Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2023 | May 08, 2023 | |
Document And Entity Information | ||
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2023 | |
Entity Registrant Name | Corvus Pharmaceuticals, Inc. | |
Entity Tax Identification Number | 46-4670809 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity File Number | 001-37719 | |
Entity Incorporation, State or Country Code | DE | |
Entity Address, Address Line One | 863 Mitten Road, Suite 102 | |
Entity Address, City or Town | Burlingame | |
Entity Address, Postal Zip Code | 94010 | |
Entity Address, State or Province | CA | |
City Area Code | 650 | |
Local Phone Number | 900-4520 | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Title of 12(b) Security | Common Stock | |
Security Exchange Name | NASDAQ | |
Trading Symbol | CRVS | |
Entity Common Stock, Shares Outstanding | 46,568,511 | |
Entity Central Index Key | 0001626971 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 9,654 | $ 13,159 |
Marketable securities | 24,813 | 29,144 |
Accounts receivable - related party | 429 | 588 |
Prepaid and other current assets | 655 | 773 |
Total current assets | 35,551 | 43,664 |
Property and equipment, net | 330 | 353 |
Operating lease right-of-use asset | 1,953 | 2,217 |
Investment in Angel Pharmaceuticals | 20,234 | 21,877 |
Other assets | 129 | 129 |
Total assets | 58,197 | 68,240 |
Current liabilities: | ||
Accounts payable | 1,407 | 1,976 |
Operating lease liability | 1,263 | 1,228 |
Accrued and other liabilities | 5,620 | 7,548 |
Total current liabilities | 8,290 | 10,752 |
Operating lease liability | 1,040 | 1,373 |
Total liabilities | 9,330 | 12,125 |
Commitments and contingencies (Note 13) | ||
Stockholders' equity: | ||
Preferred stock: $0.0001 par value; 10,000,000 shares authorized at March 31, 2023 and December 31, 2022; 0 shares issued and outstanding at March 31, 2022 and December 31, 2022 | ||
Common stock: $0.0001 par value; 290,000,000 shares authorized at March 31, 2023 and December 31, 2022; 46,568,511 and 46,553,511 shares issued and outstanding at March 31, 2023 and December 31, 2022 | 5 | 5 |
Additional paid-in capital | 364,857 | 364,361 |
Accumulated other comprehensive (loss) income | (434) | (563) |
Accumulated deficit | (315,561) | (307,688) |
Total stockholders' equity | 48,867 | 56,115 |
Total liabilities and stockholders' equity | $ 58,197 | $ 68,240 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Mar. 31, 2023 | Dec. 31, 2022 |
CONDENSED CONSOLIDATED BALANCE SHEETS | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 290,000,000 | 290,000,000 |
Common stock, shares issued | 46,568,511 | 46,553,511 |
Common stock, shares outstanding | 46,568,511 | 46,553,511 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Operating expenses: | ||
Research and development | $ 4,594,000 | $ 5,100,000 |
General and administrative | 1,980,000 | 2,313,000 |
Total operating expenses | 6,574,000 | 7,413,000 |
Loss from operations | (6,574,000) | (7,413,000) |
Interest income and other expense, net | 376,000 | 11,000 |
Sublease income - related party | 56,000 | 146,000 |
Loss from equity method investment | (1,731,000) | (1,041,000) |
Net loss | $ (7,873,000) | $ (8,297,000) |
Net loss per share, basic | $ (0.17) | $ (0.18) |
Net loss per share, diluted | $ (0.17) | $ (0.18) |
Shares used to compute net loss per share, basic | 46,556,178 | 46,553,511 |
Shares used to compute net loss per share, diluted | 46,556,178 | 46,553,511 |
Other comprehensive loss: | ||
Unrealized gain (loss) on marketable securities | $ 41,000 | $ (28,000) |
Cumulative foreign currency translation adjustment | 88,000 | 146,000 |
Comprehensive loss | $ (7,744,000) | $ (8,179,000) |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Common Stock. | Additional Paid-In Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit | Total |
Balance at Dec. 31, 2021 | $ 5 | $ 361,669 | $ 1,869 | $ (266,381) | $ 97,162 |
Balance (in shares) at Dec. 31, 2021 | 46,553,511 | ||||
Stock-based compensation expense | 739 | 739 | |||
Unrealized gain (loss) on marketable securities | (28) | (28) | |||
Foreign currency translation adjustment | 146 | 146 | |||
Net loss | (8,297) | (8,297) | |||
Balance at Mar. 31, 2022 | $ 5 | 362,408 | 1,987 | (274,678) | 89,722 |
Balance (in shares) at Mar. 31, 2022 | 46,553,511 | ||||
Balance at Dec. 31, 2022 | $ 5 | 364,361 | (563) | (307,688) | 56,115 |
Balance (in shares) at Dec. 31, 2022 | 46,553,511 | ||||
Common stock issued on exercise of stock options | 4 | 4 | |||
Common stock issued on exercise of stock options (in shares) | 15,000 | ||||
Stock-based compensation expense | 492 | 492 | |||
Unrealized gain (loss) on marketable securities | 41 | 41 | |||
Foreign currency translation adjustment | 88 | 88 | |||
Net loss | (7,873) | (7,873) | |||
Balance at Mar. 31, 2023 | $ 5 | $ 364,857 | $ (434) | $ (315,561) | $ 48,867 |
Balance (in shares) at Mar. 31, 2023 | 46,568,511 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Cash flows from operating activities | |||
Net loss | $ (7,873) | $ (8,297) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization | 57 | 87 | |
Accretion related to marketable securities | (264) | 55 | |
Stock-based compensation | 492 | 739 | |
Loss from equity method investment | 1,731 | 1,041 | |
Changes in operating assets and liabilities: | |||
Accounts receivable - related party | 159 | 134 | |
Prepaid and other current assets | 118 | 304 | |
Operating lease right-of-use asset | 264 | 238 | |
Accounts payable | (569) | 624 | |
Accrued and other liabilities | (1,928) | (1,095) | |
Operating lease liability | (298) | (254) | |
Net cash used in operating activities | (8,111) | (6,424) | |
Cash flows from investing activities | |||
Purchases of marketable securities | (13,089) | (26,384) | |
Maturities of marketable securities | 17,725 | 810 | |
Purchases of property and equipment | (34) | ||
Net cash provided by (used in) investing activities | 4,602 | (25,574) | |
Cash flows from financing activities | |||
Proceeds from exercise of common stock options | 4 | ||
Net cash provided by financing activities | 4 | ||
Net increase (decrease) in cash and cash equivalents | (3,505) | (31,998) | |
Cash and cash equivalents at beginning of the period | 13,159 | 63,458 | $ 63,458 |
Cash and cash equivalents at end of the period | $ 9,654 | $ 31,460 | $ 13,159 |
Organization
Organization | 3 Months Ended |
Mar. 31, 2023 | |
Organization | |
Organization | 1. Organization Corvus Pharmaceuticals, Inc. (“Corvus” or the “Company”) was incorporated in Delaware on January 27, 2014 and commenced operations in November 2014. Corvus is a clinical-stage biopharmaceutical company. The Company’s operations are located in Burlingame, California. Presentation The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, Corvus Biopharmaceuticals, Ltd. and Corvus Hong Kong Limited. All intercompany accounts and transactions have been eliminated from the consolidated financial statements. Initial Public Offering Follow-on Public Offerings Liquidity approvals, manufacturing and supply, sales and marketing and general operations. In addition, other unanticipated costs may arise. Because the outcome of any clinical trial and/or regulatory approval process is highly uncertain, the Company may not be able to accurately estimate the actual amounts necessary to successfully complete the development, regulatory approval process and commercialization of CPI-818, ciforadenant and mupadolimab or any other product candidates. The Company does not expect its existing capital resources to be sufficient to enable it to fund the completion of its clinical trials and remaining development program of CPI-818, ciforadenant and mupadolimab through commercialization. In addition, its operating plan may change as a result of many factors, including those described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 filed on March 28, 2023 and this Quarterly Report on Form 10-Q. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2023 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). The Company’s functional and reporting currency is the U.S. dollar, except for its investment in its equity method investee which is the Chinese renminbi (RMB). The accompanying condensed consolidated financial statements have been prepared on a going-concern basis, which contemplates the realization of assets and discharge of liabilities in the normal course of business. Unaudited Interim Financial Information The accompanying interim condensed consolidated financial statements and related disclosures are unaudited, have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for a fair statement of the results of operations for the periods presented. The year-end condensed consolidated balance sheet data was derived from audited financial statements, but does not include all disclosures required by GAAP. The condensed consolidated results of operations for the three months ended March 31, 2023 are not necessarily indicative of the results to be expected for the full year or for any other future year or interim period. The accompanying condensed consolidated financial statements should be read in conjunction with the audited financial statements and the related notes for the year ended December 31, 2022 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 28, 2023. Use of Estimates The preparation of the Company’s condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Actual results could differ from such estimates. Investments in Equity Securities For equity method investees with a functional currency different than the Company’s reporting currency, the Company follows the guidance under ASC 830-10-15-5, pursuant to which, the foreign currency financial statements of a foreign investee accounted for by the equity method should be translated to the reporting entity's reporting currency. Concentrations of Credit Risk and Other Risks and Uncertainties Substantially all of the Company’s cash and cash equivalents are deposited in accounts with two financial institutions that management believes are of high credit quality. Such deposits may, at times, exceed federally insured limits. The Company maintains its cash with an accredited financial institution and accordingly, such funds are subject to minimal credit risk. The Company’s marketable securities consist of investments in U.S. Treasury securities and U.S. government agency securities, which can be subject to certain credit risks. However, the Company mitigates the risks by investing in high-grade instruments, limiting its exposure to any one issuer, and monitoring the ongoing creditworthiness of the financial institutions and issuers. The Company has not experienced any losses on its deposits of cash, cash equivalents or marketable securities. The Company is subject to a number of risks similar to other early stage biopharmaceutical companies, including, but not limited to, the need to obtain adequate additional funding, possible failure of preclinical testing or clinical trials, its reliance on third parties to conduct its clinical trials, the need to obtain marketing approval for its product candidates, competitors developing new technological innovations, the need to successfully commercialize and gain market acceptance of the Company’s product candidates, its right to develop and commercialize its product candidates pursuant to the terms and conditions of the licenses granted to the Company, and protection of proprietary technology. If the Company does not successfully commercialize or partner any of its product candidates, it will be unable to generate product revenue or achieve profitability. Segments Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business in one operating segment, that of the development of and commercialization of precisely targeted oncology therapies. Significant Accounting Policies The Company’s significant accounting policies are described in Note 2 to its consolidated financial statements for the year ended December 31, 2022, included in its Annual Report on Form 10-K. There have been no material changes to the Company’s significant accounting policies during the three months ended March 31, 2023. Recent Accounting Pronouncements In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes. ASU 2019-12 simplifies the accounting for income taxes by eliminating certain exceptions to the guidance in ASC 740 related to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences. ASU 2019-12 is effective in 2021 and interim periods within that year and permits for an early adoption. The Company adopted ASU 2019-12 effective January 1, 2021. The adoption of the guidance did not have a material impact on its financial statements and related disclosures. In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments. The standard amends the impairment model by requiring entities to use a forward-looking approach based on expected losses to estimate credit losses for most financial assets and certain other instruments that are not measured at fair value through net income. For available-for-sale debt securities, entities will be required to recognize an allowance for credit losses rather than a reduction in carrying value of the asset. Entities will no longer be permitted to consider the length of time that fair value has been less than amortized cost when evaluating when credit losses should be recognized. This new guidance is effective in the first quarter of 2023 for calendar-year SEC filers that are smaller reporting companies as of the one-time determination date. The Company has adopted the new guidance as of January 1, 2023, and it did not have a material impact on its financial statements and related disclosures. |
Net Loss per Share
Net Loss per Share | 3 Months Ended |
Mar. 31, 2023 | |
Net Loss per Share | |
Net Loss per Share | 3. Net Loss per Share The following table shows the calculation of net loss per share (in thousands, except share and per share data): Three Months Ended March 31, 2023 2022 Numerator: Net loss - basic and diluted $ (7,873) $ (8,297) Denominator: Weighted average common shares outstanding used to compute basic and diluted net loss per share 46,556,178 46,553,511 Net loss per share, basic and diluted $ (0.17) $ (0.18) The amounts in the table below were excluded from the calculation of diluted net loss per share, due to their anti-dilutive effect: Three Months Ended March 31, 2023 2022 Outstanding options 7,731,807 5,773,988 |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2023 | |
Fair Value Measurements | |
Fair Value Measurements | 4. Fair Value Measurements Financial assets and liabilities are measured and recorded at fair value. The Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values. The fair value hierarchy prioritizes valuation inputs based on the observable nature of those inputs. The fair value hierarchy applies only to the valuation inputs used in determining the reported fair value of the investments and is not a measure of the investment credit quality. The hierarchy defines three levels of valuation inputs: ● Level 1—Quoted prices in active markets for identical assets or liabilities ● Level 2—Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly ● Level 3—Unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability There have been no transfers of assets and liabilities between levels of hierarchy. The Company’s Level 2 investments are valued using third-party pricing sources. The pricing services utilize industry standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker/dealer quotes on the same or similar investments, issuer credit spreads, benchmark investments, prepayment/default projections based on historical data and other observable inputs. The following tables present information as of March 31, 2023 and December 31, 2022 about the Company’s assets that are measured at fair value on a recurring basis and indicate the level of the fair value hierarchy the Company utilized to determine such fair values (in thousands): March 31, 2023 Fair Value Measured Using Total (Level 1) (Level 2) (Level 3) Balance Assets Cash equivalents $ 9,407 $ — $ — $ 9,407 Marketable securities 14,698 10,115 — 24,813 $ 24,105 $ 10,115 $ — $ 34,220 December 31, 2022 Fair Value Measured Using Total (Level 1) (Level 2) (Level 3) Balance Assets Cash equivalents $ 11,942 $ — $ — $ 11,942 Marketable securities 22,001 7,143 — 29,144 $ 33,943 $ 7,143 $ — $ 41,086 As of March 31, 2023 marketable securities had a maximum remaining maturity of nine months. As of March 31, 2023 and December 31, 2022, the fair value of available for sale marketable securities by type of security were as follows (in thousands): March 31, 2023 Gross Gross Amortized Unrealized Unrealized Fair Cost Gains Losses Value U.S. Treasury securities $ 14,697 $ 4 $ (3) $ 14,698 U.S. Government agency securities 10,126 2 (13) 10,115 $ 24,823 $ 6 $ (16) $ 24,813 December 31, 2022 Gross Gross Amortized Unrealized Unrealized Fair Cost Gains Losses Value U.S. Treasury securities $ 22,020 $ 4 $ (23) $ 22,001 U.S. Government agency securities 7,175 — (32) 7,143 $ 29,195 $ 4 $ (55) $ 29,144 |
Equity Method Investment
Equity Method Investment | 3 Months Ended |
Mar. 31, 2023 | |
Equity Method Investment | |
Equity Method Investment | 5. Equity Method Investment As of March 31, 2023 and December 31, 2022, the Company’s ownership interest in Angel was approximately 49.7%, excluding 7% of Angel’s equity reserved for issuance under the Angel ESOP. The Company recognized its share of losses in Angel for the total amount of $1.7 million and $1.0 million as loss from equity method investment on the consolidated statement of operations for the three months ended March 31, 2023 and 2022, respectively. Summary Financial Information Summary financial information for Angel Pharmaceuticals is as follows: As of As of Balance Sheet Data March 31, 2023 December 31, 2022 (in thousands) Current assets $ 24,463 $ 29,062 Non-current assets 1,572 1,652 Current liabilities 3,625 6,293 Non-current liabilities 903 985 Stockholders' equity 21,507 23,436 Three Months Ended March 31, Statement of Operations Data 2023 2022 (in thousands) Revenue $ — $ — Gross Profit — — Net loss (2,032) (1,325) Share of loss from investments accounted for using the equity method (1,731) (1,041) |
License and Collaboration Agree
License and Collaboration Agreements | 3 Months Ended |
Mar. 31, 2023 | |
License and Collaboration Agreements | |
License and Collaboration Agreements | 6. License and Collaboration Agreements Scripps Licensing Agreement In December 2014, the Company entered into a license agreement with The Scripps Research Institute (“Scripps”), pursuant to which it was granted a non-exclusive, world-wide license for all fields of use under Scripps’ rights in certain know-how and technology related to a mouse hybridoma clone expressing an anti-human CD73 antibody, and to progeny, mutants or unmodified derivatives of such hybridoma and any antibodies expressed by such hybridoma, from which we developed mupadolimab. Scripps also granted the Company the right to grant sublicenses in conjunction with other proprietary rights the Company holds, or to others collaborating with or performing services for the Company. Under this license agreement, Scripps has agreed not to grant any additional commercial licenses with respect to such materials, other than march-in rights granted to the U.S. government. Upon execution of the agreement, the Company made a one-time cash payment to Scripps of $10,000 and is also obligated to pay a minimum annual fee to Scripps of $25,000. The first minimum annual fee payment is due on each anniversary of the effective date of the agreement and will be due on each subsequent anniversary of the effective date for the term of the agreement. The Company is also required to make performance-based cash payments upon successful completion of clinical and sales milestones. The aggregate potential milestone payments are $2.6 million. The Company is also required to pay royalties on net sales of licensed products (including mupadolimab) sold by it, its affiliates and its sublicensees at a rate in the low-single digits. In addition, should the Company sublicense the rights licensed under the agreement, it has agreed to pay a percentage of sublicense revenue received at specified rates that start at double digit percentages and decrease to single digit percentages based on the elapsed time from the effective date of the agreement and the time of entry into such sublicense. To date, no milestone payments have been made. The Company’s license agreement with Scripps will terminate upon expiration of its obligation to pay royalties to Scripps under the license agreement. The Company’s license agreement with Scripps is terminable by the consent of the parties, at will by the Company upon providing 90 days written notice to Scripps, or by Scripps for certain material breaches, or if the Company undergoes a bankruptcy event. In addition, Scripps may terminate the license on a product-by-product basis, or the entire agreement, if the Company fails to meet specified diligence obligations related to the development and commercialization of licensed products. Scripps may also terminate the agreement after the third anniversary of the effective date of the agreement if it reasonably believes, based on reports the Company provides to Scripps, that the Company has not used commercially reasonable efforts as required under the agreement, subject to a specified notice and cure period. Vernalis Licensing Agreement In February 2015, the Company entered into a license agreement with Vernalis (R&D) Limited (“Vernalis”), which was subsequently amended as of November 5, 2015, and, pursuant to which the Company was granted an exclusive, worldwide license under certain patent rights and know-how, including a limited right to grant sublicenses, for all fields of use to develop, manufacture and commercialize products containing certain adenosine receptor antagonists, including ciforadenant. Pursuant to this agreement, the Company made a one-time cash payment to Vernalis in the amount of $1.0 million, which was recorded as research and development expense as technological feasibility of the asset had not been established and there was no alternative future use. The Company is also required to make cash milestone payments to Vernalis upon the successful completion of clinical and regulatory milestones for licensed products depending on the indications for which such licensed products are developed and upon achievement of certain sales milestones. In February 2017, the Company made a milestone payment of $3.0 million to Vernalis following the expansion of a cohort of patients with renal cell cancer treated with single agent ciforadenant in the Company’s Phase 1/1b clinical trial. During the three months ended March 31, 2023, no clinical or regulatory milestones were completed or paid to Vernalis and the aggregate potential milestone payments were approximately $220 million for all indications as of March 31, 2023. The Company has also agreed to pay Vernalis tiered incremental royalties based on the annual net sales of licensed products containing ciforadenant on a product by product and country by country basis, subject to certain offsets and reductions. The tiered royalty rates for products containing ciforadenant range from the mid single digits up to the low double digits on a country by country net sales basis. The royalties on other licensed products that do not include ciforadenant also increase with the amount of net sales on a product-by-product and country by country basis and range from the low single digits up to the mid single digits on a country by country net sales basis. The Company is also obligated to pay to Vernalis certain sales milestones as indicated above when worldwide net sales reach specified levels over an agreed upon time period. The Company has also agreed to pay Vernalis tiered incremental royalties based on the annual net sales of licensed products containing ciforadenant on a product-by-product and country-by-country basis, subject to certain offsets and reductions. The tiered royalty rates for products containing ciforadenant range from the mid-single digits up to the low-double digits on a country-by-country net sales basis. The royalties on other licensed products that do not include ciforadenant also increase with the amount of net sales on a product-by-product and country-by-country basis and range from the low-single digits up to the mid-single digits on a country-by-country net sales basis. The Company is also obligated to pay to Vernalis certain sales milestones as indicated above when worldwide net sales reach specified levels over an agreed upon time period. The agreement will expire on a product-by-product and country-by-country basis upon the expiration of the Company’s payment obligations to Vernalis in respect of a particular product and country. Both parties have the right to terminate the agreement for an uncured material breach by the other party. The Company may also terminate the agreement at its convenience by providing 90 days written notice, provided that the Company has not received notice of its own default under the agreement at the time the Company exercises such termination right. Vernalis may also terminate the agreement if the Company challenges a licensed patent or undergoes a bankruptcy event. Monash License Agreement In April 2017, the Company entered into a license agreement with Monash University (Monash), pursuant to which the Company was granted an exclusive, sublicensable worldwide license under certain know-how, patent rights and other intellectual property rights controlled by Monash to research, develop, and commercialize certain antibodies directed to CXCR2 for the treatment of human diseases. Upon execution of the agreement, the Company made a one time cash payment to Monash of $275,000 and reimbursed Monash for certain patent prosecution costs incurred prior to execution of the agreement. The Company recorded these payments as research and development expenses for the year ended December 31, 2017. The Company is also obligated to pay an annual license maintenance fee to Monash of $25,000 until a certain development milestone is met with respect to the licensed product, after which no further maintenance fee will be due. The Company is also required to make development and sales milestone payments to Monash with respect to the licensed products. During the three months ended March 31, 2023, no development or sales milestones were completed or paid to Monash and the aggregate potential milestones were $45.1 million as of March 31, 2023. The Company is also required to pay to Monash tiered royalties on net sales of licensed products sold by it, its affiliates and its sublicensees at a rate ranging in the low single digits. In addition, should the Company sublicense its rights under the agreement, the Company has agreed to pay a percentage of sublicense revenue received at specified rates that are currently at low double digit percentages and decrease to single digit percentages based on the achievement of development milestones. The term of the Company’s agreement with Monash continues until the expiration of its obligation to pay royalties to Monash thereunder. The license agreement is terminable at will by the Company upon providing 30 days written notice to Monash, or by either party for material breaches by the other party. In addition, Monash may terminate the entire agreement or convert the license to a non-exclusive license if the Company has materially breached its obligation to use commercially reasonable efforts to develop and commercialize a licensed product, subject to a specified notice and cure mechanism. |
Balance Sheet Components
Balance Sheet Components | 3 Months Ended |
Mar. 31, 2023 | |
Balance Sheet Components | |
Balance Sheet Components | 7. Balance Sheet Components (in thousands) March 31, December 31, 2023 2022 Prepaid and Other Current Assets Interest receivable $ 38 $ 45 Prepaid research and development manufacturing expenses 221 192 Prepaid facility expenses 196 182 Prepaid insurance 69 252 Other 131 102 $ 655 $ 773 Property and Equipment Laboratory equipment $ 2,678 $ 2,673 Computer equipment and purchased software 171 142 Leasehold improvements 2,084 2,084 4,933 4,899 Less: accumulated depreciation and amortization (4,603) (4,546) $ 330 $ 353 Accrued and Other Liabilities Accrued clinical trial expense $ 2,893 $ 2,934 Accrued manufacturing expense 1,482 3,254 Personnel related 658 1,113 Accrued legal and accounting 208 89 Other 379 158 $ 5,620 $ 7,548 During the three months ended March 31, 2023 and 2022, the Company recorded approximately $57,000 and $87,000 in depreciation expense, respectively. |
Common Stock
Common Stock | 3 Months Ended |
Mar. 31, 2023 | |
Common Stock | |
Common Stock | 8. Common Stock As of March 31, 2023, the amended and restated certificate of incorporation authorizes the Company to issue 290 million shares of common stock and 10 million shares of preferred stock. Each share of common stock is entitled to one vote. Common stockholders are entitled to dividends if and when declared by the board of directors. As of March 31, 2023, no dividends on common stock had been declared. In March 2020, the Company entered into an open market sale agreement (the “2020 Sales Agreement”) with Jefferies LLC (“Jefferies”) to sell shares of the Company’s common stock, from time-to-time, with aggregate gross sales proceeds of up to $50,000,000, through an at-the-market equity offering program under which Jefferies will act as its sales agent. In November 2021, the Company entered into another Sale Agreement (“2021 Sales Agreement”) with Jefferies to sell shares of its common stock from time-to-time, with aggregate gross sales proceeds of up to $40,000,000. On March 28, 2023, the Company terminated both the 2020 Sales Agreement and the 2021 Sales Agreement and concurrently entered into a new open market sale agreement (the “2023 Sales Agreement”) with Jefferies to sell shares of the Company’s common stock, from time-to-time, with aggregate gross sales proceeds of up to $90,000,000 , through an at-the-market equity offering program under which Jefferies will act as its sales agent. The issuance and sale of shares of common stock by the Company pursuant to the 2023 Sales Agreement are deemed an “at-the-market” offering under the Securities Act of 1933, as amended. Jefferies is entitled to compensation for its services equal to During the three months ended March 31, 2023, the Company did not sell any shares of common stock under its at-the-market offering program. As of March 31, 2023, the Company had sold 6,920,339 shares of common stock for gross proceeds of $31.1 million under the 2020 Sales Agreement. The Company has reserved shares of common stock for issuance as follows: March 31, December 31, 2023 2022 Shares available for future option grants 5,138,454 4,017,011 Outstanding options 7,731,807 7,006,250 Shares reserved for employee stock purchase plan 400,000 400,000 Total 13,270,261 11,423,261 |
Stock Option Plans
Stock Option Plans | 3 Months Ended |
Mar. 31, 2023 | |
Stock Option Plans | |
Stock Option Plans | 9. Stock Option Plans In February 2014, the Company adopted the 2014 Equity Incentive Plan (the “2014 Plan”), which was subsequently amended in November 2014, July 2015 and September 2015, under which it granted incentive stock options (“ISOs”) or non-qualified stock options (“NSOs”). Terms of stock agreements, including vesting requirements, are determined by the board of directors or a committee authorized by the board of directors, subject to the provisions of the 2014 Plan. In general, awards granted by the Company vest over four years and have a maximum exercise term of 10 years. The 2014 Plan provides that grants must be at an exercise price of 100% of fair market value of the Company’s common stock as determined by the board of directors on the date of the grant. In connection with the consummation of the IPO in March 2016, the 2016 Equity Incentive Award Plan (the “2016 Plan”), became effective. Under the 2016 Plan, incentive stock options, non-statutory stock options, stock purchase rights and other stock-based awards may be granted. Terms of stock agreements, including vesting requirements, are determined by the board of directors or a committee authorized by the board of directors, subject to the provisions of the 2016 Plan. In general, awards granted by the Company vest over four years and have a maximum exercise term of 10 years. The 2016 Plan provides that grants must be at an exercise price of 100% of fair market value of the Company’s common stock as determined by the board of directors on the date of the grant. In conjunction with adopting the 2016 Plan, the 2014 Plan was terminated and no further awards will be granted under the 2014 Plan. Options outstanding under the 2014 Plan as of the effective date of the 2016 Plan that are forfeited or lapse unexercised may be re-issued under the 2016 Plan, up to a maximum of 1,136,229 shares. Activity under the Company’s stock option plans is set forth below: Options Outstanding Weighted ‑ Shares Average Available Number of Exercise for Grant Options Price Balance at December 31, 2022 4,017,011 7,006,250 $ 5.25 Additional shares authorized 1,862,000 — — Options granted (860,000) 860,000 0.90 Options exercised — (15,000) 0.28 Options forfeited 119,443 (119,443) 6.75 Balance at March 31, 2023 5,138,454 7,731,807 $ 4.75 |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2023 | |
Stock-Based Compensation | |
Stock-Based Compensation | 10. Stock-Based Compensation The Company’s results of operations include expenses relating to employee and non-employee stock-based awards as follows (in thousands): Three Months Ended March 31, 2023 2022 Research and development $ 192 $ 302 General and administrative 300 437 Total $ 492 $ 739 |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2023 | |
Income Taxes | |
Income Taxes | 11. Income Taxes During the three months ended March 31, 2023 and 2022, the Company recorded no income tax benefits for the net operating losses (NOLs) incurred due to the uncertainty of realizing a benefit from those items. The Company continues to maintain a full valuation allowance against its net deferred tax assets. |
Facility Lease
Facility Lease | 3 Months Ended |
Mar. 31, 2023 | |
Facility Lease | |
Facility lease | 12. Facility Lease In January 2015, the Company signed an initial operating lease, effective February 1, 2015 for 8,138 square feet of office and laboratory space with a one year term. Between January 2015 and September 2021, the Company entered into a series of lease amendments to increase the amount of leased space to 27,280 square feet and extend the expiration of the lease to February 2025. The lease agreement includes annual rent escalations. Under the lease and subsequent amendments, the landlord provided approximately $1.9 million in free rent and lease incentives. The Company records rent expense on a straight-line basis over the effective term of the lease, including any free rent periods and incentives. As the interest rate implicit in lease arrangements is typically not readily available, in calculating the present value of the lease payments, the Company has utilized its incremental borrowing rate, which was determined based on the prevailing market rates for collateralized debt with maturity dates commensurate with the term of its lease. The Company’s facility lease is a net lease, as the non-lease components (i.e. common area maintenance) are paid separately from rent based on actual costs incurred. Therefore, the non-lease components were not included in the right-of-use asset and liability and are reflected as an expense in the period incurred. In September 2021, the Company entered into a lease amendment to extend the expiration of its operating lease by two years from February 2023 to February 2025. As a result of this lease extension, the Company recorded a $2.4 million increase in the operating lease right-of-use asset and a corresponding increase in the operating lease liability As of March 31, 2023 and December 31, 2022, the right-of-use asset under operating lease was $2.0 million and $2.2 million, respectively. The elements of lease expense for the three months ended March 31, 2023 and 2022 were as follows (in thousands): Three Months Ended Statements of operations and March 31, comprehensive loss location 2023 2022 Costs of operating lease Operating lease costs Research and development, $ 306 $ 306 Costs of non-lease components (previously common area maintenance) Research and development, 111 108 Total operating lease cost $ 417 $ 414 Other Information Operating cash flows used for operating lease $ 459 $ 433 Remaining lease term 1.8 years 2.8 years Discount rate 8.0% 8.0% Year Ended December 31 (in thousands) 2023* $ 1,043 2024 1,434 Total lease payments 2,477 Less: imputed interest (174) Total $ 2,303 * Remainder of the year Year Ended December 31 (in thousands) 2023 $ 1,391 2024 1,434 Total lease payments 2,825 Less: imputed interest (224) Total $ 2,601 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies | |
Commitments and Contingencies | 13. Commitments and Contingencies Indemnifications In the ordinary course of business, the Company enters into agreements that may include indemnification provisions. Pursuant to such agreements, the Company may indemnify, hold harmless and defend an indemnified party for losses suffered or incurred by the indemnified party. Some of the provisions will limit losses to those arising from third-party actions. In some cases, the indemnification will continue after the termination of the agreement. The maximum potential amount of future payments the Company could be required to make under these provisions is not determinable. The Company has never incurred material costs to defend lawsuits or settle claims related to these indemnification provisions. The Company has also entered into indemnification agreements with its directors and officers that may require the Company to indemnify its directors and officers against liabilities that may arise by reason of their status or service as directors or officers to the fullest extent permitted by Delaware corporate law. There have been no claims to date and the Company has a directors and officers insurance policy that may enable it to recover a portion of any amounts paid for future claims. Legal Proceedings |
Related Party Transactions
Related Party Transactions | 3 Months Ended |
Mar. 31, 2023 | |
Related Party Transactions | |
Related Party Transactions | 14. Related Party Transactions |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2023 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The accompanying condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). The Company’s functional and reporting currency is the U.S. dollar, except for its investment in its equity method investee which is the Chinese renminbi (RMB). The accompanying condensed consolidated financial statements have been prepared on a going-concern basis, which contemplates the realization of assets and discharge of liabilities in the normal course of business. |
Unaudited Interim Financial Information | Unaudited Interim Financial Information The accompanying interim condensed consolidated financial statements and related disclosures are unaudited, have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for a fair statement of the results of operations for the periods presented. The year-end condensed consolidated balance sheet data was derived from audited financial statements, but does not include all disclosures required by GAAP. The condensed consolidated results of operations for the three months ended March 31, 2023 are not necessarily indicative of the results to be expected for the full year or for any other future year or interim period. The accompanying condensed consolidated financial statements should be read in conjunction with the audited financial statements and the related notes for the year ended December 31, 2022 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 28, 2023. |
Use of Estimates | Use of Estimates The preparation of the Company’s condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Actual results could differ from such estimates. |
Concentrations of Credit Risk and Other Risks and Uncertainties | Concentrations of Credit Risk and Other Risks and Uncertainties Substantially all of the Company’s cash and cash equivalents are deposited in accounts with two financial institutions that management believes are of high credit quality. Such deposits may, at times, exceed federally insured limits. The Company maintains its cash with an accredited financial institution and accordingly, such funds are subject to minimal credit risk. The Company’s marketable securities consist of investments in U.S. Treasury securities and U.S. government agency securities, which can be subject to certain credit risks. However, the Company mitigates the risks by investing in high-grade instruments, limiting its exposure to any one issuer, and monitoring the ongoing creditworthiness of the financial institutions and issuers. The Company has not experienced any losses on its deposits of cash, cash equivalents or marketable securities. The Company is subject to a number of risks similar to other early stage biopharmaceutical companies, including, but not limited to, the need to obtain adequate additional funding, possible failure of preclinical testing or clinical trials, its reliance on third parties to conduct its clinical trials, the need to obtain marketing approval for its product candidates, competitors developing new technological innovations, the need to successfully commercialize and gain market acceptance of the Company’s product candidates, its right to develop and commercialize its product candidates pursuant to the terms and conditions of the licenses granted to the Company, and protection of proprietary technology. If the Company does not successfully commercialize or partner any of its product candidates, it will be unable to generate product revenue or achieve profitability. |
Segments | Segments Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business in one operating segment, that of the development of and commercialization of precisely targeted oncology therapies. |
Significant Accounting Policies | Significant Accounting Policies The Company’s significant accounting policies are described in Note 2 to its consolidated financial statements for the year ended December 31, 2022, included in its Annual Report on Form 10-K. There have been no material changes to the Company’s significant accounting policies during the three months ended March 31, 2023. |
Investments in Equity Securities | Investments in Equity Securities For equity method investees with a functional currency different than the Company’s reporting currency, the Company follows the guidance under ASC 830-10-15-5, pursuant to which, the foreign currency financial statements of a foreign investee accounted for by the equity method should be translated to the reporting entity's reporting currency. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes. ASU 2019-12 simplifies the accounting for income taxes by eliminating certain exceptions to the guidance in ASC 740 related to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences. ASU 2019-12 is effective in 2021 and interim periods within that year and permits for an early adoption. The Company adopted ASU 2019-12 effective January 1, 2021. The adoption of the guidance did not have a material impact on its financial statements and related disclosures. In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments. The standard amends the impairment model by requiring entities to use a forward-looking approach based on expected losses to estimate credit losses for most financial assets and certain other instruments that are not measured at fair value through net income. For available-for-sale debt securities, entities will be required to recognize an allowance for credit losses rather than a reduction in carrying value of the asset. Entities will no longer be permitted to consider the length of time that fair value has been less than amortized cost when evaluating when credit losses should be recognized. This new guidance is effective in the first quarter of 2023 for calendar-year SEC filers that are smaller reporting companies as of the one-time determination date. The Company has adopted the new guidance as of January 1, 2023, and it did not have a material impact on its financial statements and related disclosures. |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Net Loss per Share | |
Schedule of net loss per share, basic and diluted | The following table shows the calculation of net loss per share (in thousands, except share and per share data): Three Months Ended March 31, 2023 2022 Numerator: Net loss - basic and diluted $ (7,873) $ (8,297) Denominator: Weighted average common shares outstanding used to compute basic and diluted net loss per share 46,556,178 46,553,511 Net loss per share, basic and diluted $ (0.17) $ (0.18) |
Schedule of antidilutive securities excluded from calculation of diluted net loss per share | The amounts in the table below were excluded from the calculation of diluted net loss per share, due to their anti-dilutive effect: Three Months Ended March 31, 2023 2022 Outstanding options 7,731,807 5,773,988 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Fair Value Measurements | |
Schedule of fair value of assets measured at fair value on a recurring basis, by level of fair value hierarchy | The following tables present information as of March 31, 2023 and December 31, 2022 about the Company’s assets that are measured at fair value on a recurring basis and indicate the level of the fair value hierarchy the Company utilized to determine such fair values (in thousands): March 31, 2023 Fair Value Measured Using Total (Level 1) (Level 2) (Level 3) Balance Assets Cash equivalents $ 9,407 $ — $ — $ 9,407 Marketable securities 14,698 10,115 — 24,813 $ 24,105 $ 10,115 $ — $ 34,220 December 31, 2022 Fair Value Measured Using Total (Level 1) (Level 2) (Level 3) Balance Assets Cash equivalents $ 11,942 $ — $ — $ 11,942 Marketable securities 22,001 7,143 — 29,144 $ 33,943 $ 7,143 $ — $ 41,086 |
Schedule of fair value of available for sale marketable securities | As of March 31, 2023 and December 31, 2022, the fair value of available for sale marketable securities by type of security were as follows (in thousands): March 31, 2023 Gross Gross Amortized Unrealized Unrealized Fair Cost Gains Losses Value U.S. Treasury securities $ 14,697 $ 4 $ (3) $ 14,698 U.S. Government agency securities 10,126 2 (13) 10,115 $ 24,823 $ 6 $ (16) $ 24,813 December 31, 2022 Gross Gross Amortized Unrealized Unrealized Fair Cost Gains Losses Value U.S. Treasury securities $ 22,020 $ 4 $ (23) $ 22,001 U.S. Government agency securities 7,175 — (32) 7,143 $ 29,195 $ 4 $ (55) $ 29,144 |
Equity Method Investment (Table
Equity Method Investment (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Equity Method Investment | |
Schedule of financial information of Angel Pharmaceuticals Co. | As of As of Balance Sheet Data March 31, 2023 December 31, 2022 (in thousands) Current assets $ 24,463 $ 29,062 Non-current assets 1,572 1,652 Current liabilities 3,625 6,293 Non-current liabilities 903 985 Stockholders' equity 21,507 23,436 Three Months Ended March 31, Statement of Operations Data 2023 2022 (in thousands) Revenue $ — $ — Gross Profit — — Net loss (2,032) (1,325) Share of loss from investments accounted for using the equity method (1,731) (1,041) |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Balance Sheet Components | |
Schedule of balance sheet components | March 31, December 31, 2023 2022 Prepaid and Other Current Assets Interest receivable $ 38 $ 45 Prepaid research and development manufacturing expenses 221 192 Prepaid facility expenses 196 182 Prepaid insurance 69 252 Other 131 102 $ 655 $ 773 Property and Equipment Laboratory equipment $ 2,678 $ 2,673 Computer equipment and purchased software 171 142 Leasehold improvements 2,084 2,084 4,933 4,899 Less: accumulated depreciation and amortization (4,603) (4,546) $ 330 $ 353 Accrued and Other Liabilities Accrued clinical trial expense $ 2,893 $ 2,934 Accrued manufacturing expense 1,482 3,254 Personnel related 658 1,113 Accrued legal and accounting 208 89 Other 379 158 $ 5,620 $ 7,548 |
Common Stock (Tables)
Common Stock (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Common Stock | |
Schedule of shares of common stock reserved for issuance | The Company has reserved shares of common stock for issuance as follows: March 31, December 31, 2023 2022 Shares available for future option grants 5,138,454 4,017,011 Outstanding options 7,731,807 7,006,250 Shares reserved for employee stock purchase plan 400,000 400,000 Total 13,270,261 11,423,261 |
Stock Option Plans (Tables)
Stock Option Plans (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Stock Option Plans | |
Schedule of stock option activity | Activity under the Company’s stock option plans is set forth below: Options Outstanding Weighted ‑ Shares Average Available Number of Exercise for Grant Options Price Balance at December 31, 2022 4,017,011 7,006,250 $ 5.25 Additional shares authorized 1,862,000 — — Options granted (860,000) 860,000 0.90 Options exercised — (15,000) 0.28 Options forfeited 119,443 (119,443) 6.75 Balance at March 31, 2023 5,138,454 7,731,807 $ 4.75 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Stock-Based Compensation | |
Schedule of expenses relating to employee and non-employee stock-based awards | The Company’s results of operations include expenses relating to employee and non-employee stock-based awards as follows (in thousands): Three Months Ended March 31, 2023 2022 Research and development $ 192 $ 302 General and administrative 300 437 Total $ 492 $ 739 |
Facility Lease (Tables)
Facility Lease (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Facility Lease | |
Schedule of Operating Lease Costs | Three Months Ended Statements of operations and March 31, comprehensive loss location 2023 2022 Costs of operating lease Operating lease costs Research and development, $ 306 $ 306 Costs of non-lease components (previously common area maintenance) Research and development, 111 108 Total operating lease cost $ 417 $ 414 Other Information Operating cash flows used for operating lease $ 459 $ 433 Remaining lease term 1.8 years 2.8 years Discount rate 8.0% 8.0% |
Schedule of Minimum rental commitments | Year Ended December 31 (in thousands) 2023* $ 1,043 2024 1,434 Total lease payments 2,477 Less: imputed interest (174) Total $ 2,303 * Remainder of the year Year Ended December 31 (in thousands) 2023 $ 1,391 2024 1,434 Total lease payments 2,825 Less: imputed interest (224) Total $ 2,601 |
Organization - Public Offerings
Organization - Public Offerings (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | ||||
Apr. 26, 2016 | Mar. 29, 2016 | Feb. 28, 2021 | Mar. 31, 2018 | Mar. 31, 2023 | Dec. 31, 2022 | |
Public Offerings | ||||||
Accumulated deficit | $ 315,561 | $ 307,688 | ||||
Cash, cash equivalents and short-term marketable securities | $ 34,500 | |||||
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | ||||
Shelf Registration Statement | ||||||
Public Offerings | ||||||
Securities offering period | 60 days | |||||
Minimum | Shelf Registration Statement | ||||||
Public Offerings | ||||||
Public Float | $ 75,000 | |||||
Follow-on Public Offering | ||||||
Public Offerings | ||||||
Share offering price | $ 3.50 | $ 8.50 | ||||
Proceeds from sale of stock | $ 32,000 | $ 64,900 | ||||
Issuance of common stock | 9,783,660 | 8,117,647 | ||||
Over-Allotment Option | ||||||
Public Offerings | ||||||
Share offering price | $ 15 | |||||
Issuance of common stock | 502,618 | 1,212,231 | 1,058,823 | |||
IPO | ||||||
Public Offerings | ||||||
Share offering price | $ 15 | |||||
Net proceeds from IPO | $ 70,600 | |||||
Issuance of common stock | 4,700,000 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 USD ($) segment item | Dec. 31, 2022 USD ($) | |
Summary of Significant Accounting Policies | ||
Accumulated deficit | $ (315,561) | $ (307,688) |
Cash, cash equivalents and marketable securities | 34,500 | |
Accumulated other comprehensive income | $ (434) | $ (563) |
Concentrations of Credit Risk and Other Risks and Uncertainties | ||
Number of financial institutions used for cash and cash equivalent deposits | item | 2 | |
Segments | ||
Number of operating segments | segment | 1 |
Net Loss per Share - Net Loss p
Net Loss per Share - Net Loss per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Numerator: | ||
Net loss - basic and diluted | $ (7,873) | $ (8,297) |
Denominator: | ||
Weighted average common shares outstanding used to compute basic net loss per share | 46,556,178 | 46,553,511 |
Weighted average common shares outstanding used to compute diluted net loss per share | 46,556,178 | 46,553,511 |
Net loss per share, basic | $ (0.17) | $ (0.18) |
Net loss per share, diluted | $ (0.17) | $ (0.18) |
Net Loss per Share - Anti-Dilut
Net Loss per Share - Anti-Dilutive Securities (Details) - shares | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Outstanding options | ||
Excluded from the calculation of diluted net loss per share, due to anti-dilutive effect | ||
Anti dilutive securities were excluded from the calculation of diluted net loss per share | 7,731,807 | 5,773,988 |
Fair Value Measurements - Recur
Fair Value Measurements - Recurring (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Dec. 31, 2022 | |
Assets | ||
Maximum remaining maturity of marketable securities | 9 months | |
Recurring | ||
Assets | ||
Cash equivalents | $ 9,407 | $ 11,942 |
Marketable securities | 24,813 | 29,144 |
Total Assets | 34,220 | 41,086 |
Recurring | Level 1 | ||
Assets | ||
Cash equivalents | 9,407 | 11,942 |
Marketable securities | 14,698 | 22,001 |
Total Assets | 24,105 | 33,943 |
Recurring | Level 2 | ||
Assets | ||
Marketable securities | 10,115 | 7,143 |
Total Assets | $ 10,115 | $ 7,143 |
Fair Value Measurements - Avail
Fair Value Measurements - Available For Sale (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Fair value of available for sale marketable securities | ||
Amortized Cost | $ 24,823 | $ 29,195 |
Gross Unrealized Gains | 6 | 4 |
Gross Unrealized Losses | (16) | (55) |
Fair Value | 24,813 | 29,144 |
U.S. Treasury securities | ||
Fair value of available for sale marketable securities | ||
Amortized Cost | 14,697 | 22,020 |
Gross Unrealized Gains | 4 | 4 |
Gross Unrealized Losses | (3) | (23) |
Fair Value | 14,698 | 22,001 |
U.S. Government agency securities | ||
Fair value of available for sale marketable securities | ||
Amortized Cost | 10,126 | 7,175 |
Gross Unrealized Gains | 2 | |
Gross Unrealized Losses | (13) | (32) |
Fair Value | $ 10,115 | $ 7,143 |
Equity Method Investment (Detai
Equity Method Investment (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Schedule of Equity Method Investments [Line Items] | |||
Loss from equity method investment | $ 1,731 | $ 1,041 | |
Net loss | $ (7,873) | (8,297) | |
Angel Pharmaceuticals | |||
Schedule of Equity Method Investments [Line Items] | |||
Ownership interest (as percent) | 49.70% | 49.70% | |
Equity reserved (as percent) | 7% | 7% | |
Loss from equity method investment | $ 1,700 | $ (1,000) | |
Net loss | (2,032) | (1,325) | |
Share of loss from investments accounted for using the equity method | $ (1,731) | $ (1,041) |
Equity Method Investment - Summ
Equity Method Investment - Summary Financial Information (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 | Mar. 31, 2022 | Dec. 31, 2021 |
Schedule of Equity Method Investments [Line Items] | ||||
Current assets | $ 35,551 | $ 43,664 | ||
Current liabilities | 8,290 | 10,752 | ||
Stockholders' equity | 48,867 | 56,115 | $ 89,722 | $ 97,162 |
Angel Pharmaceuticals | ||||
Schedule of Equity Method Investments [Line Items] | ||||
Current assets | 24,463 | 29,062 | ||
Non-current assets | 1,572 | 1,652 | ||
Current liabilities | 3,625 | 6,293 | ||
Non-current liabilities | 903 | 985 | ||
Stockholders' equity | $ 21,507 | $ 23,436 |
License and Collaboration Agr_2
License and Collaboration Agreements (Details) - USD ($) | 3 Months Ended | ||||
Mar. 31, 2023 | Apr. 30, 2017 | Feb. 28, 2017 | Dec. 31, 2015 | Nov. 05, 2015 | |
Monash License | |||||
License and Collaboration Agreements | |||||
Period of written notice to terminate | 30 days | ||||
Licensing Agreement | Scripps Research Institute | |||||
License and Collaboration Agreements | |||||
Minimum annual fee | $ 25,000 | ||||
Aggregate potential milestone payments | $ 2,600,000 | ||||
Period of written notice to terminate | 90 days | ||||
Licensing Agreement | Scripps Research Institute | Research and development | |||||
License and Collaboration Agreements | |||||
One-time cash payment | $ 10,000 | ||||
Licensing Agreement | Vernalis (R&D) Limited | |||||
License and Collaboration Agreements | |||||
Milestone payments made | $ 0 | $ 3,000,000 | |||
Period of written notice to terminate | 90 days | ||||
Licensing Agreement | Vernalis (R&D) Limited | Maximum | |||||
License and Collaboration Agreements | |||||
Aggregate potential milestone payments | $ 220,000,000 | ||||
Licensing Agreement | Vernalis (R&D) Limited | Research and development | |||||
License and Collaboration Agreements | |||||
One-time cash payment | $ 1,000,000 | ||||
Licensing Agreement | Monash License | |||||
License and Collaboration Agreements | |||||
Minimum annual fee | $ 25,000 | ||||
Milestone payments made | 0 | ||||
Licensing Agreement | Monash License | Maximum | |||||
License and Collaboration Agreements | |||||
Aggregate potential milestone payments | $ 45,100,000 | ||||
Licensing Agreement | Monash License | Research and development | |||||
License and Collaboration Agreements | |||||
One-time cash payment | $ 275,000 |
Balance Sheet Components - Prep
Balance Sheet Components - Prepaid and Other Current Assets (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Prepaid and Other Current Assets | ||
Interest receivable | $ 38 | $ 45 |
Prepaid research and development manufacturing expenses | 221 | 192 |
Prepaid facility expenses | 196 | 182 |
Prepaid insurance | 69 | 252 |
Other | 131 | 102 |
Total of prepaid and other current assets | $ 655 | $ 773 |
Balance Sheet Components - Prop
Balance Sheet Components - Property and Equipment (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Property and Equipment | ||
Property and equipment, gross | $ 4,933 | $ 4,899 |
Less: accumulated depreciation and amortization | (4,603) | (4,546) |
Property and equipment, net | 330 | 353 |
Laboratory equipment | ||
Property and Equipment | ||
Property and equipment, gross | 2,678 | 2,673 |
Computer equipment and purchased software | ||
Property and Equipment | ||
Property and equipment, gross | 171 | 142 |
Leasehold improvements | ||
Property and Equipment | ||
Property and equipment, gross | $ 2,084 | $ 2,084 |
Balance Sheet Components - Accr
Balance Sheet Components - Accrued and Other Liabilities (Details) - USD ($) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2023 | Dec. 31, 2022 | |
Accrued and Other Liabilities | ||
Accrued clinical trial expense | $ 2,893,000 | $ 2,934,000 |
Accrued manufacturing expense | 1,482,000 | 3,254,000 |
Personnel related | 658,000 | 1,113,000 |
Accrued legal and accounting | 208,000 | 89,000 |
Other | 379,000 | 158,000 |
Total of accrued and other liabilities | 5,620,000 | 7,548,000 |
Depreciation expense | $ 57,000 | $ 87,000 |
Common Stock (Details)
Common Stock (Details) | 1 Months Ended | 3 Months Ended | |||
Mar. 28, 2023 USD ($) | Nov. 30, 2021 USD ($) | Mar. 31, 2020 USD ($) | Mar. 31, 2023 USD ($) Vote shares | Dec. 31, 2022 shares | |
Common Stock | |||||
Common stock, shares authorized for issuance | 290,000,000 | 290,000,000 | |||
Preferred stock, shares authorized for issuance | 10,000,000 | 10,000,000 | |||
Number of votes per share of common stock | Vote | 1 | ||||
Dividends on common stock | $ | $ 0 | ||||
Shares of common stock reserved for issuance, on an as-converted basis | |||||
Shares available for future option grants | 5,138,454 | 4,017,011 | |||
Outstanding options | 7,731,807 | 7,006,250 | |||
Shares reserved for employee stock purchase plan | 400,000 | 400,000 | |||
Total | 13,270,261 | 11,423,261 | |||
At-the-market offering | Jefferies LLC | 2020 Sales Agreement | |||||
Common Stock | |||||
Common stock shares sold | 6,920,339 | ||||
Common stock gross proceeds | $ | $ 31,100,000 | ||||
At-the-market offering | Jefferies LLC | 2020 Sales Agreement | Maximum | |||||
Common Stock | |||||
Potential gross proceeds | $ | $ 50,000,000 | ||||
At-the-market offering | Jefferies LLC | 2021 sales agreement | Maximum | |||||
Common Stock | |||||
Potential gross proceeds | $ | $ 40,000,000 | ||||
At-the-market offering | Jefferies LLC | 2023 Sales Agreement | |||||
Common Stock | |||||
Stock issuance costs, as a percent of gross proceeds | 3% | ||||
Common stock shares sold | 0 | ||||
At-the-market offering | Jefferies LLC | 2023 Sales Agreement | Maximum | |||||
Common Stock | |||||
Potential gross proceeds | $ | $ 90,000,000 |
Stock Option Plans - Stock Opti
Stock Option Plans - Stock Option Activity (Details) - $ / shares | 1 Months Ended | 3 Months Ended | |
Mar. 31, 2016 | Feb. 28, 2014 | Mar. 31, 2023 | |
Stock Option Plans | |||
Shares available for future option grants | 5,138,454 | ||
Shares Available for Grant | |||
Beginning balance | 4,017,011 | ||
Ending balance | 5,138,454 | ||
Number of Options | |||
Beginning balance | 7,006,250 | ||
Ending balance | 7,731,807 | ||
2014 Plan | |||
Stock Option Plans | |||
Vesting period | 4 years | ||
Maximum exercise term | 10 years | ||
Exercise price of common stock of its fair value (as a percent) | 100% | ||
Shares available for future option grants | 0 | ||
Maximum number of options that may be re-issued under the 2016 plan | 1,136,229 | ||
Shares Available for Grant | |||
Ending balance | 0 | ||
2016 Plan | |||
Stock Option Plans | |||
Vesting period | 4 years | ||
Maximum exercise term | 10 years | ||
Exercise price of common stock of its fair value (as a percent) | 100% | ||
Shares available for future option grants | 5,138,454 | ||
Shares Available for Grant | |||
Beginning balance | 4,017,011 | ||
Additional shares authorized | 1,862,000 | ||
Granted | (860,000) | ||
Forfeited | 119,443 | ||
Ending balance | 5,138,454 | ||
Number of Options | |||
Beginning balance | 7,006,250 | ||
Granted | 860,000 | ||
Exercised | (15,000) | ||
Forfeited | (119,443) | ||
Ending balance | 7,731,807 | ||
Weighted-Average Exercise Price | |||
Beginning balance (in dollars per share) | $ 5.25 | ||
Granted (in dollars per share) | 0.90 | ||
Exercised (in dollars per share) | 0.28 | ||
Forfeited (in dollars per share) | 6.75 | ||
Ending balance (in dollars per share) | $ 4.75 |
Stock-Based Compensation - Expe
Stock-Based Compensation - Expense Allocation (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Stock-based compensation | ||
Stock-based compensation expense | $ 492 | $ 739 |
Research and development | ||
Stock-based compensation | ||
Stock-based compensation expense | 192 | 302 |
General and administrative | ||
Stock-based compensation | ||
Stock-based compensation expense | $ 300 | $ 437 |
Income Taxes - Components of lo
Income Taxes - Components of loss before income tax and Income tax benefits (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Income Taxes | ||
Income tax benefits | $ 0 | $ 0 |
Facility Lease - Lessee informa
Facility Lease - Lessee information (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 46 Months Ended | |||
Sep. 30, 2021 USD ($) ft² | Mar. 31, 2023 USD ($) | Mar. 31, 2022 USD ($) | Oct. 31, 2018 USD ($) | Dec. 31, 2022 USD ($) | Feb. 01, 2015 ft² | |
Lease | ||||||
Area of leased facility | ft² | 27,280 | 8,138 | ||||
Lease term | 1 year | |||||
Landlord Provided Free Rent And Lease Incentives | $ 1,900 | |||||
Lease extension period | 2 years | |||||
Increase in operating lease right-of-use asset | $ 2,400 | $ 264 | $ 238 | |||
Increase in the operating lease liability | $ 2,400 | 298 | $ 254 | |||
Operating lease right-of-use asset | $ 1,953 | $ 2,217 |
Facility Lease - Lease cost (De
Facility Lease - Lease cost (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Operating lease cost | ||
Operating lease costs | $ 306 | $ 306 |
Costs of non-lease components (previously common area maintenance) | 111 | 108 |
Total operating lease cost | 417 | 414 |
Other Information | ||
Operating cash flows used for operating lease | $ 459 | $ 433 |
Remaining lease term | 1 year 9 months 18 days | 2 years 9 months 18 days |
Discount rate | 8% | 8% |
Facility Lease - Minimum rental
Facility Lease - Minimum rental commitments (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Quarter Ended March 31, 2023 | ||
Minimum rental commitments 2023 | ||
2023 | $ 1,043 | |
2024 | 1,434 | |
Total lease payments | 2,477 | |
Less: imputed interest | (174) | |
Total | 2,303 | |
Minimum rental commitments 2022 | ||
2023 | 1,043 | |
2024 | 1,434 | |
Total lease payments | 2,477 | |
Less: imputed interest | (174) | |
Total | $ 2,303 | |
Year Ended December 31, 2022 | ||
Minimum rental commitments 2023 | ||
2023 | $ 1,391 | |
2024 | 1,434 | |
Total lease payments | 2,825 | |
Less: imputed interest | (224) | |
Total | 2,601 | |
Minimum rental commitments 2022 | ||
2023 | 1,391 | |
2024 | 1,434 | |
Total lease payments | 2,825 | |
Less: imputed interest | (224) | |
Total | $ 2,601 |
Facility Lease - Additional inf
Facility Lease - Additional information (Details) | 1 Months Ended | 3 Months Ended | 12 Months Ended | |
Aug. 31, 2021 ft² | Mar. 31, 2023 USD ($) | Mar. 31, 2022 USD ($) | Dec. 31, 2022 USD ($) | |
Facility Lease | ||||
Area of property subleased | ft² | 7,585 | |||
Sublease income - related party | $ | $ 56,000 | $ 146,000 | $ 146,000 |
Commitments and Contingencies -
Commitments and Contingencies - Line of Credit (Details) $ in Millions | Aug. 31, 2015 USD ($) |
Line of credit | |
Security deposit | $ 0.1 |
Secured debt | |
Line of credit | |
Line of credit | $ 0.1 |
Related Party Transactions (Det
Related Party Transactions (Details) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||
Apr. 26, 2016 $ / shares shares | Aug. 31, 2021 ft² | Feb. 28, 2021 USD ($) $ / shares shares | Mar. 31, 2018 USD ($) $ / shares shares | Mar. 31, 2023 USD ($) | Mar. 31, 2022 USD ($) | Dec. 31, 2022 USD ($) | |
Owners of More Than 5% of Our Common Stock or Board of Directors | |||||||
Area of property subleased | ft² | 7,585 | ||||||
Sublease income - related party | $ 56,000 | $ 146,000 | $ 146,000 | ||||
Angel Pharmaceuticals | |||||||
Owners of More Than 5% of Our Common Stock or Board of Directors | |||||||
Area of property subleased | ft² | 7,585 | ||||||
Sublease income - related party | 56,000 | $ 146,000 | |||||
ICON plc | |||||||
Owners of More Than 5% of Our Common Stock or Board of Directors | |||||||
Clinical trial expense | $ 118,000 | 69,000 | |||||
Follow-on Public Offering | |||||||
Public Offerings | |||||||
Issuance of common stock | shares | 9,783,660 | 8,117,647 | |||||
Share offering price | $ / shares | $ 3.50 | $ 8.50 | |||||
Proceeds from sale of stock | $ 32,000,000 | $ 64,900,000 | |||||
Over-Allotment Option | |||||||
Public Offerings | |||||||
Issuance of common stock | shares | 502,618 | 1,212,231 | 1,058,823 | ||||
Share offering price | $ / shares | $ 15 | ||||||
Angel Pharmaceuticals | |||||||
Related Party Transactions | |||||||
Ownership interest (as percent) | 49.70% | 49.70% | |||||
Angel Pharmaceuticals | Angel Pharmaceuticals | |||||||
Related Party Transactions | |||||||
Ownership interest (as percent) | 49.70% | ||||||
Owners of More Than 5% of Our Common Stock or Board of Directors | |||||||
Internal personnel costs | $ 0 | 50,000 | |||||
Related party research service costs | 100,000 | ||||||
Third-party costs | $ 48,000 | $ 101,000 |