Stockholders' Equity | Stockholders’ Equity Public and Private Placements Common Purchase Agreement On March 27, 2023, the Company entered into a securities purchase agreement (the “Common Purchase Agreement”) with the Company’s Chief Executive Officer, Gerard Michel, pursuant to which the Company agreed to issue and sell, in a private placement (the “Common Offering”) shares of common stock, tranche A warrants (“Common Tranche A Warrants”) to acquire 31,110 shares of common stock, tranche B warrants (“Common Tranche B Warrants”, together with the Common Tranche A Warrants, the “Common Warrants”) to acquire 16,666 shares of common stock. On March 29, 2023, the Company closed the Common Offering. The aggregate exercise price of the Common Tranche A Warrants issued pursuant to the Common Offering is approximately $0.1 million. On August 14, 2023, the Company announced the receipt of the FDA Approval and all Common Tranche A Warrants were exercised and converted into 31,110 shares of common stock. The aggregate exercise price of the Common Tranche B Warrants issued in the Common Offering is approximately $0.1 million. The Common Tranche B Warrants are exercisable for an aggregate of 16,666 shares of common stock until the earlier of 21 days following the Company’s announcement of receipt of recording at least $10 million in quarterly U.S. revenue from the commercialization of HEPZATO and March 31, 2026. The Company determined that the outstanding Common Warrants should be liability-classified. See “Note 1 – Warrant Liabilities” for a discussion of the accounting treatment of the Common Warrants and Preferred Warrants. Registration Rights for Preferred and Common Offerings Pursuant to the Preferred Purchase Agreement and the Common Purchase Agreement (collectively, the “Purchase Agreements”), the Company filed a registration statement on Form S-3 (the “Resale Registration Statement”) providing for the resale by the investors party thereto of the common stock issuable upon conversion of the Registrable Shares (as defined in the Purchase Agreements). The Resale Registration Statement became effective on June 28, 2023. There is no established public trading market for the Series F Preferred Stock, the Preferred Warrants, or the Common Warrants and the Company does not intend to list such securities on any national securities exchange or nationally recognized trading system. At-the-Market Offering The Company has entered into a Controlled Equity Offering SM Sales Agreement (“ATM Sales Agreement”), with Cantor Fitzgerald & Co. (the “Sales Agent”), pursuant to which the Company may offer and sell, at its sole discretion through the Sales Agent, shares of common stock having an aggregate offering price of up to $17.0 million. To date, the Company has sold approximately $4.0 million of its common stock, prior to issuance costs, under the ATM Sales Agreement. No sales were made during the three and nine months ended September 30, 2023. Authorized Shares In June 2023, stockholders approved an amendment to the Company’s Amended and Restated Certificate of Incorporation to increase the total number of shares of its common stock authorized for issuance from 40 million shares to 80 million shares. The Company is authorized to issue 80 million shares of common stock, $0.01 par value, and 10 million shares of preferred stock, $0.01 par value. As of September 30, 2023, the Company has designated the following preferred stock: Designated Preferred Shares September 30, 2023 Series A 4,200 Series B 2,360 Series C 590 Series D 10,000 Series E 40,000 Series E-1 12,960 Series F-1 24,900 Series F-2 24,900 Series F-3 34,860 Series F-4 24,900 Total 179,670 Preferred Stock As of September 30, 2023, there were an aggregate of 11,257 shares of Series E and Series E-1, 4,903 Series F-2 and 21,627 Series F-3 Convertible Preferred Stock outstanding, respectively. Omnibus Equity Incentive Plan On September 30, 2020, the Company’s 2020 Omnibus Equity Incentive Plan (the “2020 Plan”) was adopted by the Company’s Board of Directors. On November 23, 2020, the Company’s stockholders approved the 2020 Plan. The 2020 Plan will continue in effect until the tenth anniversary of the date of its adoption by the Board or until earlier terminated by the Board. The 2020 Plan is administered by the Board of Directors or a committee designated by the Board of Directors. On June 12, 2023, the stockholders approved the amendment to the Company’s 2020 Plan to increase the number of shares of common stock available under the plan by 2.65 million shares. The 2020 Plan provides for the grant of incentive stock options, non-qualified stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards, performance awards, as well as other stock-based awards or cash awards that are deemed to be consistent with the purposes of the plan to Company employees, directors and consultants. As of September 30, 2023, there are 5,125,000 shares of common stock reserved under the 2020 Plan, of which 1,802,841 remained available to be issued. In addition to options granted from the 2020 Plan, the Company also grants employment inducement grants pursuant to Listing Rule 5635(c) of the corporate governance rules of the NASDAQ Stock Market. These inducement grants are intended to provide incentive to certain individuals to enter into employment with the Company. Inducement grants are Stock Options The following tables include information for all options granted including inducement grants that are granted outside of the 2020 Plan. The Company values stock options using the Black-Scholes option pricing model and used the following assumptions, on a weighted-average basis, during the reporting periods: Nine Months Ended September 30, 2023 2022 Expected terms (years) 5.7 5.4 Expected volatility 160.4% 164.3% Risk-free interest rate 3.99% 1.86% Expected dividends 0.00% 0.00% The following is a summary of stock option activity for the nine months ended September 30, 2023: Number of Options Weighted Average Weighted Average Aggregate Intrinsic Outstanding at January 1, 2023 2,235,052 $ 10.30 7.8 $ 35,875 Granted 2,122,757 6.08 9.1 Exercised (819) 4.67 Expired (115,772) 8.80 Cancelled/Forfeited (104,390) 7.22 Outstanding at September 30, 2023 4,136,828 $ 8.26 8.5 $ 72,850 Exercisable at September 30, 2023 2,020,026 $ 10.29 7.7 $ — The following table summarizes information for stock option shares outstanding and exercisable at September 30, 2023: Options Outstanding Range of Exercise Prices Outstanding Number of Weighted Average Number of Options $2.83 - $51.50 4,136,329 8.5 4,136,329 $51.50+ 499 5.3 499 4,136,828 8.5 4,136,828 The following is a summary of share-based compensation expense in the statement of operations for the three and nine months ended September 30, 2023: Three Months Ended September 30, Nine Months Ended September 30, (In thousands) 2023 2022 2023 2022 Selling, general and administrative $ 1,674 $ 1,117 $ 3,774 $ 3,984 Research and development 1,027 458 2,095 1,872 Cost of goods sold 129 52 283 160 Total $ 2,830 $ 1,627 $ 6,152 $ 6,016 At September 30, 2023, there was $7.7 million of aggregate unrecognized compensation expense related employee and board stock option grants. The cost is expected to be recognized over a weighted average period of 2.4 years. Common Stock Warrants The following is a summary of common stock warrant activity for the nine months ended September 30, 2023: Warrants Weighted Average Exercise Price Weighted Average Outstanding at January 1, 2023 5,153,291 $ 7.01 Warrants issued 81,848 2.94 Warrants exercised (569,938) 0.26 Outstanding at September 30, 2023 4,665,201 $ 7.76 1.9 Exercisable at September 30, 2023 4,665,201 $ 7.76 1.9 The following table presents information related to common stock warrants outstanding at September 30, 2023: Warrants Exercisable Range of Exercise Prices Outstanding Weighted Average Number of Warrants $0.01 1,037,792 3.4 1,037,792 $6.00 16,666 2.5 16,666 $10.00 3,610,743 1.4 3,610,743 4,665,201 1.9 4,665,201 As of September 30, 2023, there were 538,828 warrants priced at $0.01 and 31,110 warrants priced at $4.50 exercised for 569,938 common shares. Preferred Stock Warrants The following is a summary of preferred stock warrant activity for the nine months ended September 30, 2023: Warrants Weighted Average Exercise Price Weighted Average Outstanding at January 1, 2023 — $ — Warrants issued 59,759 1,000 Warrants exercised (34,859) 1,000 Outstanding at September 30, 2023 24,900 $ 1,000 2.5 Exercisable at September 30, 2023 24,900 $ 1,000 2.5 Employee Stock Purchase Plan In August 2021, the Company’s Board of Directors, with shareholder approval in May 2022, adopted the Employee Stock Purchase Plan (the “ESPP”). The ESPP provides for a maximum of 260,295 shares of common stock to be purchased by participating employees. Employees who elect to participate in the ESPP will be able to purchase common stock at the lower of 85% of the fair market value of common stock on the first or last day of the applicable six-month offering period. In January 2023, an aggregate of 15,417 shares were purchased by participating employees for the offering period of July 1, 2022 to December 31, 2022. In July 2023, an aggregate of 26,018 shares were purchased by participating employees for the offering period of January 1, 2023 to June 30, 2023. |