WORCESTER, Mass., May 02, 2024 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. ("Mustang" or the "Company") (NASDAQ:MBIO), a clinical-stage biopharmaceutical company focused on translating today's medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers, today announced the closing of its previously announced public offering for the purchase and sale of an aggregate of 16,877,638 shares of its common stock (or common stock equivalents in lieu thereof), Series A-1 warrants t ...

WORCESTER, Mass., April 29, 2024 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. ("Mustang" or the "Company") (NASDAQ:MBIO), a clinical-stage biopharmaceutical company focused on translating today's medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers and rare genetic diseases, today announced the pricing of a public offering of an aggregate of 16,877,638 shares of its common stock (or common stock equivalents in lieu thereof), Series A-1 warrants to purchase up to 16,8 ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2023 Delaware 20-5157386 (State or Other Jurisdiction of Incorporation or Organization) (I.R.S. Employer Identification No.) 1111 Kane Concourse Suite 301 Bay Harbor Islands, FL 33154 33154 (Address of Principal Executive Offices) (Zip Code) Registrant's telephone number, including are ...

[Executive Summary](index=1&type=section&id=Executive%20Summary) Fortress Biotech achieved record $84.5 million net revenue in 2023, anticipating up to four regulatory decisions, including DFD-29's NDA acceptance, by November 2024 [2023 Performance and Strategic Outlook](index=1&type=section&id=2023%20Performance%20and%20Strategic%20Outlook) Fortress Biotech achieved record $84.5 million net revenue in 2023, with up to four regulatory decisions, including DFD-29's NDA acceptance, expected by November 2024 - Record consolidated net revenue of **$84.5 million** for full-year 2023[1](index=1&type=chunk)[2](index=2&type=chunk) - Up to **four regulatory decisions** (NDAs/BLAs) expected in the next 18 months[1](index=1&type=chunk)[2](index=2&type=chunk) - FDA accepted NDA filing for DFD-29 (rosacea treatment) with PDUFA goal date of **November 4, 2024**[1](index=1&type=chunk)[2](index=2&type=chunk) [Company Information](index=3&type=section&id=Company%20Information) Fortress Biotech is a biopharmaceutical company focused on acquiring and advancing assets across oncology, rare diseases, and gene therapy [About Fortress Biotech](index=3&type=section&id=About%20Fortress%20Biotech) Fortress Biotech acquires and advances assets to generate shareholder value, managing seven marketed products and over 25 development programs in oncology, rare diseases, and gene therapy - Core Business: Acquiring and advancing assets to generate product, equity, dividend, and royalty revenue for shareholders[8](index=8&type=chunk) - Portfolio Scope: **Seven marketed prescription products** and over **25 development programs** in oncology, rare diseases, and gene therapy[8](index=8&type=chunk) - Operational Strategy: Streamlined operating structure, leveraging biopharmaceutical expertise and network, with partnerships including AstraZeneca and City of Hope[8](index=8&type=chunk) [2023 and Recent Corporate Highlights](index=1&type=section&id=2023%20and%20Recent%20Corporate%20Highlights) This section details Fortress Biotech's recent regulatory milestones, corporate developments, and financial activities in 2023 and early 2024 [Regulatory Milestones and Updates](index=1&type=section&id=Regulatory%20Milestones%20and%20Updates) Fortress submitted DFD-29's NDA for rosacea in Jan 2024, accepted by FDA in March with a PDUFA goal date of November 4, 2024 - DFD-29 NDA Submission & Acceptance: Submitted **Jan 2024**, accepted **March 2024**, for rosacea treatment[3](index=3&type=chunk) - PDUFA Goal Date: **November 4, 2024**, for DFD-29[3](index=3&type=chunk) - Market Potential: DFD-29 could be the only oral, systemic therapy for both inflammatory lesions and erythema of rosacea[3](index=3&type=chunk) [General Corporate Developments](index=2&type=section&id=General%20Corporate) Key developments include a CRL for cosibelimab, anticipated CAEL-101 BLA in 2025, CUTX-101 asset transfer, Qbrexza licensing, and 2023 fundraising - Cosibelimab BLA: FDA issued CRL in **Dec 2023** due to third-party manufacturing findings; resubmission expected for **2024 marketing approval**[6](index=6&type=chunk) - CAEL-101 (AstraZeneca): BLA submission anticipated in **2025**, with potential for approximately **$148 million** in milestone payments to Fortress[6](index=6&type=chunk) - CUTX-101: Asset transfer to Sentynl completed in **Dec 2023**; Cyprium Therapeutics retains **100% ownership** of any FDA priority review voucher[6](index=6&type=chunk) - MB-109: FDA accepted Investigational New Drug application for a Phase 1 clinical trial for recurrent GBM and high-grade astrocytoma[6](index=6&type=chunk) - Journey Medical - Qbrexza Licensing: Entered exclusive license agreement with Maruho for hyperhidrosis treatment in South Korea and other Asian territories, receiving a **$19 million nonrefundable upfront payment**[6](index=6&type=chunk) Journey Medical Net Revenues (YoY) | Metric | 2023 (Millions) | 2022 (Millions) | Change (%) | | :-------------------- | :-------------- | :-------------- | :--------- | | Total Net Revenues | $79.2 | $73.7 | +7% | | Total Product Net Revenues | $59.7 | $71.0 | -15.9% | - Fortress Fundraising: Raised approximately **$34.9 million** in gross proceeds through registered direct offerings and a public offering in **2023 and Jan 2024**[6](index=6&type=chunk) - Reverse Stock Split: Effected a **1-for-15 reverse stock split** in **October 2023** to meet Nasdaq's minimum bid price requirement[6](index=6&type=chunk) - 4DMT Asset Purchase: Agreement for short-form human complement factor H asset, with potential payments up to **~$140 million** in late-stage development, regulatory, and sales milestones, plus single-digit royalties[6](index=6&type=chunk) [Financial Review](index=3&type=section&id=Financial%20Review) This section provides a detailed analysis of Fortress Biotech's financial performance, including revenues, expenses, and balance sheet changes for 2023 [Summary of Key Financials](index=3&type=section&id=Financial%20Results) Fortress Biotech reported $84.5 million net revenue in 2023, an 11.6% increase, with reduced operating expenses and an improved net loss of $(68.7) million Consolidated Cash, Cash Equivalents and Restricted Cash | Date | Amount (Millions) | Change (YoY) | Change (QoQ) | | :---------------- | :---------------- | :----------- | :----------- | | Dec 31, 2023 | $83.4 | -$97.6M | +$8.7M | | Sep 30, 2023 | $74.7 | - | - | | Dec 31, 2022 | $181.0 | - | - | Consolidated Net Revenue (YoY) | Metric | 2023 (Millions) | 2022 (Millions) | Change (%) | | :-------------------- | :-------------- | :-------------- | :--------- | | Total Net Revenue | $84.5 | $75.7 | +11.6% | | Net Revenue from Marketed Dermatology Products | $59.7 | $71.0 | -15.9% | Consolidated Operating Expenses (YoY) | Metric | 2023 (Millions) | 2022 (Millions) | Change (%) | | :-------------------- | :-------------- | :-------------- | :--------- | | R&D Expenses (incl. licenses) | $106.1 | $134.9 | -21.3% | | SG&A Costs | $94.1 | $113.7 | -17.2% | Consolidated Net Loss Attributable to Common Stockholders (YoY) | Metric | 2023 (Millions) | 2022 (Millions) | Change (%) | | :-------------------- | :-------------- | :-------------- | :--------- | | Net Loss | $(68.7) | $(94.6) | +27.4% | | Net Loss Per Share | $(8.47) | $(15.97) | +47.0% | - Subsequent Fundraising (Jan 2024): Fortress raised **~$11.0 million**, Checkpoint **~$14.0 million**, and Avenue **~$5.0 million** in gross proceeds[9](index=9&type=chunk) [Consolidated Balance Sheets](index=5&type=section&id=Consolidated%20Balance%20Sheets) Total assets decreased to $167.5 million as of December 31, 2023, driven by reduced cash, with total stockholders' equity declining to $1.6 million Balance Sheet Highlights (Dec 31, 2023 vs Dec 31, 2022) | Metric | 2023 (Thousands) | 2022 (Thousands) | Change (Thousands) | Change (%) | | :-------------------------------- | :--------------- | :--------------- | :----------------- | :--------- | | Cash and cash equivalents | $80,927 | $178,266 | $(97,339) | -54.6% | | Total current assets | $117,022 | $230,432 | $(113,410) | -49.2% | | Total assets | $167,526 | $294,301 | $(126,775) | -43.1% | | Total current liabilities | $84,908 | $127,715 | $(42,807) | -33.5% | | Total liabilities | $165,939 | $244,276 | $(78,337) | -32.1% | | Total stockholders' equity (deficit) | $1,587 | $50,025 | $(48,438) | -96.8% | [Consolidated Statements of Operations](index=6&type=section&id=Consolidated%20Statements%20of%20Operations) Net revenue increased 11.6% to $84.5 million in 2023, driven by collaboration and other revenues, with operating expenses decreasing by 18.8% Revenue Breakdown (2023 vs 2022) | Revenue Type | 2023 (Thousands) | 2022 (Thousands) | Change (Thousands) | Change (%) | | :-------------------- | :--------------- | :--------------- | :----------------- | :--------- | | Product revenue, net | $59,662 | $70,995 | $(11,333) | -15.9% | | Collaboration revenue | $5,229 | $1,882 | $3,347 | +177.8% | | Other revenue | $19,519 | $2,674 | $16,845 | +630.0% | | **Net revenue** | **$84,513** | **$75,743** | **$8,770** | **+11.6%** | Operating Expenses (2023 vs 2022) | Expense Type | 2023 (Thousands) | 2022 (Thousands) | Change (Thousands) | Change (%) | | :-------------------------------- | :--------------- | :--------------- | :----------------- | :--------- | | Cost of goods sold - product revenue | $26,660 | $30,775 | $(4,115) | -13.4% | | Research and development | $101,747 | $134,199 | $(32,452) | -24.2% | | Research and development - licenses acquired | $4,324 | $677 | $3,647 | +538.7% | | Selling, general and administrative | $94,124 | $113,656 | $(19,532) | -17.2% | | **Total operating expenses** | **$226,855** | **$279,307** | **$(52,452)** | **-18.8%** | Net Loss Attributable to Common Stockholders (2023 vs 2022) | Metric | 2023 (Thousands) | 2022 (Thousands) | Change (Thousands) | Change (%) | | :-------------------------------- | :--------------- | :--------------- | :----------------- | :--------- | | Net loss attributable to common stockholders | $(68,669) | $(94,607) | $25,938 | +27.4% | | Net loss per common share - basic and diluted | $(8.47) | $(15.97) | $7.50 | +47.0% | | Weighted average common shares outstanding | 8,110,906 | 5,924,967 | 2,185,939 | +36.9% | [Legal and Contact Information](index=4&type=section&id=Legal%20and%20Contact%20Information) This section outlines the company's forward-looking statement disclaimer and provides essential contact information for investor and media relations [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) All non-historical statements are forward-looking, subject to risks in growth, financing, development, and regulatory approval, with no obligation to update - Nature of Statements: Non-historical statements are forward-looking, subject to risks and uncertainties[10](index=10&type=chunk) - Risk Factors: Include growth strategy, financing, product development, regulatory approval, commercialization, manufacturing, intellectual property, and competition[10](index=10&type=chunk) - Disclaimer: Company disclaims obligation to update forward-looking statements, except as required by law[10](index=10&type=chunk) [Company Contact Information](index=4&type=section&id=Company%20Contact%3A) This section provides contact details for Fortress Biotech's investor relations and media relations - Company Contact: Jaclyn Jaffe, Fortress Biotech, Inc., **(781) 652-4500**, ir@fortressbiotech.com[11](index=11&type=chunk) - Media Relations Contact: Tony Plohoros, 6 Degrees, **(908) 591-2839**, tplohoros@6degreespr.com[11](index=11&type=chunk)

MIAMI, March 12, 2024 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (NASDAQ:FBIO) ("Fortress"), an innovative biopharmaceutical company focused on efficiently acquiring, developing and commercializing or monetizing promising therapeutic products and product candidates, today announced that Lindsay A. Rosenwald, M.D., Chairman, President and Chief Executive Officer, will participate in a fireside chat at the 36th Annual ROTH Conference on Monday, March 18, 2024, at 2:00 p.m. PT in Dana Point, California. The Co ...

WORCESTER, Mass., March 11, 2024 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. ("Mustang" or the "Company") (NASDAQ:MBIO), a clinical-stage biopharmaceutical company focused on translating today's medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers and rare genetic diseases, today announced financial results and recent corporate highlights for the full-year ended December 31, 2023. "2023 was an exciting year for Mustang filled with many highlights, including compelli ...

MB-101 was well-tolerated and 50% of patients achieved stable disease or better with two partial responses and two complete responses lasting 7.5 and 66+ months, respectively ~70% improvement in median overall survival compared to expected survival rate in cohort with dual intratumoral (ICT)/ intraventricular (ICV) delivery and an optimized manufacturing process This is the largest reported trial to date of CAR-T therapy for solid tumors WORCESTER, Mass., March 07, 2024 (GLOBE NEWSWIRE) -- Mustang Bio, Inc ...

LOS ANGELES--(BUSINESS WIRE)--A pioneering Phase 1 CAR T cell therapy trial for the treatment of glioblastoma at City of Hope, one of the largest cancer treatment and research organizations in the United States, demonstrates promising clinical activity against incurable brain tumors, according to research published today in Nature Medicine. The study, which is the largest reported trial to date of CAR T therapy for solid tumors, evaluated CAR T cells engineered to target the tumor-associated antigen inte ...

Encouraging preclinical studies demonstrate potential to combine AAV-ATP7A gene therapy with CUTX-101, which could be the first FDA-approved treatment for Menkes disease Cyprium Therapeutics, a majority-owned subsidiary of Fortress Biotech, is developing AAV-ATP7A gene therapy to be used in conjunction with CUTX-101 for the treatment of Menkes disease MIAMI, March 04, 2024 (GLOBE NEWSWIRE) -- Cyprium Therapeutics, Inc. ("Cyprium"), a majority-owned subsidiary of Fortress Biotech, Inc. (NASDAQ:FBIO) ("Fortre ...

PART I. FINANCIAL INFORMATION [Unaudited Condensed Consolidated Financial Statements](index=5&type=section&id=Item%201.%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for Fortress Biotech, Inc. and its subsidiaries, including balance sheets, statements of operations, and cash flows, for the three and nine months ended September 30, 2023, and 2022, along with explanatory notes Consolidated Balance Sheet Highlights (Unaudited) | ($ in thousands) | Sep 30, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $72,307 | $178,266 | | Total current assets | $97,826 | $230,432 | | Total assets | $150,549 | $294,301 | | **Liabilities & Equity** | | | | Total current liabilities | $97,351 | $127,715 | | Total liabilities | $163,792 | $244,276 | | Total stockholders' equity (deficit) | $(13,243) | $50,025 | Consolidated Statements of Operations Highlights (Unaudited) | ($ in thousands) | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | :--- | :--- | | Net revenue | $34,752 | $16,528 | $64,567 | $59,339 | | Loss from operations | $(13,758) | $(50,734) | $(122,728) | $(148,930) | | Net loss | $(10,724) | $(53,060) | $(125,170) | $(156,468) | | Net loss attributable to common stockholders | $(7,053) | $(24,519) | $(57,382) | $(65,651) | | Net loss per common share - basic and diluted | $(0.94) | $(4.11) | $(7.94) | $(11.15) | - On October 9, 2023, the company effected a **1-for-15 reverse stock split** of its common stock, with all share and per-share information retroactively adjusted[46](index=46&type=chunk)[48](index=48&type=chunk) - Current cash, including proceeds from a November 2023 offering, is believed sufficient to fund operations for at least the next 12 months, though additional funding will be required for further development and commercialization[51](index=51&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=46&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial performance, condition, and liquidity, highlighting recent corporate and clinical developments, a significant Q3 revenue increase, reduced operating expenses, and various financing activities Q3 2023 vs Q3 2022 Operational Results Comparison | ($ in thousands) | Q3 2023 | Q3 2022 | Change $ | Change % | | :--- | :--- | :--- | :--- | :--- | | Net revenue | $34,752 | $16,528 | $18,224 | 110% | | Research and development | $20,288 | $29,855 | $(9,567) | (32)% | | Selling, general and administrative | $21,733 | $30,139 | $(8,406) | (28)% | | Loss from operations | $(13,758) | $(50,734) | $36,976 | (73)% | | Net loss attributable to Fortress | $(5,045) | $(22,511) | $17,466 | (78)% | - Net revenue for Q3 2023 increased by **110% year-over-year**, primarily due to a **$19 million non-refundable upfront payment** from Maruho for an expanded Qbrexza® license agreement[239](index=239&type=chunk)[259](index=259&type=chunk)[267](index=267&type=chunk) - Operating expenses significantly decreased in Q3 2023, with R&D expenses falling by **32%** and SG&A expenses dropping by **28%**, driven by cost reduction initiatives at Mustang, Checkpoint, and Journey[270](index=270&type=chunk)[273](index=273&type=chunk)[276](index=276&type=chunk) - Subsequent to quarter-end, Fortress raised approximately **$8.9 million net**, Avenue raised approximately **$5.0 million gross**, Mustang raised approximately **$4.4 million gross**, and Checkpoint raised approximately **$11.1 million gross** through various offerings and warrant exercises[252](index=252&type=chunk)[255](index=255&type=chunk) - Key clinical updates include a PDUFA goal date of **January 3, 2024**, for cosibelimab, ongoing rolling NDA submission for CUTX-101, and an expected NDA submission for DFD-29 in the second half of 2023[240](index=240&type=chunk)[242](index=242&type=chunk) [Quantitative and Qualitative Disclosures About Market Risks](index=63&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risks) As a 'smaller reporting company,' Fortress Biotech, Inc. is exempt from providing quantitative and qualitative disclosures about market risks - The company, as a 'smaller reporting company' under Item 10 of Regulation S-K, is not required to provide quantitative and qualitative disclosures about market risks[318](index=318&type=chunk) [Controls and Procedures](index=64&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of September 30, 2023, with no material changes in internal control over financial reporting during the quarter - The principal executive and financial officers concluded that the company's disclosure controls and procedures are **effective** as of September 30, 2023[320](index=320&type=chunk) - No material changes in internal control over financial reporting occurred during the most recent quarter[321](index=321&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=64&type=section&id=Item%201.%20Legal%20Proceedings) No material developments occurred in previously disclosed legal proceedings during the quarter, with routine litigation not expected to have a material adverse effect - No material developments occurred in previously disclosed legal proceedings for the quarter ended September 30, 2023[323](index=323&type=chunk) [Risk Factors](index=64&type=section&id=Item%201A.%20Risk%20Factors) This section outlines substantial investment risks, including drug development uncertainties, a history of operating losses, reliance on Journey Medical's revenue, dependence on third-party manufacturing, intellectual property protection, and regulatory compliance - The company has a history of operating losses, totaling **$203.6 million in 2022**, and expects them to continue, necessitating substantial additional funding that may not be available on favorable terms[351](index=351&type=chunk)[359](index=359&type=chunk) - A majority of operating income is expected from Journey Medical's dermatology products, a revenue stream vulnerable to generic competition, patent challenges, and reimbursement issues[364](index=364&type=chunk)[365](index=365&type=chunk)[366](index=366&type=chunk) - The company heavily relies on third parties for critical functions, including manufacturing of all clinical and commercial products and conducting clinical trials, which introduces control and operational risks[405](index=405&type=chunk)[412](index=412&type=chunk) - The debt agreement with Oaktree contains restrictive covenants that may limit the company's ability to finance future operations, make acquisitions, or pursue other business activities[350](index=350&type=chunk) - Risks related to the business structure include acting as a guarantor for subsidiaries, potential conflicts of interest for officers serving multiple entities, and the complexity of integrating acquisitions[391](index=391&type=chunk)[394](index=394&type=chunk)[398](index=398&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=99&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities occurred during the period - No unregistered sales of equity securities were reported[507](index=507&type=chunk) [Defaults Upon Senior Securities](index=99&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities occurred during the period - No defaults upon senior securities were reported[507](index=507&type=chunk) [Mine Safety Disclosures](index=99&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's operations - This item is not applicable to the company[507](index=507&type=chunk) [Other Information](index=99&type=section&id=Item%205.%20Other%20Information) No other material information is reported for the period - No other information was reported[508](index=508&type=chunk) [Exhibits](index=100&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including corporate governance documents and CEO/CFO certifications required by the Sarbanes-Oxley Act - Exhibits include corporate governance documents, such as the Amended and Restated Certificate of Incorporation and bylaws, and officer certifications required under Sections 302 and 906 of the Sarbanes-Oxley Act[510](index=510&type=chunk)[513](index=513&type=chunk)