Fortress Biotech Reports 2024 Financial Results and Recent Corporate Highlights

Emrosi$(TM)$ approved by FDA for the treatment of inflammatory lesions of rosacea in adults, with commercial launch underway; initial distribution ongoing and first prescriptions filled

Fortress subsidiary Checkpoint Therapeutics to be acquired by Sun Pharma; Checkpoint's lead product, UNLOXCYT(TM), approved by FDA for the treatment of metastatic or locally advanced cutaneous squamous cell carcinoma

FDA accepted New Drug Application filing for priority review for CUTX-101 to treat Menkes disease; PDUFA goal date of September 30, 2025

MIAMI, March 31, 2025 (GLOBE NEWSWIRE) -- 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 revenue, today announced financial results and recent corporate highlights for the full-year ended December 31, 2024.

Lindsay A. Rosenwald, M.D., Fortress' Chairman, President and Chief Executive Officer, said, "The fourth quarter of 2024 was transformational for Fortress, marked by two FDA approvals -- Emrosi(TM) and UNLOXCYT(TM) -- as well as the FDAs' recent acceptance of the New Drug Application for CUTX-101. Additionally, we congratulate Fortress-founded partner company, Checkpoint Therapeutics, Inc. ("Checkpoint"), as earlier this month they signed an exciting agreement that delivers FDA approved UNLOXCYT into the capable and established global commercial organization at Sun Pharma, which is expected to expedite patient access. This transaction is also a successful milestone for Fortress as we expect to receive approximately $28 million at closing in addition to a 2.5% royalty on net sales of UNLOXCYT, and up to an additional $4.8 million if the contingent value right $(CVR)$ is achieved. These milestones continue to validate the Fortress business model. We aim to acquire and advance assets to their full potential, in this specific case, with an exit strategy that benefits patients and maximizes value for our shareholders."

Dr. Rosenwald continued, "Looking ahead, we are focused on our next key milestone: the September 30, 2025, Prescription Drug User Fee Act ("PDUFA") goal date for CUTX-101. Upon approval of the New Drug Application, our majority-owned subsidiary, Cyprium Therapeutics, may be eligible for a Priority Review Voucher. The commercial launch of Emrosi for inflammatory lesions of rosacea is underway with first prescriptions filled, and we expect continued revenue growth, portfolio milestone achievements and additional future monetization opportunities given our significant pipeline of late clinical-stage candidates and recently approved products. This is an exciting time for Fortress, and we remain committed to building shareholder value while delivering innovative treatment options to patients with unmet medical needs."

Recent Corporate Highlights(1) :

Monetization Updates

   -- In March 2025, our subsidiary Checkpoint entered into an agreement to be 
      acquired by Sun Pharmaceutical Industries Limited (together with its 
      subsidiaries and/or associated companies, "Sun Pharma"). Fortress owns 
      approximately 6.9 million shares (including Class A Common on an 
      as-converted basis) of Checkpoint's common stock and is eligible for a 
      2.5% royalty on future sales of UNLOXCYT (cosibelimab-ipdl), pursuant to 
      a royalty agreement between Checkpoint, Sun Pharma and Fortress. Upon 
      completion of the transaction, Sun Pharma will acquire all outstanding 
      shares of Checkpoint and Checkpoint stockholders will receive, for each 
      share of common stock they hold, an upfront cash payment of $4.10, 
      without interest, and a non-transferable contingent value right $(CVR.AU)$ 
      entitling the stockholder to receive up to an additional $0.70 in cash if 
      cosibelimab is approved prior to certain deadlines in the European Union 
      pursuant to the centralized approval procedure or in Germany, France, 
      Italy, Spain or the United Kingdom, subject to the terms and conditions 
      in the contingent value rights agreement. The transaction is expected to 
      be completed in the second quarter of 2025. The transaction is subject to 
      customary closing conditions, including required regulatory approvals and 
      approval by the holders of a majority of the voting power of outstanding 
      shares of Checkpoint common stock, and by the holders of a majority of 
      the shares of Checkpoint common stock that are not held by Fortress or by 
      certain other affiliates of Checkpoint. In connection with the 
      transaction, Fortress, which holds a majority of Checkpoint's outstanding 
      voting power, has agreed to vote in favor of the transaction. 
 
   -- In July 2024, our majority-owned and controlled subsidiary company Urica 
      Therapeutics ("Urica"), entered into an asset purchase agreement, royalty 
      agreement and related agreements with Crystalys Therapeutics 
      ("Crystalys"). Urica transferred rights to dotinurad, its URAT1 inhibitor 
      product candidate in development for the treatment of gout, and related 
      intellectual property, licenses and agreements to Crystalys. In return, 
      Crystalys issued to Urica shares of its common stock equal to 35% of 
      Crystalys' outstanding equity and granted Urica a secured 3% royalty on 
      future net sales of dotinurad. 

Regulatory Updates

   -- In November 2024, the U.S. Food and Drug Administration ("FDA") approved 
      Emrosi (Minocycline Hydrochloride Extended-Release Capsules, 40mg), also 
      known as DFD-29. Emrosi has the potential to be the new treatment 
      paradigm for the millions of patients suffering from inflammatory lesions 
      of rosacea. In February 2025, we hosted a webcast to discuss the U.S. 
      commercial launch plan for Emrosi, and in March 2025, we announced the 
      launch of Emrosi by our partner company, Journey Medical Corporation 
      ("Journey Medical") (Nasdaq: DERM). 
 
   -- In December 2024, the FDA approved UNLOXCYT, also known as cosibelimab, 
      our anti-PD-L1 antibody, as a treatment for patients with metastatic or 
      locally advanced cutaneous squamous cell carcinoma ("cSCC") who are not 
      candidates for curative surgery or radiation. UNLOXCYT was developed at 
      our partner company, Checkpoint (Nasdaq: CKPT). 
 
   -- The FDA recently accepted the New Drug Application ("NDA") submission for 
      CUTX-101 (copper histidinate for Menkes disease) for priority review with 
      a PDUFA goal date of September 30, 2025. In December 2023, we completed 
      the asset transfer of CUTX-101 to Sentynl Therapeutics ("Sentynl"), a 
      wholly owned subsidiary of Zydus Lifesciences Ltd. Sentynl completed the 
      rolling submission of the NDA for CUTX-101 in the fourth quarter of 2024. 
      Cyprium Therapeutics, our subsidiary company that developed CUTX-101, 
      will retain 100% ownership over any FDA Priority Review Voucher that may 
      be issued at NDA approval. 

Clinical Updates

   -- In March 2025, we announced that full results from two Phase 3 
      multicenter, randomized, double-blind, parallel-group, active-comparator 
      and placebo-controlled clinical trials, Minocycline Versus Oracea$(R)$ in 
      Rosacea-1 ("MVOR-1") and Minocycline Versus Oracea in Rosacea-2 
      ("MVOR-2"), evaluating Minocycline Hydrochloride Extended Release 
      Capsules, 40 mg ("DFD-29" or "Emrosi") for the treatment of 
      moderate-to-severe papulopustular rosacea in adults were published in the 
      Journal of the American Medical Association - Dermatology. The results 
      demonstrated the efficacy, safety and tolerability of oral DFD-29 in 
      rosacea. The full publication is available at 
      https://jamanetwork.com/journals/jamadermatology/article-abstract/2830693. 
      Information on such website is not a part of this release. 
 
   -- In January 2025, we announced that the first patient was dosed in a 
      multicenter, placebo-controlled and randomized Phase 2 clinical trial to 
      evaluate Triplex, a cytomegalovirus ("CMV") vaccine, when administered to 
      human leukocyte antigen matched related stem cell donors to reduce CMV 
      events in patients undergoing hematopoietic stem cell transplantation. 
 
   -- In October 2024, clinical data were presented at the 44th Fall Clinical 
      Dermatology Conference assessing the dermal and systemic pharmacokinetics 
      of Emrosi versus oral doxycycline 40 mg capsules (Oracea(R)) in healthy 
      subjects. With its extended-release formulation, Emrosi provides higher 
      dermal concentration than doxycycline from day 1 onward at a similar dose, 
      expected to translate into a clinically meaningful impact for treating 
      patients with rosacea, and as demonstrated in Emrosi's Phase 3 clinical 
      trials. 
 
   -- In September 2024, we presented longer-term data from Checkpoint's 
      pivotal trial of UNLOXCYT in locally advanced and metastatic cSCC during 
      the European Society for Medical Oncology Congress 2024. The longer-term 
      results for UNLOXCYT demonstrate a deepening of response over time, with 
      higher objective response and complete response rates than initially 
      observed at the primary analyses. 
 
   -- In May 2024, we announced that the first patient was dosed in a 
      multicenter, placebo-controlled, randomized Phase 2 study of Triplex in 
      patients undergoing liver transplantation. The trial will enroll up to 
      416 CMV seronegative prospective liver transplant recipients and will be 
      conducted across up to 20 nationally recognized transplant centers in the 
      U.S. The trial is funded by a grant from the National Institute of 
      Allergy and Infectious Diseases of the National Institutes of Health that 
      could provide over $20 million in non-dilutive funding. We believe this 

(MORE TO FOLLOW) Dow Jones Newswires

March 31, 2025 16:05 ET (20:05 GMT)