You should read the following discussion and analysis of our financial condition and results of operations together with our consolidated financial statements and related notes thereto included elsewhere in this Annual Report on Form 10-K. Some of the information contained in this discussion and analysis or set forth elsewhere in this Annual Report on Form 10-K, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the "Risk Factors" section of this Annual Report on Form 10-K, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.
References in the following discussion to "we," "our," "us," "Mirati" or "the
Company" refer to
Overview
Mirati Therapeutics, Inc. is a clinical-stage oncology company developing product candidates to address the genetic and immunological promoters of cancer. In immuno-oncology, we are advancing our kinase inhibitor clinical program where our product candidate has the potential to improve the immune environment of tumor cells and enhance and expand the efficacy of existing cancer immunotherapy medicines when given in combination. Our KRAS inhibitor program is focused on developing novel inhibitors of KRAS mutations and includes one clinical program and a preclinical program. We also have additional preclinical programs which include potentially first-in-class and best-in-class product candidates specifically designed to address mutations and tumors where few treatment options exist. We approach each of our discovery and development programs with a singular focus: to translate our deep understanding of the molecular drivers of cancer into better therapies and better outcomes for patients. Our clinical programs consist of two product candidates: MRTX849, a KRAS G12C inhibitor, and sitravatinib, a multi-kinase inhibitor. We have several early discovery programs, including a preclinical program for a KRAS G12D inhibitor.
KRAS Inhibitor Program
The RAS family of genes is the most commonly mutated oncogene and mutations in this gene family occur in up to approximately 25% of all human cancers. Among the RAS family members, mutations most frequently occur in KRAS (approximately 85% of all RAS family mutations). Tumors characterized by KRAS mutations are commonly associated with poor prognosis and resistance to therapy. Nonclinical studies have demonstrated that cancer cells exhibiting KRAS mutations are highly dependent on KRAS function for cell growth and survival. Historically, KRAS has been extremely difficult to directly inhibit due to the absence of a tractable small molecule drug binding site. Our KRAS inhibitor program is focused on the discovery and development of small molecule compounds that target KRAS G12C and G12D. We intend to pursue development of our KRAS G12C inhibitor program in both single agent and rational combination approaches. We also have a KRAS G12D inhibitor program in preclinical development.
MRTX849
Background
MRTX849, our lead KRAS G12C compound, is an investigational, specific, potent and orally available small molecule. MRTX849 is designed to directly inhibit KRAS G12C mutations. KRAS G12C mutations are present in approximately 14% of non-small cell lung cancer ("NSCLC") adenocarcinoma patients, 4% of colorectal cancer ("CRC") patients, 2% of pancreatic cancer patients, as well as smaller percentages of several other difficult-to-treat cancers. Based on observed preclinical attributes, we believe MRTX849 has the potential to be a best-in-class product candidate for the suppression of G12C mutant KRAS signaling. Single agent treatment with MRTX849 has shown complete regression in a subset of KRAS G12C-positive human tumor models implanted in mice.
Program Update
We receivedU.S. Food and Drug Administration ("FDA") authorization of our investigational new drug application for MRTX849 inNovember 2018 , and onJanuary 15, 2019 , we announced that we had dosed the first patient in the dose escalation phase of a Phase 1/2 clinical trial in patients with advanced solid tumors that harbor G12C mutations. This trial is designed to enable rapid expansion of the single agent cohorts and could potentially serve as the basis of a new drug application ("NDA") submission seeking accelerated approval by the FDA. This trial also enables exploratory combination cohorts. Following single 40 --------------------------------------------------------------------------------
agent dose escalation, we are expanding into cohorts that include patients with NSCLC, CRC and those with other tumors that carry the G12C mutation.
OnOctober 28, 2019 , we reported the first interim clinical data from this Phase 1/2 clinical trial in a presentation at the 2019American Association for Cancer Research-National Cancer Institute-European Organisation for Research and Treatment of Cancer ("AACR-NCI-EORTC")International Conference on Molecular Targets and Cancer Therapeutics inBoston, Massachusetts . As ofOctober 11, 2019 , the trial had enrolled 17 patients, including 10 patients with NSCLC, four patients with CRC, and three patients with other tumor types. Five dose cohorts have been evaluated: 150 mg, 300 mg, 600 mg, and 1200 mg, taken orally once daily ("QD"), and 600 mg, taken orally twice daily ("BID"). The trial enrolled single patient dose escalation cohorts in an accelerated titration design. Trial objectives include evaluation of safety, tolerability, pharmacodynamics, pharmacokinetics ("PK") and tumor response evaluated using RECIST v1.1 criteria.
As of the data cut-off date of
• 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. Treatment-related adverse events were primarily grade 1 events. One patient experienced a dose-limiting toxicity ("DLT") at the 1200 mg QD dose (capsule burden intolerance 12 capsules) and one patient experienced a DLT at the 600 mg BID dose (grade 3/4 isolated amylase/lipase increase). The maximum tolerated dose was not established and further dose escalation may be explored. Enrollment into dose expansion at the 600 mg BID dose is underway.
InJuly 2019 , we announced a clinical collaboration agreement with Novartis to evaluate the combination of MRTX849 and Novartis' investigationalSHP2 inhibitor, TNO155, in patients with advanced solid tumors that harbor G12C mutations. Under the terms of the non-exclusive collaboration, we will sponsor the trial and Novartis and Mirati will jointly oversee and share the costs of clinical development activities for the combined therapy. Novartis will provide TNO155 at no cost. Sitravatinib
Sitravatinib is a spectrum-selective kinase inhibitor designed to potently inhibit receptor tyrosine kinases ("RTK"s), including TAM family receptors (TYRO3, Axl, Mer), split family receptors (VEGFR2, KIT) and RET. Sitravatinib is an investigational agent that is being evaluated in combination with immune checkpoint inhibitors.
Sitravatinib in Combination with Immune Checkpoint Inhibitors
Background
Sitravatinib's potent inhibition of TAM and split family RTKs may overcome resistance to checkpoint inhibitor therapy through targeted reversal of an immunosuppressive tumor microenvironment, enhancing antigen-specific T cell response and expanding dendritic cell-dependent antigen presentation. As an immuno-oncology agent, sitravatinib is being evaluated in combination with nivolumab (OPDIVO®), Bristol-Myers Squibb Company's ("BMS") anti-PD-1 checkpoint inhibitor, in patients with NSCLC who have experienced documented disease progression following treatment with a checkpoint inhibitor. Sitravatinib is also being developed in certain Asian territories in collaboration with BeiGene, Ltd. ("BeiGene") who is evaluating sitravatinib in combination with tislelizumab, BeiGene's investigational anti-PD-1 checkpoint inhibitor in a number of advanced solid tumors.
Program Update
41 -------------------------------------------------------------------------------- In an ongoing Phase 2 clinical trial, we are evaluating sitravatinib in combination with nivolumab in patients with NSCLC who have experienced documented disease progression following prior treatment with a checkpoint inhibitor. OnOctober 22, 2018 , we reported data from this clinical trial at the 2018European Society of Medical Oncology Congress ("ESMO"), based on a data cutoff date ofAugust 27, 2018 . A summary of these data, with response confirmations updated after the data cutoff date, is presented below:
• 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.
We held an end of Phase 2 meeting with the FDA in the third quarter of 2018 with respect to the development of sitravatinib in combination with a checkpoint inhibitor in NSCLC. Based on feedback received from the FDA, we initiated inJuly 2019 a Phase 3 randomized clinical trial in second-line NSCLC patients. The Phase 3 clinical trial is comparing the combination of sitravatinib plus nivolumab to docetaxel in patients whose tumors have progressed on prior therapy with platinum-chemotherapy in combination with a checkpoint inhibitor. Ultimately, we expect the results of this clinical trial, if positive, to enable a NDA submission for the treatment of NSCLC patients whose tumors have progressed following treatment with a platinum-containing regimen in combination with a checkpoint inhibitor. Enrollment is ongoing in the Phase 3 clinical trial. InJanuary 2020 , we amended the protocol to include third line patients who have received chemotherapy followed by a checkpoint inhibitor, in addition to second line patients treated with a combination of chemotherapy and a checkpoint inhibitor. Based on a data cut ofAugust 27, 2018 , from the ongoing Phase 2 study in a similar patient population, the Kaplan-Meier median overall survival was greater than 15 months. We also amended the statistical design to include an interim analysis of overall survival that we believe, if positive, could support an NDA submission seeking full approval. By amending the protocol, the overall sample size decreased from approximately 660 to 530 patients. OnJanuary 7, 2019 , we announced a clinical collaboration with BMS in connection with the aforementioned Phase 3 clinical trial. Under the terms of the collaboration, we will sponsor and fund the clinical trial and BMS will provide nivolumab at no cost. In certain specified cases, BMS will have an exclusive right to negotiate a commercial agreement with us for a limited period of time with respect to developing and commercializing sitravatinib worldwide excluding certain territories inAsia ,Australia and New Zealand . We maintain global development and commercial rights to sitravatinib outside of certain Asian territories, where we have partnered with BeiGene, and we are free to develop the program in combination with other agents. During the third quarter of 2018, we initiated an open label, multi-cohort Phase 2 clinical trial of sitravatinib in combination with nivolumab in patients with advanced or metastatic urothelial carcinoma. OnNovember 9, 2019 , we reported data from this clinical trial at the 2019Society of Immunotherapy of Cancer (SITC) 34th Annual Meeting, based on a data cutoff ofOctober 17, 2019 . Data from Cohort 1 of the trial were presented, where patients must have been previously treated with an immune checkpoint inhibitor and prior platinum-based chemotherapy and had documented disease progression. A summary of these data is presented below: • as of the data cut-off date ofOctober 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;
42 --------------------------------------------------------------------------------
• 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.
During the third quarter of 2018, we also initiated an open label Phase 2 clinical trial to assess the mechanism of action of sitravatinib combined with nivolumab in patients with advanced clear cell renal cell cancer ("RCC").
We recently determined to cease enrollment in the Phase 1b expansion clinical trial evaluating sitravatinib as a single agent in patients with NSCLC and other tumor types who have genetic alterations in Casitas B-lineage Lymphoma.
InJanuary 2018 , we entered into a Collaboration and License Agreement (the "BeiGene Agreement") with BeiGene, pursuant to which we and BeiGene agreed to collaboratively develop sitravatinib inAsia (excludingJapan and certain other countries),Australia and New Zealand (the "Licensed Territory"). Under the BeiGene Agreement, we granted BeiGene an exclusive license to develop, manufacture and commercialize sitravatinib in the Licensed Territory, and we retained exclusive rights for the development, manufacturing and commercialization of sitravatinib outside the Licensed Territory. InNovember 2018 , we announced the dosing of the first patient under the BeiGene Agreement in a Phase 1b clinical trial to assess the safety and tolerability, pharmacokinetics and preliminary anti-tumor activity of sitravatinib in combination with BeiGene's investigational anti-PD-1 antibody, tislelizumab, in patients with advanced solid tumors. The clinical trial is currently enrolling patients inChina andAustralia . BeiGene's clinical trials will evaluate the combination of sitravatinib and tislelizumab in patients with NSCLC, RCC, hepatocellular cancer, gastric cancer and ovarian cancer. InDecember 2019 , BeiGene reported initial proof of concept data for the ovarian cancer arm of the trial at the 2019ESMO Immuno-Oncology Congress .
Critical Accounting Policies and Significant Judgments and Estimates
Our discussion and analysis of financial condition and results of operations are based upon our consolidated financial statements, which have been prepared in accordance withU.S. generally accepted accounting principles. The preparation of these financial statements requires us to make significant estimates and judgments that affect the reported amounts of assets, liabilities, revenue and expenses and related disclosures. On an ongoing basis, our actual results may differ significantly from our estimates. While our significant accounting policies are more fully described in Note 2 to our consolidated financial statements appearing elsewhere in this Annual Report on Form 10-K, we believe the following accounting policies to be critical to the judgments and estimates used in the preparation of our consolidated financial statements. Revenue Recognition EffectiveJanuary 1, 2017 , we adopted Accounting Standards Codification ("ASC") Topic 606, Revenue from Contracts with Customers, using the full retrospective transition method. This standard applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. Under Topic 606, we recognize revenue when our customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for contracts with customers, we perform the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. We only apply the five-step model to contracts when it is probable that we will collect the consideration we are entitled to in exchange for the goods or services we transfer. At contract inception, once the contract is determined to be within the scope of Topic 606, we assess the goods or services promised within each contract, determine those that are performance obligations, and assess whether each promised good or service is distinct. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. We utilize key assumptions to determine a stand-alone selling price for performance obligations, which may include revenue forecasts, expected development timelines, discount rates, probabilities of technical and regulatory success and costs for manufacturing clinical supplies. Because the amount of revenue recognized for each performance obligation is determined based upon its relative stand-alone selling price, an increase or decrease of 10% in the estimated fair value of each performance obligation would not have a significant impact on the amount of revenue recognized. 43 --------------------------------------------------------------------------------
We accrue and expense clinical trial activities performed by third parties 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. We determine the estimates 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. However, actual costs and timing of clinical trials are highly uncertain, subject to risks and may change depending upon a number of factors, including our clinical development plan. We make estimates of our accrued expenses as of each balance sheet date in our consolidated financial statements based on facts and circumstances known to us at that time. If the actual timing of the performance of services or the level of effort varies from the estimate, we will adjust the accrual accordingly. Nonrefundable advance payments for goods and services, including fees for process development or manufacturing and distribution of clinical supplies that will be used in future research and development activities, are deferred and recognized as expense in the period that the related goods are consumed or services are performed.
Share-Based Compensation
We measure and recognize compensation expense for share-based payments based on estimated fair value. We estimate the fair value of stock options granted using the Black-Scholes option-pricing model. The Black-Scholes option- pricing model requires the use of certain estimates and judgmental assumptions that affect the amount of share-based compensation expense recognized in our consolidated financial statements. These assumptions include the expected volatility of our stock price, expected term of the options, the risk-free interest rate and expected dividend yields. Share-based compensation is recognized using the graded accelerated vesting method. If any of the assumptions used in our calculation change significantly, share-based compensation expense may differ materially from what we have recorded in the current period.
Results of Operations
Comparison of the Years Ended
This section provides an analysis of our financial results for the fiscal year endedDecember 31, 2019 compared to the fiscal year endedDecember 31, 2018 . For the discussion covering the fiscal year endedDecember 31, 2018 compared to the fiscal year endedDecember 31, 2017 , please refer to Item 7, "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Annual Report on Form 10-K for the fiscal year endedDecember 31, 2018 filed with theSEC onFebruary 28, 2019 .
The following table summarizes our results of operations for the year ended
Year EndedDecember 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
License and collaboration revenues
License and collaboration revenues relate to the BeiGene Agreement under which BeiGene was granted an exclusive license to develop, manufacture and commercialize sitravatinib in the Licensed Territory. License and collaboration revenues for the year endedDecember 31, 2019 were$3.3 million and relate to revenues earned related to a manufacturing supply services agreement with BeiGene. License and collaboration revenues for the year endedDecember 31, 2018 were$12.9 million and relate primarily to the transfer of the license and associated know-how to BeiGene, a related milestone achievement under the BeiGene Agreement, as well as revenues earned related to a manufacturing supply services agreement with BeiGene. 44 --------------------------------------------------------------------------------
Research and Development Expenses
Research and development expenses consist primarily of:
• salaries and related expenses for personnel, including expenses related to stock options or other share-based compensation granted to personnel in development functions; • fees paid to external service providers such as CROs and contract manufacturing organizations related to clinical trials, including contractual obligations for clinical development, clinical sites, manufacturing and scale-up, and formulation of clinical drug supplies;
• costs for allocated facilities and depreciation of equipment; and
• license fees paid in connection with our early discovery efforts.
We record research and development expenses as incurred.
Our research and development efforts during the years endedDecember 31, 2019 and 2018 were focused primarily on our clinical development programs and our preclinical programs. The following table summarizes our research and development expenses, (in thousands): Year Ended December
31, Increase
2019 2018 (Decrease) Third-party research and development expenses: Clinical development programs: Sitravatinib$ 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
Research and development expenses for the year endedDecember 31, 2019 were$182.9 million compared to$93.9 million during the year endedDecember 31, 2018 . The increase of$89.0 million during the year endedDecember 31, 2019 relates to an increase in third-party research and development expenses of$57.8 million , share-based compensation expense of$23.8 million , and salaries and other employee related expense of$6.7 million . The increase in third-party research and development expense primarily relates to an increase in expenses associated with the development of MRTX849 of$46.0 million and sitravatinib of$22.6 million , offset by decreases in expenses associated with discontinued programs of$6.6 million . The increase in expenses associated with MRTX849 relates to the Phase 1 clinical trial which was initiated in the first quarter of 2019 and the costs are comprised largely of manufacturing production expenses, CRO and other clinical trial-related expenses. The increase in development expense for sitravatinib is due to increased manufacturing production expenses, investigator payment expenses, and CRO expenses to support the expansion of existing and new sitravatinib clinical trials. The decreases in expenses associated with discontinued programs are due to decisions made in prior years to discontinue development of glesatinib and mocetinostat. The increase in share-based compensation expense of$23.8 million is due to an increase in the fair value of stock options granted during the year endedDecember 31, 2019 compared to the year endedDecember 31, 2018 . The increase in salaries and other employee related expense of$6.7 million is primarily due to an increase in the number of research and development employees during the twelve months endedDecember 31, 2019 compared to the same period in 2018. 45 -------------------------------------------------------------------------------- At this time, due to the risks inherent in the clinical development process and the early stage of our product development programs we are unable to estimate with any certainty the costs we will incur in the continued development of sitravatinib and MRTX849. The process of conducting clinical trials necessary to obtain regulatory approval and manufacturing scale-up to support expanded development and potential future commercialization is costly and time consuming. Any failure by us or delay in completing clinical trials, manufacturing scale up or in obtaining regulatory approvals could lead to increased research and development expense and, in turn, have a material adverse effect on our results of operations. We expect that our research and development expenses may increase if we are successful in advancing sitravatinib, MRTX849 and our preclinical KRAS G12D program, or any of our other preclinical programs into more advanced stages of clinical development.
General and Administrative Expenses
General and administrative expenses consist primarily of salaries and related benefits, including share-based compensation, related to our executive, finance, business development, legal, human resources and support functions. Other general and administrative expenses include professional fees for auditing, tax, consulting and patent-related services, rent and utilities and insurance. General and administrative expenses for the year endedDecember 31, 2019 were$42.6 million compared to$21.7 million for the same period in 2018. The increase of$20.9 million is primarily due to an increase in share-based compensation expense of$15.9 million , and to a lesser extent increases in salaries and other employee related expense of$2.3 million , facilities, insurance and other expense of$1.6 million , and professional services expense of$1.0 million . The increase in share-based compensation expense is due to an increase in the fair value of stock options granted during the year endedDecember 31, 2019 compared to the same period in 2018. The increase in salaries and other employee related expense, and facilities, insurance and other expense is primarily due to an increase in the number of general and administrative employees during the year endedDecember 31, 2019 compared to the same period in 2018. The increase in professional services expense is due to an increase in consulting fees. Other Income, Net Other income, net consisted primarily of interest income of$8.8 million for the year endedDecember 31, 2019 and$4.2 million for the year endedDecember 31, 2018 . The increase in interest income during the twelve months endedDecember 31, 2019 compared toDecember 31, 2018 is due to an increase in short-term investment balances.
Liquidity and Capital Resources
AtDecember 31, 2019 , we had$415.1 million of cash, cash equivalents and short-term investments compared to$222.8 million atDecember 31, 2018 . InJanuary 2020 , we completed a public offering of our common stock that generated net proceeds of$324.1 million . InJune 2019 , we completed a public offering of our common stock that generated net proceeds of$219.9 million , and inJanuary 2019 , we completed a public offering of our common stock that generated net proceeds of$107.9 million . Based on our current and anticipated level of operations, we believe that our cash, cash equivalents and short-term investments will be sufficient to meet our anticipated obligations for at least one year from the date this Annual Report on Form 10-K is filed with theSEC . To date, we have funded our operations primarily through the sale of our common stock, pre-funded warrants to purchase our common stock, and to a lesser extent through up-front payments, research funding and milestone payments under collaborative arrangements. Since inception, we have primarily devoted our resources to funding research and development programs, including discovery research, preclinical and clinical development activities. To fund future operations, we will likely need to raise additional capital. The amount and timing of future funding requirements will depend on many factors, including the timing and results of our ongoing development efforts, the potential expansion of our current development programs, potential new development programs and related general and administrative support. We anticipate that we will seek to fund our operations through public or private equity or debt financings or other sources, such as potential collaboration agreements. We cannot make assurances that anticipated additional financing will be available to us on favorable terms, or at all. Although we have previously been successful in obtaining financing through our equity securities offerings, there can be no assurance that we will be able to do so in the future.
Cash Flows for the Years Ended
The following table provides a summary of the net cash flow activity for each of the periods set forth below (in thousands):
46 --------------------------------------------------------------------------------
Year Ended December 31, 2019 2018 Net cash used in operating activities$ (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 )
Net cash used in operating activities
Net cash used for operating activities was$147.7 million and$70.1 million for the years endedDecember 31, 2019 and 2018, respectively. Cash used in operating activities during 2019 primarily related to our net loss of$213.3 million , adjusted for non-cash share-based compensation expense of$55.5 million and net cash inflows from a change in our operating assets and liabilities of$13.2 million . Cash used in operating activities during 2018 primarily related to our net loss of$98.4 million , adjusted for non-cash share-based compensation expense of$15.9 million and net cash outflows from a change in our operating assets and liabilities of$13.6 million .
Net cash used in investing activities
Net cash used in investing activities for the years endedDecember 31, 2019 and 2018 was$176.1 million and$145.8 million , respectively, and reflects the purchases of short-term investments and property and equipment, offset by sales and maturities of short-term investments.
Net cash provided by financing activities
Net cash provided by financing activities for the year endedDecember 31, 2019 was$338.0 million and consisted of proceeds received from the issuance of common stock, exercise of common stock options, disgorgement of stockholders' short-swing profits, and stock issuances under the employee stock option plan. Net cash provided by financing activities for the year endedDecember 31, 2018 was$140.9 million and consisted of proceeds from issuance of common stock and pre-funded warrants, exercise of common stock options, and stock issuances under the employee stock option plan.
Contractual Obligations and Commitments
The following table summarizes our contractual obligations and commitments as of
Less Than 1 1
-3 3 -5 More Than 5
Total year Years Years Years Operating lease obligations (1)$ 41,804 $ 272 $ 10,376 $ 13,090 $ 18,066 Total Contractual Obligations$ 41,804 $ 272 $
10,376
(1) InJune 2014 we entered into a multi-year non-cancelable building lease for 18,000 square feet of completed office and laboratory space inSan Diego, California which was originally set to expire inJanuary 2018 . InMarch 2017 , we amended the lease to extend the term throughJanuary 2019 , and inApril 2018 , we amended the lease to extend the term throughJanuary 2020 , and inAugust 2018 , we amended the lease to expand the size of the existing space by approximately 6,100 square feet. OnOctober 30, 2019 , we amended the lease to extend the lease term to approximatelyOctober 1, 2020 , and to expand the size of the existing space for no additional base rent. Also onAugust 22, 2019 , we entered into a new lease agreement for office and laboratory space located inSan Diego, California , for our future corporate headquarters. We enter into contracts in the normal course of business with clinical sites for the conduct of clinical trials, CROs for clinical research studies, professional consultants for expert advice and other vendors for clinical supply manufacturing or other services. These contracts generally provide for termination on notice, and therefore are cancelable contracts and not included in the table of contractual obligations and commitments.
Off-Balance Sheet Arrangements
47 -------------------------------------------------------------------------------- During the years endedDecember 31, 2019 and 2018, we did not have any off-balance sheet arrangements (as defined by applicableSEC regulations) that are reasonably likely to have a current or future material effect on our financial condition, results of operations, liquidity, capital expenditures or capital resources. 48
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