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Stockholders' Equity | 12 Months Ended
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Dec. 31, 2023
Stockholders' Equity Note [Abstract] |
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. 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 year ended December 31, 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 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 December 31, 2023, the Company has designated the following preferred stock:
Designated Preferred Shares |  | December 31, 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 December 31, 2023, there were an aggregate of 11,257 shares of Series E and Series E-1, 2,542 Series F-2 and 11,020 Series F-3 Convertible Preferred Stock outstanding, respectively. Equity Incentive Plans 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 December 31, 2023, there are 5,123,742 shares of common stock reserved under the 2020 Plan for future issuance, of which 1,837,509 remained available to be granted. 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 December 31, 2023, there are 650,000 shares of common stock reserved under the 2023 Plan, of which 623,000 remain available to be granted. Stock Options The following table sets forth information as of December 31, 2023 with respect to compensation plans (including individual compensation arrangements) under which shares of common stock of the Company are authorized for issuance.
Plan category |  | Number of securities to be issued upon exercise of outstanding options, warrants and rights (a) |  | Weighted-average exercise price of outstanding options, warrants and rights (b) |  | Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a)) (c)
Equity compensation plans approved by security holders |  | 3,286,233 |  | $ | 7.69 |  |  | 1,837,509
Equity compensation plans not approved by security holders (1) |  | 896,999 |  | $ | 9.93 |  |  | 623,000
Total |  | 4,183,232 |  | $ | 8.17 |  |  | 2,460,509
(1)Includes (a) stock options for an aggregate of 499 shares of common stock issued under the Company’s 2019 Equity Incentive Plan, which allows for grants in the form of incentive stock options, non-qualified stock options, stock units, stock awards, stock appreciation rights, and other stock-based awards to the Company’s officers, directors, employees, consultants, and advisors, including options to purchase shares of common stock at exercise prices not less than 100% of fair value on the dates of grant. As of November 2, 2020, no additional grants may be made under this plan, which has been superseded by the Company’s 2020 Omnibus Equity Incentive Plan; however, outstanding awards granted under this plan will remain outstanding and continue to be administered in accordance with the terms of this plan and the applicable award agreements; (b) pursuant to an employment agreement dated as of August 31, 2020 between the Company and Gerard Michel, the Company’s Chief Executive Officer, on October 1, 2020, a non-qualified and non-plan stock option “inducement award” to purchase 498,000 shares of the Company’s common stock in reliance on Nasdaq Rule 5635(c)(4) pursuant to the terms of a stock option award agreement between the Company and Mr. Michel; and (c) new hire inducement awards to purchase 398,500 shares of the Company’s common stock in reliance on Nasdaq Rule 5635(c)(4) pursuant to the terms of a stock option award agreement between the Company and 12 employees hired during 2022 and 2023. 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 during the reporting periods:
| Years Ended December 31
| 2023 |  | 2022
Expected terms (years) | 0.8 - 5.9 |  | 0.7 - 8.4
Expected volatility | 96.4% -172.8% |  | 166.4.% - 180.3%
Risk-free interest rate | 3.9% - 5.4% |  | 1.2% - 4.4%
Expected dividends | 0.00% |  | 0.00%
The weighted average estimated fair value of the stock options granted during the years ended December 31, 2023 and 2022 was approximately $5.62 and $6.05 per share, respectively. The following is a summary of stock option activity for the year ended December 31, 2023:
| Number of Options |  | Weighted Average Exercise Price Per Share |  | Weighted Average Grant Date Fair Value Per Share |  | Weighted Average Remaining Contractual Term (in years) |  | Aggregate Intrinsic Value
Outstanding at January 1, 2023 | 2,235,052 |  | $ | 10.30 |  |  | $ | 9.40 |  |  | 7.7 |  | $ | 36 |
Granted | 2,218,757 |  | 5.97 |  |  | 5.62 |  |  | 9.1 |  |
Exercised | (819) |  | 4.67 |  |  | 4.51 |  |  |  |  | $ | 1 |
Expired | (141,059) |  | 8.40 |  |  | 5.76 |  |  |  |  |
Cancelled/Forfeited | (128,699) |  | 7.02 |  |  | 6.74 |  |  |  |  |
Outstanding at December 31, 2023 | 4,183,232 |  | $ | 8.17 |  |  | $ | 7.60 |  |  | 8.3 |  | $ | 147 |
Exercisable at December 31, 2023 | 2,252,556 |  | $ | 9.93 |  |  | $ | 9.15 |  |  | 7.6 |  | $ | 24 |
Unvested at December 31, 2023 | 1,930,676 |  | $ | 6.12 |  |  | $ | 5.79 |  |  | 9.1 |  | $ | 123 |
The following table summarizes information for stock option shares outstanding and exercisable at December 31, 2023:
|  |  |  | Options Exercisable
Range of Exercise Prices |  | Outstanding Number of Options |  | Weighted Average Remaining Option Term (in years) |  | Number of Options
2.83 - $51.50 |  | 4,182,733 |  | 8.3 |  | 2,252,057
51.50+ |  | 499 |  | 5.1 |  | 499
|  | 4,183,232 |  | 8.3 |  | 2,252,556
The following is a summary of the share-based compensation expense in the statement of operations for the twelve months ended December 31, 2023:
| Years Ended December 31,
| 2023 |  | 2022
Selling, general and administrative | $ | 4,944 |  |  | $ | 5,282 |
Research and development | 2,837 |  |  | 2,449 |
Cost of goods sold | 370 |  |  | 210 |
Total | $ | 8,151 |  |  | $ | 7,941 |
At December 31, 2023, there was approximately $5.9 million of aggregate unrecognized compensation expense related to employee, consultant and Non-employee Director stock option grants. The Company does not estimate forfeitures and only recognizes forfeitures as they occur. The cost is expected to be recognized over a weighted average period of 2.1 years. 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 of which 41,435 have been issued as of December 31, 2023 since the inception of the benefit in 2021. 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 2024, an aggregate 21,140 shares were purchased by participating employees for the offering period of July 3, 2023 to December 29, 2023. Common Stock Warrants The following is a summary of common stock warrant activity for the year ended December 31, 2023:
| Warrants |  | Weighted Average Exercise Price |  | Weighted Average Remaining Life (in years)
Outstanding at January 1, 2023 | 5,153,291 |  | $ | 7.01 |  |  |
Warrants issued | 81,848 |  | 2.94 |  |  |
Warrants exercised | (569,938) |  |  | $ | 0.26 |  |  |
Outstanding at December 31, 2023 | 4,665,201 |  | $ | 7.76 |  |  | 1.6
Exercisable at December 31, 2023 | 4,665,201 |  | $ | 7.76 |  |  | 1.6
The following table presents information related to stock warrants at December 31, 2023:
|  |  |  | Warrants Exercisable
Range of Exercise Prices |  | Outstanding Number of Warrants |  | Weighted Average Remaining Warrant Term (in years) |  | Number of Warrants
$0.01 |  | 1,037,792 |  | 3.2 |  | 1,037,792
$6.00 |  | 16,666 |  | 2.2 |  | 16,666
$10.00 |  | 3,610,743 |  | 1.2 |  | 3,610,743
|  | 4,665,201 |  | 1.6 |  | 4,665,201
Preferred Stock Warrants The following is a summary of preferred stock warrant activity for the year ended December 31, 2023:
| Warrants |  | Weighted Average Exercise Price |  | Weighted Average Remaining Life (in years)
Outstanding at January 1, 2023 | — |  | $ | — |  |  |
Warrants issued | 59,759 |  | 1,000.00 |  |  |
Warrants exercised | (34,859) |  |  | $ | 1,000.00 |  |  |
Outstanding at December 31, 2023 | 24,900 |  | $ | 1,000.00 |  |  | 2.3
Exercisable at December 31, 2023 | 24,900 |  | $ | 1,000.00 |  |  | 2.3

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