Document And Entity Information
Document And Entity Information - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 10, 2023 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Sep. 30, 2023 | |
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 | 36,146,574 | |
Entity Central Index Key | 0000921114 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets | ||
Cash and cash equivalents | $ 23,958,000 | $ 14,852,000 |
Prepaid expenses | 4,130,000 | 3,664,000 |
Other receivables | 8,497,000 | 8,531,000 |
Total current assets | 36,585,000 | 27,047,000 |
Restricted cash | 5,824,000 | 5,960,000 |
Property and equipment, net | 9,250,000 | 3,617,000 |
Operating lease right-of-use asset | 44,886,000 | 43,035,000 |
In-process research and development | 10,256,000 | 10,256,000 |
Goodwill | 3,490,000 | 3,490,000 |
Other assets | 2,470,000 | 2,429,000 |
Total assets | 112,761,000 | 95,834,000 |
Current liabilities | ||
Accounts payable and accrued liabilities | 6,700,000 | 6,034,000 |
Accrued compensation | 1,741,000 | 1,828,000 |
Current portion of operating lease liabilities | 13,443,000 | 17,011,000 |
Total current liabilities | 21,884,000 | 24,873,000 |
Operating lease liabilities, net of current portion | 28,162,000 | 31,804,000 |
Convertible debt | 49,747,000 | |
Long-term debt | 22,277,000 | |
Deferred tax liability | 3,077,000 | 3,077,000 |
Total liabilities | 125,147,000 | 59,754,000 |
Shareholders' (deficit) equity | ||
Common stock, $0.01 par value; 217,000,000 shares authorized; 36,122,591 and 36,144,706 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively | 361,000 | 361,000 |
Additional paid-in capital | 276,225,000 | 275,493,000 |
Accumulated deficit | (288,972,000) | (239,774,000) |
Total shareholders' (deficit) equity | (12,386,000) | 36,080,000 |
Total liabilities and shareholders' (deficit) equity | $ 112,761,000 | $ 95,834,000 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
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 | 36,122,591 | 36,144,706 |
Common stock, shares outstanding | 36,122,591 | 36,144,706 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Condensed Consolidated Statements of Operations | ||||
Grant revenue | $ 1,225,000 | $ 1,338,000 | $ 3,001,000 | $ 4,457,000 |
Operating expenses | ||||
Research and development | 7,978,000 | 8,400,000 | 25,842,000 | 25,448,000 |
General and administrative | 3,583,000 | 1,561,000 | 8,470,000 | 5,627,000 |
Total operating expenses | 11,561,000 | 9,961,000 | 34,312,000 | 31,075,000 |
Loss from operations | (10,336,000) | (8,623,000) | (31,311,000) | (26,618,000) |
Other income (expense) | ||||
Interest income | 47,000 | 9,000 | 111,000 | 15,000 |
Interest expense | (1,176,000) | (1,176,000) | ||
Change in fair value of convertible debt | (15,833,000) | (12,959,000) | ||
Loss on convertible debt extinguishment | (3,863,000) | (3,863,000) | ||
Total other income (expense), net | (20,825,000) | 9,000 | (17,887,000) | 15,000 |
Net loss | $ (31,161,000) | $ (8,614,000) | $ (49,198,000) | $ (26,603,000) |
Per share information: | ||||
Net loss per share, basic (in dollars per share) | $ (0.86) | $ (0.24) | $ (1.36) | $ (0.79) |
Net loss per share, diluted (in dollars per share) | $ (0.86) | $ (0.24) | $ (1.36) | $ (0.79) |
Weighted average shares outstanding, basic (in shares) | 36,086,990 | 36,038,686 | 36,067,025 | 33,704,071 |
Weighted average shares outstanding, diluted (in shares) | 36,086,990 | 36,038,686 | 36,067,025 | 33,704,071 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Shareholders' (Deficit) Equity - USD ($) | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Total |
Balances at Dec. 31, 2021 | $ 271,000 | $ 227,983,000 | $ (202,857,000) | $ 25,397,000 |
Balances (in shares) at Dec. 31, 2021 | 27,112,299 | |||
Sale of common stock, net of issuance costs | $ 90,000 | 44,301,000 | 44,391,000 | |
Sale of common stock, net of issuance costs (in shares) | 9,000,000 | |||
Return of restricted stock awards for tax withholdings | (21,000) | (21,000) | ||
Return of restricted stock awards for tax withholdings, shares | (5,511) | |||
Forfeiture of restricted stock awards (in shares) | (369) | |||
Exercise of stock options | 54,000 | 54,000 | ||
Exercise of stock options (in shares) | 16,512 | |||
Issuance of inducement stock awards | 71,000 | 71,000 | ||
Issuance of inducement stock awards (in shares) | 21,775 | |||
Share-based compensation expense | 2,288,000 | 2,288,000 | ||
Net loss | (26,603,000) | (26,603,000) | ||
Balances at Sep. 30, 2022 | $ 361,000 | 274,676,000 | (229,460,000) | 45,577,000 |
Balances (in shares) at Sep. 30, 2022 | 36,144,706 | |||
Balances at Jun. 30, 2022 | $ 361,000 | 273,776,000 | (220,846,000) | 53,291,000 |
Balances (in shares) at Jun. 30, 2022 | 36,128,194 | |||
Exercise of stock options | 54,000 | 54,000 | ||
Exercise of stock options (in shares) | 16,512 | |||
Share-based compensation expense | 846,000 | 846,000 | ||
Net loss | (8,614,000) | (8,614,000) | ||
Balances at Sep. 30, 2022 | $ 361,000 | 274,676,000 | (229,460,000) | 45,577,000 |
Balances (in shares) at Sep. 30, 2022 | 36,144,706 | |||
Balances at Dec. 31, 2022 | $ 361,000 | 275,493,000 | (239,774,000) | 36,080,000 |
Balances (in shares) at Dec. 31, 2022 | 36,144,706 | |||
Return of restricted stock awards for tax withholdings | (18,000) | (18,000) | ||
Return of restricted stock awards for tax withholdings, shares | (13,701) | |||
Forfeiture of restricted stock awards (in shares) | (9,914) | |||
Exercise of stock options | 5,000 | $ 5,000 | ||
Exercise of stock options (in shares) | 1,500 | 1,500 | ||
Share-based compensation expense | 745,000 | $ 745,000 | ||
Net loss | (49,198,000) | (49,198,000) | ||
Balances at Sep. 30, 2023 | $ 361,000 | 276,225,000 | (288,972,000) | (12,386,000) |
Balances (in shares) at Sep. 30, 2023 | 36,122,591 | |||
Balances at Jun. 30, 2023 | $ 361,000 | 276,593,000 | (257,811,000) | 19,143,000 |
Balances (in shares) at Jun. 30, 2023 | 36,127,306 | |||
Forfeiture of restricted stock awards (in shares) | (6,215) | |||
Exercise of stock options | 5,000 | 5,000 | ||
Exercise of stock options (in shares) | 1,500 | |||
Share-based compensation expense | (373,000) | (373,000) | ||
Net loss | (31,161,000) | (31,161,000) | ||
Balances at Sep. 30, 2023 | $ 361,000 | $ 276,225,000 | $ (288,972,000) | $ (12,386,000) |
Balances (in shares) at Sep. 30, 2023 | 36,122,591 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Operating activities: | ||
Net loss | $ (49,198,000) | $ (26,603,000) |
Adjustments required to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization expense | 679,000 | 647,000 |
Share-based compensation expense | 745,000 | 2,288,000 |
Change in fair value of convertible debt | 12,959,000 | |
Non-cash interest expense | 1,176,000 | |
Loss on convertible debt extinguishment | 3,863,000 | |
Change in right-of-use asset | 662,000 | 1,215,000 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | (72,000) | (2,354,000) |
Accounts payable and accrued liabilities | (321,000) | 584,000 |
Accrued compensation | (87,000) | 770,000 |
Operating lease liability | (9,723,000) | 1,457,000 |
Net cash used in operating activities | (39,317,000) | (21,996,000) |
Investing activities: | ||
Purchases of property and equipment | (5,744,000) | (2,666,000) |
Net cash used in investing activities | (5,744,000) | (2,666,000) |
Financing activities: | ||
Proceeds from issuance of convertible debt, net of issuance costs | 29,101,000 | |
Proceeds from issuance of long-term debt, net of issuance costs | 24,925,000 | |
Proceeds from sale of common stock, net of offering costs | 44,391,000 | |
Proceeds from exercise of stock options | 5,000 | 125,000 |
Net cash provided by financing activities | 54,031,000 | 44,516,000 |
Net increase in cash, cash equivalents and restricted cash | 8,970,000 | 19,854,000 |
Cash, cash equivalents and restricted cash, beginning of period | 20,812,000 | 11,488,000 |
Cash, cash equivalents and restricted cash, end of period | 29,782,000 | 31,342,000 |
Supplemental disclosure of cash flow information: | ||
Property and equipment included in accounts payable | 1,047,000 | $ 101,000 |
Right-of-use assets obtained in exchange for operating lease liability | $ 2,513,000 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Parenthetical) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | Dec. 31, 2021 |
Reconciliation of cash, cash equivalents, and restricted cash | ||||
Cash and cash equivalents | $ 23,958,000 | $ 14,852,000 | $ 25,382,000 | |
Restricted cash | 5,824,000 | 5,960,000 | 5,960,000 | |
Cash, cash equivalents and restricted cash | $ 29,782,000 | $ 20,812,000 | $ 31,342,000 | $ 11,488,000 |
Organization and Description of
Organization and Description of the Business | 9 Months Ended |
Sep. 30, 2023 | |
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 | 9 Months Ended |
Sep. 30, 2023 | |
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 September 30, 2023, the Company had an accumulated deficit of $289.0 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. Management expects that the existing cash and cash equivalents of $24.0 million as of September 30, 2023 will be sufficient to fund its operations into the first quarter of 2024. These circumstances raise substantial doubt about the Company’s ability to continue as a going concern. The Company plans to continue to control expenses and raise additional capital through a combination of public and private equity, debt financings, strategic alliances and grant arrangements. 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: 2023 Credit Agreement On July 10, 2023, the Company entered into a credit and security agreement (the “Credit Agreement”) for a loan in an aggregate amount of $25.0 million (the “Loan”) with Innoviva Strategic Opportunities LLC (“Innoviva”), a wholly owned subsidiary of Innoviva, Inc. Innoviva Inc. is a principal shareholder and related party of the Company. The Loan bears interest at an annual rate of 14% and matures on January 10, 2025. Principal and accrued interest are payable at maturity. Repayment of the 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. See Note 8 for additional details. 2023 Convertible Credit Agreement On January 10, 2023, the Company entered into a secured convertible credit and security agreement (the “Convertible Credit Agreement”) with Innoviva. The Convertible Credit Agreement provides for a secured term loan facility in an aggregate amount of $30.0 million (the “Convertible Loan”), which bears interest at a rate of 8.0% per annum, and was scheduled to mature on January 10, 2024. Concurrently with the execution of the Credit Agreement, the Company amended certain provisions of the Convertible Credit Agreement to, among other changes, extend the term of the Convertible Loan to January 10, 2025. 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 for various conversion and repayment options, including the conversion of principal and accrued interest into the shares of the Company’s Common Stock upon a Qualified Financing (as defined below) and the Company’s option to repay the loan prior to maturity. See Note 7 for additional details. 2022 Equity Financing On February 9, 2022, the Company entered into a securities purchase agreement (“February 2022 Securities Purchase Agreement”) to sell its Common Stock and warrants to Innoviva. Pursuant and subject to the terms and conditions of the February 2022 Securities Purchase Agreement and related agreements, Innoviva agreed to purchase 9,000,000 newly issued shares of the Company’s Common Stock, at a price of $5.00 per share, and warrants to purchase up to 4,500,000 additional shares of Common Stock, with an exercise price of $5.00 per share. The stock purchases closed in two tranches. On February 9, 2022, Innoviva purchased 3,614,792 shares of common stock and warrants to purchase 1,807,396 shares of Common Stock for an aggregate purchase price of approximately $18.1 million. At the closing of the second tranche, following the Company’s shareholders voting in favor of the transaction on March 30, 2022, Innoviva purchased 5,385,208 shares of Common Stock and warrants to purchase 2,692,604 shares of Common Stock for an aggregate purchase price of $26.9 million on March 31, 2022. 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 shareholders may experience dilution, and the new equity securities may have rights, preferences and privileges senior to those of the Company’s existing shareholders. 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 | 9 Months Ended |
Sep. 30, 2023 | |
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, 2022 included in the Company’s Form 10-K, filed with the SEC on March 16, 2023. 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”) for interim financial statements. 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 and nine months ended September 30, 2023 and 2022 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, 2022, filed with the SEC on March 16, 2023, 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 the convertible debt, stock-based compensation expense, accruals for research and development costs, lease liabilities and right of use assets, the valuation of deferred tax assets, valuation of uncertain income tax positions, 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. Basic and Diluted Net Loss per Share Net earnings or loss per share (“EPS”) is calculated in accordance with the applicable accounting guidance provided in ASC 260, Earnings per Share. Accordingly, basic income or loss per share is calculated by dividing net income or loss by the weighted-average number of common shares outstanding, or using the two-class method, whichever is more dilutive. Diluted net income or loss per share is computed using the more dilutive of the treasury stock method which reflects the potential dilution that would occur if securities or other contracts to issue common stock were exercised or converted to common stock, or the two-class method. The calculation of diluted loss per share requires that, to the extent the average market price of the underlying shares for the reporting period exceeds the exercise price of liability classified warrants, and the presumed exercise of such securities are dilutive to net loss per share for the period, an adjustment to net loss available to common shareholders used in the calculation is required to remove the change in fair value of the warrants from the numerator for the period. Likewise, an adjustment to the denominator is required to reflect the related dilutive shares, if any, under the treasury stock method. Recently Adopted Accounting Pronouncements In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments . The standard amends the impairment model by requiring entities to use a forward-looking approach based on expected losses to estimate credit losses for most financial assets and certain other instruments that aren’t measured at fair value through net income. For available-for-sale debt securities, entities will be required to recognize an allowance for credit losses rather than a reduction in carrying value of the asset. Entities will no longer be permitted to consider the length of time that fair value has been less than amortized cost when evaluating when credit losses should be recognized. Recent Accounting Pronouncements Not Yet Adopted 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) . |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2023 | |
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 cash equivalents include investments in a money market fund of $0.5 million as of September 30, 2023 and December 31, 2022, which are carried at fair value and represent Level 1 financial instruments under the fair value hierarchy. 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 condensed 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 significant assumptions and estimates such as volatility, expected term and risk-free interest rates, which are Level 3 fair value inputs unobservable from active markets. The following table presents the Company’s fair value measurements using Level 3 inputs during the three and nine months ended September 30, 2023. Three Months Ended Nine Months Ended September 30, 2023 Discount rate 22.38%-42.49% 22.38%-45.88% Probabilities of settlement scenarios 0%-85% 0%-85% Volatility 106.7%-123.6% 101.1%-123.6% Expected term 0.2-1.5 Year 0.2-1.5 Year Risk-free rate 4.97%-5.39% 4.62%-5.39% The following table presents a summary of the changes in the fair value of the Company’s Level 3 financial liabilities (in thousands): Convertible Loan Pre Modification Convertible Loan Post Modification Balance at December 31, 2022 $ — $ — Net issuance of the Convertible Loan (1) 29,226,000 — Initial recognition of modified Convertible Loan (1) — 35,031,000 Change in fair value (1,757,000) 14,716,000 Amount exchanged (2) (31,332,000) — Loss on extinguishment 3,863,000 — Balance at September 30, 2023 $ — $ 49,747,000 (1) The Convertible Loan before and after amendment was carried at fair value in the condensed consolidated balance sheets. As such, the principal and accrued interest were included in the determination of fair value. The related debt issuance costs were expensed. (2) The Company concluded that the amendment to the Convertible Loan was an extinguishment for accounting purposes and the amount exchanged was the relative fair value allocated to the Convertible Loan at the extinguishment date. See Note 7 for further details. |
Net Loss per Share
Net Loss per Share | 9 Months Ended |
Sep. 30, 2023 | |
Net Loss per Share | |
Net Loss per Share | 5. Net Loss per Share The following outstanding securities as of September 30, 2023 and 2022 have been excluded from the computation of diluted weighted average shares outstanding, as they would have been anti-dilutive: September 30, 2023 September 30, 2022 Options 2,913,300 3,385,162 Unvested restricted stock units 30,000 30,000 Restricted stock awards 34,851 99,666 Warrants 20,549,338 20,549,338 Total 23,527,489 24,064,166 |
Balance Sheet Details
Balance Sheet Details | 9 Months Ended |
Sep. 30, 2023 | |
Balance Sheet Details | |
Balance Sheet Details | 6. Balance Sheet Details Property and Equipment Property and equipment as of September 30, 2023 and December 31, 2022 consisted of the following: September 30, 2023 December 31, 2022 Laboratory and manufacturing equipment $ 16,317,000 $ 10,007,000 Furniture and fixtures 817,000 817,000 Office and computer equipment 438,000 449,000 Leasehold improvements 3,447,000 3,447,000 Total 21,019,000 14,720,000 Less: accumulated depreciation and amortization (11,769,000) (11,103,000) Property and equipment, net $ 9,250,000 $ 3,617,000 Depreciation and amortization expense totaled $0.2 million for each of the three months ended September 30, 2023 and 2022, and $0.7 million and $0.6 million for the nine months ended September 30, 2023 and 2022, respectively. Construction in progress and fixed assets not in use were $9.3 million and $1.0 million as of September 30, 2023 and December 31, 2022, 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 September 30, 2023 and December 31, 2022 consisted of the following: September 30, 2023 December 31, 2022 Tenant improvement allowance receivable (Note 12) $ 7,272,000 $ 6,595,000 Awards receivable 1,225,000 1,936,000 $ 8,497,000 $ 8,531,000 Accounts payable and accrued liabilities Accounts payable and accrued liabilities as of September 30, 2023 and December 31, 2022 consisted of the following: September 30, 2023 December 31, 2022 Accounts payable $ 3,772,000 $ 1,678,000 Accrued clinical trial expenses 1,879,000 2,650,000 Other accrued expenses 1,049,000 1,706,000 $ 6,700,000 $ 6,034,000 |
Convertible Debt
Convertible Debt | 9 Months Ended |
Sep. 30, 2023 | |
Convertible Debt | |
Convertible Debt | 7. Convertible Debt On January 10, 2023, the Company received the Convertible Loan in the aggregated 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 Credit Agreement with Innoviva, 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. On July 10, 2023, in connection with the Credit Agreement with Innoviva, as discussed below, the Company amended the terms of the Convertible Credit Agreement, to, among other changes, extend the maturity of the Convertible Loan to January 10, 2025. The Company concluded that the amendment is an extinguishment for accounting purposes. The Company recognized a $1.8 million gain as the change in fair value of the Convertible Loan before the extinguishment date. The Company estimated fair value of the combined transaction, the Loan and the Convertible Loan, before and after modification and calculated an extinguishment loss of $3.9 million, which was recognized as other income (expense) in the condensed consolidated statement of operations for the three months ended September 30, 2023. The Company recognized a $14.7 million loss as the change in fair value of the Convertible Loan from July 10, 2023, the modification date, to September 30, 2023. |
Long-Term Debt
Long-Term Debt | 9 Months Ended |
Sep. 30, 2023 | |
Long-Term Debt | |
Long-Term Debt | 8. Long-Term Debt On July 10, 2023, the Company entered into the Credit Agreement with Innoviva. The Credit Agreement provides for 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 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. The Credit Agreement contains 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 Credit Agreement also includes 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 Credit Agreement, certain bankruptcy or insolvency events, and a material deviation from the Company’s operating budget. The 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 expenses over the term of the Loan. The Loan’s annual effective interest rate was 27.31% as of September 30, 2023. |
Shareholders' Equity
Shareholders' Equity | 9 Months Ended |
Sep. 30, 2023 | |
Shareholders' Equity | |
Shareholders' Equity | 9. Shareholders’ Equity Private Investment February 2022 Private Placement On February 9, 2022, the Company entered into the February 2022 Securities Purchase Agreement to sell its Common Stock and warrants to Innoviva. Pursuant and subject to the terms and conditions of the February 2022 Securities Purchase Agreement and related agreements, Innoviva agreed to purchase Warrants issued to Innoviva expire in Warrants On September 30, 2023, outstanding warrants to purchase shares of Common Stock are as follows: Shares Underlying Outstanding Warrants Exercise Price Expiration Date 1,183,491 $ 5.60 October 16, 2023 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 20,549,338 |
Equity Incentive Plans
Equity Incentive Plans | 9 Months Ended |
Sep. 30, 2023 | |
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. The awards may be granted by the Company’s Board of Directors to its employees, directors and officers and to consultants, agents, advisors and independent contractors who provide services to the Company or to a subsidiary of the Company. The exercise price for stock options must not be less than the fair market value of the underlying shares on the date of grant. Stock options expire no later than ten years from the date of grant and generally vest and typically become exercisable over a four-year period following the date of grant. Under the 2016 Plan, the number of shares authorized for issuance automatically increases annually beginning January 1, 2017 and through January 1, 2026. The Company has issued restricted stock awards (“RSAs”) under certain legacy option plans that generally vest two 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 nine months ended September 30, 2023 and 2022 are presented below. Three Months Ended Nine Months Ended September 30, 2023 September 30, 2022 September 30, 2023 September 30, 2022 Risk-free interest rate 5.49%-5.54% 3.3%-3.4% 3.54% - 5.54% 2.65% - 3.52% Expected volatility 75.4%-116.96% 81.81%-85.0% 75.40% - 116.96% 81.81% - 85.67% Expected term (in years) 0.12-0.6 5.5-6.3 0.12 - 7.00 5.50 - 7.00 Expected dividend yield 0% 0% 0% 0% The risk-free interest rate is based on the U.S. Treasury yield for a period consistent with the expected term of the option in effect at the time of the grant. Expected volatility is based on the historical volatility of the Company and peer companies’ common stock. The expected term represents the period that the Company expects its stock options to be outstanding. The expected term assumption is estimated using the simplified method set forth in the SEC Staff Accounting Bulletin 110, which is the mid-point between the option vesting date and the expiration date. For stock options granted to parties other than employees or directors, the Company elects, on a grant-by-grant basis, to use the expected term or the contractual term of the option award. The Company has never declared or paid dividends on its Common Stock and has no plans to do so in the foreseeable future. Forfeitures are recognized as a reduction of share-based compensation expense as they occur. In July 2023, in connection with the resignation of its chief executive officer, the Company amended the terms of certain of his awards. As a result, the Company reversed $0.6 million previously recognized stock-based compensation expense related to his forfeited and unvested awards. The tables below summarize the total share-based compensation expense (reversal) included in the Company’s consolidated statements of operations for the periods presented: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Research and development $ 144,000 $ 570,000 $ 948,000 $ 1,249,000 General and administrative (517,000) 276,000 (203,000) 1,039,000 Total share-based compensation $ (373,000) $ 846,000 $ 745,000 $ 2,288,000 Stock option transactions during the nine months ended September 30, 2023 are presented below: Options Outstanding Weighted Average Weighted Remaining Average Contractual Aggregate Exercise Term Intrinsic Shares Price (Years) Value Outstanding at December 31, 2022 3,352,803 $ 5.32 7.8 Granted 17,500 2.36 Exercised (1,500) 3.15 $ 1,000 Forfeited/Cancelled (455,503) 5.16 1,000 Outstanding at September 30, 2023 2,913,300 $ 5.33 5.8 $ 45,000 Vested and expected to vest at September 30, 2023 2,913,300 $ 5.33 5.8 $ 45,000 Exercisable at September 30, 2023 2,136,125 $ 5.53 5.2 $ — Restricted stock award transactions under the Assumed 2016 Plan and restricted stock unit award transactions during the nine months ended September 30, 2023 are presented below: Weighted Avg Grant Date Shares Fair Value Outstanding at December 31, 2022 129,666 $ 27.11 Forfeited/Cancelled (9,914) 39.54 Vested and Issued as Common Stock (54,901) 29.97 Outstanding at September 30, 2023 64,851 $ 22.79 The aggregate intrinsic value of options at September 30, 2023 is based on the Company’s closing stock price on that date of Shares Reserved for Future Issuance As of September 30, 2023, the Company had reserved shares of its Common Stock for future issuance as follows: Shares Reserved Stock options outstanding 2,913,300 Unvested restricted stock units 30,000 Restricted stock awards 34,851 Employee stock purchase plan 9,748 Available for future grants under the 2016 Plan 2,826,291 Warrants outstanding 20,549,338 Total shares reserved 26,363,528 |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2023 | |
Income Taxes | |
Income Taxes | 11. Income Taxes The Company did no t record a provision or benefit for income taxes during the three and nine months ended September 30, 2023 and 2022. As of both September 30, 2023 and December 31, 2022, the Company continues to maintain a full valuation allowance against all of its deferred tax assets in light of its history of cumulative losses. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2023 | |
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 in April 2020, the Company amended the lease (“2020 Lease Amendment”) which, among other things, extended the lease term through December 31, 2031. Base annual rent for calendar year 2022, the first year under the Lease Amendment extended term, was approximately $1.9 million, and base rent increases by 3% annually and will be $2.5 million by the end of the amended term. In addition, the Company received a six-month rent abatement in 2020. The Company did not use an allowance for tenant improvements of $0.8 million during 2021, which will offset rent payments as prescribed by the 2020 Lease Amendment starting in 2022. In accordance with authoritative guidance, the Company re-measured the lease liability in April 2020 to be $11.7 million and related right of use asset of $11.0 million as of the Lease Amendment date with an incremental borrowing rate of 12.89%. 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 September 30, 2023, the letter of credit was $0.7 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 are fully or partially abated while the lessor and the Company complete planned tenant improvements to the facility. Base monthly rent will be approximately $0.25 million in 2024. The Company is entitled to receive an allowance for tenant improvements of up to $7.3 million, and 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. As of November 16, 2022, the Company finalized the budget to complete the construction of the 2021 Lease. Accordingly, the Company re-measured the lease liability and related right-of-use asset as of November 30, 2022, using an incremental borrowing rate of 11.8% . The re-measured lease liability of the 2021 Lease as of November 16, 2022 was $37.0 million, and the related right of use asset was $33.8 million During the nine months ended September 30, 2023, the budget was modified and the Company re-measured the lease liability. As a result, the lease liability and related right-of-use asset increased by approximately $2.5 million, using an incremental borrowing rate of 14.27%. In connection with the 2021 Lease, the Company delivered an irrevocable standby letter of credit in the total amount of $5.0 million to the landlord in 2022. 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 | 9 Months Ended |
Sep. 30, 2023 | |
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 the Medical Technology Enterprise Consortium (“MTEC”), pursuant to which the Company received a Staphylococcus aureus CFF Therapeutics Development Award On March 13, 2020, the Company entered into an award agreement (the “Award Agreement”) with CFF, pursuant to which the Company received a Therapeutics Development Award of up to Pseudomonas aeruginosa P. aeruginosa Pseudomonas The first payment under the Award Agreement, in the amount of 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 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 term of the Award Agreement commenced on March 10, 2020 and expires on the earlier of the date on which the Company has paid CFF all of the fixed royalty payments set forth therein, the effective date of any license granted to CFF following an Interruption, or upon earlier termination of the Award Agreement. Either CFF or the Company may terminate the Award Agreement for cause, which includes the Company’s material failure to achieve certain development milestones. The Company’s payment obligations survive the termination of the Award Agreement. 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. million in credits to research and development expenses 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) | 9 Months Ended |
Sep. 30, 2023 | |
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, 2022 included in the Company’s Form 10-K, filed with the SEC on March 16, 2023. 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”) for interim financial statements. 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 the convertible debt, stock-based compensation expense, accruals for research and development costs, lease liabilities and right of use assets, the valuation of deferred tax assets, valuation of uncertain income tax positions, 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. |
Basic and Diluted Net Loss per Share | Basic and Diluted Net Loss per Share Net earnings or loss per share (“EPS”) is calculated in accordance with the applicable accounting guidance provided in ASC 260, Earnings per Share. Accordingly, basic income or loss per share is calculated by dividing net income or loss by the weighted-average number of common shares outstanding, or using the two-class method, whichever is more dilutive. Diluted net income or loss per share is computed using the more dilutive of the treasury stock method which reflects the potential dilution that would occur if securities or other contracts to issue common stock were exercised or converted to common stock, or the two-class method. The calculation of diluted loss per share requires that, to the extent the average market price of the underlying shares for the reporting period exceeds the exercise price of liability classified warrants, and the presumed exercise of such securities are dilutive to net loss per share for the period, an adjustment to net loss available to common shareholders used in the calculation is required to remove the change in fair value of the warrants from the numerator for the period. Likewise, an adjustment to the denominator is required to reflect the related dilutive shares, if any, under the treasury stock method. |
Recent Accounting Pronouncements Not Yet Adopted | Recently Adopted Accounting Pronouncements In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments . The standard amends the impairment model by requiring entities to use a forward-looking approach based on expected losses to estimate credit losses for most financial assets and certain other instruments that aren’t measured at fair value through net income. For available-for-sale debt securities, entities will be required to recognize an allowance for credit losses rather than a reduction in carrying value of the asset. Entities will no longer be permitted to consider the length of time that fair value has been less than amortized cost when evaluating when credit losses should be recognized. Recent Accounting Pronouncements Not Yet Adopted 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) . |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value of Financial Assets and Liabilities - Derivative Instruments | |
Schedule of Fair Value Measurements | The following table presents the Company’s fair value measurements using Level 3 inputs during the three and nine months ended September 30, 2023. Three Months Ended Nine Months Ended September 30, 2023 Discount rate 22.38%-42.49% 22.38%-45.88% Probabilities of settlement scenarios 0%-85% 0%-85% Volatility 106.7%-123.6% 101.1%-123.6% Expected term 0.2-1.5 Year 0.2-1.5 Year Risk-free rate 4.97%-5.39% 4.62%-5.39% |
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): Convertible Loan Pre Modification Convertible Loan Post Modification Balance at December 31, 2022 $ — $ — Net issuance of the Convertible Loan (1) 29,226,000 — Initial recognition of modified Convertible Loan (1) — 35,031,000 Change in fair value (1,757,000) 14,716,000 Amount exchanged (2) (31,332,000) — Loss on extinguishment 3,863,000 — Balance at September 30, 2023 $ — $ 49,747,000 (1) The Convertible Loan before and after amendment was carried at fair value in the condensed consolidated balance sheets. As such, the principal and accrued interest were included in the determination of fair value. The related debt issuance costs were expensed. (2) The Company concluded that the amendment to the Convertible Loan was an extinguishment for accounting purposes and the amount exchanged was the relative fair value allocated to the Convertible Loan at the extinguishment date. See Note 7 for further details. |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Net Loss per Share | |
Schedule of Antidilutive Securities Excluded from Computation of Diluted Weighted Shares Outstanding | The following outstanding securities as of September 30, 2023 and 2022 have been excluded from the computation of diluted weighted average shares outstanding, as they would have been anti-dilutive: September 30, 2023 September 30, 2022 Options 2,913,300 3,385,162 Unvested restricted stock units 30,000 30,000 Restricted stock awards 34,851 99,666 Warrants 20,549,338 20,549,338 Total 23,527,489 24,064,166 |
Balance Sheet Details (Tables)
Balance Sheet Details (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Balance Sheet Details | |
Schedule of Property and Equipment | September 30, 2023 December 31, 2022 Laboratory and manufacturing equipment $ 16,317,000 $ 10,007,000 Furniture and fixtures 817,000 817,000 Office and computer equipment 438,000 449,000 Leasehold improvements 3,447,000 3,447,000 Total 21,019,000 14,720,000 Less: accumulated depreciation and amortization (11,769,000) (11,103,000) Property and equipment, net $ 9,250,000 $ 3,617,000 |
Schedule of Other receivables | Other receivables as of September 30, 2023 and December 31, 2022 consisted of the following: September 30, 2023 December 31, 2022 Tenant improvement allowance receivable (Note 12) $ 7,272,000 $ 6,595,000 Awards receivable 1,225,000 1,936,000 $ 8,497,000 $ 8,531,000 |
Schedule of Accounts Payable and Accrued Liabilities | Accounts payable and accrued liabilities as of September 30, 2023 and December 31, 2022 consisted of the following: September 30, 2023 December 31, 2022 Accounts payable $ 3,772,000 $ 1,678,000 Accrued clinical trial expenses 1,879,000 2,650,000 Other accrued expenses 1,049,000 1,706,000 $ 6,700,000 $ 6,034,000 |
Shareholders' Equity (Tables)
Shareholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Shareholders' Equity | |
Schedule of Warrant Information | On September 30, 2023, outstanding warrants to purchase shares of Common Stock are as follows: Shares Underlying Outstanding Warrants Exercise Price Expiration Date 1,183,491 $ 5.60 October 16, 2023 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 20,549,338 |
Equity Incentive Plans (Tables)
Equity Incentive Plans (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Equity Incentive Plans | |
Schedule of Stock-Based Compensation Expenses | The tables below summarize the total share-based compensation expense (reversal) included in the Company’s consolidated statements of operations for the periods presented: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Research and development $ 144,000 $ 570,000 $ 948,000 $ 1,249,000 General and administrative (517,000) 276,000 (203,000) 1,039,000 Total share-based compensation $ (373,000) $ 846,000 $ 745,000 $ 2,288,000 |
Schedule of Stock Option Activity | Stock option transactions during the nine months ended September 30, 2023 are presented below: Options Outstanding Weighted Average Weighted Remaining Average Contractual Aggregate Exercise Term Intrinsic Shares Price (Years) Value Outstanding at December 31, 2022 3,352,803 $ 5.32 7.8 Granted 17,500 2.36 Exercised (1,500) 3.15 $ 1,000 Forfeited/Cancelled (455,503) 5.16 1,000 Outstanding at September 30, 2023 2,913,300 $ 5.33 5.8 $ 45,000 Vested and expected to vest at September 30, 2023 2,913,300 $ 5.33 5.8 $ 45,000 Exercisable at September 30, 2023 2,136,125 $ 5.53 5.2 $ — |
Schedule of Restricted Stock Awards and Restricted Stock Unit Activity | Restricted stock award transactions under the Assumed 2016 Plan and restricted stock unit award transactions during the nine months ended September 30, 2023 are presented below: Weighted Avg Grant Date Shares Fair Value Outstanding at December 31, 2022 129,666 $ 27.11 Forfeited/Cancelled (9,914) 39.54 Vested and Issued as Common Stock (54,901) 29.97 Outstanding at September 30, 2023 64,851 $ 22.79 |
Schedule of Shares Reserved for Future Issuance | As of September 30, 2023, the Company had reserved shares of its Common Stock for future issuance as follows: Shares Reserved Stock options outstanding 2,913,300 Unvested restricted stock units 30,000 Restricted stock awards 34,851 Employee stock purchase plan 9,748 Available for future grants under the 2016 Plan 2,826,291 Warrants outstanding 20,549,338 Total shares reserved 26,363,528 |
Organization and Description _2
Organization and Description of the Business (Narrative) (Details) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
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) | Mar. 31, 2022 USD ($) shares | Feb. 09, 2022 USD ($) tranche $ / shares shares | Sep. 30, 2023 USD ($) | Jul. 10, 2023 USD ($) | Jan. 10, 2023 USD ($) | Dec. 31, 2022 USD ($) | Sep. 30, 2022 USD ($) |
Accumulated deficit | $ | $ (288,972,000) | $ (239,774,000) | |||||
Cash and cash equivalents | $ | $ 23,958,000 | $ 14,852,000 | $ 25,382,000 | ||||
Innoviva Strategic Opportunities LLC [Member] | Secured term loan | |||||||
Aggregate amount | $ | $ 25,000,000 | $ 30,000,000 | |||||
Interest rate (as a percent) | 27.31% | 14% | 8% | ||||
Securities Purchase Agreement [Member] | Innoviva Strategic Opportunities LLC [Member] | |||||||
Number of tranches | tranche | 2 | ||||||
Shares Issued, Price Per Share | $ / shares | $ 5 | ||||||
Stock Issued During Period, Shares, New Issues | 9,000,000 | ||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 4,500,000 | ||||||
Exercise price of warrants | $ / shares | $ 5 | ||||||
Securities Purchase Agreement First Tranche [Member] | Innoviva Strategic Opportunities LLC [Member] | |||||||
Stock Issued During Period, Shares, New Issues | 3,614,792 | ||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 1,807,396 | ||||||
Proceeds from issuance of common stock and warrants | $ | $ 18,100,000 | ||||||
Securities Purchase Agreement Second Tranche [Member] | Innoviva Strategic Opportunities LLC [Member] | |||||||
Stock Issued During Period, Shares, New Issues | 5,385,208 | ||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 2,692,604 | ||||||
Proceeds from issuance of common stock and warrants | $ | $ 26,900,000 |
Fair Value Measurements (Narrat
Fair Value Measurements (Narrative) (Details) - USD ($) $ in Millions | Sep. 30, 2023 | Dec. 31, 2022 |
Fair Value Measurements | ||
Money market funds | $ 0.5 | $ 0.5 |
Fair Value Measurements (Compan
Fair Value Measurements (Company's Fair Value Measurements Using Level 3 Inputs) (Details) - Fair Value, Inputs, Level 3 | 3 Months Ended | 9 Months Ended |
Sep. 30, 2023 Y | Sep. 30, 2023 Y | |
Discount rate | Minimum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Debt instrument, measurement input, for the period | 22.38 | 22.38 |
Discount rate | Maximum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Debt instrument, measurement input, for the period | 42.49 | 45.88 |
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 | 85 | 85 |
Volatility | Minimum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Debt instrument, measurement input, for the period | 106.7 | 101.1 |
Volatility | Maximum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Debt instrument, measurement input, for the period | 123.6 | 123.6 |
Expected term | Minimum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Debt instrument, measurement input, for the period | 0.2 | 0.2 |
Expected term | Maximum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Debt instrument, measurement input, for the period | 1.5 | 1.5 |
Risk-free rate | Minimum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Debt instrument, measurement input, for the period | 4.97 | 4.62 |
Risk-free rate | Maximum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Debt instrument, measurement input, for the period | 5.39 | 5.39 |
Fair Value Measurement (Changes
Fair Value Measurement (Changes in Fair Value of Liabilities) (Details) - Fair Value, Inputs, Level 3 $ in Thousands | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Convertible Loan Pre Modification | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Net issuance of the Convertible Loan | $ 29,226,000 |
Change in fair value | (1,757,000) |
Amount exchanged | (31,332,000) |
Loss on extinguishment | 3,863,000 |
Convertible Loan Post Modification | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Initial recognition of modified Convertible Loan | 35,031,000 |
Change in fair value | 14,716,000 |
Balance at September 30, 2023 | $ 49,747,000 |
Net Loss per Share (Antidilutiv
Net Loss per Share (Antidilutive Shares Excluded from Computation of Diluted Shares Outstanding) (Details) - shares | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of diluted weighted shares outstanding | 23,527,489 | 24,064,166 |
Options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of diluted weighted shares outstanding | 2,913,300 | 3,385,162 |
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 | 30,000 | 30,000 |
Restricted stock awards | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of diluted weighted shares outstanding | 34,851 | 99,666 |
Warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of diluted weighted shares outstanding | 20,549,338 | 20,549,338 |
Balance Sheet Details (Narrativ
Balance Sheet Details (Narrative) (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Balance Sheet Details | ||||
Depreciation | $ 0.2 | $ 0.2 | $ 0.7 | $ 0.6 |
Construction in progress and fixed assets | $ 9.3 | $ 1 | $ 9.3 | $ 1 |
Balance Sheet Details (Property
Balance Sheet Details (Property and Equipment) (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 21,019,000 | $ 14,720,000 |
Less: accumulated depreciation and amortization | (11,769,000) | (11,103,000) |
Property and equipment, net | 9,250,000 | 3,617,000 |
Laboratory and manufacturing equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 16,317,000 | 10,007,000 |
Office and Computer Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 438,000 | 449,000 |
Furniture and Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 817,000 | 817,000 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 3,447,000 | $ 3,447,000 |
Balance Sheet Details (Other re
Balance Sheet Details (Other receivables) (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Balance Sheet Details | ||
Tenant improvement allowance receivable (Note 12) | $ 7,272,000 | $ 6,595,000 |
Awards receivable | 1,225,000 | 1,936,000 |
Other receivables | $ 8,497,000 | $ 8,531,000 |
Balance Sheet Details (Accounts
Balance Sheet Details (Accounts payable and accrued liabilities) (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Balance Sheet Details | ||
Accounts payable | $ 3,772,000 | $ 1,678,000 |
Accrued clinical trial expenses | 1,879,000 | 2,650,000 |
Other accrued expenses | 1,049,000 | 1,706,000 |
Accounts Payable and Accrued Liabilities, Current, Total | $ 6,700,000 | $ 6,034,000 |
Convertible Debt (Narrative) (D
Convertible Debt (Narrative) (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Jul. 10, 2023 | Jan. 10, 2023 | Sep. 30, 2023 | Sep. 30, 2023 | |
Change in fair value of convertible debt | $ 12,959,000 | |||
Loss on convertible debt extinguishment | $ (3,863,000) | $ (3,863,000) | ||
Innoviva Strategic Opportunities LLC [Member] | ||||
Proceeds from qualified financing per agreement benchmark | $ 30,000,000 | |||
Innoviva Strategic Opportunities LLC [Member] | Secured term loan | ||||
Aggregate amount | $ 25,000,000 | $ 30,000,000 | ||
Interest rate (as a percent) | 14% | 8% | 27.31% | 27.31% |
Price per share | $ 1.52 | |||
Discount on share price for conversion | 15% | |||
Change in fair value of convertible debt | $ 14,700,000 | $ 1,800,000 | ||
Loss on convertible debt extinguishment | $ 3,900,000 |
Long-Term Debt (Details)
Long-Term Debt (Details) - Secured term loan - Innoviva Strategic Opportunities LLC - USD ($) $ in Millions | Sep. 30, 2023 | Jul. 10, 2023 | Jan. 10, 2023 |
Term Loan | |||
Aggregate amount | $ 25 | $ 30 | |
Interest rate (as a percent) | 27.31% | 14% | 8% |
Debt issuance costs | $ 0.1 | ||
Recognized at fair value | 21.2 | ||
Debt discount | $ 3.8 |
Shareholders' Equity (Narrative
Shareholders' Equity (Narrative) (Details) $ / shares in Units, $ in Millions | 9 Months Ended | ||
Mar. 31, 2022 USD ($) shares | Feb. 09, 2022 USD ($) tranche $ / shares shares | Sep. 30, 2022 shares | |
Common Stock | |||
Class of Stock [Line Items] | |||
Sale of common stock, net of issuance costs (in shares) | 9,000,000 | ||
Innoviva Strategic Opportunities LLC [Member] | Securities Purchase Agreement [Member] | |||
Class of Stock [Line Items] | |||
Sale of common stock, net of issuance costs (in shares) | 9,000,000 | ||
Shares Issued, Price Per Share | $ / shares | $ 5 | ||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 4,500,000 | ||
Exercise price of warrants | $ / shares | $ 5 | ||
Number of tranches | tranche | 2 | ||
Innoviva Strategic Opportunities LLC [Member] | Securities Purchase Agreement First Tranche [Member] | |||
Class of Stock [Line Items] | |||
Sale of common stock, net of issuance costs (in shares) | 3,614,792 | ||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 1,807,396 | ||
Proceeds from issuance of common stock and warrants | $ | $ 18.1 | ||
Innoviva Strategic Opportunities LLC [Member] | Securities Purchase Agreement Second Tranche [Member] | |||
Class of Stock [Line Items] | |||
Sale of common stock, net of issuance costs (in shares) | 5,385,208 | ||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 2,692,604 | ||
Proceeds from issuance of common stock and warrants | $ | $ 26.9 |
Shareholders' Equity (Summary o
Shareholders' Equity (Summary of Warrants Outstanding) (Details) | 9 Months Ended |
Sep. 30, 2023 $ / shares shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Warrants | 20,549,338 |
Term of warrant | 5 years |
Exercise Price $5.60 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Warrants | 1,183,491 |
Exercise Price | $ / shares | $ 5.60 |
Warrant Expiration Date | Oct. 16, 2023 |
Exercise Price $2.87 | |
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. | |
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. | |
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 | |
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 | |
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. | |
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 |
Equity Incentive Plans (Narrati
Equity Incentive Plans (Narrative) (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 9 Months Ended |
Jul. 31, 2023 | Sep. 30, 2023 | |
Stock-based compensation expense | $ 0.6 | |
Stock Option [Member] | ||
Common stock closing price | $ 3 | |
Unrecognized compensation cost related to unvested options | $ 1.1 | |
Restricted Stock Awards [Member] | ||
Additional awards | 0 | |
Restricted Stock Awards [Member] | Minimum [Member] | ||
Vesting period of share-based compensation award | 2 years | |
Restricted Stock Awards [Member] | Maximum [Member] | ||
Vesting period of share-based compensation award | 4 years | |
Stock Options And Restricted Stock Awards [Member] | ||
Weighted-average remaining period for recognition of compensation costs related to unvested options | 1 year 8 months 15 days | |
Equity Incentive Plan 2016 [Member] | ||
Vesting period of share-based compensation award | 4 years | |
Equity Incentive Plan 2016 [Member] | Maximum [Member] | ||
Expiration period of share-based payment award | 10 years |
Equity Incentive Plans (Assumpt
Equity Incentive Plans (Assumptions Used in the Black-Scholes Model) (Details) - Common Stock Options [Member] | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 Y | Sep. 30, 2022 Y | Sep. 30, 2023 Y | Sep. 30, 2022 Y | |
Measurement Input, Expected Dividend Rate [Member] | ||||
Fair value input, equity securities | 0 | 0 | 0 | 0 |
Minimum [Member] | Measurement Input, Risk Free Interest Rate [Member] | ||||
Fair value input, equity securities | 5.49 | 3.3 | 3.54 | 2.65 |
Minimum [Member] | Measurement Input, Price Volatility [Member] | ||||
Fair value input, equity securities | 75.4 | 81.81 | 75.40 | 81.81 |
Minimum [Member] | Measurement Input, Expected Term [Member] | ||||
Fair value input, equity securities | 0.12 | 5.5 | 0.12 | 5.50 |
Maximum [Member] | Measurement Input, Risk Free Interest Rate [Member] | ||||
Fair value input, equity securities | 5.54 | 3.4 | 5.54 | 3.52 |
Maximum [Member] | Measurement Input, Price Volatility [Member] | ||||
Fair value input, equity securities | 116.96 | 85 | 116.96 | 85.67 |
Maximum [Member] | Measurement Input, Expected Term [Member] | ||||
Fair value input, equity securities | 0.6 | 6.3 | 7 | 7 |
Equity Incentive Plans (Allocat
Equity Incentive Plans (Allocation of Share-Based Compensation Expense) (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total share-based compensation expense | $ (373,000) | $ 846,000 | $ 745,000 | $ 2,288,000 |
Research and development expense [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total share-based compensation expense | 144,000 | 570,000 | 948,000 | 1,249,000 |
General and administrative expense [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total share-based compensation expense | $ (517,000) | $ 276,000 | $ (203,000) | $ 1,039,000 |
Equity Incentive Plans (Summary
Equity Incentive Plans (Summary of Stock Option Activity) (Details) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 USD ($) $ / shares shares | Dec. 31, 2022 $ / shares shares | |
Equity Incentive Plans | ||
Shares, Balance Beginning | shares | 3,352,803 | |
Shares, Granted | shares | 17,500 | |
Shares, Exercised | shares | (1,500) | |
Shares, Forfeited/Cancelled | shares | (455,503) | |
Shares, Balance Ending | shares | 2,913,300 | 3,352,803 |
Vested and expected to vest at September 30, 2023 | shares | 2,913,300 | |
Exercisable at September 30, 2023 | shares | 2,136,125 | |
Weighted Average Exercise Price, Outstanding Beginning | $ / shares | $ 5.32 | |
Weighted Average Exercise Price, Granted | $ / shares | 2.36 | |
Weighted Average Exercise Price, Exercised | $ / shares | 3.15 | |
Weighted Average Exercise Price, Forfeited/Cancelled | $ / shares | 5.16 | |
Weighted Average Exercise Price, Outstanding Ending | $ / shares | 5.33 | $ 5.32 |
Weighted Average Exercise Price, Vested and expected to vest at September 30, 2023 | $ / shares | 5.33 | |
Weighted Average Exercise Price, Exercisable at September 30, 2023 | $ / shares | $ 5.53 | |
Weighted Average Remaining Contractual Term (Years), Outstanding | 5 years 9 months 18 days | 7 years 9 months 18 days |
Weighted Average Remaining Contractual Term (Years), Vested and expected to vest at September 30, 2023 | 5 years 9 months 18 days | |
Weighted Average Remaining Contractual Term (Years), Exercisable at September 30, 2023 | 5 years 2 months 12 days | |
Aggregate Intrinsic Value, Exercised | $ | $ 1,000 | |
Aggregate Intrinsic Value, Forfeited/Cancelled | $ | 1,000 | |
Aggregate Intrinsic Value, Outstanding Ending | $ | 45,000 | |
Aggregate Intrinsic Value, Vested and expected to vest at September 30, 2023 | $ | $ 45,000 |
Equity Incentive Plans (Restric
Equity Incentive Plans (Restricted stock award and restricted stock unit award activity) (Details) - Restricted stock unit | 9 Months Ended |
Sep. 30, 2023 $ / shares shares | |
Shares | |
Outstanding at beginning of period (in shares) | shares | 129,666 |
Forfeited/Cancelled (in shares) | shares | (9,914) |
Vested and Issued as Common Stock (in shares) | shares | (54,901) |
Outstanding at end of period (in shares) | shares | 64,851 |
Weighted Avg Grant Date Fair Value | |
Outstanding at beginning of period (in dollars per share) | $ / shares | $ 27.11 |
Forfeited/Cancelled (in dollars per share) | $ / shares | 39.54 |
Vested and Issued as Common Stock (in dollars per shares) | $ / shares | 29.97 |
Outstanding at end of period (in dollars per share) | $ / shares | $ 22.79 |
Equity Incentive Plans (Shares
Equity Incentive Plans (Shares Reserved for Future Issuance) (Details) - shares | Sep. 30, 2023 | Dec. 31, 2022 |
Stock options outstanding | 2,913,300 | 3,352,803 |
Employee stock purchase plan | 9,748 | |
Warrants outstanding | 20,549,338 | |
Total shares reserved | 26,363,528 | |
Unvested Restricted Stock Units [Member] | ||
Restricted stock awards/units | 64,851 | 129,666 |
Restricted stock awards | ||
Restricted stock awards/units | 34,851 | |
Restricted Stock Units [Member] | ||
Restricted stock awards/units | 30,000 | |
Equity Incentive Plan 2016 [Member] | ||
Available for future grants under the 2016 Plan | 2,826,291 |
Income Taxes (Narrative) (Detai
Income Taxes (Narrative) (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Income Taxes | ||||
Income tax expense (benefit) | $ 0 | $ 0 | $ 0 | $ 0 |
Commitments and Contingencies (
Commitments and Contingencies (Narrative) (Details) - USD ($) | 1 Months Ended | 9 Months Ended | |||||
Apr. 30, 2020 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Nov. 30, 2022 | Nov. 16, 2022 | Oct. 28, 2021 | |
Lease term | 16 years | ||||||
Base annual rent for 2024 | $ 250,000 | ||||||
Maximum allowance for tenant improvements | 7,300,000 | ||||||
Operating lease expected yearly base rent | $ 1,900,000 | ||||||
Annual increase in rent percentage | 3% | ||||||
Base rent at the end of lease term | $ 2,500,000 | ||||||
Period of lease and rental abatement credit | 6 months | ||||||
Lease and rental abatement credit | $ 800,000 | ||||||
Operating Lease, Liability | 11,700,000 | $ 37,000,000 | |||||
Operating Lease, Right-of-Use Asset | $ 11,000,000 | $ 44,886,000 | $ 43,035,000 | $ 33,800,000 | |||
Lessee, Operating Lease, Discount Rate | 12.89% | 11.80% | |||||
Standby letter of credit | $ 5,000,000 | ||||||
Increase (decrease) operating lease right-of-use and liability | $ (9,723,000) | $ 1,457,000 | |||||
2021 Lease [Member] | |||||||
Lessee, Operating Lease, Discount Rate | 14.27% | ||||||
Increase (decrease) operating lease right-of-use and liability | $ 2,500,000 | ||||||
Cash [Member] | |||||||
Standby letter of credit | $ 1,200,000 | $ 700,000 | |||||
Annual reduction of standby letter of credit | 20% |
Grant and Awards (Narrative) (D
Grant and Awards (Narrative) (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||||||
Sep. 29, 2022 | Jun. 15, 2020 | Mar. 13, 2020 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Award [Line Items] | ||||||||
Revenue from grants | $ 1,225,000 | $ 1,338,000 | $ 3,001,000 | $ 4,457,000 | ||||
Medical Technology Enterprise Consortium [Member] | ||||||||
Award [Line Items] | ||||||||
Revenue from grants | $ 16,300,000 | $ 15,000,000 | 1,200,000 | 1,300,000 | 3,000,000 | 4,500,000 | ||
Increase in expected revenue from grants | $ 1,300,000 | |||||||
Unbilled award receivable | 1,000,000 | 1,000,000 | $ 1,600,000 | |||||
Cystic Fibrosis Foundation [Member] | ||||||||
Award [Line Items] | ||||||||
Research and development benefit | $ 0 | $ 500,000 | $ 0 | $ 500,000 | ||||
Award receivable | $ 1,000,000 | |||||||
Award agreement interruption period | 360 days | |||||||
Maximum [Member] | Cystic Fibrosis Foundation [Member] | ||||||||
Award [Line Items] | ||||||||
Amount of threshold development award | $ 5,000,000 |