Cover
Cover - shares | 9 Months Ended | |
Sep. 30, 2023 | Oct. 31, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2023 | |
Document Transition Report | false | |
Entity File Number | 001-36912 | |
Entity Registrant Name | CIDARA THERAPEUTICS, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 46-1537286 | |
Entity Address, Address Line One | 6310 Nancy Ridge Drive, | |
Entity Address, Address Line Two | Suite 101 | |
Entity Address, City or Town | San Diego, | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 92121 | |
City Area Code | (858) | |
Local Phone Number | 752-6170 | |
Title of 12(b) Security | Common Stock, Par Value $0.0001 Per Share | |
Trading Symbol | CDTX | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 90,433,777 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Entity Central Index Key | 0001610618 | |
Current Fiscal Year End Date | --12-31 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 48,670 | $ 32,731 |
Accounts receivable | 2,855 | 5,833 |
Inventory | 2,467 | 0 |
Prepaid expenses and other current assets | 3,712 | 6,530 |
Total current assets | 57,704 | 45,094 |
Property and equipment, net | 580 | 222 |
Operating lease right-of-use asset | 4,131 | 1,205 |
Other assets | 1,053 | 1,072 |
Total assets | 63,468 | 47,593 |
Current liabilities: | ||
Accounts payable | 3,661 | 1,447 |
Accrued liabilities | 11,772 | 7,672 |
Accrued compensation and benefits | 4,457 | 4,922 |
Current contract liabilities | 14,679 | 14,614 |
Current portion of lease liability | 1,051 | 1,317 |
Total current liabilities | 35,620 | 29,972 |
Long-term contract liabilities | 16,504 | 20,525 |
Long-term lease liability | 3,306 | 0 |
Total liabilities | 55,430 | 50,497 |
Commitments and contingencies | ||
Stockholders’ equity (deficit): | ||
Preferred stock | ||
Common stock, $0.0001 par value; 200,000,000 shares authorized at September 30, 2023 and December 31, 2022; 90,415,944 shares issued and outstanding at September 30, 2023 and 72,470,440 shares issued and outstanding at December 31, 2022 | 9 | 7 |
Additional paid-in capital | 432,315 | 404,055 |
Accumulated deficit | (424,286) | (406,966) |
Total stockholders’ equity (deficit) | 8,038 | (2,904) |
Total liabilities and stockholders’ equity (deficit) | 63,468 | 47,593 |
Series X Convertible Preferred Stock | ||
Stockholders’ equity (deficit): | ||
Preferred stock | $ 0 | $ 0 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 200,000,000 | 200,000,000 |
Common stock, shares issued (in shares) | 90,415,944 | 72,470,440 |
Common stock, shares outstanding (in shares) | 90,415,944 | 72,470,440 |
Series X Convertible Preferred Stock | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 4,947,759 | 4,947,759 |
Preferred stock, shares issued (in shares) | 2,156,713 | 1,870,713 |
Preferred stock, shares outstanding (in shares) | 2,104,472 | 1,818,472 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Revenues: | ||||
Collaboration revenue | $ 11,250 | $ 40,744 | $ 44,854 | $ 54,069 |
Product revenue | 1,468 | 0 | 1,468 | 0 |
Total revenues | 12,718 | 40,744 | 46,322 | 54,069 |
Operating expenses: | ||||
Cost of product revenue | 387 | 0 | 387 | 0 |
Research and development | 17,330 | 20,041 | 53,180 | 55,462 |
General and administrative | 3,556 | 5,780 | 11,164 | 15,058 |
Total operating expenses | 21,273 | 25,821 | 64,731 | 70,520 |
Income (loss) from operations | (8,555) | 14,923 | (18,409) | (16,451) |
Other income, net: | ||||
Interest income, net | 613 | 55 | 1,468 | 29 |
Total other income, net | 613 | 55 | 1,468 | 29 |
Net income (loss) before income tax expense | (7,942) | 14,978 | (16,941) | (16,422) |
Income tax expense | (230) | 0 | (379) | 0 |
Net income (loss) and comprehensive income (loss) | (8,172) | 14,978 | (17,320) | (16,422) |
Net income (loss) and comprehensive income (loss) | (8,172) | 14,978 | (17,320) | (16,422) |
Allocation of earnings to participating securities | 0 | (3,081) | 0 | 0 |
Net income (loss) attributable to common stockholders | $ (8,172) | $ 11,897 | $ (17,320) | $ (16,422) |
Basic net earnings (loss) per common share (in dollars per share) | $ (0.09) | $ 0.17 | $ (0.20) | $ (0.24) |
Diluted net earnings (loss) per common share (in dollars per share) | $ (0.09) | $ 0.17 | $ (0.20) | $ (0.24) |
Shares used to compute basic net earnings (loss) per common share (in shares) | 90,287,441 | 70,217,985 | 86,390,446 | 69,170,865 |
Shares used to compute diluted net earnings (loss) per common share (in shares) | 90,287,441 | 88,592,568 | 86,390,446 | 69,170,865 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Operating activities: | ||
Net loss | $ (17,320) | $ (16,422) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 2,231 | 2,859 |
Non-cash operating lease expense | 921 | 796 |
Depreciation and amortization | 79 | 114 |
Amortization of costs to obtain a contract with a customer | 53 | 1,772 |
Non-cash interest expense | 0 | 1 |
Changes in assets and liabilities: | ||
Accounts receivable | 2,978 | 314 |
Inventory | (2,467) | 0 |
Prepaid expenses, other current assets, and other assets | 2,776 | (1,662) |
Accounts payable and accrued liabilities | 6,204 | (1,037) |
Accrued compensation and benefits | (402) | (670) |
Contract liabilities | (3,956) | 7,314 |
Lease liabilities | (807) | (850) |
Net cash used in operating activities | (9,710) | (7,471) |
Investing activities: | ||
Purchases of property and equipment | (327) | (109) |
Net cash used in investing activities | (327) | (109) |
Financing activities: | ||
Proceeds from underwritten public offering, net of issuance costs | 17,256 | 0 |
Proceeds from public offering of common stock, net of issuance costs | 8,706 | 1,698 |
Proceeds from exercise of stock options | 14 | 0 |
Issuance costs for underwritten public offering | 0 | (720) |
Principal repayments of Term Loan | 0 | (2,593) |
Net cash provided by (used in) financing activities | 25,976 | (1,615) |
Net increase (decrease) in cash and cash equivalents | 15,939 | (9,195) |
Cash and cash equivalents at beginning of period | 32,731 | 62,273 |
Cash and cash equivalents at end of period | 48,670 | 53,078 |
Supplemental disclosure of cash flows: | ||
Interest paid | 0 | 40 |
Income taxes paid | 651 | 0 |
Non-cash investing activities: | ||
Purchases of property and equipment, included in accounts payable and accrued liabilities | 178 | 0 |
Right-of-use asset obtained in exchange for lease liability | 3,847 | 0 |
Non-cash financing activities: | ||
Purchase of shares pursuant to Employee Stock Purchase Plan | 63 | 69 |
Proceeds from public offering of common stock, net of issuance costs, included in prepaid expenses, other current assets, and other assets | $ 0 | $ 10 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Changes in Convertible Preferred Stock and Stockholders’ Equity (Deficit) - USD ($) $ in Thousands | Total | Underwritten Public Offerings | Public Offering | Common Stock | Common Stock Underwritten Public Offerings | Common Stock Public Offering | Additional Paid-In Capital | Additional Paid-In Capital Underwritten Public Offerings | Additional Paid-In Capital Public Offering | Accumulated Deficit | Series X Convertible Preferred Stock | Series X Convertible Preferred Stock Preferred Stock | Series X Convertible Preferred Stock Preferred Stock Underwritten Public Offerings |
Balance, beginning (in shares) at Dec. 31, 2021 | 1,818,472 | ||||||||||||
Balance, beginning at Dec. 31, 2021 | $ 21,573 | $ 7 | $ 398,733 | $ (377,167) | $ 0 | ||||||||
Balance, beginning (in shares) at Dec. 31, 2021 | 67,863,674 | ||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||
Public offering, net of issuance costs (in shares) | 644,265 | ||||||||||||
Public offering, net of issuance costs | $ 500 | $ 500 | |||||||||||
Issuance of common stock for restricted share units vested (in shares) | 541,308 | ||||||||||||
Stock-based compensation | 1,165 | 1,165 | |||||||||||
Net income (loss) | (18,281) | (18,281) | |||||||||||
Balance, ending (in shares) at Mar. 31, 2022 | 1,818,472 | ||||||||||||
Balance, ending at Mar. 31, 2022 | 4,957 | $ 7 | 400,398 | (395,448) | $ 0 | ||||||||
Balance, ending (in shares) at Mar. 31, 2022 | 69,049,247 | ||||||||||||
Balance, beginning (in shares) at Dec. 31, 2021 | 1,818,472 | ||||||||||||
Balance, beginning at Dec. 31, 2021 | 21,573 | $ 7 | 398,733 | (377,167) | $ 0 | ||||||||
Balance, beginning (in shares) at Dec. 31, 2021 | 67,863,674 | ||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||
Issuance of common stock under Employee Stock Purchase Plan | 69 | ||||||||||||
Net income (loss) | (16,422) | ||||||||||||
Balance, ending (in shares) at Sep. 30, 2022 | 1,818,472 | ||||||||||||
Balance, ending at Sep. 30, 2022 | 9,067 | $ 7 | 402,649 | (393,589) | $ 0 | ||||||||
Balance, ending (in shares) at Sep. 30, 2022 | 71,181,197 | ||||||||||||
Balance, beginning (in shares) at Mar. 31, 2022 | 1,818,472 | ||||||||||||
Balance, beginning at Mar. 31, 2022 | 4,957 | $ 7 | 400,398 | (395,448) | $ 0 | ||||||||
Balance, beginning (in shares) at Mar. 31, 2022 | 69,049,247 | ||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||
Issuance of common stock for restricted share units vested (in shares) | 5,042 | ||||||||||||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 184,219 | ||||||||||||
Issuance of common stock under Employee Stock Purchase Plan | 69 | 69 | |||||||||||
Stock-based compensation | 852 | 852 | |||||||||||
Issuance costs for underwritten public offering | (720) | (720) | |||||||||||
Net income (loss) | (13,119) | (13,119) | |||||||||||
Balance, ending (in shares) at Jun. 30, 2022 | 1,818,472 | ||||||||||||
Balance, ending at Jun. 30, 2022 | (7,961) | $ 7 | 400,599 | (408,567) | $ 0 | ||||||||
Balance, ending (in shares) at Jun. 30, 2022 | 69,238,508 | ||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||
Public offering, net of issuance costs (in shares) | 1,664,170 | ||||||||||||
Public offering, net of issuance costs | 1,208 | 1,208 | |||||||||||
Issuance of common stock for restricted share units vested (in shares) | 278,519 | ||||||||||||
Stock-based compensation | 842 | 842 | |||||||||||
Net income (loss) | 14,978 | 14,978 | |||||||||||
Balance, ending (in shares) at Sep. 30, 2022 | 1,818,472 | ||||||||||||
Balance, ending at Sep. 30, 2022 | 9,067 | $ 7 | 402,649 | (393,589) | $ 0 | ||||||||
Balance, ending (in shares) at Sep. 30, 2022 | 71,181,197 | ||||||||||||
Balance, beginning (in shares) at Dec. 31, 2022 | 1,818,472 | 1,818,472 | |||||||||||
Balance, beginning at Dec. 31, 2022 | $ (2,904) | $ 7 | 404,055 | (406,966) | $ 0 | ||||||||
Balance, beginning (in shares) at Dec. 31, 2022 | 72,470,440 | 72,470,440 | |||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||
Public offering, net of issuance costs (in shares) | 11,086,000 | 6,158,799 | 286,000 | ||||||||||
Public offering, net of issuance costs | $ 17,256 | 8,622 | $ 1 | $ 1 | $ 17,255 | 8,621 | |||||||
Issuance of common stock for exercise of options (in shares) | 16,250 | ||||||||||||
Issuance of common stock for exercise of options | $ 14 | 14 | |||||||||||
Issuance of common stock for restricted share units vested (in shares) | 293,073 | ||||||||||||
Stock-based compensation | 640 | 640 | |||||||||||
Net income (loss) | 3,209 | 3,209 | |||||||||||
Balance, ending (in shares) at Mar. 31, 2023 | 2,104,472 | ||||||||||||
Balance, ending at Mar. 31, 2023 | 26,837 | $ 9 | 430,585 | (403,757) | $ 0 | ||||||||
Balance, ending (in shares) at Mar. 31, 2023 | 90,024,562 | ||||||||||||
Balance, beginning (in shares) at Dec. 31, 2022 | 1,818,472 | 1,818,472 | |||||||||||
Balance, beginning at Dec. 31, 2022 | $ (2,904) | $ 7 | 404,055 | (406,966) | $ 0 | ||||||||
Balance, beginning (in shares) at Dec. 31, 2022 | 72,470,440 | 72,470,440 | |||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||
Issuance of common stock for exercise of options (in shares) | 16,250 | ||||||||||||
Issuance of common stock under Employee Stock Purchase Plan | $ 63 | ||||||||||||
Net income (loss) | (17,320) | ||||||||||||
Balance, ending (in shares) at Sep. 30, 2023 | 2,104,472 | 2,104,472 | |||||||||||
Balance, ending at Sep. 30, 2023 | $ 8,038 | $ 9 | 432,315 | (424,286) | $ 0 | ||||||||
Balance, ending (in shares) at Sep. 30, 2023 | 90,415,944 | 90,415,944 | |||||||||||
Balance, beginning (in shares) at Mar. 31, 2023 | 2,104,472 | ||||||||||||
Balance, beginning at Mar. 31, 2023 | $ 26,837 | $ 9 | 430,585 | (403,757) | $ 0 | ||||||||
Balance, beginning (in shares) at Mar. 31, 2023 | 90,024,562 | ||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||
Public offering, net of issuance costs (in shares) | 60,942 | ||||||||||||
Public offering, net of issuance costs | $ 76 | $ 76 | |||||||||||
Issuance of common stock for restricted share units vested (in shares) | 4,875 | ||||||||||||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 161,367 | ||||||||||||
Issuance of common stock under Employee Stock Purchase Plan | 63 | 63 | |||||||||||
Stock-based compensation | 795 | 795 | |||||||||||
Net income (loss) | (12,357) | ||||||||||||
Balance, ending (in shares) at Jun. 30, 2023 | 2,104,472 | ||||||||||||
Balance, ending at Jun. 30, 2023 | 15,414 | $ 9 | 431,519 | (416,114) | $ 0 | ||||||||
Balance, ending (in shares) at Jun. 30, 2023 | 90,251,746 | ||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||
Issuance of common stock for restricted share units vested (in shares) | 164,198 | ||||||||||||
Stock-based compensation | 796 | 796 | |||||||||||
Net income (loss) | (8,172) | (8,172) | |||||||||||
Balance, ending (in shares) at Sep. 30, 2023 | 2,104,472 | 2,104,472 | |||||||||||
Balance, ending at Sep. 30, 2023 | $ 8,038 | $ 9 | $ 432,315 | $ (424,286) | $ 0 | ||||||||
Balance, ending (in shares) at Sep. 30, 2023 | 90,415,944 | 90,415,944 |
THE COMPANY AND BASIS OF PRESEN
THE COMPANY AND BASIS OF PRESENTATION | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
THE COMPANY AND BASIS OF PRESENTATION | THE COMPANY AND BASIS OF PRESENTATION Description of Business Cidara Therapeutics, Inc., or the Company, was originally incorporated in Delaware in December 2012 as K2 Therapeutics, Inc., and its name was changed to Cidara Therapeutics, Inc. in July 2014. The Company is a biotechnology company focused on developing targeted therapies designed to save lives and improve the standard of care for patients facing serious diseases. The Company’s first commercially approved product in the United States, or U.S., is REZZAYO TM (rezafungin for injection) which is indicated for the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options. Melinta Therapeutics, LLC, or Melinta, is commercializing REZZAYO in the U.S. The Company’s proprietary Cloudbreak® platform enables development of novel drug-Fc conjugates, or DFCs, that inhibit specific disease targets while simultaneously engaging the immune system. The Company’s most advanced DFC program is CD388, a highly potent antiviral designed to deliver universal prevention and treatment of seasonal and pandemic influenza, which is in Phase 1 and Phase 2a clinical trials. Additional programs are targeting multiple oncology and autoimmune indications. The Company formed wholly-owned subsidiaries, Cidara Therapeutics UK Limited, in England, and Cidara Therapeutics (Ireland) Limited, in Ireland, in March 2016 and October 2018, respectively, for the purpose of developing its product candidates in Europe. Basis of Presentation The Company has a limited operating history and the sales and income potential of the Company’s business and market are unproven. The Company has experienced net losses and negative cash flows from operating activities since its inception. At September 30, 2023, the Company had an accumulated deficit of $424.3 million. The Company expects to continue to incur net losses into the foreseeable future. Successful transition to attaining profitable operations is dependent upon achieving a level of revenues adequate to support the Company’s cost structure. At September 30, 2023, the Company had cash and cash equivalents of $48.7 million. Based on the Company’s current business plan, management believes that existing cash and cash equivalents will not be sufficient to fund the Company’s obligations for twelve months from the issuance of these financial statements. The Company’s ability to execute its operating plan depends on its ability to obtain additional funding through equity offerings, debt financings or potential licensing and collaboration arrangements. The accompanying condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and settlement of liabilities in the normal course of business. However, the Company’s current working capital, anticipated operating expenses and net losses and the uncertainties surrounding its ability to raise additional capital as needed, as discussed below, raise substantial doubt about its ability to continue as a going concern for a period of one year following the date that these condensed consolidated financial statements are issued. The condensed consolidated financial statements do not include any adjustments for the recovery and classification of assets or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern. The Company plans to continue to fund its losses from operations through cash and cash equivalents on hand, as well as through future equity offerings, debt financings, other third party funding, and potential licensing or collaboration arrangements. There can be no assurance that additional funds will be available when needed from any source or, if available, will be available on terms that are acceptable to the Company. Even if the Company raises additional capital, it may also be required to modify, delay or abandon some of its plans which could have a material adverse effect on the Company’s business, operating results and financial condition and the Company’s ability to achieve its intended business objectives. Any of these actions could materially harm the Company’s business, results of operations and future prospects. Unaudited Interim Financial Data The accompanying condensed consolidated financial statements are unaudited and have been prepared by the Company in accordance with U.S. generally accepted accounting principles, or GAAP, as found in the Accounting Standards Codification, or ASC, of the Financial Accounting Standards Board, or FASB. Certain information and footnote disclosures normally included in the Company’s annual financial statements have been condensed or omitted. These interim condensed consolidated financial statements, in the opinion of management, reflect all normal recurring adjustments necessary for a fair presentation of the Company’s financial position and results of operations for the interim periods ended September 30, 2023 and 2022. Basis of Consolidation The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All significant intercompany accounts and transactions have been eliminated in consolidation. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of expenses during the reporting period. The Company evaluates its estimates and assumptions on an ongoing basis. The most significant estimates in the Company’s condensed consolidated financial statements relate to estimated collaboration expenses related to the Company’s collaboration and license agreements, certain accruals, including those related to nonclinical and clinical activities, the stand-alone selling price of performance obligations associated with the Company’s collaboration and license agreements, work-in-process inventory and inventory overhead. Although the estimates are based on the Company’s knowledge of current events, comparable companies, and actions it may undertake in the future, actual results may ultimately materially differ from these estimates and assumptions. Segment Information Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, the Chief Executive Officer, in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business as one operating segment. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Cash and Cash Equivalents The Company considers all short-term investments purchased with a maturity of three months or less when acquired to be cash equivalents. Accounts Receivable Accounts receivable is stated at the original invoice amount and consists of amounts due from customers related to milestones achieved, certain research and development and clinical supply costs subject to reimbursement under the collaboration and license agreements, royalties earned, and product sales. The Company records accounts receivables net of any allowances for doubtful accounts for potential credit losses. An allowance for doubtful accounts is determined based on the financial condition and creditworthiness of customers and the Company considers economic factors and events or trends expected to affect future collections experience. Any allowance would reduce the net receivables to the amount that is expected to be collected. The payment history of the Company’s customers will be considered in future assessments of collectability as these patterns are established over a longer period of time. The Company did not record any credit losses as of September 30, 2023 or December 31, 2022. Inventory The Company began capitalizing inventory for REZZAYO, which received approval by the U.S. Food and Drug Administration, or FDA, in March 2023. REZZAYO (rezafungin for injection) is approved for the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options. Prior to regulatory approval, all direct and indirect manufacturing costs were charged to research and development expense in the period incurred. Inventory is comprised of raw materials, work-in-process and finished goods, and includes costs related to materials, third-party contract manufacturing, freight-in and overhead. Inventory is stated at the lower of cost or net realizable value with cost based on the first-in-first-out method. The Company performs an assessment of recoverability of capitalized inventory during each reporting period based on an analysis of forecasted demand compared to quantities on hand and any firm purchase orders, as well as product shelf life, and writes down any excess, obsolete or unsaleable inventory to its estimated realizable value in the period which the required reserve is first identified. Such write downs, should they occur, are charged to cost of product revenue in the condensed consolidated statements of operations and comprehensive income (loss). As of September 30, 2023, the Company did not identify any excess, obsolete or unsaleable inventory. Property and Equipment The Company records property and equipment at cost, which consists of laboratory equipment, computer equipment and software, office equipment, furniture and fixtures and leasehold improvements. Property and equipment is depreciated using the straight-line method over the estimated useful lives (generally three Income Taxes The Company follows the FASB ASC 740, Income Taxes , or ASC 740, in reporting deferred income taxes. ASC 740 requires a company to recognize deferred tax assets and liabilities for expected future income tax consequences of events that have been recognized in the Company’s condensed consolidated financial statements. Under this method, deferred tax assets and liabilities are determined based on temporary differences between financial statement carrying amounts and the tax basis of assets and liabilities using enacted tax rates in the years in which the temporary differences are expected to reverse. Valuation allowances are provided if, based on the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The Company accounts for uncertain tax positions pursuant to ASC 740, which prescribes a recognition threshold and measurement process for financial statement recognition of uncertain tax positions taken or expected to be taken in a tax return. If the tax position meets this threshold, the benefit to be recognized is measured as the tax benefit having the highest likelihood of being realized upon ultimate settlement with the taxing authority. The Company recognizes interest accrued related to unrecognized tax benefits and penalties in the provision for income taxes. Revenue Recognition The Company recognizes revenue is accordance with ASC Topic 606, Revenue from Contracts with Customers , or Topic 606, which applies to all contracts with customers, except for elements of certain contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. Under Topic 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of Topic 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of Topic 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. In a contract with multiple performance obligations, the Company must develop estimates and assumptions that require judgment to determine the underlying stand-alone selling price for each performance obligation, which determines how the transaction price is allocated among the performance obligations. The estimation of the stand-alone selling price(s) may include estimates regarding forecasted revenues or costs, development timelines, discount rates, and probabilities of technical and regulatory success. The Company evaluates each performance obligation to determine if it can be satisfied at a point in time or over time. Any change made to estimated progress towards completion of a performance obligation and, therefore, revenue recognized will be recorded as a change in estimate. In addition, variable consideration must be evaluated to determine if it is constrained and, therefore, excluded from the transaction price. Collaboration Revenue If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in a contract, the Company recognizes revenues from the transaction price allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from the allocated transaction price. The Company evaluates the measure of progress at each reporting period and, if necessary, adjusts the measure of performance and related revenue or expense recognition as a change in estimate. At the inception of each arrangement that includes milestone payments, the Company evaluates whether the milestones are considered probable of being reached. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the Company’s or a collaboration partner’s control, such as regulatory approvals, are generally not considered probable of being achieved until those approvals are received. At the end of each reporting period, the Company re-evaluates the probability of achievement of milestones that are within its or a collaboration partner’s control, such as operational developmental milestones and any related constraint, and, if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which will affect collaboration revenues and earnings in the period of adjustment. Revisions to the Company’s estimate of the transaction price may also result in negative collaboration revenues and earnings in the period of adjustment. For arrangements that include sales-based royalties, including commercial milestone payments based on the level of sales, and a license is deemed to be the predominant item to which the royalties relate, the Company will recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied, or partially satisfied. In September 2019, the Company entered into a Collaboration and License Agreement, or the Mundipharma Collaboration Agreement, with Mundipharma Medical Company, or Mundipharma. The Company concluded that there were three performance obligations under the Mundipharma Collaboration Agreement: the license, the research and development services, and the clinical supply services, and that the obligations are distinct from each other. In March 2021, the Company entered into an exclusive worldwide license and collaboration agreement, or the Janssen Collaboration Agreement, with Janssen Pharmaceuticals, Inc., or Janssen, one of the Janssen Pharmaceutical Companies of Johnson & Johnson. The Company concluded that there were three performance obligations under the Janssen Collaboration Agreement: the license, the research and development services, and the clinical supply services, and that the obligations are distinct from each other. In July 2022, the Company entered into a License Agreement with Melinta, or the Melinta License Agreement. The Company concluded that there were three performance obligations under the Melinta License Agreement: the license, the research and development services, and the clinical supply services, and that the obligations are distinct from each other. The Company concluded that progress towards completion of the research and development and clinical supply performance obligations related to the Mundipharma Collaboration Agreement and the Melinta License Agreement, is best measured in an amount proportional to the collaboration expenses incurred and the total estimated collaboration expenses. The Company periodically reviews and updates the estimated collaboration expenses, when appropriate, which may adjust revenue recognized for the period. While such changes to the Company’s estimates have no impact on the Company’s reported cash flows, the amount of revenue recorded in the period could be materially impacted. Revenue from research and development services for the Janssen Collaboration Agreement is recognized based on actual amounts billed as the underlying services are provided and billed at market rates. The transaction prices to be recognized as revenue under both the Mundipharma Collaboration Agreement and the Janssen Collaboration Agreement consist of upfront payments, estimated reimbursable research and development and clinical supply costs, and milestones achieved to date. The transaction price to be recognized as revenue under the Melinta License Agreement consists of an upfront payment and milestones achieved to date. Potential future payments for variable consideration, such as clinical, regulatory or commercial milestones, will be recognized when it is probable that, if recorded, a significant reversal will not take place. Potential future royalty payments will be recorded as revenue when the associated sales occur. See Note 8 for additional information. Product Revenue In December 2022 and January 2023, the Company entered into separate Commercial Supply Agreements with Mundipharma and Melinta, respectively, for the batch supply of REZZAYO naked vials for commercial use. Under the Commercial Supply Agreements, Mundipharma and Melinta are required to submit purchase orders to the Company for batches of REZZAYO naked vials. The Company concluded that the delivery of each batch of REZZAYO naked vials and the related quality assessment certification represents a distinct performance obligation. The transaction price to be recognized as revenue for each performance obligation under the Commercial Supply Agreements consists of variable consideration which is determined based on the estimated per vial costs, plus the contractually stated margin rate. The amounts recognized as revenue are adjusted, as needed, each reporting period based on actual costs incurred for each batch. Variable consideration is included in the transaction price only to the extent that it is considered probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The transaction price will be fully allocated to the single performance obligation. The Company concluded that the performance obligation is satisfied and product revenue is recognized when the customer obtains control of the product, which occurs at a point in time, typically upon the later of (i) completion of a positive quality assessment, or (ii) shipment of the Company’s product to the customer. Shipping and handling activities that are performed after a customer obtains control of the product are treated as activities to fulfill the promise to a customer and any amounts billed to a customer represent revenues for the product provided. Costs related to such shipping and handling billings are classified as cost of product revenue. Cost of Product Revenue Cost of product revenue consists primarily of costs related to materials, third-party contract manufacturing, freight-in and overhead. Prior to regulatory approval, all direct and indirect manufacturing costs were charged to research and development expense in the period incurred. Research and Development Costs Research and development expenses consist of wages, benefits and stock-based compensation charges for research and development employees, scientific consultant fees, facilities and overhead expenses, laboratory supplies, manufacturing expenses in preclinical development and certain manufacturing expenses before FDA approval, and nonclinical and clinical trial costs. The Company accrues nonclinical and clinical trial expenses based on work performed, which relies on estimates of total costs incurred based on patient enrollment, completion of studies, and other events. Costs incurred in purchasing technology assets and intellectual property are charged to research and development expense if the technology has not been conclusively proven to be feasible and has no alternative future use. Preclinical and Clinical Trial Accruals The Company makes estimates of its accrued expenses as of each balance sheet date in the financial statements based on the facts and circumstances known at that time. Accrued expenses for preclinical studies and clinical trials are based on estimates of costs incurred and fees that may be associated with services provided by contract research organizations, or CROs, clinical trial investigational sites and other clinical trial-related activities. Payments under certain contracts with such parties depend on factors such as successful enrollment of patients, site initiation and the completion of clinical trial milestones. In accruing for these services, the Company estimates the time period over which services will be performed and the level of effort to be expended in each period. If possible, the Company obtains information regarding unbilled services directly from these service providers. However, the Company may be required to estimate these services based on other available information. If the Company underestimates or overestimates the activities or fees associated with a study or service at a given point in time, adjustments to research and development expenses may be necessary in future periods. Historically, estimated accrued liabilities have approximated actual expense incurred. Subsequent changes in estimates may result in a material change in accruals. Stock-Based Compensation The Company accounts for stock-based compensation expense related to stock options, restricted stock units, or RSUs, performance-based RSUs, or PRSUs, and Employee Stock Purchase Plan, or ESPP, rights by estimating the fair value on the date of grant. The Company estimates the fair value of stock options granted to employees and non-employees using the Black-Scholes option pricing model. The fair value of RSUs and PRSUs granted to employees is estimated based on the closing price of the Company’s common stock on the date of grant. The assumptions included in the Black-Scholes option pricing model include (a) the risk-free interest rate, (b) the expected volatility of the Company’s stock, (c) the expected term of the award, and (d) the expected dividend yield. The Company computed the expected volatility data using the daily close prices for the Company’s common stock during the equivalent period of the calculated expected term of the Company’s stock-based awards. The Company estimated the expected life of employee stock options using the “simplified” method, whereby the expected life equals the average of the vesting term and the original contractual term of the option. The risk-free interest rates for periods within the expected life of the option are based on the yields of zero-coupon U.S. treasury securities. The expected dividend yield of zero reflects that the Company has not paid cash dividends since inception and do not intend to pay cash dividends in the foreseeable future. For awards subject to time-based vesting conditions, including those with a graded vesting schedule, stock-based compensation expense is recognized using the straight-line method. For performance-based awards to employees, (i) the fair value of the award is determined on the grant date, (ii) the Company assesses the probability of the individual performance milestones under the award being achieved and (iii) the fair value of the shares subject to the milestone is expensed over the implicit service period commencing once management believes the performance criteria is probable of being met. The Company recognizes forfeitures related to stock-based compensation as they occur and any compensation cost previously recognized for awards for which the requisite service has not been completed is reversed in the period that the award is forfeited. Net Earnings (Loss) Per Share The Company follows the guidance in FASB ASC 260, Earnings Per Share , or ASC 260, which establishes standards regarding the computation of earnings per share, or EPS, by companies that have issued securities other than common stock that contractually entitle the holder to participate in dividends and earnings of a company. The guidance requires earnings to be hypothetically allocated between the common, preferred, and other participating stockholders based on their respective rights to receive non-forfeitable dividends, whether or not declared. Participating securities include Series X Convertible Preferred Stock (see Note 6). Basic net EPS is then calculated by dividing the net income attributable to common stockholders (after the reduction for any preferred stock and assuming current income for the period had been distributed) by the weighted-average number of common shares outstanding for the period. The Company calculates diluted net EPS by using the more dilutive of the (1) treasury stock method, reverse treasury stock method or if-converted method, as applicable, or (2) the two-class method. Dilutive common stock equivalents are comprised of warrants, Series X Convertible Preferred Stock, RSUs, PRSUs and options outstanding under the Company’s stock option plans and ESPP, on an as converted basis. Basic net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding for the period, without consideration for potentially dilutive securities. Diluted net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares and dilutive stock equivalents outstanding for the period determined using the treasury stock method or if-converted method. Under the two-class method, the net loss attributable to common stockholders is not allocated to the Series X Convertible Preferred Stock as the preferred stockholders do not have a contractual obligation to share in the Company’s losses. In loss periods, basic and diluted net loss per share are identical because the otherwise dilutive potential common shares become anti-dilutive and are therefore excluded. The following table sets forth the computation of basic and diluted net earnings (loss) per common share (in thousands, except share and per share data): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Numerator: Net income (loss) $ (8,172) $ 14,978 $ (17,320) $ (16,422) Allocation of earnings to participating securities — (3,081) — — Numerator for basic net earnings (loss) per common share - net income (loss) attributable to common stockholders $ (8,172) $ 11,897 $ (17,320) $ (16,422) Effect of participating securities: Add back allocation of earnings to participating securities — 3,081 — — Numerator for diluted net earnings (loss) per common share - net income (loss) attributable to common stockholders $ (8,172) $ 14,978 $ (17,320) $ (16,422) Denominator: Denominator for basic net earnings (loss) per common share - weighted average common shares outstanding 90,287,441 70,217,985 86,390,446 69,170,865 Effect of dilutive securities: Series X Convertible Preferred Stock, as converted — 18,184,720 — — Common stock options, RSUs, PRSUs, and ESPP — 189,863 — — Denominator for diluted net earnings (loss) per common share - adjusted weighted average common shares outstanding 90,287,441 88,592,568 86,390,446 69,170,865 Basic net earnings (loss) per common share $ (0.09) $ 0.17 $ (0.20) $ (0.24) Diluted net earnings (loss) per common share $ (0.09) $ 0.17 $ (0.20) $ (0.24) The following table sets forth the outstanding potentially dilutive securities that have been excluded in the calculation of basic and diluted net loss per share because doing so would be anti-dilutive (in common stock equivalent shares): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Common stock warrants 17,331 12,517,328 17,331 12,517,328 Series X Convertible Preferred Stock 21,044,720 — 21,044,720 18,184,720 Common stock options, RSUs and PRSUs issued and outstanding 12,924,675 10,041,333 12,924,675 10,086,839 Total 33,986,726 22,558,661 33,986,726 40,788,887 Fair Value of Financial Instruments The Company follows ASC 820-10 issued by the FASB with respect to fair value reporting for financial assets and liabilities. The guidance defines fair value, provides guidance for measuring fair value and requires certain disclosures. The guidance does not apply to measurements related to share-based payments. The guidance discusses valuation techniques such as the market approach (comparable market prices), the income approach (present value of future income or cash flow), and the cost approach (cost to replace the service capacity of an asset or replacement cost). The guidance establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into three broad levels. The Company’s financial instruments consist of cash and cash equivalents, accounts receivable, accounts payable, accrued liabilities, accrued compensation and benefits, and lease liability. The carrying amount of these financial instruments are generally considered to be representative of their respective fair values because of their short-term nature. Recently Issued and Recently Adopted Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that are adopted by the Company as of the specified effective date. The Company believes, based on its preliminary assessment, that the recently issued, but not yet adopted, accounting pronouncements will not have a material impact on the Company’s condensed consolidated financial statements or related disclosures, or do not apply to the Company. |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE MEASUREMENTS | FAIR VALUE MEASUREMENTS The Company follows ASC 820-10, Fair Value Measurements and Disclosures, which among other things, defines fair value, establishes a consistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or nonrecurring basis. Fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in measuring fair value as follows: Level 1: Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities; Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and Level 3: Unobservable inputs for which there is little or no market data, which require the reporting entity to develop its own assumptions, which reflect those that a market participant would use. The Company classifies investments in money market accounts within Level 1 as the prices are available from quoted prices in active markets. None of the Company’s non-financial assets or liabilities are recorded at fair value on a non-recurring basis. No transfers between levels have occurred during the periods presented. The following tables summarize the Company’s financial instruments measured at fair value on a recurring basis (in thousands): TOTAL LEVEL 1 LEVEL 2 LEVEL 3 September 30, 2023 Assets: Cash and money market accounts $ 48,670 $ 48,670 $ — $ — Total assets at fair value $ 48,670 $ 48,670 $ — $ — December 31, 2022 Assets: Cash and money market accounts $ 32,731 $ 32,731 $ — $ — Total assets at fair value $ 32,731 $ 32,731 $ — $ — |
INVENTORY
INVENTORY | 9 Months Ended |
Sep. 30, 2023 | |
Inventory Disclosure [Abstract] | |
INVENTORY | INVENTORY Inventory consisted of the following (in thousands): September 30, December 31, Raw materials $ 733 $ — Work-in-process 1,734 — Finished goods — — Total inventory $ 2,467 $ — The Company’s capitalized inventory consists of costs incurred subsequent to FDA approval of REZZAYO in March 2023. Prior to regulatory approval, all direct and indirect manufacturing costs were charged to research and development expense in the period incurred. There were no inventory write downs during the nine months ended September 30, 2023. |
DEBT
DEBT | 9 Months Ended |
Sep. 30, 2023 | |
Debt Disclosure [Abstract] | |
DEBT | DEBT Term Loan On October 3, 2016, the Company entered into a loan and security agreement, or the Loan Agreement, with Pacific Western Bank, as the collateral agent and a lender, or the Lender, pursuant to which the Company has borrowed $10.0 million from the Lender, or the Term A Loan. The Term A Loan bore interest at a variable annual rate equal to the greater of (i) 4.5% or (ii) the Lender’s prime interest rate plus 0.75%, and matured on July 3, 2022. The Term A Loan had an interest-only period through April 3, 2020, which was followed by equal monthly principal payments and was paid in full on July 5, 2022. |
STOCKHOLDERS_ EQUITY
STOCKHOLDERS’ EQUITY | 9 Months Ended |
Sep. 30, 2023 | |
Equity [Abstract] | |
STOCKHOLDERS’ EQUITY | STOCKHOLDERS’ EQUITY Controlled Equity Sales Agreement In September 2019, the Company began to sell shares of common stock under a controlled equity sales agreement, or the Sales Agreement, entered into on November 8, 2018 with Cantor Fitzgerald & Co, or Cantor. During the nine months ended September 30, 2023, the Company sold 6,219,741 shares of common stock, at a weighted average price of $1.44 per share for gross proceeds of approximately $9.0 million, and for net proceeds of approximately $8.7 million after deducting placement agent fees. During the nine months ended September 30, 2022, the Company sold 2,308,435 shares of common stock for net proceeds of approximately $1.7 million after deducting placement agent fees. As of September 30, 2023, the remaining capacity under the Sales Agreement is $37.1 million. 2023 Underwritten Public Offering On March 7, 2023, the Company completed concurrent but separate underwritten public offerings with Cantor, the underwriter, to issue and sell 11,086,000 shares of its common stock, including the exercise in full by Cantor of their option to purchase an additional 1,446,000 shares of common stock, and 286,000 shares of the Company’s Series X Convertible Preferred Stock. Cantor agreed to purchase the shares of common stock at a price of $1.267 per share and the shares of Series X Convertible Preferred Stock at a price of $12.67 per share. The total gross proceeds from the offerings, including the full exercise by Cantor of its option to purchase additional shares of common stock, were approximately $19.5 million, before deducting underwriting discounts and commissions and offering expenses. The Company received total net proceeds of approximately $17.3 million, after deducting underwriting discounts, commissions, and other expenses payable by the Company. Preferred Stock Under the amended and restated certificate of incorporation, the Company’s board of directors has the authority, without further action by the stockholders, to issue up to 10,000,000 shares of preferred stock in one or more series, to establish from time to time the number of shares to be included in each such series, to fix the rights, preferences and privileges of the shares of each wholly unissued series and any qualifications, limitations or restrictions thereon and to increase or decrease the number of shares of any such series, but not below the number of shares of such series then outstanding. The Company had 10,000,000 shares of preferred stock authorized at September 30, 2023. In May 2018, the Company designated 5,000,000 shares of preferred stock as Series X Convertible Preferred Stock with a par value of $0.0001 per share. On August 12, 2020, at the request of certain holders, 52,241 shares of the Company’s Series X Convertible Preferred Stock were converted to an aggregate of 522,410 shares of the Company’s common stock. As of September 30, 2023 and December 31, 2022, shares of preferred stock designated as Series X Convertible Preferred Stock totaled 4,947,759. The specific terms of the Series X Convertible Preferred Stock are as follows: Conversion: Each share of Series X Convertible Preferred Stock is convertible at the option of the holder into 10 shares of common stock. Holders are not permitted to convert Series X Convertible Preferred Stock into common stock if, after conversion, the holder, its affiliates, and any other person whose beneficial ownership of common stock would be aggregated with the holder’s for purposes of Section 13(d) or Section 16 of the Exchange Act, would beneficially own more than 9.99% of the number of shares of common stock outstanding immediately after the conversion. Dividends: Holders of Series X Convertible Preferred Stock are not entitled to receive any dividends except to the extent that dividends are paid on the Company’s common stock. If dividends are paid on shares of common stock, holders of Series X Convertible Preferred Stock are entitled to participate in such dividends on an as-converted basis. Liquidation: Upon the liquidation, dissolution, or winding up of the Company, each holder of Series X Convertible Preferred Stock will participate pari passu with any distribution of proceeds to holders of common stock. Voting: Shares of Series X Convertible Preferred Stock will generally have no voting rights, except as required by law and except that the consent of the holders of a majority of the outstanding Series X Convertible Preferred Stock will be required to amend the terms of the Series X Convertible Preferred Stock, if such action would adversely alter or change the preferences, rights, privileges or powers of, or restrictions provided for the benefit of the Series X Convertible Preferred Stock, or to increase or decrease (other than by conversion) the number of authorized shares of Series X Convertible Preferred Stock. The Company evaluated the Series X Convertible Preferred Stock for liability or equity classification under ASC 480, Distinguishing Liabilities from Equity , and determined that equity treatment was appropriate because the Series X Convertible Preferred Stock did not meet the definition of liability instruments defined thereunder as convertible instruments. Additionally, the Series X Convertible Preferred Stock is not redeemable for cash or other assets (i) on a fixed or determinable date, (ii) at the option of the holder, and (iii) upon the occurrence of an event that is not solely within control of the Company. As such, the Series X Convertible Preferred Stock is recorded as permanent equity. Common Stock The Company had 200,000,000 shares of common stock authorized as of September 30, 2023. Holders of outstanding shares of common stock are entitled to one vote for each share held of record on all matters submitted to a vote of the holders of common stock. Subject to the rights of the holders of any class of the Company’s capital stock having any preference or priority over common stock, the holders of common stock are entitled to receive dividends that are declared by the Company’s board of directors out of legally available funds. In the event of a liquidation, dissolution or winding-up, the holders of common stock are entitled to share ratably in the net assets remaining after payment of liabilities, subject to prior rights of preferred stock, if any, then outstanding. The common stock has no preemptive rights, conversion rights, redemption rights or sinking fund provisions, and there are no dividends in arrears or default. All shares of common stock have equal distribution, liquidation and voting rights, and have no preferences or exchange rights. Common Stock Warrants As of September 30, 2023, warrants to purchase 17,331 shares of the Company’s common stock were outstanding with a weighted average exercise price of $11.54 per share. During the nine months ended September 30, 2023, 12,499,997 common stock warrants expired unexercised. As of December 31, 2022, warrants to purchase 12,517,328 shares of the Company’s common stock were outstanding with a weighted average exercise price of $6.82 per share. The warrants had no intrinsic value at September 30, 2023 and December 31, 2022. The intrinsic value of a common stock warrant is the difference between the market price of the common stock at the measurement date and the exercise price of the warrant. Common Stock Reserved for Future Issuance Common stock reserved for future issuance is as follows (in common stock equivalent shares): September 30, December 31, Common stock warrants 17,331 12,517,328 Series X Convertible Preferred Stock 21,044,720 18,184,720 Common stock options, RSUs and PRSUs issued and outstanding 12,924,675 9,323,495 Authorized for future stock awards 3,288,730 4,469,969 Awards available under the ESPP 1,135,937 806,968 Total 38,411,393 45,302,480 |
EQUITY INCENTIVE PLANS
EQUITY INCENTIVE PLANS | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
EQUITY INCENTIVE PLANS | EQUITY INCENTIVE PLANS 2020 Inducement Incentive Plan and 2015 Equity Incentive Plan In December 2020, the Company’s board of directors approved and adopted the 2020 Inducement Incentive Plan, or 2020 IIP. Under the 2020 IIP, the Company may grant stock options, stock appreciation rights, restricted stock, RSUs, and other awards to individuals who were not previously employees or directors of the Company, or who are returning to employment following a bona fide period of non-employment with the Company, as an inducement material to such persons entering into employment with the Company. In March 2015, the Company’s board of directors and stockholders approved and adopted the 2015 Equity Incentive Plan, or 2015 EIP. Under the 2015 EIP, the Company may grant stock options, stock appreciation rights, restricted stock, RSUs, and other awards to individuals who are employees, officers, directors or consultants of the Company. The number of shares of stock available for issuance under the 2015 EIP is automatically increased each January 1 by 4% of the outstanding number of shares of the Company’s common stock on the immediately preceding December 31 or such lesser number as determined by the Company’s board of directors. Terms of stock award agreements, including vesting requirements, are determined by the board of directors, subject to the provisions of the 2020 IIP and 2015 EIP. Stock options granted by the Company generally vest over a three 2015 Employee Stock Purchase Plan In March 2015, the Company’s board of directors and stockholders approved and adopted the 2015 Employee Stock Purchase Plan, or the ESPP. The number of shares of stock available for issuance under the ESPP will be automatically increased each January 1 by the lesser of (i) 1% of the outstanding number of shares of the Company’s common stock on the immediately preceding December 31, (ii) 490,336 shares, or (iii) such lesser number as determined by the Company’s board of directors. The ESPP allows substantially all employees to purchase the Company’s common stock through a payroll deduction at a price equal to 85% of the lower of the fair market value of the stock as of the beginning or the end of each purchase period. An employee’s payroll deductions under the ESPP are limited to 15% of the employee’s eligible compensation. During the nine months ended September 30, 2023 and 2022, 161,367 shares and 184,219 shares, respectively, were issued pursuant to the ESPP. As of September 30, 2023, total unrecognized compensation expense related to the ESPP was immaterial and is expected to be recognized over approximately 0.3 years. Restricted Stock Units The following table summarizes RSU and PRSU activity during the nine months ended September 30, 2023: Number of Weighted Average Grant Date Fair Value Outstanding at December 31, 2022 1,223,871 $ 1.47 RSUs and PRSUs granted 1,465,817 1.00 RSUs and PRSUs vested (462,146) 1.51 RSUs and PRSUs canceled (127,201) 1.29 Outstanding at September 30, 2023 2,100,341 $ 1.15 The weighted-average grant date fair value of RSUs and PRSUs granted by the Company during the nine months ended September 30, 2022 was $0.83 per share. The total fair value of RSUs and PRSUs vested during the nine months ended September 30, 2023 and 2022 was approximately $0.7 million and $1.6 million, respectively. At September 30, 2023, estimated unrecognized compensation expense related to RSUs and PRSUs granted was approximately $2.0 million. Stock Options The following table summarizes stock option activity during the nine months ended September 30, 2023: Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life in Years Total Aggregate Intrinsic Value (in thousands) Outstanding at December 31, 2022 8,099,624 $ 2.78 6.65 $ 48 Options granted 3,233,558 1.02 Options exercised (16,250) 0.83 Options canceled (492,598) 3.60 Outstanding at September 30, 2023 10,824,334 $ 2.22 6.99 $ 246 Vested and expected to vest at September 30, 2023 10,824,334 $ 2.22 6.99 $ 246 Exercisable at September 30, 2023 6,874,604 $ 2.83 5.77 $ 163 The intrinsic value of a stock option is the difference between the market price of the common stock at the measurement date and the exercise price of the option. The weighted-average grant date fair value of stock options granted by the Company during the nine months ended September 30, 2023 and 2022 was $0.72 and $0.51 per share, respectively. As of September 30, 2023, total unrecognized share-based compensation expense related to unvested stock options was approximately $3.0 million. This unrecognized compensation cost is expected to be recognized over a weighted-average period of approximately 2.0 years. Stock-based compensation expense recognized for RSUs, PRSUs, stock options, and the ESPP has been reported in the condensed consolidated statements of operations and comprehensive income (loss) as follows (in thousands): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Research and development $ 393 $ 443 $ 1,193 $ 1,366 General and administrative 403 399 1,038 1,666 Total $ 796 $ 842 $ 2,231 $ 3,032 |
SIGNIFICANT AGREEMENTS AND CONT
SIGNIFICANT AGREEMENTS AND CONTRACTS | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
SIGNIFICANT AGREEMENTS AND CONTRACTS | SIGNIFICANT AGREEMENTS AND CONTRACTS Mundipharma Collaboration Agreement On September 3, 2019, the Company entered into the Mundipharma Collaboration Agreement with Mundipharma, a related party, for a strategic collaboration to develop and commercialize rezafungin in an intravenous formulation, or the Mundipharma Licensed Product, for the treatment and prevention of invasive fungal infections. Collaboration . Under the Mundipharma Collaboration Agreement, the Company is responsible for leading the conduct of an agreed global development plan, or the Global Development Plan, that includes the Company’s ongoing Phase 3 pivotal clinical trial of the Mundipharma Licensed Product for the treatment of candidemia and/or invasive candidiasis, or the ReSTORE Trial, and the Company’s ongoing Phase 3 pivotal clinical trial of the Mundipharma Licensed Product for the prophylaxis of invasive fungal infections in adult allogeneic blood and marrow transplant recipients, or the ReSPECT Trial, as well as specified GLP-compliant non‑clinical studies and chemistry, manufacturing and controls, or CMC, development activities for the Mundipharma Licensed Product. Mundipharma is responsible for performing all development activities, other than Global Development Plan activities, that may be necessary to obtain and maintain regulatory approvals for the Mundipharma Licensed Product outside of the U.S. and Japan, or the Mundipharma Territory, at Mundipharma’s sole cost. Licenses . Pursuant to the Mundipharma Collaboration Agreement, the Company granted Mundipharma an exclusive, royalty‑bearing license to develop, register and commercialize the Mundipharma Licensed Product in the Mundipharma Territory, subject to the Company’s retained right as described below. The Company also granted Mundipharma an option to obtain exclusive licenses to develop, register and commercialize rezafungin in a formulation for subcutaneous administration, or Subcutaneous Product, and in formulations for other modes of administration, or Other Products, in the Mundipharma Territory, subject to similar retained rights of the Company to conduct mutually agreed global development activities for such products. In addition, the Company granted Mundipharma a co‑exclusive, worldwide license to manufacture the Mundipharma Licensed Product and rezafungin. Until the seventh anniversary of the first commercial sale of the Mundipharma Licensed Product in the Mundipharma Territory, each party has granted the other party an exclusive, time-limited right of first negotiation to obtain a license to any anti-fungal product (other than Mundipharma Licensed Product, Subcutaneous Product and Other Products) that such party proposes to out-license in the other party’s territory. The Company’s Retained Rights. As of September 30, 2023, the Company retained the exclusive right to develop, register and commercialize the Mundipharma Licensed Product, Subcutaneous Product and Other Products in Japan, or the Company Territory, and Mundipharma has granted the Company certain licenses under Mundipharma-controlled technology and jointly-developed technology to develop, register and commercialize Mundipharma Licensed Product, Subcutaneous Product and Other Products in the Company Territory and to manufacture such products and rezafungin worldwide. Financial Terms . As of the execution of the Mundipharma Collaboration Agreement, the parties have agreed to share equally (50/50) the costs of Global Development Plan activities, or Global Development Costs, subject to a cap on Mundipharma’s Global Development Cost share of $31.2 million. The total potential transaction value is $568.4 million, including an equity investment, an up-front payment, global development funding, and certain development, regulatory, and commercial milestones. The Company is also eligible to receive double-digit royalties in the teens on tiers of annual net sales. Termination . Either party may terminate the Mundipharma Collaboration Agreement for uncured material breach by the other party. Mundipharma may terminate the Mundipharma Collaboration Agreement at will, provided that if Mundipharma terminates the Mundipharma Collaboration Agreement in its entirety prior to the last visit of the last patient in both the ReSTORE Trial and the ReSPECT Trial, Mundipharma will continue to be liable for its share of Global Development Costs as described above. The Company may terminate the Mundipharma Collaboration Agreement if Mundipharma or any of its affiliates or sublicensees, directly or indirectly through any third party, commences any interference or opposition proceeding with respect to, challenges the validity or enforceability of, or opposes any extension of or the grant of a supplementary protection certificate with respect to, any of the Company’s patent rights licensed to Mundipharma, or upon an insolvency event of Mundipharma. Revenue Recognition As of September 30, 2023, the Company determined the transaction price is equal to the up-front fee of $30.0 million, plus the research and development funding of $31.2 million, plus milestones achieved of $13.9 million. The common stock issued pursuant to the Mundipharma Stock Purchase Agreement was determined to be issued at fair market value after applying a lack of marketability discount as Mundipharma received restricted shares. Therefore, no additional premium or discount was allocated to the transaction price of the Mundipharma Collaboration Agreement for the share issuance. The transaction price was allocated to the performance obligations on the basis of the relative stand-alone selling price estimated for each performance obligation. In estimating the stand-alone selling price for each performance obligation, the Company utilized discounted cash flows and developed assumptions that required judgment and included forecasted revenues, expected development timelines, discount rates, probabilities of technical and regulatory success and costs for manufacturing clinical supplies. A description of the distinct performance obligations identified under the Mundipharma Collaboration Agreement, as well as the amount of revenue allocated to each distinct performance obligation, is as follows: Licenses of Intellectual Property. The license to the Company’s intellectual property, bundled with the associated know-how, represents a distinct performance obligation. The license and associated know-how was transferred to Mundipharma during September 2019, therefore the Company recognized the revenue related to this performance obligation in the amount of $17.9 million in September 2019 as collaboration revenue in its condensed consolidated statements of operations and comprehensive income (loss). Research and Development Services. The Company and Mundipharma share equally in the costs of ongoing rezafungin clinical development in the Mundipharma Territory up to the specified cap, which represents a distinct performance obligation. The Company records these cost-sharing payments due from Mundipharma as collaboration revenue. The Company concluded that progress towards completion of the performance obligation related to the research and development services is best measured in an amount proportional to the research and development expenses incurred and the total estimated research and development expenses. Clinical Supply Services. The Company’s initial obligation to supply rezafungin for ongoing clinical development in the Mundipharma Territory represents a distinct performance obligation. The Company concluded that progress towards completion of the performance obligations related to the clinical supply services is best measured in an amount proportional to the clinical supply services expenses incurred and the total estimated clinical supply services. Milestone Payments. In November 2020, the Company achieved a $11.1 million milestone under the Mundipharma Collaboration Agreement, which is recorded as long-term contract liabilities as of September 30, 2023 because the rights to consideration is not expected to be satisfied within one year. The Company received payment for this milestone in January 2021. Mundipharma is entitled to credit the full amount of this milestone payment toward future royalties payable to the Company, subject to a limit on the amount by which royalty payments to the Company may be reduced in any quarter. If Mundipharma has not fully credited the amount of such milestone payment toward royalties payable to the Company before the earlier of (i) December 31, 2024 and (ii) termination of the Mundipharma Collaboration Agreement by Mundipharma, the Company will be obligated to refund the uncredited portion of such milestone payment to Mundipharma on the earlier of such dates. As of September 30, 2023, the Company estimated the uncredited portion to be approximately $10.1 million in December 2024. In December 2021 and August 2022, the Company achieved milestones of $2.8 million and $11.1 million, respectively, under the Mundipharma Collaboration Agreement that the Company deems to be tied to all the performance obligations identified in the original agreement. Revenue associated with these milestones has been allocated proportionately to the original transaction price which was allocated to the performance obligations on the basis of the relative stand-alone selling price estimated for each performance obligation. In conjunction with the performance obligations already delivered, revenue is recognized based on the progress of these performance obligations, the unrecognized portion is recorded as contract liabilities at the reporting period end and will be recognized as revenue over the remaining progress of these performance obligations. The Company received payment for these milestones in January 2022 and September 2022, respectively. The Company determined that as of September 30, 2023, all remaining potential milestone payments are probable of significant revenue reversal as their achievement is highly dependent on factors outside the Company’s control or are otherwise constrained under the variable consideration guidance. Therefore, these milestone payments have been fully constrained and are not included in the transaction price. At the end of each subsequent reporting period, the Company will re-evaluate the probability of achievement of each milestone and any related constraint. Royalties. As the license is deemed to be the predominant item to which sales-based royalties relate, the Company will recognize royalty revenue when the related sales occur. No royalty revenue was recognized during the three and nine months ended September 30, 2023 and 2022. Janssen Collaboration Agreement On March 31, 2021, the Company and Janssen entered into the Janssen Collaboration Agreement to develop and commercialize one or more DFCs based on the Company’s Cloudbreak platform, for the prevention and treatment of influenza, including CD388 and CD377, or the Products. The effectiveness of the Janssen Collaboration Agreement, including the effectiveness of the terms and conditions described below, was subject to the expiration or earlier termination of all applicable waiting periods under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, or HSR. HSR clearance was obtained on May 12, 2021 and the Janssen Collaboration Agreement became effective on the same date. Collaboration . The Company and Janssen will collaborate in the research, preclinical development and early clinical development of CD388 or another mutually-agreed influenza DFC development candidate, or, in each case, the Development Candidate, under a mutually-agreed research and development plan, or the Research Plan, with the objective of advancing such Development Candidate through the completion of mutually-agreed Phase 1 clinical trials and the first Phase 2 clinical trial, or Phase 2 Study. Unless otherwise agreed by the parties, the Company will be responsible for performing, or having performed, all investigational new drug application, or IND, -enabling studies and clinical trials under the Research Plan, and the Company will be the IND holder for the Research Plan clinical trials. Both parties will be responsible for conducting certain specified CMC development activities under the Research Plan. Janssen will be solely responsible, and reimburse the Company, for internal full-time equivalent and out-of-pocket costs incurred by the Company in performing Research Plan activities in accordance with a mutually-agreed budget. As part of a recent prioritization of its R&D business, in July 2023 Janssen disclosed its intention to discontinue internal development of multiple product candidates in its infectious disease pipeline, including CD388. However, in September 2023 Janssen delivered its Election to Proceed Notice for CD388 whereby Janssen will assume the future development, manufacturing and commercialization activities of CD388 but intends to transfer its rights and obligations under the Janssen Collaboration Agreement to another transferee. The Company continues to work in collaboration with Janssen to complete the Phase 1 and Phase 2a clinical trials and will be reimbursed for all ongoing development activities by Janssen as per the Janssen Collaboration Agreement. Following Janssen’s Election to Proceed Notice, Janssen, or any third-party transferee, is obligated at its sole expense to diligently continue development and commercialization either itself or through the transferee to whom it sublicenses or assigns the rights. If Janssen sublicenses or assigns the rights to a third party, then all terms under the current Janssen Collaboration Agreement will survive without modification. Licenses . Upon the effectiveness of the Janssen Collaboration Agreement, the Company granted Janssen an exclusive, worldwide, royalty-bearing license to develop, register and commercialize Products, subject to the Company’s retained right to conduct Research Plan activities as described above. In addition, the Company granted Janssen an exclusive right of first negotiation until December 31, 2021, to negotiate and enter into a separate definitive agreement pursuant to which the parties would collaborate in the research and development of DFCs for the treatment or prevention of respiratory syncytial virus. This right of first negotiation expired on December 31, 2021. Non-Compete Covenant . The Company will covenant that, except for the performance of Research Plan activities, from the effectiveness of the Janssen Collaboration Agreement until the fifth anniversary of the completion of all Research Plan activities and the Company’s delivery to Janssen of all Research Plan deliverables, the Company and its affiliates will not directly or indirectly (including through any third-party contractor or through or in collaboration with any third-party licensee) develop, file any IND or application for marketing approval for, or commercialize any DFC that binds influenza or influenza viral proteins at therapeutic levels, except that the Company has the right to conduct limited internal research of such DFCs for the purposes of generating data to support patent filings and improving and further developing the Company’s DFC technology more broadly. The Company’s non-compete covenant described above will not apply to any DFC that demonstrates high specificity for a virus other than the influenza virus and does not possess significant activity against the influenza virus. Financial Terms . Upon the effectiveness of the Janssen Collaboration Agreement, Janssen paid the Company an upfront payment of $27.0 million. As of the execution of the Janssen Collaboration Agreement, the Company was eligible for reimbursement by Janssen of up to $58.2 million in research and development costs incurred in conducting Research Plan activities. The Company will also be eligible to receive up to $695.0 million in development, regulatory and commercial milestone payments, as well as royalties on tiers of annual net sales at rates from the mid-single digits to the high-single digits. Termination . In addition to the Company’s right to terminate the Janssen Collaboration Agreement for Janssen’s failure to deliver the Election to Proceed Notice prior to expiration of the Election Period, the Janssen Collaboration Agreement includes standard termination provisions upon material breach, insolvency or safety concerns. In addition, Janssen may terminate the Janssen Collaboration Agreement for convenience as follows: • prior to the completion of all Research Plan activities and the Company’s delivery to Janssen of all Research Plan deliverables, upon 90 days’ written notice to the Company, provided that if any clinical trial under the Research Plan is ongoing at the time of such termination, such clinical trial will be completed in accordance with the terms of the Janssen Collaboration Agreement; • after completion of the Phase 2 Study and before expiration of the Election Period, immediately upon written notice to the Company; or • after delivery of the Election to Proceed Notice, upon 90 days’ written notice to the Company, which termination may be of the Janssen Collaboration Agreement in its entirety or on a country-by-country or Product-by-Product basis. Revenue Recognition As of September 30, 2023, the Company determined the transaction price is equal to the up-front fee of $27.0 million, plus the research and development funding of $50.2 million, plus milestones achieved of $10.0 million. The transaction price includes the total estimated costs related to research and development and clinical supply services, which can increase or decrease as costs to continue the research and development efforts become known. No revenue was reversed due to the change in transaction price as revenue is recognized based on actual amounts billed. The transaction price was allocated to the performance obligations on the basis of the relative stand-alone selling price estimated for each performance obligation. In estimating the stand-alone selling price for each performance obligation, the Company utilized discounted cash flows and developed assumptions that required judgment and included forecasted revenues, expected development timelines, discount rates, probabilities of technical and regulatory success, costs to continue the research and development efforts and costs for manufacturing clinical supplies. A description of the distinct performance obligations identified under the Janssen Collaboration Agreement, as well as the amount of revenue allocated to each distinct performance obligation, is as follows: Licenses of Intellectual Property. The license to the Company’s intellectual property, bundled with the associated know-how, represents a distinct performance obligation. The license and associated know-how was transferred to Janssen in May 2021, therefore the Company recognized the revenue related to this performance obligation in the amount of $27.0 million in May 2021 as collaboration revenue in its condensed consolidated statements of operations and comprehensive income (loss). Research and Development Services. The research and development services to be performed represents a distinct performance obligation. The Company recognizes revenue based on actual amounts incurred as the underlying services are provided and billed at fair value. Clinical Supply Services. The Company’s initial obligation to supply drug supply for ongoing development represents a distinct performance obligation. The Company recognizes revenue based on actual amounts incurred as the underlying services are provided and billed at fair value. Milestone Payments. In March 2022 and September 2023, the Company achieved milestones of $3.0 million and $7.0 million, respectively, under the Janssen Collaboration Agreement that the Company deems to be tied to all the performance obligations identified in the original agreement. Revenue associated with these milestones has been allocated proportionately to the original transaction price which was allocated to the performance obligations on the basis of the relative stand-alone selling price estimated for each performance obligation. In conjunction with the performance obligations already delivered, revenue is recognized based on the progress of these performance obligations, the unrecognized portion is recorded as contract liabilities at the reporting period end and will be recognized as revenue over the remaining progress of these performance obligations. The Company received payment for these milestones in May 2022 and September 2023, respectively. The Company determined that as of September 30, 2023, all remaining potential milestone payments are probable of significant revenue reversal as their achievement is highly dependent on factors outside the Company’s control or are otherwise constrained under the variable consideration guidance. Therefore, these milestone payments have been fully constrained and are not included in the transaction price. At the end of each subsequent reporting period, the Company will re-evaluate the probability of achievement of each milestone and any related constraint. Royalties. As the license is deemed to be the predominant item to which sales-based royalties relate, the Company will recognize royalty revenue when the related sales occur. No royalty revenue was recognized during the three and nine months ended September 30, 2023 and 2022. Melinta License Agreement On July 26, 2022, the Company entered into the Melinta License Agreement with Melinta under which the Company granted Melinta an exclusive license to develop and commercialize products that contain or incorporate rezafungin, or the Melinta Licensed Product, in the U.S., or the Melinta Territory. Licenses . Pursuant to the Melinta License Agreement, the Company granted Melinta an exclusive, royalty‑bearing license (including the right to sublicense through multiple tiers), to develop, register and commercialize the Melinta Licensed Product for all uses in humans and non-human animals in the Melinta Territory, subject to the Company’s retained right, as described below. Non-Compete Covenant . Until the fifth anniversary of the first commercial sale of the first Melinta Licensed Product in the Melinta Territory, neither the Company nor Melinta, nor any of their respective majority-owned subsidiaries may, directly or indirectly, itself or in collaboration with any third party, develop, manufacture for development or commercialization, or commercialize any product in the echinocandin class of drugs in the Melinta Territory without the other party’s prior written consent, subject to certain provisions in connection with a change of control of a party. Commercialization. Melinta will be solely responsible for the commercialization of rezafungin in the Melinta Territory, at its sole expense. The Company’s Retained Rights. The Company retains the non-exclusive right to practice the intellectual property rights licensed to Melinta in the Melinta Territory solely for the purpose of performing its obligations under the Melinta License Agreement and Mundipharma Collaboration Agreement. The Company also retains the right to grant licenses under the intellectual property rights licensed to Melinta to third parties to which the Company has granted licenses or rights to market, promote and sell Melinta Licensed Product outside the Melinta Territory, to make and have made Melinta Licensed Product anywhere in the world solely to develop, register, use, sell, have sold, offer for sale, commercialize and import Melinta Licensed Product outside the Melinta Territory, subject to the terms of the Melinta License Agreement. Continued Development and Regulatory Activities. The Company will be responsible, at its sole expense, for conducting an agreed upon development plan, or the Melinta Development Plan, that includes, among other activities, (a) completion of the ongoing ReSPECT Phase 3 pivotal clinical trial for the prophylaxis of invasive fungal infections in adult allogeneic blood and marrow transplant recipients, or the Prophylaxis Indication, (b) preparation and submission to the FDA of a supplemental new drug application, or sNDA, for the Melinta Licensed Product in the Prophylaxis Indication, (c) site close-out activity worldwide (outside of China) for the Company’s ReSTORE Phase 3 pivotal clinical trial for the treatment of candidemia and invasive candidiasis, or the Treatment Indication, (d) certain nonclinical studies and other nonclinical activities, (e) certain CMC activities for the Melinta Licensed Product, and (f) all other development activities that are required by the FDA to obtain marketing approval of the Melinta Licensed Product in the Treatment Indication and the Prophylaxis Indication in the Melinta Territory. The Company will remain the holder of the rezafungin IND and new drug application, or NDA. Both regulatory applications will transfer to Melinta on a transfer date determined based on the status of the ReSPECT trial and the associated sNDA for the Prophylaxis Indication, after which Melinta will be responsible for performing all activities that may be necessary to maintain NDA approvals for the Melinta Licensed Product in the Treatment Indication and the Prophylaxis Indication in the Melinta Territory, at Melinta’s sole expense, subject to Melinta’s right to deduct from royalties payable to the Company the internal expenses (not to exceed a specified dollar amount per calendar year) and certain out-of-pocket expenses incurred by Melinta. Supply and Transfer of CMC activities. Until Melinta assumes responsibility for the manufacture and supply of the Melinta Licensed Product for development and commercialization in the Melinta Territory, which it may do by direct purchase from the Company’s contract manufacturing organizations for the Melinta Licensed Product or by having a manufacturing technology transfer to Melinta or its designee performed at Melinta’s sole expense, which, in either case, will be no later than December 31, 2026, the Company will be responsible for the manufacture and supply of the Melinta Licensed Product for development and commercialization by Melinta in the Melinta Territory, and during such period, shall supply Melinta Licensed Product to Melinta pursuant to the terms of a supply agreement negotiated by the parties. Financial Terms. Upon execution of the Melinta License Agreement, the total potential transaction value is $460.0 million, including a $30.0 million upfront payment and up to $430.0 million in regulatory and commercial milestone payments. In addition, the Company is eligible to receive tiered royalties on U.S. sales in the low double digits to mid-teens. Termination. Either party may terminate the Melinta License Agreement for uncured material breach by the other party. After July 26, 2023, Melinta may terminate the Melinta License Agreement at will. The Company may terminate the Melinta License Agreement if Melinta or any of its affiliates or sublicensees, directly or indirectly through any third party, commences any interference or opposition proceeding with respect to, challenges the validity or enforceability of, or opposes any extension of or the grant of a supplementary protection certificate with respect to, any of the patent rights licensed to Melinta by the Company. Revenue Recognition As of September 30, 2023, the Company determined the transaction price is equal to the up-front fee of $30.0 million, plus a milestone achieved of $20.0 million. The transaction price was allocated to the performance obligations on the basis of the relative stand-alone selling price estimated for each performance obligation. In estimating the stand-alone selling price for each performance obligation, the Company utilized discounted cash flows and developed assumptions that required judgment and included forecasted revenues, expected development timelines, discount rates, probabilities of technical and regulatory success, costs to continue the research and development efforts and costs for manufacturing clinical supplies. A description of the distinct performance obligations identified under the Melinta License Agreement, as well as the amount of revenue allocated to each distinct performance obligation, is as follows: Licenses of Intellectual Property. The license to the Company’s intellectual property, bundled with the associated know-how, represents a distinct performance obligation. The license and associated know-how was transferred to Melinta in August 2022, therefore the Company recognized the revenue related to this performance obligation in the amount of $25.9 million in August 2022 as collaboration revenue in its condensed consolidated statements of operations and comprehensive income (loss). Research and Development Services. The Company is required to provide research and development services, at its sole expense, as described under the Melinta Development Plan, which represents a distinct performance obligation. The Company concluded that progress towards completion of the performance obligation related to the research and development services is best measured in an amount proportional to the research and development expenses incurred and the total estimated research and development expenses. Clinical Supply Services. The Company’s obligation to supply rezafungin for ongoing clinical development in the Melinta Territory represents a distinct performance obligation. The Company concluded that progress towards completion of the performance obligations related to the clinical supply services is best measured in an amount proportional to the clinical supply services expenses incurred and the total estimated clinical supply services. Revenue related to the clinical supply services performance obligation recognized during the three and nine months ended September 30, 2023 was immaterial. Milestone Payments. In March 2023, the Company achieved a $20.0 million milestone under the Melinta License Agreement that the Company deems to be tied to all the performance obligations identified in the original agreement. Revenue associated with the milestone has been allocated proportionately to the original transaction price which was allocated to the performance obligations on the basis of the relative stand-alone selling price estimated for each performance obligation. In conjunction with the performance obligations already delivered, revenue is recognized based on the progress of these performance obligations, the unrecognized portion is recorded as contract liabilities at the reporting period end and will be recognized as revenue over the remaining progress of these performance obligations. The Company received payment for this milestone in April 2023. The Company determined that as of September 30, 2023, all remaining potential milestone payments are probable of significant revenue reversal as their achievement is highly dependent on factors outside the Company’s control or are otherwise constrained under the variable consideration guidance. Therefore, these milestone payments have been fully constrained and are not included in the transaction price. At the end of each subsequent reporting period, the Company will re-evaluate the probability of achievement of each milestone and any related constraint. Royalties. As the license is deemed to be the predominant item to which sales-based royalties relate, the Company will recognize royalty revenue when the related sales occur. The Company recognized $0.1 million in royalty revenue during the three and nine months ended September 30, 2023 following initiation of the commercial launch of REZZAYO by Melinta in the U.S. on July 31, 2023. No royalty revenue was recognized during the three and nine months ended September 30, 2022. Costs to Obtain a Contract with a Customer The Company incurred costs to a third party to obtain the Melinta License Agreement and capitalized $2.0 million upon execution of the Melinta License Agreement, and capitalized an additional $0.5 million upon achievement of a milestone, in accordance with ASC 340. The Company incurred these costs in connection with all the performance obligations identified in the Melinta License Agreement and allocated the capitalized contract costs to performance obligations on a relative basis (i.e., in proportion to the transaction price allocated to each performance obligation) to determine the period of amortization. Amortization during the three and nine months ended September 30, 2023 was immaterial and $0.5 million, respectively, and i |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | COMMITMENTS AND CONTINGENCIES Lease Obligations On April 20, 2023, the Company entered into a seventh amendment to its lease with Nancy Ridge Technology Center, L.P. which extended the term of the lease by an additional 36 months and increases the base rent to $133,371 per month effective January 1, 2024, subject to 4% increases every January. The lease expires on December 31, 2026 with options for two individual two-year extensions, as described in the original lease agreement, which have not been exercised, and remain in effect and available to the Company. As of September 30, 2023, the Company was not reasonably certain that it would exercise the extension options, and therefore did not include these options in the determination of the total lease term for accounting purposes. The incremental borrowing rate used in measuring the Company’s lease liability was 12.0%. The following table presents information about the amount, timing and uncertainty of cash flows arising from the Company’s operating lease as of September 30, 2023 (in thousands): 2023 $ 321 2024 1,600 2025 1,665 2026 1,731 Total undiscounted operating lease payments $ 5,317 Less: Imputed interest (960) Present value of lease payments $ 4,357 The balance sheet classification of the Company’s operating lease is as follows (in thousands): Balance Sheet Classification: Operating lease right-of-use asset $ 4,131 Current portion of lease liability $ 1,051 Long-term lease liability 3,306 Total operating lease liability $ 4,357 As of September 30, 2023, the weighted average remaining lease term was 3.3 years. Cash paid for amounts included in the measurement of operating lease liabilities was $1.0 million for the nine months ended September 30, 2023 and 2022. Operating lease costs were $1.2 million and $1.0 million for the nine months ended September 30, 2023 and 2022, respectively. These costs are primarily related to the Company’s operating lease, but also include immaterial amounts for variable leases and short-term leases with terms greater than 30 days. Contractual Obligations The Company enters into contracts in the normal course of business with vendors for research and development activities, manufacturing, and professional services. These contracts generally provide for termination either on notice or after a notice period. |
INCOME TAXES
INCOME TAXES | 9 Months Ended |
Sep. 30, 2023 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | INCOME TAXES The Company estimates an annual effective income tax rate based on projected results for the year and applies this rate to net loss before taxes to calculate income tax expense. When applicable, the income tax provision also includes adjustments for discrete tax items. Any refinements made due to subsequent information that affects the estimated annual effective income tax rate are reflected as adjustments in the current period. For the three and nine months ended September 30, 2023, the Company recognized an income tax expense of $0.2 million and $0.4 million, respectively, resulting in effective tax rates of -2.90% and -2.24%, respectively. The effective tax rate for the three and nine months ended September 30, 2023 varies from the U.S. federal statutory rate of 21% primarily due to the change in the valuation allowance against net deferred tax assets and tax benefits relating to research and development tax credits. Current year tax expense is primarily the result of capitalized Internal Revenue Code, or IRC, Section 174 research and development expenditures, effective January 1, 2022, creating taxable income which can be partially offset with net operating losses and credits that are limited in use by IRC Sections 382 and 383. Management assesses the available positive and negative evidence to estimate if sufficient future taxable income will be generated to use the existing deferred tax assets. Based on the weight of all evidence, including a history of operating losses, management has determined that it is more likely than not that the net deferred tax assets will not be realized. In general, under IRC Section 382, a corporation that undergoes an “ownership change” is subject to limitations on its ability to utilize its pre-change net operating losses and tax credit carryforwards to offset future taxable income. An ownership change occurs when a cumulative change in ownership of more than 50% occurs within a three-year period. The Company has completed an IRC Section 382/383 analysis regarding the limitation of net operating losses and research and development credit carryforwards through 2022 and has adjusted the tax attributes for the annual limitation. |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The Company has a limited operating history and the sales and income potential of the Company’s business and market are unproven. The Company has experienced net losses and negative cash flows from operating activities since its inception. At September 30, 2023, the Company had an accumulated deficit of $424.3 million. The Company expects to continue to incur net losses into the foreseeable future. Successful transition to attaining profitable operations is dependent upon achieving a level of revenues adequate to support the Company’s cost structure. At September 30, 2023, the Company had cash and cash equivalents of $48.7 million. Based on the Company’s current business plan, management believes that existing cash and cash equivalents will not be sufficient to fund the Company’s obligations for twelve months from the issuance of these financial statements. The Company’s ability to execute its operating plan depends on its ability to obtain additional funding through equity offerings, debt financings or potential licensing and collaboration arrangements. The accompanying condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and settlement of liabilities in the normal course of business. However, the Company’s current working capital, anticipated operating expenses and net losses and the uncertainties surrounding its ability to raise additional capital as needed, as discussed below, raise substantial doubt about its ability to continue as a going concern for a period of one year following the date that these condensed consolidated financial statements are issued. The condensed consolidated financial statements do not include any adjustments for the recovery and classification of assets or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern. The Company plans to continue to fund its losses from operations through cash and cash equivalents on hand, as well as through future equity offerings, debt financings, other third party funding, and potential licensing or collaboration arrangements. There can be no assurance that additional funds will be available when needed from any source or, if available, will be available on terms that are acceptable to the Company. Even if the Company raises additional capital, it may also be required to modify, delay or abandon some of its plans which could have a material adverse effect on the Company’s business, operating results and financial condition and the Company’s ability to achieve its intended business objectives. Any of these actions could materially harm the Company’s business, results of operations and future prospects. |
Unaudited Interim Financial Data | Unaudited Interim Financial Data The accompanying condensed consolidated financial statements are unaudited and have been prepared by the Company in accordance with U.S. generally accepted accounting principles, or GAAP, as found in the Accounting Standards Codification, or ASC, of the Financial Accounting Standards Board, or FASB. Certain information and footnote disclosures normally included in the Company’s annual financial statements have been condensed or omitted. These interim condensed consolidated financial statements, in the opinion of management, reflect all normal recurring adjustments necessary for a fair presentation of the Company’s financial position and results of operations for the interim periods ended September 30, 2023 and 2022. |
Basis of Consolidation | Basis of Consolidation The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All significant intercompany accounts and transactions have been eliminated in consolidation. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of expenses during the reporting period. The Company evaluates its estimates and assumptions on an ongoing basis. The most significant estimates in the Company’s condensed consolidated financial statements relate to estimated collaboration expenses related to the Company’s collaboration and license agreements, certain accruals, including those related to nonclinical and clinical activities, the stand-alone selling price of performance obligations associated with the Company’s collaboration and license agreements, work-in-process inventory and inventory overhead. Although the estimates are based on the Company’s knowledge of current events, comparable companies, and actions it may undertake in the future, actual results may ultimately materially differ from these estimates and assumptions. |
Segment Information | Segment Information Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, the Chief Executive Officer, in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business as one operating segment. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all short-term investments purchased with a maturity of three months or less when acquired to be cash equivalents. |
Accounts Receivable | Accounts Receivable Accounts receivable is stated at the original invoice amount and consists of amounts due from customers related to milestones achieved, certain research and development and clinical supply costs subject to reimbursement under the collaboration and license agreements, royalties earned, and product sales. The Company records accounts receivables net of any allowances for doubtful accounts for potential credit losses. An allowance for doubtful accounts is determined based on the financial condition and creditworthiness of customers and the Company considers economic factors and events or trends expected to affect future collections experience. Any allowance would reduce the net receivables to the amount that is expected to be collected. The payment history of the Company’s customers will be considered in future assessments of collectability as these patterns are established over a longer period of time. The Company did not record any credit losses as of September 30, 2023 or December 31, 2022. |
Inventory | Inventory The Company began capitalizing inventory for REZZAYO, which received approval by the U.S. Food and Drug Administration, or FDA, in March 2023. REZZAYO (rezafungin for injection) is approved for the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options. Prior to regulatory approval, all direct and indirect manufacturing costs were charged to research and development expense in the period incurred. |
Property and Equipment | Property and Equipment The Company records property and equipment at cost, which consists of laboratory equipment, computer equipment and software, office equipment, furniture and fixtures and leasehold improvements. Property and equipment is depreciated using the straight-line method over the estimated useful lives (generally three |
Income Taxes | Income Taxes The Company follows the FASB ASC 740, Income Taxes , or ASC 740, in reporting deferred income taxes. ASC 740 requires a company to recognize deferred tax assets and liabilities for expected future income tax consequences of events that have been recognized in the Company’s condensed consolidated financial statements. Under this method, deferred tax assets and liabilities are determined based on temporary differences between financial statement carrying amounts and the tax basis of assets and liabilities using enacted tax rates in the years in which the temporary differences are expected to reverse. Valuation allowances are provided if, based on the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The Company accounts for uncertain tax positions pursuant to ASC 740, which prescribes a recognition threshold and measurement process for financial statement recognition of uncertain tax positions taken or expected to be taken in a tax return. If the tax position meets this threshold, the benefit to be recognized is measured as the tax benefit having the highest likelihood of being realized upon ultimate settlement with the taxing authority. The Company recognizes interest accrued related to unrecognized tax benefits and penalties in the provision for income taxes. |
Revenue Recognition | Revenue Recognition The Company recognizes revenue is accordance with ASC Topic 606, Revenue from Contracts with Customers , or Topic 606, which applies to all contracts with customers, except for elements of certain contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. Under Topic 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of Topic 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of Topic 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. In a contract with multiple performance obligations, the Company must develop estimates and assumptions that require judgment to determine the underlying stand-alone selling price for each performance obligation, which determines how the transaction price is allocated among the performance obligations. The estimation of the stand-alone selling price(s) may include estimates regarding forecasted revenues or costs, development timelines, discount rates, and probabilities of technical and regulatory success. The Company evaluates each performance obligation to determine if it can be satisfied at a point in time or over time. Any change made to estimated progress towards completion of a performance obligation and, therefore, revenue recognized will be recorded as a change in estimate. In addition, variable consideration must be evaluated to determine if it is constrained and, therefore, excluded from the transaction price. Collaboration Revenue If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in a contract, the Company recognizes revenues from the transaction price allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from the allocated transaction price. The Company evaluates the measure of progress at each reporting period and, if necessary, adjusts the measure of performance and related revenue or expense recognition as a change in estimate. At the inception of each arrangement that includes milestone payments, the Company evaluates whether the milestones are considered probable of being reached. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the Company’s or a collaboration partner’s control, such as regulatory approvals, are generally not considered probable of being achieved until those approvals are received. At the end of each reporting period, the Company re-evaluates the probability of achievement of milestones that are within its or a collaboration partner’s control, such as operational developmental milestones and any related constraint, and, if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which will affect collaboration revenues and earnings in the period of adjustment. Revisions to the Company’s estimate of the transaction price may also result in negative collaboration revenues and earnings in the period of adjustment. For arrangements that include sales-based royalties, including commercial milestone payments based on the level of sales, and a license is deemed to be the predominant item to which the royalties relate, the Company will recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied, or partially satisfied. In September 2019, the Company entered into a Collaboration and License Agreement, or the Mundipharma Collaboration Agreement, with Mundipharma Medical Company, or Mundipharma. The Company concluded that there were three performance obligations under the Mundipharma Collaboration Agreement: the license, the research and development services, and the clinical supply services, and that the obligations are distinct from each other. In March 2021, the Company entered into an exclusive worldwide license and collaboration agreement, or the Janssen Collaboration Agreement, with Janssen Pharmaceuticals, Inc., or Janssen, one of the Janssen Pharmaceutical Companies of Johnson & Johnson. The Company concluded that there were three performance obligations under the Janssen Collaboration Agreement: the license, the research and development services, and the clinical supply services, and that the obligations are distinct from each other. In July 2022, the Company entered into a License Agreement with Melinta, or the Melinta License Agreement. The Company concluded that there were three performance obligations under the Melinta License Agreement: the license, the research and development services, and the clinical supply services, and that the obligations are distinct from each other. The Company concluded that progress towards completion of the research and development and clinical supply performance obligations related to the Mundipharma Collaboration Agreement and the Melinta License Agreement, is best measured in an amount proportional to the collaboration expenses incurred and the total estimated collaboration expenses. The Company periodically reviews and updates the estimated collaboration expenses, when appropriate, which may adjust revenue recognized for the period. While such changes to the Company’s estimates have no impact on the Company’s reported cash flows, the amount of revenue recorded in the period could be materially impacted. Revenue from research and development services for the Janssen Collaboration Agreement is recognized based on actual amounts billed as the underlying services are provided and billed at market rates. The transaction prices to be recognized as revenue under both the Mundipharma Collaboration Agreement and the Janssen Collaboration Agreement consist of upfront payments, estimated reimbursable research and development and clinical supply costs, and milestones achieved to date. The transaction price to be recognized as revenue under the Melinta License Agreement consists of an upfront payment and milestones achieved to date. Potential future payments for variable consideration, such as clinical, regulatory or commercial milestones, will be recognized when it is probable that, if recorded, a significant reversal will not take place. Potential future royalty payments will be recorded as revenue when the associated sales occur. See Note 8 for additional information. Product Revenue In December 2022 and January 2023, the Company entered into separate Commercial Supply Agreements with Mundipharma and Melinta, respectively, for the batch supply of REZZAYO naked vials for commercial use. Under the Commercial Supply Agreements, Mundipharma and Melinta are required to submit purchase orders to the Company for batches of REZZAYO naked vials. The Company concluded that the delivery of each batch of REZZAYO naked vials and the related quality assessment certification represents a distinct performance obligation. The transaction price to be recognized as revenue for each performance obligation under the Commercial Supply Agreements consists of variable consideration which is determined based on the estimated per vial costs, plus the contractually stated margin rate. The amounts recognized as revenue are adjusted, as needed, each reporting period based on actual costs incurred for each batch. Variable consideration is included in the transaction price only to the extent that it is considered probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The transaction price will be fully allocated to the single performance obligation. The Company concluded that the performance obligation is satisfied and product revenue is recognized when the customer obtains control of the product, which occurs at a point in time, typically upon the later of (i) completion of a positive quality assessment, or (ii) shipment of the Company’s product to the customer. Shipping and handling activities that are performed after a customer obtains control of the product are treated as activities to fulfill the promise to a customer and any amounts billed to a customer represent revenues for the product provided. Costs related to such shipping and handling billings are classified as cost of product revenue. |
Cost Of Product Revenue | Cost of Product Revenue Cost of product revenue consists primarily of costs related to materials, third-party contract manufacturing, freight-in and overhead. Prior to regulatory approval, all direct and indirect manufacturing costs were charged to research and development expense in the period incurred. |
Research and Development Costs | Research and Development Costs Research and development expenses consist of wages, benefits and stock-based compensation charges for research and development employees, scientific consultant fees, facilities and overhead expenses, laboratory supplies, manufacturing expenses in preclinical development and certain manufacturing expenses before FDA approval, and nonclinical and clinical trial costs. The Company accrues nonclinical and clinical trial expenses based on work performed, which relies on estimates of total costs incurred based on patient enrollment, completion of studies, and other events. Costs incurred in purchasing technology assets and intellectual property are charged to research and development expense if the technology has not been conclusively proven to be feasible and has no alternative future use. |
Preclinical and Clinical Trial Accruals | Preclinical and Clinical Trial Accruals The Company makes estimates of its accrued expenses as of each balance sheet date in the financial statements based on the facts and circumstances known at that time. Accrued expenses for preclinical studies and clinical trials are based on estimates of costs incurred and fees that may be associated with services provided by contract research organizations, or CROs, clinical trial investigational sites and other clinical trial-related activities. Payments under certain contracts with such parties depend on factors such as successful enrollment of patients, site initiation and the completion of clinical trial milestones. In accruing for these services, the Company estimates the time period over which services will be performed and the level of effort to be expended in each period. If possible, the Company obtains information regarding unbilled services directly from these service providers. However, the Company may be required to estimate these services based on other available information. If the Company underestimates or overestimates the activities or fees associated with a study or service at a given point in time, adjustments to research and development expenses may be necessary in future periods. Historically, estimated accrued liabilities have approximated actual expense incurred. Subsequent changes in estimates may result in a material change in accruals. |
Stock-Based Compensation | Stock-Based Compensation The Company accounts for stock-based compensation expense related to stock options, restricted stock units, or RSUs, performance-based RSUs, or PRSUs, and Employee Stock Purchase Plan, or ESPP, rights by estimating the fair value on the date of grant. The Company estimates the fair value of stock options granted to employees and non-employees using the Black-Scholes option pricing model. The fair value of RSUs and PRSUs granted to employees is estimated based on the closing price of the Company’s common stock on the date of grant. The assumptions included in the Black-Scholes option pricing model include (a) the risk-free interest rate, (b) the expected volatility of the Company’s stock, (c) the expected term of the award, and (d) the expected dividend yield. The Company computed the expected volatility data using the daily close prices for the Company’s common stock during the equivalent period of the calculated expected term of the Company’s stock-based awards. The Company estimated the expected life of employee stock options using the “simplified” method, whereby the expected life equals the average of the vesting term and the original contractual term of the option. The risk-free interest rates for periods within the expected life of the option are based on the yields of zero-coupon U.S. treasury securities. The expected dividend yield of zero reflects that the Company has not paid cash dividends since inception and do not intend to pay cash dividends in the foreseeable future. For awards subject to time-based vesting conditions, including those with a graded vesting schedule, stock-based compensation expense is recognized using the straight-line method. For performance-based awards to employees, (i) the fair value of the award is determined on the grant date, (ii) the Company assesses the probability of the individual performance milestones under the award being achieved and (iii) the fair value of the shares subject to the milestone is expensed over the implicit service period commencing once management believes the performance criteria is probable of being met. The Company recognizes forfeitures related to stock-based compensation as they occur and any compensation cost previously recognized for awards for which the requisite service has not been completed is reversed in the period that the award is forfeited. |
Net Earnings (Loss) Per Share | Net Earnings (Loss) Per Share The Company follows the guidance in FASB ASC 260, Earnings Per Share , or ASC 260, which establishes standards regarding the computation of earnings per share, or EPS, by companies that have issued securities other than common stock that contractually entitle the holder to participate in dividends and earnings of a company. The guidance requires earnings to be hypothetically allocated between the common, preferred, and other participating stockholders based on their respective rights to receive non-forfeitable dividends, whether or not declared. Participating securities include Series X Convertible Preferred Stock (see Note 6). Basic net EPS is then calculated by dividing the net income attributable to common stockholders (after the reduction for any preferred stock and assuming current income for the period had been distributed) by the weighted-average number of common shares outstanding for the period. The Company calculates diluted net EPS by using the more dilutive of the (1) treasury stock method, reverse treasury stock method or if-converted method, as applicable, or (2) the two-class method. Dilutive common stock equivalents are comprised of warrants, Series X Convertible Preferred Stock, RSUs, PRSUs and options outstanding under the Company’s stock option plans and ESPP, on an as converted basis. Basic net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding for the period, without consideration for potentially dilutive securities. Diluted net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares and dilutive stock equivalents outstanding for the period determined using the treasury stock method or if-converted method. Under the two-class method, the net loss attributable to common stockholders is not allocated to the Series X Convertible Preferred Stock as the preferred stockholders do not have a contractual obligation to share in the Company’s losses. In loss periods, basic and diluted net loss per share are identical because the otherwise dilutive potential common shares become anti-dilutive and are therefore excluded. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The Company follows ASC 820-10 issued by the FASB with respect to fair value reporting for financial assets and liabilities. The guidance defines fair value, provides guidance for measuring fair value and requires certain disclosures. The guidance does not apply to measurements related to share-based payments. The guidance discusses valuation techniques such as the market approach (comparable market prices), the income approach (present value of future income or cash flow), and the cost approach (cost to replace the service capacity of an asset or replacement cost). The guidance establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into three broad levels. |
Recently Issued and Recently Adopted Accounting Pronouncements | Recently Issued and Recently Adopted Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that are adopted by the Company as of the specified effective date. The Company believes, based on its preliminary assessment, that the recently issued, but not yet adopted, accounting pronouncements will not have a material impact on the Company’s condensed consolidated financial statements or related disclosures, or do not apply to the Company. |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Summary of Computation of Basic and Diluted Net Earnings (Loss) Per Common Share | The following table sets forth the computation of basic and diluted net earnings (loss) per common share (in thousands, except share and per share data): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Numerator: Net income (loss) $ (8,172) $ 14,978 $ (17,320) $ (16,422) Allocation of earnings to participating securities — (3,081) — — Numerator for basic net earnings (loss) per common share - net income (loss) attributable to common stockholders $ (8,172) $ 11,897 $ (17,320) $ (16,422) Effect of participating securities: Add back allocation of earnings to participating securities — 3,081 — — Numerator for diluted net earnings (loss) per common share - net income (loss) attributable to common stockholders $ (8,172) $ 14,978 $ (17,320) $ (16,422) Denominator: Denominator for basic net earnings (loss) per common share - weighted average common shares outstanding 90,287,441 70,217,985 86,390,446 69,170,865 Effect of dilutive securities: Series X Convertible Preferred Stock, as converted — 18,184,720 — — Common stock options, RSUs, PRSUs, and ESPP — 189,863 — — Denominator for diluted net earnings (loss) per common share - adjusted weighted average common shares outstanding 90,287,441 88,592,568 86,390,446 69,170,865 Basic net earnings (loss) per common share $ (0.09) $ 0.17 $ (0.20) $ (0.24) Diluted net earnings (loss) per common share $ (0.09) $ 0.17 $ (0.20) $ (0.24) |
Summary of Outstanding Potentially Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share | The following table sets forth the outstanding potentially dilutive securities that have been excluded in the calculation of basic and diluted net loss per share because doing so would be anti-dilutive (in common stock equivalent shares): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Common stock warrants 17,331 12,517,328 17,331 12,517,328 Series X Convertible Preferred Stock 21,044,720 — 21,044,720 18,184,720 Common stock options, RSUs and PRSUs issued and outstanding 12,924,675 10,041,333 12,924,675 10,086,839 Total 33,986,726 22,558,661 33,986,726 40,788,887 |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Summary of Financial Instruments Measured at Fair Value on a Recurring Basis | The following tables summarize the Company’s financial instruments measured at fair value on a recurring basis (in thousands): TOTAL LEVEL 1 LEVEL 2 LEVEL 3 September 30, 2023 Assets: Cash and money market accounts $ 48,670 $ 48,670 $ — $ — Total assets at fair value $ 48,670 $ 48,670 $ — $ — December 31, 2022 Assets: Cash and money market accounts $ 32,731 $ 32,731 $ — $ — Total assets at fair value $ 32,731 $ 32,731 $ — $ — |
INVENTORY (Tables)
INVENTORY (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | Inventory consisted of the following (in thousands): September 30, December 31, Raw materials $ 733 $ — Work-in-process 1,734 — Finished goods — — Total inventory $ 2,467 $ — |
STOCKHOLDERS_ EQUITY (Tables)
STOCKHOLDERS’ EQUITY (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Equity [Abstract] | |
Summary of Common Stock Reserved for Future Issuance | Common stock reserved for future issuance is as follows (in common stock equivalent shares): September 30, December 31, Common stock warrants 17,331 12,517,328 Series X Convertible Preferred Stock 21,044,720 18,184,720 Common stock options, RSUs and PRSUs issued and outstanding 12,924,675 9,323,495 Authorized for future stock awards 3,288,730 4,469,969 Awards available under the ESPP 1,135,937 806,968 Total 38,411,393 45,302,480 |
EQUITY INCENTIVE PLANS (Tables)
EQUITY INCENTIVE PLANS (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Summary of Restricted Stock Units and Performance-based Restricted Stock Units Activity | The following table summarizes RSU and PRSU activity during the nine months ended September 30, 2023: Number of Weighted Average Grant Date Fair Value Outstanding at December 31, 2022 1,223,871 $ 1.47 RSUs and PRSUs granted 1,465,817 1.00 RSUs and PRSUs vested (462,146) 1.51 RSUs and PRSUs canceled (127,201) 1.29 Outstanding at September 30, 2023 2,100,341 $ 1.15 |
Summary of Stock Option Activity | The following table summarizes stock option activity during the nine months ended September 30, 2023: Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life in Years Total Aggregate Intrinsic Value (in thousands) Outstanding at December 31, 2022 8,099,624 $ 2.78 6.65 $ 48 Options granted 3,233,558 1.02 Options exercised (16,250) 0.83 Options canceled (492,598) 3.60 Outstanding at September 30, 2023 10,824,334 $ 2.22 6.99 $ 246 Vested and expected to vest at September 30, 2023 10,824,334 $ 2.22 6.99 $ 246 Exercisable at September 30, 2023 6,874,604 $ 2.83 5.77 $ 163 |
Summary of Stock-based Compensation Expense | Stock-based compensation expense recognized for RSUs, PRSUs, stock options, and the ESPP has been reported in the condensed consolidated statements of operations and comprehensive income (loss) as follows (in thousands): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Research and development $ 393 $ 443 $ 1,193 $ 1,366 General and administrative 403 399 1,038 1,666 Total $ 796 $ 842 $ 2,231 $ 3,032 |
SIGNIFICANT AGREEMENTS AND CO_2
SIGNIFICANT AGREEMENTS AND CONTRACTS (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Summary of Collaborative Agreement Liabilities and Revenues Disaggregated by Timing of Revenue Recognition | The following table presents a summary of the activity in the Company’s contract liabilities pertaining to the Mundipharma Collaboration Agreement, Janssen Collaboration Agreement, and Melinta License Agreement during the nine months ended September 30, 2023 (in thousands): Opening balance, December 31, 2022 $ 35,139 Payments received in advance 2,209 Payments receivable 70 Revenue from performance obligations satisfied during reporting period (6,235) Closing balance, September 30, 2023 $ 31,183 Current portion of contract liabilities $ 14,679 Long-term portion of contract liabilities 16,504 Total contract liabilities, September 30, 2023 $ 31,183 The following table presents our collaboration revenue disaggregated by collaborator and timing of revenue recognition (in thousands): Three Months Ended Nine Months Ended Mundipharma Janssen Melinta Mundipharma Janssen Melinta Revenue from Collaboration and License Agreements: Point in Time: License of Intellectual Property - upon milestone achieved $ — $ 2,347 $ — $ — $ 2,347 $ 17,257 Clinical Drug Supply — — — 26 — — Royalty Revenue — — 70 — — 70 Over Time: Research and Development Services 1,550 5,592 408 4,870 16,324 1,859 Clinical Supply Services 5 1,278 — 245 1,856 — Total Revenue from Collaboration and License Agreements $ 1,555 $ 9,217 $ 478 $ 5,141 $ 20,527 $ 19,186 Three Months Ended Nine Months Ended Mundipharma Janssen Melinta Mundipharma Janssen Melinta Revenue from Collaboration and License Agreements: Point in Time: License of Intellectual Property - upon transfer of license $ — $ — $ 25,885 $ — $ — $ 25,885 License of Intellectual Property - upon milestone achieved 3,252 — — 3,252 816 — Clinical Drug Supply 459 — — 459 — — Over Time: Research and Development Services 3,945 6,250 328 7,965 11,235 328 Clinical Supply Services 363 262 — 792 3,337 — Total Revenue from Collaboration and License Agreements $ 8,019 $ 6,512 $ 26,213 $ 12,468 $ 15,388 $ 26,213 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Summary of Amount, Timing and Uncertainty of Cash Flows from Operating Lease | The following table presents information about the amount, timing and uncertainty of cash flows arising from the Company’s operating lease as of September 30, 2023 (in thousands): 2023 $ 321 2024 1,600 2025 1,665 2026 1,731 Total undiscounted operating lease payments $ 5,317 Less: Imputed interest (960) Present value of lease payments $ 4,357 |
Summary of Supplemental Balance Sheet Information | The balance sheet classification of the Company’s operating lease is as follows (in thousands): Balance Sheet Classification: Operating lease right-of-use asset $ 4,131 Current portion of lease liability $ 1,051 Long-term lease liability 3,306 Total operating lease liability $ 4,357 |
THE COMPANY AND BASIS OF PRES_2
THE COMPANY AND BASIS OF PRESENTATION (Details) $ in Thousands | 9 Months Ended | |||
Sep. 30, 2023 USD ($) segment | Dec. 31, 2022 USD ($) | Sep. 30, 2022 USD ($) | Dec. 31, 2021 USD ($) | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||
Accumulated deficit | $ 424,286 | $ 406,966 | ||
Cash and cash equivalents | $ 48,670 | $ 32,731 | $ 53,078 | $ 62,273 |
Number of operating segments | segment | 1 |
SUMMARY OF SIGNIFICANT ACCOUN_4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Additional Information (Details) - obligation | 9 Months Ended | |||
Sep. 30, 2023 | Jul. 31, 2022 | Mar. 31, 2021 | Sep. 30, 2019 | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Expected dividend rate | 0% | |||
Mundipharma Medical Company | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Number of performance obligations | 3 | |||
Melinta Therapeutics, Inc. | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Number of performance obligations | 3 | |||
Janssen Pharmaceuticals, Inc. | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Number of performance obligations | 1 | |||
Janssen Pharmaceuticals, Inc. | Janssen Collaboration Agreement | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Number of performance obligations | 3 | |||
Minimum | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Useful life (in years) | 3 years | |||
Maximum | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Useful life (in years) | 7 years |
SUMMARY OF SIGNIFICANT ACCOUN_5
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Summary of Computation of Basic and Diluted Net Earnings (Loss) Per Common Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Numerator: | ||||||||
Net income (loss) | $ (8,172) | $ (12,357) | $ 3,209 | $ 14,978 | $ (13,119) | $ (18,281) | $ (17,320) | $ (16,422) |
Allocation of earnings to participating securities | 0 | (3,081) | 0 | 0 | ||||
Numerator for basic net earnings (loss) per common share - net income (loss) attributable to common stockholders | (8,172) | 11,897 | (17,320) | (16,422) | ||||
Effect of participating securities: | ||||||||
Add back allocation of earnings to participating securities | 0 | 3,081 | 0 | 0 | ||||
Numerator for diluted net earnings (loss) per common share - net income (loss) attributable to common stockholders | $ (8,172) | $ 14,978 | $ (17,320) | $ (16,422) | ||||
Denominator: | ||||||||
Denominator for basic net earnings (loss) per common share - weighted average common shares outstanding (in shares) | 90,287,441 | 70,217,985 | 86,390,446 | 69,170,865 | ||||
Effect of dilutive securities: | ||||||||
Series X Convertible Preferred Stock, as converted (in shares) | 0 | 18,184,720 | 0 | 0 | ||||
Common stock options, RSUs, PRSUs, and ESPP (in shares) | 0 | 189,863 | 0 | 0 | ||||
Denominator for diluted net earnings (loss) per common share - adjusted weighted average common shares outstanding (in shares) | 90,287,441 | 88,592,568 | 86,390,446 | 69,170,865 | ||||
Basic net earnings (loss) per common share (in dollars per share) | $ (0.09) | $ 0.17 | $ (0.20) | $ (0.24) | ||||
Diluted net earnings (loss) per common share (in dollars per share) | $ (0.09) | $ 0.17 | $ (0.20) | $ (0.24) |
SUMMARY OF SIGNIFICANT ACCOUN_6
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Summary of Outstanding Potentially Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities excluded in the calculation of diluted net loss per share (in shares) | 33,986,726 | 22,558,661 | 33,986,726 | 40,788,887 |
Common stock warrants | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities excluded in the calculation of diluted net loss per share (in shares) | 17,331 | 12,517,328 | 17,331 | 12,517,328 |
Series X Convertible Preferred Stock | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities excluded in the calculation of diluted net loss per share (in shares) | 21,044,720 | 0 | 21,044,720 | 18,184,720 |
Common stock options, RSUs and PRSUs issued and outstanding | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities excluded in the calculation of diluted net loss per share (in shares) | 12,924,675 | 10,041,333 | 12,924,675 | 10,086,839 |
FAIR VALUE MEASUREMENTS - Summa
FAIR VALUE MEASUREMENTS - Summary of Financial Instruments Measured at Fair Value on a Recurring Basis (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Assets: | ||
Cash and money market accounts | $ 48,670 | $ 32,731 |
Total assets at fair value | 48,670 | 32,731 |
LEVEL 1 | ||
Assets: | ||
Cash and money market accounts | 48,670 | 32,731 |
Total assets at fair value | 48,670 | 32,731 |
LEVEL 2 | ||
Assets: | ||
Cash and money market accounts | 0 | 0 |
Total assets at fair value | 0 | 0 |
LEVEL 3 | ||
Assets: | ||
Cash and money market accounts | 0 | 0 |
Total assets at fair value | $ 0 | $ 0 |
INVENTORY - Schedule of Invento
INVENTORY - Schedule of Inventory (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 733 | $ 0 |
Work-in-process | 1,734 | 0 |
Finished goods | 0 | 0 |
Total inventory | $ 2,467 | $ 0 |
INVENTORY - Additional Informat
INVENTORY - Additional Information (Details) | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Inventory Disclosure [Abstract] | |
Inventory write-down | $ 0 |
DEBT (Details)
DEBT (Details) - Term A Loan - Term Loan | Oct. 03, 2016 USD ($) |
Debt Instrument [Line Items] | |
Borrowed from the lender | $ 10,000,000 |
Variable annual rate (as a percent) | 4.50% |
Prime Rate | |
Debt Instrument [Line Items] | |
Prime interest rate (as a percent) | 0.75% |
STOCKHOLDERS_ EQUITY - Addition
STOCKHOLDERS’ EQUITY - Additional Information (Details) | 9 Months Ended | |||||
Mar. 07, 2023 USD ($) $ / shares shares | Aug. 12, 2020 shares | Sep. 30, 2023 USD ($) vote $ / shares shares | Sep. 30, 2022 USD ($) shares | Dec. 31, 2022 USD ($) $ / shares shares | May 31, 2018 $ / shares shares | |
Class of Stock [Line Items] | ||||||
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 | ||||
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | ||||
Common stock, shares authorized (in shares) | 200,000,000 | 200,000,000 | ||||
Number of votes for each share held | vote | 1 | |||||
Common Stock Warrant | ||||||
Class of Stock [Line Items] | ||||||
Warrants outstanding (in shares) | 17,331 | 12,517,328 | ||||
Warrants expired (in shares) | 12,499,997 | |||||
Warrants, aggregate intrinsic value, outstanding | $ | $ 0 | $ 0 | ||||
Common Stock | ||||||
Class of Stock [Line Items] | ||||||
Issuance of common stock upon conversion of Series X convertible preferred stock (in shares) | 522,410 | |||||
Series X Convertible Preferred Stock | ||||||
Class of Stock [Line Items] | ||||||
Preferred stock, shares authorized (in shares) | 4,947,759 | 4,947,759 | 5,000,000 | |||
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 | |||
Issuance of common stock upon conversion of Series X convertible preferred stock (in shares) | 52,241 | |||||
Common stock issued for each preferred stock (in shares) | 10 | |||||
Maximum ownership following conversion (as a percent) | 9.99% | |||||
Weighted Average | Common Stock Warrant | ||||||
Class of Stock [Line Items] | ||||||
Exercise price of warrant (in dollars per share) | $ / shares | $ 11.54 | $ 6.82 | ||||
Controlled Equity Sales Agreement, Cantor Fitzgerald and Company | ||||||
Class of Stock [Line Items] | ||||||
Shares sold (in shares) | 6,219,741 | 2,308,435 | ||||
Sale of stock, gross | $ | $ 9,000,000 | |||||
Sale of stock, net | $ | 8,700,000 | $ 1,700,000 | ||||
Consideration remaining on transaction | $ | $ 37,100,000 | |||||
Controlled Equity Sales Agreement, Cantor Fitzgerald and Company | Weighted Average | ||||||
Class of Stock [Line Items] | ||||||
Offering price (in dollars per share) | $ / shares | $ 1.44 | |||||
2023 Underwritten Public Offering | ||||||
Class of Stock [Line Items] | ||||||
Sale of stock, gross | $ | $ 19,500,000 | |||||
Sale of stock, net | $ | $ 17,300,000 | |||||
2023 Underwritten Public Offering | Common Stock | ||||||
Class of Stock [Line Items] | ||||||
Shares sold (in shares) | 11,086,000 | |||||
Offering price (in dollars per share) | $ / shares | $ 1.267 | |||||
2023 Underwritten Public Offering | Series X Convertible Preferred Stock | ||||||
Class of Stock [Line Items] | ||||||
Shares sold (in shares) | 286,000 | |||||
Offering price (in dollars per share) | $ / shares | $ 12.67 | |||||
Over-Allotment Option | Common Stock | ||||||
Class of Stock [Line Items] | ||||||
Shares sold (in shares) | 1,446,000 |
STOCKHOLDERS_ EQUITY - Summary
STOCKHOLDERS’ EQUITY - Summary of Common Stock Reserved for Future Issuance (Details) - shares | Sep. 30, 2023 | Dec. 31, 2022 |
Class of Stock [Line Items] | ||
Total (in shares) | 38,411,393 | 45,302,480 |
Common stock warrants | ||
Class of Stock [Line Items] | ||
Total (in shares) | 17,331 | 12,517,328 |
Series X Convertible Preferred Stock | ||
Class of Stock [Line Items] | ||
Total (in shares) | 21,044,720 | 18,184,720 |
Common stock options, RSUs and PRSUs issued and outstanding | ||
Class of Stock [Line Items] | ||
Total (in shares) | 12,924,675 | 9,323,495 |
Authorized for future stock awards | ||
Class of Stock [Line Items] | ||
Total (in shares) | 3,288,730 | 4,469,969 |
Awards available under the ESPP | ||
Class of Stock [Line Items] | ||
Total (in shares) | 1,135,937 | 806,968 |
EQUITY INCENTIVE PLANS - Additi
EQUITY INCENTIVE PLANS - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 9 Months Ended | |
Mar. 31, 2015 | Sep. 30, 2023 | Sep. 30, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Term for stock options to be granted (in years) | 10 years | ||
Price of stock option as percentage of estimated fair value of shares on date of grant (as a percent) | 100% | ||
Voting power threshold (as a percent) | 10% | ||
Weighted-average grant date fair value of employee stock options granted (in dollars per share) | $ 0.72 | $ 0.51 | |
Unrecognized share-based compensation expense, options | $ 3 | ||
ESPP | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Automatic annual increase in shares authorized for issuance in equity incentive plan (as a percent) | 1% | ||
Price of stock option as percentage of estimated fair value of shares on date of grant (as a percent) | 85% | ||
Employee payroll deduction under the stock plan (as a percent) | 15% | ||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 161,367 | 184,219 | |
Weighted-average period to recognize unrecognized compensation cost (in years) | 3 months 18 days | ||
Restricted Stock Units and Performance-based Restricted Stock Units | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
RSUs and PRSUs granted (in dollars per share) | $ 1 | $ 0.83 | |
Fair value of RSUs and PRSUs | $ 0.7 | $ 1.6 | |
Estimated unrecognized share-based compensation expense | $ 2 | ||
Options | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Weighted-average period to recognize unrecognized compensation cost (in years) | 2 years | ||
More than 10% of Voting Power | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Price of stock option as percentage of estimated fair value of shares on date of grant (as a percent) | 110% | ||
Minimum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Vesting period (in years) | 3 years | ||
Maximum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Vesting period (in years) | 4 years | ||
Maximum | ESPP | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Common stock shares outstanding (in shares) | 490,336 | ||
Authorized for future stock awards | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Automatic annual increase in shares authorized for issuance in equity incentive plan (as a percent) | 4% |
EQUITY INCENTIVE PLANS - Summar
EQUITY INCENTIVE PLANS - Summary of Restricted Stock Units and Performance-based Restricted Stock Units Activity (Details) - Restricted Stock Units and Performance-based Restricted Stock Units - $ / shares | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Number of RSUs and PRSUs | ||
Outstanding, beginning balance (in shares) | 1,223,871 | |
RSUs and PRSUs granted (in shares) | 1,465,817 | |
RSUs and PRSUs vested (in shares) | (462,146) | |
RSUs and PRSUs canceled (in shares) | (127,201) | |
Outstanding, ending balance (in shares) | 2,100,341 | |
Weighted Average Grant Date Fair Value | ||
Outstanding, beginning of period (in dollars per share) | $ 1.47 | |
RSUs and PRSUs granted (in dollars per share) | 1 | $ 0.83 |
RSUs and PRSUs vested (in dollars per share) | 1.51 | |
RSUs and PRSUs canceled (in dollars per share) | 1.29 | |
Outstanding, end of period (in dollars per share) | $ 1.15 |
EQUITY INCENTIVE PLANS - Summ_2
EQUITY INCENTIVE PLANS - Summary of Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Number of Shares | ||
Outstanding, beginning balance (in shares) | 8,099,624 | |
Options granted (in shares) | 3,233,558 | |
Options exercised (in shares) | (16,250) | |
Options canceled (in shares) | (492,598) | |
Outstanding, ending balance (in shares) | 10,824,334 | 8,099,624 |
Vested and expected to vest (in shares) | 10,824,334 | |
Exercisable (in shares) | 6,874,604 | |
Weighted Average Exercise Price | ||
Outstanding, beginning balance (in dollars per share) | $ 2.78 | |
Options granted (in dollars per share) | 1.02 | |
Options exercised (in dollars per share) | 0.83 | |
Options canceled (in dollars per share) | 3.60 | |
Outstanding, ending balance (in dollars per share) | 2.22 | $ 2.78 |
Vested and expected to vest (in dollars per share) | 2.22 | |
Exercisable (in dollars per share) | $ 2.83 | |
Weighted Average Remaining Contractual Life in Years | ||
Outstanding | 6 years 11 months 26 days | 6 years 7 months 24 days |
Vested and expected to vest | 6 years 11 months 26 days | |
Exercisable | 5 years 9 months 7 days | |
Total Aggregate Intrinsic Value (in thousands) | ||
Outstanding | $ 246 | $ 48 |
Vested and expected to vest | 246 | |
Exercisable | $ 163 |
EQUITY INCENTIVE PLANS - Summ_3
EQUITY INCENTIVE PLANS - Summary of Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total | $ 796 | $ 842 | $ 2,231 | $ 3,032 |
Research and development | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total | 393 | 443 | 1,193 | 1,366 |
General and administrative | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total | $ 403 | $ 399 | $ 1,038 | $ 1,666 |
SIGNIFICANT AGREEMENTS AND CO_3
SIGNIFICANT AGREEMENTS AND CONTRACTS - Additional Information (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||||||||||||
Sep. 30, 2023 | Jul. 26, 2022 | Mar. 31, 2021 | Sep. 03, 2019 | Sep. 30, 2023 | Mar. 31, 2023 | Aug. 31, 2022 | Mar. 31, 2022 | Dec. 31, 2021 | May 31, 2021 | Sep. 30, 2019 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Nov. 30, 2020 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Revenue from collaborative agreement | $ 11,250,000 | $ 40,744,000 | $ 44,854,000 | $ 54,069,000 | |||||||||||||
Capitalized contract cost, amortization | 53,000 | 1,772,000 | |||||||||||||||
Accounts receivable | $ 2,855,000 | $ 2,855,000 | 2,855,000 | 2,855,000 | $ 5,833,000 | ||||||||||||
Mundipharma Medical Company | Related Party | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Cost sharing (as a percent) | 50% | ||||||||||||||||
Collaborative agreement, maximum cost share | 31,200,000 | $ 31,200,000 | |||||||||||||||
Collaborative agreement, potential transaction value | $ 568,400,000 | ||||||||||||||||
Payments related to collaborative agreement | 30,000,000 | ||||||||||||||||
Accounts receivable | 400,000 | 400,000 | 400,000 | 400,000 | 200,000 | ||||||||||||
Mundipharma Medical Company | Related Party | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2023-10-01 | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Revenue, remaining performance obligation, amount | $ 11,200,000 | $ 11,200,000 | $ 11,200,000 | $ 11,200,000 | |||||||||||||
Revenue, remaining performance obligation, expected timing of satisfaction, period (in years) | 2 years 3 months 18 days | 2 years 3 months 18 days | 2 years 3 months 18 days | 2 years 3 months 18 days | |||||||||||||
Mundipharma Medical Company | Related Party | Licenses of Intellectual Property | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Revenue from collaborative agreement | $ 17,900,000 | ||||||||||||||||
Long-term portion of contract liabilities | $ 11,100,000 | ||||||||||||||||
Mundipharma Medical Company | Related Party | Milestone Achievement | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Revenue from collaborative agreement | $ 13,900,000 | $ 11,100,000 | $ 2,800,000 | ||||||||||||||
Uncredited portion | 10,100,000 | $ 10,100,000 | $ 10,100,000 | $ 10,100,000 | |||||||||||||
Mundipharma Medical Company | Related Party | Royalty | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Revenue from collaborative agreement | 0 | 0 | 0 | 0 | |||||||||||||
Janssen Pharmaceuticals, Inc. | Related Party | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Collaborative agreement, maximum cost share | 50,200,000 | ||||||||||||||||
Payments related to collaborative agreement | 27,000,000 | ||||||||||||||||
Termination provisions, required period of written notice (in days) | 90 days | ||||||||||||||||
Accounts receivable | 2,400,000 | 2,400,000 | 2,400,000 | 2,400,000 | $ 5,600,000 | ||||||||||||
Janssen Pharmaceuticals, Inc. | Related Party | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2023-10-01 | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Revenue, remaining performance obligation, amount | $ 7,000,000 | $ 7,000,000 | $ 7,000,000 | $ 7,000,000 | |||||||||||||
Revenue, remaining performance obligation, expected timing of satisfaction, period (in years) | 9 months 18 days | 9 months 18 days | 9 months 18 days | 9 months 18 days | |||||||||||||
Janssen Pharmaceuticals, Inc. | Related Party | Licenses of Intellectual Property | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Revenue from collaborative agreement | $ 27,000,000 | ||||||||||||||||
Janssen Pharmaceuticals, Inc. | Related Party | Milestone Achievement | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Revenue from collaborative agreement | $ 10,000,000 | $ 7,000,000 | $ 3,000,000 | ||||||||||||||
Janssen Pharmaceuticals, Inc. | Related Party | Royalty | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Revenue from collaborative agreement | $ 0 | 0 | $ 0 | 0 | |||||||||||||
Janssen Pharmaceuticals, Inc. | Related Party | Upfront Payment | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Payments related to collaborative agreement | $ 27,000,000 | ||||||||||||||||
Janssen Pharmaceuticals, Inc. | Related Party | R&D Funding | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Collaborative agreement, potential transaction value | 58,200,000 | ||||||||||||||||
Janssen Pharmaceuticals, Inc. | Related Party | Development, Regulatory, and Commercial Milestones | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Collaborative agreement, potential transaction value | $ 695,000,000 | ||||||||||||||||
Melinta Therapeutics, Inc. | Licenses of Intellectual Property | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Capitalized contract cost, gross | 2,000,000 | 2,000,000 | 2,000,000 | 2,000,000 | |||||||||||||
Capitalized contract cost, amortization | 500,000 | ||||||||||||||||
Capitalized contract cost, net | 200,000 | 200,000 | 200,000 | 200,000 | |||||||||||||
Melinta Therapeutics, Inc. | Milestone Achievement | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Capitalized contract cost, gross | 500,000 | 500,000 | 500,000 | 500,000 | |||||||||||||
Melinta Therapeutics, Inc. | Related Party | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Collaborative agreement, potential transaction value | $ 460,000,000 | ||||||||||||||||
Payments related to collaborative agreement | 30,000,000 | ||||||||||||||||
Accounts receivable | 100,000 | 100,000 | 100,000 | 100,000 | |||||||||||||
Melinta Therapeutics, Inc. | Related Party | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2023-10-01 | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Revenue, remaining performance obligation, amount | $ 4,200,000 | $ 4,200,000 | $ 4,200,000 | $ 4,200,000 | |||||||||||||
Revenue, remaining performance obligation, expected timing of satisfaction, period (in years) | 2 years 3 months 18 days | 2 years 3 months 18 days | 2 years 3 months 18 days | 2 years 3 months 18 days | |||||||||||||
Melinta Therapeutics, Inc. | Related Party | Licenses of Intellectual Property | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Revenue from collaborative agreement | $ 25,900,000 | ||||||||||||||||
Melinta Therapeutics, Inc. | Related Party | Milestone Achievement | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Revenue from collaborative agreement | $ 20,000,000 | $ 20,000,000 | |||||||||||||||
Melinta Therapeutics, Inc. | Related Party | Royalty | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Revenue from collaborative agreement | $ 100,000 | $ 0 | $ 100,000 | $ 0 | |||||||||||||
Melinta Therapeutics, Inc. | Related Party | Upfront Payment | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Payments related to collaborative agreement | 30,000,000 | ||||||||||||||||
Melinta Therapeutics, Inc. | Related Party | Development, Regulatory, and Commercial Milestones | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Collaborative agreement, potential transaction value | $ 430,000,000 |
SIGNIFICANT AGREEMENTS AND CO_4
SIGNIFICANT AGREEMENTS AND CONTRACTS - Summary of Contract Liability Activity (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Dec. 31, 2022 | |
Revenue From Collaborative Arrangement, Excluding Revenue From Contract With Customer, Liability [Roll Forward] | ||
Closing balance | $ 31,183 | |
Current contract liabilities | 14,679 | $ 14,614 |
Long-term portion of contract liabilities | 16,504 | 20,525 |
Total deferred revenue | 31,183 | |
Related Party | ||
Revenue From Collaborative Arrangement, Excluding Revenue From Contract With Customer, Liability [Roll Forward] | ||
Opening balance | 35,139 | |
Payments received in advance | 2,209 | |
Payments receivable | 70 | |
Revenue from performance obligations satisfied during reporting period | (6,235) | |
Closing balance | 31,183 | |
Total deferred revenue | $ 31,183 | $ 35,139 |
SIGNIFICANT AGREEMENTS AND CO_5
SIGNIFICANT AGREEMENTS AND CONTRACTS - Summary of Revenues Disaggregated by Timing of Revenue Recognition (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenues | $ 11,250,000 | $ 40,744,000 | $ 44,854,000 | $ 54,069,000 |
Related Party | Mundipharma | Royalty Revenue | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenues | 0 | 0 | 0 | 0 |
Related Party | Janssen | Royalty Revenue | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenues | 0 | 0 | 0 | 0 |
Related Party | Melinta | Royalty Revenue | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenues | 100,000 | 0 | 100,000 | 0 |
Related Party | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Mundipharma | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenues | 1,555,000 | 8,019,000 | 5,141,000 | 12,468,000 |
Related Party | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Janssen | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenues | 9,217,000 | 6,512,000 | 20,527,000 | 15,388,000 |
Related Party | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Melinta | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenues | 478,000 | 26,213,000 | 19,186,000 | 26,213,000 |
Related Party | Transferred at Point in Time | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Mundipharma | License of Intellectual Property - upon transfer of license | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenues | 0 | 0 | ||
Related Party | Transferred at Point in Time | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Mundipharma | License of Intellectual Property - upon milestone achieved | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenues | 0 | 3,252,000 | 0 | 3,252,000 |
Related Party | Transferred at Point in Time | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Mundipharma | Clinical Drug Supply | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenues | 0 | 26,000 | ||
Related Party | Transferred at Point in Time | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Janssen | License of Intellectual Property - upon transfer of license | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenues | 0 | 0 | ||
Related Party | Transferred at Point in Time | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Janssen | License of Intellectual Property - upon milestone achieved | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenues | 2,347,000 | 0 | 2,347,000 | 816,000 |
Related Party | Transferred at Point in Time | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Janssen | Clinical Drug Supply | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenues | 0 | 0 | ||
Related Party | Transferred at Point in Time | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Melinta | License of Intellectual Property - upon transfer of license | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenues | 25,885,000 | 25,885,000 | ||
Related Party | Transferred at Point in Time | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Melinta | License of Intellectual Property - upon milestone achieved | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenues | 0 | 0 | 17,257,000 | 0 |
Related Party | Transferred at Point in Time | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Melinta | Clinical Drug Supply | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenues | 0 | 0 | ||
Related Party | Transferred over Time | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Mundipharma | Royalty Revenue | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenues | 0 | 0 | ||
Related Party | Transferred over Time | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Mundipharma | Research and Development Services | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenues | 1,550,000 | 3,945,000 | 4,870,000 | 7,965,000 |
Related Party | Transferred over Time | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Mundipharma | Clinical Supply Services | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenues | 5,000 | 363,000 | 245,000 | 792,000 |
Related Party | Transferred over Time | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Janssen | Royalty Revenue | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenues | 0 | 0 | ||
Related Party | Transferred over Time | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Janssen | Research and Development Services | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenues | 5,592,000 | 6,250,000 | 16,324,000 | 11,235,000 |
Related Party | Transferred over Time | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Janssen | Clinical Supply Services | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenues | 1,278,000 | 262,000 | 1,856,000 | 3,337,000 |
Related Party | Transferred over Time | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Melinta | Royalty Revenue | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenues | 70,000 | 70,000 | ||
Related Party | Transferred over Time | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Melinta | Research and Development Services | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenues | 408,000 | 328,000 | 1,859,000 | 328,000 |
Related Party | Transferred over Time | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Melinta | Clinical Supply Services | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenues | $ 0 | 0 | $ 0 | 0 |
Affiliated Entity | Transferred at Point in Time | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Mundipharma | Clinical Drug Supply | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenues | 459,000 | 459,000 | ||
Affiliated Entity | Transferred at Point in Time | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Janssen | Clinical Drug Supply | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenues | 0 | 0 | ||
Affiliated Entity | Transferred at Point in Time | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Melinta | Clinical Drug Supply | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Total revenues | $ 0 | $ 0 |
COMMITMENTS AND CONTINGENCIES -
COMMITMENTS AND CONTINGENCIES - Additional Information (Details) | 9 Months Ended | ||
Apr. 20, 2023 USD ($) option | Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | |
Commitments and Contingencies Disclosure [Abstract] | |||
Renewal term (in months) | 36 months | ||
Base rent per month | $ 133,371 | ||
Percentage increase in base rent annual (as a percent) | 4% | ||
Number of options to extend | option | 2 | ||
Option renewal term (in years) | 2 years | ||
Incremental borrowing rate (as a percent) | 12% | ||
Weighted average remaining lease term (in years) | 3 years 3 months 18 days | ||
Lease payments | $ 1,000,000 | $ 1,000,000 | |
Lease cost | $ 1,200,000 | $ 1,000,000 | |
Variable lease and short-term lease term included within operating lease cost (in days) | 30 days |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES - Summary of Amount, Timing and Uncertainty of Cash Flows from Operating Lease (Details) $ in Thousands | Sep. 30, 2023 USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2023 | $ 321 |
2024 | 1,600 |
2025 | 1,665 |
2026 | 1,731 |
Total undiscounted operating lease payments | 5,317 |
Less: Imputed interest | (960) |
Present value of lease payments | $ 4,357 |
COMMITMENTS AND CONTINGENCIES_3
COMMITMENTS AND CONTINGENCIES - Summary of Supplemental Balance Sheet Information (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Commitments and Contingencies Disclosure [Abstract] | ||
Operating lease right-of-use asset | $ 4,131 | $ 1,205 |
Current portion of lease liability | 1,051 | 1,317 |
Long-term lease liability | 3,306 | $ 0 |
Total operating lease liability | $ 4,357 |
INCOME TAXES (Details)
INCOME TAXES (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Income Tax Disclosure [Abstract] | ||||
Income tax expense | $ 230 | $ 0 | $ 379 | $ 0 |
Effective income tax rates (as a percent) | (2.90%) | (2.24%) |