On November 14, 2025 Fortress Biotech, Inc. (Nasdaq: FBIO) ("Fortress"), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty income, reported financial results and recent corporate highlights for the third quarter ended September 30, 2025.

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Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, "Fortress has achieved several strategic milestones that reinforce the strength of our diversified business model and our continued ability to enhance shareholder value across our portfolio. The acquisition of two subsidiaries this year, Checkpoint Therapeutics, Inc. ("Checkpoint"), by Sun Pharma and Baergic Bio, Inc. ("Baergic") by Axsome Therapeutics ("Axsome"), are both strategic exits that represent validation of our approach. The sale of Checkpoint generated approximately $28 million in upfront consideration, with the potential for additional contingent value right (CVR) payments and future royalty income from sales of UNLOXCYT (cosibelimab-ipdl) to Fortress. We also anticipate the resubmission of the New Drug Application ("NDA") for CUTX-101, which, upon approval, may qualify for a Priority Review Voucher—further demonstrating the potential embedded value in our pipeline. Journey Medical Corporation ("Journey Medical") continues to deliver strong operational execution, highlighted by the successful launch of Emrosi and accelerating commercial performance, supported by expanded payer coverage and new pooled Phase 3 data analysis presented at Fall Clinical demonstrating Emrosi’s statistical and clinical superiority over Oracea and placebo for the treatment of rosacea. Additionally, our late-stage pipeline continues to progress meaningfully, with dotinurad advancing in two Phase 3 trials for the treatment of gout. The $205 million Series A financing announced by Crystalys Therapeutics, Inc. ("Crystalys") underscores the market’s confidence in dotinurad’s best-in-class potential for safety and efficacy. Urica Therapeutics’ ("Urica") strategic sale of dotinurad to Crystalys last year, in exchange for equity and a 3% royalty on future net sales, further positions Fortress to participate in long-term value creation. As we move forward, Fortress remains focused on disciplined execution, optimizing our capital allocation, and advancing high-impact assets that drive sustainable growth and deliver innovative treatments to patients worldwide."

Recent Corporate Highlights1:

Monetization Updates

● In November 2025, Avenue Therapeutics, Inc. ("Avenue") announced the acquisition of its subsidiary Baergic by Axsome. Under the terms of the purchase agreement, Baergic shareholders will receive a $0.3 million upfront payment (less transaction expenses) and are eligible to receive milestone payments of up to $2.5 million upon the occurrence of certain development and regulatory events for the first indication for AXS-17 (formerly known as BAER-101) and $1.5 million for each indication thereafter, up to $79 million in potential sales-based milestones, and a tiered mid-to-high single-digit royalty on potential global net sales of AXS-17. Avenue is eligible to receive ~74% of all future payments and royalties payable under the agreement. Avenue is a subsidiary of Fortress.
● In May 2025, Fortress’ subsidiary, Checkpoint, was acquired by Sun Pharmaceutical Industries, Inc. (together with its subsidiaries and/or associated companies, "Sun Pharma"). Checkpoint was acquired for an aggregate upfront payment totaling ~$355 million and ~$60 million payable in a CVR, of which Fortress received approximately $28 million upfront, with the potential for an additional CVR payment of up to $4.8 million and a 2.5% royalty on future net sales of UNLOXCYT (cosibelimab-ipdl) to Fortress.

Clinical Updates

● In October 2025, the first patients were dosed in two randomized, double-blind, multicenter global Phase 3 trials evaluating dotinurad, a next-generation, once daily oral, URAT1 inhibitor with potential for best-in-class safety and efficacy for the treatment of gout.
● Also in October 2025, we presented efficacy data from a pooled analysis of the two Phase 3 multicenter, randomized, double-blind, parallel-group, active-comparator and placebo-controlled clinical trials, Minocycline Versus Oracea in Rosacea-1 and Minocycline Versus Oracea in Rosacea-2, evaluating DFD-29 (40 mg Minocycline Hydrochloride Modified-Release Capsules, 10 mg immediate release and 30 mg extended release) (or "Emrosi") for the treatment of inflammatory lesions of rosacea in adults, at the 2025 Fall Clinical Dermatology Conference. DFD-29 demonstrated superior efficacy in Investigator’s Global Assessment ("IGA") treatment success rates and inflammatory lesion counts versus both placebo and doxycycline (P<0.001 for all comparisons).
● In July 2025, AstraZeneca announced that anselamimab (formerly known as CAEL-101) did not achieve statistical significance for the primary endpoint in its Phase III Cardiac Amyloid Reaching for Extended Survival ("CARES") clinical program for Mayo stages IIIa and IIIb AL amyloidosis patients. However, the drug showed clinically meaningful improvement in a prespecified subgroup and was well tolerated. AstraZeneca indicated that the company plans to submit the prespecified subgroup analysis from the CARES trials with regulatory authorities.

Regulatory Updates

● In December 2023, we completed the asset transfer of CUTX-101 to Sentynl Therapeutics ("Sentynl"), a wholly owned subsidiary of Zydus Lifesciences Ltd. Pursuant to the transaction with Sentynl, Sentynl will transfer to Cyprium, if issued upon approval, a Rare Pediatric Disease Priority Review Voucher ("PRV"), and Cyprium will also be eligible to receive royalties on net sales of CUTX-101 and up to $129 million in aggregate development and sales milestones from Sentynl. On September 30, 2025, the FDA issued a Complete Response Letter ("CRL") relating to the NDA for CUTX-101 (copper histidinate), intended to treat Menkes disease in pediatric patients. The CRL noted cGMP deficiencies had been observed at the facility where CUTX-101 is manufactured, and Sentynl expects to resubmit the CUTX-101 NDA shortly. The CRL did not cite any other approvability concerns, nor did it identify any deficiencies in CUTX-101’s efficacy and safety data.

● In July 2025, the FDA granted Orphan Drug Designation to Mustang Bio, Inc. ("Mustang Bio") for MB-101 (IL13Ra2-targeted CAR T-cells) for the treatment of recurrent diffuse and anaplastic astrocytoma and glioblastoma. MB-101 received Orphan Drug Designation on time and with a designation that is broader than the indication proposed. We intend to advance MB-101, in combination with MB-108, as a potential treatment option. Our novel therapeutic strategy, combining our MB-101 CAR-T cell therapy with our MB-108 oncolytic virus, leverages MB-108 to reshape the tumor microenvironment ("TME") to make cold tumors "hot," thereby potentially improving the efficacy of MB-101 CAR-T cell therapy.

Commercial Product Updates

● Journey Medical’s net product revenues for the third quarter ended September 30, 2025, were $17.0 million, compared to net product revenues of $14.6 million for the third quarter ended September 30, 2024.
● In July 2025, Journey Medical announced expanded payer access with over 100 million commercial lives in the United States for Emrosi (40mg Minocycline Hydrochloride Modified-Release Capsules, 10mg immediate release and 30mg extended release), the Company’s recently launched treatment for the inflammatory lesions of rosacea in adults. This compares to 54 million commercial lives in May 2025.

General Corporate:

● In the third quarter of 2025, Crystalys, in which Urica Therapeutics, Inc. ("Urica") maintains an equity position, announced a $205 million Series A financing to support the advancement of global Phase 3 clinical studies evaluating dotinurad for the treatment of gout. In addition, Urica is eligible to receive a 3% royalty on future net sales of dotinurad. Urica is a majority-owned and controlled subsidiary of Fortress.

Financial Results:

● As of September 30, 2025, Fortress’ consolidated cash and cash equivalents totaled $86.2 million, compared to $57.3 million as of December 31, 2024, an increase of $28.9 million year-to-date.
● Fortress’ consolidated cash and cash equivalents, totaling $86.2 million as of September 30, 2025, includes $38.6 million attributable to Fortress and the private subsidiaries, $3.7 million attributable to Avenue, $19.0 million attributable to Mustang Bio and $24.9 million attributable to Journey Medical.
o Fortress’ consolidated cash and cash equivalents totaled $57.3 million as of December 31, 2024, and included $20.9 million attributable to Fortress and private subsidiaries, $2.6 million attributable to Avenue, $6.6 million attributable to Checkpoint, $6.8 million attributable to Mustang Bio and $20.3 million attributable to Journey Medical. Checkpoint was acquired by Sun Pharma in May 2025.
● Fortress’ consolidated net revenue totaled $17.6 million for the third quarter ended September 30, 2025, $17.0 million of which was generated from our marketed dermatology products. This compares to consolidated net revenue totaling $14.6 million for the third quarter of 2024, all of which was generated from our marketed dermatology products.
● Consolidated research and development expenses totaled $0.2 million for the third quarter ended September 30, 2025, compared to $9.4 million for the third quarter ended September 30, 2024.
● Consolidated selling, general and administrative costs were $17.4 million for the third quarter ended September 30, 2025, compared to $22.0 million for the third quarter ended September 30, 2024.
● Consolidated net income attributable to common stockholders was $3.7 million, or $0.13 per share basic, and $0.11 per share diluted, for the third quarter ended September 30, 2025, compared to net loss attributable to common stockholders of $(15.0) million, or $(0.76) per share basic and diluted, for the third quarter ended September 30, 2024.

(Press release, Fortress Biotech, NOV 14, 2025, View Source [SID1234659968])