ý
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ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934.
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¨
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TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934.
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Delaware
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46-2693615
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(State or other jurisdiction of
incorporation or organization)
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(IRS Employer
Identification No.)
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9363 Towne Centre Drive Suite 200, San Diego, California
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92121
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(Address of principal executive offices)
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(Zip Code)
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Large accelerated filer
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¨
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Accelerated filer
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ý
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Non-accelerated filer
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¨
(Do not check if a smaller reporting company)
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Smaller reporting company
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¨
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Table of Contents
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Page
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PART I
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Item 1.
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Business
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3
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Item 1A.
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Risk Factors
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Item 1B.
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Unresolved Staff Comments
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Item 2.
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Properties
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Item 3.
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Legal Proceedings
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Item 4.
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Mine Safety Disclosures
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PART II
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Item 5.
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Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
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Item 6.
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Selected Consolidated Financial Data
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Item 7.
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Management’s Discussion and Analysis of Financial Condition and Results of Operations
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Item 7A.
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Quantitative and Qualitative Disclosures About Market Risk
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Item 8.
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Financial Statements and Supplementary Data
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Item 9.
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Changes in and Disagreements With Accountants on Accounting and Financial Disclosure
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Item 9A.
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Controls and Procedures
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Item 9B.
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Other Information
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52
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PART III
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Item 10.
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Directors, Executive Officers and Corporate Governance
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Item 11.
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Executive Compensation
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Item 12.
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Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
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Item 13.
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Certain Relationships and Related Transactions, and Director Independence
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Item 14.
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Principal Accountant Fees and Services
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PART IV
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Item 15.
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Exhibits and Financial Statement Schedules
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SIGNATURES
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•
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MGCD265
is an orally-bioavailable, potent, small molecule kinase inhibitor of MET and Axl receptor tyrosine kinases, or RTKs. MGCD265 is in development for the treatment of solid tumors, with an initial focus on NSCLC but including other solid tumors including gastroesophageal cancers and squamous cell carcinoma of the head and neck, or HNSCC. In 2014 we completed development of a new formulation to improve plasma exposure thereby improving the degree of target inhibition to levels which we believe can be sufficient to demonstrate single agent clinical activity in patients with genetic alterations of MET and Axl. In late 2014 we established the maximum tolerated dose, or MTD, for the new formulation and initiated dose expansion cohorts in patients selected for certain genetic driver mutations that activate the MET and Axl pathways. The patient selection strategy based upon these genetic mutations is designed to result in a high response rate that could enable an accelerated development pathway. We anticipate initial data regarding clinical proof of concept by mid-2015 and, if positive, to begin a single-arm registration trial in the second half of 2015.
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•
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MGCD516
is an orally-bioavailable, potent, small molecule spectrum-selective kinase inhibitor in development for the treatment of solid tumors with an emphasis on genetic alterations involving the Trk, RET and DDR RTK families. We plan to focus on solid tumors exhibiting genetic alterations or dysregulation of these key drivers of tumor growth, initially in NSCLC. In addition, we plan to evaluate other tumor types where the profile of MGCD516 would suggest clinical benefit. An ongoing Phase 1 dose escalation study is designed to identify the optimal biologic dose or MTD and evaluate a cohort of patients selected for key driver mutations in Trk, RET and DDR receptor families. Based upon preclinical and early clinical information, we believe that we will reach a dose that potently inhibits the targeted genetic alterations in the first half of 2015 and initiate dose expansion cohorts in selected patients in mid-2015. We believe that initial data on clinical activity in patients with genetic alterations of Trk, RET or DDR family members could be available in the second half of 2015.
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•
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Mocetinostat
is an orally-bioavailable, spectrum-selective HDAC inhibitor in Phase 2 clinical trials in patients with bladder cancer, myelodysplastic syndrome, or MDS, and NHL, specifically DLBCL and FL. Patients in the bladder cancer and NHL Phase 2 studies are selected for tumors with genetic alteration in two histone acetyl transferase genes, or HATs, that regulate histone acetylation and that have been shown to increase the sensitivity of tumor cells to mocetinostat in preclinical models. We are also evaluating mocetinostat for the first line treatment of patients with MDS in combination with Vidaza, a hypomethylating agent, or HMA. We believe that this is the first and only ongoing clinical development plan for an HDAC inhibitor in a genetically selected subset of patients. We have completed 13 clinical trials with mocetinostat which enrolled approximately 450 patients with a variety of hematologic malignancies and solid tumors.
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Develop a pipeline of targeted cancer therapies.
We believe that an increased understanding of the genomic factors that drive tumor cell growth will lead to the development of cancer drugs with increased efficacy while reducing side effects. We are leveraging the prior successful experience of certain members of our management team in the development and approval of targeted oncology drugs (crizotinib or Xalkori) to develop targeted cancer therapies to address unmet needs in specific cancer populations. Our clinical pipeline is comprised of two novel kinase inhibitors that target specific mutations that drive cancer cell growth and an HDAC inhibitor which is one of the most advanced epigenetic therapies in development. We plan to identify additional targets by leveraging our deep scientific understanding of molecular drug targets and mechanisms of resistance through internal drug discovery activities or potentially in-licensing promising, early-stage novel drug candidates.
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Employ efficient and flexible approaches to accelerate clinical development.
We will pursue indications and select specific patient populations in which activity of our product candidates can be assessed in small proof of concept, or POC, clinical trials leading to accelerated clinical development. When designing clinical trials, we structure our clinical development approach to test multiple clinical hypotheses in a single trial and design trials with the flexibility to adapt quickly and accelerate once a signal of clinical benefit is observed. We believe our approach may increase the likelihood of seeing results early in clinical trials with fewer patients, reducing our clinical development risk and development costs and allowing us to potentially accelerate the development of our product pipeline.
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Advance our two lead kinase inhibitors.
Kinase inhibitors have significantly improved the care of many cancer patients and represent a commercially successful category of targeted cancer therapies with global sales of over $29.1 billion in 2011, according to BCC Research. We have two internally discovered novel kinase inhibitors in development: MGCD265 and MGCD516. These product candidates target pathways of high scientific interest, including MET, Axl, Trk, RET, and DDR RTK families and are believed to be drivers of tumor growth and responsible for the development of tumor resistance to several anti-cancer treatments. MGCD265 is in Phase 1b development and MGCD516 is in Phase 1 development in the dose escalation portion of the trial. In the second half of 2015, we plan to initiate a registration trial for MGCD265 following POC and initiate dose expansion cohorts for MGCD516 in selected patients once we achieve a dose at which we are confident our targets are sufficiently inhibited.
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Advance mocetinostat, our HDAC inhibitor.
HDAC inhibitors have been shown to be effective in treating hematologic malignancies, as evidenced by the approvals of Istodax and Zolinza. We have completed 13 clinical trials with mocetinostat in approximately 450 patients. We are focused on the development of mocetinostat in the treatment of bladder cancer and NHL, specifically DLBCL and FL, in patients whose tumors have certain genetic alterations in one of two genes that regulate histone acetylation, CREBBP and EP300. Certain alterations in the CREBBP and EP300 genes have been shown to increase the sensitivity of tumor cells or cancer models to mocetinostat in preclinical studies. We are also evaluating mocetinostat for the first line treatment of patients with MDS in combination with Vidaza, an HMA. Phase 2 trials of single agent mocetinostat in bladder cancer and NHL (DLBCL and FL) are ongoing. We anticipate initial proof of concept clinical data in bladder cancer patients and DLBCL patients by the mid-2015.
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Leverage partnerships to develop our product candidates.
We plan to collaborate with third parties and partner certain rights to our product candidates as a means to accelerate their broader clinical development and maximize their therapeutic
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PRODUCT CANDIDATE
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INDICATION
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TARGETS
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COMMERCIAL
RIGHTS
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STAGE OF DEVELOPMENT AND
ANTICIPATED MILESTONES
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MGCD265
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Solid Tumors
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MET, Axl
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Mirati: Global
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Initial data from Phase 1b expansion cohorts in selected patients in mid-2015.
Initiate Registration Trial in second half of 2015.
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MGCD516
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Solid Tumors
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Trk, RET,DDR
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Mirati: Global
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Phase 1 dose escalation ongoing.
Initiate expansion cohorts in the second half of 2015.
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Mocetinostat
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Bladder Cancer
and NHL (DLBCL and FL)
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HDACs
1, 2, 3, 11
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Taiho: Certain Asian Territories
Mirati: All Other Territories
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Phase 2 in bladder cancer ongoing.
Phase 2 in DLBCL and FL ongoing.
Initial POC data in bladder in mid-2015.
Initial POC data in DLBCL in mid-2015.
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Brand Name
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2013Worldwide Sales
(1)
(in millions)
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Gleevec
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$
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4,693
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Tarceva
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$
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1,445
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Sutent
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$
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1,204
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Nexavar
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$
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1,024
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Sprycel
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$
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1,280
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Tykerb
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$
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324
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Zelboraf
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$
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382
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Xalkori
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$
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282
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(1)
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Source: Evaluate Pharma.
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Indication
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Supporting
Rationale
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U.S. Annual Patient Incidence
(United States, Europe and Japan)
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Lung Cancer
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Genetic alterations of MET and Axl in up to 8% of NSCLC
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224,210
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Head & Neck Cancer
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Genetic alterations of MET and Axl in up to 8% of patients
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42,440
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Gastric Cancer
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Genetic alterations of MET in up to 6% of patients
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22,220
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(1)
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Source: National Cancer Institute
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•
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therapeutic action against specific mutations and genetic alterations of MET;
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therapeutic action against a novel target (Axl);
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high specificity reduces the risk of side effects from off-target activity; and
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the selection of patients whose tumors exhibit genetic alterations of MET or Axl that may be drivers of tumor growth provides an opportunity to demonstrate single agent clinical responses of MGCD265.
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Phase 1 Clinical Trial
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Single Agent Dose Escalation, 21 day cycle
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Completed (trial amended and continuing as described under Phase 1b clinical trial below)
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Phase 1b Clinical Trial*
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Single Agent Expansion Cohort in patients with genetic alterations of MET and Axl in NSCLC, HNSCC and other solid tumors, 21 day cycle
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Ongoing
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Phase 1/2 Clinical Trial
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Combination with Erlotinib or Docetaxel in Subjects with advanced NSCLC, 21 day cycle
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Completed
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Phase 1 Clinical Trial
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Daily dosing regimen (14 days on, 7 days off)
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Three times weekly (14 days on, 7 days off)
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Three times weekly (continuously)
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Twice weekly (continuously)
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Phase 2 Monotherapy Clinical Trial
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AML/High-risk MDS
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Relapsed/Refractory NHL (DLBCL, FL)
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Refractory chronic lymphocytic leukemia
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Relapsed/Refractory HL
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Phase 1/2 Combination Clinical Trial with Vidaza
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AML and MDS
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Other Clinical Trials
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Phase 1/2 clinical trial of Mocetinostat in Combination with Gemcitabine
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Combination of mocetinostat with Vidaza and with Taxotere
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Program
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Granted
(United
States)
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Pending
(United
States)
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Kinase
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14
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3
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HDAC
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11
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4
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TOTAL
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25
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7
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Name
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Age
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Position
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Charles M. Baum, M.D., Ph.D.
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56
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President and Chief Executive Officer, Director
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Mark J. Gergen
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52
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Executive Vice President and Chief Operating Officer
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Isan Chen, M.D.
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52
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Executive Vice President and Chief Medical and Development Officer
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James Christensen, Ph.D.
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46
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Senior Vice President and Chief Scientific Officer
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Jamie A. Donadio
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39
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Vice President, Finance
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Rodney W. Lappe, Ph.D.
(3)
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60
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Chairman of the Board
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Michael Grey
(1)(3)
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62
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Director
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Henry J. Fuchs, M.D.
(2)(3)
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55
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Director
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Craig Johnson
(1)(2)
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53
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Director
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William R. Ringo
(1)(2)
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69
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Director
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(1)
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Member of the Audit Committee.
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(2)
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Member of the Compensation Committee.
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(3)
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Member of the Nominating and Corporate Governance Committee.
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•
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the success of our clinical trials through all phases of clinical development;
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delays in the commencement, enrollment and timing of clinical trials;
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our ability to secure and maintain collaborations, licensing or other arrangements for the future development and/or commercialization of our product candidates, as well as the terms of those arrangements;
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our ability to obtain, as well as the timeliness of obtaining, additional funding to develop our product candidates;
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the results of clinical trials or marketing applications for product candidates that may compete with our product candidates;
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competition from existing products or new products that may receive marketing approval;
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potential side effects of our product candidates that could delay or prevent approval or cause an approved drug to be taken off the market;
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any delays in regulatory review and approval of our clinical development plans or product candidates;
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our ability to identify and develop additional product candidates;
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the ability of patients or healthcare providers to obtain coverage or sufficient reimbursement for our products;
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our ability, and the ability of third parties such as Clinical Research Organizations, or CROs, to adhere to clinical study and other regulatory requirements;
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the ability of third-party manufacturers to manufacture our product candidates and key ingredients needed to conduct clinical trials and, if approved, successfully commercialize our products;
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the costs to us, and our ability as well as the ability of any third-party collaborators, to obtain, maintain and protect our intellectual property rights;
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costs related to and outcomes of potential intellectual property litigation;
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our ability to adequately support future growth;
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our ability to attract and retain key personnel to manage our business effectively; and
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our ability to build our finance infrastructure and, to the extent required, improve our accounting systems and controls.
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completing development and clinical trial programs for our product candidates;
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entering into collaboration and license agreements;
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seeking and obtaining marketing approvals for any product candidates that successfully complete clinical trials;
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establishing and maintaining supply and manufacturing relationships with third parties;
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successfully commercializing any product candidates for which marketing approval is obtained; and
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successfully establishing a sales force and marketing and distribution infrastructure.
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the development of these product candidates may be adversely affected if we are unable to appropriately select patients for enrollment in our clinical trials;
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these product candidates may not receive marketing approval if their safe and effective use depends on a companion diagnostic; and
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we may not realize the full commercial potential of these product candidates that receive marketing approval if, among other reasons, we are unable to appropriately identify patients or types of tumors with the specific genetic alterations targeted by these product candidates.
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inability to raise funding necessary to initiate or continue a trial;
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delays in obtaining regulatory approval to commence a trial;
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delays in reaching agreement with the FDA on final trial design;
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imposition of a clinical hold following an inspection of our clinical trial operations or trial sites by the FDA or other regulatory authorities;
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delays in reaching agreement on acceptable terms with prospective CROs and clinical trial sites;
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delays in obtaining required institutional review board approval at each site;
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delays in recruiting suitable patients to participate in a trial;
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delays in having subjects complete participation in a trial or return for post-treatment follow-up;
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delays caused by subjects dropping out of a trial due to side effects or otherwise;
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clinical sites dropping out of a trial to the detriment of enrollment;
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time required to add new clinical sites; and
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delays by our contract manufacturers to produce and deliver a sufficient supply of clinical trial materials.
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regulatory authorities may withdraw approvals of such product;
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regulatory authorities may require additional warnings on the product label;
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we may be required to create a medication guide outlining the risks of such side effects for distribution to patients;
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we could be sued and held liable for harm caused to patients; and
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our reputation may suffer.
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Contract manufacturers can encounter difficulties in achieving the scale-up, optimization, formulation, volume production of a compound as well as maintaining quality control with appropriate quality assurance. They may also experience shortages of qualified personnel. Contract manufacturers are required to undergo a satisfactory GMP inspection prior to regulatory approval and are obliged to operate in accordance with FDA, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, or ICH, European and other nationally mandated GMP regulations and/or guidelines governing manufacturing processes, stability testing, record keeping and quality standards. A failure of these contract manufacturers to follow GMP and to document their adherence to such practices or failure of an inspection by a regulatory agency may lead to significant delays in the availability of our product candidate materials for clinical study, leading to delays in our trials.
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For each of our current product candidates we will initially rely on a limited number of contract manufacturers. Changing these or identifying future manufacturers may be difficult. Changing manufacturers requires re-validation of the manufacturing processes and procedures in accordance with FDA, ICH, European and other mandated GMP regulations and/or guidelines. Such re-validation may be costly and time-consuming. It may be difficult or impossible for us to quickly find replacement manufacturers on acceptable terms, if at all.
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Our contract manufacturers may not perform as agreed or may not remain in the contract manufacturing business for the time required to produce, store and distribute our products successfully.
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demonstration of the clinical efficacy and safety of our products;
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the prevalence and severity of any adverse side effects;
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limitations or warnings contained in the product’s approved labeling;
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cost-effectiveness and availability of acceptable pricing;
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competitive product profile versus alternative treatment methods and the superiority of alternative treatment or therapeutics;
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the effectiveness of marketing and distribution methods and support for the products; and
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coverage and reimbursement policies of government and third-party payors to the extent that our products could receive regulatory approval but not be approved for coverage by or receive adequate reimbursement from government and quasi-government agencies or other third-party payors.
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an annual, nondeductible fee on any entity that manufactures or imports specified branded prescription drugs and biologic agents, apportioned among these entities according to their market share in certain government healthcare programs;
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an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program, to 23.1% and 13.0% of the average manufacturer price for most branded and generic drugs, respectively;
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expansion of healthcare fraud and abuse laws, including the False Claims Act and the Anti-Kickback Statute, new government investigative powers, and enhanced penalties for noncompliance;
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a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for a manufacturer’s outpatient drugs to be covered under Medicare Part D;
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extension of a manufacturer’s Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations;
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expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals and by adding new mandatory eligibility categories for certain individuals with income at or below 133% of the federal poverty level beginning in 2014, thereby potentially increasing a manufacturer’s Medicaid rebate liability;
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expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program;
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new requirements under the federal Open Payments program and its implementing regulations (as described below);
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a new requirement to annually report drug samples that manufacturers and distributors provide to physicians; and
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a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research.
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the federal Anti-Kickback Statute, which 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, or in return for, 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;
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federal civil and criminal false claims laws and civil monetary penalty laws, including the federal False Claims Act, which impose criminal and 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, including the Medicare and Medicaid programs, 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;
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the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;
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HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and their respective implementing regulations, which impose obligations on covered healthcare providers, health plans, and healthcare clearinghouses, as well as their business associates that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;
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•
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the federal Open Payments program, which requires manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report annually to CMS information related to “payments or other transfers of value” made to physicians, which is defined to include doctors, dentists, optometrists, podiatrists and chiropractors, and teaching hospitals and applicable manufacturers and applicable group purchasing organizations to report annually to CMS ownership and investment interests held by the physicians and their immediate family members, and contains requirements for manufacturers to submit reports to CMS by the 90th day of each calendar year, and disclosure of such information to be made by CMS on a publicly available website which began in September 2014; and
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•
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analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers; state and foreign laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers; state and foreign laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
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•
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decreased demand for our product candidates;
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•
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injury to our reputation;
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•
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withdrawal of clinical trial participants;
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•
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initiation of investigations by regulators;
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•
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costs to defend the related litigation;
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•
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a diversion of management’s time and our resources;
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•
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substantial monetary awards to trial participants or patients;
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•
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product recalls, withdrawals or labeling, marketing or promotional restrictions;
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•
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loss of revenue from product sales; and
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•
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the inability to commercialize any our product candidates, if approved.
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Stock Exchange
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High
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Currency
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Low
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Currency
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||||
Year Ended December 31, 2014
|
|
|
|
|
|
||||
Fourth Quarter
|
The NASDAQ Capital Market*
|
$
|
19.90
|
|
USD
|
$
|
13.69
|
|
USD
|
Third Quarter
|
The NASDAQ Capital Market*
|
$
|
21.58
|
|
USD
|
$
|
15.59
|
|
USD
|
Second Quarter
|
The NASDAQ Capital Market*
|
$
|
23.75
|
|
USD
|
$
|
15.86
|
|
USD
|
First Quarter
|
The NASDAQ Capital Market*
|
$
|
25.97
|
|
USD
|
$
|
16.50
|
|
USD
|
Year Ended December 31, 2013
|
|
|
|
|
|
||||
Fourth Quarter
|
The NASDAQ Capital Market*
|
$
|
20.90
|
|
USD
|
$
|
15.00
|
|
USD
|
Third Quarter (from July 15, 2013 through September 30, 2013)
|
The NASDAQ Capital Market*
|
$
|
17.24
|
|
USD
|
$
|
7.00
|
|
USD
|
Third Quarter (from July 1, 2013 through July 14, 2013)
|
TSX**
|
$
|
7.20
|
|
CAD
|
$
|
6.80
|
|
CAD
|
Second Quarter
|
TSX**
|
$
|
8.50
|
|
CAD
|
$
|
3.50
|
|
CAD
|
First Quarter
|
TSX**
|
$
|
10.00
|
|
CAD
|
$
|
6.50
|
|
CAD
|
|
|
Year Ended December 31,
|
||||||||||||||
Consolidated Statements of Operations and Comprehensive Loss
|
|
2014
|
|
2013
|
|
2012
|
|
2011
|
||||||||
|
|
(in thousands, except share and per share amounts)
|
||||||||||||||
Revenue
|
|
|
|
|
|
|
|
|
||||||||
Collaboration, contract and license revenue
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
3,144
|
|
Total revenue
|
|
—
|
|
|
—
|
|
|
—
|
|
|
3,144
|
|
||||
|
|
|
|
|
|
|
|
|
||||||||
Expenses
|
|
|
|
|
|
|
|
|
||||||||
Research and development
|
|
26,071
|
|
|
19,797
|
|
|
15,081
|
|
|
8,891
|
|
||||
General and administrative
|
|
12,699
|
|
|
11,177
|
|
|
5,417
|
|
|
4,340
|
|
||||
Restructuring costs
|
|
334
|
|
|
1,025
|
|
|
—
|
|
|
—
|
|
||||
Total operating expenses
|
|
39,104
|
|
|
31,999
|
|
|
20,498
|
|
|
13,231
|
|
||||
Loss from operations
|
|
(39,104
|
)
|
|
(31,999
|
)
|
|
(20,498
|
)
|
|
(10,087
|
)
|
||||
Other income (expense), net
|
|
(77
|
)
|
|
(1,084
|
)
|
|
251
|
|
|
309
|
|
||||
Change in fair value of warrant liability*
|
|
(4,517
|
)
|
|
(19,799
|
)
|
|
—
|
|
|
—
|
|
||||
Loss before income taxes
|
|
(43,698
|
)
|
|
(52,882
|
)
|
|
(20,247
|
)
|
|
(9,778
|
)
|
||||
Income tax benefit (expense)
|
|
—
|
|
|
23
|
|
|
(39
|
)
|
|
—
|
|
||||
Net loss
|
|
$
|
(43,698
|
)
|
|
$
|
(52,859
|
)
|
|
$
|
(20,286
|
)
|
|
$
|
(9,778
|
)
|
Unrealized gain (loss) on available-for-sale investments
|
|
14
|
|
|
(13
|
)
|
|
—
|
|
|
—
|
|
||||
Comprehensive loss
|
|
$
|
(43,684
|
)
|
|
$
|
(52,872
|
)
|
|
$
|
(20,286
|
)
|
|
$
|
(9,778
|
)
|
Basic and diluted net loss per share
|
|
$
|
(3.24
|
)
|
|
$
|
(4.78
|
)
|
|
$
|
(3.00
|
)
|
|
$
|
(1.98
|
)
|
Weighted average number of shares used in computing net loss per share, basic and diluted
|
|
13,483,467
|
|
|
11,057,040
|
|
|
6,762,985
|
|
|
4,944,184
|
|
|
|
December 31,
|
||||||||||||||
Consolidated Balance Sheet Data
|
|
2014
|
|
2013
|
|
2012
|
|
2011
|
||||||||
|
|
(in thousands)
|
||||||||||||||
Cash, cash equivalents and short-term investments
|
|
$
|
29,303
|
|
|
$
|
62,070
|
|
|
$
|
36,983
|
|
|
$
|
28,445
|
|
Working capital
|
|
27,261
|
|
|
25,563
|
|
|
33,989
|
|
|
26,711
|
|
||||
Total assets
|
|
33,479
|
|
|
64,537
|
|
|
39,801
|
|
|
31,082
|
|
||||
Accumulated deficit
|
|
(242,089
|
)
|
|
(198,391
|
)
|
|
(140,491
|
)
|
|
(120,205
|
)
|
||||
Total stockholders' equity
|
|
28,062
|
|
|
25,885
|
|
|
34,416
|
|
|
27,305
|
|
•
|
salaries and related expenses for personnel, including expenses related to stock options or other share-based compensation granted to personnel in development functions;
|
•
|
fees paid to external service providers such as CROs and contract manufacturing organizations related to clinical trials;
|
•
|
contractual obligations for clinical development, clinical sites, manufacturing and scale-up, and formulation of clinical drug supplies; and
|
•
|
costs for facilities and amortization of equipment.
|
|
Year Ended December 31,
|
|
Increase
|
||||||||
|
2014
|
|
2013
|
|
(Decrease)
|
||||||
Research and development expenses
|
$
|
26,071
|
|
|
$
|
19,797
|
|
|
$
|
6,274
|
|
General and administrative expenses
|
12,699
|
|
|
11,177
|
|
|
1,522
|
|
|||
Restructuring costs
|
334
|
|
|
1,025
|
|
|
(691
|
)
|
|||
Other income/(expense), net
|
(77
|
)
|
|
(1,084
|
)
|
|
1,007
|
|
|||
Change in fair value of warrant liability
|
(4,517
|
)
|
|
(19,799
|
)
|
|
15,282
|
|
|
Year Ended December 31,
|
|
Increase
|
||||||||
|
2014
|
|
2013
|
|
(Decrease)
|
||||||
Third-party development expense:
|
|
|
|
|
|
||||||
MGCD265
|
$
|
7,273
|
|
|
$
|
6,588
|
|
|
$
|
685
|
|
MGCD516
|
2,932
|
|
|
2,495
|
|
|
437
|
|
|||
mocetinostat
|
4,507
|
|
|
2,580
|
|
|
1,927
|
|
|||
MGCD290*
|
123
|
|
|
1,629
|
|
|
(1,506
|
)
|
|||
Total third-party development expense
|
14,835
|
|
|
13,292
|
|
|
1,543
|
|
|||
Internal research and development expense
|
11,236
|
|
|
7,336
|
|
|
3,900
|
|
|||
Research and development expense, gross
|
26,071
|
|
|
20,628
|
|
|
5,443
|
|
|||
Less: Investment tax credits
|
—
|
|
|
(831
|
)
|
|
831
|
|
|||
Research and development expense
|
$
|
26,071
|
|
|
$
|
19,797
|
|
|
$
|
6,274
|
|
|
Year Ended December 31,
|
|
Increase (Decrease)
|
||||||||
|
2013
|
|
2012
|
|
|||||||
Research and development, net
|
$
|
19,797
|
|
|
$
|
15,081
|
|
|
$
|
4,716
|
|
General and administrative
|
11,177
|
|
|
5,417
|
|
|
5,760
|
|
|||
Restructuring costs
|
1,025
|
|
|
—
|
|
|
1,025
|
|
|||
Other income (expense), net
|
(1,084
|
)
|
|
251
|
|
|
(1,335
|
)
|
|||
Change in fair value of warrant liability
|
(19,799
|
)
|
|
—
|
|
|
(19,799
|
)
|
|
Year Ended December 31,
|
|
Increase
|
||||||||
|
2013
|
|
2012
|
|
(Decrease)
|
||||||
Third-party development expense:
|
|
|
|
|
|
||||||
MGCD265
|
$
|
6,588
|
|
|
$
|
7,261
|
|
|
$
|
(673
|
)
|
MGCD516
|
2,495
|
|
|
—
|
|
|
2,495
|
|
|||
mocetinostat
|
2,580
|
|
|
59
|
|
|
2,521
|
|
|||
MGCD290*
|
1,629
|
|
|
3,477
|
|
|
(1,848
|
)
|
|||
Total third-party development expense
|
13,292
|
|
|
10,797
|
|
|
2,495
|
|
|||
Internal research and development expense
|
7,336
|
|
|
5,959
|
|
|
1,377
|
|
|||
Research and development expense, gross
|
20,628
|
|
|
16,756
|
|
|
3,872
|
|
|||
Less: Investment tax credits
|
(831
|
)
|
|
(1,675
|
)
|
|
844
|
|
|||
Research and development expense
|
$
|
19,797
|
|
|
$
|
15,081
|
|
|
$
|
4,716
|
|
|
Year Ended December 31,
|
|||||||
|
2014
|
|
2013
|
|
2012
|
|||
Net cash used in operating activities
|
(32,748
|
)
|
|
(29,455
|
)
|
|
(16,650
|
)
|
Net cash provided by (used in) investing activities
|
24,219
|
|
|
(29,470
|
)
|
|
55
|
|
Net cash provided by financing activities
|
887
|
|
|
54,757
|
|
|
24,813
|
|
Increase (decrease) in cash
|
(7,642
|
)
|
|
(4,168
|
)
|
|
8,218
|
|
|
Year Ended December 31,
|
|
|
|
|
||||||||||||||
|
Total
|
|
Less Than 1 year
|
|
1 -3
Years
|
|
3 -5
Years
|
|
More Than 5 Years
|
||||||||||
Operating lease obligations(1)
|
$
|
841
|
|
|
$
|
223
|
|
|
$
|
618
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Total Contractual Obligations
|
$
|
841
|
|
|
$
|
223
|
|
|
$
|
618
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
Page(s)
|
Consolidated Financial Statements
|
|
|
|
||
Financial Statements:
|
|
|
|
||
|
||
|
||
|
||
|
Montreal, Canada
|
|
/s/Ernst & Young LLP
(1)
|
||
March 17, 2014
|
|
|
|
|
December 31,
|
||||||
|
2014
|
|
2013
|
||||
ASSETS
|
|
|
|
||||
Current assets
|
|
|
|
||||
Cash and cash equivalents
|
$
|
6,593
|
|
|
$
|
14,235
|
|
Short-term investments
|
22,710
|
|
|
47,835
|
|
||
Other current assets
|
3,354
|
|
|
2,145
|
|
||
Total current assets
|
32,657
|
|
|
64,215
|
|
||
Property and equipment, net
|
496
|
|
|
322
|
|
||
Other assets
|
326
|
|
|
—
|
|
||
Total assets
|
$
|
33,479
|
|
|
$
|
64,537
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY
|
|
|
|
||||
Current liabilities
|
|
|
|
||||
Accounts payable and accrued liabilities
|
5,396
|
|
|
5,245
|
|
||
Warrant liability
|
—
|
|
|
33,407
|
|
||
Total current liabilities
|
5,396
|
|
|
38,652
|
|
||
Other liability
|
21
|
|
|
—
|
|
||
Total liabilities
|
5,417
|
|
|
38,652
|
|
||
Commitments and contingencies
|
|
|
|
||||
Stockholders' equity
|
|
|
|
||||
Preferred stock, $0.001 par value, 10,000,000 shares authorized; none issued and outstanding at both December 31, 2014 and December 31, 2013
|
—
|
|
|
—
|
|
||
Common stock, $0.001 par value; 100,000,000 authorized; 13,566,726 and 13,446,976 issued and outstanding at December 31, 2014 and December 31, 2013, respectively
|
14
|
|
|
13
|
|
||
Additional paid-in capital
|
260,616
|
|
|
214,756
|
|
||
Accumulated other comprehensive income
|
9,521
|
|
|
9,507
|
|
||
Accumulated deficit
|
(242,089
|
)
|
|
(198,391
|
)
|
||
Total stockholders' equity
|
28,062
|
|
|
25,885
|
|
||
Total liabilities and stockholders' equity
|
$
|
33,479
|
|
|
$
|
64,537
|
|
|
Year Ended December 31,
|
||||||||||
|
2014
|
|
2013
|
|
2012
|
||||||
Expenses
|
|
|
|
|
|
||||||
Research and development
|
$
|
26,071
|
|
|
$
|
19,797
|
|
|
$
|
15,081
|
|
General and administrative
|
12,699
|
|
|
11,177
|
|
|
5,417
|
|
|||
Restructuring costs
|
334
|
|
|
1,025
|
|
|
—
|
|
|||
Total operating expenses
|
39,104
|
|
|
31,999
|
|
|
20,498
|
|
|||
|
|
|
|
|
|
||||||
Loss from operations
|
(39,104
|
)
|
|
(31,999
|
)
|
|
(20,498
|
)
|
|||
|
|
|
|
|
|
||||||
Other income (expense), net
|
(77
|
)
|
|
(1,084
|
)
|
|
251
|
|
|||
Change in fair value of warrant liability
|
(4,517
|
)
|
|
(19,799
|
)
|
|
—
|
|
|||
|
|
|
|
|
|
||||||
Loss before income taxes
|
(43,698
|
)
|
|
(52,882
|
)
|
|
(20,247
|
)
|
|||
|
|
|
|
|
|
||||||
Income tax benefit (expense)
|
—
|
|
|
23
|
|
|
(39
|
)
|
|||
|
|
|
|
|
|
||||||
Net loss
|
$
|
(43,698
|
)
|
|
$
|
(52,859
|
)
|
|
$
|
(20,286
|
)
|
|
|
|
|
|
|
||||||
Unrealized gain (loss) on available-for-sale investments
|
14
|
|
|
(13
|
)
|
|
—
|
|
|||
|
|
|
|
|
|
||||||
Comprehensive loss
|
$
|
(43,684
|
)
|
|
$
|
(52,872
|
)
|
|
$
|
(20,286
|
)
|
Basic and diluted net loss per share
|
$
|
(3.24
|
)
|
|
$
|
(4.78
|
)
|
|
$
|
(3.00
|
)
|
Weighted average number of shares used in computing net loss per share, basic and diluted
|
13,483,467
|
|
|
11,057,040
|
|
|
6,762,985
|
|
|
Common Stock
|
|
Common
Stock
Warrants
|
|
Additional
paid-in
capital
|
|
Accumulated
other
comprehensive
income
|
|
Accumulated
deficit
|
|
Total
stockholders'
equity
|
|||||||||||||||
|
|
|
|
|
|
|
|
|
||||||||||||||||||
|
Shares
|
|
Amount
|
|
|
|
|
|
||||||||||||||||||
Balance at January 1, 2012
|
6,358,253
|
|
|
$
|
6
|
|
|
$
|
6,247
|
|
|
$
|
132,312
|
|
|
$
|
8,945
|
|
|
$
|
(120,205
|
)
|
|
$
|
27,305
|
|
Net loss for the year
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(20,286
|
)
|
|
(20,286
|
)
|
||||||
Share-based compensation expense
|
—
|
|
|
—
|
|
|
—
|
|
|
2,009
|
|
|
—
|
|
|
—
|
|
|
2,009
|
|
||||||
Costs of reorganization
|
—
|
|
|
—
|
|
|
—
|
|
|
(15
|
)
|
|
—
|
|
|
—
|
|
|
(15
|
)
|
||||||
Issuance of common stock, net of costs
|
3,593,819
|
|
|
4
|
|
|
—
|
|
|
19,882
|
|
|
—
|
|
|
—
|
|
|
19,886
|
|
||||||
Issuance of warrants, net of costs
|
—
|
|
|
—
|
|
|
4,942
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
4,942
|
|
||||||
Net exercise of warrants
|
5,653
|
|
|
—
|
|
|
(36
|
)
|
|
36
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Foreign currency translation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
575
|
|
|
—
|
|
|
575
|
|
||||||
Balance at December 31, 2012
|
9,957,725
|
|
|
$
|
10
|
|
|
$
|
11,153
|
|
|
$
|
154,224
|
|
|
$
|
9,520
|
|
|
$
|
(140,491
|
)
|
|
$
|
34,416
|
|
Net loss for the year
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(52,859
|
)
|
|
(52,859
|
)
|
||||||
Share-based compensation expense
|
—
|
|
|
—
|
|
|
—
|
|
|
1,823
|
|
|
—
|
|
|
—
|
|
|
1,823
|
|
||||||
Reclassification of warrants
|
—
|
|
|
—
|
|
|
(11,153
|
)
|
|
—
|
|
|
—
|
|
|
(5,041
|
)
|
|
(16,194
|
)
|
||||||
Reclassification of stock option liability
|
—
|
|
|
—
|
|
|
—
|
|
|
1,369
|
|
|
—
|
|
|
—
|
|
|
1,369
|
|
||||||
Issuance of common stock, net of costs
|
3,337,500
|
|
|
3
|
|
|
—
|
|
|
54,193
|
|
|
—
|
|
|
—
|
|
|
54,196
|
|
||||||
Exercise of options for cash
|
40,534
|
|
|
—
|
|
|
—
|
|
|
540
|
|
|
—
|
|
|
—
|
|
|
540
|
|
||||||
Exercise of warrants for cash
|
2,896
|
|
|
—
|
|
|
—
|
|
|
21
|
|
|
—
|
|
|
—
|
|
|
21
|
|
||||||
Net exercise of warrants
|
108,321
|
|
|
—
|
|
|
—
|
|
|
2,586
|
|
|
—
|
|
|
—
|
|
|
2,586
|
|
||||||
Unrealized loss on investments
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(13
|
)
|
|
—
|
|
|
(13
|
)
|
||||||
Balance at December 31, 2013
|
13,446,976
|
|
|
$
|
13
|
|
|
$
|
—
|
|
|
$
|
214,756
|
|
|
$
|
9,507
|
|
|
$
|
(198,391
|
)
|
|
$
|
25,885
|
|
Net loss for the year
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(43,698
|
)
|
|
(43,698
|
)
|
||||||
Reclassification of warrants from liability
|
—
|
|
|
—
|
|
|
—
|
|
|
36,931
|
|
|
—
|
|
|
—
|
|
|
36,931
|
|
||||||
Share-based compensation expense
|
—
|
|
|
—
|
|
|
—
|
|
|
7,050
|
|
|
—
|
|
|
—
|
|
|
7,050
|
|
||||||
Exercise of options for cash
|
76,224
|
|
|
1
|
|
|
—
|
|
|
886
|
|
|
—
|
|
|
—
|
|
|
887
|
|
||||||
Net exercise of warrants
|
43,526
|
|
|
—
|
|
|
—
|
|
|
993
|
|
|
—
|
|
|
—
|
|
|
993
|
|
||||||
Unrealized gain on investments
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
14
|
|
|
—
|
|
|
14
|
|
||||||
Balance at December 31, 2014
|
13,566,726
|
|
|
$
|
14
|
|
|
$
|
—
|
|
|
$
|
260,616
|
|
|
$
|
9,521
|
|
|
$
|
(242,089
|
)
|
|
$
|
28,062
|
|
|
Years Ended
December 31,
|
||||||||||
|
2014
|
|
2013
|
|
2012
|
||||||
Operating activities:
|
|
|
|
|
|
||||||
Net loss
|
$
|
(43,698
|
)
|
|
$
|
(52,859
|
)
|
|
$
|
(20,286
|
)
|
Non-cash adjustments reconciling net loss to operating cash flows
|
|
|
|
|
|
||||||
Depreciation of property and equipment
|
199
|
|
|
171
|
|
|
123
|
|
|||
Amortization of premium on investments
|
534
|
|
|
—
|
|
|
—
|
|
|||
Share-based compensation expense
|
7,050
|
|
|
1,823
|
|
|
2,009
|
|
|||
Loss on disposal of property and equipment
|
—
|
|
|
40
|
|
|
—
|
|
|||
Change in lease incentive liability
|
—
|
|
|
(70
|
)
|
|
85
|
|
|||
Change in fair value of warrant liability
|
4,517
|
|
|
19,799
|
|
|
—
|
|
|||
Change in fair value adjustment of share-based compensation liability
|
—
|
|
|
1,369
|
|
|
—
|
|
|||
Change in restructuring costs
|
13
|
|
|
—
|
|
|
—
|
|
|||
Changes in operating assets and liabilities
|
|
|
|
|
|
||||||
Other current assets
|
(1,209
|
)
|
|
340
|
|
|
(15
|
)
|
|||
Other assets
|
(326
|
)
|
|
—
|
|
|
—
|
|
|||
Accounts payable and accrued liabilities
|
151
|
|
|
(68
|
)
|
|
1,434
|
|
|||
Other liabilities
|
21
|
|
|
—
|
|
|
—
|
|
|||
Cash flows used for operating activities
|
(32,748
|
)
|
|
(29,455
|
)
|
|
(16,650
|
)
|
|||
Investing activities:
|
|
|
|
|
|
||||||
Purchases of short-term investments
|
(10,468
|
)
|
|
(68,408
|
)
|
|
(29,431
|
)
|
|||
Disposal and maturities of short-term investments
|
35,073
|
|
|
39,138
|
|
|
29,716
|
|
|||
Purchases of property and equipment
|
(386
|
)
|
|
(204
|
)
|
|
(230
|
)
|
|||
Proceeds from disposal of property and equipment
|
—
|
|
|
4
|
|
|
—
|
|
|||
Cash flows provided by / (used for) investing activities
|
24,219
|
|
|
(29,470
|
)
|
|
55
|
|
|||
Financing activities:
|
|
|
|
|
|
||||||
Proceeds from issuance of common stock, net of issuance costs
|
—
|
|
|
54,196
|
|
|
19,886
|
|
|||
Proceeds from issuance of warrants, net of issuance costs
|
—
|
|
|
—
|
|
|
4,927
|
|
|||
Proceeds from exercise of common stock options and warrants
|
887
|
|
|
561
|
|
|
—
|
|
|||
Cash flows provided by financing activities
|
887
|
|
|
54,757
|
|
|
24,813
|
|
|||
Increase / (decrease) in cash and cash equivalents
|
(7,642
|
)
|
|
(4,168
|
)
|
|
8,218
|
|
|||
Effect of exchange rate changes on cash and cash equivalents
|
—
|
|
|
—
|
|
|
303
|
|
|||
Cash and cash equivalents, beginning of year
|
14,235
|
|
|
18,403
|
|
|
9,882
|
|
|||
Cash and cash equivalents, end of year
|
$
|
6,593
|
|
|
$
|
14,235
|
|
|
$
|
18,403
|
|
|
|
|
|
|
|
||||||
Supplemental disclosures of non-cash investing and financing activities:
|
|
|
|
|
|
||||||
Income taxes paid
|
$
|
—
|
|
|
$
|
35
|
|
|
$
|
34
|
|
|
|
|
|
|
|
||||||
Net exercise of warrants
|
$
|
993
|
|
|
$
|
2,586
|
|
|
$
|
—
|
|
|
|
|
|
|
|
||||||
|
|
|
|
|
|
1.
|
Description of Business
|
Computer equipment
|
|
3 years
|
Office and other equipment
|
|
6 years
|
Laboratory equipment
|
|
6 years
|
Leasehold improvements
|
|
The lesser of the lease term or the life of the asset
|
•
|
Level 1- Quoted prices (unadjusted) in active markets for identical assets or liabilities;
|
•
|
Level 2- Inputs other than quoted prices included within Level 1 that are either directly or indirectly observable; and
|
•
|
Level 3- Unobservable inputs in which little or no market activity exists, therefore requiring an entity to develop its own assumptions about the assumptions that market participants would use in pricing.
|
|
December 31,
2014 |
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||
Assets
|
|
|
|
|
|
|
|
||||||||
Cash and cash equivalents
|
$
|
6,593
|
|
|
$
|
4,590
|
|
|
$
|
2,003
|
|
|
$
|
—
|
|
Short-term investments
|
22,710
|
|
|
—
|
|
|
22,710
|
|
|
—
|
|
||||
|
$
|
29,303
|
|
|
$
|
4,590
|
|
|
$
|
24,713
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
|
December 31,
2013 |
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||
Assets
|
|
|
|
|
|
|
|
||||||||
Cash and cash equivalents
|
$
|
14,235
|
|
|
$
|
12,431
|
|
|
$
|
1,804
|
|
|
$
|
—
|
|
Short-term investments
|
47,835
|
|
|
—
|
|
|
47,835
|
|
|
—
|
|
||||
|
$
|
62,070
|
|
|
$
|
12,431
|
|
|
$
|
49,639
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
||||||||
Liabilities
|
|
|
|
|
|
|
|
||||||||
Warrant liability
|
$
|
33,407
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
33,407
|
|
|
$
|
33,407
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
33,407
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements at Reporting Date Using Significant Unobservable Inputs (Level 3)
|
||
Warrant liability:
|
|
|
||
Balance at January 1, 2013
|
|
$
|
—
|
|
Fair value upon reclassification of balance as of January 1, 2013
|
|
16,194
|
|
|
Change in fair value of warrant liability
included in net loss
|
|
19,799
|
|
|
Fair value of warrants exercised
|
|
(2,586
|
)
|
|
Balance at December 31, 2013
|
|
33,407
|
|
|
Change in fair value of warrant liability included in net loss
|
|
4,517
|
|
|
Fair value of warrants exercised
|
|
(993
|
)
|
|
Reclassification of warrants to stockholders' equity
|
|
(36,931
|
)
|
|
Balance at December 31, 2014
|
|
$
|
—
|
|
|
|
September 2014
|
|
December 2014
|
|||||
|
|
2011 Warrants
|
|
2012 Warrants
|
|
2011 Warrants
|
|||
Risk-free interest rate
|
|
1.2
|
%
|
|
1.2
|
%
|
|
1.0
|
%
|
Volatility
|
|
108.6
|
%
|
|
100.8
|
%
|
|
62.8% - 63.9%
|
|
Dividend yield
|
|
—
|
|
|
—
|
|
|
—
|
|
Expected life in years
|
|
1.6
|
|
|
3.2
|
|
|
1.3
|
|
|
|
December 31, 2013
|
|
||||
|
|
2011 Warrants
|
|
2012 Warrants
|
|
||
Risk-free interest rate
|
|
1.2
|
%
|
|
1.6
|
%
|
|
Volatility
|
|
112.0
|
%
|
|
115.9
|
%
|
|
Dividend yield
|
|
—
|
|
|
—
|
|
|
Expected life in years
|
|
2.3
|
|
|
3.9
|
|
|
|
|
Year ended
|
|
|||||||
|
|
December 31,
|
|
|||||||
|
|
2014
|
|
2013
|
|
2012
|
|
|||
Common stock options
|
|
253,595
|
|
|
495
|
|
|
15,663
|
|
|
Common stock warrants
|
|
1,515,445
|
|
|
644,426
|
|
|
690,046
|
|
|
Total
|
|
1,769,040
|
|
|
644,921
|
|
|
705,709
|
|
|
|
|
|
As of December 31, 2014
|
||||||||
|
Maturity (in years)
|
|
Amortized cost
|
Gross unrealized gains
|
Gross unrealized losses
|
Estimated fair value
|
|||||
Corporate debt securities (1)
|
1 year or less
|
|
21,208
|
|
3
|
|
(1
|
)
|
21,210
|
|
|
Commercial paper (1)
|
1 year or less
|
|
1,500
|
|
—
|
|
—
|
|
1,500
|
|
|
|
|
|
22,708
|
|
3
|
|
(1
|
)
|
22,710
|
|
|
|
|
As of December 31, 2013
|
||||||||
|
Maturity (in years)
|
|
Amortized cost
|
Gross unrealized gains
|
Gross unrealized losses
|
Estimated fair value
|
|||||
Government sponsored enterprise (1)
|
2 years or less
|
|
3,001
|
|
—
|
|
(3
|
)
|
2,998
|
|
|
Corporate debt securities (1)
|
2 years or less
|
|
31,319
|
|
—
|
|
(22
|
)
|
31,297
|
|
|
Commercial paper (1)
|
1 year or less
|
|
8,485
|
|
12
|
|
—
|
|
8,497
|
|
|
Guaranteed investment certificates (2)
|
1 year or less
|
|
5,046
|
|
—
|
|
(3
|
)
|
5,043
|
|
|
|
|
|
47,851
|
|
12
|
|
(28
|
)
|
47,835
|
|
|
December 31,
|
||||||
|
2014
|
|
2013
|
||||
|
(in thousands)
|
||||||
Prepaid expenses
|
1,827
|
|
|
667
|
|
||
Refundable research and development tax credits
|
809
|
|
|
809
|
|
||
Security deposits and other receivables
|
622
|
|
|
506
|
|
||
Interest receivables
|
96
|
|
|
163
|
|
||
|
$
|
3,354
|
|
|
$
|
2,145
|
|
|
December 31,
|
||||||
|
2014
|
|
2013
|
||||
|
(in thousands)
|
||||||
Computer equipment
|
$
|
329
|
|
|
$
|
1,534
|
|
Office and other equipment
|
56
|
|
|
122
|
|
||
Laboratory equipment
|
346
|
|
|
1,794
|
|
||
Leasehold improvements
|
—
|
|
|
53
|
|
||
|
$
|
731
|
|
|
$
|
3,503
|
|
Less: Accumulated depreciation
|
(235
|
)
|
|
(3,181
|
)
|
||
|
$
|
496
|
|
|
$
|
322
|
|
|
December 31,
|
||||||
|
2014
|
|
2013
|
||||
|
(in thousands)
|
||||||
Accounts payable
|
$
|
1,655
|
|
|
$
|
1,302
|
|
Accrued expenses
|
2,327
|
|
|
2,335
|
|
||
Accrued compensation and benefits
|
1,414
|
|
|
1,608
|
|
||
|
$
|
5,396
|
|
|
$
|
5,245
|
|
Balance as of October 1, 2013
|
|
$
|
—
|
|
|
Accrued restructuring charges
|
|
1,025
|
|
|
|
Payments
|
|
(729
|
)
|
|
|
Balance as of December 31, 2013
|
|
296
|
|
|
|
Accrued restructuring charges
|
|
334
|
|
|
|
Payments
|
|
(630
|
)
|
|
|
Balance as of December 31, 2014
|
|
$
|
—
|
|
|
|
December 31,
|
|
|
2014
|
|
Common stock options outstanding and available for future grant
|
1,891,107
|
|
Warrants to purchase common stock
|
2,465,713
|
|
Employee Stock Purchase Plan
|
300,000
|
|
|
4,656,820
|
|
Issue date
|
|
Expiration date
|
|
Exercise price (Denominated in US Dollars)
|
|
Number of warrants outstanding
|
|||
April 4, 2011
|
|
April 4, 2016
|
|
$
|
6.74
|
|
|
1,397,921
|
|
November 21, 2012
|
|
November 21, 2017
|
|
$
|
7.86
|
|
|
1,067,792
|
|
|
|
|
|
|
|
2,465,713
|
|
|
Number of
options
|
|
Weighted
average
exercise
price
|
|
Weighted-Average Remaining Contractual Term (years)
|
|
Aggregate Intrinsic Value (millions)
|
|||||
Balance, December 31, 2013
|
968,923
|
|
|
$
|
11.13
|
|
|
|
|
|
||
Granted
|
599,410
|
|
|
$
|
18.64
|
|
|
|
|
|
||
Exercised
|
(76,224
|
)
|
|
$
|
11.20
|
|
|
|
|
|
||
Canceled/forfeited
|
(34,640
|
)
|
|
$
|
15.44
|
|
|
|
|
|
||
Expired
|
(2,609
|
)
|
|
$
|
55.80
|
|
|
|
|
|
||
Balance, December 31, 2014
|
1,454,860
|
|
|
$
|
14.00
|
|
|
|
|
|
||
Options exercisable at December 31, 2014
|
431,088
|
|
|
$
|
12.25
|
|
|
7.0
|
|
$
|
3.21
|
|
Options vested and expected to vest at December 31, 2014
|
1,383,082
|
|
|
$
|
14.89
|
|
|
8.1
|
|
$
|
6.83
|
|
|
Year ended December 31,
|
||||||||||
|
2014
|
|
2013
|
|
2012
|
||||||
Research and development expense
|
$
|
2,565
|
|
|
$
|
245
|
|
|
$
|
817
|
|
General and administrative expense
|
4,485
|
|
|
2,947
|
|
|
1,192
|
|
|||
|
$
|
7,050
|
|
|
$
|
3,192
|
|
|
$
|
2,009
|
|
|
|
Year Ended
December 31,
|
||||
|
|
2014
|
|
2013
|
|
2012
|
Risk-free interest rate
|
|
2.1%
|
|
2.0%
|
|
1.2%
|
Dividend yield
|
|
—%
|
|
—%
|
|
—%
|
Volatility factor
|
|
113.0%
|
|
112.9%
|
|
116.4%
|
Expected term (in years)
|
|
6.7
|
|
7.0
|
|
4.4
|
Weighted average estimated fair value per share
|
|
$16.09
|
|
$9.75
|
|
$9.00
|
|
Year ended December 31,
|
||||||||||
Current:
|
2014
|
|
2013
|
|
2012
|
||||||
Federal
|
$
|
—
|
|
|
$
|
23
|
|
|
$
|
(30
|
)
|
State
|
—
|
|
|
—
|
|
|
(9
|
)
|
|||
Canada
|
—
|
|
|
—
|
|
|
—
|
|
|||
Total current tax expense (benefit)
|
$
|
—
|
|
|
$
|
23
|
|
|
$
|
(39
|
)
|
|
Year Ended December 31,
|
||||||||||
|
2014
|
|
2013
|
|
2012
|
||||||
Net loss before tax
|
$
|
(43,698
|
)
|
|
$
|
(52,882
|
)
|
|
$
|
(20,247
|
)
|
Statutory combined US federal and state tax rate (2012 - statutory combined Canadian federal and provincial tax rate)
|
39.83
|
%
|
|
39.83
|
%
|
|
26.90
|
%
|
|||
Statutory federal and provincial taxes
|
$
|
(17,405
|
)
|
|
$
|
(21,063
|
)
|
|
$
|
(5,446
|
)
|
Increase (decrease) in taxes recoverable resulting from:
|
|
|
|
|
|
||||||
Effect of change in valuation allowance
|
12,273
|
|
|
8,537
|
|
|
5,145
|
|
|||
Non-deductible share-based compensation
|
930
|
|
|
1,085
|
|
|
539
|
|
|||
Non-deductible warrant expenses for tax purposes
|
1,799
|
|
|
8,403
|
|
|
—
|
|
|||
Tax credits
|
(180
|
)
|
|
(96
|
)
|
|
(70
|
)
|
|||
Share issue costs - temporary difference
|
(184
|
)
|
|
(184
|
)
|
|
(183
|
)
|
|||
Share issue costs - permanent difference
|
—
|
|
|
206
|
|
|
—
|
|
|||
Effect of foreign jurisdiction tax expense
|
—
|
|
|
—
|
|
|
39
|
|
|||
Differential in income tax rates of foreign subsidiary
|
3,047
|
|
|
3,059
|
|
|
—
|
|
|||
Other differences
|
(280
|
)
|
|
30
|
|
|
15
|
|
|||
Income tax expense (benefit)
|
$
|
—
|
|
|
$
|
(23
|
)
|
|
$
|
39
|
|
|
December 31,
|
||||||
|
2014
|
|
2013
|
||||
Deferred tax assets:
|
|
|
|
||||
Tangible and intangible depreciable assets
|
$
|
185
|
|
|
$
|
874
|
|
Stock compensation
|
2,360
|
|
|
—
|
|
||
Manufactured drug product inventory to be used in research
|
1,425
|
|
|
1,459
|
|
||
Provisions
|
554
|
|
|
93
|
|
||
Financing fees
|
261
|
|
|
445
|
|
||
Net operating loss carry forwards
|
23,243
|
|
|
13,099
|
|
||
Scientific research and experimental development expenditures
|
5,715
|
|
|
5,766
|
|
||
Research and development tax credits
|
266
|
|
|
—
|
|
||
Total gross deferred tax assets
|
34,009
|
|
|
21,736
|
|
||
Less valuation allowance
|
(34,009
|
)
|
|
(21,736
|
)
|
||
Net deferred tax assets
|
$
|
—
|
|
|
$
|
—
|
|
|
US
|
|
Canada
|
||||||||||||
|
Federal
|
|
State
|
|
Federal
|
|
Provincial
|
||||||||
Expires in:
|
|
|
|
|
|
|
|
||||||||
2030
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
5,907
|
|
|
$
|
5,985
|
|
2031
|
—
|
|
|
—
|
|
|
7,059
|
|
|
7,066
|
|
||||
2032
|
—
|
|
|
—
|
|
|
13,312
|
|
|
12,433
|
|
||||
2033
|
3,261
|
|
|
2,286
|
|
|
18,623
|
|
|
19,385
|
|
||||
2034
|
7,012
|
|
|
7,185
|
|
|
26,741
|
|
|
26,149
|
|
||||
|
$
|
10,273
|
|
|
$
|
9,471
|
|
|
$
|
71,642
|
|
|
$
|
71,018
|
|
|
Federal
|
|
Provincial/State
|
||||||||||||||||||||
|
December 31,
|
|
December 31,
|
||||||||||||||||||||
|
2014
|
|
2013
|
|
2012
|
|
2014
|
|
2013
|
|
2012
|
||||||||||||
Unrecognized tax positions, beginning of year
|
$
|
35
|
|
|
$
|
43
|
|
|
$
|
42
|
|
|
$
|
6
|
|
|
$
|
2
|
|
|
$
|
1
|
|
Gross decrease — current period tax positions
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Gross increase — current period tax positions
|
35
|
|
|
—
|
|
|
1
|
|
|
12
|
|
|
—
|
|
|
1
|
|
||||||
Gross decrease — prior period tax positions
|
(28
|
)
|
|
(13
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Gross increase — prior period tax positions
|
—
|
|
|
5
|
|
|
—
|
|
|
—
|
|
|
4
|
|
|
—
|
|
||||||
Unrecognized tax positions, end of year
|
$
|
42
|
|
|
$
|
35
|
|
|
$
|
43
|
|
|
$
|
18
|
|
|
$
|
6
|
|
|
$
|
2
|
|
|
|
||
|
FEDERAL ITC
|
||
Expires in:
|
|
||
2030
|
$
|
764
|
|
2031
|
1,000
|
|
|
2032
|
1,125
|
|
|
2033
|
$
|
1,018
|
|
|
$
|
3,907
|
|
Year Ending December 31:
|
|||
2015
|
$
|
223
|
|
2016
|
290
|
|
|
2017
|
303
|
|
|
2018
|
25
|
|
|
Total minimum lease payments
|
$
|
841
|
|
|
|
Quarted Ended
|
|
Year Ended
|
||||||||||||||||
2014:
|
|
First
|
Second
|
Third
|
Fourth
|
|
December 31,
|
|||||||||||||
Operating Loss
|
|
$
|
(7,979
|
)
|
|
$
|
(10,134
|
)
|
|
$
|
(10,548
|
)
|
|
$
|
(10,443
|
)
|
|
$
|
(39,104
|
)
|
Net loss
|
|
$
|
(13,656
|
)
|
|
$
|
(11,038
|
)
|
|
$
|
(8,617
|
)
|
|
$
|
(10,387
|
)
|
|
$
|
(43,698
|
)
|
Per common share:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Loss per share, basic
|
|
$
|
(1.01
|
)
|
|
$
|
(0.82
|
)
|
|
$
|
(0.64
|
)
|
|
$
|
(0.77
|
)
|
|
$
|
(3.24
|
)
|
Loss per share, diluted
|
|
$
|
(1.01
|
)
|
|
$
|
(0.82
|
)
|
|
$
|
(0.72
|
)
|
|
$
|
(0.77
|
)
|
|
$
|
(3.24
|
)
|
|
|
|
||||||||||||||||||
|
|
Three Months Ended
|
|
Year Ended
|
||||||||||||||||
2013:
|
|
First
|
Second
|
Third
|
Fourth
|
|
December 31,
|
|||||||||||||
Operating Loss
|
|
$
|
(8,006
|
)
|
|
$
|
(6,898
|
)
|
|
$
|
(9,209
|
)
|
|
$
|
(7,886
|
)
|
|
$
|
(31,999
|
)
|
Net loss
|
|
$
|
(4,217
|
)
|
|
$
|
(8,012
|
)
|
|
$
|
(29,398
|
)
|
|
$
|
(11,232
|
)
|
|
$
|
(52,859
|
)
|
Per common share:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Loss per share, basic
|
|
$
|
(0.42
|
)
|
|
$
|
(0.80
|
)
|
|
$
|
(2.95
|
)
|
|
$
|
(0.96
|
)
|
|
$
|
(4.78
|
)
|
Loss per share, diluted
|
|
$
|
(0.68
|
)
|
|
$
|
(0.80
|
)
|
|
$
|
(2.95
|
)
|
|
$
|
(0.96
|
)
|
|
$
|
(4.78
|
)
|
|
|
|
|
|
|
|
MIRATI THERAPEUTICS, INC.
|
|
|
|
Date: March 11, 2015
|
by:
|
/s/ Charles M. Baum, M.D., Ph.D.
|
|
|
Chief Executive Officer
|
|
|
|
|
|
|
Date: March 11, 2015
|
by:
|
/s/ Mark J. Gergen
|
|
|
Executive Vice President and
|
|
|
Chief Operations Officer
|
|
|
|
|
|
|
Signature
|
|
Title
|
|
Date
|
/S/ CHARLES M. BAUM
|
|
Chief Executive Officer and Director (Principal Executive Officer)
|
|
March 11, 2015
|
Charles M. Baum, M.D., Ph.D.
|
|
|
|
|
|
|
|
|
|
/S/ MARK J. GERGEN
|
|
Executive Vice President, Chief Operations Officer (Principal Financial Officer)
|
|
March 11, 2015
|
Mark J. Gergen
|
|
|
|
|
|
|
|
|
|
/S/ JAMIE A. DONADIO
|
|
Vice President, Finance (Principal Accounting Officer)
|
|
March 11, 2015
|
Jamie A. Donadio
|
|
|
|
|
|
|
|
|
|
/S/ RODNEY LAPPE
|
|
Chairman of the Board
|
|
March 11, 2015
|
Rodney Lappe, Ph.D.
|
|
|
|
|
|
|
|
|
|
/S/ MICHAEL GREY
|
|
Director
|
|
March 11, 2015
|
Michael Grey
|
|
|
|
|
|
|
|
|
|
/S/ HENRY J. FUCHS
|
|
Director
|
|
March 11, 2015
|
Henry J. Fuchs, M.D.
|
|
|
|
|
|
|
|
|
|
/S/ CRAIG JOHNSON
|
|
Director
|
|
March 11, 2015
|
Craig Johnson
|
|
|
|
|
|
|
|
|
|
/S/ WILLIAM R. RINGO
|
|
Director
|
|
March 11, 2015
|
William R. Ringo
|
|
|
|
|
|
|
|
|
|
Exhibit number
|
Description of document
|
2.1
|
Arrangement Agreement, dated May 8, 2013, by and between MethylGene Inc. and the Registrant.
(2)
|
3.1
|
Amended and Restated Certificate of Incorporation.
(1)
|
3.2
|
Bylaws.
(1)
|
4.1
|
Form of Common Stock Certificate.
(2)
|
10.1
|
Form of Securities Purchase Agreement relating to the 2011 private placement.
(1)
|
10.2
|
Form of Securities Purchase Agreement relating to the 2012 private placement.
(1)
|
10.3
|
Form of Warrant Certificate issued in connection with the 2011 private placement.
(1)
|
10.4
|
Form of Warrant Certificate issued in connection with the 2012 private placement.
(1)
|
10.5+
|
Amended and Restated Incentive Stock Option Plan.
(1)
|
10.6+
|
Form of 2013 Equity Incentive Plan and Form of Stock Option Grant Notice and Form of Stock Option Agreement thereunder.
(1)
|
10.7+
|
Form of 2013 Employee Stock Purchase Plan.
(1)
|
10.12
|
Collaboration and License Agreement, dated October 16, 2003, by and between MethylGene Inc. and Taiho Pharmaceutical Co. Ltd.
|
10.13
|
Amendment Number One to Collaboration and License Agreement, dated January 25, 2005, by and between MethylGene Inc. and Taiho Pharmaceutical Co., Ltd.
|
10.14
|
Letter Agreement, dated January 25, 2005, by and between MethylGene Inc. and Taiho Pharmaceutical Co., Ltd., relating to Collaboration and License Agreement dated October 16, 2003.
|
10.15+
|
Senior Executive Employment Agreement, dated September 24, 2012, by and among MethylGene Inc. and Dr. Charles M. Baum.
(1)
|
10.16+
|
Employment Agreement, dated February 15, 2013, by and between MethylGene Inc. and Mark J. Gergen.
(1)
|
10.17+
|
Amended and Restated Employment Agreement, dated July 2, 2013, by and between the Registrant and Dr. Charles M. Baum.
(3)
|
10.18+
|
Amended and Restated Employment Agreement, dated July 2, 2013, by and between the Registrant and Mark J. Gergen.
(3)
|
10.19
|
Sublease Agreement, dated May 28, 2013, by and between Amylin Pharmaceuticals, LLC and MethylGene US, Inc.
(4)
|
10.2
|
Lease Agreement, dated June 24, 2014, by and between the Company and ARE-SD Region No. 20, LLC.
(6)
|
10.21+
|
Letter Agreement, dated August 30, 2013, by and between the Registrant and Dr. Isan Chen.
(5)
|
10.22+
|
Letter Agreement, Dated May 20, 2013, by and between Methylgene Inc. and James Christensen
|
10.23+
|
Form of Indemnity Agreement.
(5)
|
21.1
|
Subsidiaries of the Registrant.
(1)
|
23.1
|
Consent of Independent Registered Public Accounting Firm- US.
|
23.2
|
Consent of Independent Registered Public Accounting Firm- Canada.
|
31.1
|
Certification of the Principal Executive Officer pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934.
|
31.2
|
Certification of the Principal Financial Officer pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934.
|
32.1
|
Certifications Pursuant to U.S.C. Section 1350, As Adopted Pursuant to Section 906 of the Public Company Accounting Reform and Investor Protection Act of 2002.
|
101.INS
|
XBRL Instance Document.
|
101.SCH
|
XBRL Taxonomy Extension Schema Document.
|
101.CAL
|
XBRL Taxonomy Extension Schema 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.
|
+
|
Indicates management contract or compensatory plan.
|
*
|
We have received confidential treatment for certain portions of this agreement, which have been omitted and filed separately with the SEC pursuant to Rule 406 under the Securities Act.
|
(1)
|
Incorporated by reference to Mirati Therapeutics, Inc.’s Registration Statement on Form 10-12B (No. 001-35921), filed with the Securities and Exchange Commission on May 10, 2013.
|
(2)
|
Incorporated by reference to Mirati Therapeutics, Inc.’s Amended Registration Statement on Form 10-12B/A (No. 001-35921), filed with the Securities and Exchange Commission on June 14, 2013.
|
(3)
|
Incorporated by reference to Mirati Therapeutics, Inc.’s Amended Registration Statement on Form 10-12B/A (No. 001-35921), filed with the Securities and Exchange Commission on July 9, 2013.
|
(4)
|
Incorporated by reference to Mirati Therapeutics, Inc.’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2013, filed with the Securities and Exchange Commission on August 13, 2013.
|
(5)
|
Incorporated by reference to Mirati Therapeutics, Inc.’s Registration Statement on Form S-1 (No. 333-191544), filed with the Securities and Exchange Commission on October 3, 2013.
|
(6)
|
Incorporated by reference to Mirati Therapeutics, Inc.’s Current Report on Form 8-K, filed with the Securities and Exchange Commission on June 27, 2014.
|
•
|
Your annual base salary will be $US270,000 payable bi-weekly adjusted from time-to-time through the Company’s ordinary compensation practices.
|
•
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You are eligible to receive an annual cash bonus up to 30% of your base salary, based on achievement of performance objectives and goals to be established by the Company in consultation with you. You will be eligible for a bonus in 2013, prorated to your start date and based on satisfactory performance. You must continue to be employed through the date the bonus is paid in order to earn a bonus for any particular year, unless the Board of Directors of the Company (the “Board”) determines, in its sole discretion, that you have earned a bonus prior to such time. In accordance with Company policies, you will be entitled to accrue up to four (4) weeks of paid time off during each calendar year (January 1- December 31), subject to applicable maximum accrual caps, and you will also be entitled to certain paid holidays.
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You will receive a signing bonus of $US75,000. This bonus will be paid within the first thirty (30) days after joining the Company, if you commence employment on or about June 24, 2013. In the event you voluntarily leave the Company prior to your first anniversary date, you would need to reimburse the Company for a prorated amount of this bonus.
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Stock options will be issued to you to purchase 1,500,000 shares of MethylGene common stock at the next Board of Directors’ meeting following your hire date where options are awarded, tentatively scheduled for June 2013, in accordance with the terms of the Company’s stock option plan. Because of the plans to move the Company and list on the NASDAQ exchange, these options may be subject to a reverse stock split and be issues under the new equity plan in which case the option grant would be for 30,000 shares on a post split basis assuming a 50:1 reverse split as currently proposed. Your
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The Company will provide you with comprehensive health benefits as part of a health insurance plan as provided by the Company’s health insurance provider (Aetna). In the event of a waiting period, MethylGene will cover your monthly COBRA costs in order for you to maintain health coverage in the US. The Company will also provide a 401K contribution up to a maximum of $2,500 for 2013 and future years as determined from time-to-time by the Board of Directors.
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The Company will provide you with three (3) months of salary in the event you are dismissed for reason(s) other than cause. In addition, you will entitled to three (3) weeks for each completed year of service up to a maximum total of six (6) months of salary, in the event you are dismissed for reason(s) other than cause. Such Severance Payment will be conditioned upon you providing an executed waiver and release of claims in a form acceptable to the Company within the applicable deadline described therein and permitting the release to become effective in accordance with its terms, which date may not be later than sixty (60) days after your termination with us (the “Release Deadline”). The Severance Payment will be made to you on the Release Deadline.
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Consent of Independent Registered Public Accounting Firm
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We consent to the incorporation by reference in the following Registration Statements:
Registration Statement (Form S-8 No. 333-189965) pertaining to the Amended and Restated Incentive Stock Option Plan, 2013 Equity Incentive Plan, and 2013 Employee Stock Purchase Plan of Mirati Therapeutics Inc.,
Registration Statement (Form S-8 No. 333-196487) pertaining to the 2013 Equity Incentive Plan of Mirati Therapeutics Inc., and
Registration Statement (Form S-3 No. 333-198678) of Mirati Therapeutics Inc.
of our report dated March 17, 2014, with respect to the consolidated financial statements of Mirati Therapeutics Inc. for the year ended December 31, 2013 included in this Annual Report (Form 10-K) for the year ended December 31, 2014.
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Date: March 11, 2015
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/s/ Charles M. Baum
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Charles M. Baum
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President and Chief Executive Officer
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(Principal Executive Officer)
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Date: March 11, 2015
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/s/ Mark J. Gergen
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Mark J. Gergen
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Executive Vice President and Chief Operations Officer
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(Principal Financial Officer)
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/s/ Charles M. Baum
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/s/ Mark J. Gergen
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Charles M. Baum
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Mark J. Gergen
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President and Chief Executive Officer
(Principal Executive Officer)
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Executive Vice President and Chief Operations Officer
(Principal Financial Officer)
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