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. Securities Purchase Agreement On March 14, 2024, the Company and certain accredited investors (each an “Investor” and collectively, the “Investors”) entered into a securities purchase agreement (the “Securities Purchase Agreement”) pursuant to which the Company agreed to sell and issue to the Investors in a private placement (the “Private Placement”) (i) an aggregate of 876,627 shares of the Company’s common stock, par value $0.01 per share, at a purchase price of $3.72 per share, and (ii) to certain investors, in lieu of shares of common stock, 1,008,102 pre-funded warrants (the “Pre-Funded Warrants”) at a price per Pre-Funded Warrant of $3.71 (the “Warrant Shares” and together with the Shares, the “Securities”). The Pre-Funded Warrants will have an exercise price of $0.01 per share of common stock, be immediately exercisable and remain exercisable until exercised in full. The Private Placement closed on March 19, 2024. The Company received gross proceeds of approximately $7.0 million, before deducting offering expenses payable by the Company. 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 “June 2023 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 June 2023 Resale Registration Statement became effective on June 28, 2023. Pursuant to the Securities Purchase Agreement, the Company filed a registration statement on Form S-3 (the “April 2024 Resale Registration Statement”) providing for the resale of the common stock and common stock issuable upon the exercise of the Pre-Funded Warrants. The April 2024 Resale Registration Statement also provided for the common stock issued upon the exercise of pre-funded warrants to purchase common stock issued by the Company pursuant to the Avenue Amendment. The registration became effective on May 9, 2024. There is no established public trading market for the Series F Preferred Stock, the Preferred Warrants, Common Warrants or the Pre-Funded 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 months ended March 31, 2024. Authorized 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 March 31, 2024, the Company has designated the following preferred stock: Designated Preferred Shares March 31, 2024 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 March 31, 2024, there were an aggregate of 11,257 shares of Series E and Series E-1, 2,542 Series F-2 and 3,010 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. 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 March 31, 2024, there have been 5,125,000 shares of common stock reserved under the 2020 Plan, of which 232,566 remained available to be issued. In addition to options granted from the 2020 Plan, the Company also grants employment inducement awards pursuant to Listing Rule 5635(c)(4) of the corporate governance rules of the NASDAQ Stock Market. The inducement grants are intended to provide incentive to certain individuals to enter into employment with the Company. Prior to December 5, 2023, the inducement awards were granted outside of the 2020 Plan, however they are governed in all respects as if they were issued under the 2020 Plan. These grants do not reduce the number of options available for issuance under the 2020 Plan. On December 5, 2023, the Company’s 2023 Inducement Plan (the “2023 Plan”) was adopted by the Company’s Board of Directors. The 2023 Plan is administered by a Compensation Committee of two or more Independent Directors appointed by the Board of Directors and is intended to provide for the grant of 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 appropriate to incentivize employment with the Company. Awards from the 2023 Plan can only be granted to individuals who have not previously worked for the Company or have not worked for the Company for a bona fide period of time. As of March 31, 2024, there have been 650,000 shares of common stock reserved under the 2023 Plan, of which 372,000 remain available to be granted. 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: Three Months Ended March 31, 2024 2023 Expected terms (years) 5.6 5.8 Expected volatility 115.0% 172.8% Risk-free interest rate 4.19% 4.08% Expected dividends 0.00% 0.00% The following is a summary of stock option activity for the three months ended March 31, 2024: Number of Options Weighted Average Weighted Average Grant Date Fair Value Per Share Weighted Average Aggregate Intrinsic Outstanding at January 1, 2024 4,183,232 $ 8.17 $ 7.60 8.3 $ 147 Granted 2,017,596 4.80 3.92 9.7 Exercised — — — — Expired (15,341) 7.16 6.91 Cancelled/Forfeited (146,312) 6.08 5.75 Outstanding at March 31, 2024 6,039,175 $ 7.10 $ 6.42 8.6 $ 433 Exercisable at March 31, 2024 2,569,497 $ 9.47 $ 8.73 7.4 $ 74 Unvested at March 31, 2024 3,469,678 $ 5.34 $ 4.70 9.4 $ 358 The following table summarizes information for stock option shares outstanding and exercisable at March 31, 2024: Options Outstanding Range of Exercise Prices Outstanding Number of Weighted Average Number of Options $2.83 - $51.50 6,038,676 8.6 6,038,676 $51.50+ 499 4.8 499 6,039,175 8.6 6,039,175 The following is a summary of share-based compensation expense in the statement of operations for the three months ended March 31, 2024: Three Months Ended March 31, (In thousands) 2024 2023 Selling, general and administrative $ 2,042 $ 1,118 Research and development 647 417 Cost of goods sold 256 126 Total $ 2,945 $ 1,661 At March 31, 2024, there was $10.3 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 1.2 years. Common Stock Warrants The following is a summary of common stock warrant activity for the three months ended March 31, 2024: Warrants Weighted Average Exercise Price Weighted Average Outstanding at January 1, 2024 4,665,201 $ 7.76 1.6 Warrants issued 1,008,102 0.01 5.0 Warrants exercised — — Outstanding at March 31, 2024 5,673,303 2.0 Exercisable at March 31, 2024 5,673,303 $ 6.39 2.0 The following table presents information related to common stock warrants outstanding at March 31, 2024: Warrants Exercisable Range of Exercise Prices Outstanding Weighted Average Number of Warrants $0.01 2,045,894 4.0 2,045,894 $6.00 16,666 2.0 16,666 $10.00 3,610,743 1.0 3,610,743 5,673,303 2.0 5,673,303 As of March 31, 2024, there were no warrants exercised for common shares. Preferred Stock Warrants The following is a summary of preferred stock warrant activity for the three months ended March 31, 2024: Warrants Weighted Average Exercise Price Weighted Average Outstanding at January 1, 2024 24,900 $ 1,000 2.3 Warrants issued — Warrants exercised — Outstanding at March 31, 2024 24,900 $ 1,000 2.0 Exercisable at March 31, 2024 24,900 $ 1,000 2.0 Employee Stock Purchase Plan |