
2014
|
June 30,
2014
|
September 30,
2014
|
December 31,
2014
|
|||||||||||||
Revenue
|
$ | 798,788 | $ | 473,163 | $ | 398,615 | $ | 303,453 | ||||||||
Operating expenses:
|
||||||||||||||||
Research and development
|
8,472,195 | 10,569,134 | 12,998,409 | 13,459,178 | ||||||||||||
General and administrative
|
1,933,476 | 1,865,822 | 2,320,036 | 2,480,025 | ||||||||||||
Operating loss
|
(9,606,883 | ) | (11,961,793 | ) | (14,919,830 | ) | (15,635,750 | ) | ||||||||
Other income (expense), net
|
(394,097 | ) | (21,738 | ) | (181,187 | ) | (584,660 | ) | ||||||||
Net loss
|
(10,000,980 | ) | (11,983,531 | ) | (15,101,017 | ) | (16,220,410 | ) | ||||||||
Accretion of redeemable convertible preferred stock
|
(863,226 | ) | — | — | — | |||||||||||
Net loss attributable to common stockholders
|
$ | (10,864,206 | ) | $ | (11,983,531 | ) | $ | (15,101,017 | ) | $ | (16,220,410 | ) | ||||
Net loss attributable to common stockholders per share, basic and diluted
|
$ | (1.05 | ) | $ | (0.61 | ) | $ | (0.77 | ) | $ | (0.83 | ) | ||||
Weighted average shares outstanding, basic and diluted
|
10,376,561 | 19,655,187 | 19,655,561 | 19,656,209 |
Quarter Ended
|
||||||||||||||||
March 31,
2013
|
June 30,
2013
|
September 30,
2013
|
December 31,
2013
|
|||||||||||||
Revenue
|
$ | 1,461,687 | $ | 1,263,008 | $ | 981,247 | $ | 715,747 | ||||||||
Operating expenses:
|
||||||||||||||||
Research and development
|
5,189,461 | 6,102,320 | 5,630,219 | 7,069,151 | ||||||||||||
General and administrative
|
1,078,357 | 939,725 | 1,024,167 | 1,620,068 | ||||||||||||
Operating loss
|
(4,806,131 | ) | (5,779,037 | ) | (5,673,139 | ) | (7,973,472 | ) | ||||||||
Other income (expense), net
|
356,929 | 196 | 541 | (47,450 | ) | |||||||||||
Net loss
|
(4,449,202 | ) | (5,778,841 | ) | (5,672,598 | ) | (8,020,922 | ) | ||||||||
Accretion of redeemable convertible preferred stock
|
(64,940 | ) | (10,446 | ) | 5,325,406 | (477,029 | ) | |||||||||
Less: Preferred stock dividend due to exchanges of preferred shares
|
— | — | (14,726,088 | ) | — | |||||||||||
Net loss attributable to common stockholders
|
$ | (4,514,142 | ) | $ | (5,789,287 | ) | $ | (15,073,280 | ) | $ | (8,497,951 | ) | ||||
Net loss attributable to common stockholders per share, basic and diluted
|
$ | (19.91 | ) | $ | (25.53 | ) | $ | (65.23 | ) | $ | (36.19 | ) | ||||
Weighted average shares outstanding, basic and diluted
|
226,757 | 226,757 | 231,084 | 234,789 |
Additions
|
||||||||||||||||||||
Balance at
Beginning
of Year
|
Charged to
Expenses
(a)
|
Charged to
Other
Accounts
|
Increases
|
Balance at
End of Year
|
||||||||||||||||
Year Ended December 31, 2014
|
$ | 47,945 | $ | 20,252 | $ | — | $ | — | $ | 68,197 | ||||||||||
Year Ended December 31, 2013
|
$ | 39,134 | $ | 8,811 | $ | — | $ | — | $ | 47,945 | ||||||||||
Year Ended December 31, 2012
|
$ | 36,515 | $ | 2,619 | $ | — | $ | — | $ | 39,134 |
(a)
|
– Impact of providing full valuation allowance against all deferred tax assets since the Company could not assert that it was more likely than not that these deferred tax assets would be realized.
|
Confidential Materials omitted and filed separately with the
|
Exhibit 10.27
|
|
Securities and Exchange Commission. Double asterisks denote omissions.
|
||
A.
|
SGPPL specializes in the development, manufacture, sale, research, design, engineering, testing, and prototyping of products for life sciences and other industrial applications.
|
B.
|
Argos specializes in the development of and commercialization of personalized immunotherapies for the treatment of cancer and infectious diseases.
|
C.
|
Argos desires for SGPPL, and SGPPL is willing, to develop Products (defined in Section 1) for use in connection with Argos’ AGS-003 clinical stage therapeutic product candidate for the treatment of metastatic renal cell carcinoma and potentially other oncology applications
.
|
D.
|
In consideration of the Parties’ investment and time in developing the Products, SGPPL and Argos desire to enter into a Supply Agreement whereby SGPPL will serve as the exclusive manufacturer and supplier of the Products to Argos and its licensees for use in the Field of Application (defined in Section 1), which the Parties will negotiate in good faith as more fully set forth herein (the “Supply Agreement”).
|
E.
|
Additionally, SGPPL and Argos desire to set forth intellectual property protections and each Party’s responsibilities
,
including certain cost allocations relating to the materials and equipment required for the Project (defined in Section 1)
.
|
|
NOW, THEREFORE, THE PARTIES AGREE AS FOLLOWS:
|
1.1
|
“Affiliate”
means, as to a Party or other entity, a company or other entity directly or indirectly Controlling, Controlled by or under common Control with such Party or other entity during the time such Control exists. For purposes of this definition, “Control,” “Controlling” or “Controlled” means the ability to determine the management policies of a company or other entity through ownership of a majority of shares, by control of the board of management, by agreement or otherwise.
|
1.2
|
“Agreement”
means this Development Agreement and its exhibits.
|
1.3
|
“Arcelis Technology”
means Argos’ Arcelis Personalized Immunotherapy Platform for the treatment of cancer, including but not limited to the technology described on
Exhibit A
attached hereto and the automated equipment, devices, tools, systems, methods and designs developed for Argos by Invetech Pty Ltd or its Affiliates (collectively, “Invetech”).
|
1.4
|
“Argos Results”
means all Results related to dendritic cell treatments and vaccines for cancer and infectious diseases, including compositions and methods of manufacturing Arcelis Technology based products and all Results that rely on or necessarily incorporate Arcelis Technology and any related technology independently developed. For the avoidance of doubt, Argos Results shall include all Results that are not SGPPL Results.
|
1.5
|
“Background Information”
means, as to either Party, any invention, whether or not patentable, invention disclosures, know-how, trade secrets, data, technical information, method, process, article of manufacture or composition of matter, or any improvement thereof (whether or not patentable) created, developed or owned by that Party or licensed to that Party by a third party prior to the Effective Date, or after the Effective Date but in such case outside the scope of the Results.
|
1.6
|
“Components”
means individual parts that combine to form a Product. For example, Components include, but are not limited to injection molded parts, tubing assemblies, bags, sensors, filters, formulations, sterile welding/sealing techniques, connectors, retainers, manifolds, multi-lumen tubing, any assemblies to be designed thereof and any clean room assemblies, including packaging and RFID/bar coding.
|
1.7
|
“Field of Application” or “FOA”
means for the treatment of metastatic renal cell carcinoma and other solid tumor applications.
|
1.8
|
“IP Rights”
means all forms of intellectual property rights and protections including, without limitation, all right, title and interest (including license rights) in and to all (i) patents, patent applications, utility models, continuations, continuations-in-part (except for any claims therein that are supported only by new matter not otherwise subject to this Agreement), divisionals, reexaminations and reissues, and (ii) inventions and know-how.
|
1.9
|
“NDA”
means the Confidential Disclosure Agreement entered by and between the Parties having an effective date of May 22, 2014.
|
1.10
|
“Products”
means the disposable sets to be used for cellular and RNA automated processing developed in connection with the Project. The Parties understand that Products will include not only the specific Product in question, but any obvious and/or minor modifications of the Product in question.
|
1.11
|
“Project”
means the joint development work to design, integrate and scale the production of the Products which are to be integrated with Arcelis Technology to manufacture cell-based immunotherapies using SGPPL manufacturing technology for use in the FOA.
|
1.12
|
“Project Plan”
means the description, orientation and time framework of the Project, and the division of work between the Parties, described in
Exhibit B
.
|
1.13
|
“Results”
means any invention, whether or not patentable, invention disclosures, know-how, trade secrets, data, technical information, method, process, article of manufacture or composition of matter, or any improvement thereof (whether or not patentable) that are acquired or invented by one or both of the Parties in the course of work under the Project. For the avoidance of doubt, Results shall not include any of the foregoing if first acquired or invented by Invetech.
|
1.14
|
“SGPPL Results”
means all Results related to (i) Components in developing and producing disposable systems, including manufacturing processes thereof; (ii) the technology know-how related to fluid transfer assemblies and systems; (iii) testing capabilities and know-how and test results related thereto; and (iv) any related technology independently developed by SGPPL or its Affiliates. SGPPL Results shall exclude any Results related to Argos Results and any Results that incorporate Argos Background Information and/or Arcelis Technology
|
1.15
|
“Technical Specifications”
shall be jointly-agreed in writing. The Parties understand that the Technical Specifications will evolve during the course of the Project by jointly-agreed written modifications, based on an improved understanding of the requirements of the Project and manufacturing constraints.
|
2.1
|
The purpose of this Agreement is to (i) set forth the terms and conditions under which the Parties will carry out the joint-development work necessary to develop the Products; (ii) provide for the ownership of the Results; and (iii) provide the basic principles for the Supply Agreement.
|
2.2
|
From the effective date until [**], SGPPL shall not knowingly carry out cell therapy-related automation projects with any third party for use in the treatment of Renal Cell Cancer (RCC) and neither SGPPL nor its Affiliates may knowingly commercialize disposable automated systems for the production of cell therapies for the treatment of RCC. During the Term, Argos will not enter into discussions or collaborations with any third parties for projects similar to the concept of the Project in the Field of Application and will work solely with SGPPL for the development and supply of disposable sets in the Field of Application.
|
3.1
|
Tooling and Equipment
. Except as otherwise agreed by the Parties in writing and as set forth in this Section 3.1, SGPPL will manufacture or purchase and own (a) all of the tooling required to produce Products, including all of the tooling listed on
Exhibit C
(the “Tooling”), (b) the specific equipment listed on
Exhibit D
(the “Listed Equipment”), and (c) all of the other equipment required to produce the Products. Notwithstanding the foregoing, Argos shall deliver to SGPPL, and, as between Argos and SGPPL, Argos shall continue to own, the tooling and equipment listed on Exhibit E (the “Argos Provided Tooling and Equipment”). SGPPL shall use the Argos Provided Tooling and Equipment solely for the performance of this Agreement. The Tooling, Listed Equipment and Argos Provided Tooling and Equipment are collectively referred to in this Agreement as the “Tooling and Equipment”. In the event the Parties fail to enter into a Supply Agreement, SGPPL shall deliver, at Argos’ sole cost and expense, the (a) Argos Provided Tooling and Equipment to Argos upon the termination of this Agreement or the expiration of the Term and (b) the Tooling and Listed Equipment at such time as Argos has paid all amounts due hereunder, including all deferred amounts and interest. SGPPL shall bear the risk of loss as to the Tooling and Equipment while it is in SGPPL’s possession. SGPPL shall be responsible for maintenance of the Tooling and Equipment while it is in SGPPL’s possession. In the event any or all of the Tooling and Equipment need to be refurbished or have reached the end of useful life, SGPPL will procure replacements or refurbish such Tooling and Equipment and will invoice Argos at cost for such refurbishment or replacement.
|
3.2
|
Transfer to Argos
. At such time as Argos has paid all of the amounts due to SGPPL pursuant to Section 3.5, SGPPL will transfer, convey and assign ownership of the Listed Equipment and Tooling to Argos, free and clear of all liens, claims and encumbrances.
|
3.3
|
Facilities
. SGPPL will provide the facilities needed to produce the Products.
|
3.4
|
Budget
. Except as provided in the following sentence, a detailed budget for the development of the Products, including the cost of purchase of the Tooling and Listed Equipment, is attached as
Exhibit F
(the “Budget”). The Parties acknowledge that the Budget does not include the costs of the items not yet designed (the “Omitted Budget Items”) and agree to negotiate in good faith as to the costs of the Omitted Budget Items and, upon reaching a written agreement, each such cost will become part of the Budget. The Parties agree that Omitted Budget Items included any costs incurred to refurbish or replace any of the Tooling and Equipment. Notwithstanding the preceding sentence, SGPPL will not be required to incur any costs or expenses relating to any Omitted Budget Items until the Parties agree on such cost. SGPPL will not incur aggregate costs chargeable to Argos in connection with the Project beyond the amounts set forth in the Budget absent the prior written consent of Argos, which consent will not be unreasonably withheld or delayed (“Cost Increases”). Except as expressly provided in this Agreement, SGPPL will pay all costs relating to the development of the Products, including all amounts required to manufacture and/or purchase the Tooling and the Listed Equipment. The Budget shall not exceed $6,000,000 exclusive of the Omitted Budget Items without the prior written authorization of Argos.
|
3.5
|
Payments by Argos
. In exchange for SGPPL’s performance under this Agreement, Argos has paid and will pay fees to SGPPL as follows:
|
(a)
|
$400,000 to SGPPL prior to the Effective Date, the receipt of which is acknowledged by SGPPL, which shall be credited toward the first invoice(s) under section 3.5(b);
|
(b)
|
During the term, SGGPL shall invoice Argos, at a frequency not to exceed [**], for the expenses actually incurred in accordance with the Budget. Argos shall pay one-half of all invoiced amounts within [**] days of the date of each invoice with payment of the other one-half of such invoice deferred and paid pursuant to Section 3.5(c) or Section 3.5(d), as applicable. Notwithstanding the foregoing, SGPPL shall not be required to continue to incur expenses in excess of the Budget once the total amount deferred pursuant to the preceding sentence expenses reaches $3,000,000.
|
(c)
|
The outstanding amount of the expenses actually incurred in accordance with the Budget, as amended pursuant to the written agreements of the Parties, and all interest which has accrued thereon pursuant to Section 3.5(f), will be paid by Argos to SGPPL on or before September 30, 2016.
|
(d)
|
All amounts remaining due pursuant to Sections 3.5(b) and 3.5(c), including any accrued interest thereon, will become due on the date on which Argos, (i) from the Effective Date, raises additional capital in an aggregate amount exceeding $60,000,000, regardless of whether such additional capital is raised by the sale of shares of stock or other ownership interests, the sale of bonds or other debt instruments, borrowing or by other means and regardless of whether such amounts are raised in one or more transactions or (ii) is acquired or merged into a third party (in either case, a “Capital Transaction”), and will be paid by Argos to SGPPL within [**] days of the date of such Capital Transaction. Thereafter, Sections 3.5(b) and 3.5(c) shall be of no further force or effect and Argos will pay SGPPL for any additional amounts due pursuant to the Budget, as amended pursuant to the written agreements of the Parties, within [**] days of the date of invoice.
|
(e)
|
Argos may prepay the amounts due under Sections 3.5(b) and (c), including any accrued interest thereon, in whole or in part at any time without penalty.
|
(f)
|
All invoiced amounts for which payment is deferred pursuant to Section 3.5(b) will accrue interest until such amounts are paid at a rate equal to [**] percent per annum. Interest on the unpaid principal balance of this Note, from time to time outstanding, at the above rate, will be calculated on the basis of the actual number of days elapsed during a year consisting of 365 days or 366 days, as the case may be.
|
4.1
|
Argos Representations
. Argos represents and warrants that:
|
A.
|
Argos (i) is, and will continue to be, organized and existing under the laws of its state of organization and qualified to conduct business in all jurisdictions where it conducts business; and (ii) has the right and authority to execute this Agreement;
|
B.
|
Argos’s execution, delivery and performance of this Agreement do not conflict with, or create a default or require consent under, any agreement binding Argos or affecting any of its property; and
|
C.
|
Argos shall perform the Project in accordance with all applicable laws, rules and regulations.
|
4.2
|
SGPPL Representations
. SGPPL represents and warrants that:
|
A.
|
SGPPL (i) is, and will continue to be, organized and existing under the laws of its state of organization and qualified to conduct business in all jurisdictions where it conducts business; and (ii) has the right and authority to execute this Agreement;
|
B.
|
SGPPL’s execution, delivery and performance of this Agreement do not conflict with, or create a default or require consent under, any agreement binding SGPPL or affecting any of its property;
|
C.
|
SGPPL shall perform the Project in accordance with all applicable laws, rules and regulations; and
|
D.
|
SGPPL shall use commercially reasonable best efforts to ensure that the Products meet the Technical Specifications.
|
4.3
|
EXCEPT AS EXPRESSLY SET FORTH HEREIN, NEITHER PARTY MAKES ANY REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, AND EACH PARTY HEREBY DISCLAIMS ALL IMPLIED WARRANTIES INCLUDING THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE AND NONINFRINGEMENT.
|
5.1
|
Negotiation of Supply Agreement
. The Parties will commence good faith negotiations of the Supply Agreement by [**].
|
5.2
|
Terms of Supply Agreement
. The Supply Agreement will provide that:
|
A.
|
SGPPL will be the exclusive supplier of Products in the Field of Application to Argos and its licensees for a period of not less than 15 years from the effective date of the Supply Agreement;
|
B.
|
Argos will not compete with SGPPL in the manufacture, sale or distribution of products which are competitive with the Products during the term of the Supply Agreement except that Argos may sell the Products to its licensees;
|
C.
|
During the term of the Supply Agreement, neither SGPPL nor its Affiliates will supply Products to any third party.
|
D.
|
The prices charged to Argos and its licensees by SGPPL under the Supply Agreement will equal a specified gross margin over SGPPL’s reasonable documented cost of manufacture or acquisition of (i) [**] percent for Products and (ii) [**] percent for specified Components which are acquired but not manufactured by SGPPL. SGPPL may adjust the prices charged for the Products (but not the specified percentages of the gross margins) no more frequently than [**] period and will provide Argos with not less than [**] days prior written notice of any such price adjustment. At the request of Argos, a mutually agreeable third party auditor may audit SGPPL’s cost of manufacture to determine compliance with the price provisions of the Supply Agreement but shall only report to the accuracy of such pricing to Argos and SGPPL and will not disclose any of SGPPL’s costs or records to Argos.
|
E.
|
SGPPL will meet Argos and its licensee’s requirements for Products, provided that such requirements are forecasted by Argos in good faith and in advance in writing to SGPPL such that SGPPL can use reasonable commercial efforts to ensure adequate manufacturing capacity. The parties will meet no less than [**] to discuss the forecasted requirements. SGPPL shall promptly notify Argos if SGPPL has reason to believe it cannot meet the forecasted requirements of Argos and its licensees. If SGPPL cannot meet the forecasted requirements for Products of Argos and its licensees for any reason, including without limitation during a force majeure, Argos and its licensees may purchase products competitive with the Products from third parties in quantities equal to the quantity which SGPPL is unable to supply. For this purpose, Argos may engage a third party supplier of Products and transfer all necessary Argos Provided Tooling, as well as Tooling and Listed Equipment owned by Argos in accordance with Section 3.2, to such third party so that such third party can supply in a timely manner Products that SGPPL is unable to supply; however, SGPPL shall not be required to transfer its trade secret information, which, for the sake of clarity, includes but is not limited to any inventions, ideas, know-how, whether or not patentable, or Background Information, to such third party unless otherwise agreed by SGPPL in its sole discretion. Nothing in the Supply Agreement shall be construed as prohibiting Argos from purchasing the minimum required volume of Product for qualifying and maintaining such third party supplier during any period for which SGPPL cannot meet the forecasted requirements of Argos and its licensees.
|
F.
|
SGPPL and Argos will work in good faith to negotiate terms for the development and supply of other disposable sets needed by Argos for the Project or other similar uses in the Field of Application, the terms for development which will be set forth in the Supply Agreement, an amendment to this Agreement or in a stand-alone agreement between the parties.
|
6.1
|
Project Managers
. Each Party will appoint one (1) individual within its staff as being responsible for the overall management of the Project (each a “Project Manager”). Each Party will be entitled to change its Project Manager at any time during the term of this Agreement upon [**] days prior written notice to the other Party as provided in Section 11.4 below.
|
6.2
|
Duties of Project Managers
. The Project Managers will (a) monitor the progress of the Project and may agree to convene meetings from time to time upon reasonable prior written notice, in a place agreed by both Parties or by conference call; and (b) define and agree on proposed modifications and extensions to the Project for written approval by the Parties. For the avoidance of doubt, the Project Managers may not amend any portion of this Agreement.
|
6.3
|
Reports of Decisions
. Either Project Manager may make a written record of the decisions taken and send it to the other Project Manager without delay by electronic mail. If there is no written objection sent via electronic mail by the other Project Manager regarding the content of the written record within [**] working days of its receipt, the content of the written record will be deemed approved by the other Party.
|
6.4
|
Periodic Reporting
. At the end of each phase of the Project, the Parties will make a written report.
|
7.1
|
Background Information
. Each Party retains ownership (or license rights, as the case may be) of its respective Background Information and of any IP Rights in and to its Background Information. Except as otherwise expressly provided herein, nothing in this Agreement will be construed as granting or conferring any rights by license or otherwise or as an assignment of a Party’s Background Information and/or IP Rights in and to that Party’s Background Information to the other Party.
|
7.2
|
Argos Results
. All Argos Results and all IP Rights in and to the Argos Results will be the property of Argos. Argos will be entitled to seek and maintain all IP Rights in the Argos Results at its own expense.
|
7.3
|
SGPPL Results
. All SGPPL Results and all IP Rights in and to the SGPPL Results will be the property of SGPPL. SGPPL will be entitled to seek and maintain all IP Rights in the SGPPL Results at its own expense.
|
8.1
|
Confidentiality
|
(a)
|
Testing capabilities, test results, and the conditions related thereto developed by SGPPL, including but not limited to the price models and prices, is the proprietary information of SGPPL and will be treated as Confidential Information subject to the provisions of paragraphs 8.1.1 to 8.1.4 hereinabove.
|
(b)
|
All information related to the Arcelis Technology and Argos’ programs related thereto are proprietary information of Argos and will be treated as Confidential Information subject to the provisions of paragraphs 8.1.1 to 8.1.4 hereinabove.
|
(c)
|
The cellular automation equipment and the related tools, designs and methods developed by Invetech on behalf of Argos are Argos’ TRADE SECRET.
|
(a)
|
notify the Other Party; and
|
(b)
|
give the Other Party a reasonable opportunity to take any steps that the Other Party considers necessary to protect the confidentiality of that information and provide reasonable assistance so that the Other Party may take such steps; and
|
(c)
|
notify the third person that the information is Confidential Information of the Other Party.
|
9.1
|
Term
. This Agreement will commence on the Effective Date and will remain in force until December 31, 2016 unless prior to such date the term of this Agreement is (a) mutually extended or terminated by written agreement of the Parties or (b) terminated pursuant to the provisions of Section 9.3 (the “Term”). Notwithstanding the foregoing sentence, this Agreement will automatically terminate on December 31, 2015, unless the Parties (y) have entered into the Supply Agreement by such date or (z) mutually agree in writing to waive such automatic termination.
|
9.2
|
Events of Default
. A Party will be in default under this Agreement if such Party (each a “Default”):
|
A.
|
fails to perform or observe any material covenant or agreement made in this Agreement or any other agreement between the Parties;
|
B.
|
fails to achieve any of its material Performance Milestones as defined, and by the date provided, in
Exhibit B
where as such fault is not attributable to the other Party;
|
C.
|
any representation or warranty made by such Party in this Agreement or in any other agreement between the Parties is untrue or incorrect in any material respect when made; or
|
D.
|
commences or becomes the subject of any bankruptcy or insolvency proceeding, including making an assignment for the benefit of creditors, allowing the entry against it of a judgment, decree or order for relief by a court in an involuntary case commenced under any bankruptcy or insolvency law (which involuntary case is not dismissed within 30 days of filing) or the appointment of a receiver, trustee, or similar official for any of its assets, or has a final judgment entered against it.
|
9.3
|
Remedies
.
|
A.
|
Upon the occurrence of a Default, the Party which has not committed the Default may send written notice of its intent to terminate this Agreement to the Party in Default and this Agreement will terminate without further action by either Party if such Default is not cured on or before the [**] day following the date of such notice, except that a Party may terminate this Agreement immediately upon written notice following a Default by the other Party pursuant to Section 9.2.D above. Upon the termination of this Agreement following a Default, the non-defaulting Party may pursue any remedies available hereunder or pursuant to applicable law.
|
B.
|
Neither Party shall be liable under this Agreement for any consequential, indirect, remote, speculative, special, incidental, punitive or exemplary damages under any theory, arising out of activities or obligations under or related to this Agreement, regardless of the acts, omissions, negligence or fault of any person or entity
.
|
9.4
|
Argos Change of Control
. In the event Argos undergoes a change of control, other than as a consequence of an equity investment by a venture capital or other financial institution, the Parties will meet in order to discuss whether they will continue this Agreement. This Agreement will continue in effect unless and until the Parties otherwise mutually agree in writing.
|
9.5
|
Survival
. The provisions of Articles 4, 7, 8, 9.5, 10 and 11 will survive the expiration or earlier termination of this Agreement for any reason and will remain in full force and effect until the duties recited therein expire according to their terms or are specifically terminated by mutual written agreement of the Parties. Additionally, the expiration or earlier termination of this Agreement will not relieve Argos of its obligation to pay any and all amounts which are owed to SGPPL under Article 3.
|
10.1
|
Governing Law
. This Agreement will be governed and construed in accordance with the laws of New York to the exclusion of its conflict of law provisions.
|
10.2
|
Discussion and Arbitration.
Both Parties shall use reasonable commercial efforts to resolve any dispute, controversy or claim arising in connection with this Agreement (a "Dispute"). Except with respect to seeking injunctive relief or specific performance in connection with a Party’s obligations regarding protection of Confidential Information or intellectual property or disputes involving third parties, any Dispute initiated by either Party arising out of or relating to this Agreement, its negotiations, execution or interpretation, or the performance by either Party of its obligations under this Agreement, whether before or after termination of this Agreement, shall be finally resolved by binding arbitration. Whenever a Party decides to institute arbitration proceedings, it shall give prompt written notice to that effect to the other Party. Any such arbitration shall be conducted pursuant to the prevailing rules of the American Arbitration Association pursuant to the Commercial Arbitration Rule. Any such arbitration shall be held in New York City, New York. Such arbitration shall be conducted by a single arbitrator and the arbitrator shall be either mutually acceptable or, if the Parties cannot agree on an arbitrator within [**] days after the matter is referred to arbitration, the single arbitrator shall be a person selected by the applicable rules. The arbitrator shall be a person knowledgeable as to the subject matter of this Agreement who is not employed by, or has a financial relationship with, either Party or any of their respective Affiliates. The arbitration award rendered pursuant to this provision shall be enforceable by any court having jurisdiction. Unless otherwise provided for in the arbitral award, each Party shall be responsible for its own attorneys’ fees and costs incurred in connection with the arbitration. Unless otherwise determined by the arbitrator, each Party shall pay an equal share of the fees and costs of the arbitrator.
|
11.1
|
Amendment
. No amendment to this Agreement will be binding upon the Parties unless such amendment is reduced to writing and executed by both Parties.
|
11.2
|
Assignment
. Neither Party will be entitled to assign or transfer this Agreement or any rights and obligations arising hereunder to any third party without first obtaining the prior written consent of the other Party, which consent shall not be unreasonably withheld or delayed.
|
11.3
|
Entire Agreement
. This Agreement constitutes the entire understanding between the Parties as to the subject matter hereof and supersedes all prior agreements and understandings whether written or oral between the Parties in relation to its subject matter. The Exhibits are integral part of this Agreement. In case of discrepancy between any of the Exhibits and the provisions of the main body of this Agreement, the latter will prevail.
|
11.4
|
Notices
. Notices, requests and other communications relating to this Agreement will be in writing (including telecopy, email, or similar writing) and will be given:
|
If to Argos:
Argos Therapeutics, Inc.
4233 Technology Drive
Durham, NC 27704
Attention: President
Facsimile: (919) 287-6336
Email:
jabbey@argostherapeutics.com
|
With a copy to:
Hutchison PLLC
3110 Edwards Mill Road, Suite 3
00
Raleigh, NC 27612
Attention: William N. Wofford
Facsimile No.: (866) 479
-
7550
Email:
bwofford@hutchlaw.com
|
|
If to SGPPL:
Mr. Benjamin Le Quere
Saint-Gobain Performance Plastics Corporation
1199 S. Chillicothe Rd.
Aurora, OH 44202
Phone: (216) 539-4385
Fax: (314) 762-4750
Email:
benjamin.lequere@saint-gobain.com
|
With a copy to:
Chi Suk Kim, Esq.
Intellectual Property Counsel
Saint-Gobain Corporation
One New Bond Street
Box No. 15008
Worcester, MA 01615-0008
Phone: (508) 795-5174
Fax: (508) 795-2653
Email:
chi.s.kim@saint-gobain.com
|
11.5
|
Headings
. The headings of this Agreement will be for reference purposes only and will not affect the meaning of any provision under the heading.
|
11.6
|
No waiver
. No delay in or failure to exercise of any right under this Agreement by a Party will impair such right or be construed as a waiver or continuing waiver of such right or acquiescence in any default or preclude any subsequent exercise of such right. No right or Default under this Agreement will be deemed to have been definitely waived by either Party unless such waiver is expressed in writing and signed by such Party in which event such waiver will be effective only in the specified instance and for the specific purpose for which it is given.
|
11.7
|
Usury Laws
. The Parties, intending to comply with applicable usury laws, agree that notwithstanding any contrary term in this Agreement or in any related agreement, no term will require the payment or permit the collection of interest in excess of the maximum permitted by applicable law. If excessive interest is provided for, then: (a) this paragraph will govern and control; (b) neither Argos nor its successors or assigns will be obligated to pay interest to the extent it exceeds the maximum amount permitted by applicable law; (c) any excess interest that may be collected will, at the option of the party to which such obligation is due, be either applied as a credit against the unpaid principal amount of the obligations or refunded to Argos; and (d) the effective rate of interest will be automatically reduced to the maximum amount permitted by applicable usury laws.
|
11.8
|
Cumulative Remedies
. The rights and remedies provided in this Agreement are cumulative and in addition to, and not exclusive or in substitution, novation or discharge of, any rights or remedies provided by law or any other agreement between the Parties.
|
11.9
|
Costs and Expenses
. Each Party will bear its own costs and expenses in carrying out the Project, unless stipulated otherwise in accordance with this Agreement. Neither Party will incur any legal obligation as to any supplemental or follow-up agreements, whether or not contemplated hereunder, unless and until such agreements have been finalized and signed on behalf of both Parties.
|
11.10
|
Counterparts.
This Agreement may be executed in one or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same document.
|
Date:
1-5-15
|
Date:
1-5-15
|
SAINT-GOBAIN PERFORMANCE
|
ARGOS THERAPEUTICS, INC. |
PLASTICS CORPORATION
|
|
/s/ Stephen E. Maddox | /s/ Jeffrey D. Abbey |
Name: Stephen E. Maddox
Title: General Manager, Life Sciences
|
Name: Jeffrey D. Abbey
Title: Chief Executive Officer
|
•
|
a disease sample from the patient — tumor cells in the case of cancer or a blood sample containing virus in the case of infectious disease — which is generally collected at the time of diagnosis or initial treatment, and
|
•
|
dendritic cells derived from the patient’s monocytes, a particular type of white blood cell, which are obtained from the patient through a laboratory procedure called leukapheresis that occurs after diagnosis and at least four weeks prior to the initiation of our immunotherapy.
|
1.0
|
[**]:
|
|
[**]
|
[**]
|
|
[**]
|
[**]
|
|
[**]
|
[**]
|
|
[**]
|
[**]
|
|
2.0
|
[**]:
|
|
[**]
|
[**]
|
|
[**]
|
[**]
|
|
[**]
|
[**]
|
|
[**]
|
[**]
|
|
3.0
|
[**]:
|
|
[**]
|
[**]
|
|
[**]
|
[**]
|
|
[**]
|
[**]
|
|
[**]
|
[**]
|
No
|
Part No
|
Program
|
Description
|
1
|
[**]
|
[**]
|
[**]
|
2
|
[**]
|
[**]
|
[**]
|
3
|
[**]
|
[**]
|
[**]
|
4
|
[**]
|
[**]
|
[**]
|
5
|
[**]
|
[**]
|
[**]
|
6
|
[**]
|
[**]
|
[**]
|
7
|
[**]
|
[**]
|
[**]
|
8
|
[**]
|
[**]
|
[**]
|
9
|
[**]
|
[**]
|
[**]
|
10
|
[**]
|
[**]
|
[**]
|
11
|
[**]
|
[**]
|
[**]
|
12
|
[**]
|
[**]
|
[**]
|
13
|
[**]
|
[**]
|
[**]
|
14
|
[**]
|
[**]
|
[**]
|
15
|
[**]
|
[**]
|
[**]
|
16
|
[**]
|
[**]
|
[**]
|
17
|
[**]
|
[**]
|
[**]
|
18
|
[**]
|
[**]
|
[**]
|
19
|
[**]
|
[**]
|
[**]
|
20
|
[**]
|
[**]
|
[**]
|
21
|
[**]
|
[**]
|
[**]
|
22
|
[**]
|
[**]
|
[**]
|
23
|
[**]
|
[**]
|
[**]
|
24
|
[**]
|
[**]
|
[**]
|
25
|
[**]
|
[**]
|
[**]
|
26
|
[**]
|
[**]
|
[**]
|
27
|
[**]
|
[**]
|
[**]
|
28
|
[**]
|
[**]
|
[**]
|
29
|
[**]
|
[**]
|
[**]
|
30
|
[**]
|
[**]
|
[**]
|
31
|
[**]
|
[**]
|
[**]
|
32
|
[**]
|
[**]
|
[**]
|
33
|
[**]
|
[**]
|
[**]
|
34
|
[**]
|
[**]
|
[**]
|
35
|
[**]
|
[**]
|
[**]
|
36
|
[**]
|
[**]
|
[**]
|
37
|
[**]
|
[**]
|
[**]
|
38
|
[**]
|
[**]
|
[**]
|
39
|
[**]
|
[**]
|
[**]
|
40
|
[**]
|
[**]
|
[**]
|
41
|
[**]
|
[**]
|
[**]
|
42
|
[**]
|
[**]
|
[**]
|
43
|
[**]
|
[**]
|
[**]
|
44
|
[**]
|
[**]
|
[**]
|
45
|
[**]
|
[**]
|
[**]
|
46
|
[**]
|
[**]
|
[**]
|
47
|
[**]
|
[**]
|
[**]
|
48
|
[**]
|
[**]
|
[**]
|
49
|
[**]
|
[**]
|
[**]
|
50
|
[**]
|
[**]
|
[**]
|
51
|
[**]
|
[**]
|
[**]
|
52
|
[**]
|
[**]
|
[**]
|
53
|
[**]
|
[**]
|
[**]
|
54
|
[**]
|
[**]
|
[**]
|
55
|
[**]
|
[**]
|
[**]
|
56
|
[**]
|
[**]
|
[**]
|
57
|
[**]
|
[**]
|
[**]
|
58
|
[**]
|
[**]
|
[**]
|
59
|
[**]
|
[**]
|
[**]
|
60
|
[**]
|
[**]
|
[**]
|
61
|
[**]
|
[**]
|
[**]
|
Program Dedicated Equipment
|
Qty
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
No
|
Part No
|
Program
|
Description
|
Status
|
1
|
[**]
|
[**]
|
[**]
|
[**]
|
2
|
[**]
|
[**]
|
[**]
|
[**]
|
3
|
[**]
|
[**]
|
[**]
|
[**]
|
4
|
[**]
|
[**]
|
[**]
|
[**]
|
5
|
[**]
|
[**]
|
[**]
|
[**]
|
6
|
[**]
|
[**]
|
[**]
|
[**]
|
7
|
[**]
|
[**]
|
[**]
|
[**]
|
8
|
[**]
|
[**]
|
[**]
|
[**]
|
9
|
[**]
|
[**]
|
[**]
|
[**]
|
10
|
[**]
|
[**]
|
[**]
|
[**]
|
11
|
[**]
|
[**]
|
[**]
|
[**]
|
12
|
[**]
|
[**]
|
[**]
|
[**]
|
13
|
[**]
|
[**]
|
[**]
|
[**]
|
14
|
[**]
|
[**]
|
[**]
|
[**]
|
15
|
[**]
|
[**]
|
[**]
|
[**]
|
16
|
[**]
|
[**]
|
[**]
|
[**]
|
1.0
|
Tooling Budget
|
||
1.1
|
[**]
|
[**]
|
|
1.2
|
[**]
|
[**]
|
|
1.3
|
[**]
|
[**]
|
|
1.4
|
[**]
|
[**]
|
|
1.5
|
[**]
|
[**]
|
|
Total Tooling Cost:
|
|
$
[**]
|
|
2.0
|
Capital Equipment
|
||
Total Capital Equipment
|
|
$
[**]
|
|
3.0
|
Program Expenses
|
||
3.1
|
[**]
|
[**]
|
|
3.2
|
[**]
|
[**]
|
|
3.3
|
[**]
|
[**]
|
|
3.4
|
[**]
|
[**]
|
|
3.5
|
[**]
|
[**]
|
|
3.6
|
[**]
|
[**]
|
|
Total Program Expenses
|
|
$
[**]
|
|
Budget Total
|
|
$
[**]
|
Confidential Materials omitted and filed separately with the
|
Exhibit 10.29
|
|
Securities and Exchange Commission. Double asterisks denote omissions.
|
||
|
(i)
|
is known by the receiving Party at the time of its receipt, and not through a prior disclosure, directly or indirectly, by the disclosing Party, as documented by the receiving Party’s business records;
|
|
(ii)
|
is in the public domain by use and/or publication before its receipt from the disclosing Party, or thereafter enters the public domain through no fault of the receiving Party or its Related Parties;
|
|
(iii)
|
is subsequently disclosed to the receiving Party by a Third Party who may lawfully do so and is not under an obligation of confidentiality to the disclosing Party; or
|
|
(iv)
|
is developed by the receiving Party independently of Confidential Information received from the disclosing Party, as documented by the receiving Party’s business records.
|
(a)
|
first, to reimburse each Party for all expenses of the suit incurred by such Party, including but not limited to attorneys’ fees and disbursements, travel costs, court costs and other litigation expenses;
|
(b)
|
second, (i) if such suit is related to the Argos Technology in the Territory and is attributable to a time period in which the Commercial License is in effect, then MEDcell shall be entitled to receive that portion of the remaining Recoveries reasonably attributable to Net Sales of the Licensed Product in the Territory in the Field (as determined by a court of competent jurisdiction in a final, non-appealable decision); provided, that the Recoveries reasonably attributable to Net Sales of Licensed Product to which MEDcell is entitled after reimbursement of expenses shall be treated as Net Sales for purposes of this Agreement and Argos shall be entitled to receive royalties on such constructive Net Sales pursuant to the terms of Section 9.2.2 as if such Net Sales had occurred during the time period of the infringement, and (ii) if such suit is related to Medinet Improvements in the Territory for any period in which the Commercial License is not in effect, then Argos shall be entitled to receive that portion of the remaining Recoveries reasonably attributable to Net Sales of the Licensed Product in the Territory (as determined by a court of competent jurisdiction in a final, non-appealable decision); and
|
(c)
|
the Party initiating the suit shall be entitled to [**] percent ([**]%), and the non-initiating Party shall be entitled to [**] percent ([**]%), of the balance of the Recoveries.
|
If to Argos, to: | Argos Therapeutics, Inc. | ||
4233 Technology Drive
Durham, NC 27704
Attention: President
Facsimile: 919 287-6336
Email:jabbey@argostherapeutics.com
|
|||
With a copy to: |
Hutchison PLLC
|
||
3110 Edwards Mill Road, Suite 300
Raleigh, NC 27612
Attention: William N. Wofford
Facsimile No.: (866) 479-7550
Email: bwofford@hutchlaw.com
|
|||
If to Medinet, to: | Medinet Co., Ltd. | ||
Shin-Yokohama Square Bldg.
14F, 2-3-12 Shin-Yokohama,
Kohoku-ku, Yokohama, Kanagawa, 222-0033 JAPAN
|
|||
If to MEDcell, to: | MEDcell Co., Ltd. | ||
2-8 Tamagawa-dai Setagaya-ku
Tokyo, 158-0096 JAPAN
|
MEDCELL CO., LTD.
|
ARGOS
THERAPEUTICS, INC.
|
|||||
|
||||||
BY: | /s/ Kunihiku Suzuki | BY: | /s/ Jeffrey D. Abbey | |||
NAME: | Kunihiku Suzuki | NAME: | Jeffrey D. Abbey | |||
TITLE: | President | TITLE: | President and CEO | |||
|
||||||
MEDINET CO., LTD.
|
||||||
|
||||||
BY: | /s/ Kunihiku Suzuki | |||||
NAME: | Kunihiku Suzuki | |||||
TITLE: | President and CEO |
•
|
a disease sample from the patient — tumor cells in the case of cancer or a blood sample containing virus in the case of infectious disease — which is generally collected at the time of diagnosis or initial treatment, and
|
•
|
dendritic cells derived from the patient’s monocytes, a particular type of white blood cell, which are obtained from the patient through a laboratory procedure called leukapheresis that occurs after diagnosis and at least four weeks prior to the initiation of our immunotherapy.
|
Name
|
Jurisdiction
|
|
DC Bio Corp.
|
Nova Scotia, Canada
|
Date: March 31, 2015
|
|||
By:
|
/s/ JEFFREY D. ABBEY
|
||
Jeffrey D. Abbey
|
|||
President and Chief Executive Officer
|
|||
(Principal Executive Officer)
|
Date: March 31, 2015
|
|||
By:
|
/s/ LORI R. HARRELSON
|
||
Lori R. Harrelson
|
|||
Vice President of Finance
|
|||
(Principal Financial Officer)
|
By:
|
/s/ JEFFREY D. ABBEY
|
||
Jeffrey D. Abbey
|
|||
Chief Executive Officer
|
|||
March 31, 2015
|
By:
|
/s/ LORI R. HARRELSON
|
||
Lori R. Harrelson
|
|||
Vice President of Finance
(principal financial officer)
|
|||
March 31, 2015
|