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
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92121
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San Diego
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(Zip Code)
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California
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(Address of principal executive offices)
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Title of Each Class
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Trading Symbol
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Name of Each Exchange on Which Registered
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Common Stock, Par value $0.001 per share
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MRTX
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The Nasdaq Stock Market LLC
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Large accelerated filer
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☒
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Accelerated filer
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☐
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Non-accelerated filer
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☐
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Smaller reporting company
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☐
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Emerging growth 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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Item 16.
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Form 10-K Summary
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SIGNATURES
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|
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•
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At the highest dose (600 mg BID), three of five evaluable patients with NSCLC and one of two evaluable patients with CRC achieved a Partial Response ("PR"), and the remaining patients experienced stable disease.
|
•
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Across all dose levels, three of six patients with NSCLC and one of four patients with CRC achieved a PR. Two responding patients (one with NSCLC and one with CRC) achieved confirmed PRs, both with continuing tumor shrinkage following their first scan. The other two patients with PRs (both NSCLC) remain on study but have not yet had confirmatory scans.
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•
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Clinical PK data demonstrated that the dose of 600 mg BID results in drug levels that meet or exceed those likely to lead to full inhibition of KRAS G12C signaling.
|
•
|
Treatment duration across all dose levels ranged from 6.7- 38.6 weeks for patients with NSCLC and 9.9-30.1 weeks for patients with CRC as of the data cut-off.
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•
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56 patients were evaluable for response with at least one radiographic scan. Patients had a median of two lines of previous therapy;
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•
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45 of 56 evaluable patients demonstrated tumor reductions; 18 of whom demonstrated tumor reductions greater than 30%;
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•
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11 of 56 evaluable patients achieved a confirmed PR or Complete Response ("CR");
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•
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26 of 56 evaluable patients remained on treatment at the time of data cut-off including eight responding patients;
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•
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a preliminary Kaplan-Meier estimate of median duration of response was greater than nine months, with six responding patients treated for more than six months and two responding patients treated for more than 12 months; and
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•
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the combination has shown an acceptable toxicity profile, and most adverse events reported by investigators were Grade 1 or 2.
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•
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as of the data cut-off date of October 17, 2019, 22 patients were evaluable for response with at least one radiographic scan;
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•
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6 of 22 evaluable patients achieved a confirmed CR (1 patient) or PR (5 patients);
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•
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21 of 22 evaluable patients achieved a confirmed CR, PR, or stable disease;
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•
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4 responding patients had been treated for more than 6 months; and
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•
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the combination was well-tolerated and most adverse events were Grade 1 or 2.
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•
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completion of preclinical laboratory tests, animal studies and formulation studies in compliance with good laboratory practice, or GLP, regulations;
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•
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submission to the FDA of an IND, which must become effective before human clinical trials may begin;
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•
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performance of adequate and well-controlled human clinical trials in accordance with GCP standards and regulations to establish the safety and efficacy of the proposed drug for each indication;
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•
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submission to the FDA of an NDA;
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•
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satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the product is produced to assess compliance with cGMP requirements and to assure that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality and purity; and
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•
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FDA review and approval of the NDA.
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•
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the success of our clinical trials through all phases of clinical development;
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•
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delays in the commencement, enrollment and timing of clinical trials;
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•
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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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•
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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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•
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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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•
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competition from existing products or new products that may receive marketing approval;
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•
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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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•
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any delays in regulatory review and approval of our clinical development plans or product candidates;
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•
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our ability to identify and develop additional product candidates;
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•
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the ability of patients or healthcare providers to obtain coverage or sufficient reimbursement for our products;
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•
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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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•
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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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•
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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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•
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costs related to and outcomes of potential intellectual property litigation;
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•
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our ability to adequately support future growth;
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•
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our ability to attract and retain key personnel to manage our business effectively; and
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•
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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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•
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completing development and clinical trial programs for our product candidates;
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•
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maintaining existing collaboration and licensing agreements and entering into additional ones;
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•
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seeking and obtaining marketing approvals for any product candidates that successfully complete clinical trials;
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•
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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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•
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successfully establishing a sales force and marketing and distribution infrastructure.
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•
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BeiGene may not comply with applicable regulatory guidelines with respect to developing, manufacturing or commercializing sitravatinib, which could adversely impact sales or future development of sitravatinib in the BeiGene Territory or elsewhere;
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•
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We and BeiGene could disagree as to future development plans and BeiGene may delay, fail to commence or stop future clinical trials or other development;
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•
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There may be disputes between us and BeiGene, including disagreements regarding the BeiGene Agreement, that may result in (1) the delay of or failure to achieve developmental, regulatory and commercial objectives that would result in milestone or royalty payments, (2) the delay or termination of any future development or commercialization of sitravatinib in the BeiGene Territory, and/or (3) costly litigation or arbitration that diverts our management’s attention and resources;
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•
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BeiGene may not provide us with timely and accurate information regarding development, sales and marketing activities or supply forecasts, which could adversely impact our ability to comply with our obligations to BeiGene and manage our own inventory of sitravatinib, as well as our ability to generate accurate financial forecasts;
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•
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Business combinations or significant changes in BeiGene’ business strategy may adversely affect BeiGene’ ability or willingness to perform its obligations under the BeiGene Agreement; and
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•
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BeiGene may not properly defend our intellectual property rights, or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property rights or expose us to potential litigation.
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•
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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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•
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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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•
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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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•
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inability to raise funding necessary to initiate or continue a trial;
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•
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delays in obtaining regulatory approval to commence a trial;
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•
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delays in reaching agreement with the FDA on final trial design;
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•
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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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•
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delays in reaching agreement on acceptable terms with prospective CROs and clinical trial sites;
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•
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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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•
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delays caused by subjects dropping out of a trial due to side effects or otherwise;
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•
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clinical sites dropping out of a trial to the detriment of enrollment;
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•
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time required to add new clinical sites; and
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•
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delays by our contract manufacturers to produce and deliver a sufficient supply of clinical trial materials.
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•
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the severity of the disease under investigation
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•
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the frequency of the genetic alteration we are seeking to target in the applicable trial, and the ability to effectively identify such alteration;
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•
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the willingness of clinical sites and principal investigators to subject candidate patients to genetic screening;
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•
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the eligibility criteria for the study in question;
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•
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the perceived risks and benefits of the product candidate under study;
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•
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the availability, effectiveness and safety of other treatment options;
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•
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the patient referral practices of physicians;
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•
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the ability to monitor patients adequately during and after treatment; and
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•
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the proximity and availability of a sufficient number of clinical trial sites that are willing to comply with the requirements of our clinical protocols.
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•
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regulatory authorities may withdraw approvals of such product;
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•
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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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•
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we could be sued and held liable for harm caused to patients; and
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•
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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 Council for 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
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•
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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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•
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demonstration of the clinical efficacy and safety of our products;
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•
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the prevalence and severity of any adverse side effects;
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•
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limitations or warnings contained in the product’s approved labeling;
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•
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cost-effectiveness and availability of acceptable pricing;
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•
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competitive product profile versus alternative treatment methods and the superiority of alternative treatment or therapeutics;
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•
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the effectiveness of marketing and distribution methods and support for the products; and
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•
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the availability of coverage and adequate reimbursement from third-party payors to the extent that our products receive regulatory approval.
|
•
|
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, lease, furnishing, prescribing or recommendation of, any good or service, for which payment may be made under federal and state healthcare programs, such as Medicare and Medicaid. The term “remuneration” has been broadly interpreted to include anything of value. The ACA, among other things, amended the intent requirement of the federal Anti‑Kickback Statute such that a person or entity no longer needs to have actual knowledge of the statute or specific intent to violate, in order to commit a violation;
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•
|
federal civil and criminal false claims laws, including the federal False Claims Act which can be enforced by private individuals on behalf of the government through civil whistleblower or qui tam actions, and civil monetary penalty laws prohibit 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. Entities can be held liable under these laws if they are deemed to “cause” the submission of false or fraudulent claims by, for example, providing inaccurate billing or coding information to customers, promoting a product off‑label, or for providing medically unnecessary services or items. In addition, a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal False Claims Act;
|
•
|
the federal Health Insurance Portability and Accountability Act of 1996 ("HIPAA"), which imposes criminal and civil liability for knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including third-party payors, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense, and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statements in connection with the delivery of or payment for healthcare benefits, items or services;
|
•
|
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 certain healthcare providers, health plans, and healthcare clearinghouses, known as covered entities, as well as individuals and entities that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity, known as business associates, with respect to safeguarding the privacy, security and transmission of individually identifiable health information. HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in U.S. federal courts to enforce the federal HIPAA laws and seek attorneys' fees and costs associated with pursuing federal civil actions;
|
•
|
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 ownership and investment interests held by such healthcare professionals and their immediate family members. Beginning in 2022,
|
•
|
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, marketing expenditures, or drug pricing; state and local laws that require the registration of pharmaceutical sales representatives; 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.
|
•
|
decreased demand for our product candidates;
|
•
|
injury to our reputation;
|
•
|
withdrawal of clinical trial participants;
|
•
|
initiation of investigations by regulators;
|
•
|
costs to defend the related litigation;
|
•
|
a diversion of management’s time and our resources;
|
•
|
substantial monetary awards to trial participants or patients;
|
•
|
product recalls, withdrawals or labeling, marketing or promotional restrictions;
|
•
|
loss of revenue from product sales; and
|
•
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the inability to commercialize any of our product candidates, if approved.
|
|
Year Ended December 31,
|
||||||||||||||||||
|
2019
|
|
2018
|
|
2017
|
|
2016
|
|
2015
|
||||||||||
|
(in thousands, except share and per share amounts)
|
||||||||||||||||||
Statements of Operations Data:
|
|
|
|
|
|
|
|
|
|
||||||||||
License and collaboration revenues
|
$
|
3,335
|
|
|
$
|
12,926
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Loss from operations
|
(222,104
|
)
|
|
(102,627
|
)
|
|
(71,535
|
)
|
|
(83,779
|
)
|
|
(64,714
|
)
|
|||||
Net loss
|
(213,256
|
)
|
|
(98,418
|
)
|
|
(70,430
|
)
|
|
(83,118
|
)
|
|
(64,544
|
)
|
|||||
Comprehensive loss
|
(212,846
|
)
|
|
(98,418
|
)
|
|
(70,484
|
)
|
|
(83,143
|
)
|
|
(64,507
|
)
|
|||||
Basic and diluted net loss per share
|
$
|
(5.69
|
)
|
|
$
|
(3.19
|
)
|
|
$
|
(2.78
|
)
|
|
$
|
(4.20
|
)
|
|
$
|
(3.82
|
)
|
Weighted average common shares outstanding, basic and diluted
|
37,467,505
|
|
|
30,897,717
|
|
|
25,290,222
|
|
|
19,787,349
|
|
|
16,901,826
|
|
|
As of December 31,
|
||||||||||||||||||
|
2019
|
|
2018
|
|
2017
|
|
2016
|
|
2015
|
||||||||||
|
(in thousands)
|
||||||||||||||||||
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
||||||||||
Cash, cash equivalents and short-term investments
|
$
|
415,050
|
|
|
$
|
222,790
|
|
|
$
|
150,837
|
|
|
$
|
56,734
|
|
|
$
|
122,327
|
|
Working capital
|
375,501
|
|
|
200,514
|
|
|
142,115
|
|
|
44,553
|
|
|
115,604
|
|
|||||
Total assets
|
432,200
|
|
|
228,454
|
|
|
157,246
|
|
|
63,444
|
|
|
128,017
|
|
|||||
Accumulated deficit
|
(772,301
|
)
|
|
(559,045
|
)
|
|
(460,627
|
)
|
|
(389,751
|
)
|
|
(306,633
|
)
|
|||||
Total stockholders' equity
|
$
|
382,295
|
|
|
$
|
201,576
|
|
|
$
|
143,288
|
|
|
$
|
48,309
|
|
|
$
|
118,176
|
|
•
|
At the highest dose (600 mg BID), three of five evaluable patients with NSCLC and one of two evaluable patients with CRC achieved a Partial Response ("PR"), and the remaining patients experienced stable disease.
|
•
|
Across all dose levels, three of six patients with NSCLC and one of four patients with CRC achieved a PR. Two responding patients (one with NSCLC and one with CRC) achieved confirmed PRs, both with continuing tumor shrinkage following their first scan. The other two patients with PRs (both NSCLC) remain on study but have not yet had confirmatory scans.
|
•
|
Clinical PK data demonstrated that the dose of 600 mg BID results in drug levels that meet or exceed those likely to lead to full inhibition of KRAS G12C signaling.
|
•
|
Treatment duration across all dose levels ranged from 6.7- 38.6 weeks for patients with NSCLC and 9.9-30.1 weeks for patients with CRC as of the data cut-off.
|
•
|
56 patients were evaluable for response with at least one radiographic scan. Patients had a median of two lines of previous therapy;
|
•
|
45 of 56 evaluable patients demonstrated tumor reductions; 18 of whom demonstrated tumor reductions greater than 30%;
|
•
|
11 of 56 evaluable patients achieved a confirmed PR or Complete Response ("CR");
|
•
|
26 of 56 evaluable patients remained on treatment at the time of data cut-off including eight responding patients;
|
•
|
a preliminary Kaplan-Meier estimate of median duration of response was greater than nine months, with six responding patients treated for more than six months and two responding patients treated for more than 12 months; and
|
•
|
the combination has shown an acceptable toxicity profile, and most adverse events reported by investigators were Grade 1 or 2.
|
•
|
as of the data cut-off date of October 17, 2019, 22 patients were evaluable for response with at least one radiographic scan;
|
•
|
6 of 22 evaluable patients achieved a confirmed CR (1 patient) or PR (5 patients);
|
•
|
21 of 22 evaluable patients achieved a confirmed CR, PR, or stable disease;
|
•
|
4 responding patients had been treated for more than 6 months; and
|
•
|
the combination was well-tolerated and most adverse events were Grade 1 or 2.
|
|
Year Ended December 31,
|
|
Increase
|
||||||||
|
2019
|
|
2018
|
|
(Decrease)
|
||||||
License and collaboration revenues
|
$
|
3,335
|
|
|
$
|
12,926
|
|
|
$
|
(9,591
|
)
|
Research and development expenses
|
182,866
|
|
|
93,872
|
|
|
88,994
|
|
|||
General and administrative expenses
|
42,573
|
|
|
21,681
|
|
|
20,892
|
|
|||
Other income, net
|
8,848
|
|
|
4,209
|
|
|
4,639
|
|
•
|
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, including contractual obligations for clinical development, clinical sites, manufacturing and scale-up, and formulation of clinical drug supplies;
|
•
|
costs for allocated facilities and depreciation of equipment; and
|
•
|
license fees paid in connection with our early discovery efforts.
|
|
Year Ended December 31,
|
|
Increase
|
||||||||
|
2019
|
|
2018
|
|
(Decrease)
|
||||||
Third-party research and development expenses:
|
|
|
|
|
|
||||||
Clinical development programs:
|
|
|
|
|
|
||||||
Sitravatinib
|
$
|
60,952
|
|
|
$
|
38,377
|
|
|
$
|
22,575
|
|
MRTX849
|
46,002
|
|
|
—
|
|
|
46,002
|
|
|||
Discontinued programs
|
2,995
|
|
|
9,608
|
|
|
(6,613
|
)
|
|||
Preclinical development programs:
|
|
|
|
|
|
||||||
KRAS inhibitors
|
15,316
|
|
|
20,394
|
|
|
(5,078
|
)
|
|||
Preclinical and early discovery
|
3,353
|
|
|
2,418
|
|
|
935
|
|
|||
Total third-party research and development expenses
|
128,618
|
|
|
70,797
|
|
|
57,821
|
|
|||
Salaries and other employee related expense
|
19,835
|
|
|
13,182
|
|
|
6,653
|
|
|||
Share-based compensation expense
|
31,024
|
|
|
7,232
|
|
|
23,792
|
|
|||
Other research and development expenses
|
3,389
|
|
|
2,661
|
|
|
728
|
|
|||
Research and development expenses
|
$
|
182,866
|
|
|
$
|
93,872
|
|
|
$
|
88,994
|
|
|
Year Ended December 31,
|
||||||
|
2019
|
|
2018
|
||||
Net cash used in operating activities
|
$
|
(147,726
|
)
|
|
$
|
(70,096
|
)
|
Net cash used in investing activities
|
(176,140
|
)
|
|
(145,765
|
)
|
||
Net cash provided by financing activities
|
338,028
|
|
|
140,852
|
|
||
Increase (decrease) in cash, cash equivalents, and restricted cash
|
14,162
|
|
|
(75,009
|
)
|
|
Total
|
|
Less Than 1 year
|
|
1 -3
Years
|
|
3 -5
Years
|
|
More Than 5 Years
|
||||||||||
Operating lease obligations (1)
|
$
|
41,804
|
|
|
$
|
272
|
|
|
$
|
10,376
|
|
|
$
|
13,090
|
|
|
$
|
18,066
|
|
Total Contractual Obligations
|
$
|
41,804
|
|
|
$
|
272
|
|
|
$
|
10,376
|
|
|
$
|
13,090
|
|
|
$
|
18,066
|
|
|
|
Page
|
Consolidated Financial Statements
|
|
|
|
||
Financial Statements:
|
|
|
|
||
|
||
|
||
|
||
|
Exhibit number
|
Description of Document
|
2.1
|
|
3.1
|
|
3.2
|
|
3.3
|
|
4.1
|
|
4.2
|
|
4.3
|
|
4.4
|
|
4.5
|
|
10.1
|
|
10.2+
|
|
10.3+
|
|
10.4+
|
|
10.5+
|
|
10.6+
|
|
10.7+
|
|
10.8+
|
|
10.9+
|
|
10.10+
|
|
10.11
|
|
10.12
|
|
10.13+
|
|
10.14+
|
|
10.15+
|
|
10.16+
|
|
10.17+
|
|
10.18+
|
|
10.19+
|
|
10.20+
|
|
10.21+
|
|
10.22+
|
|
10.23
|
|
10.24
|
|
10.25
|
|
10.26
|
|
10.27
|
+
|
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.
|
**
|
Certain portions of this exhibit (indicated by "[***]") have been omitted as Mirati Therapeutics, Inc. has determined (i) the omitted information is not material and (ii) the omitted information would likely cause harm to Mirati Therapeutics, Inc. if publicly disclosed.
|
(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 Registration Statement on Form S-1 (No. 333-191544), filed with the Securities and Exchange Commission on October 3, 2013.
|
(5)
|
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.
|
(6)
|
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 11, 2015.
|
(7)
|
Incorporated by reference to Mirati Therapeutics, Inc.’s Current Report on Form 8-K, filed with the Securities and Exchange Commission on June 16, 2016.
|
(8)
|
Incorporated by reference to Mirati Therapeutics, Inc.’s Current Report on Form 8-K, filed with the Securities and Exchange Commission on January 6, 2017.
|
(9)
|
Incorporated by reference to Mirati Therapeutics, Inc.'s Current Report on Form 8-K, filed with the Securities and Exchange Commission on March 27, 2017.
|
(10)
|
Incorporated by reference to Mirati Therapeutics, Inc.’s Annual Report on Form 10-K for the year ended December 31, 2016, filed with the Securities and Exchange Commission on March 9, 2017.
|
(11)
|
Incorporated by reference to Mirati Therapeutics, Inc.'s Current Report on Form 8-K, filed with the Securities and Exchange Commission on November 16, 2017.
|
(12)
|
Incorporated by reference to Mirati Therapeutics, Inc.'s Quarterly Report on Form 10-Q/A, filed with the Securities and Exchange Commission on August 20, 2018.
|
(13)
|
Incorporated by reference to Mirati Therapeutics, Inc.'s Current Report on Form 8-K, filed with the Securities and Exchange Commission on April 24, 2018.
|
(14)
|
Incorporated by reference to Mirati Therapeutics, Inc.'s Current Report on Form 8-K, filed with the Securities and Exchange Commission on August 7, 2018.
|
(15)
|
Incorporated by reference to Mirati Therapeutics, Inc.'s Current Report on Form 8-K, filed with the Securities and Exchange Commission on June 7, 2018.
|
(16)
|
Incorporated by reference to Mirati Therapeutics, Inc.'s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission on August 5, 2019.
|
(17)
|
Incorporated by reference to Mirati Therapeutics, Inc.'s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission on April 29, 2019.
|
(18)
|
Incorporated by reference to Mirati Therapeutics, Inc.'s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission on November 4, 2019.
|
(19)
|
Incorporated by reference to Mirati Therapeutics, Inc.'s Current Report on Form 8-K, filed with the Securities and Exchange Commission on December 31, 2019.
|
|
|
MIRATI THERAPEUTICS, INC.
|
|
|
|
Date: February 26, 2020
|
by:
|
/s/ Charles M. Baum
|
|
|
President and Chief Executive Officer
|
|
|
(Principal Executive Officer)
|
|
|
|
Date: February 26, 2020
|
by:
|
/s/ Daniel R. Faga
|
|
|
Executive Vice President and Chief Operating Officer
|
|
|
(Principal Financial Officer)
|
|
|
|
Date: February 26, 2020
|
by:
|
/s/ Vickie S. Reed
|
|
|
Senior Vice President and Chief Accounting Officer
|
|
|
(Principal Accounting Officer)
|
|
|
|
Signature
|
|
Title
|
|
Date
|
/S/ CHARLES M. BAUM
|
|
President, Chief Executive Officer and Director (Principal Executive Officer)
|
|
February 26, 2020
|
Charles M. Baum, M.D., Ph.D.
|
|
|
|
|
|
|
|
|
|
/S/ DANIEL R. FAGA
|
|
Executive Vice President and Chief Operating Officer
(Principal Financial Officer)
|
|
February 26, 2020
|
Daniel R. Faga
|
|
|
|
|
|
|
|
|
|
/S/ VICKIE S. REED
|
|
Senior Vice President and Chief Accounting Officer
(Principal Accounting Officer)
|
|
February 26, 2020
|
Vickie S. Reed
|
|
|
|
|
|
|
|
|
|
/S/ FAHEEM HASNAIN
|
|
Chairman of the Board
|
|
February 26, 2020
|
Faheem Hasnain
|
|
|
|
|
|
|
|
|
|
/S/ JULIE CHERRINGTON
|
|
Director
|
|
February 26, 2020
|
Julie Cherrington, Ph.D.
|
|
|
|
|
|
|
|
|
|
/S/ BRUCE L.A. CARTER
|
|
Director
|
|
February 26, 2020
|
Bruce L.A. Carter, Ph.D.
|
|
|
|
|
|
|
|
|
|
/S/ HENRY J. FUCHS
|
|
Director
|
|
February 26, 2020
|
Henry J. Fuchs, M.D.
|
|
|
|
|
|
|
|
|
|
/S/ MICHAEL GREY
|
|
Director
|
|
February 26, 2020
|
Michael Grey
|
|
|
|
|
|
|
|
|
|
/S/ CRAIG JOHNSON
|
|
Director
|
|
February 26, 2020
|
Craig Johnson
|
|
|
|
|
|
|
|
|
|
/S/ MAYA MARTINEZ-DAVIS
|
|
Director
|
|
February 26, 2020
|
Maya Martinez-Davis
|
|
|
|
|
|
|
|
|
|
/S/ AARON DAVIS
|
|
Director
|
|
February 26, 2020
|
Aaron Davis
|
|
|
|
|
|
|
|
|
|
|
|
Accrued research and development expenses
|
Description of the Matter
|
|
At December 31, 2019, the Company incurred $182.9 million for research and development expenses and accrued $24.2 million for research and development expenses. As described in Note 2 to the consolidated financial statements, the Company records accruals for estimated costs of research and development activities, including contract services for clinical trials and related clinical manufacturing costs in connection with early discovery efforts. Clinical trial activities performed by third parties are accrued and expensed based upon estimates of the proportion of work completed over the life of the individual clinical trial and patient enrollment rates in accordance with agreements established with Clinical Research Organizations ("CROs") and clinical trial sites. Estimates are determined by reviewing contracts, vendor agreements and purchase orders, and through discussions with internal clinical personnel and external service providers as to the progress or stage of completion of trials or services and the agreed-upon fee to be paid for such services.
Auditing management’s accounting for accrued research and development expenses, for which the Company has either not been invoiced or has not received information on the actual costs incurred, was especially challenging as evaluating the progress or stage of completion of the activities under the Company’s research and development agreements is dependent upon information from internal clinical personnel and third party service providers and involves a high volume of data which is tracked in spreadsheets and other end user computing programs.
|
How We Addressed the Matter in Our Audit
|
|
We obtained an understanding, evaluated the design and tested the operating effectiveness of controls over the accounting for accrued research and development expenses. For example, we tested controls over management’s assessment and measurement of estimated accrued costs, including data inputs for study progress and remaining stages of completion under each study.
To test the completeness of the Company’s accrued research and development expenses, we obtained supporting evidence of the research and development activities performed for significant clinical trials. We attended internal clinical trial and project status meetings with accounting and clinical project managers to inspect the status of significant research and development activities. To assess the appropriate measurement of accrued research and development costs, our audit procedures included, among others, obtaining and inspecting significant agreements and agreement amendments, evaluating the Company’s documentation of trial timelines and future projections of trial progress, and testing a sample of transactions and comparing the costs against related invoices and contracts. We also tested a sample of subsequent payments to evaluate the completeness of the accrued expenses and compared the results to the current year accrual.
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
ASSETS
|
|
|
|
||||
Current assets
|
|
|
|
||||
Cash and cash equivalents
|
$
|
46,535
|
|
|
$
|
32,694
|
|
Short-term investments
|
368,515
|
|
|
190,096
|
|
||
Other current assets
|
9,357
|
|
|
3,870
|
|
||
Total current assets
|
424,407
|
|
|
226,660
|
|
||
Property and equipment, net
|
1,776
|
|
|
473
|
|
||
Other long-term assets
|
6,017
|
|
|
1,321
|
|
||
Total assets
|
$
|
432,200
|
|
|
$
|
228,454
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY
|
|
|
|
||||
Current liabilities
|
|
|
|
||||
Accounts payable and accrued liabilities
|
$
|
48,082
|
|
|
$
|
25,775
|
|
Deferred revenue and other current liabilities
|
824
|
|
|
371
|
|
||
Total current liabilities
|
48,906
|
|
|
26,146
|
|
||
Deferred revenue and other liabilities
|
999
|
|
|
732
|
|
||
Total liabilities
|
49,905
|
|
|
26,878
|
|
||
Commitments and contingencies (see Note 15)
|
|
|
|
||||
Stockholders' equity
|
|
|
|
||||
Preferred stock, $0.001 par value, 10,000,000 shares authorized; none issued and outstanding at both December 31, 2019 and December 31, 2018
|
—
|
|
|
—
|
|
||
Common stock, $0.001 par value; 100,000,000 authorized; 39,517,329 and 32,538,857 issued and outstanding at December 31, 2019 and December 31, 2018, respectively
|
40
|
|
|
33
|
|
||
Additional paid-in capital
|
1,144,667
|
|
|
751,109
|
|
||
Accumulated other comprehensive income
|
9,889
|
|
|
9,479
|
|
||
Accumulated deficit
|
(772,301
|
)
|
|
(559,045
|
)
|
||
Total stockholders' equity
|
382,295
|
|
|
201,576
|
|
||
Total liabilities and stockholders' equity
|
$
|
432,200
|
|
|
$
|
228,454
|
|
|
Year Ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Revenue
|
|
|
|
|
|
||||||
License and collaboration revenues
|
$
|
3,335
|
|
|
$
|
12,926
|
|
|
$
|
—
|
|
Total revenue
|
3,335
|
|
|
12,926
|
|
|
—
|
|
|||
Expenses
|
|
|
|
|
|
||||||
Research and development
|
$
|
182,866
|
|
|
$
|
93,872
|
|
|
$
|
58,085
|
|
General and administrative
|
42,573
|
|
|
21,681
|
|
|
13,450
|
|
|||
Total operating expenses
|
225,439
|
|
|
115,553
|
|
|
71,535
|
|
|||
Loss from operations
|
(222,104
|
)
|
|
(102,627
|
)
|
|
(71,535
|
)
|
|||
Other income, net
|
8,848
|
|
|
4,209
|
|
|
1,105
|
|
|||
Net loss
|
$
|
(213,256
|
)
|
|
$
|
(98,418
|
)
|
|
$
|
(70,430
|
)
|
Unrealized gain (loss) on available-for-sale investments
|
$
|
410
|
|
|
$
|
—
|
|
|
$
|
(54
|
)
|
Comprehensive loss
|
$
|
(212,846
|
)
|
|
$
|
(98,418
|
)
|
|
$
|
(70,484
|
)
|
Basic and diluted net loss per share
|
$
|
(5.69
|
)
|
|
$
|
(3.19
|
)
|
|
$
|
(2.78
|
)
|
Weighted average common shares outstanding, basic and diluted
|
37,467,505
|
|
|
30,897,717
|
|
|
25,290,222
|
|
|
Common Stock
|
|
Additional
paid-in
capital
|
|
Accumulated
other
comprehensive
income
|
|
Accumulated
deficit
|
|
Total
stockholders'
equity
|
|||||||||||||
|
Shares
|
|
Amount
|
|
|
|
|
|||||||||||||||
December 31, 2016
|
19,937,095
|
|
|
$
|
20
|
|
|
$
|
428,507
|
|
|
$
|
9,533
|
|
|
$
|
(389,751
|
)
|
|
$
|
48,309
|
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(70,430
|
)
|
|
(70,430
|
)
|
|||||
Issuance of common stock and warrants, net of issuance costs
|
7,941,688
|
|
|
8
|
|
|
153,522
|
|
|
—
|
|
|
—
|
|
|
153,530
|
|
|||||
Share-based compensation expense
|
—
|
|
|
—
|
|
|
6,786
|
|
|
—
|
|
|
—
|
|
|
6,786
|
|
|||||
Cumulative effect of accounting change for the adoption of ASU 2016-09
|
—
|
|
|
—
|
|
|
446
|
|
|
—
|
|
|
(446
|
)
|
|
—
|
|
|||||
Issuance of common stock from ESPP
|
59,976
|
|
|
—
|
|
|
144
|
|
|
—
|
|
|
—
|
|
|
144
|
|
|||||
Exercise of options for cash
|
45,573
|
|
|
—
|
|
|
399
|
|
|
—
|
|
|
—
|
|
|
399
|
|
|||||
Exercise of warrants for cash
|
585,729
|
|
|
1
|
|
|
4,603
|
|
|
—
|
|
|
—
|
|
|
4,604
|
|
|||||
Net exercise of warrants
|
52,825
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Unrealized loss on investments
|
—
|
|
|
—
|
|
|
—
|
|
|
(54
|
)
|
|
—
|
|
|
(54
|
)
|
|||||
Balance at December 31, 2017
|
28,622,886
|
|
|
$
|
29
|
|
|
$
|
594,407
|
|
|
$
|
9,479
|
|
|
$
|
(460,627
|
)
|
|
$
|
143,288
|
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(98,418
|
)
|
|
(98,418
|
)
|
|||||
Issuance of common stock and warrants, net of issuance costs
|
3,162,500
|
|
|
3
|
|
|
130,660
|
|
|
—
|
|
|
—
|
|
|
130,663
|
|
|||||
Share-based compensation expense
|
|
|
|
|
15,854
|
|
|
—
|
|
|
—
|
|
|
15,854
|
|
|||||||
Issuance of common stock from ESPP
|
21,536
|
|
|
—
|
|
|
442
|
|
|
—
|
|
|
—
|
|
|
442
|
|
|||||
Exercise of options for cash
|
731,935
|
|
|
1
|
|
|
9,746
|
|
|
—
|
|
|
—
|
|
|
9,747
|
|
|||||
Balance at December 31, 2018
|
32,538,857
|
|
|
$
|
33
|
|
|
$
|
751,109
|
|
|
$
|
9,479
|
|
|
$
|
(559,045
|
)
|
|
$
|
201,576
|
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(213,256
|
)
|
|
(213,256
|
)
|
|||||
Issuance of common stock, net of issuance costs
|
4,269,838
|
|
|
4
|
|
|
327,826
|
|
|
—
|
|
|
—
|
|
|
327,830
|
|
|||||
Share-based compensation expense
|
—
|
|
|
—
|
|
|
55,537
|
|
|
—
|
|
|
—
|
|
|
55,537
|
|
|||||
Issuance of common stock from ESPP
|
14,488
|
|
|
—
|
|
|
675
|
|
|
—
|
|
|
—
|
|
|
675
|
|
|||||
Exercise of options for cash
|
569,146
|
|
|
1
|
|
|
8,472
|
|
|
—
|
|
|
—
|
|
|
8,473
|
|
|||||
Proceeds from disgorgement of stockholders' short-swing profits
|
—
|
|
|
—
|
|
|
1,050
|
|
|
—
|
|
|
—
|
|
|
1,050
|
|
|||||
Net exercise of warrants
|
2,125,000
|
|
|
2
|
|
|
(2
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Unrealized gain on investments
|
—
|
|
|
—
|
|
|
—
|
|
|
410
|
|
|
—
|
|
|
410
|
|
|||||
Balance at December 31, 2019
|
39,517,329
|
|
|
$
|
40
|
|
|
$
|
1,144,667
|
|
|
$
|
9,889
|
|
|
$
|
(772,301
|
)
|
|
$
|
382,295
|
|
|
Years Ended December 31,
|
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
|
||||||
Operating activities:
|
|
|
|
|
|
|
||||||
Net loss
|
$
|
(213,256
|
)
|
|
$
|
(98,418
|
)
|
|
$
|
(70,430
|
)
|
|
Non-cash adjustments reconciling net loss to operating cash flows
|
|
|
|
|
|
|
|
|
|
|||
Depreciation of property and equipment
|
249
|
|
|
175
|
|
|
184
|
|
|
|||
Accretion of discount on investments
|
(3,421
|
)
|
|
(1,320
|
)
|
|
(266
|
)
|
|
|||
Share-based compensation expense
|
55,537
|
|
|
15,854
|
|
|
6,786
|
|
|
|||
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|||
Other current assets
|
(5,487
|
)
|
|
1,052
|
|
|
(3,409
|
)
|
|
|||
Other long-term assets
|
(4,375
|
)
|
|
(359
|
)
|
|
3,606
|
|
|
|||
Accounts payable, accrued liabilities, deferred revenue and other liabilities
|
23,027
|
|
|
12,920
|
|
|
(1,177
|
)
|
|
|||
Cash flows used in operating activities
|
(147,726
|
)
|
|
(70,096
|
)
|
|
(64,706
|
)
|
|
|||
Investing activities:
|
|
|
|
|
|
|
|
|
|
|||
Purchases of short-term investments
|
(530,228
|
)
|
|
(255,795
|
)
|
|
(100,558
|
)
|
|
|||
Sales and maturities of short-term investments
|
355,640
|
|
|
110,152
|
|
|
91,988
|
|
|
|||
Purchases of property and equipment
|
(1,552
|
)
|
|
(122
|
)
|
|
(81
|
)
|
|
|||
Cash flows used in investing activities
|
(176,140
|
)
|
|
(145,765
|
)
|
|
(8,651
|
)
|
|
|||
Financing activities:
|
|
|
|
|
|
|
|
|
|
|||
Proceeds from issuance of common stock and warrants, net of issuance costs
|
327,830
|
|
|
130,663
|
|
(1)
|
153,530
|
|
(2)
|
|||
Proceeds from exercise of common stock options and warrants
|
8,473
|
|
|
9,747
|
|
|
5,003
|
|
|
|||
Proceeds from disgorgement of stockholders' short-swing profits
|
1,050
|
|
|
—
|
|
|
—
|
|
|
|||
Proceeds from issuances under employee stock purchase plan
|
675
|
|
|
442
|
|
|
144
|
|
|
|||
Cash flows provided by financing activities
|
338,028
|
|
|
140,852
|
|
|
158,677
|
|
|
|||
Increase (decrease) in cash, cash equivalents and restricted cash
|
14,162
|
|
|
(75,009
|
)
|
|
85,320
|
|
|
|||
Cash, cash equivalents and restricted cash, beginning of year
|
32,694
|
|
|
107,703
|
|
|
22,383
|
|
|
|||
Cash, cash equivalents and restricted cash, end of year
|
$
|
46,856
|
|
|
$
|
32,694
|
|
|
$
|
107,703
|
|
|
|
|
|
|
|
|
|
||||||
Reconciliation of cash, cash equivalents and restricted cash, end of period:
|
|
|
|
|
|
|
||||||
Cash and cash equivalents
|
$
|
46,535
|
|
|
$
|
32,694
|
|
|
$
|
107,703
|
|
|
Restricted cash included in other long-term assets
|
321
|
|
|
—
|
|
|
—
|
|
|
|||
Total cash, cash equivalents and restricted cash
|
$
|
46,856
|
|
|
$
|
32,694
|
|
|
$
|
107,703
|
|
|
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
|
|
Year ended
|
|||||||
|
December 31,
|
|||||||
|
2019
|
|
2018
|
|
2017
|
|||
Common stock options
|
2,403,055
|
|
|
1,781,388
|
|
|
38,675
|
|
Common stock warrants
|
10,231,006
|
|
|
11,631,636
|
|
|
7,534,576
|
|
Total
|
12,634,061
|
|
|
13,413,024
|
|
|
7,573,251
|
|
|
|
|
As of December 31, 2019
|
|||||||||||||||
|
Maturity
|
|
Amortized cost
|
|
Gross unrealized gains
|
|
Gross unrealized losses
|
|
Estimated fair value
|
|||||||||
Corporate debt securities
|
2 years or less
|
|
$
|
160,065
|
|
|
$
|
233
|
|
|
$
|
(1
|
)
|
|
$
|
160,297
|
|
|
Commercial paper
|
1 year or less
|
|
120,862
|
|
|
74
|
|
|
—
|
|
|
120,936
|
|
|||||
U.S. Agency Bonds
|
2 years or less
|
|
50,745
|
|
|
41
|
|
|
(4
|
)
|
|
50,782
|
|
|||||
U.S. Treasury bills
|
2 years or less
|
|
36,474
|
|
|
27
|
|
|
(1
|
)
|
|
36,500
|
|
|||||
|
|
|
$
|
368,146
|
|
|
$
|
375
|
|
|
$
|
(6
|
)
|
|
$
|
368,515
|
|
|
|
|
As of December 31, 2018
|
|||||||||||||||
|
Maturity
|
|
Amortized cost
|
|
Gross unrealized gains
|
|
Gross unrealized losses
|
|
Estimated fair value
|
|||||||||
Corporate debt securities
|
1 year or less
|
|
$
|
111,933
|
|
|
$
|
26
|
|
|
$
|
(43
|
)
|
|
$
|
111,916
|
|
|
Commercial paper
|
1 year or less
|
|
74,433
|
|
|
—
|
|
|
(24
|
)
|
|
74,409
|
|
|||||
U.S. Treasury bills
|
1 year or less
|
|
3,771
|
|
|
—
|
|
|
—
|
|
|
3,771
|
|
|||||
|
|
|
$
|
190,137
|
|
|
$
|
26
|
|
|
$
|
(67
|
)
|
|
$
|
190,096
|
|
•
|
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, 2019
|
||||||||||
|
Total
|
|
Level 1
|
|
Level 2
|
||||||
Assets
|
|
|
|
|
|
||||||
Cash and cash equivalents:
|
|
|
|
|
|
||||||
Cash
|
$
|
662
|
|
|
$
|
662
|
|
|
$
|
—
|
|
Money market funds
|
45,873
|
|
|
45,873
|
|
|
—
|
|
|||
Total cash and cash equivalents
|
46,535
|
|
|
46,535
|
|
|
—
|
|
|||
|
|
|
|
|
|
||||||
Short-term investments:
|
|
|
|
|
|
||||||
U.S. Treasury bills
|
36,500
|
|
|
36,500
|
|
|
—
|
|
|||
Corporate debt securities
|
160,297
|
|
|
—
|
|
|
160,297
|
|
|||
Commercial paper
|
120,936
|
|
|
—
|
|
|
120,936
|
|
|||
U.S. Agency bonds
|
50,782
|
|
|
—
|
|
|
50,782
|
|
|||
Total short-term investments
|
368,515
|
|
|
36,500
|
|
|
332,015
|
|
|||
Total
|
$
|
415,050
|
|
|
$
|
83,035
|
|
|
$
|
332,015
|
|
|
December 31, 2018
|
||||||||||
|
Total
|
|
Level 1
|
|
Level 2
|
||||||
Assets
|
|
|
|
|
|
||||||
Cash and cash equivalents:
|
|
|
|
|
|
||||||
Cash
|
$
|
3,731
|
|
|
$
|
3,731
|
|
|
$
|
—
|
|
Money market funds
|
28,963
|
|
|
28,963
|
|
|
—
|
|
|||
Total cash and cash equivalents
|
32,694
|
|
|
32,694
|
|
|
—
|
|
|||
|
|
|
|
|
|
||||||
Short-term investments:
|
|
|
|
|
|
||||||
U.S. Treasury Bills
|
3,771
|
|
|
3,771
|
|
|
—
|
|
|||
Corporate debt securities
|
111,916
|
|
|
—
|
|
|
111,916
|
|
|||
Commercial paper
|
74,409
|
|
|
—
|
|
|
74,409
|
|
|||
Total short-term investments
|
190,096
|
|
|
3,771
|
|
|
186,325
|
|
|||
Total
|
$
|
222,790
|
|
|
$
|
36,465
|
|
|
$
|
186,325
|
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
Prepaid expenses
|
$
|
5,672
|
|
|
$
|
1,261
|
|
Deposits and other receivables
|
2,119
|
|
|
1,841
|
|
||
Interest receivables
|
1,566
|
|
|
768
|
|
||
|
$
|
9,357
|
|
|
$
|
3,870
|
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
Computer equipment
|
$
|
201
|
|
|
$
|
201
|
|
Office and other equipment
|
329
|
|
|
260
|
|
||
Laboratory equipment
|
2,212
|
|
|
729
|
|
||
Leasehold improvements
|
63
|
|
|
63
|
|
||
Gross property and equipment
|
2,805
|
|
|
1,253
|
|
||
Less: Accumulated depreciation
|
(1,029
|
)
|
|
(780
|
)
|
||
Property and equipment, net
|
$
|
1,776
|
|
|
$
|
473
|
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
Accounts payable
|
$
|
16,367
|
|
|
$
|
8,531
|
|
Accrued clinical expense
|
21,290
|
|
|
10,154
|
|
||
Accrued development and other expense
|
2,510
|
|
|
1,243
|
|
||
Accrued compensation and benefits
|
7,915
|
|
|
5,847
|
|
||
|
$
|
48,082
|
|
|
$
|
25,775
|
|
Opening balance, January 1, 2019
|
$
|
(481
|
)
|
Revenue from performance obligations satisfied during reporting period
|
309
|
|
|
Closing Balance, December 31, 2019
|
$
|
(172
|
)
|
|
December 31, 2019
|
|
Common stock options outstanding and available for future grant
|
7,923,098
|
|
Warrants to purchase common stock
|
9,692,879
|
|
Employee Stock Purchase Plan
|
142,872
|
|
|
17,758,849
|
|
Issue date
|
|
Expiration date
|
|
Exercise price
|
|
Number of warrants outstanding
|
|||
January 11, 2017
|
|
None
|
|
$
|
0.001
|
|
|
5,133,230
|
|
November 20, 2017
|
|
None
|
|
$
|
0.001
|
|
|
4,137,999
|
|
June 11, 2018
|
|
None
|
|
$
|
0.001
|
|
|
421,650
|
|
|
|
|
|
|
|
9,692,879
|
|
|
Number of
options
|
|
Weighted
average
exercise
price
|
|
Weighted-Average Remaining Contractual Term (years)
|
|
Aggregate Intrinsic Value (millions)
|
|||||
Balance outstanding as of December 31, 2018
|
3,683,786
|
|
|
$
|
19.59
|
|
|
|
|
|
||
Granted
|
2,310,994
|
|
|
$
|
76.22
|
|
|
|
|
|
||
Exercised
|
(569,146
|
)
|
|
$
|
14.89
|
|
|
|
|
|
||
Canceled/forfeited
|
(137,657
|
)
|
|
$
|
48.31
|
|
|
|
|
|
||
Balance outstanding as of December 31, 2019
|
5,287,977
|
|
|
$
|
44.10
|
|
|
7.7
|
|
$
|
448.2
|
|
Options exercisable at December 31, 2019
|
2,339,904
|
|
|
$
|
21.11
|
|
|
6.1
|
|
$
|
252.1
|
|
|
Year ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Research and development expense
|
$
|
31,024
|
|
|
$
|
7,232
|
|
|
$
|
3,192
|
|
General and administrative expense
|
24,513
|
|
|
8,622
|
|
|
3,594
|
|
|||
|
$
|
55,537
|
|
|
$
|
15,854
|
|
|
$
|
6,786
|
|
|
Year Ended December 31,
|
||||
|
2019
|
|
2018
|
|
2017
|
Risk-free interest rate
|
2.2%
|
|
2.6%
|
|
2.1%
|
Dividend yield
|
—%
|
|
—%
|
|
—%
|
Volatility factor
|
82.1%
|
|
94.3%
|
|
96.0%
|
Expected term (in years)
|
5.6
|
|
6.0
|
|
6.0
|
Weighted average estimated fair value per share
|
$52.03
|
|
$24.39
|
|
$4.17
|
|
Year Ended December 31,
|
||||||||||
|
2019
|
|
2018
|
|
2017
|
||||||
Net loss before tax
|
$
|
(213,256
|
)
|
|
$
|
(98,418
|
)
|
|
$
|
(70,430
|
)
|
Statutory combined U.S. federal and state tax rate
|
21.00
|
%
|
|
21.00
|
%
|
|
34.00
|
%
|
|||
Statutory federal and state taxes
|
(44,784
|
)
|
|
(20,668
|
)
|
|
(23,946
|
)
|
|||
Increase (decrease) in taxes recoverable resulting from:
|
|
|
|
|
|
||||||
Effect of change in valuation allowance
|
52,719
|
|
|
25,959
|
|
|
(4,154
|
)
|
|||
Non-deductible share-based compensation
|
1,810
|
|
|
884
|
|
|
695
|
|
|||
Tax deductions for share-based compensation
|
(6,917
|
)
|
|
(2,924
|
)
|
|
(80
|
)
|
|||
Tax credits
|
(8,621
|
)
|
|
(5,130
|
)
|
|
(2,563
|
)
|
|||
Write off of Methylgene US Inc. net operating loss
|
—
|
|
|
—
|
|
|
307
|
|
|||
Change in tax rate
|
—
|
|
|
—
|
|
|
303
|
|
|||
Tax Cuts and Jobs Act
|
—
|
|
|
—
|
|
|
28,569
|
|
|||
Uncertain tax positions
|
2,143
|
|
|
1,283
|
|
|
646
|
|
|||
Return to provision and other true-ups
|
(60
|
)
|
|
375
|
|
|
394
|
|
|||
Non-deductible officers' compensation
|
3,527
|
|
|
179
|
|
|
—
|
|
|||
Other differences
|
183
|
|
|
42
|
|
|
(171
|
)
|
|||
Income tax benefit
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
December 31,
|
||||||
|
2019
|
|
2018
|
||||
Deferred tax assets:
|
|
|
|
||||
Tangible and intangible depreciable assets
|
$
|
6,978
|
|
|
$
|
8,123
|
|
Stock compensation
|
12,321
|
|
|
6,515
|
|
||
Provisions
|
934
|
|
|
1,020
|
|
||
Other, net
|
35
|
|
|
—
|
|
||
Lease liability
|
137
|
|
|
—
|
|
||
Net operating loss carry forwards
|
116,345
|
|
|
74,721
|
|
||
Capital loss carryforward
|
178
|
|
|
178
|
|
||
Canada scientific research and experimental development expenditures
|
5,471
|
|
|
5,467
|
|
||
U.S. research and development tax credits
|
17,080
|
|
|
10,613
|
|
||
Total gross deferred tax assets
|
159,479
|
|
|
106,637
|
|
||
Less valuation allowance
|
(159,357
|
)
|
|
(106,637
|
)
|
||
Net deferred tax assets
|
$
|
122
|
|
|
$
|
—
|
|
|
|
|
|
||||
Deferred tax liabilities:
|
|
|
|
||||
Right-of-use Asset
|
$
|
(122
|
)
|
|
$
|
—
|
|
|
|
|
|
||||
Net deferred income taxes
|
$
|
—
|
|
|
$
|
—
|
|
|
US
|
|
Canada
|
||||||||||||
|
Federal
|
|
State
|
|
Federal
|
|
Provincial
|
||||||||
Expires in:
|
|
|
|
|
|
|
|
||||||||
2030
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
4,830
|
|
|
$
|
4,907
|
|
2031
|
—
|
|
|
—
|
|
|
7,059
|
|
|
7,066
|
|
||||
2032
|
—
|
|
|
—
|
|
|
13,308
|
|
|
12,433
|
|
||||
2033
|
2,225
|
|
|
2,232
|
|
|
18,623
|
|
|
19,385
|
|
||||
2034
|
7,276
|
|
|
22,162
|
|
|
32,401
|
|
|
31,809
|
|
||||
2035
|
53,359
|
|
|
52,950
|
|
|
1,084
|
|
|
1,084
|
|
||||
2036
|
23,379
|
|
|
—
|
|
|
777
|
|
|
777
|
|
||||
2037
|
65,509
|
|
|
—
|
|
|
697
|
|
|
697
|
|
||||
2038
|
—
|
|
|
3,817
|
|
|
—
|
|
|
—
|
|
||||
2039
|
—
|
|
|
—
|
|
|
274
|
|
|
274
|
|
||||
Does not expire
|
300,763
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
|
$
|
452,511
|
|
|
$
|
81,161
|
|
|
$
|
79,053
|
|
|
$
|
78,432
|
|
|
Federal
|
|
Provincial/State
|
||||||||||||||||||||
|
December 31,
|
|
December 31,
|
||||||||||||||||||||
|
2019
|
|
2018
|
|
2017
|
|
2019
|
|
2018
|
|
2017
|
||||||||||||
Unrecognized tax positions, beginning of year
|
$
|
2,617
|
|
|
$
|
1,693
|
|
|
$
|
1,095
|
|
|
$
|
8,010
|
|
|
$
|
7,556
|
|
|
$
|
7,333
|
|
Gross increase — current period tax positions
|
1,651
|
|
|
924
|
|
|
588
|
|
|
638
|
|
|
454
|
|
|
227
|
|
||||||
Gross decrease — prior period tax positions
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(3
|
)
|
||||||
Gross increase — prior period tax positions
|
—
|
|
|
—
|
|
|
11
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Expiration of statute of limitations
|
—
|
|
|
—
|
|
|
(1
|
)
|
|
—
|
|
|
—
|
|
|
(1
|
)
|
||||||
Unrecognized tax positions, end of year
|
$
|
4,268
|
|
|
$
|
2,617
|
|
|
$
|
1,693
|
|
|
$
|
8,648
|
|
|
$
|
8,010
|
|
|
$
|
7,556
|
|
|
Three Months Ended
|
|
Year Ended
|
||||||||||||||||
|
3/31/19
|
|
6/30/19
|
|
9/30/19
|
|
12/31/19
|
|
December 31, 2019
|
||||||||||
License and collaboration revenues
|
$
|
1,244
|
|
|
$
|
577
|
|
|
$
|
988
|
|
|
$
|
526
|
|
|
$
|
3,335
|
|
Loss from operations
|
(42,758
|
)
|
|
(47,641
|
)
|
|
(57,059
|
)
|
|
(74,646
|
)
|
|
$
|
(222,104
|
)
|
||||
Net loss
|
(40,912
|
)
|
|
(45,695
|
)
|
|
(54,273
|
)
|
|
(72,376
|
)
|
|
(213,256
|
)
|
|||||
Basic and diluted net loss per share
|
$
|
(1.17
|
)
|
|
$
|
(1.26
|
)
|
|
$
|
(1.38
|
)
|
|
$
|
(1.83
|
)
|
|
$
|
(5.69
|
)
|
|
Three Months Ended
|
|
Year Ended
|
||||||||||||||||
|
3/31/18
|
|
6/30/18
|
|
9/30/18
|
|
12/31/18
|
|
December 31, 2018
|
||||||||||
License and collaboration revenues
|
$
|
9,467
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
3,459
|
|
|
$
|
12,926
|
|
Loss from operations
|
(15,346
|
)
|
|
(28,670
|
)
|
|
(28,939
|
)
|
|
(29,672
|
)
|
|
(102,627
|
)
|
|||||
Net loss
|
(14,709
|
)
|
|
(27,869
|
)
|
|
(27,568
|
)
|
|
(28,272
|
)
|
|
(98,418
|
)
|
|||||
Basic and diluted net loss per share
|
$
|
(0.51
|
)
|
|
$
|
(0.94
|
)
|
|
$
|
(0.85
|
)
|
|
$
|
(0.87
|
)
|
|
$
|
(3.19
|
)
|
•
|
prior to that date, the board of directors approved either the business combination or the transaction that resulted in the stockholder becoming an interested stockholder;
|
•
|
upon consummation of the transaction that resulted in the stockholder becoming an interested stockholder, the interested stockholder owned at least 85 percent of the voting stock of the corporation outstanding at the time the transaction commenced, excluding for purposes of determining the number of shares outstanding those shares owned by directors, officers and specific employee stock plans; or
|
•
|
on or after that date, the business combination is approved by the board of directors and authorized at an annual or special meeting of stockholders, and not by written consent, by the affirmative vote of the holders of at least 662/3 percent of the outstanding voting stock that is not owned by the interested stockholder.
|
•
|
any merger or consolidation involving the corporation and the interested stockholder;
|
•
|
any sale, lease, exchange, mortgage, transfer, pledge or other disposition of 10 percent or more of the assets of the corporation involving the interested stockholder;
|
•
|
subject to limited exceptions, any transaction that results in the issuance or transfer by the corporation of any stock of the corporation to the interested stockholder;
|
•
|
any transaction involving the corporation that has the effect of increasing the proportionate share of the corporation’s stock of any class or series beneficially owned by the interested stockholder; and
|
•
|
the receipt by the “interested stockholder” of the benefit of any loans, advances, guarantees, pledges or other financial benefits provided by or through the corporation.
|
(1)
|
Registration Statement (Form S-3 No. 333-227209) of Mirati Therapeutics, Inc.,
|
(2)
|
Registration Statement (Form S-8 No. 333-218239) pertaining to the Amended and Restated 2013 Equity Incentive Plan of Mirati Therapeutics, Inc.,
|
(3)
|
Registration Statements (Form S-8 Nos. 333-196487, 333-204720, and 333-233027) pertaining to the 2013 Equity Incentive Plan of Mirati Therapeutics, Inc.,
|
(4)
|
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
|
(5)
|
Registration Statement (Form S-8 No. 333-235765) pertaining to the Mirati Therapeutics, Inc. Inducement Plan;
|
Date: February 26, 2020
|
/s/ Charles M. Baum
|
|
Charles M. Baum
|
|
President and Chief Executive Officer
|
|
(Principal Executive Officer)
|
Date: February 26, 2020
|
|
/s/ Daniel R. Faga
|
|
|
Daniel R. Faga
|
|
|
Executive Vice President and Chief Operating Officer
|
|
|
(Principal Financial Officer)
|
/s/ Charles M. Baum
|
|
/s/ Daniel R. Faga
|
Charles M. Baum
|
|
Daniel R. Faga
|
President and Chief Executive Officer
(Principal Executive Officer)
|
|
Executive Vice President and Chief Operating Officer
(Principal Financial Officer)
|
Vesting Schedule:
|
This Award will vest as follows: [____________].
|
Issuance Schedule:
|
Subject to any change upon a Capitalization Adjustment, one share of Common Stock will be issued for each RSU that vests at the time set forth in Section 6 of the Agreement.
|