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10:42 28 Mar 2024 FBIOP

Fortress Biotech, Inc. (FBIO) Q3 2022 Earnings Call Transcript

Fortress Biotech, Inc. (NASDAQ:FBIO ) Q3 2022 Earnings Conference Call November 10, 2022 4:30 PM ET Company Participants Matt Blazei - CORE IR Claude Maraoui - Co-Founder President and Chief Executive Officer Ernie De Paolantonio - Chief Financial Officer Ramsey Alloush - General Counsel Srinivas Sidgiddi - Vice President of Clinical Development and Medical Affairs Conference Call Participants Scott Henry - ROTH Capital Partners Brandon Folkes - Cantor Fitzgerald Operator Ladies and gentlemen, thank you for standing by. Good afternoon and welcome to the Journey Medical's Third Quarter 2022 Financial Results and Corporate Update Conference Call.

09:05 28 Mar 2024 FBIOP

Journey Medical Corporation (FBIO) CEO Claude Maraoui on Q2 2022 Results - Earnings Call Transcript

Journey Medical Corporation (NASDAQ:FBIO ) Q2 2022 Results Conference Call August 9, 2022 4:30 PM ET Company Participants Claude Maraoui - Co-Founder President and Chief Executive Officer Ernest De Paolantonio - Chief Financial Officer Ramsey Alloush - General Counsel Dr. Srinivas Sidgiddi - Vice President of Clinical Development and Medical Affairs Conference Call Participants Brandon Folkes - Cantor Fitzgerald Mayank Mamtani - B. Riley FBR Operator Ladies and gentlemen, thank you for standing by.

05:09 28 Mar 2024 FBIOP

Fortress Biotech (FBIO) Investor Presentation - Slideshow

The following slide deck was published by Fortress Biotech, Inc. in conjunction with this event..

08:41 28 Mar 2024 FBIOP

Fortress Biotech Investor Presentation - Slideshow

The following slide deck was published by Fortress Biotech, Inc. in conjunction with this event..

11:30 28 Mar 2024 FBIOP

Fortress Biotech Announces Virtual Two-Day Corporate Access Summit Hosted by B. Riley FBR on Tuesday, August 18 and Wednesday, August 19, 2020

NEW YORK, Aug. 12, 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 a two-day summit hosted by Mayank Mamtani, of B. Riley FBR, Inc., that will feature multiple programs from Fortress’ diversified pipeline. The events will be held virtually on Tuesday, August 18, and Wednesday, August 19, 2020, beginning at 1:00 p.m. ET each day. Registration links and webcast information: * Please click here to register for the event on Tuesday, August 18, 2020. * Please click here to register for the event on Wednesday, August 19, 2020.Following each event, the webcast will be available on the News / Events page, located within the Investors section of Fortress’ website, https://www.fortressbiotech.com/news-media/events, for approximately 30 days.Agenda:Day One: Tuesday, August 18, 2020 Opening Remarks – 1 p.m. ETLindsay Rosenwald, M.D., Chairman, President & CEOPanel 1 – 1:20 p.m. ET: Journey Medical CorporationClaude Maraoui, President & CEO; Robert Nevin, CCO; Nirav Jhaveri, CFOPanel 2 – 1:50 p.m. ET: Cyprium TherapeuticsLung Yam, M.D., Ph.D., President & CEO; Charles Buchen, M.D., Vice President, Business Development Stephen G. Kaler, M.D., M.P.H., Professor of Pediatrics and Genetics and a physician-scientist in the Center for Gene Therapy, Abigail Wexner Research Institute at Nationwide Children’s HospitalPanel 3 – 2:20 p.m. ET: Avenue Therapeutics (ATXI) Lucy Lu, M.D., President & CEO; Joseph Vazzano, CFO Neil Singla, M.D., Chief Scientific Officer, Lotus Clinical Research, LLCPanel 4 – 2:50 p.m. ET: Mustang Bio (MBIO) – Gene TherapyManuel Litchman, M.D., President & CEO Harry L. Malech, M.D., Chief, Genetic Immunotherapy Section, National Institute of Allergy and Infectious Diseases, NIHDay Two: Wednesday, August 19, 2020  Oncology Strategy Overview – 1 p.m. ETLindsay Rosenwald, M.D., Chairman, President & CEOPanel 1 – 1:20 p.m. ET: Mustang Bio (MBIO) – Cancer Cell TherapyManuel Litchman, M.D., President & CEO Stephen J. Forman, M.D., Professor, Department of Hematology & Hematopoietic Cell Transplantation; Director, T Cell Therapeutics Research Laboratory, City of HopePanel 2 – 1:50 p.m. ET: Checkpoint Therapeutics (CKPT)James F. Oliviero, President & CEO David M. Miller, M.D., Ph.D., Dermatologist and Medical Oncologist at Massachusetts General HospitalPanel 3 – 2:20 p.m. ET: OncogenuityArthur Ross, Chief Business Officer About Fortress Biotech Fortress Biotech, Inc. (“Fortress”) is an innovative biopharmaceutical company that was recently ranked number 10 in Deloitte’s 2019 Technology Fast 500™, an annual ranking of the fastest-growing North American companies in the technology, media, telecommunications, life sciences and energy tech sectors, based on percentage of fiscal year revenue growth over a three-year period.  Fortress is focused on acquiring, developing and commercializing high-potential marketed and development-stage drugs and drug candidates. The company has five marketed prescription pharmaceutical products and over 25 programs in development at Fortress, at its majority-owned and majority-controlled partners and at partners 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 Alexion Pharmaceuticals, Inc., AstraZeneca, City of Hope, Fred Hutchinson Cancer Research Center, InvaGen Pharmaceuticals Inc. (a subsidiary of Cipla Limited), St. Jude Children’s Research Hospital and Nationwide Children’s Hospital.  For more information, visit www.fortressbiotech.com.Forward-Looking Statements This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended. As used below and throughout this press release, the words “we”, “us” and “our” may refer to Fortress individually or together with one or more partner companies, as dictated by context. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to our growth strategy; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; uncertainties relating to preclinical and clinical testing; risks relating to the timing of starting and completing clinical trials; our dependence on third-party suppliers; risks relating to the COVID-19 outbreak and its potential impact on our employees’ and consultants’ ability to complete work in a timely manner and on our ability to obtain additional financing on favorable terms or at all;  our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law. The information contained herein is intended to be reviewed in its totality, and any stipulations, conditions or provisos that apply to a given piece of information in one part of this press release should be read as applying mutatis mutandis to every other instance of such information appearing herein.Company Contacts: Jaclyn Jaffe and William Begien Fortress Biotech, Inc. (781) 652-4500 ir@fortressbiotech.comInvestor Relations Contact: Daniel Ferry LifeSci Advisors, LLC (617) 430-7576 daniel@lifesciadvisors.comMedia Relations Contact: Tony Plohoros 6 Degrees (908) 591-2839 tplohoros@6degreespr.com

08:30 28 Mar 2024 FBIOP

Fortress Biotech Reports Second Quarter 2020 Financial Results and Recent Corporate Highlights

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 R&D 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-(L)1 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 Children’s 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.

07:34 28 Mar 2024 FBIOP

LD Micro-Announces Preliminary List of Presenters for the LD 500.

LOS ANGELES, CA / ACCESSWIRE / August 5, 2020 / LD Micro today announced the initial list of companies slated to present at the upcoming LD 500, taking place September 1st-4th, 2020, exclusively online.

12:00 28 Mar 2024 FBIOP

49 Public Companies to Present at the SNN Network Virtual Conference on August 3-6, 2020

LOS ANGELES, CA / ACCESSWIRE / August 3, 2020 / The SNN Network Virtual Conference will take place on August 3rd \\- 6th, 2020, where 49 SmallCap, MicroCap and NanoCap public companies will be presenting via virtual webcast to a global investor audience.

11:30 28 Mar 2024 FBIOP

Fortress Biotech Announces Positive Opinion on Orphan Drug Designation Received from the European Medicines Agency for CUTX-101, Copper Histidinate, for the Treatment of Menkes Disease

Rolling submission of New Drug Application to the FDA for CUTX-101 on track to begin in the fourth quarter of 2020NEW YORK, July 31, 2020 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”), an innovative biopharmaceutical company focused on acquiring, developing and commercializing high-potential marketed pharmaceutical products and development-stage pharmaceutical product candidates, today announced that the European Medicines Agency (“EMA”) Committee for Orphan Medicinal Products issued a positive opinion on Cyprium Therapeutics’ (“Cyprium”) application for Orphan Drug Designation for Copper Histidinate, also referred to as CUTX-101, a potential treatment for Menkes disease. Menkes disease is an often lethal, if untreated, X-linked recessive disorder of copper metabolism caused by mutations in ATP7A, an evolutionarily conserved copper-transporting ATPase. The U.S. Food and Drug Administration (“FDA”) previously granted Orphan Drug, Fast Track and Rare Pediatric Disease Designations to CUTX-101 for the treatment of Menkes disease. Lung S. Yam, M.D., Ph.D., President and Chief Executive Officer of Cyprium, said, “The positive opinion for Orphan Drug Designation from the EMA is an important milestone in bringing a much-needed potential therapy to patients with Menkes disease, a devastating pediatric disease with limited treatment options.  We look forward to working closely with the EMA and continuing to progress CUTX-101 for children in need. To this end, we remain on track to begin a rolling submission of a New Drug Application to the FDA for CUTX-101 in the U.S. in the fourth quarter of this year.”Orphan Drug Designation in the European Union (“EU”) is granted by the European Commission based on a positive opinion issued by the EMA Committee for Orphan Medicinal Products. To qualify, an investigational medicine must be intended to treat a seriously debilitating or life-threatening condition that affects fewer than five in 10,000 people in the EU, and there must be sufficient non-clinical or clinical data to suggest the investigational medicine may produce clinically relevant outcomes. 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.CambPharma Solutions (CY) Limited submitted the Orphan Drug Designation application on behalf of Cyprium, as its agent in the EU.About Menkes Disease and Related Copper Metabolism Disorders Menkes disease is a rare X-linked recessive pediatric disease caused by gene mutations of copper transporter ATP7A. The minimum birth prevalence for Menkes disease is believed to be 1 in 34,810 males, but could potentially be as high as 1 in 8,664 live male births, higher than previously recognized. Biochemically, Menkes patients have low levels of copper in their blood and brain, as well as abnormal levels of certain neurochemicals. Definitive diagnosis is typically made by sequencing the ATP7A gene. The condition is characterized by distinctive clinical features, including sparse and depigmented hair (“kinky hair”), connective tissue problems, and severe neurological symptoms such as seizures, hypotonia, and failure to thrive. Mortality is high in untreated Menkes disease, with many patients dying before the age of three. Milder versions of ATP7A mutations are associated with other conditions, including Occipital Horn Syndrome and ATP7A-related Distal Motor Neuropathy. Currently, there is no FDA-approved treatment for Menkes disease and its variants.About CUTX-101 (Copper Histidinate) CUTX-101 is in clinical development to treat patients with Menkes disease by replenishing Copper Histidinate, restoring copper homeostasis, and maintaining serum copper levels in the normal age appropriate range. CUTX-101 is a subcutaneous injectable formulation of Copper Histidinate manufactured under current good manufacturing practice (“cGMP”) that is intended to improve tolerability due to physiological pH and to bypass the oral absorption of copper, which is impaired in patients with Menkes disease. In a Phase 1/2 clinical trial conducted by Stephen G. Kaler, M.D., M.P.H., at the National Institutes of Health (“NIH”), early treatment of patients with Menkes disease with CUTX-101 led to an improvement in neurodevelopmental outcomes and survival. A Phase 3 trial of CUTX-101 in patients with Menkes disease also led by Dr. Kaler has completed enrollment. A Cyprium-sponsored expanded access protocol for Menkes disease patients is ongoing. About Cyprium Therapeutics Cyprium Therapeutics, Inc. (“Cyprium”) is focused on the development of novel therapies for the treatment of Menkes disease and related copper metabolism disorders. In March 2017, Cyprium entered into a Cooperative Research and Development Agreement (“CRADA”) with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (“NICHD”), part of the NIH, to advance the clinical development of CUTX-101 (Copper Histidinate injection) for the treatment of Menkes disease. In addition, Cyprium and NICHD entered into a worldwide, exclusive license agreement to develop and commercialize adeno-associated virus (AAV)-based gene therapy, called AAV-ATP7A, to deliver working copies of the copper transporter that is defective in Menkes patients, and to be used in combination with CUTX-101. CUTX-101 was granted FDA Fast Track and Rare Pediatric Disease Designations, and both CUTX-101 and AAV-ATP7A have received FDA Orphan Drug Designation previously. Cyprium was founded by Fortress Biotech, Inc. (Nasdaq: FBIO) and is based in New York City. For more information, visit www.cypriumtx.com. About Fortress Biotech Fortress Biotech, Inc. (“Fortress”) is an innovative biopharmaceutical company that was recently ranked number 10 in Deloitte’s 2019 Technology Fast 500™, an annual ranking of the fastest-growing North American companies in the technology, media, telecommunications, life sciences and energy tech sectors, based on percentage of fiscal year revenue growth over a three-year period. Fortress is focused on acquiring, developing and commercializing high-potential marketed pharmaceutical products and development-stage pharmaceutical product candidates. The company has five marketed prescription pharmaceutical products and over 25 programs in development at Fortress, at its majority-owned and majority-controlled partners and at partners 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 Alexion Pharmaceuticals, Inc., AstraZeneca, City of Hope, Fred Hutchinson Cancer Research Center, InvaGen Pharmaceuticals Inc. (a subsidiary of Cipla Limited), St. Jude Children’s Research Hospital and Nationwide Children’s Hospital. For more information, visit www.fortressbiotech.com.Forward-Looking Statements This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended. As used below and throughout this press release, the words “we”, “us” and “our” may refer to Fortress individually or together with one or more partner companies, as dictated by context. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to our growth strategy; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; uncertainties relating to preclinical and clinical testing; risks relating to the timing of starting and completing clinical trials; our dependence on third-party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our Securities and Exchange Commission filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law.

11:30 28 Mar 2024 FBIOP

Fortress Biotech Announces Publication of Study on Targeted Next Generation Sequencing for Newborn Screening of Menkes Disease in Molecular Genetics and Metabolism Reports

Cyprium Therapeutics, a Fortress partner company, is developing CUTX-101 for Menkes disease A rolling submission of a New Drug Application to the FDA is expected to begin in the fourth quarter of 2020NEW YORK, July 29, 2020 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”), an innovative biopharmaceutical company focused on acquiring, developing and commercializing high-potential marketed pharmaceutical products and development-stage pharmaceutical product candidates, today announced the publication of a study, “Targeted Next Generation Sequencing for Newborn Screening of Menkes Disease” in Molecular Genetics and Metabolism Reports. The study was published online in July 2020.The study assessed the analytic validity of an ATP7A targeted next generation DNA sequencing assay as a potential newborn screen for Menkes disease, a X-linked recessive disorder of copper metabolism caused by mutations in ATP7A, an evolutionarily conserved copper-transporting ATPase. Left undetected and untreated, Menkes disease is often fatal by three years of age. Population-based newborn screening (NBS) allows early detection and treatment of inherited disorders. For certain medically-actionable conditions, however, NBS is limited by the absence of reliable biochemical signatures amenable to detection by current platforms.In the study, supported in part by The Menkes Foundation (https://themenkesfoundation.org/) and led by Stephen G. Kaler, M.D., M.P.H., a physician-scientist in the Center for Gene Therapy in the Abigail Wexner Research Institute at Nationwide Children's Hospital, researchers blindly analyzed dried blood spots from control or Menkes disease subjects (n=22) for pathogenic variants in the copper transporter gene, ATP7A. The analytical method was optimized to minimize cost and provide rapid turnaround time. The algorithm correctly identified pathogenic ATP7A variants, including missense, nonsense, small insertions/deletions, and large copy number variants, in 21/22 (95.5%) of subjects, one of whom had inconclusive diagnostic sequencing previously. For one false negative that also had not been detected by commercial molecular laboratories, researchers identified a deep intronic variant that impaired ATP7A mRNA splicing.“The results of our study support proof-of-concept that primary DNA-based NBS would accurately detect Menkes disease, a disorder for which biochemical detection in the newborn period is currently unavailable. Targeted next generation sequencing for NBS would enable improved Menkes disease clinical outcomes through early detection, and eliminate the lengthy, expensive, and uncomfortable diagnostic odysseys endured by many affected infants and their parents,” said Dr. Kaler, who is also a professor of Pediatrics and Genetics at The Ohio State University College of Medicine.Lung S. Yam, M.D., Ph.D., President and Chief Executive Officer of Cyprium, added, “This study suggests that Menkes disease could be accurately detected by a quick NBS method that is also cost effective. NBS could potentially increase the number of Menkes disease patients identified at birth allowing for earlier treatment, a critical component correlated with clinical outcome.”The study can be accessed here.About Menkes Disease and Related Copper Metabolism Disorders Menkes disease is a rare X-linked recessive pediatric disease caused by gene mutations of copper transporter ATP7A. The minimum birth prevalence for Menkes disease is believed to be 1 in 34,810 males, but could potentially be as high as 1 in 8,664 live male births, higher than previously recognized. Biochemically, Menkes patients have low levels of copper in their blood and brain, as well as abnormal levels of certain neurochemicals. Definitive diagnosis is typically made by sequencing the ATP7A gene. The condition is characterized by distinctive clinical features, including sparse and depigmented hair (“kinky hair”), connective tissue problems, and severe neurological symptoms such as seizures, hypotonia, and failure to thrive. Mortality is high in untreated Menkes disease, with many patients dying before the age of three. Milder versions of ATP7A mutations are associated with other conditions, including Occipital Horn Syndrome and ATP7A-related Distal Motor Neuropathy. Currently, there is no FDA-approved treatment for Menkes disease and its variants.About CUTX-101 (Copper Histidinate) CUTX-101 is in clinical development to treat patients with Menkes disease by replenishing Copper Histidinate, restoring copper homeostasis, and maintaining serum copper levels in the normal age appropriate range. CUTX-101 is a subcutaneous injectable formulation of Copper Histidinate manufactured under cGMP that is intended to improve tolerability due to physiological pH and to bypass the oral absorption of copper, which is impaired in patients with Menkes disease. In a Phase 1/2 clinical trial conducted by Stephen G. Kaler, M.D., M.P.H., at the National Institutes of Health (NIH), early treatment of patients with Menkes disease with CUTX-101 led to an improvement in neurodevelopmental outcomes and survival. A Phase 3 trial of CUTX-101 in patients with Menkes disease also led by Dr. Kaler has completed enrollment. A Cyprium-sponsored expanded access protocol for Menkes disease patients is ongoing. About Cyprium Therapeutics Cyprium Therapeutics, Inc. (“Cyprium”), is focused on the development of novel therapies for the treatment of Menkes disease and related copper metabolism disorders. In March 2017, Cyprium entered into a Cooperative Research and Development Agreement (“CRADA”) with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (“NICHD”), part of the National Institutes of Health (NIH), to advance the clinical development of CUTX-101 (Copper Histidinate injection) for the treatment of Menkes disease. In addition, Cyprium and NICHD entered into a worldwide, exclusive license agreement to develop and commercialize adeno-associated virus (AAV)-based gene therapy, called AAV-ATP7A, to deliver working copies of the copper transporter that is defective in Menkes patients, and to be used in combination with CUTX-101. CUTX-101 was granted U.S. Food and Drug Administration (“FDA”) Fast Track and Rare Pediatric Disease Designations, and both CUTX-101 and AAV-ATP7A have received FDA Orphan Drug Designation previously. Cyprium was founded by Fortress Biotech, Inc. (Nasdaq: FBIO) and is based in New York City. For more information, visit www.cypriumtx.com. About Fortress Biotech Fortress Biotech, Inc. (“Fortress”) is an innovative biopharmaceutical company that was recently ranked number 10 in Deloitte’s 2019 Technology Fast 500™, an annual ranking of the fastest-growing North American companies in the technology, media, telecommunications, life sciences and energy tech sectors, based on percentage of fiscal year revenue growth over a three-year period. Fortress is focused on acquiring, developing and commercializing high-potential marketed pharmaceutical products and development-stage pharmaceutical product candidates. The company has five marketed prescription pharmaceutical products and over 25 programs in development at Fortress, at its majority-owned and majority-controlled partners and at partners 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 Alexion Pharmaceuticals, Inc., AstraZeneca, City of Hope, Fred Hutchinson Cancer Research Center, InvaGen Pharmaceuticals Inc. (a subsidiary of Cipla Limited), St. Jude Children’s Research Hospital and Nationwide Children’s Hospital. For more information, visit www.fortressbiotech.com.Forward-Looking Statements This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended. As used below and throughout this press release, the words “we”, “us” and “our” may refer to Fortress individually or together with one or more partner companies, as dictated by context. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price.

FBIOP Financial details

Company Rating
Neutral
Market Cap
36.23M
Income
-109.38M
Revenue
80.97M
Book val./share
2.22
Cash/share
9.65
Dividend
-
Dividend %
-
Employees
187
Optionable
No
Shortable
Yes
Earnings
07 Aug 2020
P/E
-716.19
Forward P/E
-
PEG
161.01
P/S
0.48
P/B
4698
P/C
1.73
P/FCF
-0.27
Quick Ratio
0.83
Current Ratio
1
Debt / Equity
4.21
LT Debt / Equity
-4.89
-
-
EPS (TTM)
-16.8
EPS next Y
-
EPS next Q
-
EPS this Y
19.3%
EPS next Y
-
EPS next 5Y
-
EPS last 5Y
4.45%
Revenue last 5Y
23.02%
Revenue Q/Q
99.88%
EPS Q/Q
-80.06%
-
-
-
-
SMA20
13.33%
SMA50
30.77%
SMA100
70%
Inst Own
0.01%
Inst Trans
0.29%
ROA
-73%
ROE
-381%
ROC
-3.32%
Gross Margin
65%
Oper. Margin
-218%
Profit Margin
-135%
Payout
-8%
Shs Outstand
2.09M
Shs Float
1.52M
-
-
-
-
Target Price
-
52W Range
6.4-19.494
52W High
-12.11%
52W Low
+178.33%
RSI
66
Rel Volume
0.77
Avg Volume
14.83K
Volume
11.47K
Perf Week
2.9%
Perf Month
6.57%
Perf Quarter
47.53%
Perf Half Y
42.13%
-
-
-
-
Beta
1.507
-
-
Volatility
0.1%, 0.63%
Prev Close
-0.42%
Price
16.7
Change
2.39%

FBIOP Financial Performance

Yearly Fundamentals Overview

Last date of statement is 2022-12-31

Metric History 2018-12-312019-12-312020-12-312021-12-31 2022-12-31
2.02K2.02K2.02K2.02K2.02K
Revenue per share
9.2810.049.512.6312.78
Net income per share
-29.04-14.2-21.45-30.26-36.1
Operating cash flow per share
-34.12-26.03-17.43-21.4-30.28
Free cash flow per share
-37.34-28.61-18.92-24.4-30.79
Cash per share
28.6841.6348.6156.1330.09
Book value per share
0.647.1920.919.957.04
Tangible book value per share
6.3217.8637.9939.173.85
Share holders equity per share
0.647.1920.919.957.04
Interest debt per share
31.0134.8220.5816.5823.8
Market cap
37.38M140.61M228.26M204.25M58.66M
Enterprise value
51.37M118.89M83.98M-26.52M7.74M
P/E ratio
-0.44-2.71-2.22-1.24-0.27
Price to sales ratio
1.393.845.012.970.77
POCF ratio
-0.38-1.48-2.73-1.75-0.33
PFCF ratio
-0.35-1.35-2.51-1.54-0.32
P/B Ratio
20.185.362.271.881.41
PTB ratio
20.185.362.271.881.41
EV to sales
1.913.251.84-0.390.1
Enterprise value over EBITDA
-0.44-1.15-0.90.15-0.04
EV to operating cash flow
-0.52-1.25-10.23-0.04
EV to free cash flow
-0.47-1.14-0.920.2-0.04
Earnings yield
-2.25-0.37-0.45-0.81-3.65
Free cash flow yield
-2.89-0.74-0.4-0.65-3.11
Debt to equity
42.934.390.890.693.05
Debt to assets
0.560.510.270.190.43
Net debt to EBITDA
-0.120.211.551.290.25
Current ratio
23.435.453.431.8
Interest coverage
-11.61-9.35-9.71-11.69-14.83
Income quality
0.760.930.810.710.84
Dividend Yield
0.060.020.030.040.15
Payout ratio
-0.03-0.05-0.07-0.05-0.04
Sales general and administrative to revenue
1.991.52000
Research and developement to revenue
3.252.221.411.871.78
Intangibles to total assets
0.010.030.040.030.09
Capex to operating cash flow
0.090.10.090.140.02
Capex to revenue
-0.35-0.26-0.16-0.24-0.04
Capex to depreciation
-4.54-2.02-1.35-2.41-0.33
Stock based compensation to revenue
0.560.360.290.280.3
Graham number
20.4447.93100.45116.5675.63
ROIC
-1.47-0.34-0.44-0.87-1.05
Return on tangible assets
-0.6-0.24-0.33-0.43-0.8
Graham Net
-11.082.5224.4328.99-6.36
Working capital
55.59M110.64M213.61M245.42M102.72M
Tangible asset value
18.33M65.16M182.37M213.33M22.83M
Net current asset value
-10.04M2.36M129.74M175.84M-13.84M
Invested capital
42.934.390.890.693.05
Average receivables
12.49M11M17.25M21.94M26.07M
Average payables
35.28M34.83M38.06M65.67M94.05M
Average inventory
424.5K767.5K1.13M5.63M12.01M
Days sales outstanding
103.1143.53160.84126.23136.6
Days payables outstanding
2.04K1.23K1.02K1.03K1.16K
Days of inventory on hand
40.429.735.11112.19167.93
Receivables turnover
3.542.542.272.892.67
Payables turnover
0.180.30.360.350.32
Inventory turnover
9.0312.2910.393.252.17
ROE
-45.44-1.98-1.03-1.52-5.13
Capex per share
-3.23-2.58-1.49-3-0.52

Quarterly Fundamentals Overview

Last date of statement is 2023-09-30 for Q3

Metric History 2022-09-302022-12-312023-03-312023-06-30 2023-09-30
2.02K2.02K2.02K2.02K2.02K
Revenue per share
2.772.721.832.364.64
Net income per share
-2.96-9.51-3.26-3.36-0.67
Operating cash flow per share
-7.26-7.92-6.36-4.51-2.24
Free cash flow per share
-7.43-7.98-6.36-4.52-2.37
Cash per share
34.9729.5122.4510.589.65
Book value per share
10.356.915.562.512.22
Tangible book value per share
12.243.78-0.93-5.13-4.58
Share holders equity per share
10.356.915.562.512.22
Interest debt per share
21.5221.5818.5411.689.61
Market cap
76.87M59.81M83.55M60.86M32.6M
Enterprise value
-6.08M8.89M53.66M63.77M30.44M
P/E ratio
-1.09-0.26-0.94-0.61-1.62
Price to sales ratio
4.653.656.723.50.94
POCF ratio
-1.78-1.25-1.93-1.83-1.94
PFCF ratio
-1.74-1.24-1.93-1.83-1.83
P/B Ratio
1.251.432.213.291.96
PTB ratio
1.251.432.213.291.96
EV to sales
-0.370.544.323.670.88
Enterprise value over EBITDA
0.13-0.17-0.96-1.39-2.9
EV to operating cash flow
0.14-0.19-1.24-1.92-1.81
EV to free cash flow
0.14-0.18-1.24-1.91-1.71
Earnings yield
-0.23-0.96-0.26-0.41-0.15
Free cash flow yield
-0.58-0.81-0.52-0.55-0.55
Debt to equity
2.033.053.244.374.21
Debt to assets
0.390.430.470.450.47
Net debt to EBITDA
1.730.970.53-0.060.21
Current ratio
2.431.81.560.991
Interest coverage
-17.63-17.88-17.63-9.63-7.33
Income quality
0.820.830.780.561.56
Dividend Yield
0.030.040.030.040.07
Payout ratio
-0.12-0.04-0.1-0.09-0.43
Sales general and administrative to revenue
00000
Research and developement to revenue
1.812.143.181.850.59
Intangibles to total assets
0.090.090.10.120.14
Capex to operating cash flow
0.020.01000.06
Capex to revenue
-0.06-0.0200-0.03
Capex to depreciation
-0.44-0.150-0.03-0.36
Stock based compensation to revenue
0.410.340.380.240.13
Graham number
26.2438.4420.1913.775.8
ROIC
-0.08-0.28-0.13-0.21-0.13
Return on tangible assets
-0.06-0.22-0.09-0.16-0.04
Graham Net
2.56-6.24-9.34-13.53-10.65
Working capital
151.69M102.72M72.91M-972K475K
Tangible asset value
72.93M22.83M-6.32M-37.86M-34.35M
Net current asset value
35.79M-13.84M-41.36M-69.05M-65.97M
Invested capital
2.033.053.244.374.21
Average receivables
28.87M28.52M28.3M22.63M12.58M
Average payables
54.85M56.5M61.56M57.23M46.66M
Average inventory
15.64M14.69M13.72M12.72M11.6M
Days sales outstanding
156.2155.52204.5888.0521.12
Days payables outstanding
695.04667.53919.23563626.19
Days of inventory on hand
189.82165.11185.3140.97154.33
Receivables turnover
0.580.580.441.024.26
Payables turnover
0.130.130.10.160.14
Inventory turnover
0.470.550.490.640.58
ROE
-0.29-1.38-0.59-1.34-0.3
Capex per share
-0.17-0.0600-0.13

FBIOP Frequently Asked Questions

What is Fortress Biotech, Inc. stock symbol ?

Fortress Biotech, Inc. is a US stock , located in Bay harbor islands of Fl and trading under the symbol FBIOP

What is Fortress Biotech, Inc. stock quote today ?

Fortress Biotech, Inc. stock price is $16.7 today.

Is Fortress Biotech, Inc. stock public?

Yes, Fortress Biotech, Inc. is a publicly traded company.

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