Cover Page
Cover Page - shares | 6 Months Ended | |
Jun. 30, 2021 | Jul. 28, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2021 | |
Document Transition Report | false | |
Entity File Number | 000-30347 | |
Entity Registrant Name | CURIS, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 04-3505116 | |
Entity Address, Address Line One | 128 Spring Street | |
Entity Address, Address Line Two | Building C - Suite 500 | |
Entity Address, City or Town | Lexington | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02421 | |
City Area Code | 617 | |
Local Phone Number | 503-6500 | |
Title of 12(b) Security | Common Stock, Par Value $0.01 per share | |
Trading Symbol | CRIS | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 91,596,369 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q2 | |
Entity Central Index Key | 0001108205 | |
Current Fiscal Year End Date | --12-31 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 75,026 | $ 129,610 |
Short-term investments | 77,544 | 38,884 |
Accounts receivable | 2,379 | 3,043 |
Prepaid expenses and other current assets | 1,583 | 1,215 |
Total current assets | 156,532 | 172,752 |
Long-term investments | 8,112 | 14,564 |
Property and equipment, net | 580 | 663 |
Restricted cash, long-term | 816 | 816 |
Operating lease right-of-use asset | 6,171 | 6,578 |
Goodwill | 8,982 | 8,982 |
Other assets | 0 | 3 |
Total assets | 181,193 | 204,358 |
Current liabilities: | ||
Accounts payable | 4,051 | 4,166 |
Accrued liabilities | 3,183 | 3,625 |
Current portion of operating lease liability | 632 | 1,731 |
Current portion long-term debt | 0 | 557 |
Total current liabilities | 7,866 | 10,079 |
Long-term operating lease liability | 4,713 | 5,040 |
Liability related to the sale of future royalties, net | 56,140 | 58,235 |
Long-term debt | 0 | 334 |
Total liabilities | 68,719 | 73,688 |
Stockholders’ equity: | ||
Common stock, $0.01 par value—227,812,500 shares authorized; 91,596,369 shares issued and outstanding at June 30, 2021; 151,875,000 shares authorized; 91,502,461 shares issued and outstanding at December 31, 2020 | 916 | 915 |
Additional paid-in capital | 1,179,215 | 1,176,647 |
Accumulated deficit | (1,067,654) | (1,046,889) |
Accumulated other comprehensive income | (3) | (3) |
Total stockholders’ equity | 112,474 | 130,670 |
Total liabilities and stockholders’ equity | $ 181,193 | $ 204,358 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Jun. 30, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Common stock par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock authorized (in shares) | 227,812,500 | 151,875,000 |
Common stock issued (in shares) | 91,596,369 | 91,502,461 |
Common stock outstanding (in shares) | 91,596,369 | 91,502,461 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Revenues, net: | ||||
Total revenues, net | $ 2,286 | $ 2,360 | $ 4,475 | $ 5,068 |
Costs and expenses: | ||||
Cost of royalties | 116 | 122 | 225 | 247 |
Research and development | 8,753 | 5,282 | 15,510 | 12,754 |
General and administrative | 4,067 | 2,386 | 8,190 | 5,980 |
Total costs and expenses | 12,936 | 7,790 | 23,925 | 18,981 |
Loss from operations | (10,650) | (5,430) | (19,450) | (13,913) |
Other expense: | ||||
Interest income | 58 | 5 | 104 | 55 |
Imputed interest expense related to the sale of future royalties | (1,136) | (1,284) | (2,309) | (2,581) |
Other income (expense), net | 890 | 1 | 890 | 22 |
Total other expense | (188) | (1,278) | (1,315) | (2,504) |
Net loss | $ (10,838) | $ (6,708) | $ (20,765) | $ (16,417) |
Net loss per common share (basic ) (in dollars per share) | $ (0.12) | $ (0.17) | $ (0.23) | $ (0.44) |
Net loss per common share (diluted) (in dollars per share) | $ (0.12) | $ (0.17) | $ (0.23) | $ (0.44) |
Weighted average common shares (basic) (in shares) | 91,547,390 | 39,517,045 | 91,527,563 | 36,985,117 |
Weighted average common shares (diluted) (in shares) | 91,547,390 | 39,517,045 | 91,527,563 | 36,985,117 |
Net loss | $ (10,838) | $ (6,708) | $ (20,765) | $ (16,417) |
Other comprehensive income: | ||||
Unrealized gain (loss) on marketable securities | 6 | 0 | 0 | 0 |
Comprehensive loss | (10,832) | (6,708) | (20,765) | (16,417) |
Royalties | ||||
Revenues, net: | ||||
Total revenues, net | 2,348 | 2,446 | 4,535 | 4,961 |
Other revenue | ||||
Revenues, net: | ||||
Total revenues, net | 1 | 0 | 1 | 211 |
Contra revenue, net | ||||
Revenues, net: | ||||
Total revenues, net | $ (63) | $ (86) | $ (61) | $ (104) |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT) - USD ($) $ in Thousands | Total | Private Placement | Aspire Capital Fund, LLC | Common Stock | Common StockPrivate Placement | Common StockAspire Capital Fund, LLC | Additional Paid-in Capital | Additional Paid-in CapitalPrivate Placement | Additional Paid-in CapitalAspire Capital Fund, LLC | Accumulated Deficit | Accumulated Other Comprehensive (Loss) Income |
Beginning balance (in shares) at Dec. 31, 2019 | 33,241,793 | ||||||||||
Beginning balance at Dec. 31, 2019 | $ (33,911) | $ 332 | $ 982,738 | $ (1,016,981) | $ 0 | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||
Recognition of stock-based compensation | 625 | 625 | |||||||||
Issuance of stock (in shares) | 3,340,516 | ||||||||||
Issuance of stock | $ 2,726 | $ 34 | $ 2,692 | ||||||||
Net loss | (9,709) | (9,709) | |||||||||
Ending balance (in shares) at Mar. 31, 2020 | 36,582,309 | ||||||||||
Ending balance at Mar. 31, 2020 | (40,269) | $ 366 | 986,055 | (1,026,690) | 0 | ||||||
Beginning balance (in shares) at Dec. 31, 2019 | 33,241,793 | ||||||||||
Beginning balance at Dec. 31, 2019 | (33,911) | $ 332 | 982,738 | (1,016,981) | 0 | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||
Net loss | (16,417) | ||||||||||
Ending balance (in shares) at Jun. 30, 2020 | 50,639,048 | ||||||||||
Ending balance at Jun. 30, 2020 | (30,380) | $ 506 | 1,002,512 | (1,033,398) | 0 | ||||||
Beginning balance (in shares) at Mar. 31, 2020 | 36,582,309 | ||||||||||
Beginning balance at Mar. 31, 2020 | (40,269) | $ 366 | 986,055 | (1,026,690) | 0 | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||
Issuance of stock (in shares) | 14,000,000 | ||||||||||
Issuance of stock | $ 15,965 | $ 140 | $ 15,825 | ||||||||
Recognition of stock-based compensation | 585 | 585 | |||||||||
Issuance of stock under Employee Stock Purchase Plan (in shares) | 41,583 | ||||||||||
Issuance of stock under Employee Stock Purchase Plan | 29 | 29 | |||||||||
Exercise of stock options (in shares) | 15,156 | ||||||||||
Exercise of stock options | 18 | 18 | |||||||||
Net loss | (6,708) | (6,708) | |||||||||
Ending balance (in shares) at Jun. 30, 2020 | 50,639,048 | ||||||||||
Ending balance at Jun. 30, 2020 | $ (30,380) | $ 506 | 1,002,512 | (1,033,398) | 0 | ||||||
Beginning balance (in shares) at Dec. 31, 2020 | 91,502,461 | 91,502,461 | |||||||||
Beginning balance at Dec. 31, 2020 | $ 130,670 | $ 915 | 1,176,647 | (1,046,889) | (3) | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||
Recognition of stock-based compensation | 1,099 | 1,099 | |||||||||
Exercise of stock options (in shares) | 31,811 | ||||||||||
Exercise of stock options | 79 | $ 1 | 78 | ||||||||
Unrealized gain (loss) on marketable securities | (6) | (6) | |||||||||
Net loss | (9,927) | (9,927) | |||||||||
Ending balance (in shares) at Mar. 31, 2021 | 91,534,272 | ||||||||||
Ending balance at Mar. 31, 2021 | $ 121,915 | $ 916 | 1,177,824 | (1,056,816) | (9) | ||||||
Beginning balance (in shares) at Dec. 31, 2020 | 91,502,461 | 91,502,461 | |||||||||
Beginning balance at Dec. 31, 2020 | $ 130,670 | $ 915 | 1,176,647 | (1,046,889) | (3) | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||
Exercise of stock options (in shares) | 72,955 | ||||||||||
Net loss | $ (20,765) | ||||||||||
Ending balance (in shares) at Jun. 30, 2021 | 91,596,369 | 91,596,369 | |||||||||
Ending balance at Jun. 30, 2021 | $ 112,474 | $ 916 | 1,179,215 | (1,067,654) | (3) | ||||||
Beginning balance (in shares) at Mar. 31, 2021 | 91,534,272 | ||||||||||
Beginning balance at Mar. 31, 2021 | 121,915 | $ 916 | 1,177,824 | (1,056,816) | (9) | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||
Recognition of stock-based compensation | 1,275 | 1,275 | |||||||||
Issuance of stock under Employee Stock Purchase Plan (in shares) | 20,791 | ||||||||||
Issuance of stock under Employee Stock Purchase Plan | 68 | 68 | |||||||||
Exercise of stock options (in shares) | 41,306 | ||||||||||
Exercise of stock options | 48 | 48 | |||||||||
Unrealized gain (loss) on marketable securities | 6 | 6 | |||||||||
Net loss | $ (10,838) | (10,838) | |||||||||
Ending balance (in shares) at Jun. 30, 2021 | 91,596,369 | 91,596,369 | |||||||||
Ending balance at Jun. 30, 2021 | $ 112,474 | $ 916 | $ 1,179,215 | $ (1,067,654) | $ (3) |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Cash flows from operating activities: | ||
Net loss | $ (20,765) | $ (16,417) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 84 | 64 |
Non-cash lease expense | 407 | 260 |
Stock-based compensation expense | 2,374 | 1,210 |
Non-cash imputed interest expense related to the sale of future royalties | 3 | 10 |
Net amortization of premiums and discounts on marketable securities | 634 | 30 |
Gain on forgiveness of PPP Loan | (890) | 0 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 664 | 758 |
Prepaid expenses and other assets | (366) | 60 |
Accounts payable and accrued and other liabilities | (557) | 107 |
Operating lease liability | (1,426) | (229) |
Total adjustments | 927 | 2,270 |
Net cash used in operating activities | (19,838) | (14,147) |
Cash flows from investing activities: | ||
Purchase of investments | (54,947) | 0 |
Sales and maturities of investments | 22,105 | 5,082 |
Purchase of property and equipment | 0 | (499) |
Net cash provided by (used in) investing activities | (32,842) | 4,583 |
Cash flows from financing activities: | ||
Proceeds from PPP Loan | 0 | 890 |
Proceeds of Aspire Capital Agreement, net of issuance costs | 0 | 2,726 |
Proceeds of direct placement | 0 | 17,500 |
Payment of issuance costs on direct placement | 0 | (1,111) |
Proceeds from issuance of common stock under the Company's share-based compensation plan | 195 | 47 |
Payment of liability of future royalties, net of imputed interest | (2,099) | (2,297) |
Net cash provided by (used in) financing activities | (1,904) | 17,755 |
Net decrease in cash and cash equivalents and restricted cash | (54,584) | 8,191 |
Cash and cash equivalents and restricted cash, beginning of period | 130,426 | 16,399 |
Cash and cash equivalents and restricted cash, end of period | 75,842 | 24,590 |
Supplemental cash flow data: | ||
Accrued issuance costs | 0 | 424 |
Property and equipment purchases in accounts payable | 0 | 147 |
Cash paid for interest | 2,305 | 2,324 |
Non-cash commitment shares issued to Aspire Capital | 0 | 900 |
Right-of-use assets obtained in exchange for lease liabilities | $ 0 | $ 7,260 |
Nature of Business
Nature of Business | 6 Months Ended |
Jun. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Business | Nature of Business Curis, Inc. is a biotechnology company focused on the development of first-in-class and innovative therapeutics for the treatment of cancer. Throughout these Condensed Consolidated Financial Statements, Curis, Inc. and its wholly owned subsidiaries are collectively referred to as “the Company” or “Curis.” The Company conducts its research and development programs both internally and through strategic collaborations. The Company’s clinical stage drug candidates are: • CA-4948, an orally available small molecule inhibitor of Interleukin-1 receptor-associated kinase 4 ("IRAK4"), which is currently undergoing testing in a Phase 1/2 open-label dose escalating clinical trial in patients with non-Hodgkin lymphomas, including those with myeloid Differentiation Primary Response Protein 88 (“MYD88”) alterations. The trial was amended to include a combination study of CA-4948 and ibrutinib, a BTK inhibitor, in patients with non-Hodgkin lymphomas for which the Company enrolled the first patient in February 2021. The Company is also conducting a separate Phase 1/2 open-label, single arm dose escalating and expansion trial in patients with acute myeloid leukemia (“AML”) and myelodysplastic syndromes (“MDS”). The study was amended in April 2021 to include dose escalation cohorts of CA-4948 in combination with azacitidine or venetoclax. In April 2021, CA-4948 was granted Orphan Drug Designation for the treatment of AML and MDS by the U.S. Food and Drug Administration ("FDA"). In June 2021, we reported updated preliminary clinical data from the Phase 1/2 study in patients with AML or MDS and announced the recommended Phase 2 dose for monotherapy dose expansion. • CI-8993, a monoclonal antibody designed to antagonize the V-domain Ig suppressor of T cell activation (“VISTA”) signaling pathway. In June 2020, the Company announced that the FDA had cleared its Investigational New Drug (“IND”) application for CI-8993. In September 2020, enrollment for a Phase 1 trial in patients with solid tumors commenced. The Company has an option to license CI-8993 from ImmuNext, Inc. ("ImmuNext"). The Company’s pipeline also includes the following: • Fimepinostat, a small molecule that potently inhibits the activity of histone deacetylase and phosphotidyl-inositol 3 kinase enzymes, which has been granted Orphan Drug Designation and Fast Track Designation for the treatment of diffuse large B-cell lymphoma, by the FDA in April 2015 and May 2018, respectively. The Company is currently evaluating future studies for fimepinostat. • CA-170, a small molecule antagonist of VISTA and PDL1, for which the Company announced initial data from a clinical study in patients with mesothelioma, in conjunction with the Society of lmmunotherapy of Cancer conference in November 2019. Based on this data, no further patients will be enrolled in the study. The Company is currently evaluating future studies for CA-170. • CA-327, a small molecule antagonist of TIM3 and PDL1, is a pre-IND stage oncology drug candidate. The Company is party to a collaboration with Genentech Inc. (“Genentech”), a member of the Roche Group, under which Genentech and F. Hoffmann-La Roche Ltd (“Roche”) are commercializing Erivedge® (vismodegib), a first-in-class orally administered small molecule Hedgehog signaling pathway antagonist. Erivedge is approved for the treatment of advanced basal cell carcinoma (“BCC”). In January 2015, the Company entered into an exclusive collaboration agreement with Aurigene Discovery Technologies Limited (“Aurigene”) for the discovery, development and commercialization of small molecule compounds in the areas of immuno-oncology and precision oncology, which was amended in September 2016 and February 2020. As of June 30, 2021, the Company had licensed four programs under the Aurigene collaboration. • IRAK4 Program - a precision oncology program of small molecule inhibitors of IRAK4. The development candidate is CA-4948, an orally available small molecule inhibitor of IRAK4. • PD1/VISTA Program - an immuno-oncology program of small molecule antagonists of PD1 and VISTA immune checkpoint pathways. The development candidate is CA-170, an orally available small molecule antagonist of VISTA and PDL1. • PD1/TIM3 Program - an immuno-oncology program of small molecule antagonists of PD1 and TIM3 immune checkpoint pathways. The development candidate is CA-327, an orally available small molecule antagonist of PDL1 and TIM3. • The Company exercised its option to license a fourth program, which is an immuno-oncology program. The COVID-19 pandemic has had and may continue to have an adverse effect on the Company’s business, financial condition, results of operations, and prospects. With respect to ongoing clinical trials, the anticipated timing of enrollment and the overall timelines of the trials have experienced delays and could be further delayed to the extent the Company experiences further delays in enrollment due to the COVID-19 pandemic. The Company’s ability to collect patient data in a timely fashion may also be impacted. The Company experienced delays in closing down its clinical trial sites related to its fimepinostat and CA-170 trials due to restrictions on non-essential workers imposed at those sites in response to COVID-19, which delayed the winding down of these trials. In addition, the Company and its collaborators, third-party contract manufacturers, contract research organizations and clinical sites could experience delays or disruptions in supply and release of product candidates and/or procuring items that are essential for the Company's research and development activities, including, for example, raw materials used in the manufacturing of its product candidates, basic medical and laboratory supplies used in its clinical trials or preclinical studies, or animals that are used for preclinical testing, in each case, for which there may be shortages because of ongoing efforts to address the outbreak. The Company cannot be certain what the overall impact of the COVID-19 pandemic will be on its business. The Company is subject to risks common to companies in the biotechnology industry as well as risks that are specific to the Company’s business, including, but not limited to: the Company’s ability to obtain adequate financing to fund its operations; the Company’s ability to advance and expand its research and development programs; the impacts of the COVID-19 pandemic and responsive actions related thereto; the Company’s relationship with Aurigene to support development of drug candidates under the parties’ collaboration agreement; the Company’s reliance on Roche and Genentech to successfully commercialize Erivedge in the approved indication of advanced BCC and to progress its clinical development in indications other than BCC; the ability of the Company and its wholly owned subsidiary, Curis Royalty, LLC (“Curis Royalty”) to satisfy the terms of the royalty interest purchase agreement (the “Oberland Purchase Agreement”) with TPC Investments I LP and TPC Investments II LP (the “Purchasers”) each of which is a Delaware limited partnership managed by Oberland Capital Management, LLC, and Lind SA LLC (the “Agent”) a Delaware limited liability company managed by Oberland Capital Management, LLC, as collateral agent for the Purchasers; the Company’s ability to obtain and maintain necessary intellectual property protection; development by the Company’s competitors of new or better technological innovations; the Company's dependence on key personnel; the Company’s ability to comply with regulatory requirements; the Company's ability to obtain and maintain applicable regulatory approvals and commercialize any approved product candidates; the Company’s ability to execute on its overall business strategies and the Company’s ability to maintain its listing on the Nasdaq Global Market. The Company’s future operating results will largely depend on the progress of drug candidates currently in its development pipeline and the magnitude of payments that it may receive and make under its current and potential future collaborations. The results of the Company’s operations have varied and will likely continue to vary significantly from year to year and quarter to quarter and depend on a number of factors, including, but not limited to: the timing, outcome and cost of the Company’s preclinical studies and clinical trials for its drug candidates; Aurigene’s ability to support advancement of development candidates under the Company’s collaboration with Aurigene, as well as the Company’s ability to further develop programs under this collaboration; and Roche and Genentech’s ability to successfully commercialize Erivedge. The Company will require substantial funds to maintain research and development programs and support operations. The Company has incurred net losses and negative cash flows from operations since its inception. As of June 30, 2021, the Company had an accumulated deficit of approximately $1.1 billion, and for the six months ended June 30, 2021, the Company incurred a net loss of $20.8 million and used $19.8 million of cash in operations. The Company expects to continue to generate operating losses in the foreseeable future. The Company anticipates that its $160.7 million of existing cash, cash equivalents and investments at June 30, 2021 will be sufficient to fund operations for at least 12 months from the date of filing this Quarterly Report on Form 10-Q. The Company’s ability to raise additional funds will depend, among other factors, on financial, economic and market conditions, many of which are outside of its control and it may be unable to raise financing when needed, or on terms favorable to the Company. If necessary funds are not available, the Company will have to delay, reduce the scope of, or eliminate some of its development programs, potentially delaying the time to market for or preventing the marketing of any of its product candidates. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies (a) Basis of Presentation and Principles of Consolidation The accompanying Condensed Consolidated Financial Statements have been prepared in accordance with the instructions to Form 10-Q and Article 8 of Regulation S-X. These statements, however, are condensed and do not include all disclosures required by accounting principles generally accepted in the U.S. (“GAAP”), for complete financial statements and should be read in conjunction with the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 as filed with the Securities and Exchange Commission (“SEC”), on March 16, 2021. In the opinion of the management of the Company, the unaudited financial statements contain all adjustments (all of which were considered normal and recurring) necessary for a fair statement of the Company’s financial position at June 30, 2021; the results of operations for the three and six-month periods ended June 30, 2021 and 2020; stockholders' equity (deficit) for the three and six-month periods ended June 30, 2021 and 2020; and the cash flows for the six-month periods ended June 30, 2021 and 2020. The Condensed Consolidated Balance Sheet at December 31, 2020 was derived from audited annual financial statements but does not contain all of the footnote disclosures from the annual financial statements. Certain prior period amounts within the statement of cash flows have been reclassified to conform to the current period presentation. (b) Use of Estimates and Assumptions The preparation of the Company’s Condensed Consolidated Financial Statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts and disclosure of certain assets and liabilities at the balance sheet date. Such estimates include the performance obligations under the Company’s collaboration agreements; the estimated repayment term of the Company’s debt and related short- and long-term classification; the collectability of receivables; the carrying value of property and equipment and goodwill; and the assumptions used in the Company’s valuation of stock-based compensation and the value of certain investments and liabilities. Actual results may differ from such estimates. These interim results are not necessarily indicative of results to be expected for a full year or subsequent interim periods. The extent to which COVID-19 has had and may continue to have impacts on the Company’s business and financial results will depend on numerous evolving factors including, but not limited to: the magnitude and duration of the COVID-19 pandemic, the extent to which it has impacted and may continue to impact worldwide macroeconomic conditions including interest rates, employment rates and health insurance coverage, the speed of the anticipated recovery, and governmental and business responses to the pandemic. The Company assessed certain accounting matters that generally require consideration of forecasted financial information in context with the information reasonably available to the Company and the unknown future impacts of COVID-19 as of June 30, 2021 and through the date of this report. The Company’s future assessment of the magnitude and duration of the COVID-19 pandemic, as well as other factors, could result in material impacts to the Company’s consolidated financial statements in future reporting periods. (c) Cash Equivalents, Restricted Cash, and Investments Cash equivalents consist of highly liquid investments purchased with original maturities of three months or less. All other liquid investments are classified as marketable securities. The Company classified $0.8 million of its cash as restricted cash as of June 30, 2021 and December 31, 2020. This amount represents the security deposit delivered to the landlord of the Company's current Massachusetts headquarters. The Company's combined cash and restricted cash balances were $75.8 million and $24.6 million as of June 30, 2021 and June 30, 2020, respectively, as presented on the Company's Condensed Consolidated Statements of Cash Flows. The Company’s short-term investments are marketable debt securities with original maturities of greater than three months from the date of purchase, but less than twelve months from the balance sheet date, and long-term investments are marketable debt securities with original maturities of greater than twelve months from the balance sheet. Marketable securities consist of commercial paper, corporate bonds and notes, and/or government obligations. All of the Company’s investments have been designated available-for-sale and are stated at fair value. Unrealized gains and temporary losses on investments are included in accumulated other comprehensive income (loss) as a separate component of stockholders’ equity (deficit). Realized gains and losses, dividends and interest income are included in other income (expense) in the period during which the securities are sold. Any premium or discount arising at purchase is amortized and/or accreted to interest income. (d) Leases The Company determines if an arrangement is a lease at contract inception. Operating lease assets represent the Company's right to use an underlying asset for the lease term and operating lease liabilities represent its obligation to make lease payments arising from the lease. Operating lease assets and liabilities are recognized at the commencement date of the lease based upon the present value of lease payments over the lease term. When determining the lease term, the Company includes options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. As most of the Company's leases do not provide an implicit interest rate, the Company uses its incremental borrowing rate, which is based on rates that would be incurred to borrow on a collateralized basis over a term equal to the lease payments in a similar economic environment, in determining the present value of lease payments. Right-of-use assets and lease liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. The lease payment used to determine the operating lease asset may include lease incentives, stated rent increases and was recognized as an operating lease right-of-use asset in the Condensed Consolidated Balance Sheets. The Company's lease agreements may include both lease and non-lease components, which are accounted for as a single lease component when the payments are fixed. Variable payments included in the lease agreement are expensed as incurred. The Company's operating lease is reflected in operating lease right-of-use asset and operating lease liability in the Condensed Consolidated Balance Sheets. Lease expense for lease payments is recognized on a straight-line basis over the lease term. (e) Revenue Recognition The Company’s business strategy includes entering into collaborative license and development agreements with biotechnology and pharmaceutical companies for the development and commercialization of the Company’s drug candidates. The terms of the agreements typically include non-refundable license fees, funding of research and development, payments based upon achievement of clinical development and regulatory objectives, and royalties on product sales. License Fees and Multiple Element Arrangements If a license to its intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company will recognize revenues from non-refundable, up-front fees allocated to the license at such time as the license is transferred to the licensee and the licensee is able to use, and benefit from, the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company evaluates the measure of progress each reporting period and, if necessary, will adjust the measure of performance and related revenue recognition. If the Company is involved in a steering committee as part of a multiple element arrangement, the Company assesses whether its involvement constitutes a performance obligation or a right to participate. Steering committee services that are not determined to be distinct performance obligations are combined with other research services or performance obligations required under an arrangement, if any, in determining the level of effort required in an arrangement and the period over which the Company expects to complete its aggregate performance obligations. Appropriate methods of measuring progress include output methods and input methods. In determining the appropriate method for measuring progress, the Company considers the nature of service that it promises to transfer to the customer. When the Company decides on a method of measurement, the Company will apply that single method of measuring progress for each performance obligation satisfied over time and will apply that method consistently to similar performance obligations and in similar circumstances. If the Company cannot reasonably measure its progress toward complete satisfaction of a performance obligation because the Company lacks reliable information that would be required to apply an appropriate method of measuring progress, but it can reasonably estimate when the performance ceases or the remaining obligations become inconsequential and perfunctory, then revenue is not recognized until the Company can reasonably estimate when the performance obligation ceases or becomes inconsequential. Revenue is then recognized over the remaining estimated period of performance. Significant management judgment is required in determining the level of effort required under an arrangement and the period over which the Company is expected to complete its performance obligations under an arrangement. Contingent Research Milestone Payments Accounting Standards Codification ("ASC") 606 constrains the amount of variable consideration included in the transaction price in that either all, or a portion, of an amount of variable consideration should be included in the transaction price. The variable consideration amount should be included only to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The assessment of whether variable consideration should be constrained is largely a qualitative one that has two elements: the likelihood of a change in estimate, and the magnitude thereof. Variable consideration is not constrained if the potential reversal of cumulative revenue recognized is not significant, for example. If the consideration in a contract includes a variable amount, a company will estimate the amount of consideration in exchange for transfer of promised goods or services. The consideration also can vary if a company’s entitlement to the consideration is contingent on the occurrence or nonoccurrence of a future event. The Company considers contingent research milestone payments to fall under the scope of variable consideration, which should be estimated for revenue recognition purposes at the inception of the contract and reassessed ongoing at the end of each reporting period. The Company assesses whether contingent research milestones should be considered variable consideration that should be constrained and thus not part of the transaction price. This includes an assessment of the probability that all or some of the milestone revenues could be reversed when the uncertainty around whether or not the achievement of each milestone is resolved, and the amount of reversal could be significant. GAAP provides factors to consider when assessing whether variable consideration should be constrained. All of the factors should be considered, and no factor is determinative. The Company considers all relevant factors. Reimbursement of Costs Reimbursement of research and development costs by third-party collaborators is recognized as revenue over time provided the Company has determined that it transfers control (i.e. performs the services) of a service over time and, therefore, satisfies a performance obligation according to the provisions outlined in ASC 606-10-25-27, Revenue Recognition . Royalty Revenue The Company recognizes royalty revenues related to Genentech’s and Roche’s sales of Erivedge. For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and where the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). The Company expects to continue recognizing royalty revenue from Genentech’s sales of Erivedge in the U.S. and in other markets where Genentech and Roche successfully obtain marketing approval, if any (see Note 9, Research and Development Collaborations ). However, a portion of potential Erivedge royalties will be paid to the Purchasers pursuant to the Oberland Purchase Agreement (see Note 8, Liability Related to the Future Sale of Royalties ). Contra Revenue, Net Contra revenue, net represents shared costs, primarily related to intellectual property, with the Company's collaboration partners, and reserves for potential royalty reductions. With respect to each of the foregoing areas of revenue recognition, the Company exercises significant judgment in determining whether an arrangement contains multiple elements, and, if so, how much revenue is allocable to each element. In addition, the Company exercises its judgment in determining when its significant obligations have been met under such agreements and the specific time periods over which the Company recognized revenue, such as non-refundable, up-front license fees. To the extent that actual facts and circumstances differ from the Company's initial judgments, its revenue recognition with respect to such transactions would change accordingly and any such change could affect the Company's reported financial results. Summary During the three and six months ended June 30, 2021, total gross revenues were 99% from the Company’s collaboration with Genentech. During the three and six months ended June 30, 2020 total gross revenues were 100% and 96%, respectively, from the Company’s collaboration with Genentech. In addition to the revenues received from Genentech, the Company received a milestone payment from a previously out-licensed technology in the first quarter of 2020 that was recorded in other revenues. There were no such revenues recorded during the three and six months ended June 30, 2021. (f) Segment Reporting The Company operates in a single reportable segment, which is the research and development of innovative cancer therapeutics. (g) New Accounting Pronouncements Recently Adopted In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. This standard requires that for most financial assets, losses be based on an expected loss approach which includes estimates of losses over the life of exposure that considers historical, current and forecasted information. Expanded disclosures related to the methods used to estimate the losses as well as a specific disaggregation of balances for financial assets are also required. The targeted transition relief standard allows filers an option to irrevocably elect the fair value option of ASC 825-10, Financial Instruments-Overall, applied on an instrument-by-instrument basis for eligible instruments. In November 2019 the effective date for smaller reporting companies was extended to January 1, 2023 with the issuance of ASU 2019-10 Financial Instruments-Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842) Effective Dates. The Company adopted ASU 2016-13 as of January 1, 2021 and the adoption did not have a material impact on the Consolidated Financial Statements. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 6 Months Ended |
Jun. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The Company has adopted the provisions of the FASB Codification Topic 820, Fair Value Measurements and Disclosures (“Topic 820”) for its financial assets and liabilities that are re-measured and reported at fair value each reporting period and the non-financial assets and liabilities that are re-measured and reported at fair value on a non-recurring basis. Fair value is the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. When determining fair value, the Company considers the principal or most advantageous market in which it would transact and consider assumptions that market participants would use when pricing the asset or liability. Topic 820 establishes a three-level valuation hierarchy for disclosure of fair value measurements. Financial assets and liabilities are categorized within the valuation hierarchy based upon the lowest level of input that is significant to the measurement of fair value. The three levels of the hierarchy are defined as follows: Level 1 Quoted prices in active markets for identical assets or liabilities. Level 2 Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3 Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. In accordance with the fair value hierarchy, the following table shows the fair value as of June 30, 2021 and December 31, 2020 of those financial assets and liabilities that are measured at fair value on a recurring basis, according to the valuation techniques the Company used to determine their fair value. No financial assets or liabilities are measured at fair value on a nonrecurring basis at June 30, 2021 and December 31, 2020. (in thousands) Quoted Prices in Other Observable Unobservable Fair Value As of June 30, 2021: Cash equivalents: Money market funds $ 60,129 $ — $ — $ 60,129 Short-term investments: Corporate commercial paper, bonds and notes — 77,544 — 77,544 Long-term investments: Corporate commercial paper, bonds and notes — 8,112 — 8,112 Total assets at fair value $ 60,129 $ 85,656 $ — $ 145,785 (in thousands) Quoted Prices in Other Observable Unobservable Fair Value As of December 31, 2020: Cash equivalents: Money market funds $ 115,278 $ — $ — $ 115,278 Short-term investments: Corporate commercial paper, bonds and notes — 38,884 — 38,884 Long-term investments: Corporate commercial paper, bonds and notes — 14,564 — 14,564 Total assets at fair value $ 115,278 $ 53,448 $ — $ 168,726 |
Investments
Investments | 6 Months Ended |
Jun. 30, 2021 | |
Investments, Debt and Equity Securities [Abstract] | |
Investments | Investments The amortized cost, unrealized gains and losses and fair value of investments available-for-sale as of June 30, 2021 are as follows: (in thousands) Amortized Unrealized Unrealized Fair Value Corporate bonds and notes—short-term $ 77,538 $ 6 $ — $ 77,544 Corporate bonds and notes—long-term $ 8,121 — (9) $ 8,112 Total investments $ 85,659 $ 6 $ (9) $ 85,656 Short-term investments have maturities ranging from one The amortized cost, unrealized gains and losses and fair value of investments available-for-sale as of December 31, 2020 are as follows: (in thousands) Amortized Unrealized Unrealized Fair Value Corporate bonds and notes—short-term $ 38,888 $ — $ (4) $ 38,884 Corporate bonds and notes—long-term 14,563 1 — 14,564 Total investments $ 53,451 $ 1 $ (4) $ 53,448 Short-term investments have maturities ranging from one No credit losses on available-for-sale securities were recognized during the three and six months ended June 30, 2021 or June 30, 2020. In its evaluation to determine expected credit losses, management considered all available historical and current information, expectations of future economic conditions, the type of security, the credit rating of the security, and the size of the loss position, as well as other relevant information. The Company does not intend to sell, and is unlikely to be required to sell, any of these available-for-sale investments before their effective maturity or market price recovery. |
Accrued Liabilities
Accrued Liabilities | 6 Months Ended |
Jun. 30, 2021 | |
Other Liabilities Disclosure [Abstract] | |
Accrued Liabilities | Accrued Liabilities Accrued liabilities consisted of the following: (in thousands) June 30, 2021 December 31, 2020 Compensation and related costs $ 1,902 $ 2,638 Chemistry, manufacturing and controls costs 512 — Professional and legal fees 634 307 License fees — 375 Other 135 305 Total $ 3,183 $ 3,625 |
Debt
Debt | 6 Months Ended |
Jun. 30, 2021 | |
Debt Disclosure [Abstract] | |
Debt | DebtIn April 2020, the Company entered into a promissory note evidencing an unsecured $0.9 million loan (the “PPP Loan”) under the Paycheck Protection Program (“PPP”), of the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) as administered by the U.S. Small Business Administration (the "SBA"). The PPP Loan was made by Silicon Valley Bank and had a term of 24-months and an interest rate of 1%. Under the terms of the CARES Act and the Paycheck Protection Program Flexibility Act of 2020, PPP Loan recipients can apply for and be granted forgiveness for all or a portion of loans granted under the PPP. The Company applied for such forgiveness in 2020 and received notification in June 2021 that the SBA has forgiven the PPP Loan in full, including interest accrued on the PPP Loan. During the three months and six months ended June 30, 2021, the Company recorded a gain of $0.9 million to Other income (expense), net for extinguishment of the debt. As of December 31, 2020, the Company recorded short- and long-term debt related to the PPP Loan of $0.6 million and $0.3 million, respectively. |
Lease
Lease | 6 Months Ended |
Jun. 30, 2021 | |
Leases [Abstract] | |
Lease | LeaseThe Company has a single lease for real estate, including laboratory and office space, and certain equipment. The lease at 128 Spring Street in Lexington, Massachusetts commenced on May 1, 2020 which is the date when the property became available for use to the Company. In accordance with the accounting requirements under ASC 842, the lease obligation was not recorded until its commencement. The discount rate associated with the Company's right-of-use asset is 9.95%. As of June 30, 2021, the Company had an operating lease liability of $5.3 million and related right-of-use asset of $6.2 million related to its operating lease. As of December 31, 2020, the Company had an operating lease liability of $6.8 million and related right-of-use asset of $6.6 million related to its operating lease. The Company recorded a lease cost of $0.3 million and $0.7 million for the three and six months ended June 30, 2021, respectively. The Company recorded a lease cost of $0.4 and $0.7 million for the three and six months ended June 30, 2020, respectively. The total cash obligation over the seven year term of this lease is approximately $9.3 million, of which $0.3 million was paid during the three months ended June 30, 2021 and $1.7 million was paid during the six months ended June 30, 2021. The payments included a one-time payment of $1.1 million for tenant improvements. The Company did not make cash payments during the three months ended June 30, 2020. The Company paid $0.2 million during the six months ended June 30, 2020 |
Liability Related to the Sale o
Liability Related to the Sale of Future Royalties | 6 Months Ended |
Jun. 30, 2021 | |
Nonmonetary Transactions [Abstract] | |
Liability Related to the Sale of Future Royalties | Liability Related to the Sale of Future Royalties In March 2019, the Company and Curis Royalty entered into the royalty interest purchase agreement (“Oberland Purchase Agreement”) with entities managed by Oberland Capital Management, LLC (the “Purchasers”). The Company sold to the Purchasers a portion of its rights to receive royalties from Genentech on potential net sales of Erivedge. Concurrently with the closing of the Oberland Purchase Agreement Curis Royalty used a portion of the proceeds to terminate and repay the then existing loan with HealthCare Royalty Partners, III, L.P.. As upfront consideration for the purchase of the royalty rights, at closing the Purchasers paid to Curis Royalty $65.0 million less certain transaction expenses. Curis Royalty will also be entitled to receive up to approximately $70.7 million in milestone payments based on sales of Erivedge as follows: (i) $17.2 million if the Purchasers and Curis Royalty receive aggregate royalty payments pursuant to the Oberland Purchase Agreement in excess of $18.0 million during the calendar year 2021, subject to certain exceptions and (ii) $53.5 million if the Purchasers receive payments pursuant to the Oberland Purchase Agreement in excess of $117.0 million on or prior to December 31, 2026. The Oberland Purchase Agreement provides that after the occurrence of an event of default as defined under the security agreement by Curis Royalty, the Purchasers shall have the option, for a period of 180 days, to require Curis Royalty to repurchase a portion of certain royalty and royalty related payments, excluding a portion of non U.S. royalties retained by Curis Royalty (the “Purchased Receivables”), at a price (the “Put/Call Price”), equal to a percentage, beginning at a low triple digit percentage and increasing over time up to a low mid triple digit percentage of the sum of the upfront purchase price and any portion of the milestone payments paid in a lump sum by the Purchasers, if any, minus certain payments previously received by the Purchasers with respect to the Purchased Receivables. Additionally, Curis Royalty shall have the option at any time to repurchase the Purchased Receivables at the Put/Call Price as of the date of such repurchase. No events of default existed as of June 30, 2021. As a result of the obligation to pay future royalties to Oberland, the Company recorded the proceeds from this transaction as a liability on its Consolidated Balance Sheet that will be accounted for using the interest method over the estimated life of the Oberland Purchase Agreement. As a result, the Company imputes interest on the transaction and records imputed interest expense at the estimated interest rate. The Company's estimate of the interest rate under the agreement is based on the amount of royalty payments expected to be received by Oberland over the life of the arrangement. The projected amount of royalty payments expected to be paid to Oberland involves the use of significant estimates and assumptions with respect to the revenue growth rate in the Company's projections of sales of Erivedge. The Company periodically assesses the expected royalty payments to Curis Royalty from Genentech using a combination of historical results and forecasts from market data sources. To the extent such payments are greater or less than its initial estimates or the timing of such payments is materially different than its original estimates, the Company will adjust the amortization of the liability. The Company determined the fair value of the liability related to the sale of future royalties at the time of the Oberland Purchase Agreement to be $65.0 million, with a current effective annual imputed interest rate of 8.0%. The Company incurred $0.6 million of transaction costs in connection with the agreement. These transaction costs are amortized to imputed interest expense over the estimated term of the Oberland Purchase Agreement. The Company determined that the fair value assessment of the liability related to the sale of future royalties is a Level 3 assessment within the valuation hierarchy. The following table shows the activity with respect to the liability related to the sale of future royalties during the six months ended June 30, 2021. (in thousands) Carrying value of liability related to the sale of future royalties at January 1, 2021 $ 58,235 Amortization of capitalized issuance costs 31 Imputed interest expense recognized for the six months ending June 30, 2021 2,278 Less: payments to Oberland Capital, LLC (4,404) Carrying value of liability related to the sale of future royalties at June 30, 2021 $ 56,140 |
Research and Development Collab
Research and Development Collaborations | 6 Months Ended |
Jun. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Research and Development Collaborations | Research and Development Collaborations (a) Genentech In June 2003, the Company licensed its proprietary Hedgehog pathway antagonist technologies to Genentech for human therapeutic use. The primary focus of the collaborative research plan has been to develop molecules that inhibit the Hedgehog pathway for the treatment of various cancers. The collaboration is currently focused on the development of Erivedge, which is being commercialized by Genentech in the U.S. and by Genentech’s parent company, Roche, in several other countries for the treatment of advanced BCC. Pursuant to the agreement, the Company is eligible to receive up to an aggregate of $115.0 million in contingent cash milestone payments, exclusive of royalty payments, in connection with the development of Erivedge or another small molecule Hedgehog pathway inhibitor, assuming the successful achievement by Genentech and Roche of specified clinical development and regulatory objectives. Of this amount, the Company has received $59.0 million in cash milestone payments as of June 30, 2021. In addition to these payments and pursuant to the collaboration agreement, the Company is entitled to a royalty on net sales of Erivedge that ranges from 5% to 7.5%. The royalty rate applicable to Erivedge may be decreased by 2% on a country-by-country basis in certain specified circumstances. The Company recognized $2.3 million and $2.4 million in royalty revenue under the Genentech collaboration during the three months ended June 30, 2021 and 2020, respectively. The Company recognized $4.5 million in royalty revenue under the Genentech collaboration during the six months ended June 30, 2021 and $5.0 million during the six months ended June 30, 2020. The Company also recorded costs of royalty revenues within the costs and expenses section of its Condensed Consolidated Statements of Operations and Comprehensive Loss of $0.1 million during the three months ended June 30, 2021 and 2020. The Company recorded $0.2 million of costs of royalty revenues during the six months ended June 30, 2021 and 2020. Cost of royalty revenues comprises 5% of the royalty payments that Curis Royalty receives from Genentech, through February 2022, which the Company is obligated to pay to university licensors. Under this collaboration, the Company is obligated to reimburse Genentech, and the Company records contra-revenues in its Condensed Consolidated Statements of Operations and Comprehensive Loss. The Company will continue to recognize revenue for expense reimbursement as such reimbursable expenses are incurred, provided that the provisions of ASC 606 are met. Genentech incurred immaterial expense during the three and six months ended June 30, 2021, and 2020. The Company recorded receivables from Genentech under this collaboration, comprised primarily of Erivedge royalties earned in the first half of 2021 and 2020. The receivable recorded in the Company's current assets section of its Condensed Consolidated Balance Sheets amounted to $2.4 million and $3.0 million as of June 30, 2021 and December 31, 2020, respectively. As previously discussed in Note 8, Liability Related to the Sale of Future Royalties, a portion of royalty revenues received from Genentech on net sales of Erivedge will be paid to the Purchasers pursuant to the Oberland Purchase Agreement. (b) Aurigene In January 2015, the Company entered into an exclusive collaboration agreement with Aurigene for the discovery, development and commercialization of small molecule compounds in the areas of immuno-oncology and selected precision oncology targets, which was amended in September 2016. Under the collaboration agreement, Aurigene granted the Company an option to obtain exclusive, royalty-bearing licenses to relevant Aurigene technology to develop, manufacture and commercialize products containing certain of such compounds anywhere in the world, except for India and Russia, which are territories retained by Aurigene. In February 2020, the collaboration agreement was further amended whereby Aurigene received rights to develop and commercialize CA-170 in Asia in addition to its existing rights in India and Russia, and the Company became entitled to receive royalty payments on potential future sales of CA-170 in Asia at percentage rates ranging from the high single digits up to 10% subject to specified reductions. As of June 30, 2021, the Company has exercised its option to license the following four programs under the collaboration: 1. IRAK4 Program - a precision oncology program of small molecule inhibitors of IRAK4. The development candidate is CA-4948, an orally available small molecule inhibitor of IRAK4. 2. PD1/VISTA Program - an immuno-oncology program of small molecule antagonists of PD1 and VISTA immune checkpoint pathways. The development candidate is CA-170, an orally available small molecule antagonist of VISTA and PDL1. 3. PD1/TIM3 Program - an immuno-oncology program of small molecule antagonists of PD1 and TIM3 immune checkpoint pathways. The development candidate is CA-327, an orally available small molecule antagonist of PDL1 and TIM3. 4. In March 2018, the Company exercised its option to license a fourth program, which is an immuno-oncology program. Since January 2015, the Company has paid $14.5 million in research payments and Aurigene has waived $19.5 million in milestone payments. For each of the IRAK4, PD1/VISTA, and PD1/TIM3 programs, and the fourth immuno-oncology program: the Company has remaining unpaid or unwaived payment obligations of $42.5 million per program, related to regulatory approval and commercial sales milestones, plus specified additional payments for approvals for additional indications, if any. The Company is further obligated to pay Aurigene tiered royalties on the Company's and its affiliates' annual net sales of products at percentage rates ranging from the high single digits up to 10%, subject to specified reductions. In addition, the Company agreed to make certain payments to Aurigene upon its entry into sublicense agreements on any program(s). In addition to the collaboration agreement, the Company has entered into a master development and manufacturing agreement with Aurigene for the supply of drug substance and drug product. Under this agreement, the Company incurred $0.4 million in research and development expense during the three months ended June 30, 2021 and $0.8 million during the six months ended June 30, 2021. The Company recorded $0.5 million in prepaid expenses as of June 30, 2021 associated with this agreement. The Company incurred immaterial expenses related to Aurigene for the three and six months ended June 30, 2020. (c) ImmuNext The Company has entered into an option and license agreement with ImmuNext (the “ImmuNext Agreement”). Under the terms of the ImmuNext Agreement, the Company agreed to engage in a collaborative effort with ImmuNext, and to conduct a Phase 1 clinical trial of CI-8993. In exchange, ImmuNext granted the Company an exclusive option, exercisable until the earlier of January 2024 or (b) 90 days after database lock for the first Phase 1 trial in which the endpoints are satisfied (the “Option Period”), to obtain an exclusive, worldwide license to develop and commercialize certain VISTA antagonizing compounds and products containing these compounds in the field of oncology. During the Option Period, the Company is obligated to pay a semi-annual fee of $0.4 million to ImmuNext and will conduct the Phase 1 trial, and ImmuNext will conduct certain agreed upon non-clinical research activities to support the Phase 1 trial. Additionally, the Company will assign to ImmuNext all right, title and interest in and to, inventions made by the Company alone or jointly with ImmuNext in conducting clinical and non-clinical activities under the ImmuNext Agreement and any patent rights covering those inventions. If the option is exercised, ImmuNext will assign to the Company (i) all such inventions that were made solely by the Company and any patent rights covering those inventions that were assigned by the Company to ImmuNext during the Option Period and (ii) a joint ownership interest in all such inventions that were made jointly by the Company and ImmuNext and patent rights covering those inventions that were assigned by the Company to ImmuNext during the Option Period, except for any of those inventions that relates to certain compounds to which ImmuNext has retained exclusive rights. In addition, the Company has agreed to reimburse ImmuNext for certain documented external costs and expenses incurred by ImmuNext in carrying out non-clinical research activities approved by the joint steering committee, up to $0.3 million per calendar year, unless otherwise agreed to by both parties in writing. ImmuNext will be eligible to receive up to $4.6 million in potential development milestones, up to $84.3 million in potential regulatory approval milestones, and up to $125.0 million in potential sales milestone payments from us. ImmuNext is also eligible to receive tiered royalties on annual net sales on a product-by-product and country-by-country basis, at percentage rates ranging from high single digits to low double digits, subject to specified adjustments. In addition, the Company has agreed to pay ImmuNext a low double-digit percentage of sublicense revenue received by the Company or its affiliates. If the Company elects to exercise the option, the Company has agreed to pay to ImmuNext an option exercise fee of $20.0 million. |
Common Stock
Common Stock | 6 Months Ended |
Jun. 30, 2021 | |
Equity [Abstract] | |
Common Stock | Common Stock (a) Charter Amendments In June 2020, the Company's stockholders approved an increase to the number of authorized shares of its common stock from 101,250,000 shares to 151,875,000 shares. The Company filed an amendment to its certificate of incorporation in June 2020 to effect such increase. In May 2021, the Company's stockholders approved an increase to the number of authorized shares of its common stock from 151,875,000 shares to 227,812,500 shares. The Company filed an amendment to its certificate of incorporation in May 2021 to effect such increase. (b) 2021 Sales Agreement with Cantor Fitzgerald & Co. and JonesTrading Institutional Services LLC In March 2021, the Company entered into a sales agreement (the “2021 Sales Agreement”) with Cantor Fitzgerald & Co., or Cantor, and JonesTrading Institutional Services LLC , or JonesTrading, to sell from time to time up to $100.0 million of the Company’s common stock through an “at the market offering” program under which Cantor and JonesTrading act as sales agents. Subject to the terms and conditions of the 2021 Sales Agreement, Cantor and JonesTrading can sell the common stock by any method deemed to be an “at-the-market” offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended (the “Securities Act”). Pursuant to the terms of the 2021 Sales Agreement, the aggregate compensation payable to each of Cantor and JonesTrading is 3% of the gross proceeds from sales of the common stock sold by Cantor or JonesTrading, as applicable. Each party agreed in the 2021 Sales Agreement to provide indemnification and contribution against certain liabilities, including liabilities under the Securities Act, subject to the terms of the 2021 Sales Agreement. To date, the Company has not made any sales of common stock pursuant to the 2021 Sales Agreement. The securities in this transaction were offered pursuant to an automatic shelf registration statement on Form S-3ASR (File No. 333-254362) that was filed with the SEC on March 16, 2021. (c) 2020 Public Offering In December 2020, the Company completed an underwritten public offering of 29,500,000 shares of the Company's common stock, including 3,847,826 shares issued and sold to the underwriters upon the exercise in full of their option to purchase additional shares, at a price of $5.75 per share, for aggregate gross proceeds of $169.6 million, before deducting underwriting discounts and commissions and other offering expenses of $10.2 million. The securities in this transaction were offered pursuant to a shelf registration statement on Form S-3 (File No. 333-224627) that was filed with the SEC on May 3, 2018 and declared effective by the SEC on May 17, 2018 and an additional registration statement on Form S-3 (File No. 333-251211) filed pursuant to Rule 462(b) which became automatically effective on December 9, 2020. (d) 2020 Registered Direct Offering In June 2020, the Company entered into a securities purchase agreement with certain institutional investors, pursuant to which the Company issued and sold, in a registered direct offering, an aggregate of 14,000,000 shares of the Company's common stock at a purchase price per share of $1.25, for aggregate gross proceeds of $17.5 million, before deducting fees of approximately $1.0 million paid to the placement agent and other estimated offering expenses of approximately $0.5 million paid by the Company. JonesTrading acted as the exclusive placement agent for the transaction, and the shares were offered by the Company pursuant to its universal shelf registration statement on Form S-3, which was filed with the SEC on May 3, 2018 and declared effective by the SEC on May 17, 2018 (File No. 333-224627), and a prospectus supplement thereunder. (e) 2020 Sales Agreement with JonesTrading Institutional Services LLC In March 2020, the Company entered into a Capital on Demand™ Sales Agreement (the “Sales Agreement”) with JonesTrading to sell from time to time up to $30.0 million of the Company’s common stock through an “at-the-market” equity offering program under which JonesTrading acted as sales agent. Subject to the terms and conditions of the Sales Agreement, JonesTrading could sell the common stock by any method deemed to be an “at-the-market” offering as defined in Rule 415 promulgated under the Securities Act, including sales made directly on the Nasdaq Global Market, on any other existing trading market for the common stock or to or through a market maker other than on an exchange. In addition, with the Company’s prior written approval, JonesTrading could also sell the common stock by any other method permitted by law, including in privately negotiated transactions. Pursuant to the terms of the Sales Agreement, the aggregate compensation payable to JonesTrading was 3% of the gross proceeds from sales of the common stock sold by JonesTrading pursuant to the Sales Agreement. Each party agreed in the Sales Agreement to provide indemnification and contribution against certain liabilities, including liabilities under the Securities Act, subject to the terms of the Sales Agreement. The Company terminated this sales agreement effective as of December 9, 2020. The Company did not incur any termination penalties as a result of the termination. As of the effective date of the termination of the Sales Agreement, the Company had sold an aggregate of 6,298,648 shares of common stock under the sales agreement for aggregate gross proceeds of $8.3 million and net proceeds of $7.9 million after deducting commissions and offering expenses. The $21.7 million of common stock that remained unsold at the time of termination is no longer available. (f) Aspire Capital Fund LLC In February 2020, the Company entered into a common stock purchase agreement (the “Agreement”) with Aspire Capital Fund, LLC (“Aspire Capital”) for the sale of up to $30.0 million of the Company's common stock. Under the terms of the Agreement, Aspire Capital has committed to purchase such shares of the Company's common stock at the Company’s request, from time to time during a 30-month period at prices based on the market price at the time of each sale, subject to specified terms and limitations. Aspire Capital made an initial investment of $3.0 million through the purchase of 2,693,965 shares of the Company's common stock. In 2020, Aspire Capital subsequently purchased an additional 4,650,000 shares of the Company's common stock for $5.4 million. In addition, as consideration for Aspire Capital’s obligation under the Agreement, the Company issued 646,551 shares of common stock to Aspire Capital as a commitment fee. As of June 30, 2021 and December 31, 2020, a total of $21.6 million remained available under the Agreement. The Company did not sell shares of common stock under the Agreement during the three and six months ended June 30, 2021. Except for the initial investment, the Company did not sell shares of common stock under the Agreement during the three and six months ended June 30, 2020. Under the terms of the Agreement, the Company has the right to sell up to 150,000 shares of common stock per day to Aspire Capital, which total may be increased by mutual agreement up to an additional 2,000,000 shares per day. The extent to which the Company relies on Aspire Capital as a source of funding will depend on a number of factors, including the prevailing market price of its common stock and the extent to which it is able to secure working capital from other sources. There are no warrants, derivatives, or other share classes associated with this Agreement. The Company will control the timing and amount of the further sale of its common stock to Aspire Capital. There are no restrictions on future financings and there are no financial covenants, participation rights, rights of first refusal, or penalties in the Agreement. The Company has the right to terminate the Agreement at any time without any additional cost or penalty. |
Stock Plans and Stock Based Com
Stock Plans and Stock Based Compensation | 6 Months Ended |
Jun. 30, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Stock Plans and Stock Based Compensation | Stock Plans and Stock-Based Compensation As of June 30, 2021, the Company had two shareholder-approved, stock-based compensation plans: (i) the Amended and Restated 2010 Employee Stock Purchase Plan (“ESPP”), adopted by the Board of Directors in April 2017 and approved by shareholders in June 2017, and (ii) the Fourth Amended and Restated 2010 Stock Incentive Plan (“2010 Plan”). New employees are typically issued options as an inducement equity award under Nasdaq Listing Rule 5635(c)(4) outside of the 2010 Plan. The Fourth Amended and Restated 2010 Stock Incentive Plan The 2010 Plan permits the granting of incentive and non-qualified stock options and stock awards to employees, officers, directors, and consultants of the Company and its subsidiaries at prices determined by the Company’s Board of Directors. In May 2021, the Company's shareholders approved the Company's Fourth Amended and Restated 2010 Stock Incentive Plan to reserve an additional 11,000,000 shares of common stock for issuance under the 2010 Plan. The Company can issue up to 23,190,000 shares of its common stock pursuant to awards granted under the 2010 Plan. Options become exercisable as determined by the Board of Directors and expire up to ten years from the date of grant. The 2010 Plan uses a “fungible share” concept under which each share of stock subject to awards granted as options and stock appreciation rights (“SARs”), will cause one share per share under the award to be removed from the available share pool, while each share of stock subject to awards granted as restricted stock, restricted stock units, other stock-based awards or performance awards where the price charged for the award is less than 100% of the fair market value of the Company’s common stock will cause 1.3 shares per share under the award to be removed from the available share pool. As of June 30, 2021 the Company has only granted options to purchase shares of the Company’s common stock with an exercise price equal to the closing market price of the Company’s common stock on the Nasdaq Global Market on the grant date. As of June 30, 2021, 13,590,840 shares remained available for grant under the 2010 Plan. Stock Options During the six months ended June 30, 2021, the Company’s board of directors granted options to purchase 1,086,000 shares of the Company’s common stock to the officers and employees of the Company, under the 2010 Plan. Shares granted to officers and employees vest as to 25% of the shares underlying the award on the first anniversary of the grant date and as to an additional 6.25% of the shares underlying the award at the end of each subsequent quarter, based upon continued employment over a four year period, and are exercisable at a price equal to the closing price of the Company’s common stock on the Nasdaq Global Market on the grant dates. During the first quarter of 2021, the Company’s board of directors granted options to its non-employee directors to purchase 132,000 shares of common stock under the 2010 Plan, which will vest and become exercisable one year from the grant date. There were no additional non-employee grants made in the three months ended June 30, 2021. In addition, during the six months ended June 30, 2021 the Company's board of directors issued options to newly-hired employees as an inducement equity award under Nasdaq Listing Rule 5635(c)(4) outside of the 2010 Plan to purchase 352,300 shares of common stock. These options will vest as to 25% of the shares underlying the option on the first anniversary of the grant date, and as to an additional 6.25% of the shares underlying the option on each successive three-month period thereafter. All option awards are exercisable at a price equal to the closing price of the Company’s common stock on the Nasdaq Global Market on the grant dates. A summary of stock option activity under the 2010 Plan and inducement awards are summarized as follows: Number of Weighted Weighted Aggregate Intrinsic Value Outstanding, December 31, 2020 8,668,005 $ 2.71 7.98 Granted 1,570,300 9.42 Exercised (72,955) 1.75 Canceled (110,825) 11.54 Outstanding, June 30, 2021 10,054,525 $ 3.66 7.83 $ 49,925 Exercisable at June 30, 2021 5,302,685 $ 3.45 7.16 $ 28,242 Vested and unvested expected to vest at June 30, 2021 9,679,572 $ 3.63 7.79 $ 48,422 The weighted average grant date fair values of the stock options granted during the six months ended June 30, 2021 and 2020 were $9.42 and $0.75, respectively, and were calculated using the following estimated assumptions: Six Months Ended 2021 2020 Expected term (years) – directors, officers and employees 5.5 5.5 Risk free interest rate 0.4-1.4% 0.4-1.7% Expected Volatility 107 % 81 % Expected Dividends None None As of June 30, 2021, there was approximately $11.1 million of unrecognized compensation cost related to unvested employee stock option awards outstanding, net of the impact of estimated forfeitures that is expected to be recognized as expense over a weighted average period of 2.38 years. The intrinsic value of employee stock options exercised during the six months ended June 30, 2021 was $0.5 million. The intrinsic value of employee stock options exercised during the six months ended June 30, 2020 was not material. Restricted Stock Awards The following table presents a summary of unvested restricted stock awards (“RSAs”) under the 2010 Plan as of June 30, 2021: Number of Weighted Unvested, December 31, 2020 20,624 $ 3.45 Awarded — — Vested (10,312) 3.45 Forfeited — — Unvested, June 30, 2021 10,312 $ 3.45 As of June 30, 2021, there were 10,312 shares outstanding covered by RSAs that are expected to vest. The weighted average grant date fair value of these shares of restricted stock was $3.45 per share and the aggregate fair value of these shares of restricted stock was $0.1 million. As of June 30, 2021, there was less than $0.1 million of unrecognized compensation costs, net of estimated forfeitures, related to RSAs granted to officers, which are expected to be recognized as expense over a remaining weighted average period of 0.56 years. Amended and Restated 2010 Employee Stock Purchase Plan The Company has reserved 2,000,000 shares of common stock for issuance under the ESPP. Eligible employees may purchase shares of the Company’s common stock at 85% of the lower closing market price of the common stock at the beginning of the enrollment period or ending date of the purchase period within a two-year enrollment period, as defined. The Company has four six-month purchase periods per each two-year enrollment period. If, within any one of the four purchase periods in an enrollment period, the purchase period ending stock price is lower than the stock price at the beginning of the enrollment period, the two-year enrollment resets at the new lower stock price. This aspect of the plan was amended in 2017. Prior to 2017, the plan included two six-month purchase periods per year with no defined enrollment period. During the three and six months ended June 30, 2021, 20,791 shares were issued under the ESPP. As of June 30, 2021, there were 1,576,599 shares available for future purchase under the ESPP. ESPP compensation expense for the three and six months ended June 30, 2021 and 2020 was not material. Total Stock-Based Compensation Expense For the three and six months ended June 30, 2021 and 2020, the Company recorded stock-based compensation expense to the following line items in its costs and expenses section of the Condensed Consolidated Statements of Operations and Comprehensive Loss, including expense related to its ESPP: Three Months Ended Six Months Ended (in thousands) 2021 2020 2021 2020 Research and development expenses $ 440 $ 185 $ 778 $ 355 General and administrative expenses 835 400 1,596 855 Total stock-based compensation expense $ 1,275 $ 585 $ 2,374 $ 1,210 |
Loss Per Common Share
Loss Per Common Share | 6 Months Ended |
Jun. 30, 2021 | |
Earnings Per Share [Abstract] | |
Loss Per Common Share | Loss Per Common ShareBasic and diluted loss per common share is computed by dividing net loss attributable to common stockholders by the weighted average number of common shares outstanding during the period. Diluted net loss per common share is the same as basic net loss per common share for the three and six months ended June 30, 2021 and 2020, because the effect of the potential common stock equivalents would be antidilutive due to the Company’s net loss position for these periods. Antidilutive securities consist of stock options outstanding of 10,054,525 and 9,162,208 as of June 30, 2021 and 2020, respectively. |
Related Party Transactions
Related Party Transactions | 6 Months Ended |
Jun. 30, 2021 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Related Party Transactions (a) Agreement with Head of Research and Development - Robert E. Martell, M.D . , Ph.D. In October 2018, the Company entered into an exclusive option and license agreement with Epi-Cure Pharmaceuticals, Inc., (“Epi-Cure”) a privately held early stage biotechnology company. Robert E. Martell, M.D., Ph.D., the Company’s Head of Research and Development and a former director of the Company, is a founder of Epi-Cure, was formerly an officer and director of Epi-Cure, and is currently a holder of a convertible promissory note to Epi-Cure. Under the terms of the option and license agreement, Epi-Cure granted Curis an exclusive option to certain program compounds that may arise during the initial research and development period, and any extension thereof. Upon execution of the option and license agreement, the Company paid Epi-Cure an upfront payment of $0.1 million for legal and consulting costs incurred by Epi-Cure in connection with the transaction. Under the terms of the agreement, Epi-Cure had primary responsibility for conducting research and development activities and Curis was responsible for funding up to $0.5 million of the research and development program costs and expenses during the initial research and development period. After the end of the research and development period, which ended in April 2020, Curis had sixty days to elect to exercise its option to license the program compounds. In June 2020, the Company decided not to exercise its option to license the program compounds, and the agreement expired. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Basis of Presentation and Principles of Consolidation | Basis of Presentation and Principles of ConsolidationThe accompanying Condensed Consolidated Financial Statements have been prepared in accordance with the instructions to Form 10-Q and Article 8 of Regulation S-X. These statements, however, are condensed and do not include all disclosures required by accounting principles generally accepted in the U.S. (“GAAP”), for complete financial statements and should be read in conjunction with the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 as filed with the Securities and Exchange Commission (“SEC”), on March 16, 2021 |
Use of Estimates and Assumptions | Use of Estimates and Assumptions The preparation of the Company’s Condensed Consolidated Financial Statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts and disclosure of certain assets and liabilities at the balance sheet date. Such estimates include the performance obligations under the Company’s collaboration agreements; the estimated repayment term of the Company’s debt and related short- and long-term classification; the collectability of receivables; the carrying value of property and equipment and goodwill; and the assumptions used in the Company’s valuation of stock-based compensation and the value of certain investments and liabilities. Actual results may differ from such estimates. These interim results are not necessarily indicative of results to be expected for a full year or subsequent interim periods. The extent to which COVID-19 has had and may continue to have impacts on the Company’s business and financial results will depend on numerous evolving factors including, but not limited to: the magnitude and duration of the COVID-19 pandemic, the extent to which it has impacted and may continue to impact worldwide macroeconomic conditions including interest rates, employment rates and health insurance coverage, the speed of the anticipated recovery, and governmental and business responses to the pandemic. The Company assessed certain accounting matters that generally require consideration of forecasted financial information in context with the information reasonably available to the Company and the unknown future impacts of COVID-19 as of June 30, 2021 and through the date of this report. The Company’s future assessment of the magnitude and duration of the COVID-19 pandemic, as well as other factors, could result in material impacts to the Company’s consolidated financial statements in future reporting periods. |
Cash Equivalents, Restricted Cash, and Investments | Cash Equivalents, Restricted Cash, and Investments Cash equivalents consist of highly liquid investments purchased with original maturities of three months or less. All other liquid investments are classified as marketable securities. The Company classified $0.8 million of its cash as restricted cash as of June 30, 2021 and December 31, 2020. This amount represents the security deposit delivered to the landlord of the Company's current Massachusetts headquarters. The Company's combined cash and restricted cash balances were $75.8 million and $24.6 million as of June 30, 2021 and June 30, 2020, respectively, as presented on the Company's Condensed Consolidated Statements of Cash Flows. The Company’s short-term investments are marketable debt securities with original maturities of greater than three months from the date of purchase, but less than twelve months from the balance sheet date, and long-term investments are marketable debt securities with original maturities of greater than twelve months from the balance sheet. Marketable securities consist of commercial paper, corporate bonds and notes, and/or government obligations. All of the Company’s investments have been designated available-for-sale and are stated at fair value. Unrealized gains and temporary losses on investments are included in accumulated other comprehensive income (loss) as a separate component of stockholders’ equity (deficit). Realized gains and losses, dividends and interest income are included in other income (expense) in the period during which the securities are sold. Any premium or discount arising at purchase is amortized and/or accreted to interest income. |
Leases | LeasesThe Company determines if an arrangement is a lease at contract inception. Operating lease assets represent the Company's right to use an underlying asset for the lease term and operating lease liabilities represent its obligation to make lease payments arising from the lease. Operating lease assets and liabilities are recognized at the commencement date of the lease based upon the present value of lease payments over the lease term. When determining the lease term, the Company includes options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. As most of the Company's leases do not provide an implicit interest rate, the Company uses its incremental borrowing rate, which is based on rates that would be incurred to borrow on a collateralized basis over a term equal to the lease payments in a similar economic environment, in determining the present value of lease payments. Right-of-use assets and lease liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. The lease payment used to determine the operating lease asset may include lease incentives, stated rent increases and was recognized as an operating lease right-of-use asset in the Condensed Consolidated Balance Sheets. The Company's lease agreements may include both lease and non-lease components, which are accounted for as a single lease component when the payments are fixed. Variable payments included in the lease agreement are expensed as incurred. |
Revenue Recognition | Revenue Recognition The Company’s business strategy includes entering into collaborative license and development agreements with biotechnology and pharmaceutical companies for the development and commercialization of the Company’s drug candidates. The terms of the agreements typically include non-refundable license fees, funding of research and development, payments based upon achievement of clinical development and regulatory objectives, and royalties on product sales. License Fees and Multiple Element Arrangements If a license to its intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company will recognize revenues from non-refundable, up-front fees allocated to the license at such time as the license is transferred to the licensee and the licensee is able to use, and benefit from, the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company evaluates the measure of progress each reporting period and, if necessary, will adjust the measure of performance and related revenue recognition. If the Company is involved in a steering committee as part of a multiple element arrangement, the Company assesses whether its involvement constitutes a performance obligation or a right to participate. Steering committee services that are not determined to be distinct performance obligations are combined with other research services or performance obligations required under an arrangement, if any, in determining the level of effort required in an arrangement and the period over which the Company expects to complete its aggregate performance obligations. Appropriate methods of measuring progress include output methods and input methods. In determining the appropriate method for measuring progress, the Company considers the nature of service that it promises to transfer to the customer. When the Company decides on a method of measurement, the Company will apply that single method of measuring progress for each performance obligation satisfied over time and will apply that method consistently to similar performance obligations and in similar circumstances. If the Company cannot reasonably measure its progress toward complete satisfaction of a performance obligation because the Company lacks reliable information that would be required to apply an appropriate method of measuring progress, but it can reasonably estimate when the performance ceases or the remaining obligations become inconsequential and perfunctory, then revenue is not recognized until the Company can reasonably estimate when the performance obligation ceases or becomes inconsequential. Revenue is then recognized over the remaining estimated period of performance. Significant management judgment is required in determining the level of effort required under an arrangement and the period over which the Company is expected to complete its performance obligations under an arrangement. Contingent Research Milestone Payments Accounting Standards Codification ("ASC") 606 constrains the amount of variable consideration included in the transaction price in that either all, or a portion, of an amount of variable consideration should be included in the transaction price. The variable consideration amount should be included only to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The assessment of whether variable consideration should be constrained is largely a qualitative one that has two elements: the likelihood of a change in estimate, and the magnitude thereof. Variable consideration is not constrained if the potential reversal of cumulative revenue recognized is not significant, for example. If the consideration in a contract includes a variable amount, a company will estimate the amount of consideration in exchange for transfer of promised goods or services. The consideration also can vary if a company’s entitlement to the consideration is contingent on the occurrence or nonoccurrence of a future event. The Company considers contingent research milestone payments to fall under the scope of variable consideration, which should be estimated for revenue recognition purposes at the inception of the contract and reassessed ongoing at the end of each reporting period. The Company assesses whether contingent research milestones should be considered variable consideration that should be constrained and thus not part of the transaction price. This includes an assessment of the probability that all or some of the milestone revenues could be reversed when the uncertainty around whether or not the achievement of each milestone is resolved, and the amount of reversal could be significant. GAAP provides factors to consider when assessing whether variable consideration should be constrained. All of the factors should be considered, and no factor is determinative. The Company considers all relevant factors. Reimbursement of Costs Reimbursement of research and development costs by third-party collaborators is recognized as revenue over time provided the Company has determined that it transfers control (i.e. performs the services) of a service over time and, therefore, satisfies a performance obligation according to the provisions outlined in ASC 606-10-25-27, Revenue Recognition . Royalty Revenue The Company recognizes royalty revenues related to Genentech’s and Roche’s sales of Erivedge. For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and where the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). The Company expects to continue recognizing royalty revenue from Genentech’s sales of Erivedge in the U.S. and in other markets where Genentech and Roche successfully obtain marketing approval, if any (see Note 9, Research and Development Collaborations ). However, a portion of potential Erivedge royalties will be paid to the Purchasers pursuant to the Oberland Purchase Agreement (see Note 8, Liability Related to the Future Sale of Royalties ). Contra Revenue, Net Contra revenue, net represents shared costs, primarily related to intellectual property, with the Company's collaboration partners, and reserves for potential royalty reductions. With respect to each of the foregoing areas of revenue recognition, the Company exercises significant judgment in determining whether an arrangement contains multiple elements, and, if so, how much revenue is allocable to each element. In addition, the Company exercises its judgment in determining when its significant obligations have been met under such agreements and the specific time periods over which the Company recognized revenue, such as non-refundable, up-front license fees. To the extent that actual facts and circumstances differ from the Company's initial judgments, its revenue recognition with respect to such transactions would change accordingly and any such change could affect the Company's reported financial results. |
Segment Reporting | Segment ReportingThe Company operates in a single reportable segment, which is the research and development of innovative cancer therapeutics. |
New Accounting Pronouncements | New Accounting Pronouncements Recently Adopted In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. This standard requires that for most financial assets, losses be based on an expected loss approach which includes estimates of losses over the life of exposure that considers historical, current and forecasted information. Expanded disclosures related to the methods used to estimate the losses as well as a specific disaggregation of balances for financial assets are also required. The targeted transition relief standard allows filers an option to irrevocably elect the fair value option of ASC 825-10, Financial Instruments-Overall, applied on an instrument-by-instrument basis for eligible instruments. In November 2019 the effective date for smaller reporting companies was extended to January 1, 2023 with the issuance of ASU 2019-10 Financial Instruments-Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842) Effective Dates. The Company adopted ASU 2016-13 as of January 1, 2021 and the adoption did not have a material impact on the Consolidated Financial Statements. |
Fair Value Measurements | Fair Value of Financial Instruments The Company has adopted the provisions of the FASB Codification Topic 820, Fair Value Measurements and Disclosures (“Topic 820”) for its financial assets and liabilities that are re-measured and reported at fair value each reporting period and the non-financial assets and liabilities that are re-measured and reported at fair value on a non-recurring basis. Fair value is the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. When determining fair value, the Company considers the principal or most advantageous market in which it would transact and consider assumptions that market participants would use when pricing the asset or liability. Topic 820 establishes a three-level valuation hierarchy for disclosure of fair value measurements. Financial assets and liabilities are categorized within the valuation hierarchy based upon the lowest level of input that is significant to the measurement of fair value. The three levels of the hierarchy are defined as follows: Level 1 Quoted prices in active markets for identical assets or liabilities. Level 2 Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3 Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
Schedule of Financial Assets or Liabilities Measured at Fair Value on Recurring Basis | In accordance with the fair value hierarchy, the following table shows the fair value as of June 30, 2021 and December 31, 2020 of those financial assets and liabilities that are measured at fair value on a recurring basis, according to the valuation techniques the Company used to determine their fair value. No financial assets or liabilities are measured at fair value on a nonrecurring basis at June 30, 2021 and December 31, 2020. (in thousands) Quoted Prices in Other Observable Unobservable Fair Value As of June 30, 2021: Cash equivalents: Money market funds $ 60,129 $ — $ — $ 60,129 Short-term investments: Corporate commercial paper, bonds and notes — 77,544 — 77,544 Long-term investments: Corporate commercial paper, bonds and notes — 8,112 — 8,112 Total assets at fair value $ 60,129 $ 85,656 $ — $ 145,785 (in thousands) Quoted Prices in Other Observable Unobservable Fair Value As of December 31, 2020: Cash equivalents: Money market funds $ 115,278 $ — $ — $ 115,278 Short-term investments: Corporate commercial paper, bonds and notes — 38,884 — 38,884 Long-term investments: Corporate commercial paper, bonds and notes — 14,564 — 14,564 Total assets at fair value $ 115,278 $ 53,448 $ — $ 168,726 |
Investments (Tables)
Investments (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Amortized Cost of Unrealized Gains and Losses and Fair Value of Investments | The amortized cost, unrealized gains and losses and fair value of investments available-for-sale as of June 30, 2021 are as follows: (in thousands) Amortized Unrealized Unrealized Fair Value Corporate bonds and notes—short-term $ 77,538 $ 6 $ — $ 77,544 Corporate bonds and notes—long-term $ 8,121 — (9) $ 8,112 Total investments $ 85,659 $ 6 $ (9) $ 85,656 The amortized cost, unrealized gains and losses and fair value of investments available-for-sale as of December 31, 2020 are as follows: (in thousands) Amortized Unrealized Unrealized Fair Value Corporate bonds and notes—short-term $ 38,888 $ — $ (4) $ 38,884 Corporate bonds and notes—long-term 14,563 1 — 14,564 Total investments $ 53,451 $ 1 $ (4) $ 53,448 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Other Liabilities Disclosure [Abstract] | |
Schedule of Accrued Liabilities | Accrued liabilities consisted of the following: (in thousands) June 30, 2021 December 31, 2020 Compensation and related costs $ 1,902 $ 2,638 Chemistry, manufacturing and controls costs 512 — Professional and legal fees 634 307 License fees — 375 Other 135 305 Total $ 3,183 $ 3,625 |
Liability Related to the Sale_2
Liability Related to the Sale of Future Royalties (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Nonmonetary Transactions [Abstract] | |
Schedule of Liability Due to Non-Cash Transaction | The following table shows the activity with respect to the liability related to the sale of future royalties during the six months ended June 30, 2021. (in thousands) Carrying value of liability related to the sale of future royalties at January 1, 2021 $ 58,235 Amortization of capitalized issuance costs 31 Imputed interest expense recognized for the six months ending June 30, 2021 2,278 Less: payments to Oberland Capital, LLC (4,404) Carrying value of liability related to the sale of future royalties at June 30, 2021 $ 56,140 |
Stock Plans and Stock Based C_2
Stock Plans and Stock Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of Stock Option Activity | A summary of stock option activity under the 2010 Plan and inducement awards are summarized as follows: Number of Weighted Weighted Aggregate Intrinsic Value Outstanding, December 31, 2020 8,668,005 $ 2.71 7.98 Granted 1,570,300 9.42 Exercised (72,955) 1.75 Canceled (110,825) 11.54 Outstanding, June 30, 2021 10,054,525 $ 3.66 7.83 $ 49,925 Exercisable at June 30, 2021 5,302,685 $ 3.45 7.16 $ 28,242 Vested and unvested expected to vest at June 30, 2021 9,679,572 $ 3.63 7.79 $ 48,422 |
Schedule of Key Assumptions for Options Awarded | The weighted average grant date fair values of the stock options granted during the six months ended June 30, 2021 and 2020 were $9.42 and $0.75, respectively, and were calculated using the following estimated assumptions: Six Months Ended 2021 2020 Expected term (years) – directors, officers and employees 5.5 5.5 Risk free interest rate 0.4-1.4% 0.4-1.7% Expected Volatility 107 % 81 % Expected Dividends None None |
Schedule of Restricted Stock Award Activity | The following table presents a summary of unvested restricted stock awards (“RSAs”) under the 2010 Plan as of June 30, 2021: Number of Weighted Unvested, December 31, 2020 20,624 $ 3.45 Awarded — — Vested (10,312) 3.45 Forfeited — — Unvested, June 30, 2021 10,312 $ 3.45 |
Schedule of Stock-Based Compensation Expense | For the three and six months ended June 30, 2021 and 2020, the Company recorded stock-based compensation expense to the following line items in its costs and expenses section of the Condensed Consolidated Statements of Operations and Comprehensive Loss, including expense related to its ESPP: Three Months Ended Six Months Ended (in thousands) 2021 2020 2021 2020 Research and development expenses $ 440 $ 185 $ 778 $ 355 General and administrative expenses 835 400 1,596 855 Total stock-based compensation expense $ 1,275 $ 585 $ 2,374 $ 1,210 |
Nature of Business (Details)
Nature of Business (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||||
Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2020 | Mar. 31, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||||||
Accumulated deficit | $ 1,067,654 | $ 1,067,654 | $ 1,046,889 | ||||
Net loss | 10,838 | $ 9,927 | $ 6,708 | $ 9,709 | 20,765 | $ 16,417 | |
Cash used in operations | 19,838 | $ 14,147 | |||||
Cash, cash equivalents, and investments | $ 160,700 | $ 160,700 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2021USD ($) | Jun. 30, 2020USD ($) | Jun. 30, 2021USD ($)segment | Jun. 30, 2020USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | |
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||||
Restricted cash | $ 800 | $ 800 | $ 800 | |||
Cash and cash equivalents, restricted cash and restricted cash equivalents | $ 75,842 | $ 24,590 | $ 75,842 | $ 24,590 | $ 130,426 | $ 16,399 |
Number of reportable segments | segment | 1 | |||||
Customer Concentration Risk | Genentech, Inc. | Revenue Benchmark | ||||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||||
Concentration risk | 99.00% | 100.00% | 99.00% | 96.00% |
Fair Value of Financial Instr_3
Fair Value of Financial Instruments - Summary (Details) - Fair Value, Measurements, Recurring - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Long-term investments: | ||
Total assets at fair value | $ 145,785 | $ 168,726 |
Corporate commercial paper, bonds and notes | ||
Short-term investments: | ||
Corporate commercial paper, bonds and notes | 77,544 | 38,884 |
Long-term investments: | ||
Corporate commercial paper, bonds and notes | 8,112 | 14,564 |
Money market funds | ||
Cash equivalents: | ||
Money market funds | 60,129 | 115,278 |
Quoted Prices in Active Markets (Level 1) | ||
Long-term investments: | ||
Total assets at fair value | 60,129 | 115,278 |
Quoted Prices in Active Markets (Level 1) | Corporate commercial paper, bonds and notes | ||
Short-term investments: | ||
Corporate commercial paper, bonds and notes | 0 | 0 |
Long-term investments: | ||
Corporate commercial paper, bonds and notes | 0 | 0 |
Quoted Prices in Active Markets (Level 1) | Money market funds | ||
Cash equivalents: | ||
Money market funds | 60,129 | 115,278 |
Other Observable Inputs (Level 2) | ||
Long-term investments: | ||
Total assets at fair value | 85,656 | 53,448 |
Other Observable Inputs (Level 2) | Corporate commercial paper, bonds and notes | ||
Short-term investments: | ||
Corporate commercial paper, bonds and notes | 77,544 | 38,884 |
Long-term investments: | ||
Corporate commercial paper, bonds and notes | 8,112 | 14,564 |
Other Observable Inputs (Level 2) | Money market funds | ||
Cash equivalents: | ||
Money market funds | 0 | 0 |
Unobservable Inputs (Level 3) | ||
Long-term investments: | ||
Total assets at fair value | 0 | 0 |
Unobservable Inputs (Level 3) | Corporate commercial paper, bonds and notes | ||
Short-term investments: | ||
Corporate commercial paper, bonds and notes | 0 | 0 |
Long-term investments: | ||
Corporate commercial paper, bonds and notes | 0 | 0 |
Unobservable Inputs (Level 3) | Money market funds | ||
Cash equivalents: | ||
Money market funds | $ 0 | $ 0 |
Investments - Amortized Cost of
Investments - Amortized Cost of Unrealized Gains and Losses and Fair Value of Investments (Details) - USD ($) $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2021 | Dec. 31, 2020 | |
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | $ 85,659 | $ 53,451 |
Unrealized Gain | 6 | 1 |
Unrealized Loss | (9) | (4) |
Fair Value | $ 85,656 | $ 53,448 |
Weighted-average maturity of short-term investments | 6 months | 7 months 6 days |
Corporate bonds and notes—short-term | ||
Debt Securities, Available-for-sale [Line Items] | ||
Weighted-average maturity of short-term investments | 1 year 6 months | |
Corporate bonds and notes—short-term | Minimum | ||
Debt Securities, Available-for-sale [Line Items] | ||
Range of maturities | 1 month | 1 month |
Corporate bonds and notes—short-term | Maximum | ||
Debt Securities, Available-for-sale [Line Items] | ||
Range of maturities | 12 months | 12 months |
Corporate bonds and notes—long-term | ||
Debt Securities, Available-for-sale [Line Items] | ||
Weighted-average maturity of short-term investments | 1 year 3 months 18 days | |
Corporate Debt Securities | Corporate bonds and notes—short-term | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | $ 77,538 | $ 38,888 |
Unrealized Gain | 6 | 0 |
Unrealized Loss | 0 | (4) |
Fair Value | 77,544 | 38,884 |
Corporate Debt Securities | Corporate bonds and notes—long-term | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 8,121 | 14,563 |
Unrealized Gain | 0 | 1 |
Unrealized Loss | (9) | 0 |
Fair Value | $ 8,112 | $ 14,564 |
Accrued Liabilities - Summary (
Accrued Liabilities - Summary (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Other Liabilities Disclosure [Abstract] | ||
Compensation and related costs | $ 1,902 | $ 2,638 |
Chemistry, manufacturing and controls costs | 512 | 0 |
Professional and legal fees | 634 | 307 |
License fees | 0 | 375 |
Other | 135 | 305 |
Accrued liabilities | $ 3,183 | $ 3,625 |
Debt (Details)
Debt (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2021 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | Apr. 30, 2020 | |
Debt Instrument [Line Items] | |||||
Unsecured loan | $ 900 | ||||
Gain on extinguishment of debt | $ 890 | $ 0 | |||
Cares Act PPP Loan | |||||
Debt Instrument [Line Items] | |||||
Gain on extinguishment of debt | $ 900 | $ 900 | |||
Silicon Valley Bank | Cares Act PPP Loan | Commercial Paper | |||||
Debt Instrument [Line Items] | |||||
Unsecured loan | $ 300 | ||||
Unsecured loan term | 24 months | ||||
Unsecured loan interest rate | 1.00% | ||||
Short-term debt | $ 600 |
Leases and Commitments (Details
Leases and Commitments (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Leases [Abstract] | |||||
Weighted average discount rate | 9.95% | 9.95% | |||
Operating lease, liability | $ 5,300,000 | $ 5,300,000 | $ 6,800,000 | ||
Operating lease right-of-use asset | 6,171,000 | 6,171,000 | $ 6,578,000 | ||
Operating lease, expense | $ 300,000 | $ 400,000 | $ 700,000 | $ 700,000 | |
Remaining lease term | 7 years | 7 years | |||
Lease obligations | $ 9,300,000 | $ 9,300,000 | |||
Operating lease payments | $ 300,000 | $ 0 | 1,700,000 | $ 200,000 | |
One time payment, tenant improvements | $ 1,100,000 |
Liability Related to the Sale_3
Liability Related to the Sale of Future Royalties - Narrative (Details) - USD ($) $ in Millions | 1 Months Ended | 6 Months Ended |
Mar. 31, 2019 | Jun. 30, 2021 | |
Nonmonetary Transaction [Line Items] | ||
Non-cash interest rate | 8.00% | |
Transaction fees | $ 0.6 | |
Oberland Capital | ||
Nonmonetary Transaction [Line Items] | ||
Proceeds from royalty interest purchase agreement with Oberland Capital Management, LLC | 65 | |
Cash proceeds from royalty purchase agreement | 70.7 | |
Purchaser default option period | 180 days | |
Oberland Capital | Royalty Amounts in 2021 | ||
Nonmonetary Transaction [Line Items] | ||
Cash proceeds from royalty purchase agreement | 17.2 | |
Royalty amount threshold | 18 | |
Oberland Capital | Aggregate Net Royalties Prior to 2027 | ||
Nonmonetary Transaction [Line Items] | ||
Cash proceeds from royalty purchase agreement | 53.5 | |
Royalty amount threshold | $ 117 |
Liability Related to the Sale_4
Liability Related to the Sale of Future Royalties - Liability Due to Non-Cash Transaction (Details) $ in Thousands | 6 Months Ended |
Jun. 30, 2021USD ($) | |
Nonmonetary Transaction [Roll Forward] | |
Carrying value of liability related to the sale of future royalties beginning balance | $ 58,235 |
Amortization of capitalized issuance costs | 31 |
Imputed interest expense recognized | 2,278 |
Less: payments to Oberland Capital, LLC | (4,404) |
Carrying value of liability related to the sale of future royalties ending balance | $ 56,140 |
Research and Development Coll_2
Research and Development Collaborations (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2003USD ($) | Jun. 30, 2021USD ($) | Jun. 30, 2020USD ($) | Jun. 30, 2021USD ($)program | Jun. 30, 2020USD ($) | Dec. 31, 2020USD ($) | Feb. 29, 2020 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Total revenues, net | $ 2,286 | $ 2,360 | $ 4,475 | $ 5,068 | |||
Cost of royalties | 116 | 122 | 225 | 247 | |||
Accounts receivable | 2,379 | $ 2,379 | $ 3,043 | ||||
Number of program licensed | program | 4 | ||||||
Royalties | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Total revenues, net | 2,348 | 2,446 | $ 4,535 | 4,961 | |||
Genentech, Inc. | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Amount received for specified clinical development and regulatory objectives | 59,000 | 59,000 | |||||
Percentage of royalty rate decrease | 2.00% | ||||||
Cost of royalties | 100 | $ 100 | 200 | $ 200 | |||
Royalty rate, percentage of sales (percent) | 5.00% | 5.00% | |||||
Accounts receivable | 2,400 | 2,400 | $ 3,000 | ||||
Genentech, Inc. | Royalties | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Total revenues, net | 2,300 | $ 2,400 | 4,500 | $ 5,000 | |||
Genentech, Inc. | Maximum | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Eligible to receive contingent cash payment for specified clinical development and regulatory objectives (up to) | $ 115,000 | ||||||
Percentage of royalty on net sales | 7.50% | ||||||
Genentech, Inc. | Minimum | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Percentage of royalty on net sales | 5.00% | ||||||
Aurigene | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Milestone payments waived to date | 19,500 | 19,500 | |||||
Aurigene | Programs Three and Four | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Payments made under collaboration arrangements | 14,500 | 14,500 | |||||
Aurigene | IRAK4, PD1/VISTA, and PD1/TIM3 Programs | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Waived payment of milestone and other payments (up to) | 42,500 | ||||||
Aurigene | Master Development and Manufacturing Agreement | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Prepaid balance | 500 | 500 | |||||
Aurigene | Master Development and Manufacturing Agreement | Research and Development Expense | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Collaborative arrangement payments agreement | 400 | 800 | |||||
Aurigene | Maximum | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Royalty fees receivable (as a percent) | 10.00% | ||||||
ImmuNext | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Semi-annual maintenance fee payments | 400 | 400 | |||||
ImmuNext | Maximum | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Maximum reimbursable expenses | 300 | 300 | |||||
Development milestone payments | 4,600 | 4,600 | |||||
Regulatory approval milestone payments | 84,300 | 84,300 | |||||
Sales milestone payments | 125,000 | 125,000 | |||||
Option exercise fee | $ 20,000 | $ 20,000 |
Common Stock (Details)
Common Stock (Details) - USD ($) | Dec. 09, 2020 | Feb. 26, 2020 | Dec. 31, 2020 | Jun. 30, 2020 | Feb. 29, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | Mar. 31, 2021 | Mar. 16, 2021 | Jun. 29, 2020 | Mar. 31, 2020 | Mar. 04, 2020 |
Class of Stock [Line Items] | |||||||||||||
Common stock authorized (in shares) | 151,875,000 | 151,875,000 | 227,812,500 | 151,875,000 | 151,875,000 | 101,250,000 | |||||||
Proceeds of aspire capital agreement, net of issuance costs | $ 0 | $ 2,726,000 | |||||||||||
Value of shares of common stock issued | $ 915,000 | 916,000 | $ 915,000 | ||||||||||
Demand Sales Agreement | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Compensation fee | 3.00% | ||||||||||||
Aspire Capital Fund, LLC | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Common stock issued (in shares) | 2,693,965 | ||||||||||||
Proceeds of aspire capital agreement, net of issuance costs | $ 3,000,000 | ||||||||||||
Stock purchase program price, period | 30 months | ||||||||||||
Additional shares authorized (in shares) | 4,650,000 | ||||||||||||
Value of shares of common stock issued | 5,400,000 | $ 5,400,000 | |||||||||||
Private Placement | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Proceeds from direct offering | 169,600,000 | $ 17,500,000 | |||||||||||
Fees payable expenses | $ 10,200,000 | 1,000,000 | |||||||||||
Other estimated offering expenses payable expense | $ 500,000 | ||||||||||||
Over-Allotment Option | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Shares of common stock sold (in shares) | 3,847,826 | ||||||||||||
Common Stock | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Common stock authorized | $ 100,000,000 | ||||||||||||
Compensation fee | 3.00% | ||||||||||||
Sale price per share (in dollars per share) | $ 5.75 | $ 5.75 | |||||||||||
Common Stock | Demand Sales Agreement | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Common stock authorized | $ 30,000,000 | ||||||||||||
Shares of common stock sold (in shares) | 6,298,648 | ||||||||||||
Proceeds from direct offering | $ 8,300,000 | ||||||||||||
Proceeds of aspire capital agreement, net of issuance costs | 7,900,000 | ||||||||||||
Remaining authorized stock purchase amount | $ 21,700,000 | ||||||||||||
Common Stock | Aspire Capital Fund, LLC | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Authorized amount of stock repurchase | $ 30,000,000 | ||||||||||||
Commitment fee (in shares) | 646,551 | ||||||||||||
Sale of stock remaining authorized amount | $ 21,600,000 | $ 21,600,000 | $ 21,600,000 | ||||||||||
Stock purchase program, authorized per day (in shares) | 150,000 | ||||||||||||
Stock purchase program, authorized per day, after mutual agreement (in shares) | 2,000,000 | ||||||||||||
Common Stock | Private Placement | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Common stock issued (in shares) | 29,500,000 | 14,000,000 | |||||||||||
Sale price per share (in dollars per share) | $ 1.25 | $ 1.25 |
Stock Plans and Stock Based C_3
Stock Plans and Stock Based Compensation - Narrative (Details) $ / shares in Units, $ in Millions | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
May 31, 2021$ / sharesshares | Jun. 30, 2021USD ($)$ / sharesshares | Mar. 31, 2021shares | Jun. 30, 2021USD ($)plannumberOfPurchasePeriod$ / sharesshares | Jun. 30, 2020USD ($)$ / shares | Dec. 31, 2016numberOfPurchasePeriod | Dec. 31, 2020$ / sharesshares | |
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | |||||||
Number of shareholder-approved, share-based compensation plans | plan | 2 | ||||||
Number of options granted (in shares) | 1,570,300 | ||||||
Weighted average grant-date fair values of stock options (in dollars per share) | $ / shares | $ 9.42 | $ 0.75 | |||||
Unrecognized compensation cost, net of estimated forfeitures | $ | $ 11.1 | $ 11.1 | |||||
Unrecognized compensation cost, weighted average period for recognition | 2 years 4 months 17 days | ||||||
Intrinsic values of employee stock options exercised | $ | $ 0.5 | $ 0.5 | |||||
Restricted Stock | |||||||
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | |||||||
Vesting period of options | 4 years | ||||||
Awarded (in shares) | 0 | ||||||
Outstanding shares (in shares) | 10,312 | 10,312 | 20,624 | ||||
Weighted average fair value (in dollars per share) | $ / shares | $ 3.45 | $ 3.45 | $ 3.45 | ||||
Fair value | $ | $ 0.1 | ||||||
Restricted Stock | Officer | |||||||
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | |||||||
Awarded (in shares) | 352,300 | ||||||
Restricted Stock | Officers and Non-Employee Directors | |||||||
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | |||||||
Unrecognized compensation cost, net of estimated forfeitures | $ | $ 0.1 | $ 0.1 | |||||
Unrecognized compensation cost, weighted average period for recognition | 6 months 21 days | ||||||
Amended and Restated 2010 Stock Incentive Plan | |||||||
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | |||||||
Shares authorized (in shares) | 23,190,000 | ||||||
Shares awarded under plan (in shares) | 13,590,840 | ||||||
Amended and Restated 2010 Stock Incentive Plan | Employee Stock | |||||||
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | |||||||
Additional shares authorized (in shares) | 11,000,000 | ||||||
Amended and Restated 2010 Stock Incentive Plan | Stock Options, or Stock Appreciation Rights | |||||||
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | |||||||
Expiration period | 10 years | ||||||
Shares removed from pool (in shares per share) | $ / shares | $ 1 | ||||||
Amended and Restated 2010 Stock Incentive Plan | Restricted Stock, RSUs, Other Stock-Based Awards, or Performance Awards | |||||||
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | |||||||
Shares removed from pool (in shares per share) | $ / shares | $ 1.3 | ||||||
Purchase price of common stock | 100.00% | ||||||
2010 Plan | |||||||
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | |||||||
Number of options granted (in shares) | 1,086,000 | ||||||
2010 Plan | Non-Employee Directors | |||||||
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | |||||||
Number of options granted (in shares) | 0 | 132,000 | |||||
Vesting period of options | 1 year | ||||||
2010 Plan | Tranche One | |||||||
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | |||||||
Percentage of vested shares which are exercisable under stock option | 25.00% | ||||||
2010 Plan | Tranche Two | |||||||
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | |||||||
Percentage of vested shares which are exercisable under stock option | 6.25% | ||||||
Employee Stock Purchase Plan | |||||||
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | |||||||
Stock issued under employee stock purchase plans (in shares) | 20,791 | 20,791 | |||||
Employee Stock Purchase Plan | Employee Stock | |||||||
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | |||||||
Shares authorized (in shares) | 2,000,000 | 2,000,000 | |||||
Purchase price of common stock | 85.00% | ||||||
Enrollment period | 2 years | ||||||
Number of purchase periods per year | numberOfPurchasePeriod | 4 | 2 | |||||
Stock plan offering period | 6 months | 6 months | |||||
Stock available under ESPPs (in shares) | 1,576,599 | 1,576,599 |
Stock Plans and Stock Based C_4
Stock Plans and Stock Based Compensation - Stock Option Activity (Details) $ / shares in Units, $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2021USD ($)$ / sharesshares | Dec. 31, 2020$ / sharesshares | |
Number of Shares | ||
Beginning balance (in shares) | shares | 8,668,005 | |
Granted (in shares) | shares | 1,570,300 | |
Exercised (in shares) | shares | (72,955) | |
Canceled (in shares) | shares | (110,825) | |
Ending balance (in shares) | shares | 10,054,525 | 8,668,005 |
Exercisable at end of period (in shares) | shares | 5,302,685 | |
Vested and unvested expected to vest at end of period (in shares) | shares | 9,679,572 | |
Weighted Average Exercise Price per Share | ||
Beginning balance (in dollars per share) | $ / shares | $ 2.71 | |
Granted (in dollars per share) | $ / shares | 9.42 | |
Exercised (in dollars per share) | $ / shares | 1.75 | |
Canceled (in dollars per share) | $ / shares | 11.54 | |
Ending balance (in dollars per share) | $ / shares | 3.66 | $ 2.71 |
Exercisable at end of period (in dollars per share) | $ / shares | 3.45 | |
Vested and unvested expected to vest at end of period (in dollars per share) | $ / shares | $ 3.63 | |
Weighted Average Remaining Contractual Life | ||
Outstanding at end of period | 7 years 9 months 29 days | 7 years 11 months 23 days |
Exercisable at end of period | 7 years 1 month 28 days | |
Vested and unvested expected to vest at end of period | 7 years 9 months 14 days | |
Aggregate Intrinsic Value | ||
Outstanding at end of period | $ | $ 49,925 | |
Exercisable at end of period | $ | 28,242 | |
Vested and unvested expected to vest at end of period | $ | $ 48,422 |
Stock Plans and Stock Based C_5
Stock Plans and Stock Based Compensation - Key Assumptions (Details) | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Share-based Payment Arrangement [Abstract] | ||
Expected term | 5 years 6 months | 5 years 6 months |
Risk -free Interest rate (minimum) | 0.40% | 0.40% |
Risk -free Interest rate (maximum) | 1.40% | 1.70% |
Expected volatility | 107.00% | 81.00% |
Stock Plans and Stock Based C_6
Stock Plans and Stock Based Compensation - Restricted Stock Award Activity (Details) - Restricted Stock | 6 Months Ended |
Jun. 30, 2021$ / sharesshares | |
Number of Shares | |
Beginning balance (in shares) | shares | 20,624 |
Awarded (in shares) | shares | 0 |
Vested (in shares) | shares | (10,312) |
Forfeited (in shares) | shares | 0 |
Ending balance (in shares) | shares | 10,312 |
Weighted Average Grant Date Fair Value | |
Beginning balance (in dollars per share) | $ / shares | $ 3.45 |
Awarded (in dollars per share) | $ / shares | 0 |
Vested (in dollars per share) | $ / shares | 3.45 |
Forfeited (in dollars per share) | $ / shares | 0 |
Ending balance (in dollars per share) | $ / shares | $ 3.45 |
Stock Plans and Stock Based C_7
Stock Plans and Stock Based Compensation - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | ||||
Total stock-based compensation expense | $ 1,275,000 | $ 585 | $ 2,374,000 | $ 1,210 |
Research and development expenses | ||||
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | ||||
Total stock-based compensation expense | 440,000 | 185 | 778,000 | 355 |
General and administrative expenses | ||||
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | ||||
Total stock-based compensation expense | $ 835,000 | $ 400 | $ 1,596,000 | $ 855 |
Loss Per Common Share (Details)
Loss Per Common Share (Details) - shares | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Stock Options Outstanding | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities (in shares) | 10,054,525 | 9,162,208 |
Related Party Transactions (Det
Related Party Transactions (Details) - Epi-Cure Pharmaceuticals, Inc. - Affiliated Entity | Oct. 18, 2018USD ($) | Jun. 30, 2020USD ($) | Jun. 30, 2021USD ($)day | Dec. 31, 2020USD ($) |
Related Party Transaction [Line Items] | ||||
Amount paid for transaction | $ 0 | $ 100,000 | ||
Agreement With Head of Research and Development | ||||
Related Party Transaction [Line Items] | ||||
Purchases from related party | $ 100,000 | |||
Maximum funding amount | $ 500,000 | |||
Minimum days notice to terminate prior to written notice | day | 60 |