Financial Performance - Fortress Biotech reported consolidated net revenue of $57.7 million for the full year ended December 31, 2024, down from $84.5 million in 2023, with dermatology product revenue decreasing from $59.7 million to $55.1 million[14]. - Fortress Biotech reported a net revenue of $57.675 million for the year ended December 31, 2024, a decrease of 31.7% compared to $84.513 million in 2023[19]. - Product revenue, net, was $55.134 million in 2024, down from $59.662 million in 2023, reflecting a decline of 7.5%[19]. - The net loss attributable to common stockholders was $(55.9) million, or $(2.69) per share, for 2024, an improvement from a net loss of $(68.7) million, or $(8.47) per share, in 2023[14]. - The net loss attributable to common stockholders for 2024 was $55.890 million, compared to a net loss of $68.669 million in 2023, showing an improvement of 18.5%[19]. - Fortress Biotech's net loss per common share attributable to common stockholders was $(2.69) in 2024, compared to $(8.47) in 2023, indicating a significant reduction in loss per share[19]. Expenses - Consolidated research and development expenses totaled $56.9 million for 2024, a significant decrease from $106.1 million in 2023[14]. - Research and development expenses were $56.629 million in 2024, down 44.4% from $101.747 million in 2023[19]. - Consolidated selling, general and administrative costs were $87.7 million for 2024, compared to $91.0 million in 2023[14]. - Total operating expenses decreased to $168.054 million in 2024 from $226.855 million in 2023, a reduction of 26%[19]. - The company reported a loss from operations of $110.379 million in 2024, an improvement from a loss of $142.342 million in 2023[19]. Cash and Assets - Fortress' cash and cash equivalents totaled $57.3 million as of December 31, 2024, down from $80.9 million at the end of 2023[14]. - Fortress Biotech's cash and cash equivalents decreased to $57.263 million as of December 31, 2024, from $80.927 million in 2023, a decline of 29%[18]. - Fortress Biotech's total assets decreased to $144.223 million in 2024 from $167.526 million in 2023, a decline of 13.9%[18]. - The company’s accumulated deficit increased to $(740.867) million in 2024 from $(694.870) million in 2023[18]. Strategic Developments - Fortress' subsidiary Checkpoint Therapeutics is set to be acquired by Sun Pharma, with Fortress expecting to receive approximately $28 million at closing and a 2.5% royalty on net sales of UNLOXCYT[2]. - The FDA accepted the New Drug Application for CUTX-101, with a PDUFA goal date of September 30, 2025[2]. - The commercial launch of Emrosi for treating inflammatory lesions of rosacea is underway, with initial prescriptions filled[2]. - Fortress raised total net proceeds of approximately $21.1 million through equity offerings in 2024[10]. - Fortress entered into a strategic collaboration with Partex NV to evaluate biopharmaceutical compounds using artificial intelligence for potential acquisition or licensing[10].

Core Insights - Fortress Biotech, Inc. announced significant developments including FDA approvals for Emrosi™ and UNLOXCYT™, and the acceptance of a New Drug Application for CUTX-101, indicating a transformative fourth quarter for the company [2][7] - The acquisition of Checkpoint Therapeutics by Sun Pharma is expected to enhance patient access to UNLOXCYT and provide Fortress with approximately $28 million at closing, along with a 2.5% royalty on net sales [2][3] - Fortress aims to leverage its pipeline of late clinical-stage candidates and recently approved products to drive revenue growth and shareholder value [2][10] Recent Corporate Highlights - Fortress' subsidiary Checkpoint Therapeutics is set to be acquired by Sun Pharma, with Fortress holding approximately 6.9 million shares of Checkpoint and eligible for a 2.5% royalty on future sales of UNLOXCYT [3] - The acquisition agreement includes an upfront cash payment of $4.10 per share for Checkpoint stockholders, plus a contingent value right potentially worth an additional $0.70 [3] - Fortress raised approximately $21.1 million through equity offerings in 2024, while Checkpoint raised about $32.8 million during the same period [11] Regulatory Updates - The FDA approved Emrosi (Minocycline Hydrochloride Extended-Release Capsules, 40mg) for treating inflammatory lesions of rosacea in November 2024, with commercial launch initiated in March 2025 [7][2] - UNLOXCYT was approved by the FDA in December 2024 for treating metastatic or locally advanced cutaneous squamous cell carcinoma [7] - The FDA accepted the New Drug Application for CUTX-101 for priority review, with a PDUFA goal date set for September 30, 2025 [7][2] Clinical Updates - Phase 3 clinical trials for Emrosi demonstrated its efficacy, safety, and tolerability in treating moderate-to-severe papulopustular rosacea, with results published in the Journal of the American Medical Association - Dermatology [7] - Clinical data for UNLOXCYT presented at the European Society for Medical Oncology Congress 2024 showed improved response rates over time [7] - A Phase 2 clinical trial for Triplex, a cytomegalovirus vaccine, commenced in January 2025, targeting patients undergoing hematopoietic stem cell transplantation [7] Financial Results - Fortress reported consolidated net revenue of $57.7 million for the year ended December 31, 2024, down from $84.5 million in 2023, with product revenue from dermatology products totaling $55.1 million [10][17] - Consolidated research and development expenses decreased to $56.9 million in 2024 from $106.1 million in 2023 [10][17] - The net loss attributable to common stockholders was $(55.9) million, or $(2.69) per share, for the year ended December 31, 2024, compared to a net loss of $(68.7) million, or $(8.47) per share, in 2023 [10][17]

Financial Data and Key Metrics Changes - Journey Medical reported annual revenue of $56 million in 2024, a decrease from $79 million in 2023, primarily due to higher rebate costs and lower unit volumes from legacy products [10][26] - Total net product revenue for 2024 was $55.1 million, down from $59.7 million in 2023 [26] - The net loss for 2024 was $14.7 million, or $0.72 per share, compared to a net loss of $3.9 million, or $0.21 per share in 2023 [30] - Non-GAAP adjusted EBITDA for 2024 was positive $800,000, down from $15.6 million in 2023 [31][32] - Cash and cash equivalents as of December 31, 2024, were $20.3 million, down from $27.4 million at the end of 2023 [32] Business Line Data and Key Metrics Changes - Research and development expenses increased by $2.3 million to $9.9 million in 2024, driven by non-recurring payments related to Emrosi's NDA filing [28][29] - Selling, general and administrative (SG&A) expenses decreased by $3.7 million to $40.2 million in 2024, attributed to expense optimization efforts [30] Market Data and Key Metrics Changes - Emrosi is entering a treatment category valued at over $1 billion, with expectations for significant operating leverage as it gains market traction [13][14] - As of early 2025, approximately 20% of commercial lives and 4% of Medicare lives have coverage for Emrosi, with expectations for substantial increases throughout the year [18][19] Company Strategy and Development Direction - The company is focused on the launch of Emrosi, which is expected to be a major growth driver, with peak annual sales estimated at $200 million in the U.S. and $100 million internationally [34] - Journey Medical plans to continue attending and presenting at dermatology-focused medical congresses throughout 2025 to promote Emrosi [23][35] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the launch of Emrosi and its potential to transform the business, highlighting the positive reception from dermatologists at recent conferences [15][17] - The company anticipates a ramp-up in payer coverage and prescription demand over the next 12 to 18 months [40][41] Other Important Information - Journey Medical completed a total of $22 million in FDA filing fees and milestone payments related to Emrosi in 2024 [11] - The company has received a $1 million milestone payment following regulatory approval for Amzeeq in China [27] Q&A Session Summary Question: What should be expected for payer coverage by the end of 2025? - Management expects peak commercial coverage to take 12 to 18 months, with ongoing efforts to increase covered lives [38][40] Question: How important was the erythema data to KOLs at AAD? - The head-to-head performance data was of significant interest, while erythema data was not a primary focus [42][44] Question: Thoughts on 2025 guidance? - Guidance for 2025 will be provided later in the year after assessing initial Emrosi prescription demand [52][54] Question: How has the reimbursement environment been? - Early indications show that around 20% coverage is on target, with prescriptions starting to come in [56][57] Question: Will Q1 report meaningful revenues from Emrosi? - Minimal revenues are expected in Q1, with more significant contributions anticipated in Q2 [59] Question: How is pricing across the legacy portfolio expected to change? - Pricing for legacy brands is expected to hold steady, with some erosion in volume due to competition [80][81] Question: What are the main bottlenecks for the Emrosi launch? - Supply and formulary coverage are key areas of focus, with ample supply already secured [86][88] Question: Will there be any pricing moves by competitors post-launch? - No significant pricing movements from competitors have been observed since the launch [104]

Core Insights - Partex NV and Fortress Biotech, Inc. have announced a strategic collaboration to utilize artificial intelligence in identifying and evaluating biopharmaceutical compounds for potential acquisition or licensing by Fortress [1][4]. Company Overview - Partex is an AI-driven biopharmaceutical company focused on revolutionizing drug discovery and development, aiming to accelerate the identification and commercialization of breakthrough therapies [5]. - Fortress Biotech is an innovative biopharmaceutical company that focuses on acquiring and advancing assets to enhance long-term shareholder value through product revenue, equity holdings, and dividend and royalty revenue [6]. Collaboration Details - Partex will deploy its proprietary AI-based drug discovery platform, which provides diverse recommendations on alternative targets and helps evaluate compounds across various therapeutic areas [2]. - The collaboration aims to leverage the strengths of both companies, combining Fortress's expertise in clinical development with Partex's advanced AI platform to enhance the efficiency of identifying and evaluating biopharmaceutical assets [3][4]. - The partnership is expected to expedite the search and evaluation process for differentiated assets, utilizing AI to maximize potential opportunities [4]. Business Development Focus - Fortress is focused on expanding its portfolio and business development opportunities, with a robust late-stage pipeline and the recent launch of two approved medicines [4]. - The collaboration with Partex is seen as a means to scale operations more efficiently and cost-effectively, enhancing long-term value for shareholders [4].

Core Viewpoint - Mustang Bio, Inc. has successfully closed a public offering, raising approximately $8 million through the issuance of 2,657,807 shares of common stock and accompanying warrants, aimed at funding working capital and corporate purposes [1][2]. Group 1: Offering Details - The public offering included 2,657,807 shares of common stock and Series C-1 and C-2 warrants, each with an exercise price of $3.01 per share [1]. - The Series C-1 warrants will expire five years from stockholder approval, while the Series C-2 warrants will expire in twenty-four months [1]. - The gross proceeds from the offering, before fees and expenses, were approximately $8 million [2]. Group 2: Use of Proceeds - Mustang intends to utilize the net proceeds from the offering for working capital and general corporate purposes [2]. Group 3: Company Overview - Mustang Bio, Inc. is a clinical-stage biopharmaceutical company focused on developing cell therapies for difficult-to-treat cancers [5]. - The company aims to acquire rights to innovative technologies and has partnered with leading medical institutions to advance CAR-T therapies [5]. - Mustang Bio's common stock is registered under the Securities Exchange Act of 1934, and it files periodic reports with the SEC [5].

Core Viewpoint - Mustang Bio, Inc. has announced a public offering of 2,657,807 shares of common stock and associated warrants at a price of $3.01 per share, aiming to raise approximately $8 million for working capital and corporate purposes [1][2]. Group 1: Offering Details - The public offering includes Series C-1 and Series C-2 warrants, each allowing the purchase of up to 2,657,807 shares at an exercise price of $3.01 [1]. - The Series C-1 warrants will expire five years from stockholder approval, while the Series C-2 warrants will expire twenty-four months from the same approval [1]. - The closing of the offering is expected around February 7, 2025, pending customary closing conditions [1]. Group 2: Financial Aspects - The gross proceeds from the offering are anticipated to be approximately $8 million before deducting fees and expenses [2]. - The net proceeds will be utilized for working capital and general corporate purposes [2]. Group 3: Company Overview - Mustang Bio, Inc. is a clinical-stage biopharmaceutical company focused on developing cell therapies for difficult-to-treat cancers [5]. - The company aims to acquire rights to innovative technologies through licensing or ownership, funding research and development, and bringing these technologies to market [5]. - Mustang has established partnerships with leading medical institutions to advance CAR-T therapy development [5].

Study is the first randomized, controlled trial examining a vaccine's effectiveness in controlling CMV in recipients of HSCT from vaccinated donors Encouraging pilot study results demonstrated the benefit of vaccinating donors with Triplex to convey protective CMV-specific T cell immunity to allogeneic HSCT recipients at risk for CMV reactivation MIAMI, Jan. 27, 2025 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (NASDAQ:FBIO) ("Fortress"), and its majority-owned subsidiary, Helocyte, Inc. ("Helocyte"), today a ...

Reverse Stock Split - Mustang Bio Inc announced a 1-for-50 reverse stock split of its issued and outstanding common stock, effective from January 16, 2025 [1] - The reverse stock split was approved by the Board of Directors and stockholders representing approximately 56% of the voting power on June 27, 2024 [2] - The number of outstanding shares will be reduced from approximately 64.8 million to approximately 1.3 million, with no fractional shares issued and proportional cash payments made instead [3] Compliance and Trading Details - The reverse stock split aims to bring the company into compliance with Nasdaq's $1.00 per share minimum bid price requirement for continued listing [2] - Mustang's common stock will continue to trade on Nasdaq under the symbol "MBIO" with a new CUSIP number of 62818Q302 [3] - VStock Transfer LLC is acting as the exchange and paying agent for the reverse stock split, providing instructions for physical share certificate exchanges [4] Company Overview - Mustang Bio Inc is a clinical-stage biopharmaceutical company focused on developing cell therapies for difficult-to-treat cancers [5] - The company partners with top medical institutions to advance CAR-T therapies and aims to license or acquire technologies for research and development [5] - Mustang was founded by Fortress Biotech Inc and its common stock is registered under the Securities Exchange Act of 1934 [5]

Core Insights - The FDA has granted a six-month priority review for CUTX-101, a potential first treatment for Menkes disease, with a target action date of June 30, 2025 [1][3] - CUTX-101 has shown promising clinical efficacy, with nearly 80% reduction in the risk of death for patients receiving early treatment compared to untreated controls [2][6] - Menkes disease is a rare and fatal pediatric condition with a prevalence estimated between 1 in 34,810 to 1 in 8,664 live male births [1][8] Company Overview - Sentynl Therapeutics, a biopharmaceutical company focused on rare diseases, is responsible for the development and commercialization of CUTX-101 [4][9] - The company was acquired by Zydus Group in 2017 and aims to address unmet medical needs through innovative therapies [9][10] - Fortress Biotech, which previously advanced the CUTX-101 program, continues to support its development [5][11] Product Details - CUTX-101 is a subcutaneous injectable formulation of copper histidinate, designed to improve tolerability and enhance neurodevelopmental outcomes in Menkes disease patients [6][7] - The drug has received multiple FDA designations, including Breakthrough Therapy and Orphan Drug Designation, indicating its potential significance in treating this condition [3][6] Market Context - There are currently no FDA-approved treatments for Menkes disease, highlighting a significant unmet need in the pediatric healthcare market [8][12] - The ongoing clinical trials and positive results for CUTX-101 may position it as a critical therapeutic option for affected children and their families [2][5]

Priority review granted for CUTX-101 with PDUFA target action date set for June 30, 2025 Cyprium is eligible to receive royalties and up to $129 million in aggregate development and sales milestones Cyprium also retains ownership over any Priority Review Voucher that may be issued at NDA approval MIAMI, Jan. 06, 2025 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) and its majority-owned subsidiary, Cyprium Therapeutics, Inc. (“Cyprium”), today announced the acceptance for review of th ...