Annual report [Section 13 and 15(d), not S-K Item 405]

Subsequent Events

v3.26.1
Subsequent Events
12 Months Ended
Dec. 31, 2025
Subsequent Events  
Subsequent Events

20. Subsequent Events

CUTX-101 Product Approval, PRV Sale, and Cyprium PPS Redemption - Cyprium

On January 13, 2026, the FDA approved ZYCUBO (formerly known as CUTX-101) for the treatment of Menkes disease in pediatric patients. A PRV was issued in connection with the FDA approval and was transferred to Cyprium (see Note 3).

On February 22, 2026, Cyprium entered into a definitive asset purchase agreement to sell its PRV (the “PRV APA”) for gross proceeds of $205 million upon the closing of the transaction.  Cyprium is obligated to pay 20% of the PRV APA proceeds to the Eunice Kennedy Shriver National Institute of Child Health and Human Development, an institute of the National Institutes of Health. The PRV APA contains customary representations, warranties, covenants and indemnification provisions, in each case subject to certain limitations.

On March 30, 2026, the Company and Cyprium announced the closing of the PRV APA transaction. The Company is currently evaluating the tax effect of the sale and whether it will be able to realize any of its net operating loss carryforwards. In connection with the PRV APA, the Cyprium PPS was automatically redeemed in accordance with its terms for an amount equal to twice the $25.00 liquidation preference, pursuant to the terms of the Cyprium PPS, plus accumulated and unpaid dividends to, but excluding, the redemption date.

New York, NY Sublease - Fortress

On February 10, 2026, the Company entered into a sublease agreement for all of its leased square footage, approximately 23,000 square feet, of its New York, NY office leased by the Company pursuant to a lease between the Company and Sage Realty Corporation (“Landlord”).  The sublease, subject to Landlord approval, will commence on April 1, 2026, and expires on August 31, 2031.  The Company will receive approximately $11.8 million in base rent payments over the term of the sublease.

ATX-04 License from Duke University – Avenue

On February 18, 2026, Avenue entered into a license agreement with Duke University (“Duke”), whereby Avenue obtained an exclusive worldwide license (the "ATX-04 License") from Duke to certain patents and know-how pertaining to clenbuterol for the treatment of lysosomal storage diseases. ATX-04 is a selective β2-adrenergic agonist with human proof-of-concept data demonstrating improved muscle function and enhanced response to enzyme replacement therapy. Under the ATX-04 License, Avenue agreed to make an upfront payment and reimburse certain patent expenses to Duke and has an obligation to make development, regulatory, and commercial milestone payments upon the achievement of certain milestones. In addition, Avenue is obligated to pay a tiered low single-digit royalty on future net sales of ATX-04. Avenue intends to advance ATX-04 through a late-stage clinical development program leveraging existing human safety and efficacy data, with an initial focus on treating Pompe disease as an adjunct to enzyme replacement therapy.

Second Amendment to the 2024 Oaktree Agreement – Fortress

On February 22, 2026, the Company, as borrower, entered into the Second Amendment to the 2024 Oaktree Agreement (the “Second Amendment”). Pursuant to the terms of the Second Amendment, certain financial covenants were amended such that in the event that the outstanding principal balance under the 2024 Oaktree Agreement is less than or equal to $15.0 million and the Company receives the distribution of proceeds from Cyprium following the closing of the sale of the PRV by Cyprium pursuant to the PRV APA (the “2026 Cyprium Monetization Event”), the minimum liquidity required will be $2.0 million (the “Minimum Liquidity Amount”), the Minimum Net Sales Covenant (whereby the product net sales of JMC must meet a consolidated minimum net sales amount on a trailing twelve-month basis, tested quarterly, as defined in the 2024 Oaktree Agreement) will no longer apply, the Capital Raise Covenant (whereby the Company must have received certain minimum amounts through capital raises or monetizations in each year, as defined in the New Oaktree Agreement) will no longer apply, and the Minimum JMC Stake Covenant (whereby the Company must maintain certain levels of ownership in JMC, as defined in the New Oaktree Agreement) will no longer apply.

Each of the above-described covenants, namely, the Minimum Liquidity Amount, the Minimum Net Sales Covenant, the Capital Raise Covenant and the Minimum JMC Stake Covenant will no longer apply in the event the outstanding principal balance under the 2024 Oaktree Agreement is less than or equal to $10.0 million. Failure by the Company to comply with the financial covenants will result in an event of default, subject to certain cure rights of the Company with respect to the described covenants.

In addition, the Second Amendment also obligates the Company to cause Cyprium to repay any amounts that the Company advanced to Cyprium pursuant to the Second Amended and Restated Future Advance Promissory Note issued by Cyprium in favor of the Company in connection with a 2026 Cyprium Monetization Event and to make a mandatory prepayment of the amount owed under the New Oaktree Agreement in an aggregate principal amount of $10.0 million (the “Cyprium Monetization Prepayment”), together with accrued interest and the Yield Protection Premium (as defined in the New Oaktree Agreement) subject to applicable fees and conditions as described in the New Oaktree Agreement. 

On March 30, 2026, the Company made aggregate prepayments on the loan under the New Oaktree Agreement, including the Cyprium Monetization Prepayment, that reduced the outstanding principal balance to $15.0 million.