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
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