 Product revenue for the first six months of 2020 increased 50 year-over-year to 21.4 million Agreement executed with Columbia University to develop novel oligonucleotide platform for the treatment of genetically driven cancers, including KRAS-driven cancers, and coronavirusesNEW YORK, Aug. 10, 2020 GLOBE NEWSWIRE -- Fortress Biotech, Inc. NASDAQ: FBIO Fortress, an innovative revenue-generating company focused on acquiring, developing and commercializing or monetizing promising biopharmaceutical products and product candidates cost-effectively, today announced financial results and recent corporate highlights for the second quarter ended June 30, 2020.Lindsay A. Rosenwald, M.D., Fortress Chairman, President and Chief Executive Officer, said, Fortress has continued to efficiently and effectively execute on its growth objectives due to our unique business model. We are proud to have generated total net revenue of 21.4 million from our five marketed pharmaceutical products in the first half of 2020, a year-over-year increase of 50, despite this unprecedented time. Moreover, during the second quarter, we acquired a broad platform technology from Columbia University to effectively deliver novel, proprietary oligonucleotides for the treatment of genetically driven cancers, with an initial target of KRAS-driven cancers. We are also exploring the potential of the platform to treat novel coronaviruses, such as COVID-19.Dr. Rosenwald continued, Additionally, we continue to work with our partner companies to steadily build and advance our growing portfolio of commercial and development-stage product candidates. Our goal is to increase intrinsic value for our shareholders. In the second half of 2020, we look forward to a multitude of key inflection points, including: additional data from our registration-enabling clinical trial of cosibelimab in patients with metastatic cutaneous squamous cell carcinoma mCSCC, the PDUFA date for IV tramadol in October and initiating the rolling submission of the New Drug Application NDA to the U.S. Food and Drug Administration FDA for CUTX-101 for the treatment of Menkes disease. We also anticipate the potential launch of four more registration-enabling clinical trials this year, two CAEL-101 pivotal trials for AL amyloidosis and two MB-107 and MB-207 lentiviral gene therapy clinical trials for newly diagnosed infants and previously transplanted patients with X-linked severe combined immunodeficiency XSCID. Recent Corporate Highlights1: Marketed Dermatology Products Our dermatology products are marketed by our partner company, Journey Medical Corporation Journey. Our products generated 21.4 million in revenues in the first half of 2020, compared to 14.3 million in the first half of 2019, representing growth of 50 year-over-year. Our products generated second quarter 2020 net revenues of 9.4 million, compared to second quarter 2019 net revenues of 8.2 million, a 15 increase. Second quarter sales were below expectations due to COVID-19. We intend to acquire up to two new prescription products in 2020. IV Tramadol In April 2020, Avenue Therapeutics Avenue announced that two e-posters highlighting efficacy and safety results from its Phase 3 program are available for online viewing from the cancelled Annual Regional Anesthesiology and Acute Pain Medicine Meeting hosted by the American Society of Regional Anesthesia and Pain Medicine ASRA. The e-poster 816, titled, Intravenous Tramadol is Effective in Management of Postoperative Pain Following Abdominoplasty: A 3-arm Randomized Controlled Trial, includes data from the Phase 3 abdominoplasty study and can be found here. The e-poster 1001, titled, IV tramadol A New Treatment Option for Management of Post-Operative Pain: A Safety Trial Including Various Types of Surgery, includes data from the Phase 3 safety study and can be found here. In June 2020, Avenue announced the following clinical study publications in peer-reviewed journals. Intravenous Tramadol is Effective in the Management of Postoperative Pain Following Abdominoplasty: A Three-Arm Randomized Placebo- and Active-Controlled Trial, was published in Drugs in RD and can be accessed here. IV Tramadol A New Treatment Option for Management of Post-Operative Pain in the U.S.: An Open-Label, Single-Arm, Safety Trial Including Various Types of Surgery, was published in Journal of Pain Research and can be accessed here. In July 2020, Avenue announced the following publication of its Phase 3 bunionectomy study. Efficacy and Safety of Intravenously Administered Tramadol in Patients with Moderate to Severe Pain Following Bunionectomy: A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study, was published in Pain and Therapy and can be accessed here. The FDA assigned IV tramadol a PDUFA date of October 10, 2020. IV tramadol is currently in development at our partner company, Avenue. CUTX-101 Copper Histidinate for Menkes disease In June 2020, we announced the publication of a study, Estimated birth prevalence of Menkes disease and ATP7A-related disorders based on the Genome Aggregation Database gnomAD, in Molecular Genetics and Metabolism Reports. Assuming Hardy-Weinberg genetic equilibrium, the allelic frequency of loss-of-function variants suggests a minimum birth prevalence for Menkes disease of 1 in 34,810 males, higher than previously recognized. If likely pathogenic missense variants are included, the estimated birth prevalence could potentially be as high as 1 in 8,664 live male births. The study can be accessed here. In July 2020, we announced the publication of a study, Targeted Next Generation Sequencing for Newborn Screening of Menkes Disease, in Molecular Genetics and Metabolism Reports. The study assessed the analytic validity of an ATP7A targeted next generation DNA sequencing assay as a potential newborn screen for Menkes disease, an X-linked recessive disorder of copper metabolism caused by mutations in ATP7A, an evolutionarily conserved copper-transporting ATPase. The study can be accessed here. In July 2020, we announced that the European Medicines Agency EMA Committee for Orphan Medicinal Products issued a positive opinion on Cyprium Therapeutics application for Orphan Drug Designation for Copper Histidinate, also referred to as CUTX-101, a potential treatment for Menkes disease. EMA Orphan Drug Designation provides companies with certain benefits and incentives, including clinical protocol assistance, differentiated evaluation procedures for Health Technology Assessments in certain countries, access to a centralized marketing authorization procedure valid in all EU member states, reduced regulatory fees and 10 years of market exclusivity. The FDA previously granted Orphan Drug, Fast Track and Rare Pediatric Disease Designations to CUTX-101 for the treatment of Menkes disease. We intend to begin the rolling submission of the NDA for CUTX-101 to the FDA in the fourth quarter of 2020. CUTX-101 is currently in development at our partner company, Cyprium Therapeutics, Inc. Cosibelimab anti-PD-L1 antibody In April 2020, we announced that the U.S. Patent and Trademark Office issued a composition of matter patent for cosibelimab. U.S. Patent No. 10,590,199 specifically covers the antibody, cosibelimab, or a fragment thereof, providing protection through at least May 2038, exclusive of any additional patent-term extensions that might become available. In July 2020, we announced that an abstract highlighting updated interim safety and efficacy data from the ongoing registration-enabling clinical trial of cosibelimab in patients with mCSCC was accepted for e-poster presentation at the European Society for Medical Oncology ESMO Virtual Congress 2020, to be held September 19-21, 2020. The registration-enabling study in mCSCC is currently over 50 enrolled, with full enrollment anticipated around year-end. With a potentially favorable safety profile and a plan to commercialize at a substantially lower price, we believe cosibelimab can be a market disruptive product in the 25 billion and growing PD-L1 class. Cosibelimab is currently in development at our partner company, Checkpoint Therapeutics, Inc. CAEL-101 light chain fibril-reactive monoclonal antibody for AL amyloidosis Dosing is complete in the Phase 2 dose selection portion of the program; the Phase 3 portion of the pivotal program is planned to begin in the third quarter of 2020, pending dose selection. CAEL-101 is currently in development at Caelum Biosciences, Inc. MB-107 and MB-207 lentiviral gene therapies for XSCID In April 2020, we announced that the EMA granted Advanced Therapy Medicinal Product ATMP classification to MB-107, a lentiviral gene therapy for the treatment of XSCID, also known as bubble boy disease. In May 2020, Mustang Bio, Inc. Mustang submitted an Investigational New Drug IND application to the FDA to initiate a multi-center Phase 2 clinical trial of MB-107 in newly diagnosed infants with XSCID who are under the age of two. The trial is expected to enroll 10 patients who, together with 15 patients enrolled in the current multicenter trial led by St. Jude Childrens Research Hospital, will be compared to 25 matched historical control patients who have undergone hematopoietic stem cell transplant HSCT. The primary efficacy endpoint will be event-free survival. The initiation of this trial is currently on hold pending CMC clearance by the FDA, which is expected in early Q4 2020. Mustang is targeting top-line data from the trial in the second half of 2022. 