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Going Concern and Management's Plans | 6 Months Ended
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Jun. 30, 2024
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
Going Concern and Management's Plans | Note 2. Going Concern and Management’s Plans The accompanying condensed consolidated financial statements have been prepared under the assumption the Company will continue to operate as a going concern, which contemplates the realization of assets and the settlement of liabilities in the normal course of business. The 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 of liabilities that may result from uncertainty related to the Company’s ability to continue as a going concern. The Company had a net loss of $68.5 million for the six months ended June 30, 2024, negative cash flows from operations of $16.5 million and an accumulated deficit of $387.9 million as of June 30, 2024, as a result of incurring losses since its inception. The Company expects to continue to incur net losses into the foreseeable future in connection with its ongoing activities, particularly as the Company expands its clinical program with tegoprubart, continues the research and development of, and seeks marketing approval for, its product candidates. In addition, if the Company obtains marketing approval for any of its product candidates, the Company expects to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. The Company has financed operations primarily by net proceeds from the sale of preferred and common stock and warrants. On April 28, 2023, the Company entered into a Securities Purchase Agreement (the “2023 Securities Purchase Agreement”) with certain institutional and accredited investors, pursuant to which the Company agreed to issue and sell to the investors in a private placement (the “2023 Private Placement”) shares of common stock and warrants in a series of three potential closings. On May 5, 2023, the initial closing occurred and the Company received $35.0 million, in exchange for 8,730,168 shares of common stock, pre-funded warrants to purchase 6,421,350 shares of common stock and additional common stock warrants to purchase 15,151,518 shares of common stock (or pre-funded warrants in lieu thereof). As described in Note 12, on July 8, 2024, the Company completed the sale of 909,088 shares of its common stock, $0.001 par value share, pursuant to a second closing under the 2023 Securities Purchase Agreement (the "Second Closing"). The sale resulted in gross proceeds to the Company of approximately $2.1 million, or net proceeds of approximately $2.0 million after deducting offering costs. Effective with this sale, the Company is no longer obliged to sell, and investors are no longer obliged to purchase, additional shares of the Company's common stock in the Second Closing. The Company may receive up to an additional $58.3 million in tranche financing in a third closing, (the “Third Closing”), subject to the satisfaction or waiver of specified conditions, including achieving specified clinical development milestones, volume weighted average share price levels and trading volume conditions, and an additional $45.5 million assuming the exercise of all common stock warrants issued in the initial closing of the 2023 Private Placement. See Note 9. “Stockholders’ Equity (Deficit)” for further information regarding the 2023 Private Placement. On May 6, 2024, the Company entered into a Securities Purchase Agreement (the “2024 Securities Purchase Agreement”) with certain institutional and accredited investors, pursuant to which the Company agreed to issue and sell to the investors in a private placement (the “2024 Private Placement”) an aggregate of 13,110,484 shares (the “2024 Shares”) of the Company’s common stock, $0.001 par value per share (the “Common Stock”) at a price of $2.37 per share, and pre-funded warrants (the “2024 Pre-Funded Warrants”) at a price of $2.369 per underlying share, which are exercisable to purchase 7,989,516 shar es of common stock at an exercise price of $0.001 per share. The 2024 Private Placement resulted in gross proceeds to the Company of $50.0 million, or net proceeds of approximately $48.1 million after deducting offering costs. Due to the contingent nature of the exercise of the common stock warrants and the Third Closing, accounting principles generally accepted in the United States of America (“GAAP”) requires the Company to exclude them from its going concern analysis. If these events do not occur or the Company is unable to raise additional capital or is unable to do so on acceptable terms, it will be forced to significantly alter its business strategy, substantially curtail its current operations, or liquidate and cease operations altogether. As of June 30, 2024, the Company had cash and cash equivalents and short-term investments of approximately $83.6 million. However, in view of the Company’s expectation to incur significant losses for the foreseeable future and uncertainty with regard to the timing and amount of expenditures for progression of continued development, the Company will be required to raise additional capital to finance its operation. However, the availability of, and the Company’s access, to such resources is not assured. Accordingly, management believes that there is substantial doubt about regarding the Company’s ability to continue operating as a going concern for a year from the date these financial statements are issued.

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- Definition The entire disclosure when substantial doubt is raised about the ability to continue as a going concern. Includes, but is not limited to, principal conditions or events that raised substantial doubt about the ability to continue as a going concern, management's evaluation of the significance of those conditions or events in relation to the ability to meet its obligations, and management's plans that alleviated or are intended to mitigate the conditions or events that raise substantial doubt about the ability to continue as a going concern. + References Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef -Topic 205 -SubTopic 40 -Name Accounting Standards Codification -Publisher FASB -URI https://asc.fasb.org/205-40/tableOfContent + Details
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