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Stockholders' Equity
 9 Months Ended
Sep. 30, 2024
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 the HEPZATO KIT and March 31, 2026.
During the quarter ending September 30, 2024, we recorded at least $10 million in quarterly U.S. revenue from the commercialization of the HEPZATO KIT, which was announced by the Company on October 17, 2024, triggering the 21 day exercise period for the Common Tranche B Warrants. All 16,666 Common Tranche B Warrants were exercised prior to the November 6, 2024 expiration date which resulted in $0.1 million of cash proceeds to the Company.
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”) with an exercise price of $0.01. As of September 30, 2024 the Pre-Funded Warrants have been 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.
June 2024 Shelf Registration Statement
On June 28, 2024, the Company filed a universal shelf registration statement on Form S-3 (the “June 2024 Shelf Registration Statement”) with the SEC, pursuant to which the Company may offer, issue and sell any combination of shares of the Company’s common stock, par value $0.01 per share, shares of the Company’s preferred stock, par value $0.01 per share, debt securities, warrants to purchase common stock, preferred stock and/or debt securities, in one or more series, and units consisting of any combination of the other types of securities registered under such June 2024 Shelf Registration Statement in an aggregate amount of up to $150 million, in each case, to the public in one or more registered offerings. The June 2024 Shelf Registration Statement was declared effective on August 5, 2024.
At-the-Market Offering
The Company previously entered into a Controlled Equity OfferingSM 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 its common stock from time to time. Pursuant to a prospectus supplement (the “ATM Prospectus Supplement”), filed with the SEC on February 27, 2023, the Company could sell shares of common stock under the ATM Sales Agreement up to an aggregate of $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 or nine months ended September 30, 2024.
The registration statement the ATM Prospectus Supplement was part of, expired on July 1, 2024 and the Company can no longer make sales under the ATM Prospectus Supplement.
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 September 30, 2024, the Company has designated the following preferred stock:

Designated Preferred SharesSeptember 30, 2024
Series A4,200 
Series B2,360 
Series C590 
Series D10,000 
Series E 40,000 
Series E-112,960 
Series F-1 24,900 
Series F-224,900 
Series F-334,860 
Series F-424,900 
Total179,670 
Preferred Stock
As of September 30, 2024, there were an aggregate of 11,257 shares of Series E and Series E-1, 1,085 Series F-2 and no shares of Series F-3 or Series F-4 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 September 30, 2024, there have been 7,125,000 shares of common stock reserved under the 2020 Plan, which includes an additional 2,000,000 shares approved by shareholders on May 23, 2024 and registered on a Form S-8 registration statement, filed with the SEC on June 28, 2024, of which 2,232,925 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 September 30, 2024, there have been 650,000 shares of common stock reserved under the 2023 Plan, of which 285,000 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:
 Nine Months Ended September 30,
 20242023
Expected terms (years)5.65.7
Expected volatility114.0%160.4%
Risk-free interest rate4.20%3.99%
Expected dividends0.00%0.00%
The following is a summary of stock option activity for the nine months ended September 30, 2024:
Number of Options Weighted Average
Exercise Price Per Share		Weighted Average Grant Date Fair Value Per ShareWeighted Average
Remaining
Contractual Term
(in years)		Aggregate Intrinsic
Value
(in thousands)
Outstanding at January 1, 20244,183,232$8.17 $7.60 8.3$147 
Granted2,282,0965.17 4.228.9
Exercised(70,088)5.19 3.72 221 
Expired(56,910)8.05 7.73
Cancelled/Forfeited(282,602)5.73 5.29
Outstanding at September 30, 20246,055,728$7.19 $6.47 7.6$15,453 
Exercisable at September 30, 20243,373,334$8.59 $7.78 6.5$5,692 
Unvested at September 30, 20242,682,394 $5.42 $4.83 9.1$9,761 
The following table summarizes information for stock option shares outstanding and exercisable at September 30, 2024:
Options Outstanding
Range of Exercise PricesOutstanding Number of
Options		Weighted Average
Remaining Option Term
(in years)
$2.83 - $51.50
6,055,2297.6
$51.50+
4991.2
6,055,7287.6
The following is a summary of share-based compensation expense in the statement of operations:
Three Months Ended September 30,Nine Months Ended September 30,
(In thousands)2024202320242023
Selling, general and administrative$1,530 $1,674 $5,502 $3,774 
Research and development411 1,027 1,954 2,095 
Cost of goods sold200 129 699 283 
Total$2,141 $2,830 $8,155 $6,152 
At September 30, 2024, there was $6.3 million of aggregate unrecognized compensation expense related to employee and board stock option grants. The cost is expected to be recognized over a weighted average period of one year.
Common Stock Warrants
The following is a summary of common stock warrant activity for the nine months ended September 30, 2024:
 Warrants
Weighted Average Exercise Price
Weighted Average
Remaining Life
(in years)
Outstanding at January 1, 20244,665,201$7.76 1.6
Warrants issued1
1,008,1020.01 
Warrants exercised(1,308,473)0.01 
Outstanding and exercisable at September 30, 20244,364,830$8.30 0.8
1All warrants issued in 2024 have been exercised and therefore have no remaining life.
The following table presents information related to common stock warrants outstanding at September 30, 2024:
Warrants Exercisable
Range of Exercise PricesOutstanding
Number of
Warrants		Weighted Average
Remaining Warrant Term
(in years)		Number of Warrants
$0.01737,4212.8737,421
$6.00
16,6660.216,666
$10.003,610,7430.43,610,743
4,364,8300.84,364,830
Preferred Stock Warrants
The following is a summary of preferred stock warrant activity for the nine months ended September 30, 2024:
WarrantsWeighted Average Exercise PriceWeighted Average
Remaining Life
(in years)
Outstanding at January 1, 202424,900 $1,000 2.3
Warrants issued— 
Warrants exercised(250)1,000 
Outstanding and exercisable at September 30, 202424,650$1,000 0.2
As of November 5, 2024, all 24,900 Tranche B Warrants were exercised by the November 6, 2024 expiration date which resulted in $24.9 million of cash proceeds to the Company.
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 112,993 have been issued as of September 30, 2024 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.