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)

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-35366 FORTRESS BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 20-5157386 (State or other ju ...

Financial Performance - Journey's commercial portfolio generated net revenue of $12.2 million for the three months ended March 31, 2023, down from $20.8 million in the same period of 2022[179]. - For the three months ended March 31, 2023, net revenue was $12.4 million, a decrease of 48% from $23.9 million in the same period of 2022[196][207]. - Product revenue, net decreased by $8.6 million, or 42%, primarily due to higher gross-to-net allowances and lower unit sales volumes for key products[205][207]. - The company reported a net loss attributable to common stockholders of $21.5 million for the three months ended March 31, 2023, an increase of 37% from a net loss of $15.8 million in the same period of 2022[205]. - As of March 31, 2023, the company had an accumulated deficit of $655.7 million, indicating ongoing financial challenges[198]. - Collaboration revenue decreased to $0.2 million in Q1 2023 from $0.6 million in Q1 2022, reflecting changes in project timelines[196][208]. - Total other income increased by $5.9 million, or 269%, from a loss of $2.2 million in Q1 2022 to an income of $3.7 million in Q1 2023[216]. - Cash used in operating activities decreased by $3.6 million from $46.9 million in Q1 2022 to $43.2 million in Q1 2023[221]. - Net cash provided by financing activities decreased by $32.8 million from $50.0 million in Q1 2022 to $17.2 million in Q1 2023[223]. - Cash and cash equivalents as of March 31, 2023, totaled $152.5 million, with $55.3 million related to Fortress[224]. Research and Development - Research and development expenses for the three months ended March 31, 2023 were approximately $35.3 million, a slight decrease from $36.7 million in the same period of 2022[200]. - Research and development spending at Checkpoint increased by $1.1 million, primarily due to increased regulatory costs[212]. - The increase in research and development licenses acquired was $4.2 million, or 100%, due to a new license with AnnJi[213]. - Research and development expenses decreased by $1.4 million, or 4%, from $36.7 million in Q1 2022 to $35.3 million in Q1 2023[210]. Product Development and Milestones - CUTX-101 demonstrated a 79% reduction in the risk of death in patients treated within four weeks of birth compared to historical controls, with median overall survival of 177.1 months versus 16.1 months[184]. - Cosibelimab's Biologics License Application was accepted by the FDA with a PDUFA goal date of January 3, 2024, indicating no potential filing review issues[184]. - DFD-29 achieved a 66.04% treatment success rate in Investigator's Global Assessment compared to 33.33% for Oraycea, demonstrating nearly double the efficacy[184]. - MB-106 is generating favorable safety and efficacy data, with a product profile compared to CD19-directed CAR Ts that have an annualized run rate of $3 billion in net sales[190]. - Dotinurad was approved in Japan in 2020 and is expected to begin pivotal clinical trials in early 2024, following positive Phase 3 results in over 1,000 patients[190]. - The FDA is expected to accept AstraZeneca's BLA submission for CAEL-101 for review during calendar year 2024[184]. - Fortress's subsidiaries and partner companies are actively pursuing multiple late-stage product candidates, including CAEL-101 and CUTX-101, with significant clinical milestones anticipated in 2023 and 2024[184]. Expenses and Cost Management - Selling, general and administrative expenses were approximately $25.3 million for the three months ended March 31, 2023, compared to $26.3 million in the same period of 2022[202]. - Cost of goods sold decreased by $1.8 million, or 21%, primarily due to lower product royalties related to decreased sales volumes[209]. - Stock-based compensation expenses decreased by $473,000, or 33%, from $1.42 million in Q1 2022 to $947,000 in Q1 2023[210]. - General and administrative expenses decreased by $0.9 million, or 4%, from $26.3 million in Q1 2022 to $25.3 million in Q1 2023[214]. Financing Activities - The company completed a registered direct offering in February 2023, raising approximately $13.9 million in gross proceeds[194]. - Mustang executed a 15-for-1 reverse stock split in April 2023 to comply with Nasdaq listing requirements[194]. - For the three-month period ended March 31, 2023, the Company issued approximately 0.6 million shares at an average price of $0.76, resulting in gross proceeds of $0.5 million[227]. - On February 10, 2023, the Company completed a registered direct offering, issuing 16,642,894 shares at a purchase price of $0.835 per share, securing approximately $13.3 million in net proceeds[228]. - As of March 31, 2023, approximately $11.1 million of securities remain available for sale under the 2020 Shelf registration statement[227]. - As of March 31, 2023, approximately $14.8 million of the Checkpoint shelf remains available for sale through the Checkpoint 2020 S-3[233]. - In March 2023, Checkpoint filed a new shelf registration statement allowing for the sale of up to $150 million of its securities, effective May 5, 2023[234]. - During the three months ended March 31, 2023, Urica issued an aggregate of 34,160 Urica Class B Preferred Stock at a price of $25.00 per share, for gross proceeds of $0.8 million[238]. - Avenue received $2.8 million in net proceeds from a registered direct offering and concurrent private placement of common stock and warrants[236]. - As of March 31, 2023, there have been no sales of securities under the Mustang 2021 S-3 registration statement[231]. - The Company has determined that liability classification is appropriate for certain instruments, which were accounted for as liabilities as of March 31, 2023[238]. - There were no material changes in the Company's contractual obligations and commitments during the three months ended March 31, 2023[239].

☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2022 or Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from ____ to _____. Commission File No. 001-35366 FORTRESS BIOTECH, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 20-5157386 (State or Oth ...

Fortress Biotech Corporate Presentation September 2022 BIOTECH Forward Looking Statements This presentation may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. For such forward-looking statements, we claim the protection of the safe harbor for forward- looking statements contained in the Private Securities Litigation Reform Act of 1995. As used below and throughout this prese ...