Cover
Cover - shares | 3 Months Ended | |
Mar. 31, 2024 | May 13, 2024 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2024 | |
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 $0.0001 Per Share | |
Trading Symbol | CDTX | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 4,561,708 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q1 | |
Entity Central Index Key | 0001610618 | |
Current Fiscal Year End Date | --12-31 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 29,018 | $ 35,778 |
Accounts receivable | 7,281 | 16,246 |
Inventory | 7,269 | 6,097 |
Prepaid expenses and other current assets | 3,266 | 2,734 |
Total current assets | 46,834 | 60,855 |
Property and equipment, net | 534 | 557 |
Finance lease right-of-use asset, net | 762 | 782 |
Operating lease right-of-use asset | 3,599 | 3,788 |
Other assets | 987 | 1,048 |
Total assets | 52,716 | 67,030 |
Current liabilities: | ||
Accounts payable | 5,055 | 3,772 |
Accrued liabilities | 8,241 | 14,177 |
Accrued indirect tax liabilities | 20,618 | 18,040 |
Accrued compensation and benefits | 5,723 | 5,034 |
Current contract liabilities | 24,324 | 25,095 |
Current portion of finance lease liability | 249 | 218 |
Current portion of operating lease liability | 1,215 | 1,082 |
Total current liabilities | 65,425 | 67,418 |
Long-term contract liabilities | 1,888 | 4,245 |
Long-term finance lease liability | 510 | 575 |
Long-term operating lease liability | 2,673 | 3,002 |
Total liabilities | 70,496 | 75,240 |
Commitments and contingencies | ||
Stockholders’ deficit: | ||
Preferred stock | ||
Common stock, $0.0001 par value; 20,000,000 shares authorized at March 31, 2024 and December 31, 2023; 4,561,696 shares issued and outstanding at March 31, 2024 and 4,530,113 shares issued and outstanding at December 31, 2023 | 1 | 1 |
Additional paid-in capital | 433,976 | 433,220 |
Accumulated deficit | (451,757) | (441,431) |
Total stockholders’ deficit | (17,780) | (8,210) |
Total liabilities and stockholders’ deficit | 52,716 | 67,030 |
Series X Convertible Preferred Stock | ||
Stockholders’ deficit: | ||
Preferred stock | $ 0 | $ 0 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2024 | Dec. 31, 2023 |
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) | 20,000,000 | 20,000,000 |
Common stock, shares issued (in shares) | 4,561,696 | 4,530,113 |
Common stock, shares outstanding (in shares) | 4,561,696 | 4,530,113 |
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 | 2,156,713 |
Preferred stock, shares outstanding (in shares) | 2,104,472 | 2,104,472 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Revenues: | ||
Collaboration revenue | $ 5,637 | $ 26,107 |
Product revenue | $ 2,826 | $ 0 |
Product revenue [Extensible Enumeration] | Product [Member] | Product [Member] |
Total revenues | $ 8,463 | $ 26,107 |
Operating expenses: | ||
Cost of product revenue | 1,563 | 0 |
Research and development | 11,593 | 18,869 |
Selling, general and administrative | 5,998 | 4,457 |
Total operating expenses | 19,154 | 23,326 |
Income (loss) from operations | (10,691) | 2,781 |
Other income, net: | ||
Interest income, net | 365 | 232 |
Total other income, net | 365 | 232 |
Net income (loss) and comprehensive income (loss) | (10,326) | 3,013 |
Net income (loss) and comprehensive income (loss) | (10,326) | 3,013 |
Allocation of earnings to participating securities | 0 | (636) |
Net income (loss) attributable to common stockholders | $ (10,326) | $ 2,377 |
Basic net earnings (loss) per common share (in dollars per share) | $ (2.28) | $ 0.60 |
Diluted net earnings (loss) per common share (in dollars per share) | $ (2.28) | $ 0.60 |
Shares used to compute basic net earnings (loss) per common share (in shares) | 4,537,782 | 3,932,050 |
Shares used to compute diluted net earnings (loss) per common share (in shares) | 4,537,782 | 5,059,514 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Operating activities: | ||
Net income (loss) | $ (10,326) | $ 3,013 |
Adjustments to reconcile net income (loss) to net cash used in operating activities: | ||
Stock-based compensation | 795 | 640 |
Non-cash operating lease expense | 188 | 262 |
Depreciation and amortization | 36 | 32 |
Amortization of costs to obtain a contract with a customer | 16 | 475 |
Amortization of finance lease right-of-use asset | 20 | 0 |
Non-cash interest expense | 16 | 0 |
Changes in assets and liabilities: | ||
Accounts receivable | 8,965 | (20,288) |
Inventory | (1,172) | 0 |
Prepaid expenses, other current assets, and other assets | (273) | 848 |
Accounts payable and accrued liabilities | (4,851) | 3,192 |
Accrued indirect tax liabilities | 2,578 | 261 |
Accrued compensation and benefits | 689 | 921 |
Contract liabilities | (3,128) | 36 |
Operating lease liabilities | (197) | (290) |
Net cash used in operating activities | (6,644) | (10,898) |
Investing activities: | ||
Purchases of property and equipment | (23) | (94) |
Net cash used in investing activities | (23) | (94) |
Financing activities: | ||
Proceeds from underwritten public offering, net of issuance costs | 0 | 17,593 |
Proceeds from public offering of common stock, net of issuance costs | 0 | 8,630 |
Proceeds from exercise of stock options | 0 | 14 |
Issuance costs for private placement | (4) | 0 |
Payment of finance lease liabilities | (50) | 0 |
Payment for shares withheld to fund payroll taxes | (39) | 0 |
Net cash (used in) provided by financing activities | (93) | 26,237 |
Net (decrease) increase in cash and cash equivalents | (6,760) | 15,245 |
Cash and cash equivalents at beginning of period | 35,778 | 32,731 |
Cash and cash equivalents at end of period | 29,018 | 47,976 |
Non-cash investing activities: | ||
Purchases of property and equipment, included in accounts payable and accrued liabilities | 0 | 55 |
Non-cash financing activities: | ||
Issuance costs incurred but not yet paid, included in accounts payable and accrued liabilities | $ 105 | $ 337 |
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, 2022 | 1,818,472 | ||||||||||||
Balance, beginning at Dec. 31, 2022 | $ (14,438) | $ 1 | $ 404,061 | $ (418,500) | $ 0 | ||||||||
Balance, beginning (in shares) at Dec. 31, 2022 | 3,623,591 | ||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||
Issuance of stock, net of issuance costs (in shares) | 554,300 | 307,936 | 286,000 | ||||||||||
Issuance of stock, net of issuance costs | $ 17,256 | $ 8,622 | $ 17,256 | $ 8,622 | |||||||||
Issuance of common stock for exercise of options (in shares) | 812 | ||||||||||||
Issuance of common stock for exercise of options | 14 | 14 | |||||||||||
Issuance of common stock for restricted share units vested (in shares) | 14,617 | ||||||||||||
Stock-based compensation | 640 | 640 | |||||||||||
Net (loss) income | 3,013 | 3,013 | |||||||||||
Balance, ending (in shares) at Mar. 31, 2023 | 2,104,472 | ||||||||||||
Balance, ending at Mar. 31, 2023 | 15,107 | $ 1 | 430,593 | (415,487) | $ 0 | ||||||||
Balance, ending (in shares) at Mar. 31, 2023 | 4,501,256 | ||||||||||||
Balance, beginning (in shares) at Dec. 31, 2023 | 2,104,472 | 2,104,472 | |||||||||||
Balance, beginning at Dec. 31, 2023 | $ (8,210) | $ 1 | 433,220 | (441,431) | $ 0 | ||||||||
Balance, beginning (in shares) at Dec. 31, 2023 | 4,530,113 | 4,530,113 | |||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||
Issuance of common stock for exercise of options (in shares) | 0 | ||||||||||||
Issuance of common stock for restricted share units vested (in shares) | 31,583 | ||||||||||||
Value of shares withheld to fund payroll taxes | $ (39) | (39) | |||||||||||
Stock-based compensation | 795 | 795 | |||||||||||
Net (loss) income | (10,326) | (10,326) | |||||||||||
Balance, ending (in shares) at Mar. 31, 2024 | 2,104,472 | 2,104,472 | |||||||||||
Balance, ending at Mar. 31, 2024 | $ (17,780) | $ 1 | $ 433,976 | $ (451,757) | $ 0 | ||||||||
Balance, ending (in shares) at Mar. 31, 2024 | 4,561,696 | 4,561,696 |
THE COMPANY AND BASIS OF PRESEN
THE COMPANY AND BASIS OF PRESENTATION | 3 Months Ended |
Mar. 31, 2024 | |
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 using its proprietary Cloudbreak ® platform to develop drug-Fc conjugate, or DFC, immunotherapies 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 ® (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. and Mundipharma Medical Company, or Mundipharma, is commercializing REZZAYO in the EU and UK. The Company’s proprietary Cloudbreak platform enables development of novel 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 has completed Phase 1 and Phase 2a clinical trials. Additional programs are targeting multiple immuno-oncology 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 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 March 31, 2024 and 2023. On April 24, 2024, the Company received total gross proceeds of $240.0 million in the Private Placement (see Note 10), which coupled with the other subsequent events disclosed in Note 10, has alleviated substantial doubt about the Company’s ability to continue as a going concern and provides sufficient liquidity for a period of one year following the date that these condensed consolidated financial statements are issued. The Company’s ability to execute its current business plan depends on its ability to obtain additional funding through equity offerings, debt financings or potential licensing and collaboration arrangements. The Company may not be able to raise additional funding on terms acceptable to the Company, or at all, and any failure to raise funds as and when needed will compromise the Company’s ability to execute on its business plan. 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, the Company 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. Reverse Stock Split On April 23, 2024, the Company effected the approved 1-for-20 reverse stock split of its shares of common stock. All references in this Quarterly Report on Form 10-Q to number of common shares, price per share and weighted average number of shares outstanding have been adjusted to reflect the Reverse Stock Split on a retroactive basis. As a result of the reverse stock split, an immaterial amount was reclassified from common stock to additional paid-in capital. 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, and the stand-alone selling price of performance obligations associated with the Company’s collaboration and license agreements. 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 | 3 Months Ended |
Mar. 31, 2024 | |
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, or R&D, 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 March 31, 2024 or December 31, 2023. 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 R&D 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 March 31, 2024, 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 Finance Lease In accordance with Accounting Standards Codification , or ASC, 842, Leases , or ASC 842, the Company determines if a contract contains a lease at inception and recognizes finance lease right-of-use assets and finance lease liabilities based on the present value of the future minimum lease payments at the commencement date. The implicit rate within the Company’s finance lease was determinable and therefore used in determining the present value of future payments at the commencement date. Lease agreements that have lease and non-lease components are accounted for as a single lease component. The Company recognizes amortization of the right-of-use assets and interest on the lease liabilities for its finance lease. Finance lease right-of-use assets are amortized on a straight-line basis from the commencement date to the earlier of the end of the useful life of the right-of-use asset or the end of the lease term. However, if the lease transfers ownership of the underlying asset to the lessee or the lessee is reasonably certain to exercise an option to purchase the underlying asset, the right-of-use assets are amortized to the end of the useful life of the underlying asset. Operating Lease In accordance with ASC 842 the Company determines if a contract contains a lease at inception and recognizes operating lease right-of-use assets and operating lease liabilities based on the present value of the future minimum lease payments at the commencement date. As the Company’s operating leases do not provide an implicit rate, management develops incremental borrowing rates based on the information available at the commencement date in determining the present value of future payments. Lease agreements that have lease and non-lease components are accounted for as a single lease component. Lease expense is recognized on a straight-line basis over the lease term. Income Taxes The Company reports deferred income taxes in accordance with ASC 740, Income Taxes , or ASC 740. 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. Indirect Taxes The Company’s purchases of clinical drug supplies and raw materials, inventory transfers, and sales of commercial drug product are subject to indirect taxation in various jurisdictions outside of the U.S. Indirect tax payable is included in accrued indirect tax liabilities, the related expense is included in R&D expenses, and the related interest and penalties are included in selling, general and administrative, or SG&A, expenses. The accrual is for the indirect tax incurred in various tax jurisdictions outside of the U.S. as a consequence of the Company’s supply chain activities or in connection with commercial sales of REZZAYO. To the extent that any accrued indirect taxes are determined to not be due and payable, then any associated liabilities and operating expenses will be reversed in future periods. Indirect tax amounts on commercial sales (product revenue) that can be billed to and recovered from our customers are included in accounts receivables. Indirect tax amounts related to inventory purchases and manufacturing are included within inventory. Revenue Recognition The Company recognizes revenue in accordance with ASC 606, Revenue from Contracts with Customers , or ASC 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 ASC 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 ASC 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 ASC 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 development 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. The Company concluded that there were three performance obligations under the Mundipharma Collaboration Agreement: the license, the R&D 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 R&D 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 R&D services, and the clinical supply services, and that the obligations are distinct from each other. The Company concluded that progress towards completion of the R&D 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 R&D 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 R&D 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 7 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 Company has made an accounting policy election to exclude from the transaction price any indirect taxes collected from customers. As a result, any such collections are recorded as indirect tax liabilities. 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 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 R&D expense in the period incurred. Research and Development Costs R&D expenses consist of wages, benefits and stock-based compensation charges for R&D employees, scientific consultant fees, facilities and overhead expenses, laboratory supplies, manufacturing expenses in preclinical development and certain manufacturing expenses before FDA approval, nonclinical and clinical trial costs, and indirect taxes on clinical supplies and development materials. 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 R&D expense if the technology has not been conclusively proven to be feasible and has no alternative future use. Selling, General and Administrative Expenses SG&A expenses relate to selling, finance, human resources, legal and other administrative activities. SG&A expenses consist primarily of salaries and related benefits, including stock-based compensation, related to our executive, finance, legal, business development, commercial planning and support functions. Other SG&A expenses include facility and overhead costs not otherwise included in cost of product revenue or R&D expenses, consultant expenses, travel expenses, professional fees for auditing, tax, legal, and other services, the branded prescription drug fee, and any accrued interest and penalties on accrued indirect tax liabilities. 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 R&D 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 does 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 5). 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 2024 2023 Numerator: Net income (loss) $ (10,326) $ 3,013 Allocation of earnings to participating securities — (636) Numerator for basic net earnings (loss) per common share - net income (loss) attributable to common stockholders $ (10,326) $ 2,377 Effect of participating securities: Add back allocation of earnings to participating securities — 636 Numerator for diluted net earnings (loss) per common share - net income (loss) attributable to common stockholders $ (10,326) $ 3,013 Denominator: Denominator for basic net earnings (loss) per common share - weighted average common shares outstanding 4,537,782 3,932,050 Effect of dilutive securities: Series X Convertible Preferred Stock, as converted — 1,052,236 Common stock options, RSUs, PRSUs, and ESPP — 75,228 Denominator for diluted net earnings (loss) per common share - adjusted weighted average common shares outstanding 4,537,782 5,059,514 Basic net earnings (loss) per common share $ (2.28) $ 0.60 Diluted net earnings (loss) per common share $ (2.28) $ 0.60 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 2024 2023 Common stock warrants 866 625,859 Series X Convertible Preferred Stock 1,052,236 — Common stock options, RSUs and PRSUs issued and outstanding 828,655 587,953 Total 1,881,757 1,213,812 Fair Value of Financial Instruments The Company follows ASC 820-10, Fair Value Measurements and Disclosures , or ASC 820-10, 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 liabilities. 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 Financial Accounting Standards Board, or FASB, or other standard setting bodies that are adopted by the Company as of the specified effective date. In December 2023, the FASB issued Accounting Standards Update 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which requires public entities to disclose disaggregated information about their effective tax rate reconciliation as well as expanded information on income taxes paid by jurisdiction. The disclosure requirements will be applied on a prospective basis, with the option to apply them retrospectively. The standard is effective for annual periods beginning after December 15, 2024, with early adoption permitted. The Company plans to adopt this guidance for the fiscal year ending December 31, 2025 and believes, based on its preliminary assessment, that this new guidance will not have a material impact on the Company’s consolidated financial statements or related disclosures. The Company believes, based on its preliminary assessment, that any other recently issued, but not yet adopted, accounting pronouncements will not have a material impact on the Company’s consolidated financial statements or related disclosures, or do not apply to the Company. |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 3 Months Ended |
Mar. 31, 2024 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE MEASUREMENTS | FAIR VALUE MEASUREMENTS The Company follows ASC 820-10, 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 March 31, 2024 Assets: Cash and money market accounts $ 29,018 $ 29,018 $ — $ — Total assets at fair value $ 29,018 $ 29,018 $ — $ — December 31, 2023 Assets: Cash and money market accounts $ 35,778 $ 35,778 $ — $ — Total assets at fair value $ 35,778 $ 35,778 $ — $ — |
INVENTORY
INVENTORY | 3 Months Ended |
Mar. 31, 2024 | |
Inventory Disclosure [Abstract] | |
INVENTORY | INVENTORY Inventory consisted of the following (in thousands): March 31, December 31, Raw materials $ 4,544 $ 2,691 Work-in-process 2,725 3,406 Finished goods — — Total inventory $ 7,269 $ 6,097 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 R&D expense in the period incurred. There were no inventory write downs during the three months ended March 31, 2024. |
STOCKHOLDERS_ EQUITY
STOCKHOLDERS’ EQUITY | 3 Months Ended |
Mar. 31, 2024 | |
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 three months ended March 31, 2024, the Company sold zero shares of common stock. During the three months ended March 31, 2023, the Company sold 307,936 shares of common stock for net proceeds of approximately $8.6 million after deducting placement agent fees. As of March 31, 2024, 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 554,300 shares of its common stock, including the exercise in full by Cantor of their option to purchase an additional 72,300 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 $25.34 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 March 31, 2024. 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 26,120 shares of the Company’s common stock. As of March 31, 2024 and December 31, 2023, 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 0.5 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 20,000,000 shares of common stock authorized as of March 31, 2024. 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 March 31, 2024 and December 31, 2023, warrants to purchase 866 shares of the Company’s common stock were outstanding with a weighted average exercise price of $230.95 per share. The warrants had no intrinsic value at March 31, 2024 and December 31, 2023. 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): March 31, December 31, Common stock warrants 866 866 Series X Convertible Preferred Stock 1,052,236 1,052,236 Common stock options, RSUs and PRSUs issued and outstanding 828,655 638,037 Authorized for future stock awards 129,785 170,783 Awards available under the ESPP 74,139 49,623 Total 2,085,681 1,911,545 |
EQUITY INCENTIVE PLANS
EQUITY INCENTIVE PLANS | 3 Months Ended |
Mar. 31, 2024 | |
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) 24,516 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 three months ended March 31, 2024 and 2023, zero shares were issued pursuant to the ESPP. As of March 31, 2024, total unrecognized compensation expense related to the ESPP was immaterial and is expected to be recognized over approximately 0.4 years. Restricted Stock Units The following table summarizes RSU and PRSU activity during the three months ended March 31, 2024: Number of Weighted Average Grant Date Fair Value Outstanding at December 31, 2023 104,886 $ 22.83 RSUs and PRSUs granted 58,160 13.70 RSUs and PRSUs vested (34,416) 20.14 RSUs and PRSUs canceled (1,288) 22.05 Outstanding at March 31, 2024 127,342 $ 19.40 The weighted-average grant date fair value of RSUs and PRSUs granted by the Company during the three months ended March 31, 2023 was $20.20 per share. The total fair value of RSUs and PRSUs vested during the three months ended March 31, 2024 and 2023 was approximately $0.7 million and $0.3 million, respectively. At March 31, 2024, estimated unrecognized compensation expense related to RSUs and PRSUs granted was approximately $2.2 million. This unrecognized compensation cost is expected to be recognized over a weighted-average period of approximately 2.3 years. Stock Options The following table summarizes stock option activity during the three months ended March 31, 2024: Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life in Years Total Aggregate Intrinsic Value (in thousands) Outstanding at December 31, 2023 533,151 $ 44.61 6.72 $ 57 Options granted 171,019 13.70 Options exercised — — Options canceled (2,857) 34.99 Outstanding at March 31, 2024 701,313 $ 37.11 7.35 $ 1,009 Vested and expected to vest at March 31, 2024 701,313 $ 37.11 7.35 $ 1,009 Exercisable at March 31, 2024 383,998 $ 53.39 5.65 $ 160 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 three months ended March 31, 2024 and 2023 was $9.80 and $14.29 per share, respectively. As of March 31, 2024, total unrecognized share-based compensation expense related to unvested stock options was approximately $3.6 million. This unrecognized compensation cost is expected to be recognized over a weighted-average period of approximately 2.3 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 2024 2023 Research and development $ 382 $ 367 Selling, general and administrative 413 273 Total $ 795 $ 640 |
SIGNIFICANT AGREEMENTS AND CONT
SIGNIFICANT AGREEMENTS AND CONTRACTS | 3 Months Ended |
Mar. 31, 2024 | |
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 March 31, 2024, 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 March 31, 2024, the Company determined the transaction price is equal to the up-front fee of $30.0 million, plus the R&D funding of $31.2 million, plus milestones achieved of $27.9 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 R&D services is best measured in an amount proportional to the R&D expenses incurred and the total estimated R&D 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 current contract liabilities as of March 31, 2024 because the rights to consideration is 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 March 31, 2024, the Company estimated the uncredited portion to be approximately $10.1 million in December 2024. In December 2021, August 2022, December 2023 and January 2024, the Company achieved milestones of $2.8 million, $11.1 million, $11.1 million and $2.8 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, September 2022, February 2024 and April 2024, respectively. The Company determined that as of March 31, 2024, 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. Royalty revenue recognized during the three months ended March 31, 2024 was immaterial. No royalty revenue was recognized during the three months ended March 31, 2023. 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 R&D 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 is 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 is 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. 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 under the Janssen Collaboration Agreement. 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 is obligated at its sole expense to diligently continue development and commercialization. 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 R&D 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 R&D costs incurred in conducting Research Plan activities. The Company was also 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 March 31, 2024, the Company determined the transaction price is equal to the up-front fee of $27.0 million, plus the R&D funding of $47.8 million, plus milestones achieved of $10.0 million. The transaction price includes the total estimated costs related to R&D and clinical supply services, which can increase or decrease as costs to continue the R&D 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 R&D 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 $26.8 million in May 2021 as collaboration revenue in its condensed consolidated statements of operations and comprehensive income (loss). Research and Development Services. The R&D 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 March 31, 2024, 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 months ended March 31, 2024 and 2023. 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 is 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 is 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 March 31, 2024, 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 R&D 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 R&D 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 R&D services is best measured in an amount proportional to the R&D expenses incurred and the total estimated R&D 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 months ended March 31, 2024 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 March 31, 2024, 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 months ended March 31, 2024 following the commercial launch of REZZAYO by Melinta in the U.S. on July 31, 2023. No royalty revenue was recognized during the three months ended March 31, 2023. 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, Other Assets and Deferred Costs . 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. The expense recognized during the three months ended March 31, 2024 was immaterial and the expense recognized during the three months ended March 31, 2023 was $0.5 million, and is included within SG&A expense in the Company’s condensed consolidated statements of operations and comprehensive income (loss). As of March 31, 2024, the remaining balance of the asset recognized from costs to obtain the Melinta License Agreement was $0.2 million. Contract Liabilities 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 three months ended March 31, 2024 (in thousands): Opening balance, December 31, 2023 $ 29,340 Payments received in advance 56 Payments receivable 351 Revenue from performance obligations satisfied during reporting period (3,535) Closing balance, March 31, 2024 $ 26,212 Current portion of contract liabilities $ 24,324 Lo |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 3 Months Ended |
Mar. 31, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | COMMITMENTS AND CONTINGENCIES Finance Lease Obligations The Company has a finance lease for lab equipment which was entered into in November 2023. The finance lease has a term of 36 months, monthly lease payments of $25,009, and an option to purchase the lab equipment for $1 at the end of the finance lease term. As of March 31, 2024, the Company was reasonably certain that it would exercise the option to purchase the lab equipment at the end of the finance lease term. The useful life of the lab equipment is estimated to be 10 years. The rate implicit to the finance lease used in measuring the Company’s finance lease liability was 8.0%. The following table presents information about the amount, timing and uncertainty of cash flows arising from the Company’s finance lease as of March 31, 2024 (in thousands): 2024 $ 225 2025 300 2026 300 2027 25 Total undiscounted finance lease payments 850 Less: Imputed interest (91) Present value of finance lease payments $ 759 The balance sheet classification of the Company’s finance lease is as follows (in thousands): Balance Sheet Classification: Finance lease right-of-use asset $ 788 Accumulated amortization (26) Net finance lease right-of-use asset $ 762 Current portion of finance lease liability $ 249 Long-term finance lease liability 510 Total finance lease liabilities $ 759 As of March 31, 2024, the weighted average remaining finance lease term was 2.8 years. Cash paid for amounts included in the measurement of finance lease liabilities was immaterial for the three months ended March 31, 2024. Finance lease costs were immaterial for the three months ended March 31, 2024. Operating Lease Obligations The Company has an operating lease for laboratory and office space in San Diego, California which was entered into in June 2014. Amendments for additional space were entered into in February 2015, March 2015 and August 2015. On April 20, 2023, the Company entered into a seventh amendment to its operating lease with Nancy Ridge Technology Center, L.P. which extended the term of the operating 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 operating 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 March 31, 2024, 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 operating lease term for accounting purposes. The incremental borrowing rate used in measuring the Company’s operating 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 March 31, 2024 (in thousands): 2024 $ 1,200 2025 1,665 2026 1,731 Total undiscounted operating lease payments $ 4,596 Less: Imputed interest (708) Present value of operating lease payments $ 3,888 The balance sheet classification of the Company’s operating lease is as follows (in thousands): Balance Sheet Classification: Operating lease right-of-use asset $ 3,599 Current portion of operating lease liability $ 1,215 Long-term operating lease liability 2,673 Total operating lease liabilities $ 3,888 As of March 31, 2024, the weighted average remaining operating lease term was 2.8 years. Cash paid for amounts included in the measurement of operating lease liabilities was $0.4 million and $0.3 million for the three months ended March 31, 2024 and 2023, respectively. Operating lease costs were $0.4 million and $0.3 million for the three months ended March 31, 2024 and 2023, 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 R&D activities, manufacturing, and professional services. These contracts generally provide for termination either on notice or after a notice period. |
INCOME TAXES
INCOME TAXES | 3 Months Ended |
Mar. 31, 2024 | |
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 months ended March 31, 2024 and 2023, the Company recognized no income tax expense. |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 3 Months Ended |
Mar. 31, 2024 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | SUBSEQUENT EVENTS Reverse Stock Split At the Company’s special meeting of stockholders held on April 4, 2024, the Company’s stockholders approved a proposal to (i) amend the Company’s Amended and Restated Certificate of Incorporation to effect a reverse stock split of the Company’s outstanding common stock at a ratio in the range of 1-for-10 to 1-for-30, inclusive; and (ii) if and only if the reverse stock split is approved and implemented, a reduction in the number of authorized shares of common stock, at a ratio that is equal to half of the reverse stock split ratio, with such ratio to be determined in the discretion of the Company’s board of directors and with such reverse stock split to be effected at such time and date, if at all, as determined by the Company’s board of directors in its sole discretion. On April 12, 2024, the Company’s board of directors approved a reverse stock split of all outstanding shares of the Company’s common stock at a ratio of 1-for-20, or the Reverse Stock Split. The Company’s board of directors also approved a reduction in the number of authorized shares of common stock, at a ratio that is equal to half of the Reverse Stock Split ratio. On April 22, 2024, the Company filed with the Secretary of State of the State of Delaware a Certificate of Amendment of its Amended and Restated Certificate of Incorporation, or the Charter Amendment, to effect the Reverse Stock Split. The Charter Amendment became effective at 5:00 p.m. Eastern Time on April 23, 2024. The Company’s common stock began trading on The Nasdaq Capital Market on a split-adjusted basis when the market opened on April 24, 2024 under a new CUSIP number (171757206). All references in this Quarterly Report on Form 10-Q to number of common shares, price per share and weighted average number of shares outstanding have been adjusted to reflect the Reverse Stock Split on a retroactive basis. Sale of Rezafungin On April 24, 2024, the Company and Napp Pharmaceutical Group Limited, or Napp, an affiliate of Mundipharma Medical Company, entered into an Asset Purchase Agreement, or the Purchase Agreement, pursuant to which the Company sold to Napp, effective as of April 24, 2024, the following: • all of the Company’s rezafungin acetate assets, including all of the Company’s right to receive future milestones and royalties under the Melinta License Agreement and the Mundipharma Collaboration Agreement, • all rezafungin intellectual property rights, including patents and know-how, all product data, regulatory approvals and documentation, • rezafungin and comparator inventory, • specified prepaid assets and specified contracts, in exchange for Napp’s assumption of certain liabilities of the rezafungin business, including the ongoing costs of the ReSPECT Phase 3 clinical trial and the ReSTORE Phase 3 clinical trial in China and the Company’s obligations from and after closing under the Melinta License Agreement, • the Commercial Supply Agreement dated January 23, 2023 between the Company and Melinta, and • the Commercial Supply Agreement, dated December 12, 2022 between the Company and Mundipharma, or the Mundipharma Commercial Supply Agreement. The Company, Napp and Mundipharma also entered into an Assignment and Novation Agreement to transfer the Mundipharma Collaboration Agreement and Mundipharma Commercial Supply Agreement from the Company to Napp, or the Novation Agreement. In the Novation Agreement, Mundipharma agreed to forgive the Company’s obligation to refund a $11.1 million development milestone advance due as of December 31, 2024, net of royalties, to Mundipharma under the Mundipharma Collaboration Agreement, provided that (a) the Company performs its obligation to provide carryover services under a Transition Services Agreement with Napp, or the TSA, for a period of 45 days following the closing, (b) the Company delivers all of the purchased assets, including product know-how and product-data, in accordance with the Purchase Agreement and a know-how transfer plan delivered in connection with the Purchase Agreement and (c) the Company performs its obligation to provide other services in accordance with the TSA for 75 days following the closing. If such conditions are not met, the Company will be obligated to refund the development milestone advance, net of royalties, within 10 business days of the date on which it is determined that the conditions for forgiveness were not satisfied. The Company made a one-time payment to Napp of $1.9 million in connection with the execution of the Novation Agreement. In connection with the Purchase Agreement and as a condition to entering into the Purchase Agreement, the Company entered into an amendment, dated April 23, 2024, to the Melinta License Agreement that, among other changes, modified the regulatory milestones payable upon receipt of marketing approval of the current rezafungin acetate product for an Additional Indication (as defined in the Melinta License Agreement). The Melinta License Agreement, as amended, was assigned and novated to Napp at the closing of the asset sale. All assets and liabilities included in the Purchase Agreement were transferred over on April 24, 2024 and all amounts pertaining to rezafungin that were part of the transaction will be written off the Company’s consolidated balance sheet in the second quarter of 2024. The Company has not yet determined the gain or loss on disposal. The Company determined that the held for sale criteria was not met as of March 31, 2024, and therefore, all balances are included in the condensed consolidated balance sheet and statement of operations as if they would be used in the normal course of business. The action to divest rezafungin was taken because of the Company’s strategy to streamline its portfolio and focus on the Cloudbreak platform and other financial considerations. Janssen License Agreement On April 23, 2024, the Company and Janssen entered into a license and technology transfer agreement, or the Janssen License Agreement, related to DFCs based on the Company’s Cloudbreak platform for the prevention and treatment of influenza, or the Influenza Program, including CD388, the Company’s most advanced DFC program, which has completed a Phase 2a clinical trial. Upon the effectiveness of the Janssen License Agreement, the Janssen Collaboration Agreement, including the license granted by the Company to Janssen and the Company’s non‑compete covenant thereunder, terminated, and the Company assumed responsibility for further clinical development, manufacture, registration and commercialization of DFCs within the Influenza Program, or Compounds, including CD388, and products containing Compounds, or Products, including Products containing CD388, or CD388 Product. As a condition to the effectiveness of the Janssen License Agreement, the Company paid Janssen an upfront payment of $85.0 million in April 2024. The Company will also be obligated to pay Janssen up to $150.0 million in development and regulatory milestone payments with respect to CD388 Product and up to $455.0 million in commercialization milestone payments with respect to CD388 Product. The Company has no obligation to pay any royalties to Janssen on the sale of any Product and no obligation to pay any milestone payment or other amount to Janssen with respect to the development, registration, manufacture or commercialization of any Compound other than CD388 or any Product other than CD388 Product. Securities Purchase Agreement On April 23, 2024, the Company entered into a securities purchase agreement, or the Securities Purchase Agreement, with certain institutional and other accredited investors, or the Purchasers, pursuant to which the Company issued and sold, in a private placement, or the Private Placement, 240,000 shares of Series A Convertible Voting Preferred Stock, par value $0.0001 per share, or the Series A Preferred Stock, at a purchase price of $1,000 per share. The closing of the Private Placement took place on April 24, 2024, or the Closing Date, and the Company received total gross proceeds of $240.0 million. Pursuant to the Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Voting Preferred Stock, which was filed with the Secretary of State of the State of Delaware on the Closing Date, or the Certificate of Designation, each share of Series A Preferred Stock is, subject to the Stockholder Approval (as defined below) and certain beneficial ownership conversion limitations, automatically convertible into shares of common stock, par value $0.0001 per share, of the Company. Subject to the terms and limitations contained in the Certificate of Designation, the Series A Preferred Stock issued in the Private Placement will not become convertible until the Company’s stockholders approve the issuance of all common stock issuable upon conversion of the Series A Preferred Stock, or the Conversion Shares, and an amendment to the Company’s certificate of incorporation to increase the authorized number of shares of common stock to enable the issuance or reservation for issuance, as applicable, of all of the Conversion Shares, or the Stockholder Approval. On the first Trading Day (as defined in the Certificate of Designation) following the announcement of the Stockholder Approval, each share of Series A Preferred Stock shall automatically convert into common stock, at the conversion price of $14.20 per share, rounded down to the nearest whole share, subject to the terms and limitations contained in the Certificate of Designation, including that shares of Series A Preferred Stock shall not be convertible if the conversion would result in a holder beneficially owning more than 9.99% of the Company’s outstanding shares of common stock as of the applicable conversion date. |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 3 Months Ended |
Mar. 31, 2024 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation 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 March 31, 2024 and 2023. |
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, and the stand-alone selling price of performance obligations associated with the Company’s collaboration and license agreements. 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, or R&D, 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 March 31, 2024 or December 31, 2023. |
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 R&D 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 March 31, 2024, the Company did not identify any excess, obsolete or unsaleable inventory. |
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 |
Finance Lease and Operating Lease | Finance Lease In accordance with Accounting Standards Codification , or ASC, 842, Leases , or ASC 842, the Company determines if a contract contains a lease at inception and recognizes finance lease right-of-use assets and finance lease liabilities based on the present value of the future minimum lease payments at the commencement date. The implicit rate within the Company’s finance lease was determinable and therefore used in determining the present value of future payments at the commencement date. Lease agreements that have lease and non-lease components are accounted for as a single lease component. The Company recognizes amortization of the right-of-use assets and interest on the lease liabilities for its finance lease. Finance lease right-of-use assets are amortized on a straight-line basis from the commencement date to the earlier of the end of the useful life of the right-of-use asset or the end of the lease term. However, if the lease transfers ownership of the underlying asset to the lessee or the lessee is reasonably certain to exercise an option to purchase the underlying asset, the right-of-use assets are amortized to the end of the useful life of the underlying asset. Operating Lease In accordance with ASC 842 the Company determines if a contract contains a lease at inception and recognizes operating lease right-of-use assets and operating lease liabilities based on the present value of the future minimum lease payments at the commencement date. As the Company’s operating leases do not provide an implicit rate, management develops incremental borrowing rates based on the information available at the commencement date in determining the present value of future payments. Lease agreements that have lease and non-lease components are accounted for as a single lease component. Lease expense is recognized on a straight-line basis over the lease term. |
Income Taxes | Income Taxes The Company reports deferred income taxes in accordance with ASC 740, Income Taxes , or ASC 740. 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. |
Indirect Taxes | Indirect Taxes The Company’s purchases of clinical drug supplies and raw materials, inventory transfers, and sales of commercial drug product are subject to indirect taxation in various jurisdictions outside of the U.S. Indirect tax payable is included in accrued indirect tax liabilities, the related expense is included in R&D expenses, and the related interest and penalties are included in selling, general and administrative, or SG&A, expenses. The accrual is for the indirect tax incurred in various tax jurisdictions outside of the U.S. as a consequence of the Company’s supply chain activities or in connection with commercial sales of REZZAYO. To the extent that any accrued indirect taxes are determined to not be due and payable, then any associated liabilities and operating expenses will be reversed in future periods. Indirect tax amounts on commercial sales (product revenue) that can be billed to and recovered from our customers are included in accounts receivables. Indirect tax amounts related to inventory purchases and manufacturing are included within inventory. |
Revenue Recognition | Revenue Recognition The Company recognizes revenue in accordance with ASC 606, Revenue from Contracts with Customers , or ASC 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 ASC 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 ASC 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 ASC 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 development 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. The Company concluded that there were three performance obligations under the Mundipharma Collaboration Agreement: the license, the R&D 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 R&D 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 R&D services, and the clinical supply services, and that the obligations are distinct from each other. The Company concluded that progress towards completion of the R&D 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 R&D 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 R&D 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 7 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 Company has made an accounting policy election to exclude from the transaction price any indirect taxes collected from customers. As a result, any such collections are recorded as indirect tax liabilities. 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 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 R&D expense in the period incurred. |
Research and Development Costs | Research and Development Costs R&D expenses consist of wages, benefits and stock-based compensation charges for R&D employees, scientific consultant fees, facilities and overhead expenses, laboratory supplies, manufacturing expenses in preclinical development and certain manufacturing expenses before FDA approval, nonclinical and clinical trial costs, and indirect taxes on clinical supplies and development materials. 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 R&D expense if the technology has not been conclusively proven to be feasible and has no alternative future use. |
Selling, General and Administrative Expenses | Selling, General and Administrative Expenses SG&A expenses relate to selling, finance, human resources, legal and other administrative activities. SG&A expenses consist primarily of salaries and related benefits, including stock-based compensation, related to our executive, finance, legal, business development, commercial planning and support functions. Other SG&A expenses include facility and overhead costs not otherwise included in cost of product revenue or R&D expenses, consultant expenses, travel expenses, professional fees for auditing, tax, legal, and other services, the branded prescription drug fee, and any accrued interest and penalties on accrued indirect tax liabilities. |
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 R&D 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 does 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 5). 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, Fair Value Measurements and Disclosures , or ASC 820-10, 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 liabilities. 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 | Recently Issued and Recently Adopted Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board, or FASB, or other standard setting bodies that are adopted by the Company as of the specified effective date. In December 2023, the FASB issued Accounting Standards Update 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which requires public entities to disclose disaggregated information about their effective tax rate reconciliation as well as expanded information on income taxes paid by jurisdiction. The disclosure requirements will be applied on a prospective basis, with the option to apply them retrospectively. The standard is effective for annual periods beginning after December 15, 2024, with early adoption permitted. The Company plans to adopt this guidance for the fiscal year ending December 31, 2025 and believes, based on its preliminary assessment, that this new guidance will not have a material impact on the Company’s consolidated financial statements or related disclosures. The Company believes, based on its preliminary assessment, that any other recently issued, but not yet adopted, accounting pronouncements will not have a material impact on the Company’s consolidated financial statements or related disclosures, or do not apply to the Company. |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Accounting Policies [Abstract] | |
Schedule 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 2024 2023 Numerator: Net income (loss) $ (10,326) $ 3,013 Allocation of earnings to participating securities — (636) Numerator for basic net earnings (loss) per common share - net income (loss) attributable to common stockholders $ (10,326) $ 2,377 Effect of participating securities: Add back allocation of earnings to participating securities — 636 Numerator for diluted net earnings (loss) per common share - net income (loss) attributable to common stockholders $ (10,326) $ 3,013 Denominator: Denominator for basic net earnings (loss) per common share - weighted average common shares outstanding 4,537,782 3,932,050 Effect of dilutive securities: Series X Convertible Preferred Stock, as converted — 1,052,236 Common stock options, RSUs, PRSUs, and ESPP — 75,228 Denominator for diluted net earnings (loss) per common share - adjusted weighted average common shares outstanding 4,537,782 5,059,514 Basic net earnings (loss) per common share $ (2.28) $ 0.60 Diluted net earnings (loss) per common share $ (2.28) $ 0.60 |
Schedule of Outstanding Potentially Dilutive Securities Excluded from Calculation of Diluted Net Earnings (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 2024 2023 Common stock warrants 866 625,859 Series X Convertible Preferred Stock 1,052,236 — Common stock options, RSUs and PRSUs issued and outstanding 828,655 587,953 Total 1,881,757 1,213,812 |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Fair Value Disclosures [Abstract] | |
Schedule 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 March 31, 2024 Assets: Cash and money market accounts $ 29,018 $ 29,018 $ — $ — Total assets at fair value $ 29,018 $ 29,018 $ — $ — December 31, 2023 Assets: Cash and money market accounts $ 35,778 $ 35,778 $ — $ — Total assets at fair value $ 35,778 $ 35,778 $ — $ — |
INVENTORY (Tables)
INVENTORY (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | Inventory consisted of the following (in thousands): March 31, December 31, Raw materials $ 4,544 $ 2,691 Work-in-process 2,725 3,406 Finished goods — — Total inventory $ 7,269 $ 6,097 |
STOCKHOLDERS_ EQUITY (Tables)
STOCKHOLDERS’ EQUITY (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Equity [Abstract] | |
Schedule of Common Stock Reserved for Future Issuance | Common stock reserved for future issuance is as follows (in common stock equivalent shares): March 31, December 31, Common stock warrants 866 866 Series X Convertible Preferred Stock 1,052,236 1,052,236 Common stock options, RSUs and PRSUs issued and outstanding 828,655 638,037 Authorized for future stock awards 129,785 170,783 Awards available under the ESPP 74,139 49,623 Total 2,085,681 1,911,545 |
EQUITY INCENTIVE PLANS (Tables)
EQUITY INCENTIVE PLANS (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Restricted Stock Units and Performance-based Restricted Stock Units Activity | The following table summarizes RSU and PRSU activity during the three months ended March 31, 2024: Number of Weighted Average Grant Date Fair Value Outstanding at December 31, 2023 104,886 $ 22.83 RSUs and PRSUs granted 58,160 13.70 RSUs and PRSUs vested (34,416) 20.14 RSUs and PRSUs canceled (1,288) 22.05 Outstanding at March 31, 2024 127,342 $ 19.40 |
Schedule of Stock Option Activity | The following table summarizes stock option activity during the three months ended March 31, 2024: Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life in Years Total Aggregate Intrinsic Value (in thousands) Outstanding at December 31, 2023 533,151 $ 44.61 6.72 $ 57 Options granted 171,019 13.70 Options exercised — — Options canceled (2,857) 34.99 Outstanding at March 31, 2024 701,313 $ 37.11 7.35 $ 1,009 Vested and expected to vest at March 31, 2024 701,313 $ 37.11 7.35 $ 1,009 Exercisable at March 31, 2024 383,998 $ 53.39 5.65 $ 160 |
Schedule 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 2024 2023 Research and development $ 382 $ 367 Selling, general and administrative 413 273 Total $ 795 $ 640 |
SIGNIFICANT AGREEMENTS AND CO_2
SIGNIFICANT AGREEMENTS AND CONTRACTS (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule 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 three months ended March 31, 2024 (in thousands): Opening balance, December 31, 2023 $ 29,340 Payments received in advance 56 Payments receivable 351 Revenue from performance obligations satisfied during reporting period (3,535) Closing balance, March 31, 2024 $ 26,212 Current portion of contract liabilities $ 24,324 Long-term portion of contract liabilities 1,888 Total contract liabilities, March 31, 2024 $ 26,212 The following table presents our collaboration revenue disaggregated by collaborator and timing of revenue recognition (in thousands): Three Months Ended Mundipharma Janssen Melinta Revenue from Collaboration and License Agreements: Point in Time: License of Intellectual Property - upon milestone achieved $ 813 $ — $ — Royalty Revenue 26 — 76 Over Time: Research and Development Services 3,266 971 317 Clinical Supply Services 166 2 — Total Revenue from Collaboration and License Agreements $ 4,271 $ 973 $ 393 Three Months Ended Mundipharma Janssen Melinta Revenue from Collaboration and License Agreements: Point in Time: License of Intellectual Property - upon milestone achieved $ — $ — $ 17,257 Over Time: Research and Development Services 1,655 5,828 975 Clinical Supply Services — 392 — Total Revenue from Collaboration and License Agreements $ 1,655 $ 6,220 $ 18,232 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Amount, Timing and Uncertainty of Cash Flows from Finance Lease | The following table presents information about the amount, timing and uncertainty of cash flows arising from the Company’s finance lease as of March 31, 2024 (in thousands): 2024 $ 225 2025 300 2026 300 2027 25 Total undiscounted finance lease payments 850 Less: Imputed interest (91) Present value of finance lease payments $ 759 |
Schedule of Supplemental Balance Sheet Information For Finance Leases | The balance sheet classification of the Company’s finance lease is as follows (in thousands): Balance Sheet Classification: Finance lease right-of-use asset $ 788 Accumulated amortization (26) Net finance lease right-of-use asset $ 762 Current portion of finance lease liability $ 249 Long-term finance lease liability 510 Total finance lease liabilities $ 759 |
Schedule 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 March 31, 2024 (in thousands): 2024 $ 1,200 2025 1,665 2026 1,731 Total undiscounted operating lease payments $ 4,596 Less: Imputed interest (708) Present value of operating lease payments $ 3,888 |
Schedule 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 $ 3,599 Current portion of operating lease liability $ 1,215 Long-term operating lease liability 2,673 Total operating lease liabilities $ 3,888 |
THE COMPANY AND BASIS OF PRES_2
THE COMPANY AND BASIS OF PRESENTATION (Details) $ in Millions | 3 Months Ended | ||
Apr. 24, 2024 USD ($) | Apr. 23, 2024 | Mar. 31, 2024 segment | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Number of operating segments | segment | 1 | ||
Subsequent Event | |||
Subsequent Event [Line Items] | |||
Reverse stock split | 0.05 | ||
Subsequent Event | Series A Convertible Voting Preferred Stock | Private Placement | |||
Subsequent Event [Line Items] | |||
Sale of stock, gross | $ | $ 240 |
SUMMARY OF SIGNIFICANT ACCOUN_4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Additional Information (Details) - obligation | 3 Months Ended | |||
Mar. 31, 2024 | Jul. 31, 2022 | Mar. 31, 2021 | Sep. 30, 2019 | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Expected dividend rate (as a percent) | 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 - Schedule of Computation of Basic and Diluted Net Earnings (Loss) Per Common Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Numerator: | ||
Net income (loss) | $ (10,326) | $ 3,013 |
Allocation of earnings to participating securities | 0 | (636) |
Numerator for basic net earnings (loss) per common share - net income (loss) attributable to common stockholders | (10,326) | 2,377 |
Effect of participating securities: | ||
Add back allocation of earnings to participating securities | 0 | 636 |
Numerator for diluted net earnings (loss) per common share - net income (loss) attributable to common stockholders | $ (10,326) | $ 3,013 |
Denominator: | ||
Denominator for basic net earnings (loss) per common share - weighted average common shares outstanding (in shares) | 4,537,782 | 3,932,050 |
Effect of dilutive securities: | ||
Series X Convertible Preferred Stock, as converted (in shares) | 0 | 1,052,236 |
Common stock options, RSUs, PRSUs, and ESPP (in shares) | 0 | 75,228 |
Denominator for diluted net earnings (loss) per common share - adjusted weighted average common shares outstanding (in shares) | 4,537,782 | 5,059,514 |
Basic net earnings (loss) per common share (in dollars per share) | $ (2.28) | $ 0.60 |
Diluted net earnings (loss) per common share (in dollars per share) | $ (2.28) | $ 0.60 |
SUMMARY OF SIGNIFICANT ACCOUN_6
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Schedule of Outstanding Potentially Dilutive Securities Excluded from Calculation of Diluted Net Earnings (Loss) Per Share (Details) - shares | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
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) | 1,881,757 | 1,213,812 |
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) | 866 | 625,859 |
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) | 1,052,236 | 0 |
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) | 828,655 | 587,953 |
FAIR VALUE MEASUREMENTS - Sched
FAIR VALUE MEASUREMENTS - Schedule of Financial Instruments Measured at Fair Value on a Recurring Basis (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Assets: | ||
Cash and money market accounts | $ 29,018 | $ 35,778 |
Total assets at fair value | 29,018 | 35,778 |
LEVEL 1 | ||
Assets: | ||
Cash and money market accounts | 29,018 | 35,778 |
Total assets at fair value | 29,018 | 35,778 |
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 | Mar. 31, 2024 | Dec. 31, 2023 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 4,544 | $ 2,691 |
Work-in-process | 2,725 | 3,406 |
Finished goods | 0 | 0 |
Total inventory | $ 7,269 | $ 6,097 |
INVENTORY - Additional Informat
INVENTORY - Additional Information (Details) | 3 Months Ended |
Mar. 31, 2024 USD ($) | |
Inventory Disclosure [Abstract] | |
Inventory write-down | $ 0 |
STOCKHOLDERS_ EQUITY - Addition
STOCKHOLDERS’ EQUITY - Additional Information (Details) | 1 Months Ended | 3 Months Ended | ||||
Mar. 07, 2023 USD ($) $ / shares shares | Aug. 12, 2020 shares | May 31, 2018 $ / shares shares | Mar. 31, 2024 USD ($) vote $ / shares shares | Mar. 31, 2023 USD ($) shares | Dec. 31, 2023 USD ($) $ / 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) | 20,000,000 | 20,000,000 | ||||
Dividends in arrears or default | $ | $ 0 | |||||
Common Stock Warrant | ||||||
Class of Stock [Line Items] | ||||||
Warrants outstanding (in shares) | 866 | 866 | ||||
Warrants, aggregate intrinsic value, outstanding | $ | $ 0 | $ 0 | ||||
Common Stock Warrant | Weighted Average | ||||||
Class of Stock [Line Items] | ||||||
Exercise price of warrant (in dollars per share) | $ / shares | $ 230.95 | $ 230.95 | ||||
Common Stock | ||||||
Class of Stock [Line Items] | ||||||
Issuance of common stock upon conversion of Series X convertible preferred stock (in shares) | 26,120 | |||||
Common Stock | ||||||
Class of Stock [Line Items] | ||||||
Number of votes for each share held | vote | 1 | |||||
Series X Convertible Preferred Stock | ||||||
Class of Stock [Line Items] | ||||||
Preferred stock, shares authorized (in shares) | 5,000,000 | 4,947,759 | 4,947,759 | |||
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) | 0.5 | |||||
Maximum ownership following conversion (more than) (as a percent) | 9.99% | |||||
Number of votes for each share held | vote | 0 | |||||
Controlled Equity Sales Agreement, Cantor Fitzgerald and Company | ||||||
Class of Stock [Line Items] | ||||||
Shares sold (in shares) | 0 | 307,936 | ||||
Sale of stock, net | $ | $ 8,600,000 | |||||
Consideration remaining on transaction | $ | $ 37,100,000 | |||||
2023 Underwritten Public Offering | ||||||
Class of Stock [Line Items] | ||||||
Sale of stock, net | $ | $ 17,300,000 | |||||
Sale of stock, gross | $ | $ 19,500,000 | |||||
2023 Underwritten Public Offering | Common Stock | ||||||
Class of Stock [Line Items] | ||||||
Shares sold (in shares) | 554,300 | |||||
Offering price (in dollars per share) | $ / shares | $ 25.34 | |||||
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) | 72,300 |
STOCKHOLDERS_ EQUITY - Schedule
STOCKHOLDERS’ EQUITY - Schedule of Common Stock Reserved for Future Issuance (Details) - shares | Mar. 31, 2024 | Dec. 31, 2023 |
Class of Stock [Line Items] | ||
Total (in shares) | 2,085,681 | 1,911,545 |
Common stock warrants | ||
Class of Stock [Line Items] | ||
Total (in shares) | 866 | 866 |
Series X Convertible Preferred Stock | ||
Class of Stock [Line Items] | ||
Total (in shares) | 1,052,236 | 1,052,236 |
Common stock options, RSUs and PRSUs issued and outstanding | ||
Class of Stock [Line Items] | ||
Total (in shares) | 828,655 | 638,037 |
Authorized for future stock awards | ||
Class of Stock [Line Items] | ||
Total (in shares) | 129,785 | 170,783 |
Awards available under the ESPP | ||
Class of Stock [Line Items] | ||
Total (in shares) | 74,139 | 49,623 |
EQUITY INCENTIVE PLANS - Additi
EQUITY INCENTIVE PLANS - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 3 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2024 | Mar. 31, 2023 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Weighted-average grant date fair value of employee stock options granted (in dollars per share) | $ 9.80 | $ 14.29 | |
Unrecognized share-based compensation expense, options | $ 3.6 | ||
Restricted Stock Units and Performance-based Restricted Stock Units | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Weighted-average period to recognize unrecognized compensation cost (in years) | 2 years 3 months 18 days | ||
RSUs and PRSUs granted (in dollars per share) | $ 13.70 | $ 20.20 | |
Fair value of RSUs and PRSUs | $ 0.7 | $ 0.3 | |
Estimated unrecognized share-based compensation expense | $ 2.2 | ||
Options | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Weighted-average period to recognize unrecognized compensation cost (in years) | 2 years 3 months 18 days | ||
2020 Inducement Incentive Plan and 2015 Equity Incentive Plan | |||
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% | ||
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% | ||
2020 Inducement Incentive Plan and 2015 Equity Incentive Plan | 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% | ||
2020 Inducement Incentive Plan and 2015 Equity Incentive Plan | Minimum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Vesting period (in years) | 3 years | ||
2020 Inducement Incentive Plan and 2015 Equity Incentive Plan | Maximum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Vesting period (in years) | 4 years | ||
2015 Employee Stock Purchase Plan | 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) | 0 | 0 | |
Weighted-average period to recognize unrecognized compensation cost (in years) | 4 months 24 days | ||
2015 Employee Stock Purchase Plan | Maximum | ESPP | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Common stock shares outstanding (in shares) | 24,516 |
EQUITY INCENTIVE PLANS - Schedu
EQUITY INCENTIVE PLANS - Schedule of Restricted Stock Units and Performance-based Restricted Stock Units Activity (Details) - Restricted Stock Units and Performance-based Restricted Stock Units - $ / shares | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Number of RSUs and PRSUs | ||
Outstanding, beginning balance (in shares) | 104,886 | |
RSUs and PRSUs granted (in shares) | 58,160 | |
RSUs and PRSUs vested (in shares) | (34,416) | |
RSUs and PRSUs canceled (in shares) | (1,288) | |
Outstanding, ending balance (in shares) | 127,342 | |
Weighted Average Grant Date Fair Value | ||
Outstanding, beginning of period (in dollars per share) | $ 22.83 | |
RSUs and PRSUs granted (in dollars per share) | 13.70 | $ 20.20 |
RSUs and PRSUs vested (in dollars per share) | 20.14 | |
RSUs and PRSUs canceled (in dollars per share) | 22.05 | |
Outstanding, end of period (in dollars per share) | $ 19.40 |
EQUITY INCENTIVE PLANS - Sche_2
EQUITY INCENTIVE PLANS - Schedule of Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Number of Shares | ||
Outstanding, beginning balance (in shares) | 533,151 | |
Options granted (in shares) | 171,019 | |
Options exercised (in shares) | 0 | |
Options canceled (in shares) | (2,857) | |
Outstanding, ending balance (in shares) | 701,313 | 533,151 |
Vested and expected to vest (in shares) | 701,313 | |
Exercisable (in shares) | 383,998 | |
Weighted Average Exercise Price | ||
Outstanding, beginning balance (in dollars per share) | $ 44.61 | |
Options granted (in dollars per share) | 13.70 | |
Options exercised (in dollars per share) | 0 | |
Options canceled (in dollars per share) | 34.99 | |
Outstanding, ending balance (in dollars per share) | 37.11 | $ 44.61 |
Vested and expected to vest (in dollars per share) | 37.11 | |
Exercisable (in dollars per share) | $ 53.39 | |
Weighted Average Remaining Contractual Life in Years | ||
Outstanding (in years) | 7 years 4 months 6 days | 6 years 8 months 19 days |
Vested and expected to vest (in years) | 7 years 4 months 6 days | |
Exercisable (in years) | 5 years 7 months 24 days | |
Total Aggregate Intrinsic Value (in thousands) | ||
Outstanding | $ 1,009 | $ 57 |
Vested and expected to vest | 1,009 | |
Exercisable | $ 160 |
EQUITY INCENTIVE PLANS - Sche_3
EQUITY INCENTIVE PLANS - Schedule of Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total | $ 795 | $ 640 |
Research and development | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total | 382 | 367 |
Selling, general and administrative | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total | $ 413 | $ 273 |
SIGNIFICANT AGREEMENTS AND CO_3
SIGNIFICANT AGREEMENTS AND CONTRACTS - Additional Information (Details) - USD ($) | 1 Months Ended | 3 Months Ended | |||||||||||||
Jul. 26, 2022 | Mar. 31, 2021 | Sep. 03, 2019 | Jan. 31, 2024 | Dec. 31, 2023 | Sep. 30, 2023 | Mar. 31, 2023 | Aug. 31, 2022 | Mar. 31, 2022 | Dec. 31, 2021 | May 31, 2021 | Sep. 30, 2019 | Mar. 31, 2024 | Mar. 31, 2023 | Nov. 30, 2020 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||
Revenue from collaborative agreement | $ 5,637,000 | $ 26,107,000 | |||||||||||||
Current contract liabilities | $ 25,095,000 | 24,324,000 | |||||||||||||
Capitalized contract cost, amortization | 16,000 | 475,000 | |||||||||||||
Accounts receivable | 16,246,000 | 7,281,000 | |||||||||||||
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 | 13,900,000 | 6,600,000 | |||||||||||||
Mundipharma Medical Company | Related Party | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2024-04-01 | |||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||
Revenue, remaining performance obligation, amount | $ 10,200,000 | ||||||||||||||
Revenue, remaining performance obligation, expected timing of satisfaction, period (in years) | 1 year 9 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 | ||||||||||||||
Current 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 | $ 2,800,000 | 11,100,000 | $ 11,100,000 | $ 2,800,000 | $ 27,900,000 | ||||||||||
Uncredited portion | 10,100,000 | ||||||||||||||
Mundipharma Medical Company | Related Party | Royalty | |||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||
Revenue from collaborative agreement | 0 | 0 | |||||||||||||
Janssen Pharmaceuticals, Inc. | Related Party | |||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||
Collaborative agreement, maximum cost share | 47,800,000 | ||||||||||||||
Payments related to collaborative agreement | 27,000,000 | ||||||||||||||
Termination provisions, required period of written notice (in days) | 90 days | ||||||||||||||
Accounts receivable | 1,900,000 | 300,000 | |||||||||||||
Janssen Pharmaceuticals, Inc. | Related Party | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2024-04-01 | |||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||
Revenue, remaining performance obligation, amount | $ 800,000 | ||||||||||||||
Revenue, remaining performance obligation, expected timing of satisfaction, period (in years) | 3 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 | $ 26,800,000 | ||||||||||||||
Janssen Pharmaceuticals, Inc. | Related Party | Milestone Achievement | |||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||
Revenue from collaborative agreement | $ 7,000,000 | $ 3,000,000 | $ 10,000,000 | ||||||||||||
Janssen Pharmaceuticals, Inc. | Related Party | Royalty | |||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||
Revenue from collaborative agreement | 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 | ||||||||||||||
Capitalized contract cost, amortization | 0 | 500,000 | |||||||||||||
Capitalized contract cost, net | 200,000 | ||||||||||||||
Melinta Therapeutics, Inc. | Milestone Achievement | |||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||
Capitalized contract cost, gross | 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 | $ 400,000 | 400,000 | |||||||||||||
Melinta Therapeutics, Inc. | Related Party | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2024-04-01 | |||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||
Revenue, remaining performance obligation, amount | $ 3,300,000 | ||||||||||||||
Revenue, remaining performance obligation, expected timing of satisfaction, period (in years) | 1 year 9 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 | |||||||||||||
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 | 3 Months Ended | |
Mar. 31, 2024 | Dec. 31, 2023 | |
Revenue From Collaborative Arrangement, Excluding Revenue From Contract With Customer, Liability [Roll Forward] | ||
Closing balance | $ 26,212 | |
Current portion of contract liabilities | 24,324 | $ 25,095 |
Long-term portion of contract liabilities | 1,888 | 4,245 |
Total contract liability | 26,212 | |
Related Party | ||
Revenue From Collaborative Arrangement, Excluding Revenue From Contract With Customer, Liability [Roll Forward] | ||
Opening balance | 29,340 | |
Payments received in advance | 56 | |
Payments receivable | 351 | |
Revenue from performance obligations satisfied during reporting period | (3,535) | |
Closing balance | 26,212 | |
Total contract liability | $ 26,212 | $ 29,340 |
SIGNIFICANT AGREEMENTS AND CO_5
SIGNIFICANT AGREEMENTS AND CONTRACTS - Summary of Revenues Disaggregated by Timing of Revenue Recognition (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Total Revenue from Collaboration and License Agreements | $ 5,637,000 | $ 26,107,000 |
Related Party | Mundipharma | Royalty Revenue | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Total Revenue from Collaboration and License Agreements | 0 | 0 |
Related Party | Janssen | Royalty Revenue | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Total Revenue from Collaboration and License Agreements | 0 | 0 |
Related Party | Melinta | Royalty Revenue | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Total Revenue from Collaboration and License Agreements | 100,000 | 0 |
Related Party | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Mundipharma | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Total Revenue from Collaboration and License Agreements | 4,271,000 | 1,655,000 |
Related Party | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Janssen | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Total Revenue from Collaboration and License Agreements | 973,000 | 6,220,000 |
Related Party | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Melinta | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Total Revenue from Collaboration and License Agreements | 393,000 | 18,232,000 |
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 Revenue from Collaboration and License Agreements | 813,000 | 0 |
Related Party | Transferred at Point in Time | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Mundipharma | Royalty Revenue | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Total Revenue from Collaboration and License Agreements | 26,000 | |
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 Revenue from Collaboration and License Agreements | 0 | 0 |
Related Party | Transferred at Point in Time | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Janssen | Royalty Revenue | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Total Revenue from Collaboration and License Agreements | 0 | |
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 Revenue from Collaboration and License Agreements | 0 | 17,257,000 |
Related Party | Transferred at Point in Time | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Melinta | Royalty Revenue | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Total Revenue from Collaboration and License Agreements | 76,000 | |
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 Revenue from Collaboration and License Agreements | 3,266,000 | 1,655,000 |
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 Revenue from Collaboration and License Agreements | 166,000 | 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 Revenue from Collaboration and License Agreements | 971,000 | 5,828,000 |
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 Revenue from Collaboration and License Agreements | 2,000 | 392,000 |
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 Revenue from Collaboration and License Agreements | 317,000 | 975,000 |
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 Revenue from Collaboration and License Agreements | $ 0 | $ 0 |
COMMITMENTS AND CONTINGENCIES -
COMMITMENTS AND CONTINGENCIES - Additional Information (Details) | 1 Months Ended | 3 Months Ended | ||
Apr. 20, 2023 USD ($) option | Nov. 30, 2023 USD ($) | Mar. 31, 2024 USD ($) | Mar. 31, 2023 USD ($) | |
Finance Lease Obligations | ||||
Lessee, finance lease, term of contract (in months) | 36 months | |||
Lessee, finance lease, monthly rate | $ 25,009 | |||
Lessee, finance lease, option, purchase equipment | $ 1 | |||
Lessee, finance lease, discount rate (as a percent) | 8% | |||
Finance lease, weighted average remaining lease term (in years) | 2 years 9 months 18 days | |||
Operating Lease Obligations | ||||
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) | 2 years 9 months 18 days | |||
Lease payments | $ 400,000 | $ 300,000 | ||
Lease cost | $ 400,000 | $ 300,000 | ||
Variable lease and short-term lease term included within operating lease cost (in days) | 30 days | |||
Equipment | ||||
Finance Lease Obligations | ||||
Useful life (in years) | 10 years |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES - Summary of Amount, Timing and Uncertainty of Cash Flows from Finance Lease (Details) $ in Thousands | Mar. 31, 2024 USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2024 | $ 225 |
2025 | 300 |
2026 | 300 |
2027 | 25 |
Total undiscounted finance lease payments | 850 |
Less: Imputed interest | (91) |
Present value of finance lease payments | $ 759 |
COMMITMENTS AND CONTINGENCIES_3
COMMITMENTS AND CONTINGENCIES - Summary of Supplemental Balance Sheet Information For Finance Leases (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Commitments and Contingencies Disclosure [Abstract] | ||
Finance lease right-of-use asset | $ 788 | |
Accumulated amortization | (26) | |
Net finance lease right-of-use asset | 762 | $ 782 |
Current portion of finance lease liability | 249 | 218 |
Long-term finance lease liability | 510 | $ 575 |
Total finance lease liabilities | $ 759 |
COMMITMENTS AND CONTINGENCIES_4
COMMITMENTS AND CONTINGENCIES - Summary of Amount, Timing and Uncertainty of Cash Flows from Operating Lease (Details) $ in Thousands | Mar. 31, 2024 USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2024 | $ 1,200 |
2025 | 1,665 |
2026 | 1,731 |
Total undiscounted operating lease payments | 4,596 |
Less: Imputed interest | (708) |
Present value of operating lease payments | $ 3,888 |
COMMITMENTS AND CONTINGENCIES_5
COMMITMENTS AND CONTINGENCIES - Summary of Supplemental Balance Sheet Information (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Commitments and Contingencies Disclosure [Abstract] | ||
Operating lease right-of-use asset | $ 3,599 | $ 3,788 |
Current portion of operating lease liability | 1,215 | 1,082 |
Long-term operating lease liability | 2,673 | $ 3,002 |
Total operating lease liabilities | $ 3,888 |
INCOME TAXES (Details)
INCOME TAXES (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Income Tax Disclosure [Abstract] | ||
Income tax expense | $ 0 | $ 0 |
SUBSEQUENT EVENTS (Details)
SUBSEQUENT EVENTS (Details) $ / shares in Units, $ in Millions | 1 Months Ended | 3 Months Ended | |||||
Apr. 24, 2024 USD ($) | Apr. 23, 2024 $ / shares shares | Mar. 31, 2021 USD ($) | Sep. 03, 2019 USD ($) | Apr. 30, 2024 USD ($) | Mar. 31, 2024 USD ($) $ / shares | Dec. 31, 2023 $ / shares | |
Subsequent Event [Line Items] | |||||||
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | |||||
Related Party | Mundipharma Medical Company | |||||||
Subsequent Event [Line Items] | |||||||
Payments related to collaborative agreement | $ 30 | ||||||
Collaborative agreement, potential transaction value | $ 568.4 | ||||||
Related Party | Janssen Pharmaceuticals, Inc. | |||||||
Subsequent Event [Line Items] | |||||||
Payments related to collaborative agreement | $ 27 | ||||||
Related Party | Janssen Pharmaceuticals, Inc. | Upfront Payment | |||||||
Subsequent Event [Line Items] | |||||||
Payments related to collaborative agreement | $ 27 | ||||||
Related Party | Janssen Pharmaceuticals, Inc. | Development, Regulatory, and Commercial Milestones | |||||||
Subsequent Event [Line Items] | |||||||
Collaborative agreement, potential transaction value | $ 695 | ||||||
Subsequent Event | |||||||
Subsequent Event [Line Items] | |||||||
Reverse stock split | 0.05 | ||||||
Subsequent Event | Private Placement | Series A Convertible Voting Preferred Stock | |||||||
Subsequent Event [Line Items] | |||||||
Shares sold (in shares) | shares | 240,000 | ||||||
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.0001 | ||||||
Purchase price (in dollars per share) | $ / shares | 1,000 | ||||||
Sale of stock, gross | $ 240 | ||||||
Preferred stock, convertible, conversion price (in dollars per share) | $ / shares | $ 14.20 | ||||||
Maximum ownership following conversion (more than) (as a percent) | 9.99% | ||||||
Subsequent Event | Related Party | Mundipharma Medical Company | |||||||
Subsequent Event [Line Items] | |||||||
Collaborative arrangement, carry over services agreement term (in days) | 45 days | ||||||
Collaborative arrangement, other services agreement term (in days) | 75 days | ||||||
Collaborative agreement, maximum cost share, forgiveness, not satisfied, refund period (in days) | 10 days | ||||||
Subsequent Event | Related Party | Napp Pharmaceutical Group Limited | Novation Agreement | |||||||
Subsequent Event [Line Items] | |||||||
Payments related to collaborative agreement | $ 1.9 | ||||||
Subsequent Event | Related Party | Janssen Pharmaceuticals, Inc. | Upfront Payment | |||||||
Subsequent Event [Line Items] | |||||||
Payments related to collaborative agreement | $ 85 | ||||||
Subsequent Event | Related Party | Janssen Pharmaceuticals, Inc. | Development, Regulatory, and Commercial Milestones | |||||||
Subsequent Event [Line Items] | |||||||
Collaborative agreement, potential transaction value | 150 | ||||||
Subsequent Event | Related Party | Janssen Pharmaceuticals, Inc. | Commercialization Milestone | |||||||
Subsequent Event [Line Items] | |||||||
Collaborative agreement, potential transaction value | $ 455 | ||||||
Subsequent Event | Related Party | Milestone Achievement | Mundipharma Medical Company | |||||||
Subsequent Event [Line Items] | |||||||
Collaborative agreement, maximum cost share, forgiveness amount | $ 11.1 |