Document And Entity Information
Document And Entity Information - shares | 3 Months Ended | |
Mar. 31, 2024 | Apr. 30, 2024 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Mar. 31, 2024 | |
Entity File Number | 001-37544 | |
Entity Registrant Name | ARMATA PHARMACEUTICALS, INC. | |
Entity Incorporation, State or Country Code | WA | |
Entity Tax Identification Number | 91-1549568 | |
Entity Address, Address Line One | 5005 McConnell Avenue | |
Entity Address, City or Town | Los Angeles | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 90066 | |
City Area Code | 310 | |
Local Phone Number | 665-2928 | |
Title of 12(b) Security | Common Stock | |
Trading Symbol | ARMP | |
Security Exchange Name | NYSEAMER | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Interactive Data Current | Yes | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 36,154,617 | |
Entity Central Index Key | 0000921114 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Current assets | ||
Cash | $ 37,860 | $ 13,523 |
Prepaid expenses and other current assets | 2,143 | 2,265 |
Other receivables | 1,714 | 3,363 |
Total current assets | 41,717 | 19,151 |
Restricted cash | 5,480 | 5,720 |
Property and equipment, net | 12,700 | 12,559 |
Operating lease right-of-use asset | 44,243 | 44,717 |
In-process research and development | 10,256 | 10,256 |
Goodwill | 3,490 | 3,490 |
Other assets | 2,470 | 2,470 |
Total assets | 120,356 | 98,363 |
Current liabilities | ||
Accounts payable and accrued liabilities | 4,610 | 5,689 |
Accrued compensation | 948 | 768 |
Convertible debt | 71,658 | |
Term debt, current | 25,010 | |
Current portion of operating lease liabilities | 7,497 | 9,481 |
Other current liabilities | 322 | 523 |
Total current liabilities | 110,045 | 16,461 |
Operating lease liabilities, net of current portion | 28,376 | 28,583 |
Convertible debt | 58,633 | |
Term debt non-current | 35,368 | 23,674 |
Deferred tax liability | 3,077 | 3,077 |
Total liabilities | 176,866 | 130,428 |
Commitments and contingencies (Note 12) | ||
Stockholders' deficit | ||
Common stock, $0.01 par value; 217,000,000 shares authorized; 36,132,117 and 36,122,932 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively | 361 | 361 |
Additional paid-in capital | 276,969 | 276,393 |
Accumulated deficit | (333,840) | (308,819) |
Total stockholders' deficit | (56,510) | (32,065) |
Total liabilities and stockholders' deficit | $ 120,356 | $ 98,363 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2024 | Dec. 31, 2023 |
Condensed Consolidated Balance Sheets | ||
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 217,000,000 | 217,000,000 |
Common stock, shares issued | 36,132,117 | 36,122,932 |
Common stock, shares outstanding | 36,132,117 | 36,122,932 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Condensed Consolidated Statements of Operations | ||
Grant revenue | $ 966 | $ 796 |
Operating expenses | ||
Research and development | 8,016 | 9,604 |
General and administrative | 3,178 | 2,538 |
Total operating expenses | 11,194 | 12,142 |
Loss from operations | (10,228) | (11,346) |
Other income (expense) | ||
Interest income | 52 | 18 |
Interest expense | (1,820) | |
Change in fair value of convertible debt | (13,025) | (3,162) |
Total other (expense) income, net | (14,793) | (3,144) |
Net loss | $ (25,021) | $ (14,490) |
Per share information: | ||
Net loss per share, basic (in dollars per share) | $ (0.69) | $ (0.40) |
Net loss per share, diluted (in dollars per share) | $ (0.69) | $ (0.40) |
Weighted average shares outstanding, basic (in shares) | 36,124,980 | 36,045,040 |
Weighted average shares outstanding, diluted (in shares) | 36,124,980 | 36,045,040 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' (Deficit) Equity - USD ($) $ in Thousands | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Total |
Balances at Dec. 31, 2022 | $ 361 | $ 275,493 | $ (239,774) | $ 36,080 |
Balances (in shares) at Dec. 31, 2022 | 36,144,706 | |||
Stock-based compensation | 857 | 857 | ||
Net loss | (14,490) | (14,490) | ||
Balances at Mar. 31, 2023 | $ 361 | 276,350 | (254,264) | 22,447 |
Balances (in shares) at Mar. 31, 2023 | 36,144,706 | |||
Balances at Dec. 31, 2023 | $ 361 | 276,393 | (308,819) | (32,065) |
Balances (in shares) at Dec. 31, 2023 | 36,122,932 | |||
Withholdings for taxes related to net share settlement of equity awards, shares | (4,222) | |||
Exercise of stock options | 42 | $ 42 | ||
Exercise of stock options (in shares) | 13,407 | 13,407 | ||
Stock-based compensation | 534 | $ 534 | ||
Net loss | (25,021) | (25,021) | ||
Balances at Mar. 31, 2024 | $ 361 | $ 276,969 | $ (333,840) | $ (56,510) |
Balances (in shares) at Mar. 31, 2024 | 36,132,117 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Operating activities: | ||
Net loss | $ (25,021) | $ (14,490) |
Adjustments required to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization expense | 317 | 230 |
Stock-based compensation expense | 534 | 857 |
Change in fair value of convertible debt | 13,025 | 3,162 |
Non-cash interest expense | 1,815 | |
Non-cash interest income | (26) | |
Change in right-of-use asset | 464 | |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | 1,797 | (1,418) |
Accounts payable and accrued liabilities | (1,488) | (1,342) |
Accrued compensation | 180 | (905) |
Operating lease liability | (2,181) | (3,664) |
Net cash used in operating activities | (10,584) | (17,570) |
Investing activities: | ||
Purchases of property and equipment | (250) | (2,010) |
Net cash used in investing activities | (250) | (2,010) |
Financing activities: | ||
Proceeds from issuance of convertible debt, net of issuance costs | 29,594 | |
Proceeds from issuance of long-term debt, net of issuance costs | 34,889 | |
Proceeds from exercise of stock options | 42 | |
Net cash provided by financing activities | 34,931 | 29,594 |
Net increase in cash and restricted cash | 24,097 | 10,014 |
Cash and restricted cash, beginning of period | 19,243 | 20,812 |
Cash and restricted cash, end of period | 43,340 | 30,826 |
Supplemental disclosure of cash flow information: | ||
Property and equipment included in accounts payable | 425 | 40 |
Unpaid debt issuance costs | $ 26 | $ 268 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (Parenthetical) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 | Mar. 31, 2023 | Dec. 31, 2022 |
Reconciliation of cash, cash equivalents, and restricted cash | ||||
Cash | $ 37,860 | $ 13,523 | $ 25,106 | |
Restricted cash | 5,480 | 5,720 | 5,720 | |
Cash and restricted cash | $ 43,340 | $ 19,243 | $ 30,826 | $ 20,812 |
Organization and Description of
Organization and Description of the Business | 3 Months Ended |
Mar. 31, 2024 | |
Organization and Description of the Business | |
Organization and Description of the Business | 1. Organization and Description of the Business Armata Pharmaceuticals, Inc. (“Armata”) together with its subsidiaries (the “Company”), is a clinical-stage biotechnology company focused on the development of pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections using its proprietary bacteriophage-based technology. Armata’s common stock, par value $0.01 per share (the “Common Stock”) is traded on the NYSE American exchange under the ticker symbol “ARMP.”. |
Liquidity and Going Concern
Liquidity and Going Concern | 3 Months Ended |
Mar. 31, 2024 | |
Liquidity and Going Concern | |
Liquidity and Going Concern | 2. Liquidity and Going Concern The Company has incurred significant operating losses since inception and has primarily relied on equity, debt and grant financing to fund its operations. As of March 31, 2024, the Company had an accumulated deficit of $333.8 million. The Company expects to continue to incur substantial losses, and its transition to profitability will depend on the successful development, approval and commercialization of product candidates and on the achievement of sufficient revenues to support its cost structure. The Company may never achieve profitability, and unless and until then, the Company will need to continue to raise additional capital. Existing cash of $37.9 million as of March 31, 2024 will not be sufficient to fund the Company’s operations for the next 12 months from the date of these condensed consolidated financial statements. These circumstances raise substantial doubt about the Company’s ability to continue as a going concern. The Company has prepared its condensed consolidated financial statements on a going concern basis, which assumes that the Company will realize its assets and satisfy its liabilities in the normal course of business. The accompanying condensed consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from the outcome of the uncertainty concerning the Company’s ability to continue as a going concern. Recent Financing: 2024 Credit Agreement On March 4, 2024, the Company entered into a credit and security agreement (the “2024 Credit Agreement”) for a loan in an aggregate amount of $35.0 million (the “2024 Loan”) with Innoviva Strategic Opportunities LLC, a wholly owned subsidiary of Innoviva, Inc. (NASDAQ: INVA), our principal stockholder and a related party (collectively, “Innoviva”). The 2024 Loan bears interest at an annual rate of 14% and matures on June 4, 2025. Principal and accrued interest are payable at maturity. Repayment of the 2024 Loan is guaranteed by the Company’s domestic subsidiaries, and the loan is secured by substantially all of the assets of the Company and the subsidiary guarantors. Concurrently with the execution of the 2024 Credit Agreement, the Company amended certain provisions of its existing convertible loan (the “Convertible Loan”) (see Note 7) and secured credit and security agreement, dated January 10, 2023, with Innoviva (the “Convertible Credit Agreement”) and its existing secured term loan facility (the “2023 Loan”) and credit and security agreement, dated July 10, 2023, with Innoviva (the “2023 Credit Agreement”) to, among other things, conform certain terms relating to permitted indebtedness and permitted liens (see Note 8). The Company plans to raise additional capital through equity offerings, debt financings, or other capital sources, including potential collaborations, licenses and other similar arrangements. While the Company believes this plan to raise additional funds will alleviate the conditions that raise substantial doubt about the Company’s ability to continue as a going concern, these plans are not entirely within its control and cannot be assessed as being probable of occurring. The Company’s ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and the recent disruptions to, and volatility in, financial markets in the United States and worldwide. The Company may not be able to secure additional financing in a timely manner or on favorable terms, if at all. Furthermore, if the Company issues equity securities to raise additional funds, its existing stockholders may experience dilution, and the new equity securities may have rights, preferences and privileges senior to those of the Company’s existing stockholders. If the Company raises additional funds through collaboration, licensing or other similar arrangements, it may be necessary to relinquish valuable rights to its potential products on terms that are not favorable to the Company. If the Company is unable to raise capital when needed or on attractive terms, it would be forced to delay, reduce or eliminate its research and development programs or other operations. If any of these events occur, the Company’s ability to achieve the development and commercialization goals would be adversely affected. |
Significant Accounting Policies
Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2024 | |
Significant Accounting Policies | |
Significant Accounting Policies | 3. Significant Accounting Policies Basis of Presentation The condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany accounts and transactions have been eliminated. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements and accompanying notes thereto as of and for the year ended December 31, 2023 included in the Company’s Form 10-K, filed with the Securities and Exchange Commission (the “SEC”) on March 21, 2024. The information as of December 31, 2023 included in the condensed consolidated balance sheets was derived from the Company’s audited financial statements. The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and the requirements of the SEC for interim reporting. In the opinion of management, the accompanying condensed consolidated financial statements include all adjustments that are of a normal and recurring nature and that are necessary for the fair presentation of the Company’s financial position and the results of its operations and cash flows for the periods presented. Interim results are not necessarily indicative of results for the full year or any future period. Any reference in the condensed consolidated financial statements to applicable guidance is meant to refer to authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). Significant Accounting Policies The significant accounting policies used in preparation of the condensed consolidated financial statements for the three months ended March 31, 2024 and 2023 are consistent with those discussed in Note 3 to the consolidated financial statements included in the Company’s Form 10-K for the year ended December 31, 2023, filed with the SEC on March 21, 2024, except as noted below and within the “Recently Adopted Accounting Pronouncements” section. Use of Estimates The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, and the reported amounts of expenses during the reporting period. On an ongoing basis, the Company evaluates estimates and assumptions, including but not limited to those related to convertible debt, stock-based compensation expense, accruals for research and development costs, the valuation of deferred tax assets, impairment of goodwill and intangible assets and impairment of long-lived assets. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ materially from those estimates. Segments The Company operates and manages its business as one reportable operating segment, which is the business of developing a pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat acute and chronic bacterial infections using its proprietary bacteriophage-based technology. The Company’s chief executive officer, who is the chief operating decision maker, reviews financial information on an aggregate basis for allocating resources and evaluating financial performance. The long-lived assets of $12.6 million, which represents 98.9% of the Company’s total long-lived assets, are maintained in the United States. Concentration of Credit Risks and Certain Other Risks Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash and restricted cash. As of December 31, 2023 and March 31, 2024, restricted cash was invested primarily in money market funds and U.S. treasury securities through highly rated financial institutions in accordance with the Company’s investment policy, to a concentration limit per issuer or sector. Other receivables represent amounts due from the Medical Technology Enterprise Consortium (“MTEC”) (Note 13) and reimbursement for tenant improvements (Note 12). Recently Adopted Accounting Pronouncements In August 2020, the FASB issued ASU 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40) (“ASU 2020-06”). ASU 2020-06 eliminates the beneficial conversion and cash conversion accounting models for convertible instruments. It also amends the accounting for certain contracts in an entity’s own equity that are currently accounted for as derivatives because of specific settlement provisions. In addition, ASU 2020-06 modifies how particular convertible instruments and certain contracts that may be settled in cash or shares impact the diluted EPS computation. The Company adopted this ASU as of January 1, 2024, which did not have an impact on its consolidated financial statements or related disclosures. Recent Accounting Pronouncements Not Yet Adopted In October 2023, the FASB issued ASU 2023-06, Disclosure Improvements: Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2024 | |
Fair Value Measurements | |
Fair Value Measurements | 4. Fair Value Measurements The Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. The Company determines fair value based on assumptions that market participants would use in pricing an asset or liability in the principal or most advantageous market. When considering market participant assumptions in fair value measurements, the following fair value hierarchy distinguishes between observable and unobservable inputs, which are categorized in one of the following three levels: ● Level 1: ● Level 2: ● Level 3: The Company’s Convertible Loan (Note 7) is measured at fair value and remeasured at each measurement period, with changes in fair value recorded as other income (expense) in the consolidated statement of operations. The Company estimates the fair value of its Convertible Loan using a weighted probability model of various debt settlement scenarios during its term discounted to the reporting date. Conversion option scenarios are valued using option pricing models with assumptions and estimates such as volatility, expected term and risk-free interest rates. Level 3 fair value inputs include probability and timing of various settlement scenarios and selection of comparable companies. The Company estimated the fair value of its convertible debt using the following inputs as of March 31, 2024 and December 31, 2023: March 31, 2024 December 31, 2023 Discount rate 23.75% 21.01% Probabilities of settlement scenarios 0%-75% 0%-75% Volatility 109.80% 123.3% Expected term (in years) 0.3-0.8 0.2-1.0 Risk-free rate 5.05%-5.32% 4.66%-5.36% The following table presents a summary of the changes in the fair value of the Company’s Level 3 financial liabilities (in thousands): Three months ended March 31, 2024 March 31, 2023 Convertible debt opening balance $ 58,633 $ — Issuance of the convertible debt — 29,226 Change in fair value 13,025 3,162 Convertible debt closing balance $ 71,658 $ 32,388 |
Net Loss per Share
Net Loss per Share | 3 Months Ended |
Mar. 31, 2024 | |
Net Loss per Share | |
Net Loss per Share | 5. Net Loss per Share The following outstanding securities as of March 31, 2024 and December 31, 2023 have been excluded from the computation of diluted weighted average shares outstanding, as they would have been anti-dilutive: March 31, 2024 December 31, 2023 Outstanding stock options 4,874,620 3,165,216 Unvested restricted stock units 290,000 200,000 Shares issuable upon the conversion of convertible debt 21,692,982 21,293,861 Outstanding warrants 19,365,847 19,365,847 Total 46,223,449 44,024,924 |
Balance Sheet Details
Balance Sheet Details | 3 Months Ended |
Mar. 31, 2024 | |
Balance Sheet Details | |
Balance Sheet Details | 6. Balance Sheet Details Property and Equipment Property and equipment as of March 31, 2024 and December 31, 2023 consisted of the following: March 31, 2024 December 31, 2023 Laboratory equipment $ 20,136 $ 19,678 Furniture and fixtures 817 817 Office and computer equipment 438 438 Leasehold improvements 3,447 3,447 Total 24,838 24,380 Less: accumulated depreciation (12,138) (11,821) Property and equipment, net $ 12,700 $ 12,559 Depreciation and amortization expense totaled $0.3 million and $0.2 million for the three months ended March 31, 2024 and 2023, respectively. Construction in progress and fixed assets not in use were $8.5 million and $8.1 million as of March 31, 2024 and December 31, 2023, respectively, and are included in the laboratory and manufacturing equipment in the table above. These assets are not depreciated until they are placed in service. Other receivables Other receivables as of March 31, 2024 and December 31, 2023 consisted of the following: March 31, 2024 December 31, 2023 Tenant improvement allowance receivable (Note 12) $ 748 $ 1,835 Grant and award receivable 966 1,528 $ 1,714 $ 3,363 Accounts payable and accrued liabilities Accounts payable and accrued liabilities as of March 31, 2024 and December 31, 2023 consisted of the following: March 31, 2024 December 31, 2023 Accounts payable $ 2,057 $ 1,585 Accrued clinical trial expenses 1,817 3,021 Other accrued expenses 736 1,083 $ 4,610 $ 5,689 |
Convertible Debt
Convertible Debt | 3 Months Ended |
Mar. 31, 2024 | |
Convertible Debt | |
Convertible Debt | 7. Convertible Debt On January 10, 2023, the Company received the Convertible Loan in the aggregate amount of $30.0 million from Innoviva pursuant to the Convertible Credit Agreement. The Convertible Loan bears interest at a rate of 8.0% per annum and was scheduled to mature on January 10, 2024. The Convertible Credit Agreement was amended on July 10, 2023, in connection with the Company’s entry into the 2023 Credit Agreement, to, among other changes, extend the maturity of the Convertible Loan to January 10, 2025. The Convertible Loan principal and accrued interest are payable at maturity. Repayment of the Convertible Loan is guaranteed by the Company’s domestic subsidiaries and foreign material subsidiaries, and the Convertible Loan is secured by substantially all of the assets of the Company and the subsidiary guarantors. The Convertible Credit Agreement provides that if there is a financing from new investors of at least $30.0 million (a “Qualified Financing”), the outstanding principal amount of and all accrued and unpaid interest on the Convertible Loan shall be converted into shares of the Company’s Common Stock, at a price per share equal to a 15.0% discount to the lowest price per share for Common Stock paid by investors in such Qualified Financing. The Convertible Credit Agreement also required the Company to file a registration statement for the resale of all securities issued to the lender in connection with any conversion under the Convertible Credit Agreement, which the Company originally filed on February 13, 2023 and which was declared effective by the SEC on April 6, 2023. The Convertible Credit Agreement also confers upon the lender the option to convert any outstanding Convertible Loan amount, including all accrued and unpaid interest thereon, at the lender’s option, into shares of Common Stock at a price per share equal to the greater of book value or market value per share of Common Stock on the date immediately preceding the effective date of the Convertible Credit Agreement, which was $1.52 (as may be appropriately adjusted for any stock split, combination or similar act). The Company evaluated authoritative guidance for accounting for the Convertible Loan and concluded that the Convertible Loan should be accounted for at fair value under ASC 480, Distinguish Liabilities from Equity, due to the fact that the Convertible Loan will predominately be settled with the Company’s Common Stock. Consequently, the Company recorded the Convertible Loan in its entirety at fair value on its condensed consolidated balance sheet, with changes in fair value recorded as other income (expenses) in the condensed consolidated statements of operations during each reporting period. The Company recognized losses of $13.0 million and $3.2 million as the change in fair value of the Convertible Loan for the three months ended March 31, 2024 and March 31, 2023, respectively. |
Long-Term Debt
Long-Term Debt | 3 Months Ended |
Mar. 31, 2024 | |
Long-Term Debt | |
Long-Term Debt | 8. Long-Term Debt On July 10, 2023, the Company entered into the 2023 Credit Agreement. The 2023 Credit Agreement provides for the 2023 Loan a secured term loan facility in an aggregate amount of $25.0 million at an interest rate of 14.0% per annum and has a maturity date of January 10, 2025. Principal and accrued interest are payable at maturity. Repayment of the 2023 Loan is guaranteed by the Company’s domestic subsidiaries, and the 2023 Loan is secured by substantially all of the assets of the Company and the subsidiary guarantors. The 2023 Loan was initially recognized at fair value of $21.2 million and subsequently recognized at the amortized cost net of debt issuance costs and debt discount. Debt issuance costs and debt discount in the amounts of $0.1 million and $3.8 million, respectively, are amortized using the effective interest method to interest expense over the term of the 2023 Loan. The 2023 Loan’s annual effective interest rate was 27.31% as of March 31, 2024. On March 4, 2024, the Company entered into the 2024 Credit Agreement. The 2024 Credit Agreement provides for the 2024 Loan a secured term loan facility in an aggregate amount of $35.0 million at an interest rate of 14.0% per annum and has a maturity date of June 4, 2025. Principal and accrued interest are payable at maturity. Repayment of the 2024 Loan is guaranteed by the Company’s domestic subsidiaries, and the 2024 Loan is secured by substantially all of the assets of the Company and the subsidiary guarantors. The 2024 Loan was initially recognized at cash proceeds of $35.0 million net of debt issuance costs of $0.1 million, and subsequently is recognized at the amortized cost. Debt issuance costs are amortized using the effective interest method to interest expense over the term of the 2024 Loan. The 2024 Loan’s annual effective interest rate was 14.25% for the three months ended March 31, 2024. The 2023 Credit Agreement and the 2024 Credit Agreement contain customary affirmative and negative covenants and representations and warranties, including financial reporting obligations and certain limitations on indebtedness, liens, investments, distributions (including dividends), collateral, investments, mergers or acquisitions and fundamental corporate changes. The 2023 Credit Agreement and the 2024 Credit Agreement also include customary events of default, including payment defaults, breaches of provisions under the loan documents, certain losses or impairment of collateral and related security interests, the occurrence of certain events that could reasonably be expected to have a “material adverse effect” as set forth in the 2023 Credit Agreement and the 2024 Credit Agreement, certain bankruptcy or insolvency events, and a material deviation from the Company’s operating budget. |
Stockholders' Deficit
Stockholders' Deficit | 3 Months Ended |
Mar. 31, 2024 | |
Stockholders' Deficit | |
Stockholders' Deficit | 9. Stockholders’ Deficit Warrants As of March 31, 2024, outstanding warrants to purchase shares of Common Stock were as follows: March 31, 2024 Exercise Price Expiration Date 993,139 $ 2.87 February 11, 2025 7,717,661 $ 2.87 March 27, 2025 1,867,912 $ 3.25 January 26, 2026 4,285,935 $ 3.25 March 16, 2026 1,807,396 $ 5.00 February 8, 2027 2,692,604 $ 5.00 March 30, 2027 1,200 $ 1,680.00 None 19,365,847 Shares Reserved for Future Issuance As of March 31, 2024 the Company had reserved shares of its Common Stock for future issuance as follows: March 31, 2024 Stock options outstanding 4,874,620 Unvested restricted stock units 290,000 Employee stock purchase plan 11,890 Shares available for future grants under the 2016 Plan 2,362,677 Warrants outstanding 19,365,847 Shares issuable upon the conversion of convertible debt 21,692,982 Total shares reserved 48,598,016 |
Equity Incentive Plans
Equity Incentive Plans | 3 Months Ended |
Mar. 31, 2024 | |
Equity Incentive Plans | |
Equity Incentive Plans | 10. Equity Incentive Plans Stock Award Plans The Company maintains a 2016 Equity Incentive Plan (the “2016 Plan”), which provides for the issuance of incentive share awards in the form of non-qualified and incentive stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards and performance-based stock awards. As of March 31, 2024, there were 2,362,677 shares available for issuance under the 2016 Plan. Stock option transactions during the three months ended March 31, 2024 are presented below: Options Outstanding Weighted Average Weighted Remaining Average Contractual Aggregate Exercise Term Intrinsic Shares Price (Years) Value (in thousands) Outstanding at December 31, 2023 3,165,216 $ 5.04 5.9 $ 429 Granted 1,784,054 $ 3.38 — Exercised (13,407) $ 3.15 $ 15 Forfeited/Cancelled/Expired (61,243) $ 5.06 $ — Outstanding at March 31, 2024 4,874,620 $ 4.44 7.2 $ 3,334 Vested and expected to vest at March 31, 2024 4,874,620 $ 4.44 7.2 $ 3,334 Exercisable at March 31, 2024 2,204,014 $ 5.51 4.7 $ 1,243 The aggregate intrinsic value of options at March 31, 2024 is based on the Company’s closing stock price on that date of $4.18 per share. Restricted stock unit awards transactions during the three months ended March 31, 2024 are presented below: Weighted Avg Grant Date Shares Fair Value Outstanding at December 31, 2023 200,000 $ 2.39 Granted 90,000 $ 3.38 Outstanding at March 31, 2024 290,000 $ 2.70 Share-based Compensation The Company estimates the fair value of stock options with performance and service conditions using the Black-Scholes valuation model (“Black-Scholes”). Compensation expense related to stock options granted is measured at the grant date based on the estimated fair value of the award and is recognized on the accelerated attribution method over the requisite service period. The assumptions used in the Black-Scholes model during the three months ended March 31, 2024 and 2023 are presented below. Three Months Ended March 31, 2024 March 31, 2023 Risk-free interest rate 4.24% - 4.25% 3.54% - 4.2% Expected volatility 89.4% - 92.5% 90.99% - 91.58% Expected term (in years) 5.12 - 7.0 5.5 - 7.00 Expected dividend yield 0% 0% The table below summarizes the total share-based compensation expense included in the Company’s condensed consolidated statements of operations for the periods presented: Three Months Ended March 31, 2024 2023 Research and development $ 52 $ 545 General and administrative 482 312 Total stock-based compensation $ 534 $ 857 As of March 31, 2024, there was $5.9 million of total unrecognized compensation expense related to unvested stock options, restricted stock awards and restricted stock units, which the Company expects to recognize over the weighted average remaining period of approximately 2.0 years. |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2024 | |
Income Taxes | |
Income Taxes | 11. Income Taxes The Company did no t record a provision or benefit for income taxes during the three months ended March 31, 2024 and 2023. The Company generates net taxable losses and continues to maintain a full valuation allowance against all of its deferred tax assets. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2024 | |
Commitments and Contingencies. | |
Commitments and Contingencies | 12. Commitments and Contingencies Operating Leases The Company leases office and research and development space under a non-cancelable operating lease in Marina del Rey, CA. The lease commenced on January 1, 2012 and was amended in April 2020 to, among other things, extend the lease term through December 31, 2031 (the “2020 Lease Amendment”). Annual base rent is from $1.9 million and increases by 3% annually and will be $2.5 million by the end of the amended term. Concurrent with the Company’s execution of the 2020 Lease Amendment, an irrevocable letter of credit in the amount of $1.2 million was delivered to the landlord. Starting on February 1, 2022, and each year thereafter, the letter of credit will be reduced by 20% of the then outstanding amount. As of March 31, 2024, the letter of credit was $0.5 million. On October 28, 2021, the Company entered into a lease for office and research and development space under a non-cancellable lease in Los Angeles, CA (the “2021 Lease”). The 2021 Lease payment start date was May 1, 2022 and the total lease term is for 16 years and runs through 2038. Monthly rent for 2022 and 2023 was fully or partially abated while the lessor and the Company completed planned tenant improvements to the facility. Base monthly rent is approximately $0.3 million in 2024. The Company is entitled to receive an allowance for tenant improvements of up to $7.3 million, of which the Company received $6.5 million as of March 31, 2024. The Company is responsible for construction costs over such allowance. Out-of-pocket expenses to be incurred by the Company are considered noncash lease payments, and included in the lease liability and right-of-use asset when the amount can be reasonably estimated. In connection with the 2021 Lease, the Company delivered an irrevocable standby letter of credit in the amount of $5.0 million to the landlord in 2022. Future minimum annual lease payments under the Company’s noncancelable operating leases as of March 31, 2024 are as follows (in thousands): Operating Leases 2024 (remaining nine months) $ 6,543 2025 5,307 2026 5,466 2027 5,452 2028 5,616 Thereafter 43,440 Total minimum lease payments 71,824 Less: amount representing interest (35,951) Present value of operating lease obligations 35,873 Less: current portion (7,497) Noncurrent operating lease obligations $ 28,376 Operating lease expenses were $2.2 million and $1.8 million for the three months ended March 31, 2024 and 2023, respectively. Variable costs related to operating expenses and taxes, which are recognized as incurred, were $0.6 million and $0.3 million for the three months ended March 31, 2024 and 2023, respectively. The following table summarizes supplemental cash flow information related to the Company’s operating leases for the three months ended March 31, 2024 and 2023: Three Months Ended March 31, 2024 2023 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases 3,355 5,197 The following table summarizes the weighted-average remaining lease term and weighted-average discount rate related to the Company’s operating leases as of March 31, 2024 and December 31, 2023: March 31, 2024 December 31, 2023 Weighted-average remaining lease term, years 12.51 12.79 Weighted-average discount rate, % 13.9 13.9 Legal Proceedings From time to time, the Company may be involved in disputes, including litigation, relating to claims arising out of operations in the normal course of business. Any of these claims could subject the Company to costly legal expenses and, while management generally believes that there is adequate insurance to cover many different types of liabilities, the Company’s insurance carriers may deny coverage or policy limits may be inadequate to fully satisfy any damage awards or settlements. If this were to happen, the payment of any such awards could have a material adverse effect on the Company’s consolidated results of operations and financial position. Additionally, any such claims, whether or not successful, could damage the Company’s reputation and business. The Company is currently not a party to any legal proceedings, the adverse outcome of which, in management’s opinion, individually or in the aggregate, would have a material adverse effect on our consolidated results of operations or financial position. |
Grant and Awards
Grant and Awards | 3 Months Ended |
Mar. 31, 2024 | |
Grant and Awards | |
Grant and Awards | 13. Grant and Awards MTEC Grant On June 15, 2020, the Company entered into a Research Project Award agreement (the “MTEC Agreement”) with MTEC, pursuant to which the Company received a Staphylococcus aureus CFF Therapeutics Development Award P. aeruginosa The first payment under the Award Agreement, in the amount of $1.0 million, became due upon signing the Award Agreement and was received in April 2020. The remainder of the CFF Award is payable to the Company incrementally in installments upon the achievement of certain milestones related to the development program and progress of the Phase 1b/2a clinical trial of AP-PA02, as set forth in the Award Agreement. If the Company ceases to use commercially reasonable efforts directed to the development of AP-PA02, or any other Product (as defined in the Award Agreement), for a period of 360 days (an “Interruption”) and fails to resume the development of the Product after receiving from CFF notice of an Interruption, then the Company must either repay the amount of the CFF Award actually received by the Company, plus interest, or grant to CFF (1) an exclusive (even as to the Company), worldwide, perpetual, sublicensable license under technology developed under the Award Agreement that covers the Product for use in treating infections in CF patients (the “CF Field”), and (2) a non-exclusive, worldwide, perpetual, sublicensable license under certain background intellectual property covering the Product, to the extent necessary to commercialize the Product in the CF Field. Upon commercialization by the Company of any Product, the Company will owe a fixed royalty amount to CFF, which is to be paid in installments determined, in part, based on commercial sales volumes of the Product. The Company will be obligated to make an additional fixed royalty payment upon achieving specified sales milestones. The Company may also be obligated to make a payment to CFF if the Company transfers, sells or licenses the Product in the CF Field, or if the Company enters into a change of control transaction. The Company concluded that the CFF Award is in the scope of ASC 808. Accordingly, as discussed in Note 3, the Company recognizes the award upon achievement of certain milestones as credits to research and development expenses. No credits to research and development expenses were recognized during the three months ended March 31, 2024 and 2023, respectively, related to the CFF Award. In addition, the Company concluded under the guidance in ASC 730 that it does not have an obligation to repay funds received once related research and development expenses are incurred |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2024 | |
Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany accounts and transactions have been eliminated. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements and accompanying notes thereto as of and for the year ended December 31, 2023 included in the Company’s Form 10-K, filed with the Securities and Exchange Commission (the “SEC”) on March 21, 2024. The information as of December 31, 2023 included in the condensed consolidated balance sheets was derived from the Company’s audited financial statements. The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and the requirements of the SEC for interim reporting. In the opinion of management, the accompanying condensed consolidated financial statements include all adjustments that are of a normal and recurring nature and that are necessary for the fair presentation of the Company’s financial position and the results of its operations and cash flows for the periods presented. Interim results are not necessarily indicative of results for the full year or any future period. Any reference in the condensed consolidated financial statements to applicable guidance is meant to refer to authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). |
Use of Estimates | Use of Estimates The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, and the reported amounts of expenses during the reporting period. On an ongoing basis, the Company evaluates estimates and assumptions, including but not limited to those related to convertible debt, stock-based compensation expense, accruals for research and development costs, the valuation of deferred tax assets, impairment of goodwill and intangible assets and impairment of long-lived assets. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ materially from those estimates. |
Segments | Segments The Company operates and manages its business as one reportable operating segment, which is the business of developing a pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat acute and chronic bacterial infections using its proprietary bacteriophage-based technology. The Company’s chief executive officer, who is the chief operating decision maker, reviews financial information on an aggregate basis for allocating resources and evaluating financial performance. The long-lived assets of $12.6 million, which represents 98.9% of the Company’s total long-lived assets, are maintained in the United States. |
Concentration of Credit Risks and Certain Other Risks | Concentration of Credit Risks and Certain Other Risks Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash and restricted cash. As of December 31, 2023 and March 31, 2024, restricted cash was invested primarily in money market funds and U.S. treasury securities through highly rated financial institutions in accordance with the Company’s investment policy, to a concentration limit per issuer or sector. Other receivables represent amounts due from the Medical Technology Enterprise Consortium (“MTEC”) (Note 13) and reimbursement for tenant improvements (Note 12). |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements In August 2020, the FASB issued ASU 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40) (“ASU 2020-06”). ASU 2020-06 eliminates the beneficial conversion and cash conversion accounting models for convertible instruments. It also amends the accounting for certain contracts in an entity’s own equity that are currently accounted for as derivatives because of specific settlement provisions. In addition, ASU 2020-06 modifies how particular convertible instruments and certain contracts that may be settled in cash or shares impact the diluted EPS computation. The Company adopted this ASU as of January 1, 2024, which did not have an impact on its consolidated financial statements or related disclosures. Recent Accounting Pronouncements Not Yet Adopted In October 2023, the FASB issued ASU 2023-06, Disclosure Improvements: Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Fair Value of Financial Assets and Liabilities - Derivative Instruments | |
Schedule of Fair Value Measurements | The Company estimated the fair value of its convertible debt using the following inputs as of March 31, 2024 and December 31, 2023: March 31, 2024 December 31, 2023 Discount rate 23.75% 21.01% Probabilities of settlement scenarios 0%-75% 0%-75% Volatility 109.80% 123.3% Expected term (in years) 0.3-0.8 0.2-1.0 Risk-free rate 5.05%-5.32% 4.66%-5.36% |
Schedule of Changes in Fair Value of Liabilities | The following table presents a summary of the changes in the fair value of the Company’s Level 3 financial liabilities (in thousands): Three months ended March 31, 2024 March 31, 2023 Convertible debt opening balance $ 58,633 $ — Issuance of the convertible debt — 29,226 Change in fair value 13,025 3,162 Convertible debt closing balance $ 71,658 $ 32,388 |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Net Loss per Share | |
Schedule of Antidilutive Securities Excluded from Computation of Diluted Weighted Shares Outstanding | The following outstanding securities as of March 31, 2024 and December 31, 2023 have been excluded from the computation of diluted weighted average shares outstanding, as they would have been anti-dilutive: March 31, 2024 December 31, 2023 Outstanding stock options 4,874,620 3,165,216 Unvested restricted stock units 290,000 200,000 Shares issuable upon the conversion of convertible debt 21,692,982 21,293,861 Outstanding warrants 19,365,847 19,365,847 Total 46,223,449 44,024,924 |
Balance Sheet Details (Tables)
Balance Sheet Details (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Balance Sheet Details | |
Schedule of Property and Equipment | Property and equipment as of March 31, 2024 and December 31, 2023 consisted of the following: March 31, 2024 December 31, 2023 Laboratory equipment $ 20,136 $ 19,678 Furniture and fixtures 817 817 Office and computer equipment 438 438 Leasehold improvements 3,447 3,447 Total 24,838 24,380 Less: accumulated depreciation (12,138) (11,821) Property and equipment, net $ 12,700 $ 12,559 |
Schedule of Other receivables | Other receivables as of March 31, 2024 and December 31, 2023 consisted of the following: March 31, 2024 December 31, 2023 Tenant improvement allowance receivable (Note 12) $ 748 $ 1,835 Grant and award receivable 966 1,528 $ 1,714 $ 3,363 |
Schedule of Accounts Payable and Accrued Liabilities | Accounts payable and accrued liabilities as of March 31, 2024 and December 31, 2023 consisted of the following: March 31, 2024 December 31, 2023 Accounts payable $ 2,057 $ 1,585 Accrued clinical trial expenses 1,817 3,021 Other accrued expenses 736 1,083 $ 4,610 $ 5,689 |
Stockholders' Deficit (Tables)
Stockholders' Deficit (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Stockholders' Deficit | |
Schedule of Warrant Information | As of March 31, 2024, outstanding warrants to purchase shares of Common Stock were as follows: March 31, 2024 Exercise Price Expiration Date 993,139 $ 2.87 February 11, 2025 7,717,661 $ 2.87 March 27, 2025 1,867,912 $ 3.25 January 26, 2026 4,285,935 $ 3.25 March 16, 2026 1,807,396 $ 5.00 February 8, 2027 2,692,604 $ 5.00 March 30, 2027 1,200 $ 1,680.00 None 19,365,847 |
Schedule of Shares Reserved for Future Issuance | As of March 31, 2024 the Company had reserved shares of its Common Stock for future issuance as follows: March 31, 2024 Stock options outstanding 4,874,620 Unvested restricted stock units 290,000 Employee stock purchase plan 11,890 Shares available for future grants under the 2016 Plan 2,362,677 Warrants outstanding 19,365,847 Shares issuable upon the conversion of convertible debt 21,692,982 Total shares reserved 48,598,016 |
Equity Incentive Plans (Tables)
Equity Incentive Plans (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Equity Incentive Plans | |
Schedule of Stock Option Activity | Stock option transactions during the three months ended March 31, 2024 are presented below: Options Outstanding Weighted Average Weighted Remaining Average Contractual Aggregate Exercise Term Intrinsic Shares Price (Years) Value (in thousands) Outstanding at December 31, 2023 3,165,216 $ 5.04 5.9 $ 429 Granted 1,784,054 $ 3.38 — Exercised (13,407) $ 3.15 $ 15 Forfeited/Cancelled/Expired (61,243) $ 5.06 $ — Outstanding at March 31, 2024 4,874,620 $ 4.44 7.2 $ 3,334 Vested and expected to vest at March 31, 2024 4,874,620 $ 4.44 7.2 $ 3,334 Exercisable at March 31, 2024 2,204,014 $ 5.51 4.7 $ 1,243 |
Schedule of Restricted Stock Awards and Restricted Stock Unit Activity | The aggregate intrinsic value of options at March 31, 2024 is based on the Company’s closing stock price on that date of $4.18 per share. Restricted stock unit awards transactions during the three months ended March 31, 2024 are presented below: Weighted Avg Grant Date Shares Fair Value Outstanding at December 31, 2023 200,000 $ 2.39 Granted 90,000 $ 3.38 Outstanding at March 31, 2024 290,000 $ 2.70 |
Schedule of Assumptions Used in the Black-Scholes Model | The assumptions used in the Black-Scholes model during the three months ended March 31, 2024 and 2023 are presented below. Three Months Ended March 31, 2024 March 31, 2023 Risk-free interest rate 4.24% - 4.25% 3.54% - 4.2% Expected volatility 89.4% - 92.5% 90.99% - 91.58% Expected term (in years) 5.12 - 7.0 5.5 - 7.00 Expected dividend yield 0% 0% |
Schedule of Stock-Based Compensation Expenses | The table below summarizes the total share-based compensation expense included in the Company’s condensed consolidated statements of operations for the periods presented: Three Months Ended March 31, 2024 2023 Research and development $ 52 $ 545 General and administrative 482 312 Total stock-based compensation $ 534 $ 857 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Commitments and Contingencies. | |
Future Minimum Lease Payments | Future minimum annual lease payments under the Company’s noncancelable operating leases as of March 31, 2024 are as follows (in thousands): Operating Leases 2024 (remaining nine months) $ 6,543 2025 5,307 2026 5,466 2027 5,452 2028 5,616 Thereafter 43,440 Total minimum lease payments 71,824 Less: amount representing interest (35,951) Present value of operating lease obligations 35,873 Less: current portion (7,497) Noncurrent operating lease obligations $ 28,376 |
Operating leases | Three Months Ended March 31, 2024 2023 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases 3,355 5,197 March 31, 2024 December 31, 2023 Weighted-average remaining lease term, years 12.51 12.79 Weighted-average discount rate, % 13.9 13.9 |
Organization and Description _2
Organization and Description of the Business (Narrative) (Details) - $ / shares | Mar. 31, 2024 | Dec. 31, 2023 |
Organization and Description of the Business | ||
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Liquidity and Going Concern (Na
Liquidity and Going Concern (Narrative) (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Mar. 04, 2024 | Dec. 31, 2023 | Mar. 31, 2023 |
Accumulated deficit | $ (333,840) | $ (308,819) | ||
Cash and cash equivalents | $ 37,860 | $ 13,523 | $ 25,106 | |
Innoviva Strategic Opportunities LLC [Member] | Credit And Security Agreement [Member] | ||||
Aggregate amount | $ 35,000 | |||
Interest rate (as a percent) | 14% |
Significant Accounting Polici_3
Significant Accounting Policies (Narrative) (Details) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 USD ($) item | Dec. 31, 2023 USD ($) | |
Operating segment | item | 1 | |
Long-lived assets | $ 12,700 | $ 12,559 |
UNITED STATES | ||
Long-lived assets | $ 12,600 | |
Percentage of long-lived assets | 98.90% |
Fair Value Measurements (Compan
Fair Value Measurements (Company's Fair Value Measurements Using Level 3 Inputs) (Details) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 Y | Dec. 31, 2023 Y | |
Discount rate | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Debt instrument, measurement input, for the period | 0.2375 | 0.2101 |
Probabilities of settlement scenarios | Minimum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Debt instrument, measurement input, for the period | 0 | 0 |
Probabilities of settlement scenarios | Maximum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Debt instrument, measurement input, for the period | 0.75 | 0.75 |
Volatility | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Debt instrument, measurement input, for the period | 1.0980 | 1.233 |
Expected term | Minimum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Debt instrument, measurement input, for the period | 0.3 | 0.2 |
Expected term | Maximum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Debt instrument, measurement input, for the period | 0.8 | 1 |
Risk-free rate | Minimum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Debt instrument, measurement input, for the period | 0.0505 | 0.0466 |
Risk-free rate | Maximum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Debt instrument, measurement input, for the period | 0.0532 | 0.0536 |
Fair Value Measurement (Changes
Fair Value Measurement (Changes in Fair Value of Liabilities) (Details) - Fair Value, Inputs, Level 3 - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Convertible debt opening balance | $ 58,633 | |
Issuance of the convertible debt | $ 29,226 | |
Change in fair value | 13,025 | 3,162 |
Convertible debt closing balance | $ 71,658 | $ 32,388 |
Net Loss per Share (Antidilutiv
Net Loss per Share (Antidilutive Shares Excluded from Computation of Diluted Shares Outstanding) (Details) - shares | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of diluted weighted shares outstanding | 46,223,449 | 44,024,924 |
Outstanding stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of diluted weighted shares outstanding | 4,874,620 | 3,165,216 |
Unvested restricted stock units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of diluted weighted shares outstanding | 290,000 | 200,000 |
Shares issuable upon the conversion of Convertible Loan | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of diluted weighted shares outstanding | 21,692,982 | 21,293,861 |
Outstanding warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of diluted weighted shares outstanding | 19,365,847 | 19,365,847 |
Balance Sheet Details (Narrativ
Balance Sheet Details (Narrative) (Details) - USD ($) $ in Millions | 3 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | |
Balance Sheet Details | |||
Depreciation | $ 0.3 | $ 0.2 | |
Construction in progress and fixed assets | $ 8.5 | $ 8.1 |
Balance Sheet Details (Property
Balance Sheet Details (Property and Equipment) (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Property, Plant and Equipment [Line Items] | ||
Total | $ 24,838 | $ 24,380 |
Less: accumulated depreciation | (12,138) | (11,821) |
Property and equipment, net | 12,700 | 12,559 |
Laboratory equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total | 20,136 | 19,678 |
Office and computer equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total | 438 | 438 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Total | 817 | 817 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Total | $ 3,447 | $ 3,447 |
Balance Sheet Details (Other re
Balance Sheet Details (Other receivables) (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Balance Sheet Details | ||
Tenant improvement allowance receivable (Note 12) | $ 748 | $ 1,835 |
Grant and award receivable | 966 | 1,528 |
Other receivables | $ 1,714 | $ 3,363 |
Balance Sheet Details (Accounts
Balance Sheet Details (Accounts payable and accrued liabilities) (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Balance Sheet Details | ||
Accounts payable | $ 2,057 | $ 1,585 |
Accrued clinical trial expenses | 1,817 | 3,021 |
Other accrued expenses | 736 | 1,083 |
Accounts Payable and Accrued Liabilities, Current, Total | $ 4,610 | $ 5,689 |
Convertible Debt (Narrative) (D
Convertible Debt (Narrative) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | ||
Jan. 10, 2023 | Mar. 31, 2024 | Mar. 31, 2023 | |
Change in fair value, gain (loss) | $ (13,025) | $ (3,162) | |
Change in fair value of convertible debt | 13,025 | 3,162 | |
Innoviva Strategic Opportunities LLC [Member] | |||
Proceeds from qualified financing per agreement benchmark | $ 30,000 | ||
Innoviva Strategic Opportunities LLC [Member] | Secured term loan | |||
Aggregate amount | $ 30,000 | ||
Interest rate (as a percent) | 8% | ||
Price per share | $ 1.52 | ||
Discount on share price for conversion | 15% | ||
Change in fair value, gain (loss) | $ (13,000) | $ (3,200) |
Long-Term Debt (Details)
Long-Term Debt (Details) - Secured term loan - Innoviva Strategic Opportunities LLC - USD ($) $ in Millions | Mar. 31, 2024 | Mar. 04, 2024 | Jul. 10, 2023 | Jan. 10, 2023 |
Term Loan | ||||
Aggregate amount | $ 30 | |||
Interest rate (as a percent) | 8% | |||
2023 Credit Agreement | ||||
Term Loan | ||||
Aggregate amount | $ 25 | |||
Interest rate (as a percent) | 27.31% | 14% | ||
Debt issuance costs | $ 0.1 | |||
Recognized at fair value | 21.2 | |||
Debt discount | $ 3.8 | |||
2024 Credit Agreement | ||||
Term Loan | ||||
Aggregate amount | $ 35 | |||
Interest rate (as a percent) | 14.25% | 14% | ||
Debt issuance costs | $ 0.1 |
Stockholders' Deficit (Summary
Stockholders' Deficit (Summary of Warrants Outstanding) (Details) | 3 Months Ended |
Mar. 31, 2024 $ / shares shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Warrants | 19,365,847 |
Exercise Price $2.87, February 11, 2025 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Warrants | 993,139 |
Exercise Price | $ / shares | $ 2.87 |
Warrant Expiration Date | Feb. 11, 2025 |
Exercise Price $2.87, March 27, 2025 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Warrants | 7,717,661 |
Exercise Price | $ / shares | $ 2.87 |
Warrant Expiration Date | Mar. 27, 2025 |
Exercise Price $3.25, January 26, 2026 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Warrants | 1,867,912 |
Exercise Price | $ / shares | $ 3.25 |
Warrant Expiration Date | Jan. 26, 2026 |
Exercise Price $3.25, March 16, 2026 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Warrants | 4,285,935 |
Exercise Price | $ / shares | $ 3.25 |
Warrant Expiration Date | Mar. 16, 2026 |
Exercise Price $5.00, February 8, 2027 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Warrants | 1,807,396 |
Exercise Price | $ / shares | $ 5 |
Warrant Expiration Date | Feb. 08, 2027 |
Exercise Price $5.00, March 30, 2027 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Warrants | 2,692,604 |
Exercise Price | $ / shares | $ 5 |
Warrant Expiration Date | Mar. 30, 2027 |
Exercise Price 1680.00 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Warrants | 1,200 |
Exercise Price | $ / shares | $ 1,680 |
Stockholders' Deficit (Shares R
Stockholders' Deficit (Shares Reserved for Future Issuance) (Details) - shares | Mar. 31, 2024 | Dec. 31, 2023 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock options outstanding | 4,874,620 | 3,165,216 |
Employee stock purchase plan | 11,890 | |
Shares available for future grants under the 2016 Plan | 2,362,677 | |
Warrants outstanding | 19,365,847 | |
Shares issuable upon the conversion of Convertible Debt | 21,692,982 | |
Total shares reserved | 48,598,016 | |
Unvested Restricted Stock Units [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Restricted stock awards/units | 290,000 | |
Equity Incentive Plan 2016 [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Shares available for future grants under the 2016 Plan | 2,362,677 |
Equity Incentive Plans (Narrati
Equity Incentive Plans (Narrative) (Details) $ / shares in Units, $ in Millions | 3 Months Ended |
Mar. 31, 2024 USD ($) $ / shares shares | |
Shares available for future grants under the 2016 Plan | shares | 2,362,677 |
Employee Stock Option [Member] | |
Common stock closing price | $ / shares | $ 4.18 |
Unrecognized compensation cost related to unvested options | $ | $ 5.9 |
Stock Options And Restricted Stock Awards [Member] | |
Weighted-average remaining period for recognition of compensation costs related to unvested options | 2 years |
Equity Incentive Plans (Summary
Equity Incentive Plans (Summary of Stock Option Activity) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Equity Incentive Plans | ||
Shares, Balance Beginning | 3,165,216 | |
Shares, Granted | 1,784,054 | |
Shares, Exercised | (13,407) | |
Shares, Forfeited/Cancelled | (61,243) | |
Shares, Balance Ending | 4,874,620 | 3,165,216 |
Vested and expected to vest at March 31, 2024 | 4,874,620 | |
Exercisable at March 31, 2024 | 2,204,014 | |
Weighted Average Exercise Price, Outstanding Beginning | $ 5.04 | |
Weighted Average Exercise Price, Granted | 3.38 | |
Weighted Average Exercise Price, Exercised | 3.15 | |
Weighted Average Exercise Price, Forfeited/Cancelled | 5.06 | |
Weighted Average Exercise Price, Outstanding Ending | 4.44 | $ 5.04 |
Weighted Average Exercise Price, Vested and expected to vest at March 31, 2024 | 4.44 | |
Weighted Average Exercise Price, Exercisable at March 31, 2024 | $ 5.51 | |
Weighted Average Remaining Contractual Term (Years), Outstanding | 7 years 2 months 12 days | 5 years 10 months 24 days |
Weighted Average Remaining Contractual Term (Years), Vested and expected to vest at March 31, 2024 | 7 years 2 months 12 days | |
Weighted Average Remaining Contractual Term (Years), Exercisable at March 31, 2024 | 4 years 8 months 12 days | |
Aggregate Intrinsic Value, Outstanding Beginning | $ 429 | |
Aggregate Intrinsic Value, Exercised | 15 | |
Aggregate Intrinsic Value, Outstanding Ending | 3,334 | $ 429 |
Aggregate Intrinsic Value, Vested and expected to vest at March 31, 2024 | 3,334 | |
Aggregate Intrinsic Value, Exercisable at March 31, 2024 | $ 1,243 |
Equity Incentive Plans (Restric
Equity Incentive Plans (Restricted stock award and restricted stock unit award activity) (Details) - Restricted Stock Awards [Member] - C3J Stock Plan 2016 [Member] | 3 Months Ended |
Mar. 31, 2024 $ / shares shares | |
Shares | |
Outstanding at beginning of period (in shares) | shares | 200,000 |
Granted (in shares) | shares | 90,000 |
Outstanding at end of period (in shares) | shares | 290,000 |
Weighted Avg Grant Date Fair Value | |
Outstanding at beginning of period (in dollars per share) | $ / shares | $ 2.39 |
Granted (in dollars per share) | $ / shares | 3.38 |
Outstanding at end of period (in dollars per share) | $ / shares | $ 2.70 |
Equity Incentive Plans (Assumpt
Equity Incentive Plans (Assumptions Used in the Black-Scholes Model) (Details) - Common Stock Options [Member] | 3 Months Ended | |
Mar. 31, 2024 Y | Mar. 31, 2023 Y | |
Measurement Input, Expected Dividend Rate [Member] | ||
Fair value input, equity securities | 0 | 0 |
Minimum [Member] | Measurement Input, Risk Free Interest Rate [Member] | ||
Fair value input, equity securities | 0.0424 | 0.0354 |
Minimum [Member] | Measurement Input, Price Volatility [Member] | ||
Fair value input, equity securities | 0.894 | 0.9099 |
Minimum [Member] | Measurement Input, Expected Term [Member] | ||
Fair value input, equity securities | 5.12 | 5.5 |
Maximum [Member] | Measurement Input, Risk Free Interest Rate [Member] | ||
Fair value input, equity securities | 0.0425 | 0.042 |
Maximum [Member] | Measurement Input, Price Volatility [Member] | ||
Fair value input, equity securities | 0.925 | 0.9158 |
Maximum [Member] | Measurement Input, Expected Term [Member] | ||
Fair value input, equity securities | 7 | 7 |
Equity Incentive Plans (Allocat
Equity Incentive Plans (Allocation of Share-Based Compensation Expense) (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Total stock-based compensation | $ 534 | $ 857 |
Research and development expense [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Total stock-based compensation | 52 | 545 |
General and administrative expense [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Total stock-based compensation | $ 482 | $ 312 |
Income Taxes (Narrative) (Detai
Income Taxes (Narrative) (Detail) - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Income Taxes | ||
Income tax expense (benefit) | $ 0 | $ 0 |
Commitments and Contingencies_2
Commitments and Contingencies (Narrative) (Details) - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | ||
Apr. 30, 2020 | Mar. 31, 2024 | Mar. 31, 2023 | Oct. 28, 2021 | |
Lease term | 16 years | |||
Base annual rent for 2024 | $ 0.3 | |||
Maximum allowance for tenant improvements | 7.3 | |||
Tenant allowances | $ 6.5 | |||
Annual increase in rent percentage | 3% | |||
Rent expense under operating leases | 2.2 | $ 1.8 | ||
Variable lease, payment | 0.6 | $ 0.3 | ||
Standby letter of credit | $ 5 | |||
Minimum [Member] | ||||
Base rent at the end of lease term | $ 1.9 | |||
Maximum [Member] | ||||
Base rent at the end of lease term | 2.5 | |||
Cash [Member] | ||||
Standby letter of credit | $ 1.2 | $ 0.5 | ||
Annual reduction of standby letter of credit | 20% |
Commitments and Contingencies_3
Commitments and Contingencies (Future Minimum Lease Payments) (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Commitments and Contingencies. | ||
2024 (remaining nine months) | $ 6,543 | |
2025 | 5,307 | |
2026 | 5,466 | |
2027 | 5,452 | |
2028 | 5,616 | |
Thereafter | 43,440 | |
Total minimum lease payments | 71,824 | |
Less: amount representing interest | (35,951) | |
Present value of operating lease obligations | 35,873 | |
Less: current portion | (7,497) | $ (9,481) |
Noncurrent operating lease obligations | $ 28,376 | $ 28,583 |
Commitments and Contingencies_4
Commitments and Contingencies (Operating leases) (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Commitments and Contingencies. | ||
Operating cash flows from operating leases | $ 3,355 | $ 5,197 |
Weighted-average remaining lease term, years | 12 years 6 months 3 days | 12 years 9 months 14 days |
Weighted-average discount rate, % | 13.90% | 13.90% |
Grant and Awards (Narrative) (D
Grant and Awards (Narrative) (Details) - USD ($) $ in Millions | 3 Months Ended | |||||
Sep. 29, 2022 | Jun. 15, 2020 | Mar. 13, 2020 | Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | |
Award [Line Items] | ||||||
Revenue from grants | $ 16.3 | |||||
Medical Technology Enterprise Consortium [Member] | ||||||
Award [Line Items] | ||||||
Revenue from grants | $ 16.3 | $ 15 | 1 | $ 0.8 | ||
Increase in expected revenue from grants | $ 1.3 | |||||
Unbilled award receivable | $ 1 | $ 1.5 | ||||
Cystic Fibrosis Foundation [Member] | ||||||
Award [Line Items] | ||||||
Award receivable | $ 1 | |||||
Award agreement interruption period | 360 days | |||||
Maximum [Member] | Cystic Fibrosis Foundation [Member] | ||||||
Award [Line Items] | ||||||
Amount of threshold development award | $ 5 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Pay vs Performance Disclosure | ||
Net Income (Loss) | $ (25,021) | $ (14,490) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Mar. 31, 2024 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |