Liquidity | Liquidity Since inception, the Company has incurred recurring losses and negative cash flows from operations and, as of September 30, 2023, has an accumulated deficit of $209.1 million. During the nine months ended September 30, 2023, the Company incurred a net loss of $29.2 million, and used $26.6 million of cash in operations. The Company expects to continue to generate operating losses and negative cash flows from operations for the next few years and will need additional funding to support its planned operating activities through profitability. The transition to profitability is dependent upon the successful development, approval, and commercialization of the Company's product candidates and the achievement of a level of revenues adequate to support its cost structure. On October 30, 2023, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with a single institutional investor (the "Investor"), pursuant to which the Company agreed to issue and sell, in a registered direct offering by the Company directly to the Investor (the “October 2023 Registered Direct Offering”), 3,100,000 shares of its common stock and 552,300 pre-funded warrants exercisable for shares of common stock, together with accompanying warrants to purchase an aggregate of 3,652,300 shares of common stock. Each share of common stock and accompanying warrant were sold together at a combined purchase price of $1.0952 and each pre-funded warrant and accompanying warrant were sold together at a combined purchase price of $1.0951. The aggregate gross proceeds to the Company from the October 2023 Registered Direct Offering were approximately $4.0 million, before deducting placement agents' fees and related offering expenses. Subsequent to the closing of the October 2023 Registered Direct Offering, all of the pre-funded warrants were exercised into shares of common stock by the Investor. On February 28, 2023, the Company consummated an underwritten public offering (the "February 2023 Offering"), issuing 7,220,217 shares of common stock and accompanying common stock warrants to purchase an aggregate of 7,220,217 shares of common stock. The shares of common stock and accompanying common stock warrants were sold at a combined price of $2.77 per share and accompanying common stock warrant. Each common stock warrant sold with the shares of common stock represents the right to purchase one share of the Company’s common stock at an exercise price of $2.77 per share, which was reduced to an exercise price of $1.35 per share in October 2023, and further reduced to an exercise price of $0.9702 per share in November 2023. The common stock warrants are exercisable immediately and will expire on February 28, 2028, five years from the date of issuance. The net proceeds to the Company from the February 2023 Offering were approximately $18.5 million, after deducting underwriting discounts and commissions, offering expenses, and excluding the exercise of any warrants. On April 16, 2021, the Company entered into a Controlled Equity Offering SM Sales Agreement (the "Sales Agreement") with Cantor Fitzgerald & Co. (the "Agent"). From time to time during the term of the Sales Agreement, subject to certain restrictions, the Company may offer and sell shares of common stock having an aggregate offering price up to a total of $50.0 million in gross proceeds. The Agent will collect a fee equal to 3% of the gross sales price of all shares of common stock sold. Shares of common stock sold under the Sales Agreement are offered and sold pursuant to the Company's registration statement on Form S-3, which was filed with the SEC on April 16, 2021 and declared effective on April 29, 2021. During the nine months ended September 30, 2023, the Company sold a total of 76,882 shares of common stock pursuant to the Sales Agreement at an average price of $3.59 per share for aggregate net proceeds of approximately $0.3 million. Subsequent to September 30, 2023, the Company sold a total of 16,000 shares of common stock pursuant to the Sales Agreement for aggregate net proceeds of approximately $21,000. In December 2020, the Company, together with its wholly-owned subsidiary, SLSG Limited, LLC, entered into an Exclusive License Agreement (the “3DMed License Agreement”) with 3D Medicines Inc. ("3DMed"), pursuant to which the Company granted 3DMed a sublicensable, royalty-bearing license, under certain intellectual property owned or controlled by the Company, to develop, manufacture and have manufactured, and commercialize GPS and heptavalent GPS product candidates for all therapeutic and other diagnostic uses in mainland China, Hong Kong, Macau and Taiwan ("3DMed Territory"). To date, the Company has received $10.5 million in upfront payments and certain technology transfer and regulatory milestones. In November 2022, the Company announced that the Company has agreed with 3DMed for 3DMed to participate in the REGAL study through the inclusion of approximately 20-25 patients from mainland China. Such participation by 3DMed, which the Company expects to occur in the fourth quarter of 2023, subject to any further delays due to supply chain or other operational reasons, will trigger two development milestone payments totaling $13.0 million which has been agreed with 3DMed. A total of $191.5 million in potential future development, regulatory, and sales milestones, not including future royalties, remains under the 3DMed License Agreement as of September 30, 2023, which milestones are all variable in nature and not under the Company's control. As of September 30, 2023, the Company had cash and cash equivalents of approximately $4.0 million and restricted cash and cash equivalents of $0.1 million. In accordance with Accounting Standards Codification ("ASC") 205-40, Presentation of Financial Statements - Going Concern , the Company evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about its ability to continue as a going concern within one year after the consolidated financial statements are issued. The Company expects its cash and cash equivalents, together with the net proceeds from the October 2023 Registered Direct Offering, will not be sufficient to fund its current planned operations for at least the next twelve months from the date of issuance of these consolidated financial statements. The $13.0 million of development milestone payments to the Company triggered by 3DMed's participation in the REGAL study through the enrollment of patients in China are variable in nature and not under the Company's control, and therefore cannot be included in the Company's going concern assumption. |