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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9393 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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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, ("RTKs"). MGCD265 is in development for the treatment of solid tumors, with an initial focus on NSCLC but including other solid tumors like those found in gastroesophageal cancers and squamous cell carcinoma of the head and neck ("HNSCC"). In September 2015, we reported interim data from the ongoing MGCD265 Phase 1b dose expansion clinical trials disclosing that two of the four NSCLC patients who were then evaluable (having had at least two on-treatment scans) had confirmed partial responses ("PRs"), based upon Response Evaluation Criteria in Solid Tumors ("RECIST") criteria and two patients had tumor regressions that did not meet the RECIST threshold for a PR. Based upon these early signs of clinical efficacy we initiated a single-arm Phase 2 clinical trial for the treatment of NSCLC patients with genetic alternations in MET in December of 2015. Based on a meeting with the U.S. Food and Drug Administration ("FDA"), in the Phase 2 trial of MGCD265, if we observe a response rate that is significantly better than the response rate for currently approved second line therapy, we believe the trial could potentially serve as a registration enabling trial and qualify for submission for accelerated approval under U.S. Code of Federal Regulations 21 CFR Part 314, Subpart H (Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses).
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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 RET, DDR and Trk RTK families as well as CHR4q12 amplicons and CBL inactivating mutations. We plan to focus on solid tumors exhibiting genetic alterations which result in 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. MGCD516 is currently in a Phase 1b dose expansion clinical trial which includes cohorts for the treatment of patients with genetic alterations involving the RET, DDR and Trk RTK families as well as CHR4q12 amplicons and CBL inactivating mutations.
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•
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Mocetinostat
is an orally-bioavailable, spectrum-selective HDAC inhibitor that we plan to evaluate in combination with durvalumab, MedImmune’s immune checkpoint inhibitor, in patients with NSCLC. We plan to initiate this trial in the second quarter of 2016. By virtue of its specificity for Class 1 HDACs, mocetinostat showed a favorable effect on the
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•
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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 multiple oncology and targeted oncology drugs (e.g. Temodar, Sutent, Inlyta, Xalkori, and Ibrance) 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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•
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Employ efficient and flexible approaches to accelerate clinical development.
Based on the prior extensive experience of certain members of our management team in oncology drug development, which includes the successful registration of several products, we take an adaptive approach to our clinical trials so that we use the information from the ongoing trials to increase our likelihood of success. We will pursue indications and select specific patient populations in which activity of our product candidates can be assessed in small proof of concept ("POC") clinical trials potentially 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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•
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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, RET, DDR, and Trk RTK families and including exploration of novel genetic alterations including CHR4q12 amplicons and CBL inactivating mutations. These pathways are believed to be drivers of tumor growth and to be responsible for the development of tumor resistance to several anti-cancer treatments. MGCD265 is in Phase 2 development and MGCD516 is currently in a Phase 1b dose expansion clinical trial.
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•
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Advance mocetinostat, our HDAC inhibitor.
HDAC inhibitors modulate epigenetic events by their potent inhibition of histone deacetylation. This class of agents has been shown to be effective, as single agents, in treating hematologic malignancies, as evidenced by the approvals of Istodax and Zolinza. A growing body of evidence indicates that Class I HDAC inhibitors like mocetinostat have effects directly on tumor cells as well as on immune cells (T-regs and MDSC)
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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 and market potential. We plan to retain certain key development and commercialization rights in our partnerships. We believe that retaining this strategic flexibility will enable us to maximize shareholder value. Specifically, we recently entered into collaboration agreements with Foundation Medicine, Inc. and Guardant Health, Inc. to explore development of their platforms as companion diagnostics for MGCD265.
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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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Single-arm, single-agent Phase 2 clinical trial in NSCLC ongoing.
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MGCD516
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Solid Tumors
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RET, CHR4q12, CBL, DDR and Trk
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Mirati: Global
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Single-agent Phase 1b dose expansion clinical trial ongoing.
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Mocetinostat
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Solid Tumors
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HDACs
Class I and IV
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Taiho: Certain Asian Territories
Mirati: All Other Territories
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Initiate a trial evaluating the combination of mocetinostat with durvalumab in NSCLC in the second quarter of 2016.
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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
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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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221,200
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Gastric Cancer
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Genetic alterations of MET in up to 6% of patients
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24,590
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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 specific 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 dose expansion 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 2 Clinical Trial
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Single Agent Phase 2 clinical trial in patients with genetic alterations of MET in NSCLC, 21 day cycle
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Ongoing
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Program
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Granted
(United
States)
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Pending
(United
States)
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Small Molecule Kinase Inhibitors
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15
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1
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HDAC
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13
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3
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TOTAL
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28
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4
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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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57
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President and Chief Executive Officer, Director
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Mark J. Gergen
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53
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Executive Vice President and Chief Operating Officer
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Isan Chen, M.D.
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53
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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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47
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Senior Vice President and Chief Scientific Officer
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Jamie A. Donadio
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40
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Vice President, Finance
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Rodney W. Lappe, Ph.D.
(3)
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61
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Chairman of the Board
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Michael Grey
(1)(3)
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63
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Director
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Henry J. Fuchs, M.D.
(2)(3)
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56
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Director
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Craig Johnson
(1)(2)
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54
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Director
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William R. Ringo
(1)(2)
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70
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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 ("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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•
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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 delayed because it may be difficult to identify patients for enrollment in our clinical trials in a timely manner;
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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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delays in recruiting patients with the specific genetic alterations we are targeting to participate in a trial;
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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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•
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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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•
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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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•
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Contract manufacturers can encounter difficulties in achieving the scale-up, optimization, formulation, or 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 ("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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•
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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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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 ("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 ("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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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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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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injury to our reputation;
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withdrawal of clinical trial participants;
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initiation of investigations by regulators;
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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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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 of our product candidates, if approved.
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High
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Low
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||||
Year Ended December 31, 2015
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|
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||||
Fourth Quarter
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$
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43.20
|
|
|
$
|
29.14
|
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Third Quarter
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$
|
52.00
|
|
|
$
|
20.68
|
|
Second Quarter
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$
|
37.43
|
|
|
$
|
25.21
|
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First Quarter
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$
|
30.76
|
|
|
$
|
18.26
|
|
Year Ended December 31, 2014
|
|
|
|
||||
Fourth Quarter
|
$
|
19.90
|
|
|
$
|
13.69
|
|
Third Quarter
|
$
|
21.58
|
|
|
$
|
15.59
|
|
Second Quarter
|
$
|
23.75
|
|
|
$
|
15.86
|
|
First Quarter
|
$
|
25.97
|
|
|
$
|
16.50
|
|
|
Year Ended December 31,
|
||||||||||||||||||
|
2015
|
|
2014
|
|
2013
|
|
2012
|
|
2011
|
||||||||||
Statements of Income Data:
|
|
|
|
|
|
|
|
|
|
||||||||||
Total revenue
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
3,144
|
|
Loss from operations
|
(64,714
|
)
|
|
(39,104
|
)
|
|
(31,999
|
)
|
|
(20,498
|
)
|
|
(10,087
|
)
|
|||||
Net loss
|
(64,544
|
)
|
|
(43,698
|
)
|
|
(52,859
|
)
|
|
(20,286
|
)
|
|
(9,778
|
)
|
|||||
Comprehensive loss
|
(64,507
|
)
|
|
(43,684
|
)
|
|
(52,872
|
)
|
|
(20,286
|
)
|
|
(9,778
|
)
|
|||||
Basic and diluted net loss per share
|
$
|
(3.82
|
)
|
|
$
|
(3.24
|
)
|
|
$
|
(4.78
|
)
|
|
$
|
(3.00
|
)
|
|
$
|
(1.98
|
)
|
Weighted average common shares outstanding, basic and diluted
|
16,901,826
|
|
|
13,483,467
|
|
|
11,057,040
|
|
|
6,762,985
|
|
|
4,944,184
|
|
|
As of December 31,
|
||||||||||||||||||
|
2015
|
|
2014
|
|
2013
|
|
2012
|
|
2011
|
||||||||||
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
||||||||||
Cash, cash equivalents and short-term investments
|
$
|
122,327
|
|
|
$
|
29,303
|
|
|
$
|
62,070
|
|
|
$
|
36,983
|
|
|
$
|
28,445
|
|
Working capital
|
115,604
|
|
|
27,261
|
|
|
25,563
|
|
|
33,989
|
|
|
26,711
|
|
|||||
Total assets
|
128,017
|
|
|
33,479
|
|
|
64,537
|
|
|
39,801
|
|
|
31,082
|
|
|||||
Accumulated deficit
|
(306,633
|
)
|
|
(242,089
|
)
|
|
(198,391
|
)
|
|
(140,491
|
)
|
|
(120,205
|
)
|
|||||
Total stockholders' equity
|
118,176
|
|
|
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 allocated facilities and depreciation of equipment.
|
|
Year Ended December 31,
|
|
Increase
|
||||||||
|
2015
|
|
2014
|
|
(Decrease)
|
||||||
Research and development expenses
|
$
|
48,959
|
|
|
$
|
26,071
|
|
|
$
|
22,888
|
|
General and administrative expenses
|
15,755
|
|
|
12,699
|
|
|
3,056
|
|
|||
Restructuring costs
|
—
|
|
|
334
|
|
|
(334
|
)
|
|||
Other income/(expense), net
|
170
|
|
|
(77
|
)
|
|
247
|
|
|||
Change in fair value of warrant liability
|
—
|
|
|
(4,517
|
)
|
|
4,517
|
|
|
Year Ended December 31,
|
|
Increase
|
||||||||
|
2015
|
|
2014
|
|
(Decrease)
|
||||||
Third-party development expense:
|
|
|
|
|
|
||||||
MGCD265
|
$
|
21,699
|
|
|
$
|
7,273
|
|
|
$
|
14,426
|
|
MGCD516
|
3,250
|
|
|
2,932
|
|
|
318
|
|
|||
Mocetinostat
|
5,371
|
|
|
4,507
|
|
|
864
|
|
|||
MGCD 290*
|
—
|
|
|
123
|
|
|
(123
|
)
|
|||
Total third-party development expense
|
30,320
|
|
|
14,835
|
|
|
15,485
|
|
|||
Internal research and development expense
|
18,639
|
|
|
11,236
|
|
|
7,403
|
|
|||
Research and development expense
|
48,959
|
|
|
26,071
|
|
|
22,888
|
|
|
Year Ended December 31,
|
|
Increase (Decrease)
|
||||||||
|
2014
|
|
2013
|
|
|||||||
Research and development, net
|
$
|
26,071
|
|
|
$
|
19,797
|
|
|
$
|
6,274
|
|
General and administrative
|
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,
|
|||||||
|
2015
|
|
2014
|
|
2013
|
|||
Net cash used in operating activities
|
(50,714
|
)
|
|
(32,748
|
)
|
|
(29,455
|
)
|
Net cash provided by (used in) investing activities
|
(50,753
|
)
|
|
24,219
|
|
|
(29,470
|
)
|
Net cash provided by financing activities
|
144,367
|
|
|
887
|
|
|
54,757
|
|
Increase (decrease) in cash
|
42,900
|
|
|
(7,642
|
)
|
|
(4,168
|
)
|
|
Total
|
|
Less Than 1 year
|
|
1 -3
Years
|
|
3 -5
Years
|
|
More Than 5 Years
|
||||||||||
Operating lease obligations
(1)
|
$
|
627
|
|
|
$
|
296
|
|
|
$
|
331
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Total Contractual Obligations
|
$
|
627
|
|
|
$
|
296
|
|
|
$
|
331
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
Page(s)
|
Consolidated Financial Statements
|
|
|
|
||
Financial Statements:
|
|
|
|
||
|
||
|
||
|
||
|
Montreal, Canada
|
|
/s/Ernst & Young LLP
(1)
|
||
March 17, 2014
|
|
|
|
|
December 31,
|
||||||
|
2015
|
|
2014
|
||||
ASSETS
|
|
|
|
||||
Current assets
|
|
|
|
||||
Cash and cash equivalents
|
$
|
49,493
|
|
|
$
|
6,593
|
|
Short-term investments
|
72,834
|
|
|
22,710
|
|
||
Other current assets
|
3,075
|
|
|
3,354
|
|
||
Total current assets
|
125,402
|
|
|
32,657
|
|
||
Property and equipment, net
|
614
|
|
|
496
|
|
||
Other long-term assets
|
2,001
|
|
|
326
|
|
||
Total assets
|
$
|
128,017
|
|
|
$
|
33,479
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY
|
|
|
|
||||
Current liabilities
|
|
|
|
||||
Accounts payable and accrued liabilities
|
$
|
9,798
|
|
|
$
|
5,396
|
|
Total current liabilities
|
9,798
|
|
|
5,396
|
|
||
Other liability
|
43
|
|
|
21
|
|
||
Total liabilities
|
9,841
|
|
|
5,417
|
|
||
Commitments and contingencies
|
|
|
|
||||
Stockholders' equity
|
|
|
|
||||
Preferred stock, $0.001 par value, 10,000,000 shares authorized; none issued and outstanding at both December 31, 2015 and December 31, 2014
|
—
|
|
|
—
|
|
||
Common stock, $0.001 par value; 100,000,000 authorized; 19,282,935 and 13,566,726 issued and outstanding at December 31, 2015 and December 31, 2014, respectively
|
19
|
|
|
14
|
|
||
Additional paid-in capital
|
415,232
|
|
|
260,616
|
|
||
Accumulated other comprehensive income
|
9,558
|
|
|
9,521
|
|
||
Accumulated deficit
|
(306,633
|
)
|
|
(242,089
|
)
|
||
Total stockholders' equity
|
118,176
|
|
|
28,062
|
|
||
Total liabilities and stockholders' equity
|
$
|
128,017
|
|
|
$
|
33,479
|
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Expenses
|
|
|
|
|
|
||||||
Research and development
|
$
|
48,959
|
|
|
$
|
26,071
|
|
|
$
|
19,797
|
|
General and administrative
|
15,755
|
|
|
12,699
|
|
|
11,177
|
|
|||
Restructuring costs
|
—
|
|
|
334
|
|
|
1,025
|
|
|||
Total operating expenses
|
64,714
|
|
|
39,104
|
|
|
31,999
|
|
|||
Loss from operations
|
(64,714
|
)
|
|
(39,104
|
)
|
|
(31,999
|
)
|
|||
Other income (expense), net
|
170
|
|
|
(77
|
)
|
|
(1,084
|
)
|
|||
Change in fair value of warrant liability
|
—
|
|
|
(4,517
|
)
|
|
(19,799
|
)
|
|||
Loss before income taxes
|
(64,544
|
)
|
|
(43,698
|
)
|
|
(52,882
|
)
|
|||
Income tax benefit
|
—
|
|
|
—
|
|
|
23
|
|
|||
Net loss
|
$
|
(64,544
|
)
|
|
$
|
(43,698
|
)
|
|
$
|
(52,859
|
)
|
Unrealized gain (loss) on available-for-sale investments
|
$
|
37
|
|
|
$
|
14
|
|
|
$
|
(13
|
)
|
Comprehensive loss
|
$
|
(64,507
|
)
|
|
$
|
(43,684
|
)
|
|
$
|
(52,872
|
)
|
Basic and diluted net loss per share
|
$
|
(3.82
|
)
|
|
$
|
(3.24
|
)
|
|
$
|
(4.78
|
)
|
Weighted average common shares outstanding, basic and diluted
|
16,901,826
|
|
|
13,483,467
|
|
|
11,057,040
|
|
|
Common Stock
|
|
Common
Stock
Warrants
|
|
Additional
paid-in
capital
|
|
Accumulated
other
comprehensive
income
|
|
Accumulated
deficit
|
|
Total
stockholders'
equity
|
|||||||||||||||
|
Shares
|
|
Amount
|
|
|
|
|
|
||||||||||||||||||
Balance at January 1, 2013
|
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
|
)
|
||||||
Share-based compensation expense
|
—
|
|
|
—
|
|
|
—
|
|
|
7,050
|
|
|
—
|
|
|
—
|
|
|
7,050
|
|
||||||
Reclassification of warrants from liability
|
—
|
|
|
—
|
|
|
—
|
|
|
36,931
|
|
|
—
|
|
|
—
|
|
|
36,931
|
|
||||||
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
|
|
Net loss for the year
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(64,544
|
)
|
|
(64,544
|
)
|
||||||
Share-based compensation expense
|
—
|
|
|
—
|
|
|
—
|
|
|
10,254
|
|
|
—
|
|
|
—
|
|
|
10,254
|
|
||||||
Issuance of common stock, net of costs
|
4,837,500
|
|
|
4
|
|
|
—
|
|
|
143,289
|
|
|
—
|
|
|
—
|
|
|
143,293
|
|
||||||
Issuance of common stock from ESPP purchase
|
32,645
|
|
|
—
|
|
|
—
|
|
|
522
|
|
|
—
|
|
|
—
|
|
|
522
|
|
||||||
Exercise of options for cash
|
36,566
|
|
|
—
|
|
|
—
|
|
|
552
|
|
|
—
|
|
|
—
|
|
|
552
|
|
||||||
Net exercise of warrants
|
809,498
|
|
|
1
|
|
|
—
|
|
|
(1
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Unrealized gain on investments
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
37
|
|
|
—
|
|
|
37
|
|
||||||
Balance at December 31, 2015
|
19,282,935
|
|
|
$
|
19
|
|
|
$
|
—
|
|
|
$
|
415,232
|
|
|
$
|
9,558
|
|
|
$
|
(306,633
|
)
|
|
$
|
118,176
|
|
|
Years Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Operating activities:
|
|
|
|
|
|
||||||
Net loss
|
$
|
(64,544
|
)
|
|
$
|
(43,698
|
)
|
|
$
|
(52,859
|
)
|
Non-cash adjustments reconciling net loss to operating cash flows
|
|
|
|
|
|
||||||
Depreciation of property and equipment
|
212
|
|
|
199
|
|
|
171
|
|
|||
Amortization of premium on investments
|
337
|
|
|
534
|
|
|
—
|
|
|||
Share-based compensation expense
|
10,254
|
|
|
7,050
|
|
|
1,823
|
|
|||
Loss on disposal of property and equipment
|
—
|
|
|
—
|
|
|
40
|
|
|||
Change in lease incentive liability
|
—
|
|
|
—
|
|
|
(70
|
)
|
|||
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
|
279
|
|
|
(1,209
|
)
|
|
340
|
|
|||
Other long-term assets
|
(1,675
|
)
|
|
(326
|
)
|
|
—
|
|
|||
Accounts payable and accrued liabilities
|
4,370
|
|
|
151
|
|
|
(68
|
)
|
|||
Other current and long term liabilities
|
53
|
|
|
21
|
|
|
—
|
|
|||
Cash flows used in operating activities
|
(50,714
|
)
|
|
(32,748
|
)
|
|
(29,455
|
)
|
|||
Investing activities:
|
|
|
|
|
|
||||||
Purchases of short-term investments
|
(104,954
|
)
|
|
(10,468
|
)
|
|
(68,408
|
)
|
|||
Disposal and maturities of short-term investments
|
54,530
|
|
|
35,073
|
|
|
39,138
|
|
|||
Purchases of property and equipment
|
(329
|
)
|
|
(386
|
)
|
|
(204
|
)
|
|||
Proceeds from disposal of property and equipment
|
—
|
|
|
—
|
|
|
4
|
|
|||
Cash flows (used in) provided by investing activities
|
(50,753
|
)
|
|
24,219
|
|
|
(29,470
|
)
|
|||
Financing activities:
|
|
|
|
|
|
||||||
Proceeds from issuance of common stock, net of issuance costs
|
143,293
|
|
|
—
|
|
|
54,196
|
|
|||
Proceeds from issuance under employee stock purchase plan
|
522
|
|
|
—
|
|
|
—
|
|
|||
Proceeds from exercise of common stock options and warrants
|
552
|
|
|
887
|
|
|
561
|
|
|||
Cash flows provided by financing activities
|
144,367
|
|
|
887
|
|
|
54,757
|
|
|||
Increase (decrease) in cash and cash equivalents
|
42,900
|
|
|
(7,642
|
)
|
|
(4,168
|
)
|
|||
Cash and cash equivalents, beginning of year
|
6,593
|
|
|
14,235
|
|
|
18,403
|
|
|||
Cash and cash equivalents, end of year
|
$
|
49,493
|
|
|
$
|
6,593
|
|
|
$
|
14,235
|
|
|
|
|
|
|
|
||||||
Supplemental disclosures of cash flow information:
|
|
|
|
|
|
||||||
Income taxes paid
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
35
|
|
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, 2015
|
||||||||||||||
|
Total
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||
Assets
|
|
|
|
|
|
|
|
||||||||
Cash and cash equivalents:
|
|
|
|
|
|
|
|
||||||||
Cash
|
$
|
757
|
|
|
$
|
757
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Money market funds
|
18,875
|
|
|
18,875
|
|
|
—
|
|
|
—
|
|
||||
Corporate debt securities
|
6,749
|
|
|
—
|
|
|
6,749
|
|
|
—
|
|
||||
Commercial paper
|
22,994
|
|
|
|
|
22,994
|
|
|
|
||||||
Total cash and cash equivalents
|
49,375
|
|
|
19,632
|
|
|
29,743
|
|
|
—
|
|
||||
|
|
|
|
|
|
|
|
||||||||
Short-term investments:
|
|
|
|
|
|
|
|
||||||||
Corporate debt securities
|
27,622
|
|
|
—
|
|
|
27,622
|
|
|
—
|
|
||||
Commercial paper
|
45,212
|
|
|
—
|
|
|
45,212
|
|
|
—
|
|
||||
Total short-term investments
|
72,834
|
|
|
—
|
|
|
72,834
|
|
|
—
|
|
||||
|
|
|
|
|
|
|
|
||||||||
Total
|
$
|
122,209
|
|
|
$
|
19,632
|
|
|
$
|
102,577
|
|
|
$
|
—
|
|
|
December 31, 2014
|
||||||||||||||
|
Total
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||
Assets
|
|
|
|
|
|
|
|
||||||||
Cash and cash equivalents:
|
|
|
|
|
|
|
|
||||||||
Cash
|
$
|
1,025
|
|
|
$
|
1,025
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Money market funds
|
3,565
|
|
|
3,565
|
|
|
—
|
|
|
—
|
|
||||
Corporate debt securities
|
2,003
|
|
|
—
|
|
|
2,003
|
|
|
—
|
|
||||
Total cash and cash equivalents
|
6,593
|
|
|
4,590
|
|
|
2,003
|
|
|
—
|
|
||||
|
|
|
|
|
|
|
|
||||||||
Short-term investments:
|
|
|
|
|
|
|
|
||||||||
Corporate debt securities
|
21,210
|
|
|
—
|
|
|
21,210
|
|
|
—
|
|
||||
Commercial paper
|
1,500
|
|
|
—
|
|
|
1,500
|
|
|
—
|
|
||||
Total short-term investments
|
22,710
|
|
|
—
|
|
|
22,710
|
|
|
—
|
|
||||
|
|
|
|
|
|
|
|
||||||||
Total
|
$
|
29,303
|
|
|
$
|
4,590
|
|
|
$
|
24,713
|
|
|
$
|
—
|
|
|
|
|
As of December 31, 2015
|
|||||||||||||||
|
Maturity (in years)
|
|
Amortized cost
|
|
Gross unrealized gains
|
|
Gross unrealized losses
|
|
Estimated fair value
|
|||||||||
Corporate debt securities
|
1 year or less
|
|
$
|
27,644
|
|
|
$
|
—
|
|
|
$
|
(22
|
)
|
|
$
|
27,622
|
|
|
Commercial paper
|
1 year or less
|
|
45,158
|
|
|
54
|
|
|
—
|
|
|
45,212
|
|
|||||
|
|
|
$
|
72,802
|
|
|
$
|
54
|
|
|
$
|
(22
|
)
|
|
$
|
72,834
|
|
|
|
|
As of December 31, 2014
|
|||||||||||||||
|
Maturity (in years)
|
|
Amortized cost
|
|
Gross unrealized gains
|
|
Gross unrealized losses
|
|
Estimated fair value
|
|||||||||
Corporate debt securities
|
1 year or less
|
|
$
|
21,208
|
|
|
$
|
3
|
|
|
$
|
(1
|
)
|
|
$
|
21,210
|
|
|
Commercial paper
|
1 year or less
|
|
1,500
|
|
|
—
|
|
|
—
|
|
|
1,500
|
|
|||||
|
|
|
$
|
22,708
|
|
|
$
|
3
|
|
|
$
|
(1
|
)
|
|
$
|
22,710
|
|
|
December 31,
|
||||||
|
2015
|
|
2014
|
||||
Prepaid expenses
|
$
|
2,287
|
|
|
$
|
1,827
|
|
Refundable research and development tax credits
|
—
|
|
|
809
|
|
||
Deposits and other receivables
|
551
|
|
|
622
|
|
||
Interest receivables
|
237
|
|
|
96
|
|
||
|
$
|
3,075
|
|
|
$
|
3,354
|
|
|
December 31,
|
||||||
|
2015
|
|
2014
|
||||
Computer equipment
|
$
|
329
|
|
|
$
|
329
|
|
Office and other equipment
|
256
|
|
|
56
|
|
||
Laboratory equipment
|
425
|
|
|
346
|
|
||
Leasehold improvements
|
51
|
|
|
—
|
|
||
Gross property and equipment
|
1,061
|
|
|
731
|
|
||
Less: Accumulated depreciation
|
(447
|
)
|
|
(235
|
)
|
||
Net property and equipment
|
$
|
614
|
|
|
$
|
496
|
|
|
December 31,
|
||||||
|
2015
|
|
2014
|
||||
Accounts payable
|
$
|
2,104
|
|
|
$
|
1,655
|
|
Accrued expenses
|
5,311
|
|
|
2,327
|
|
||
Accrued compensation and benefits
|
2,352
|
|
|
1,414
|
|
||
Other current liabilities
|
31
|
|
|
—
|
|
||
|
$
|
9,798
|
|
|
$
|
5,396
|
|
|
December 31,
|
|
|
2015
|
|
Common stock options outstanding and available for future grant
|
3,354,541
|
|
Warrants to purchase common stock
|
1,428,383
|
|
Employee Stock Purchase Plan
|
267,355
|
|
|
5,050,279
|
|
Issue date
|
|
Expiration date
|
|
Exercise price
|
|
Number of warrants outstanding
|
|||
April 4, 2011
|
|
April 4, 2016
|
|
$
|
6.74
|
|
|
733,000
|
|
November 21, 2012
|
|
November 21, 2017
|
|
$
|
7.86
|
|
|
695,383
|
|
|
|
|
|
|
|
1,428,383
|
|
|
Number of
options
|
|
Weighted
average
exercise
price
|
|
Weighted-Average Remaining Contractual Term (years)
|
|
Aggregate Intrinsic Value (millions)
|
|||||
Balance outstanding as of December 31, 2014
|
1,454,860
|
|
|
$
|
14.00
|
|
|
|
|
|
||
Granted
|
525,091
|
|
|
$
|
24.21
|
|
|
|
|
|
||
Exercised
|
(36,566
|
)
|
|
$
|
14.91
|
|
|
|
|
|
||
Canceled/forfeited
|
(10,505
|
)
|
|
$
|
24.35
|
|
|
|
|
|
||
Balance outstanding as of December 31, 2015
|
1,932,880
|
|
|
$
|
16.71
|
|
|
7.1
|
|
$
|
28.93
|
|
Options exercisable at December 31, 2015
|
861,598
|
|
|
$
|
13.82
|
|
|
6.1
|
|
$
|
15.32
|
|
Options vested and expected to vest at December 31, 2015
|
1,932,880
|
|
|
$
|
16.71
|
|
|
7.1
|
|
$
|
28.93
|
|
|
Year ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Research and development expense
|
$
|
3,669
|
|
|
$
|
2,565
|
|
|
$
|
245
|
|
General and administrative expense
|
6,585
|
|
|
4,485
|
|
|
2,947
|
|
|||
|
$
|
10,254
|
|
|
$
|
7,050
|
|
|
$
|
3,192
|
|
|
Year ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Current:
|
|
|
|
|
|
||||||
Federal
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(23
|
)
|
State
|
—
|
|
|
—
|
|
|
—
|
|
|||
Canada
|
—
|
|
|
—
|
|
|
—
|
|
|||
Total current tax benefit
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(23
|
)
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Net loss before tax
|
$
|
(64,544
|
)
|
|
$
|
(43,698
|
)
|
|
$
|
(52,882
|
)
|
Statutory combined US federal and state tax rate
|
34.00
|
%
|
|
39.83
|
%
|
|
39.83
|
%
|
|||
Statutory federal and state taxes
|
(21,945
|
)
|
|
(17,405
|
)
|
|
(21,063
|
)
|
|||
Increase (decrease) in taxes recoverable resulting from:
|
|
|
|
|
|
||||||
Effect of change in valuation allowance
|
22,350
|
|
|
12,273
|
|
|
8,537
|
|
|||
Non-deductible share-based compensation
|
923
|
|
|
930
|
|
|
1,085
|
|
|||
Non-deductible warrant expenses for tax purposes
|
—
|
|
|
1,799
|
|
|
8,403
|
|
|||
Tax credits
|
(1,814
|
)
|
|
(180
|
)
|
|
(96
|
)
|
|||
Share issue costs - temporary difference
|
(184
|
)
|
|
(184
|
)
|
|
(184
|
)
|
|||
Share issue costs - permanent difference
|
—
|
|
|
—
|
|
|
206
|
|
|||
Differential in income tax rates of foreign subsidiary
|
31
|
|
|
3,047
|
|
|
3,059
|
|
|||
Other differences
|
639
|
|
|
(280
|
)
|
|
30
|
|
|||
Income tax benefit
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(23
|
)
|
|
December 31,
|
||||||
|
2015
|
|
2014
|
||||
Deferred tax assets:
|
|
|
|
||||
Tangible and intangible depreciable assets
|
$
|
199
|
|
|
$
|
185
|
|
Stock compensation
|
4,429
|
|
|
2,360
|
|
||
Manufactured drug product inventory to be used in research
|
—
|
|
|
1,425
|
|
||
Provisions
|
725
|
|
|
554
|
|
||
Financing fees
|
78
|
|
|
261
|
|
||
Net operating loss carry forwards
|
42,864
|
|
|
23,243
|
|
||
Capital loss carryforward
|
102
|
|
|
—
|
|
||
Scientific research and experimental development expenditures
|
5,552
|
|
|
5,715
|
|
||
Research and development tax credits
|
2,411
|
|
|
266
|
|
||
Total gross deferred tax assets
|
56,360
|
|
|
34,009
|
|
||
Less valuation allowance
|
(56,360
|
)
|
|
(34,009
|
)
|
||
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
|
3,236
|
|
|
2,286
|
|
|
18,623
|
|
|
19,385
|
|
||||
2034
|
7,276
|
|
|
22,162
|
|
|
32,401
|
|
|
31,809
|
|
||||
2035
|
53,341
|
|
|
—
|
|
|
1,117
|
|
|
1,116
|
|
||||
|
$
|
63,853
|
|
|
$
|
24,448
|
|
|
$
|
78,419
|
|
|
$
|
77,794
|
|
|
Federal
|
|
Provincial/State
|
||||||||||||||||||||
|
December 31,
|
|
December 31,
|
||||||||||||||||||||
|
2015
|
|
2014
|
|
2013
|
|
2015
|
|
2014
|
|
2013
|
||||||||||||
Unrecognized tax positions, beginning of year
|
$
|
42
|
|
|
$
|
35
|
|
|
$
|
43
|
|
|
$
|
18
|
|
|
$
|
6
|
|
|
$
|
2
|
|
Gross increase — current period tax positions
|
445
|
|
|
35
|
|
|
—
|
|
|
259
|
|
|
12
|
|
|
—
|
|
||||||
Gross decrease — prior period tax positions
|
(4
|
)
|
|
(28
|
)
|
|
(13
|
)
|
|
(3
|
)
|
|
—
|
|
|
—
|
|
||||||
Gross increase — prior period tax positions
|
26
|
|
|
—
|
|
|
5
|
|
|
2,000
|
|
|
—
|
|
|
4
|
|
||||||
Unrecognized tax positions, end of year
|
$
|
509
|
|
|
$
|
42
|
|
|
$
|
35
|
|
|
$
|
2,274
|
|
|
$
|
18
|
|
|
$
|
6
|
|
|
FEDERAL ITC
|
||
Expires in:
|
|
||
2030
|
$
|
764
|
|
2031
|
1,000
|
|
|
2032
|
1,125
|
|
|
2033
|
1,018
|
|
|
|
$
|
3,907
|
|
Year Ending December 31:
|
|||
2016
|
$
|
296
|
|
2017
|
305
|
|
|
2018
|
26
|
|
|
Thereafter
|
—
|
|
|
Total minimum lease payments
|
$
|
627
|
|
|
Three Months Ended
|
|
Year Ended
|
||||||||||||||||
|
3/31/15
|
6/30/15
|
9/30/15
|
12/31/15
|
|
December 31, 2015
|
|||||||||||||
Operating Loss
|
$
|
(11,986
|
)
|
|
$
|
(15,516
|
)
|
|
$
|
(18,724
|
)
|
|
$
|
(18,488
|
)
|
|
$
|
(64,714
|
)
|
Net loss
|
(11,940
|
)
|
|
(15,446
|
)
|
|
(18,741
|
)
|
|
(18,417
|
)
|
|
(64,544
|
)
|
|||||
Per common share:
|
|
|
|
|
|
|
|
|
|
||||||||||
Loss per share, basic
(1)
|
$
|
(0.77
|
)
|
|
$
|
(0.95
|
)
|
|
$
|
(1.11
|
)
|
|
$
|
(0.96
|
)
|
|
$
|
(3.82
|
)
|
Loss per share, diluted
(1)
|
(0.77
|
)
|
|
(0.95
|
)
|
|
(1.11
|
)
|
|
(0.96
|
)
|
|
(3.82
|
)
|
|||||
|
|
|
|||||||||||||||||
|
Three Months Ended
|
|
Year Ended
|
||||||||||||||||
|
3/31/14
|
6/30/14
|
9/30/14
|
12/31/14
|
|
December 31, 2014
|
|||||||||||||
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)
|
$
|
(1.01
|
)
|
|
$
|
(0.82
|
)
|
|
$
|
(0.64
|
)
|
|
$
|
(0.77
|
)
|
|
$
|
(3.24
|
)
|
Loss per share, diluted
(1)
|
(1.01
|
)
|
|
(0.82
|
)
|
|
(0.72
|
)
|
|
(0.77
|
)
|
|
(3.24
|
)
|
|
|
MIRATI THERAPEUTICS, INC.
|
|
|
|
Date: March 9, 2016
|
by:
|
/s/ Charles M. Baum, M.D., Ph.D.
|
|
|
Chief Executive Officer
|
|
|
|
|
|
|
Date: March 9, 2016
|
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 9, 2016
|
Charles M. Baum, M.D., Ph.D.
|
|
|
|
|
|
|
|
|
|
/S/ MARK J. GERGEN
|
|
Executive Vice President, Chief Operations Officer (Principal Financial Officer)
|
|
March 9, 2016
|
Mark J. Gergen
|
|
|
|
|
|
|
|
|
|
/S/ JAMIE A. DONADIO
|
|
Vice President, Finance (Principal Accounting Officer)
|
|
March 9, 2016
|
Jamie A. Donadio
|
|
|
|
|
|
|
|
|
|
/S/ RODNEY LAPPE
|
|
Chairman of the Board
|
|
March 9, 2016
|
Rodney Lappe, Ph.D.
|
|
|
|
|
|
|
|
|
|
/S/ MICHAEL GREY
|
|
Director
|
|
March 9, 2016
|
Michael Grey
|
|
|
|
|
|
|
|
|
|
/S/ HENRY J. FUCHS
|
|
Director
|
|
March 9, 2016
|
Henry J. Fuchs, M.D.
|
|
|
|
|
|
|
|
|
|
/S/ CRAIG JOHNSON
|
|
Director
|
|
March 9, 2016
|
Craig Johnson
|
|
|
|
|
|
|
|
|
|
/S/ WILLIAM R. RINGO
|
|
Director
|
|
March 9, 2016
|
William R. Ringo
|
|
|
|
|
|
|
|
|
|
+
|
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.
|
(7)
|
Incorporated by reference to Mirati Therapeutics, Inc.’s Annual Report on Form 10-K for the year ended December 31, 2014, filed with the Securities and Exchange Commission on March 9, 2015.
|
1.
|
Annual Board Service Retainer
:
|
(1)
|
Registration Statement (Form S-3 No. 333-207848) of Mirati Therapeutics, Inc.,
|
(2)
|
Registration Statement (Form S-3 No. 333-206965) of Mirati Therapeutics, Inc.,
|
(3)
|
Registration Statement (Form S-3 No. 333-198678) of Mirati Therapeutics, Inc.,
|
(4)
|
Registration Statement (Form S-8 No. 333-204720) pertaining to the 2013 Equity Incentive Plan of Mirati Therapeutics, Inc.,
|
(5)
|
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., and
|
(6)
|
Registration Statement (Form S-8 No. 333-196487) pertaining to the 2013 Equity Incentive Plan of Mirati Therapeutics Inc.;
|
|
|
|
/s/ Ernst & Young LLP
|
|
San Diego, California
|
|
|
|
|
March 9, 2016
|
|
|
|
|
|
|
|
|
|
Consent of Independent Registered Public Accounting Firm
|
(1)
|
Registration Statement (Form S-3 No. 333-207848) of Mirati Therapeutics, Inc.,
|
(2)
|
Registration Statement (Form S-3 No. 333-206965) of Mirati Therapeutics, Inc.,
|
(3)
|
Registration Statement (Form S-3 No. 333-198678) of Mirati Therapeutics, Inc.,
|
(4)
|
Registration Statement (Form S-8 No. 333-204720) pertaining to the 2013 Equity Incentive Plan of Mirati Therapeutics, Inc.,
|
(5)
|
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., and
|
(6)
|
Registration Statement (Form S-8 No. 333-196487) pertaining to the 2013 Equity Incentive Plan of Mirati Therapeutics Inc.;
|
|
|
|
/s/ Ernst & Young LLP
1
|
|
March 9, 2016
|
|
|
|
|
Montreal, Canada
|
|
|
|
|
Date: March 9, 2016
|
/s/ Charles M. Baum
|
|
Charles M. Baum
|
|
President and Chief Executive Officer
|
|
(Principal Executive Officer)
|
Date: March 9, 2016
|
|
/s/ Mark J. Gergen
|
|
|
Mark J. Gergen
|
|
|
Executive Vice President and Chief Operations Officer
|
|
|
(Principal Financial Officer)
|
/s/ Charles M. Baum
|
|
/s/ Mark J. Gergen
|
Charles M. Baum
|
|
Mark J. Gergen
|
President and Chief Executive Officer
(Principal Executive Officer)
|
|
Executive Vice President and Chief Operations Officer
(Principal Financial Officer)
|