EQS-News: Fortress Bios Portfolio Of Marketed Drugs Could Soon See Three Additions

Fortress Biotech Inc. (NASDAQ: FBIO) is a biopharmaceutical company focused on developing a range of high-potential treatments on its own and through its growing portfolio of subsidiaries and partner companies.

With nine products already on the market and more than 30 programs in development, the biopharmaceutical company helps deliver innovative drug therapies to patients who have a wide range of diseases and disorders. Here are three of the most significant breakthrough developments it achieved this year.

Checkpoint Therapeutics Inc. (NASDAQ: CKPT) announced positive interim results in June from a registration-enabling clinical trial of its anti-PD-L1 checkpoint inhibitor.

The novel cancer immunotherapy is being studied as a possible treatment for advanced cutaneous squamous cell carcinoma (cSCC), a difficult-to-treat skin cancer. The current first-line treatment for cSCC is surgery to remove the tumor or radiation therapy to destroy the tumor. However, some patients arent candidates for surgery or radiation, either because of poor health or because cancer has spread or become too advanced.

Cosibelimab is an immunotherapy drug that works by blocking the PD-L1 inhibitor, an immune checkpoint inhibitor on the surface of cells that tells the bodys immune system not to attack that particular cell. Cancer uses those same checkpoint inhibitors to trick the immune system into believing the cancerous cell is a normal healthy cell that it should not attack.

By blocking PD-L1, cosibelimab can remove cancers ability to escape detection and allow the patients own immune system to better identify and attack cancerous cells. In the registration-enabling clinical trial, cosibelimab achieved a response rate of 54.8% far exceeding the minimum 25% target.

Checkpoint plans to discuss the potential of adding locally advanced cSCC as a second indication in addition to metastatic cSCC with the Food and Drug Administration (FDA) as it prepares its biologics license application for submission around year-end. Checkpoint provides a 4.5% royalty on net sales and a 2.5% annual equity dividend to Fortress Bio in exchange for its operational, strategic, administrative, financial, and legal support.

Last year, Cyprium Therapeutics Inc., a Fortress Bio partner company, announced the initiation of rolling submission of its new drug application (NDA) with the FDA for its novel treatment for Menkes disease. The company presented additional data in March at the 2022 American College of Medical Genetics and Genomics (ACMG) Annual Clinical Genetics Meeting. Cyprium continues to progress toward the completion of its NDA submission.

Menkes disease is a rare but fatal genetic condition that impairs the ability to transport copper through the body. This results in abnormally low levels of copper in the brain and liver along with abnormally high levels in the kidney and intestines. Symptoms include poor muscle development, low weight, and cognitive difficulties.

The difficult-to-diagnose progressive disease has no approved treatments, and most children with Menkes disease will die within the first three years of life. CUTX-101 is a copper histidinate (CuHis) injection that can be administered directly into the body to restore copper levels. Because Menkes disease affects the bodys ability to absorb copper through the gastrointestinal tract, direct injections are meant to bypass the GI tract and deliver copper straight to the bloodstream.

Clinical data showed that CUTX-101 improved neurodevelopmental outcomes and survival in treated patients, including a nearly 80% reduction in the risk of death. If approved, CUTX-101 has the potential to be the first FDA-approved treatment for Menkes disease. As with Checkpoint, Fortress Bio receives a 4.5% royalty and 2.5% annual equity dividend from Cyprium.

Journey Medical Corp. (NASDAQ: DERM) is a dermatology biopharmaceutical company founded by Fortress Bio. Journey announced 50% enrollment in its Phase 3 clinical trial of a novel rosacea treatment in August.

DFD-29, the drug candidate being studied in the clinical trial, is a minocycline-based compound meant to treat rosacea using its anti-inflammatory and antimicrobial properties. Minocycline is already used to treat other inflammatory conditions ranging from acne to rheumatoid arthritis because it can block pro-inflammatory cytokines and other inflammatory processes that cause flare-ups.

Its typically administered as a topical treatment, which can help with milder symptoms but doesnt provide enough relief for severe cases. Doctors typically prescribe a course of doxycycline for rosacea patients with severe flare-ups. But the clinical data on DFD-29 showed that it was almost twice as effective as doxycycline at reducing lesions and overall symptom improvement.

DFD-29s modified release capsule is also meant to counter the bacterial resistance that often develops with frequent antibiotic use. Rather than immediate release, the capsule slowly releases small doses of minocycline over time. The subantimicrobial dose is meant to be low enough to avoid triggering selection pressure for bacterial resistance while still offering the anti-inflammatory benefits of the treatment.

Topline data from this latest Phase 3 clinical trial is expected in the first half of 2023, and the company expects to file a new drug application by the end of that year. Fortress Bio currently owns a controlling stake in Journey Medical.

Fortress Biotech, Inc. ("Fortress") is an innovative biopharmaceutical company focused on acquiring, developing and commercializing high-potential marketed and development-stage drugs and drug candidates. The company has nine marketed prescription pharmaceutical products and over 30 programs in development at Fortress, at its majority-owned and majority-controlled partners and subsidiaries and at partners and subsidiaries it founded and in which it holds significant minority ownership positions. Such product candidates span six large-market areas, including oncology, rare diseases and gene therapy, which allow it to create value for shareholders. Fortress advances its diversified pipeline through a streamlined operating structure that fosters efficient drug development. The Fortress model is driven by a world-class business development team that is focused on leveraging its significant biopharmaceutical industry expertise to further expand the company's portfolio of product opportunities. Fortress has established partnerships with some of the world's leading academic research institutions and biopharmaceutical companies to maximize each opportunity to its full potential, including AstraZeneca plc, City of Hope, Fred Hutchinson Cancer Research Center, St. Jude Children's Research Hospital, Nationwide Children's Hospital and Sentynl Therapeutics, Inc.

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Jaclyn Jaffe and Bill Begien

+1 781-652-4500

ir@fortressbiotech.com

https://www.fortressbiotech.com/