Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2023 | Aug. 04, 2023 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Jun. 30, 2023 | |
Entity File Number | 001-39712 | |
Entity Registrant Name | OLEMA PHARMACEUTICALS, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 30-0409740 | |
Entity Address, Address Line One | 780 Brannan Street | |
Entity Address, City or Town | San Francisco | |
Entity Address, Country | CA | |
Entity Address, Postal Zip Code | 94103 | |
City Area Code | 650 | |
Local Phone Number | 243-5555 | |
Title of 12(b) Security | Common Stock | |
Trading Symbol | OLMA | |
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 | 41,352,381 | |
Entity Central Index Key | 0001750284 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q2 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 34,958 | $ 23,702 |
Marketable securities | 132,486 | 180,719 |
Prepaid expenses and other current assets | 4,065 | 4,478 |
Total current assets | 171,509 | 208,899 |
Property and equipment, net | 1,273 | 1,480 |
Operating lease right-of-use assets | 1,938 | 2,495 |
Other assets and long-term deposits | 2,904 | 2,771 |
Total assets | 177,624 | 215,645 |
Current liabilities: | ||
Accounts payable | 1,625 | 374 |
Operating lease liabilities, current | 798 | 1,015 |
Accrued and other current liabilities | 12,408 | 15,160 |
Total current liabilities | 14,831 | 16,549 |
Operating lease liabilities, net of current portion | 1,210 | 1,550 |
Total liabilities | 16,041 | 18,099 |
Commitments and contingencies (Note 10) | ||
Stockholders' equity: | ||
Preferred stock, $0.0001 par value; 10,000,000 shares authorized as of June 30, 2023 and December 31, 2022; no shares issued and outstanding as of June 30, 2023 and December 31, 2022. | ||
Common stock, $0.0001 par value; 490,000,000 shares authorized as of June 30, 2023 and December 31, 2022; 41,324,416 and 40,601,648 shares issued as of June 30, 2023 and December 31, 2022, respectively; 41,122,482 and 40,287,097 shares outstanding as of June 30, 2023 and December 31, 2022, respectively. | 3 | 3 |
Additional paid-in capital | 419,456 | 408,333 |
Accumulated other comprehensive loss | (518) | (1,813) |
Accumulated deficit | (257,358) | (208,977) |
Total stockholders' equity | 161,583 | 197,546 |
Total liabilities and stockholders' equity | $ 177,624 | $ 215,645 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2023 | Dec. 31, 2022 |
Condensed Consolidated Balance Sheets | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, issued (in shares) | 0 | 0 |
Preferred stock, outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, authorized (in shares) | 490,000,000 | 490,000,000 |
Common stock, issued (in shares) | 41,324,416 | 40,601,648 |
Common stock, outstanding (in shares) | 41,122,482 | 40,287,097 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Operating expenses: | ||||
Research and development | $ 17,989 | $ 27,054 | $ 40,815 | $ 43,063 |
General and administrative | 3,612 | 6,239 | 10,388 | 13,484 |
Total operating expenses | 21,601 | 33,293 | 51,203 | 56,547 |
Loss from operations | (21,601) | (33,293) | (51,203) | (56,547) |
Other income (expense): | ||||
Interest income | 1,550 | 415 | 2,855 | 633 |
Other (expense) income | (44) | 20 | (33) | 26 |
Total other income | 1,506 | 435 | 2,822 | 659 |
Net loss | $ (20,095) | $ (32,858) | $ (48,381) | $ (55,888) |
Net loss per share, basic | $ (0.49) | $ (0.82) | $ (1.20) | $ (1.40) |
Net loss per share, diluted | $ (0.49) | $ (0.82) | $ (1.20) | $ (1.40) |
Weighted average shares used to compute net loss per share, basic | 40,720,294 | 39,918,219 | 40,470,041 | 39,876,650 |
Weighted average shares used to compute net loss per share, diluted | 40,720,294 | 39,918,219 | 40,470,041 | 39,876,650 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Condensed Consolidated Statements of Comprehensive Loss | ||||
Net loss | $ (20,095) | $ (32,858) | $ (48,381) | $ (55,888) |
Other comprehensive loss: | ||||
Net unrealized gain (loss) on marketable securities | 460 | (772) | 1,295 | (2,249) |
Total comprehensive loss | $ (19,635) | $ (33,630) | $ (47,086) | $ (58,137) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive (Loss) Gain | Accumulated Deficit | Total |
Balances, at Beginning of period at Dec. 31, 2021 | $ 3 | $ 388,904 | $ (149) | $ (104,190) | $ 284,568 |
Balances, at Beginning of period (in shares) at Dec. 31, 2021 | 39,797,263 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Vesting of early exercised stock options | 62 | 62 | |||
Vesting of early exercised stock options (in shares) | 13,979 | ||||
Vesting of restricted stock awards (in shares) | 98,637 | ||||
Exercise of stock options | 40 | 40 | |||
Exercise of stock options (in shares) | 33,689 | ||||
Issuance of shares under the employee stock purchase plan | 57 | 57 | |||
Issuance of shares under the employee stock purchase plan (in shares) | 30,891 | ||||
Stock-based compensation expense | 9,497 | 9,497 | |||
Employee stock purchase plan expense | 196 | 196 | |||
Net unrealized gain (loss) on marketable securities | (2,249) | (2,249) | |||
Net loss | (55,888) | (55,888) | |||
Balances, at End of period at Jun. 30, 2022 | $ 3 | 398,756 | (2,398) | (160,078) | 236,283 |
Balances, at End of period (in shares) at Jun. 30, 2022 | 39,974,459 | ||||
Balances, at Beginning of period at Mar. 31, 2022 | $ 3 | 393,933 | (1,626) | (127,220) | 265,090 |
Balances, at Beginning of period (in shares) at Mar. 31, 2022 | 39,869,325 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Vesting of early exercised stock options | 31 | 31 | |||
Vesting of early exercised stock options (in shares) | 6,990 | ||||
Vesting of restricted stock awards (in shares) | 49,319 | ||||
Exercise of stock options | 7 | 7 | |||
Exercise of stock options (in shares) | 17,934 | ||||
Issuance of shares under the employee stock purchase plan | 57 | 57 | |||
Issuance of shares under the employee stock purchase plan (in shares) | 30,891 | ||||
Stock-based compensation expense | 4,623 | 4,623 | |||
Employee stock purchase plan expense | 105 | 105 | |||
Net unrealized gain (loss) on marketable securities | (772) | (772) | |||
Net loss | (32,858) | (32,858) | |||
Balances, at End of period at Jun. 30, 2022 | $ 3 | 398,756 | (2,398) | (160,078) | 236,283 |
Balances, at End of period (in shares) at Jun. 30, 2022 | 39,974,459 | ||||
Balances, at Beginning of period at Dec. 31, 2022 | $ 3 | 408,333 | (1,813) | (208,977) | 197,546 |
Balances, at Beginning of period (in shares) at Dec. 31, 2022 | 40,287,097 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Vesting of early exercised stock options | 60 | $ 60 | |||
Vesting of early exercised stock options (in shares) | 13,980 | ||||
Vesting of restricted stock awards (in shares) | 98,637 | 98,637 | |||
Exercise of stock options | 1,552 | $ 1,552 | |||
Exercise of stock options (in shares) | 452,227 | 483,411 | |||
Issuance of shares under the employee stock purchase plan | 711 | $ 711 | |||
Issuance of shares under the employee stock purchase plan (in shares) | 270,541 | ||||
Stock-based compensation expense | 8,555 | 8,555 | |||
Employee stock purchase plan expense | 245 | 245 | |||
Net unrealized gain (loss) on marketable securities | 1,295 | 1,295 | |||
Net loss | (48,381) | (48,381) | |||
Balances, at End of period at Jun. 30, 2023 | $ 3 | 419,456 | (518) | (257,358) | 161,583 |
Balances, at End of period (in shares) at Jun. 30, 2023 | 41,122,482 | ||||
Balances, at Beginning of period at Mar. 31, 2023 | $ 3 | 413,213 | (978) | (237,263) | 174,975 |
Balances, at Beginning of period (in shares) at Mar. 31, 2023 | 40,438,320 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Vesting of early exercised stock options | 30 | 30 | |||
Vesting of early exercised stock options (in shares) | 6,990 | ||||
Vesting of restricted stock awards (in shares) | 49,319 | ||||
Exercise of stock options | 1,332 | 1,332 | |||
Exercise of stock options (in shares) | 357,312 | ||||
Issuance of shares under the employee stock purchase plan | 711 | 711 | |||
Issuance of shares under the employee stock purchase plan (in shares) | 270,541 | ||||
Stock-based compensation expense | 4,040 | 4,040 | |||
Employee stock purchase plan expense | 130 | 130 | |||
Net unrealized gain (loss) on marketable securities | 460 | 460 | |||
Net loss | (20,095) | (20,095) | |||
Balances, at End of period at Jun. 30, 2023 | $ 3 | $ 419,456 | $ (518) | $ (257,358) | $ 161,583 |
Balances, at End of period (in shares) at Jun. 30, 2023 | 41,122,482 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (48,381) | $ (55,888) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization expense | 199 | 169 |
Loss on sale of equipment | 8 | |
Non-cash lease expense | 653 | 648 |
Non-cash interest income on marketable securities | (1,972) | (26) |
Stock-based compensation expense, including employee stock purchase plan expense | 8,800 | 9,693 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 413 | 204 |
Other assets and long-term deposits | (133) | (542) |
Accounts payable | 1,251 | 97 |
Accrued and other current liabilities | (2,692) | 1,915 |
Operating lease liabilities | (653) | (632) |
Net cash used in operating activities | (42,507) | (44,362) |
Cash flows from investing activities: | ||
Purchase of equipment | (51) | |
Maturities of marketable securities | 126,260 | 205,750 |
Purchases of marketable securities | (74,760) | (150,720) |
Net cash provided by investing activities | 51,500 | 54,979 |
Cash flows from financing activities: | ||
Proceeds from exercise of stock options | 1,552 | 40 |
Proceeds from issuance of common stock under employee stock purchase plan | 711 | 57 |
Net cash provided by financing activities | 2,263 | 97 |
Net increase in cash and cash equivalents | 11,256 | 10,714 |
Cash and cash equivalents at beginning of period | 23,702 | 13,812 |
Cash and cash equivalents at end of period | $ 34,958 | $ 24,526 |
Nature of the Business and Basi
Nature of the Business and Basis of Presentation | 6 Months Ended |
Jun. 30, 2023 | |
Nature of the Business and Basis of Presentation | |
Nature of the Business and Basis of Presentation | 1. Nature of the Business and Basis of Presentation Olema Pharmaceuticals, Inc. (“Olema” or the “Company”) is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of next-generation targeted therapies for women’s cancers. The Company is initially focused on developing therapies for the treatment of breast cancer. The Company’s wholly-owned, lead product candidate, palazestrant (OP-1250), is a novel oral therapy with combined activity as both a complete estrogen receptor (“ER”) antagonist (“CERAN”) and a selective ER degrader (“SERD”). It is currently being evaluated as a single agent in an ongoing Phase 2 clinical study, and in Phase 1b/2 clinical studies in combination with palbociclib, ribociclib, and alpelisib, in patients with recurrent, locally advanced or metastatic estrogen receptor-positive (“ER+”), human epidermal growth factor receptor 2 negative (“HER2-”) breast cancer. We expect to initiate in the fourth quarter of 2023 Olema’s first pivotal Phase 3 clinical trial, called OPERA-01, testing palazestrant as a monotherapy in second- and third-line metastatic breast cancer. The Company is located in San Francisco, California and was incorporated in Delaware on August 7, 2006, under the legal name of CombiThera, Inc. and on March 25, 2009, was renamed Olema Pharmaceuticals, Inc. The Company’s principal operations are based in San Francisco, California, and has operations in Cambridge, Massachusetts. Olema Oncology Australia Pty Ltd was incorporated on January 6, 2021, and is a wholly-owned subsidiary of the Company (collectively with Olema Pharmaceuticals, Inc., referred to as “Olema” or the “Company” herein). It operates in one business segment and therefore has only one reportable segment. The Company is subject to risks and uncertainties common to early-stage companies in the biopharmaceutical industry, including, but not limited to, successful discovery and development of its product candidates, development by competitors of new technological innovations, dependence on key personnel, the ability to attract and retain qualified employees, protection of proprietary technology, compliance with governmental regulations, the impact of geopolitical and macroeconomic events, such as the COVID-19 pandemic, ongoing conflict between Ukraine and Russia and related sanctions, recent and potential future bank failures and financial instability, the ability to secure additional capital to fund operations and commercial success of its product candidates. Palazestrant and any future product candidates the Company may develop will require extensive nonclinical and clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel, and infrastructure and extensive compliance-reporting capabilities. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales. Liquidity The Company had $167.4 million of cash, cash equivalents and marketable securities at June 30, 2023, which management believes is sufficient to fund its operating expenses and capital expenditure requirements into the second quarter of 2025. Impact of Geopolitical and Macroeconomic Events Global economic and business activities continue to face widespread geopolitical and macroeconomic uncertainties, including labor shortages, inflation and monetary supply shifts, bank failures and related financial market risks and instability, recession risks, as well as potential disruptions from the Russia-Ukraine conflict, which has resulted in volatility in the U.S. and global financial markets and which has led to, and may continue to lead to, additional disruptions to trade, commerce, pricing stability, credit availability and supply chain continuity globally. The extent of the impact of these factors on the Company’s operational and financial performance, including its ability to execute its business strategies and initiatives in the expected time frame, will depend on future developments, which are uncertain and cannot be predicted. Any continued or renewed disruption resulting from these factors could negatively impact the Company’s business. The Company continues to monitor the impact of these geopolitical and macroeconomic factors on its results of operations, financial condition and cash flows. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2023 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation and Consolidation The accompanying interim unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”) and applicable rules and regulations of the Securities and Exchange Commission (the “SEC”) regarding interim financial reporting, and the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. These condensed consolidated financial statements include the accounts of Olema Pharmaceuticals, Inc. and its wholly-owned subsidiary, Olema Oncology Australia Pty Ltd. All intercompany balances and transactions have been eliminated upon consolidation. Unaudited Interim Financial Information The interim condensed consolidated balance sheet as of June 30, 2023, and the statements of operations and comprehensive loss, and stockholders’ equity for the three and six months ended June 30, 2023 and 2022, and the statements of cash flows for the six months ended June 30, 2023 and 2022 are unaudited. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the annual financial statements and reflect, in the opinion of management, all adjustments of a normal and recurring nature that are necessary for the fair presentation of the Company’s condensed consolidated financial statements included in this report. The financial data and the other information disclosed in these notes to the condensed consolidated financial statements related to the three- and six-month periods are also unaudited. The results of operations presented in these unaudited condensed consolidated financial statements are not necessarily indicative of the results to be expected for the year ending December 31, 2023, or for any other future annual or interim period. The condensed consolidated balance sheet as of December 31, 2022 included herein was derived from the audited financial statements as of that date. These interim condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements included in the Company’s Form 10-K as filed with the SEC on March 9, 2023 (the “Annual Report”). Use of Estimates The accompanying condensed consolidated financial statements are prepared in accordance with GAAP. The preparation of the condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the condensed consolidated financial statements and reported amounts of expenses during the reporting period. Significant areas that require management’s estimates include accruals of research and development expenses, including accrual of research contract costs, stock-based compensation assumptions, including the fair value of common stock. On an ongoing basis, the Company evaluates its estimates and judgments, which are based on historical and anticipated results and trends and on various other assumptions that management believes to be reasonable under the circumstances. Actual results could differ from those estimates. Cash and Cash Equivalents Cash and cash equivalents are defined as short-term, highly liquid investments with original maturities of 90 days or less at the date of purchase. Cash deposits are all in reputable financial institutions in the United States as of June 30, 2023, and December 31, 2022. Cash and cash equivalents consisted of cash on deposit with U.S. banks, including the Company’s bank account for its Australia subsidiary, denominated in U.S. dollars and Australian dollars and investments in interest bearing money market funds. Marketable Securities All marketable securities have been classified as “available-for-sale” and are carried at estimated fair value as determined based upon quoted market prices or pricing models for similar securities. Management determines the appropriate classification of its investments at the time of purchase and reevaluates such designation as of each balance sheet date. Unrealized gains and losses are excluded from net loss and are reported as a component of comprehensive loss. Realized gains and losses and declines in fair value judged to be other than temporary, if any, on available-for-sale securities are included in interest income. The cost of securities sold is based on the specific-identification method. Interest earned on marketable securities is included in interest income. The Company periodically assesses its available-for-sale marketable securities for other-than-temporary impairment. For debt securities in an unrealized loss position, the Company first considers its intent to sell, or whether it is more likely than not that the Company will be required to sell the debt securities before recovery of their amortized cost basis. If either of these criteria are met, the amortized cost basis of such debt securities is written down to fair value through other expense. For debt securities in an unrealized loss position that do not meet the aforementioned criteria, the Company assesses whether the decline in the fair value of such debt securities has resulted from credit losses or other factors. The Company considers the extent to which fair value is less than amortized cost, any changes to the rating of the security by a rating agency, and any adverse conditions specifically related to the securities, among other factors. If this assessment indicates that a credit loss may exist, the Company then compares the present value of cash flows expected to be collected from such securities to their amortized cost basis. If the present value of cash flows expected to be collected is less than the amortized cost basis, a credit loss exists and an allowance for credit losses is recorded through other expense, limited by the amount that the fair value is less than the amortized cost basis. Any additional impairment not recorded through an allowance for credit losses is recognized in other comprehensive loss. The Company has not recorded any impairments for its marketable securities. Concentration of Credit Risk and Other Risks and Uncertainties Financial instruments that potentially subject the Company to concentration of credit risk consist of cash, cash equivalents, and marketable securities. The Company invests in a variety of financial instruments and, by its policy, limits these financial instruments to high credit quality securities issued by the U.S. government, U.S. government-sponsored agencies and highly rated banks and corporations, subject to certain concentration limits. The Company’s cash, cash equivalents, and marketable securities are held by financial institutions in the United States that management believes are of high credit quality. Amounts on deposit with individual banking institutions may at times exceed the limits insured by the Federal Deposit Insurance Corporation (“FDIC”); however, the Company has not experienced any losses on such deposits. The Company’s future results of operations involve a number of other risks and uncertainties. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, uncertainty of results of clinical trials and reaching milestones, uncertainty of regulatory approval of the Company’s current and potential future product candidates, uncertainty of market acceptance of the Company’s product candidates, competition from substitute products and larger companies, securing and protecting proprietary technology, strategic relationships, dependence on key individuals or sole-source suppliers, and geopolitical and macroeconomic factors. The Company’s product candidates require approvals from the U.S. Food and Drug Administration (“FDA”) and comparable foreign regulatory agencies prior to commercial sales in their respective jurisdictions. There can be no assurance that any product candidates will receive the necessary approvals. If the Company were denied approval, approval was delayed or the Company was unable to maintain approval for any product candidate, it could have a materially adverse impact on the Company. Leases The Company adopted Accounting Standard Update (“ASU”) 2016-12, Leases At the inception of an arrangement, the Company determines if an arrangement is, or contains, a lease based on the facts and circumstances present in that arrangement. Lease classification, recognition, and measurement are then determined at the lease commencement date. For arrangements that contain a lease, the Company (i) identifies lease and non-lease components, (ii) determines the consideration in the contract, (iii) determines whether the lease is an operating or finance lease; and (iv) recognizes lease ROU assets and liabilities. Lease liabilities and their corresponding ROU assets are recorded based on the present value of future lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not readily determinable and as such, the Company uses the incremental borrowing rate based on the information available at the lease commencement date, which represents an internally developed rate that would be incurred to borrow, on a collateralized basis, over a similar term, an amount equal to the lease payments in a similar economic environment. Most leases include options to renew and, or terminate the lease, which can impact the lease term. The exercise of these options is at the Company’s discretion. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise such options. For any lease modification, the Company reassesses the lease classification, remeasures the related lease liability using an updated discount rate that reflects the modified lease term, and adjusts the related ROU asset under the lease modification guidance under Topic 842. The Company has operating leases for its research and development and office facilities. Fixed lease payments on operating leases are recognized over the expected term of the lease on a straight-line basis. Variable lease expenses that are not considered fixed are recognized as incurred. Fixed and variable lease expense on operating leases is recognized within operating expenses within our condensed consolidated statements of operations and comprehensive loss. The Company elected to not apply the recognition requirements of Topic 842 to short-term leases with terms of 12 months or less. Additional information and disclosures required by Topic 842 are contained in Note 11 “Lease” in the Annual Report. Research and Development Costs Research and development costs are expensed as incurred. Research and development expenses consist of costs incurred to discover, research and develop product candidates. These costs are recorded within research and development expenses in the condensed consolidated statements of operations and include personnel expenses, stock-based compensation expenses, allocated general and administrative expenses, and external costs including fees paid to consultants and contract research organizations (“CROs”) and contract manufacturing organizations (“CMOs”), in connection with nonclinical studies and clinical trials, and other related clinical trial fees, such as for investigator fees, patient screening, laboratory work, clinical trial database management, clinical trial material management and statistical compilation and analysis. Non-refundable prepayments for goods or services that will be used or rendered for future research and development activities are recorded as prepaid expenses and other current assets. Such amounts are recognized as an expense as the goods are delivered or the related services are performed. Costs incurred in obtaining technology licenses that do not meet the definition of a business are charged immediately to research and development expense if the technology licensed has not reached technological feasibility and has no alternative future uses. Reimbursements of certain costs associated with research activities performed under the agreement with Novartis Institutes for BioMedical Research, Inc. (“Novartis”) are recorded as a reduction of research and development expenses and as a receivable due from Novartis, which is recorded under prepaid expenses and other current assets in the accompanying condensed consolidated financial statements, as described in Note 10, Commitments and Contingencies – Clinical Collaboration and Supply Agreement. Research Contract Costs and Accruals The Company has from time to time entered into various research and development and other agreements with commercial firms, researchers, universities and others for provisions of goods and services. These agreements are generally cancelable, and the related costs are recorded as research and development expenses as incurred. The Company records accruals for estimated ongoing research and development costs. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the projects, studies or clinical trials, including the phase or completion of events, invoices received and contracted costs. Judgments and estimates are made in determining the accrued balances at the end of any reporting period. Actual results could differ materially from the Company’s estimates. The Company’s historical accrual estimates have not been materially different from the actual costs. Net Loss Per Common Share Basic net loss per common share is computed by dividing the net loss per common share by the weighted average number of common shares outstanding for the period without consideration of common stock equivalents. Diluted net loss per common share is computed by adjusting net loss to reallocate undistributed earnings based on the potential impact of dilutive securities, and by dividing the diluted net loss by the weighted average number of common shares outstanding for the period, including potential dilutive common shares. For purpose of this calculation, outstanding stock options, including unvested early exercised options, unvested restricted stock awards, unvested performance-based restricted stock unit awards, contingently issuable common stock related to the 2020 Employee Stock Purchase Plan (the “ESPP”) are considered potential dilutive common shares. Since the Company was in a loss position for all periods presented, basic net loss per share is the same as diluted net loss per share for all periods as the inclusion of all potential common shares outstanding would have been anti-dilutive. Recent Accounting Pronouncements There were no new accounting pronouncements that were relevant to the Company as of and for the six months ended June 30, 2023. |
Fair Value Measurement
Fair Value Measurement | 6 Months Ended |
Jun. 30, 2023 | |
Fair Value Measurement | |
Fair Value Measurement | 3. Fair Value Measurement The Company assesses the fair value of financial instruments based on the provisions of ASC 820, Fair Value Measurements ● Level 1 — Inputs are unadjusted quoted prices in active markets for identical assets or liabilities accessible to the reporting entity at the measurement date. ● Level 2 — Inputs other than quoted prices included in Level 1 that are observable for the asset or liability, 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 that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. June 30, 2023 (in thousands) Level 1 Level 2 Level 3 Total Financial Assets Cash $ 6,123 $ — $ — $ 6,123 Money market funds 28,919 — — 28,919 Commercial paper — 67,314 — 67,314 U.S. government treasury bills 36,074 — — 36,074 Government-sponsored enterprise securities — 29,098 — 29,098 Total $ 71,116 $ 96,412 $ — $ 167,528 June 30, 2023 Gross Gross Amortized Unrealized Unrealized Estimated (in thousands) Cost Gains Losses Fair Value Financial Assets Cash and cash equivalents $ 35,042 $ — $ — $ 35,042 Short-term marketable securities (<12 months to maturity) 133,004 16 (534) 132,486 Total $ 168,046 $ 16 $ (534) $ 167,528 The Company considers its marketable securities with maturities beyond one year as current assets, based on their highly liquid nature and because such marketable securities represent the investment of cash that is available for current operations. The Company considers its investment portfolio of marketable securities to be available-for-sale. As of June 30, 2023, the Company does not have any marketable securities with maturities beyond one year. The Company periodically reviews its available-for-sale marketable securities for other-than-temporary impairment. The Company considers factors such as the duration, severity and the reason for the decline in value, the potential recovery period and its intent to sell. For debt securities, the Company also considers whether (i) it is more likely than not that the Company will be required to sell the debt securities before recovery of their amortized cost basis, and (ii) the amortized cost basis cannot be recovered as a result of credit losses. There were 14 marketable securities that have been in a consecutive loss position for more than 12 months as of June 30, 2023. These marketable securities had $0.5 million unrealized losses with a fair value of $39.0 million as of June 30, 2023. The Company does not believe that the total unrealized losses of $0.5 million as of June 30, 2023 are credit-related but are rather a reflection of current market yields and/or current marketplace bid/ask spreads. During the three and six months ended June 30, 2023, the Company did not recognize any other-than-temporary impairment loss. As of June 30, 2023, there was no allowance for losses on available-for-sale debt securities attributable to credit risk. As of June 30, 2023, all of the Company’s cash and cash equivalents consisted of cash on deposit with U.S. banks denominated in U. S. dollars and Australian dollars. |
Property and Equipment, net
Property and Equipment, net | 6 Months Ended |
Jun. 30, 2023 | |
Property and Equipment, net | |
Property and Equipment, net | 4. Property and Equipment, net Property and equipment, net consisted of the following (in thousands): June 30, December 31, 2023 2022 Lab equipment $ 1,958 $ 2,002 Computer equipment 59 59 Property and equipment, gross 2,017 2,061 Less: Accumulated depreciation (744) (581) Property and equipment, net $ 1,273 $ 1,480 |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 6 Months Ended |
Jun. 30, 2023 | |
Prepaid Expenses and Other Current Assets | |
Prepaid Expenses and Other Current Assets | 5. Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consisted of the following (in thousands): June 30, December 31, 2023 2022 Reimbursable research and development costs from a collaboration partner $ 1,825 $ 1,387 Prepaid insurance 804 1,738 Research and development tax incentive credit receivable 401 — Prepaid subscriptions and licenses 295 399 Prepaid clinical development costs 282 506 Interest receivable 221 319 Other 237 129 Total $ 4,065 $ 4,478 |
Accrued and Other Current Liabi
Accrued and Other Current Liabilities | 6 Months Ended |
Jun. 30, 2023 | |
Accrued and Other Current Liabilities | |
Accrued and Other Current Liabilities | 6. Accrued and Other Current Liabilities Accrued and other current liabilities consisted of the following (in thousands): June 30, December 31, 2023 2022 Accrued research and development related costs $ 9,026 $ 9,105 Accrued employee bonuses 1,926 4,518 Accrued professional fees 982 1,091 Accrued payroll related costs 362 296 Accrued taxes 91 68 Early exercise of unvested stock options 21 82 Total $ 12,408 $ 15,160 |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2023 | |
Stock-Based Compensation | |
Stock-Based Compensation | 7. Stock-Based Compensation In 2014, the Company’s Board of Directors (the “Board”) and stockholders approved and adopted the Company’s 2014 Stock Plan (the “2014 Plan”). The 2014 Plan permitted the grant of options and restricted stock awards (including restricted stock purchase rights and restricted stock bonus awards). The 2014 Plan was terminated on the date the Company’s 2020 Equity Incentive Plan (the “2020 Plan”), which is described below, became effective, and since that date, no additional awards have been or will be made pursuant to the 2014 Plan. However, any outstanding awards granted under the 2014 Plan will remain outstanding, subject to the terms of the 2014 Plan award agreements, until such outstanding options are exercised or until any awards terminate or expire by their terms. In 2020, the Board and the Company’s stockholders approved and adopted the 2020 Plan. The 2020 Plan permits the grant of options, restricted stock awards, stock appreciation rights, restricted stock unit awards, performance awards, and other awards. The maximum number of shares of common stock that may be issued under the 2020 Plan will not exceed 6,494,510 shares of the Company’s common stock, which is the sum of (i) 2,152,080 new shares, plus (ii) an additional number of shares not to exceed 4,342,430 shares, consisting of any shares of the Company’s common stock subject to outstanding stock options or other stock awards granted under the 2014 Plan that, on or after the 2020 Plan becomes effective, terminate or expire prior to exercise or settlement; are not issued because the award is settled in cash; are forfeited because of the failure to vest; or are reacquired or withheld (or not issued) to satisfy a tax withholding obligation or the purchase or exercise price. In addition, the number of shares of the Company’s common stock reserved for issuance under the 2020 Plan automatically increases on January 1 of each year for a period of ten years, beginning on January 1, 2021 and continuing through January 1, 2030, in an amount equal to the lesser of (1) 5% of the total number of shares of the Company’s common stock outstanding on December 31 of the immediately preceding year, or (2) a lesser number of shares determined by the Company’s Board of Directors no later than December 31 of the immediately preceding year. In 2022, the Board approved and adopted the Company’s 2022 Inducement Plan (the “2022 Inducement Plan”). Under the 2022 Inducement Plan, initially 2,000,000 shares of common stock were reserved for issuance. The 2022 Inducement Plan permits the grant of options, restricted stock awards, stock appreciation rights, restricted stock unit awards, performance awards, and other awards. The exercise price for each option and stock appreciation right shall be established at the discretion of the Board, provided that the exercise price of a stock option will not be less than 100% of the fair market value of the Company’s common stock on the date of grant. Specific vesting for stock options and stock appreciation rights is service related and determined in each award agreement, where stock options and stock appreciation rights are fully vested at the grant date or follow a graded vesting schedule. Stock options and stock appreciation rights granted under the plans generally expire ten years after the date of grant. Stock Option Valuation The fair value of stock option grants is estimated using the Black-Scholes option-pricing model. The Company lacks company-specific historical and implied volatility information. Therefore, it estimated its expected stock volatility based on the historical volatility of a publicly traded set of peer companies in addition to its own historical volatility. For options with service-based vesting conditions, the expected term of the Company’s stock options has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options. The expected term of stock options granted to nonemployees is equal to the contractual term of the option award. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is 0% since the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future. The assumptions that the Company used to determine the estimated grant-date fair value of stock options granted to employees and directors under the 2020 Plan and the 2022 Inducement Plan were as follows, presented as a weighted average: Six Months Ended June 30, 2023 2022 Risk-free interest rate 3.52% 1.81% Expected term (in years) 6.02 6.02 Expected volatility 86.88% 79.33% Expected dividend yield — — Stock Option Activity The following table summarizes the stock option activity under the 2014 Plan, the 2020 Plan and the 2022 Inducement Plan: Weighted Weighted Average Average Remaining Number of Exercise Contractual Aggregate Shares Price Term Intrinsic Value (in years) (in thousands) Outstanding as of December 31, 2022 8,384,858 $ 8.59 8.30 $ 262 Granted 2,234,718 4.98 — — Exercised(1) (483,411) 3.77 — — Forfeited (859,447) 5.62 — — Outstanding as of June 30, 2023(2) 9,276,718 $ 8.26 7.98 $ 31,572 Options vested and exercisable as of June 30, 2023 4,203,758 $ 10.05 7.18 $ 13,179 Options expected to vest as of June 30, 2023 5,072,960 $ 6.77 8.63 $ 18,305 (1) Exercised amount includes vesting of early-exercised options and shares returned for taxes withheld for exercise and net transactions. (2) Balance as of June 30, 2023 includes 4,660 unvested early-exercised stock options. Early Exercise of Stock Options The terms of the 2014 Plan permit certain option holders to exercise options before their options are vested, subject to certain limitations. The early exercised options are subject to the same vesting provisions in the original stock option awards. Shares issued as a result of early exercise that have not vested are subject to repurchase by the Company upon termination of the purchaser’s employment, at the price paid by the purchaser. Such shares are not deemed to be outstanding for accounting purposes until they vest and are therefore excluded from shares outstanding and from basic and diluted net loss per share until the repurchase right lapses and the shares are no longer subject to the repurchase feature. A liability is recognized related to the cash proceeds of the unvested options and is reclassified into common stock and additional paid-in capital as the shares vest and the repurchase right lapses. Accordingly, the Company has recorded the unvested portion of the exercise proceeds of less than $0.1 million in other current liabilities as of June 30, 2023. Restricted Stock Awards The following table summarizes the restricted stock activity under the 2014 Plan during the six months ended June 30, 2023: Number of Shares Grant Date Fair Value Unvested restricted stock as of December 31, 2022 295,911 $ 2.40 Granted — — Vested (98,637) 2.40 Forfeited — — Unvested restricted stock as of June 30, 2023 197,274 $ 2.40 Performance-Based Restricted Stock Unit Awards In November 2022, the Company granted to certain employees 710,000 shares of performance-based restricted stock unit awards (the “PSUs”) under the 2020 Plan as consideration for services subject to performance conditions with a fair value based on the closing price of the underlying common stock on the date of grant. Pursuant to the terms of the PSUs, 65% of each PSU vests upon certification by the Compensation Committee of the Company of achieving a pre-determined performance goal by June 30, 2024, and 35% of each PSU vests upon certification by the Compensation Committee of the Company of achieving a pre-determined performance goal by June 30, 2024. Expense recognition for PSUs commences when it is determined that attainment of the performance goal is probable or met. As of June 30, 2023, it was determined that the performance goals were not yet met, and therefore, the Company recorded zero stock-based compensation expense related to the PSUs for the three and six months ended June 30, 2023. 2020 Employee Stock Purchase Plan In 2020, the Board and the Company’s stockholders approved and adopted the ESPP. The ESPP permits eligible employees who elect to participate in an offering under the ESPP to have up to 15% of their eligible earnings withheld, subject to certain limitations, to purchase shares of common stock pursuant to the ESPP. The price of the common stock purchased under the ESPP is equal to the lesser of (i) 85% of the fair market value of a share of the Company’s common stock on the first day of an offering; or (ii) 85% of the fair market value of a share of the Company’s common stock on the date of purchase. Each offering period is not to exceed 27 months and will include one or more purchase periods (each a “Purchase Period”) as approved by the Board in the offering. The current offering period will consist of two (2) six-month Purchase Periods during which payroll deductions of the participants are accumulated under the ESPP. A total of 430,416 shares of common stock were initially reserved for issuance pursuant to the ESPP. The ESPP is a compensatory plan as defined by the authoritative guidance for stock-based compensation. The Company uses the Black-Scholes option-pricing model to estimate the fair value of stock offered under the ESPP. Stock-based compensation expense related to the ESPP was $0.1 million and $0.2 million for the three and six months ended June 30, 2023, respectively. Stock-Based Compensation Expense Stock-based compensation expense related to awards granted under the 2014 Plan, the 2020 Plan, the ESPP and the 2022 Inducement Plan was classified in the condensed consolidated statements of operations and comprehensive loss as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 Research and development $ 2,969 $ 3,211 $ 6,057 $ 6,278 General and administrative 1,201 1,517 2,743 3,415 Total $ 4,170 $ 4,728 $ 8,800 $ 9,693 |
Net Loss Per Share
Net Loss Per Share | 6 Months Ended |
Jun. 30, 2023 | |
Net Loss Per Share | |
Net Loss Per Share | 8. Net Loss Per Share Net Loss Per Share Basic and diluted net loss per share was calculated as follows (in thousands, except share and per share amounts): Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 Numerator: Net loss $ (20,095) $ (32,858) $ (48,381) $ (55,888) Denominator: Weighted average shares used to compute net loss per share, basic and diluted 40,720,294 39,918,219 40,470,041 39,876,650 Net loss per share, basic and diluted $ (0.49) $ (0.82) $ (1.20) $ (1.40) The potentially dilutive shares that were excluded from the calculation of diluted net loss per share because their effect would have been anti-dilutive for the periods presented are as follows: June 30, 2023 2022 Unvested restricted stock awards outstanding 197,274 394,548 Unvested performance-based restricted stock unit awards outstanding 710,000 — Options to purchase common stock 9,276,718 8,425,053 Employee stock purchase plan contingently issuable 22,749 70,477 10,206,741 8,890,078 Included in the potentially dilutive options to purchase common stock for the three and six months ended June 30, 2023 and June 30, 2022 are 4,660 unvested stock options that were early exercised in September 2020 (see Note 7, “Stock-Based Compensation”). The Company determined the early exercises to be non-substantive as the shares were subject to repurchase rights. Accordingly, the Company has excluded these shares from the calculation of basic and diluted net loss per share for the three and six months ended June 30, 2023 and 2022. |
Leases
Leases | 6 Months Ended |
Jun. 30, 2023 | |
Leases | |
Leases | 9. Leases The Company leases certain of its facilities under non-cancellable operating leases expiring at various dates through 2026. On June 1, 2013, the Company entered into a management services agreement with MandalMed, Inc. (the “MandalMed Services Agreement”) to have access to and use a portion of approximately 5,762 square feet of space for the use of laboratory benches, lab equipment, office space, and administrative and facilities services. The Company subsequently entered into six amendments to extend the agreement term to November 2023. As part of the sixth amendment, the Company gained access to use additional space of approximately 2,130 square feet for a three year period commencing on December 1, 2020 and ending on November 30, 2023. According to the terms of the MandalMed Services Agreement, the Company paid a security deposit of less than $0.1 million and is required to pay monthly rent and common area charges. On August 27, 2020, the Company entered into a lease agreement with 512 2nd Street LLC to lease approximately 3,500 square feet of office space in San Francisco, California (the “Office Space Lease Agreement”). The Office Space Lease Agreement is for a period of two years commencing on September 1, 2020 and ending August 31, 2022. In April 2022, the Company extended the Office Space Lease Agreement up to August 31, 2023 and has one year renewal option to extend the term up to August 31, 2024 On December 15, 2020, the Company entered into a lease agreement with Tennieh LLC to lease approximately 9,800 square feet of office space in San Francisco, California (the “Laboratory Lease Agreement”). The Laboratory Lease Agreement is for a period of five years commencing approximately February 1, 2021 and ending January 31, 2026. According to the terms of the Laboratory Lease Agreement, the Company paid a $0.4 million security deposit and is required to pay monthly rent and common area charges. The following table summarizes total lease expense during the three and six months ended June 30, 2023 (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2023 2023 Straight-line operating lease expense $ 326 $ 653 Short-term lease expense 53 106 Variable lease expense 10 20 Total operating lease expense $ 389 $ 779 The following table summarizes supplemental cash flow information during the three and six months ended June 30, 2023 (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2023 2023 Cash paid for amounts included measurement of lease liabilities: Operating cash flows from operating leases $ 327 $ 653 The following table summarizes the Company’s future minimum lease payments and reconciliation of lease liabilities as of June 30, 2023 (in thousands): Years Ending December 31, 2023 (from July 2023) $ 531 2024 799 2025 822 2026 69 Total future minimum lease payments 2,221 Less: Interest (213) Total lease liabilities at present value 2,008 Lease liabilities, current 798 Lease liabilities, non-current $ 1,210 The following table summarizes lease term and discount rate as of June 30, 2023: June 30, 2023 Weighted-average remaining lease term (years) 2.43 Weighted-average discount rate 8.69% |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2023 | |
Commitments and Contingencies. | |
Commitments and Contingencies | 10. Commitments and Contingencies Clinical Collaboration and Supply Agreement On July 22, 2020, the Company entered into a non-exclusive clinical collaboration and supply agreement with Novartis Institutes for BioMedical Research, Inc. (“Novartis”) and on January 13, 2022, the Company entered into the amended and restated clinical collaboration and supply agreement with Novartis (as amended and restated, the “Novartis Agreement”). The collaboration is focused on the evaluation of the safety, tolerability and efficacy of palazestrant in combination with Novartis’ proprietary CDK4/6 inhibitor Kisqali® (ribociclib) and/or Novartis’ proprietary phosphatidylinositol 3-kinase (“PI3K a The Company is responsible for manufacturing, packaging and labeling palazestrant, and for packaging and labeling all drugs used in the clinical trials for the combined therapies (other than the Novartis Study Drugs). Novartis is responsible for manufacturing and delivering to the Company the Novartis Study Drugs in such quantities as reasonably needed for the clinical trials for the combined therapies. In accordance with an agreed budget, subject to certain thresholds, Novartis will reimburse the Company for a majority of the direct outside costs that the Company incurs related to conducting the activities under the agreed development plan in conducting the clinical trials for the combined therapies. The Novartis Agreement will terminate upon completion of all activities outlined in the development plan and the relevant protocols. Either party may terminate the Novartis Agreement for the uncured material breach or insolvency of the other party, if it reasonably deems it necessary in order to protect the safety, health or welfare of subjects enrolled in the clinical trials for the combined therapies due to the existence of a material safety issue, or in certain circumstances for an unresolved clinical hold with respect to either the Novartis Study Drugs or palazestrant. In addition, Novartis may terminate the Novartis Agreement if certain disputes between the parties are not resolved after following the applicable dispute resolution procedures, and the Company may terminate the Novartis Agreement in the event the Company terminates all clinical trials of the combined therapies other than due to a material safety issue or upon a clinical hold. Costs associated with research activities performed under the agreement are included in research and development expenses in the accompanying condensed consolidated financial statements, with any reimbursable costs from Novartis reflected as a reduction of such expenses. For the three and six months ended June 30, 2023, costs reimbursable from Novartis were $0.8 million and $1.4 million, respectively. As of June 30, 2023, the receivable due from Novartis was $1.8 million, which is recorded under prepaid expenses and other current assets in the accompanying condensed consolidated balance sheets. Clinical Trial Agreement In November 2020, the Company entered into a non-exclusive clinical trial agreement with Pfizer Inc. (“Pfizer”) (the “Pfizer Agreement”), to evaluate the safety and tolerability of palazestrant in combination with Pfizer’s proprietary CDK4/6 inhibitor IBRANCE® (palbociclib) in patients with recurrent, locally advanced or metastatic ER+, HER2 breast cancer in a clinical trial. Under the terms of the non-exclusive agreement, the Company will be responsible for conducting the clinical trial for the combined therapies and Pfizer is responsible for supplying IBRANCE® to the Company at no cost to the Company. As part of the collaboration, the parties granted to each other a non-exclusive, royalty-free license under certain of the parties’ respective patent rights in the combination of IBRANCE® and palazestrant to use the parties’ respective study drugs in research and development, solely to the extent reasonably needed for the other party’s activities in the collaboration. All inventions and data developed in the performance of the clinical trials for the combined therapies (other than those specific to each component study drug), will be jointly owned by the parties. The Company is responsible for manufacturing, packaging and labeling palazestrant, and for packaging and labeling all drugs used in the clinical trials for the combined therapies (other than IBRANCE®). Pfizer is responsible for manufacturing and delivering to us IBRANCE® in such quantities as reasonably needed for the clinical trials for the combined therapies. The Pfizer Agreement will terminate upon completion of all activities outlined in the study plan and the relevant protocols. Either party may terminate the Pfizer Agreement for the uncured material breach or insolvency of the other party, if it reasonably deems it necessary in order to protect the safety, health or welfare of subjects enrolled in the clinical trials for the combined therapies due to the existence of a material safety issue, or in certain circumstances for an unresolved clinical hold with respect to either the IBRANCE® or palazestrant. In addition, either party may terminate the Pfizer Agreement if certain disputes between the parties are not resolved after following the applicable dispute resolution procedures or if either party determines to discontinue clinical development for medical, scientific, legal or other reasons. The Pfizer Agreement does not grant any right of first negotiation to participate in future clinical trials, and each of the parties retains all rights and ability to evaluate their respective compounds. Costs incurred in connection to the Pfizer Agreement are included in the research and development expense in the accompanying condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2023, and 2022. License Agreement In June 2022, the Company entered into an exclusive global license agreement with Aurigene Discovery Technologies Limited (“Aurigene”) to research, develop and commercialize novel small molecule inhibitors of an undisclosed oncology target (“the Aurigene Agreement”). Under the terms of the Aurigene Agreement, Aurigene will provide to the Company an exclusive license to its portfolio of novel small molecule inhibitors of the target. Financial terms of the Aurigene Agreement include a $8.0 million upfront payment for rights to a pre-existing Aurigene program and potential future milestone payments of up to $60.0 million in clinical development and regulatory milestones, and up to $370.0 million in commercial milestones. Aurigene is also eligible to receive mid-single digits to the low double digits royalties on product sales, if any. During the research term, the Company will contribute funding to Aurigene to facilitate Aurigene’s ongoing discovery efforts. The Company and Aurigene will jointly direct further preclinical work and, if successful, the Company will lead clinical development as well as regulatory and commercial activities. The Company and Aurigene jointly own collaboration compounds and rights to any inventions made during the research term. The term of the Aurigene Agreement will continue until the expiration of the last-to-expire of all payment obligations with respect to all licensed products thereunder, unless terminated earlier in accordance with the terms of the Aurigene Agreement. The Aurigene Agreement may be terminated (a) by the Company for convenience, in its sole discretion, upon prior written notice to Aurigene, (b) by either the Company or Aurigene in connection with the other party’s uncured material breach or (c) by either the Company or Aurigene in connection with the insolvency of the other party. The $8.0 million upfront payment was incurred in June 2022 and recorded as research and development expense in the accompanying condensed consolidated statements of operations and comprehensive loss. Costs incurred and milestones payments due to Aurigene prior to regulatory approval are recognized as research and development expenses in the period incurred. Payments due to Aurigene upon or subsequent to regulatory approval will be accrued as a provision to cost of sales in the period when achievement of respective milestone target is probable. As of June 30, 2023, it was determined that it is not probable to achieve any of the milestone target, and therefore, the Company recorded zero expense related to the milestone for the three and six months ended June 30, 2023. Management Services Agreements The Company conducts research and development programs internally and through third parties that include, among others, arrangements with vendors, consultants, CMOs, and CROs. The Company has contractual arrangements in the normal course of business with these parties, however, the contracts with these parties are cancelable generally on reasonable notice within one year and the Company’s obligations under these contracts are primarily based on services performed through termination dates plus certain cancelation charges, if any, as defined in each of the respective agreements. In addition, these agreements may, from time to time, be subjected to amendments as a result of any change orders executed by the parties. As of June 30, 2023, the Company did not have material contractual commitments with respect to these arrangements. Contingencies From time to time, the Company may have certain contingent liabilities that arise in the ordinary course of business. The Company accrues a liability for such matters when it is probable that future expenditures will be made, and such expenditures can be reasonably estimated. For all periods presented, the Company was not a party to any pending material litigation or other material legal proceedings. Indemnification Agreements In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with members of its Board and executive officers that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited. As of June 30, 2023, and December 31, 2022, the Company had not incurred any material costs as a result of such indemnifications. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2023 | |
Summary of Significant Accounting Policies | |
Basis of Presentation and Consolidation | Basis of Presentation and Consolidation The accompanying interim unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”) and applicable rules and regulations of the Securities and Exchange Commission (the “SEC”) regarding interim financial reporting, and the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. These condensed consolidated financial statements include the accounts of Olema Pharmaceuticals, Inc. and its wholly-owned subsidiary, Olema Oncology Australia Pty Ltd. All intercompany balances and transactions have been eliminated upon consolidation. |
Unaudited Interim Financial Information | Unaudited Interim Financial Information The interim condensed consolidated balance sheet as of June 30, 2023, and the statements of operations and comprehensive loss, and stockholders’ equity for the three and six months ended June 30, 2023 and 2022, and the statements of cash flows for the six months ended June 30, 2023 and 2022 are unaudited. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the annual financial statements and reflect, in the opinion of management, all adjustments of a normal and recurring nature that are necessary for the fair presentation of the Company’s condensed consolidated financial statements included in this report. The financial data and the other information disclosed in these notes to the condensed consolidated financial statements related to the three- and six-month periods are also unaudited. The results of operations presented in these unaudited condensed consolidated financial statements are not necessarily indicative of the results to be expected for the year ending December 31, 2023, or for any other future annual or interim period. The condensed consolidated balance sheet as of December 31, 2022 included herein was derived from the audited financial statements as of that date. These interim condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements included in the Company’s Form 10-K as filed with the SEC on March 9, 2023 (the “Annual Report”). |
Use of Estimates | Use of Estimates The accompanying condensed consolidated financial statements are prepared in accordance with GAAP. The preparation of the condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the condensed consolidated financial statements and reported amounts of expenses during the reporting period. Significant areas that require management’s estimates include accruals of research and development expenses, including accrual of research contract costs, stock-based compensation assumptions, including the fair value of common stock. On an ongoing basis, the Company evaluates its estimates and judgments, which are based on historical and anticipated results and trends and on various other assumptions that management believes to be reasonable under the circumstances. Actual results could differ from those estimates. |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash and cash equivalents are defined as short-term, highly liquid investments with original maturities of 90 days or less at the date of purchase. Cash deposits are all in reputable financial institutions in the United States as of June 30, 2023, and December 31, 2022. Cash and cash equivalents consisted of cash on deposit with U.S. banks, including the Company’s bank account for its Australia subsidiary, denominated in U.S. dollars and Australian dollars and investments in interest bearing money market funds. |
Marketable Securities | Marketable Securities All marketable securities have been classified as “available-for-sale” and are carried at estimated fair value as determined based upon quoted market prices or pricing models for similar securities. Management determines the appropriate classification of its investments at the time of purchase and reevaluates such designation as of each balance sheet date. Unrealized gains and losses are excluded from net loss and are reported as a component of comprehensive loss. Realized gains and losses and declines in fair value judged to be other than temporary, if any, on available-for-sale securities are included in interest income. The cost of securities sold is based on the specific-identification method. Interest earned on marketable securities is included in interest income. The Company periodically assesses its available-for-sale marketable securities for other-than-temporary impairment. For debt securities in an unrealized loss position, the Company first considers its intent to sell, or whether it is more likely than not that the Company will be required to sell the debt securities before recovery of their amortized cost basis. If either of these criteria are met, the amortized cost basis of such debt securities is written down to fair value through other expense. For debt securities in an unrealized loss position that do not meet the aforementioned criteria, the Company assesses whether the decline in the fair value of such debt securities has resulted from credit losses or other factors. The Company considers the extent to which fair value is less than amortized cost, any changes to the rating of the security by a rating agency, and any adverse conditions specifically related to the securities, among other factors. If this assessment indicates that a credit loss may exist, the Company then compares the present value of cash flows expected to be collected from such securities to their amortized cost basis. If the present value of cash flows expected to be collected is less than the amortized cost basis, a credit loss exists and an allowance for credit losses is recorded through other expense, limited by the amount that the fair value is less than the amortized cost basis. Any additional impairment not recorded through an allowance for credit losses is recognized in other comprehensive loss. The Company has not recorded any impairments for its marketable securities. |
Concentration of Credit Risk and Other Risks and Uncertainties | Concentration of Credit Risk and Other Risks and Uncertainties Financial instruments that potentially subject the Company to concentration of credit risk consist of cash, cash equivalents, and marketable securities. The Company invests in a variety of financial instruments and, by its policy, limits these financial instruments to high credit quality securities issued by the U.S. government, U.S. government-sponsored agencies and highly rated banks and corporations, subject to certain concentration limits. The Company’s cash, cash equivalents, and marketable securities are held by financial institutions in the United States that management believes are of high credit quality. Amounts on deposit with individual banking institutions may at times exceed the limits insured by the Federal Deposit Insurance Corporation (“FDIC”); however, the Company has not experienced any losses on such deposits. The Company’s future results of operations involve a number of other risks and uncertainties. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, uncertainty of results of clinical trials and reaching milestones, uncertainty of regulatory approval of the Company’s current and potential future product candidates, uncertainty of market acceptance of the Company’s product candidates, competition from substitute products and larger companies, securing and protecting proprietary technology, strategic relationships, dependence on key individuals or sole-source suppliers, and geopolitical and macroeconomic factors. The Company’s product candidates require approvals from the U.S. Food and Drug Administration (“FDA”) and comparable foreign regulatory agencies prior to commercial sales in their respective jurisdictions. There can be no assurance that any product candidates will receive the necessary approvals. If the Company were denied approval, approval was delayed or the Company was unable to maintain approval for any product candidate, it could have a materially adverse impact on the Company. |
Leases | Leases The Company adopted Accounting Standard Update (“ASU”) 2016-12, Leases At the inception of an arrangement, the Company determines if an arrangement is, or contains, a lease based on the facts and circumstances present in that arrangement. Lease classification, recognition, and measurement are then determined at the lease commencement date. For arrangements that contain a lease, the Company (i) identifies lease and non-lease components, (ii) determines the consideration in the contract, (iii) determines whether the lease is an operating or finance lease; and (iv) recognizes lease ROU assets and liabilities. Lease liabilities and their corresponding ROU assets are recorded based on the present value of future lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not readily determinable and as such, the Company uses the incremental borrowing rate based on the information available at the lease commencement date, which represents an internally developed rate that would be incurred to borrow, on a collateralized basis, over a similar term, an amount equal to the lease payments in a similar economic environment. Most leases include options to renew and, or terminate the lease, which can impact the lease term. The exercise of these options is at the Company’s discretion. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise such options. For any lease modification, the Company reassesses the lease classification, remeasures the related lease liability using an updated discount rate that reflects the modified lease term, and adjusts the related ROU asset under the lease modification guidance under Topic 842. The Company has operating leases for its research and development and office facilities. Fixed lease payments on operating leases are recognized over the expected term of the lease on a straight-line basis. Variable lease expenses that are not considered fixed are recognized as incurred. Fixed and variable lease expense on operating leases is recognized within operating expenses within our condensed consolidated statements of operations and comprehensive loss. The Company elected to not apply the recognition requirements of Topic 842 to short-term leases with terms of 12 months or less. Additional information and disclosures required by Topic 842 are contained in Note 11 “Lease” in the Annual Report. |
Research and Development Costs | Research and Development Costs Research and development costs are expensed as incurred. Research and development expenses consist of costs incurred to discover, research and develop product candidates. These costs are recorded within research and development expenses in the condensed consolidated statements of operations and include personnel expenses, stock-based compensation expenses, allocated general and administrative expenses, and external costs including fees paid to consultants and contract research organizations (“CROs”) and contract manufacturing organizations (“CMOs”), in connection with nonclinical studies and clinical trials, and other related clinical trial fees, such as for investigator fees, patient screening, laboratory work, clinical trial database management, clinical trial material management and statistical compilation and analysis. Non-refundable prepayments for goods or services that will be used or rendered for future research and development activities are recorded as prepaid expenses and other current assets. Such amounts are recognized as an expense as the goods are delivered or the related services are performed. Costs incurred in obtaining technology licenses that do not meet the definition of a business are charged immediately to research and development expense if the technology licensed has not reached technological feasibility and has no alternative future uses. Reimbursements of certain costs associated with research activities performed under the agreement with Novartis Institutes for BioMedical Research, Inc. (“Novartis”) are recorded as a reduction of research and development expenses and as a receivable due from Novartis, which is recorded under prepaid expenses and other current assets in the accompanying condensed consolidated financial statements, as described in Note 10, Commitments and Contingencies – Clinical Collaboration and Supply Agreement. |
Research Contract Costs and Accruals | Research Contract Costs and Accruals The Company has from time to time entered into various research and development and other agreements with commercial firms, researchers, universities and others for provisions of goods and services. These agreements are generally cancelable, and the related costs are recorded as research and development expenses as incurred. The Company records accruals for estimated ongoing research and development costs. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the projects, studies or clinical trials, including the phase or completion of events, invoices received and contracted costs. Judgments and estimates are made in determining the accrued balances at the end of any reporting period. Actual results could differ materially from the Company’s estimates. The Company’s historical accrual estimates have not been materially different from the actual costs. |
Net Loss Per Common Share | Net Loss Per Common Share Basic net loss per common share is computed by dividing the net loss per common share by the weighted average number of common shares outstanding for the period without consideration of common stock equivalents. Diluted net loss per common share is computed by adjusting net loss to reallocate undistributed earnings based on the potential impact of dilutive securities, and by dividing the diluted net loss by the weighted average number of common shares outstanding for the period, including potential dilutive common shares. For purpose of this calculation, outstanding stock options, including unvested early exercised options, unvested restricted stock awards, unvested performance-based restricted stock unit awards, contingently issuable common stock related to the 2020 Employee Stock Purchase Plan (the “ESPP”) are considered potential dilutive common shares. Since the Company was in a loss position for all periods presented, basic net loss per share is the same as diluted net loss per share for all periods as the inclusion of all potential common shares outstanding would have been anti-dilutive. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements There were no new accounting pronouncements that were relevant to the Company as of and for the six months ended June 30, 2023. |
Fair Value Measurement (Tables)
Fair Value Measurement (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Fair Value Measurement | |
Schedule of financial assets and liabilities measured at fair value on a recurring basis | June 30, 2023 (in thousands) Level 1 Level 2 Level 3 Total Financial Assets Cash $ 6,123 $ — $ — $ 6,123 Money market funds 28,919 — — 28,919 Commercial paper — 67,314 — 67,314 U.S. government treasury bills 36,074 — — 36,074 Government-sponsored enterprise securities — 29,098 — 29,098 Total $ 71,116 $ 96,412 $ — $ 167,528 |
Schedule of financial assets reconciliation | June 30, 2023 Gross Gross Amortized Unrealized Unrealized Estimated (in thousands) Cost Gains Losses Fair Value Financial Assets Cash and cash equivalents $ 35,042 $ — $ — $ 35,042 Short-term marketable securities (<12 months to maturity) 133,004 16 (534) 132,486 Total $ 168,046 $ 16 $ (534) $ 167,528 |
Property and Equipment, net (Ta
Property and Equipment, net (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Property and Equipment, net | |
Schedule of property and equipment, net | June 30, December 31, 2023 2022 Lab equipment $ 1,958 $ 2,002 Computer equipment 59 59 Property and equipment, gross 2,017 2,061 Less: Accumulated depreciation (744) (581) Property and equipment, net $ 1,273 $ 1,480 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Prepaid Expenses and Other Current Assets | |
Schedule of prepaid expenses and other current assets | June 30, December 31, 2023 2022 Reimbursable research and development costs from a collaboration partner $ 1,825 $ 1,387 Prepaid insurance 804 1,738 Research and development tax incentive credit receivable 401 — Prepaid subscriptions and licenses 295 399 Prepaid clinical development costs 282 506 Interest receivable 221 319 Other 237 129 Total $ 4,065 $ 4,478 |
Accrued and Other Current Lia_2
Accrued and Other Current Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Accrued and Other Current Liabilities | |
Schedule of Accrued and other current liabilities | June 30, December 31, 2023 2022 Accrued research and development related costs $ 9,026 $ 9,105 Accrued employee bonuses 1,926 4,518 Accrued professional fees 982 1,091 Accrued payroll related costs 362 296 Accrued taxes 91 68 Early exercise of unvested stock options 21 82 Total $ 12,408 $ 15,160 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Stock-Based Compensation | |
Schedule of fair value assumptions | Six Months Ended June 30, 2023 2022 Risk-free interest rate 3.52% 1.81% Expected term (in years) 6.02 6.02 Expected volatility 86.88% 79.33% Expected dividend yield — — |
Schedule of stock option activity | Weighted Weighted Average Average Remaining Number of Exercise Contractual Aggregate Shares Price Term Intrinsic Value (in years) (in thousands) Outstanding as of December 31, 2022 8,384,858 $ 8.59 8.30 $ 262 Granted 2,234,718 4.98 — — Exercised(1) (483,411) 3.77 — — Forfeited (859,447) 5.62 — — Outstanding as of June 30, 2023(2) 9,276,718 $ 8.26 7.98 $ 31,572 Options vested and exercisable as of June 30, 2023 4,203,758 $ 10.05 7.18 $ 13,179 Options expected to vest as of June 30, 2023 5,072,960 $ 6.77 8.63 $ 18,305 (1) Exercised amount includes vesting of early-exercised options and shares returned for taxes withheld for exercise and net transactions. (2) Balance as of June 30, 2023 includes 4,660 unvested early-exercised stock options. |
Summary of restricted stock activity | Number of Shares Grant Date Fair Value Unvested restricted stock as of December 31, 2022 295,911 $ 2.40 Granted — — Vested (98,637) 2.40 Forfeited — — Unvested restricted stock as of June 30, 2023 197,274 $ 2.40 |
Schedule of stock-based compensation expense | Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 Research and development $ 2,969 $ 3,211 $ 6,057 $ 6,278 General and administrative 1,201 1,517 2,743 3,415 Total $ 4,170 $ 4,728 $ 8,800 $ 9,693 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Net Loss Per Share | |
Schedule of basic and diluted net loss per share | Basic and diluted net loss per share was calculated as follows (in thousands, except share and per share amounts): Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 Numerator: Net loss $ (20,095) $ (32,858) $ (48,381) $ (55,888) Denominator: Weighted average shares used to compute net loss per share, basic and diluted 40,720,294 39,918,219 40,470,041 39,876,650 Net loss per share, basic and diluted $ (0.49) $ (0.82) $ (1.20) $ (1.40) |
Schedule of anti-dilutive securities excluded from computation of diluted loss per share | June 30, 2023 2022 Unvested restricted stock awards outstanding 197,274 394,548 Unvested performance-based restricted stock unit awards outstanding 710,000 — Options to purchase common stock 9,276,718 8,425,053 Employee stock purchase plan contingently issuable 22,749 70,477 10,206,741 8,890,078 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Leases | |
Summary of total lease expense | Three Months Ended June 30, Six Months Ended June 30, 2023 2023 Straight-line operating lease expense $ 326 $ 653 Short-term lease expense 53 106 Variable lease expense 10 20 Total operating lease expense $ 389 $ 779 |
Summary of supplemental cash flow information | Three Months Ended June 30, Six Months Ended June 30, 2023 2023 Cash paid for amounts included measurement of lease liabilities: Operating cash flows from operating leases $ 327 $ 653 |
Summary of future minimum lease payments | Years Ending December 31, 2023 (from July 2023) $ 531 2024 799 2025 822 2026 69 Total future minimum lease payments 2,221 Less: Interest (213) Total lease liabilities at present value 2,008 Lease liabilities, current 798 Lease liabilities, non-current $ 1,210 |
Summary of lease term and discount rate | June 30, 2023 Weighted-average remaining lease term (years) 2.43 Weighted-average discount rate 8.69% |
Nature of the Business and Ba_2
Nature of the Business and Basis of Presentation (Details) $ in Millions | 6 Months Ended |
Jun. 30, 2023 USD ($) segment | |
Nature of the Business and Basis of Presentation | |
Number of operating segments | 1 |
Number of reportable segments | 1 |
Cash, cash equivalents and marketable securities | $ | $ 167.4 |
Fair Value Measurement (Details
Fair Value Measurement (Details) - Recurring $ in Thousands | Jun. 30, 2023 USD ($) |
Assets | |
Cash | $ 6,123 |
Total | 167,528 |
Level 1 | |
Assets | |
Cash | 6,123 |
Total | 71,116 |
Level 2 | |
Assets | |
Total | 96,412 |
Money market funds | |
Assets | |
Cash | 28,919 |
Money market funds | Level 1 | |
Assets | |
Cash | 28,919 |
Commercial paper | |
Assets | |
Marketable securities | 67,314 |
Commercial paper | Level 2 | |
Assets | |
Marketable securities | 67,314 |
U.S. Government treasury bills | |
Assets | |
Marketable securities | 36,074 |
U.S. Government treasury bills | Level 1 | |
Assets | |
Marketable securities | 36,074 |
Government-sponsored enterprise securities | |
Assets | |
Marketable securities | 29,098 |
Government-sponsored enterprise securities | Level 2 | |
Assets | |
Marketable securities | $ 29,098 |
Fair Value Measurement - Market
Fair Value Measurement - Marketable Securities (Details) $ in Thousands | Jun. 30, 2023 USD ($) security |
Debt Securities, Available-for-sale, Fair Value to Amortized Cost [Abstract] | |
Amortized Cost | $ 168,046 |
Gross Unrealized Gains | 16 |
Gross Unrealized Losses | (534) |
Estimated Fair Value | 167,528 |
Allowance for losses on available-for-sale debt securities | $ 0 |
Marketable securities in an unrealized loss position for more than 12 months | security | 14 |
Security in continuous unrealized loss position, more than 12 months, accumulated Loss | $ 500 |
Security in continuous unrealized loss position, more than 12 months, fair value | 39,000 |
Cash and cash equivalents | |
Debt Securities, Available-for-sale, Fair Value to Amortized Cost [Abstract] | |
Amortized Cost | 35,042 |
Estimated Fair Value | 35,042 |
Short-term marketable securities | |
Debt Securities, Available-for-sale, Fair Value to Amortized Cost [Abstract] | |
Amortized Cost | 133,004 |
Gross Unrealized Gains | 16 |
Gross Unrealized Losses | (534) |
Estimated Fair Value | $ 132,486 |
Property and Equipment, net (De
Property and Equipment, net (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 2,017 | $ 2,061 |
Less: Accumulated depreciation | (744) | (581) |
Property and equipment, net | 1,273 | 1,480 |
Lab equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 1,958 | 2,002 |
Computer equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 59 | $ 59 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Prepaid Expenses and Other Current Assets | ||
Reimbursable research and development costs from a collaboration partner | $ 1,825 | $ 1,387 |
Prepaid insurance | 804 | 1,738 |
Research and development tax incentive credit receivable | 401 | |
Prepaid subscriptions and licenses | 295 | 399 |
Prepaid clinical development costs | 282 | 506 |
Interest receivable | 221 | 319 |
Other | 237 | 129 |
Total | $ 4,065 | $ 4,478 |
Accrued and Other Current Lia_3
Accrued and Other Current Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Accrued and Other Current Liabilities | ||
Accrued research and development related costs | $ 9,026 | $ 9,105 |
Accrued employee bonuses | 1,926 | 4,518 |
Accrued professional fees | 982 | 1,091 |
Accrued payroll related costs | 362 | 296 |
Accrued taxes | 91 | 68 |
Early exercise of unvested stock options | 21 | 82 |
Total | $ 12,408 | $ 15,160 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details) - shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Percent of common stock at fair market value to be exercised | 100% | |
Expiration period (in years) | 10 years | |
2020 Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
New shares authorized | 2,152,080 | |
Period of increase in common stock reserved for issuance | 10 years | |
Percentage of increase in common stock reserved for issuance | 5% | |
2020 Plan | Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of shares authorized | 6,494,510 | |
Shares available from prior equity incentive plan | 4,342,430 | |
2022 Inducement Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Common stock reserved for issuance | 2,000,000 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock Option Valuation (Details) | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Stock-Based Compensation | ||
Risk-free interest rate | 3.52% | 1.81% |
Expected term (in years) | 6 years 7 days | 6 years 7 days |
Expected volatility | 86.88% | 79.33% |
Expected dividend yield | 0% | 0% |
Stock-Based Compensation - St_2
Stock-Based Compensation - Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2023 | Dec. 31, 2022 | Jun. 30, 2022 | |
Number of shares | |||
Outstanding as at beginning of period (in shares) | 8,384,858 | ||
Granted (in shares) | 2,234,718 | ||
Exercised (in shares) | (483,411) | ||
Forfeited (in shares) | (859,447) | ||
Outstanding as at end of period (in shares) | 9,276,718 | 8,384,858 | |
Options vested and exercisable as at end of period (in shares) | 4,203,758 | ||
Options expected to vest as at end of period (in shares) | 5,072,960 | ||
Weighted Average Exercise Price | |||
Outstanding as at beginning of period (in dollars per share) | $ 8.59 | ||
Granted (in dollars per share) | 4.98 | ||
Exercised (in dollars per share) | 3.77 | ||
Forfeited (in dollars per share) | 5.62 | ||
Outstanding at end of period (in dollars per share) | 8.26 | $ 8.59 | |
Options vested and exercisable as at end of period (in dollars per share) | 10.05 | ||
Options expected to vest as at end of period (in dollars per share) | $ 6.77 | ||
Weighted Average Remaining Contractual Life | |||
Weighted average remaining contractual life of outstanding options (in years) | 7 years 11 months 23 days | 8 years 3 months 18 days | |
Weighted average remaining contractual life of vested and exercisable options (in years) | 7 years 2 months 4 days | ||
Weighted average remaining contractual life of expected to vest options (in years) | 8 years 7 months 17 days | ||
Intrinsic value of outstanding options | $ 31,572 | $ 262 | |
Intrinsic value of vested and exercisable options | 13,179 | ||
Intrinsic value of expected to vest options | $ 18,305 | ||
Unvested early exercised stock options | 4,660 | 4,660 |
Stock-Based Compensation - Earl
Stock-Based Compensation - Early Exercise of Stock Options (Details) $ in Millions | Jun. 30, 2023 USD ($) |
Maximum | |
Stock-Based Compensation | |
Current liability from early exercises of stock options | $ 0.1 |
Stock-Based Compensation - Rest
Stock-Based Compensation - Restricted Stock Awards (Details) | 6 Months Ended |
Jun. 30, 2023 $ / shares shares | |
Number of Shares | |
Unvested restricted stock as at beginning of period (in shares) | shares | 295,911 |
Vested (in shares) | shares | (98,637) |
Unvested restricted stock as at end of period (in shares) | shares | 197,274 |
Grant Date Fair Value | |
Unvested restricted stock as at beginning of period (in dollars per share) | $ / shares | $ 2.40 |
Vested (in dollars per share) | $ / shares | 2.40 |
Unvested restricted stock as at ending of period (in dollars per share) | $ / shares | $ 2.40 |
Stock Based Compensation - Perf
Stock Based Compensation - Performance-Based Restricted Stock Unit Awards (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||
Nov. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock-based compensation expense | $ 4,170,000 | $ 4,728,000 | $ 8,800,000 | $ 9,693,000 | |
Unvested performance-based restricted stock units | 2020 Plan | Share-based Payment Arrangement, Employee | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Granted (in shares) | 710,000 | ||||
Stock-based compensation expense | $ 0 | $ 0 | |||
Unvested performance-based restricted stock units | 2020 Plan | Share-based Payment Arrangement, Employee | Share-Based Payment Arrangement, Tranche One | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting Percentage | 65% | ||||
Unvested performance-based restricted stock units | 2020 Plan | Share-based Payment Arrangement, Employee | Share-Based Payment Arrangement, Tranche Two | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting Percentage | 35% |
Stock-Based Compensation - 2020
Stock-Based Compensation - 2020 Employee Stock Purchase Plan (Details) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2023 USD ($) shares | Jun. 30, 2022 USD ($) | Jun. 30, 2023 USD ($) shares | Jun. 30, 2022 USD ($) | Dec. 31, 2022 | Dec. 31, 2020 item | |
Stock-Based Compensation | ||||||
Percent of common stock at fair market value to be exercised | 100% | |||||
Stock-based compensation expense | $ 4,170 | $ 4,728 | $ 8,800 | $ 9,693 | ||
Employee stock purchase plan contingently issuable | ||||||
Stock-Based Compensation | ||||||
Percentage of eligible earnings withheld | 15% | |||||
Percent of common stock at fair market value to be exercised | 85% | |||||
Number of months for each purchase period | 6 months | |||||
Number of purchase periods | item | 2 | |||||
Common stock reserved for issuance | shares | 430,416 | 430,416 | ||||
Stock-based compensation expense | $ 100 | $ 200 | ||||
Employee stock purchase plan contingently issuable | Maximum | ||||||
Stock-Based Compensation | ||||||
Offering period | 27 months |
Stock-Based Compensation - St_3
Stock-Based Compensation - Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Stock-based compensation expense | ||||
Total stock-based compensation expense | $ 4,170 | $ 4,728 | $ 8,800 | $ 9,693 |
Research and development | ||||
Stock-based compensation expense | ||||
Total stock-based compensation expense | 2,969 | 3,211 | 6,057 | 6,278 |
General and administrative | ||||
Stock-based compensation expense | ||||
Total stock-based compensation expense | $ 1,201 | $ 1,517 | $ 2,743 | $ 3,415 |
Net Loss Per Share (Details)
Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Numerator: | ||||
Net loss | $ (20,095) | $ (32,858) | $ (48,381) | $ (55,888) |
Denominator: | ||||
Weighted average shares used to compute net loss per share, basic | 40,720,294 | 39,918,219 | 40,470,041 | 39,876,650 |
Weighted average shares used to compute net loss per share, diluted | 40,720,294 | 39,918,219 | 40,470,041 | 39,876,650 |
Net loss per share, basic | $ (0.49) | $ (0.82) | $ (1.20) | $ (1.40) |
Net loss per share, diluted | $ (0.49) | $ (0.82) | $ (1.20) | $ (1.40) |
Net Loss Per Share - Anti-dilut
Net Loss Per Share - Anti-dilutive Effect (Details) - shares | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities | 10,206,741 | 8,890,078 |
Unvested early exercised stock options | 4,660 | 4,660 |
Unvested restricted stock awards outstanding | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities | 197,274 | 394,548 |
Unvested performance-based restricted stock unit awards outstanding | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities | 710,000 | |
Options to purchase common stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities | 9,276,718 | 8,425,053 |
Employee stock purchase plan contingently issuable | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities | 22,749 | 70,477 |
Leases (Details)
Leases (Details) $ in Thousands | 1 Months Ended | ||||||
Apr. 30, 2022 USD ($) | Jun. 30, 2023 USD ($) | Dec. 31, 2022 USD ($) | Dec. 15, 2020 USD ($) ft² | Dec. 01, 2020 USD ($) ft² | Aug. 27, 2020 USD ($) ft² | Jun. 01, 2013 ft² item | |
Lease | |||||||
Operating lease right-of-use assets | $ 1,938 | $ 2,495 | |||||
Lease liabilities | $ 2,008 | ||||||
MandalMed Services Agreement Area | |||||||
Lease | |||||||
Number of lease amendments | item | 6 | ||||||
Area of property | ft² | 5,762 | ||||||
Mandalmed Services Agreement Additional Area | |||||||
Lease | |||||||
Area of property | ft² | 2,130 | ||||||
Term of contract | 3 years | ||||||
Security Deposit | $ 100 | ||||||
Office Space | |||||||
Lease | |||||||
Area of property | ft² | 3,500 | ||||||
Term of contract | 2 years | ||||||
Renewal term | 1 year | ||||||
Renewal option | true | ||||||
Security Deposit | $ 100 | ||||||
Operating lease right-of-use assets | $ 300 | ||||||
Lease liabilities | $ 300 | ||||||
Laboratory Lease Agreement | |||||||
Lease | |||||||
Area of property | ft² | 9,800 | ||||||
Term of contract | 5 years | ||||||
Security Deposit | $ 400 |
Leases - Lease Expense (Details
Leases - Lease Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended |
Jun. 30, 2023 | Jun. 30, 2023 | |
Lease expense | ||
Straight-line operating lease expense | $ 326 | $ 653 |
Short-term lease expense | 53 | 106 |
Variable lease expense | 10 | 20 |
Total operating lease expense | $ 389 | $ 779 |
Leases - Cash Flow Information
Leases - Cash Flow Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended |
Jun. 30, 2023 | Jun. 30, 2023 | |
Leases | ||
Operating cash flows from operating leases | $ 327 | $ 653 |
Leases - Future Minimum Lease P
Leases - Future Minimum Lease Payments (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Future minimum lease payments | ||
2023 (from July 2023) | $ 531 | |
2024 | 799 | |
2025 | 822 | |
2026 | 69 | |
Total future minimum lease payments | 2,221 | |
Less: Interest | (213) | |
Total lease liabilities at present value | 2,008 | |
Lease liabilities, current | 798 | $ 1,015 |
Lease liabilities, non-current | $ 1,210 | $ 1,550 |
Leases - Lease Term and Discoun
Leases - Lease Term and Discount Rate (Details) | Jun. 30, 2023 |
Leases | |
Weighted-average remaining lease term (years) | 2 years 5 months 4 days |
Weighted-average discount rate | 8.69% |
Commitments and Contingencies (
Commitments and Contingencies (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | |
Loss Contingencies [Line Items] | ||||||
Reimbursable research and development costs from a collaboration partner | $ 1,825 | $ 1,825 | $ 1,387 | |||
Research and development | 17,989 | $ 27,054 | 40,815 | $ 43,063 | ||
Novartis Agreement | Bio Medical Research Inc | ||||||
Loss Contingencies [Line Items] | ||||||
Costs reimbursable from Novartis | 800 | 1,400 | ||||
Reimbursable research and development costs from a collaboration partner | 1,800 | 1,800 | ||||
Aurigene Agreement | ||||||
Loss Contingencies [Line Items] | ||||||
Milestone payments to be paid to collaborative partner | $ 60,000 | |||||
Upfront payment, research and development. | 8,000 | |||||
Research and development | $ 0 | $ 0 | ||||
Aurigene Agreement | Commercial Milestone | ||||||
Loss Contingencies [Line Items] | ||||||
Milestone payments to be paid to collaborative partner | $ 370,000 |