MB-107

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 compelling interim data from Mustang’s multicenter Phase 1/2 clinical trial of MB-106 presented at the 2023 American Society of Hematology Annual Meeting, which builds upon the stellar data presented earlier in the year from the MB-106 Phase 1/2 single institution clinical trial conducted at Fred Hutch. In both the multicenter Phase 1/2 trial and the single institution Phase 1/2 trial, the observed deepening and durability of responses are very gratifying. We believe the CAR T-cell persistence of up to 3 years in the original single institution trial at Fred Hutch and up to 1 year in the current Mustang-sponsored multicenter trial are important potential contributors to the deepening and durability of responses," said Manuel Litchman, M.D., President and Chief Executive Officer of Mustang. "We plan to move ahead with the first ever registrational CAR-T trial focused on relapsed or refractory Waldenstrom macroglobulinemia (“WM”), a subtype of indolent lymphoma with no FDA-approved therapy or standard of care in the third-line setting and no FDA-approved CAR-T for any line of therapy. We expect to treat the first patient in the second half of 2024, which could enable topline results in the second half of 2026. In order to facilitate interactions with the FDA throughout this process, we anticipate requesting Regenerative Medicine Advanced Therapy (‘RMAT’) designation for indolent lymphoma – which includes WM – from the FDA in the first half of 2024. Advantages of the RMAT designation include all the benefits of the Fast Track and Breakthrough Therapy Designation programs, including early interactions with FDA.” Dr. Litchman continued, “Additionally, we are evaluating the potential to initiate a first-ever Phase 1 multicenter clinical trial at City of Hope (“COH”) and the University of Alabama at Birmingham (“UAB”) to assess the safety, tolerability and efficacy of MB-109, a novel combination of MB-101 (IL13Rα2‐targeted CAR T-cell therapy) and MB-108 (HSV-1 oncolytic virus) in adult patients with recurrent GBM and high-grade astrocytomas that express IL13Rα2 on the surface of the tumor cells. The combination leverages MB-108 to reshape the tumor microenvironment (“TME”) and make cold tumors “hot,” which could potentially enhance the clinical effect of MB-101 CAR T-cell therapy. As per a recent publication in Nature Medicine, two patients treated solely with MB-101 who had high levels of intratumoral CD3+ T-cells pre-therapy (i.e., “hot” tumors) achieved complete responses lasting 7.5 and 66+ months, respectively. Also noteworthy is our continued work with the Mayo Clinic to progress our exclusively licensed novel in vivo CAR-T technology platform, for which we anticipate an upcoming publication of proof-of-concept research in a murine tumor model in 2024." Financial Results: As of December 31, 2023, Mustang’s cash and cash equivalents and restricted cash totaled $7.0 million, compared to $76.7 million as of December 31, 2022, a decrease of $69.7 million year-over-year. In 2023 Mustang made a $30.4 million payment to terminate existing debt. Mustang continues to evaluate opportunities to reduce its cash utilization while focusing on its top priority development programs. Research and development expenses were $40.5 million for the year ended December 31, 2023, compared to $62.5 million for 2022. Non-cash, stock-based compensation expenses included in research and development were $0.1 million for the year ended December 31, 2023, compared to $1.6 million for 2022. Mustang recorded a gain on the sale of property and equipment of $1.5 million, in connection with the sale of assets to uBriGene. General and administrative expenses were $9.7 million for the year ended December 31, 2023, compared to $12.2 million for 2022. Non-cash, stock-based compensation expenses included in general and administrative expenses were $0.4 million for the year ended December 31, 2023, compared to $0.7 million for 2022. Net loss attributable to common stockholders was $51.6 million, or $6.00 per share, for the year ended December 31, 2023, compared to a net loss attributable to common stockholders of $77.5 million, or $10.09 per share, for 2022. 2023 and Recent Corporate Highlights: General Corporate: In July 2023, Mustang announced that it amended its previously announced asset purchase agreement with uBriGene (Boston) Biosciences Inc. (“uBriGene”) and closed the transaction. Per the terms of the amended asset purchase agreement, at closing, uBriGene acquired all of Mustang’s assets primarily relating to the manufacturing and production of cell and gene therapies at Mustang’s manufacturing facility in Worcester, Massachusetts, for upfront consideration of $6 million in cash. An additional $5 million contingent payment will be payable to Mustang upon (i) Mustang raising $10 million in gross proceeds from equity raises following the closing of the transaction and (ii) completion of the assignment of Mustang’s lease to uBriGene, which remains subject to landlord’s approval, within two years of the closing. Unless and until the lease is transferred to uBriGene, Mustang will retain its facility lease and facility personnel and will continue to occupy the leasehold premises and manufacture there its lead product candidate, MB-106. Clearance for assignment of Mustang’s lease to uBriGene remains under review by the U.S. Committee on Foreign Investment in the United States (“CFIUS”), and Mustang and uBriGene are continuing discussions with CFIUS regarding the nature and extent of national security risk posed by the assignment. In October 2023, Mustang completed a registered direct offering priced at-the-market for approximately $4.4 million in gross proceeds. MB-106 (CD20-targeted CAR T-cell therapy): Mustang’s lead clinical candidate is MB-106, a CD20-targeted, autologous CAR T-cell therapy to treat a wide range of hematologic malignancies, including WM and follicular lymphoma (“FL”). MB-106 continues to demonstrate a favorable safety and efficacy pro both the Fred Hutch single institution and Mustang multicenter Phase 1/2 clinical trials. In December 2023, Mustang announced initial data from its ongoing multicenter, open-label, non-randomized Phase 1/2 clinical trial evaluating the safety and efficacy of MB-106 CAR T-cell therapy at the 2023 American Society of Hematology (ASH) Annual Meeting. Initial data show that all patients responded clinically to treatment with MB-106 (n=9), with a 100% overall response rate for patients with FL and WM. 100% of patients with FL (n=5) had a complete response; 1 very good partial response and 2 partial responses were observed in WM patients (n=3); and the hairy cell leukemia variant (“HCL-v”) patient experienced stable disease, with prolonged, ongoing independence from blood transfusions. Complete responses were observed in patients previously treated with CD19-targeted CAR T-cell therapy. MB-106 demonstrated a tolerable safety pro patients with indolent NHL, with no occurrence of cytokine release syndrome (“CRS”) above grade 1, and no immune effector cell-associated neurotoxicity syndrome (“ICANS”) of any grade, despite not using prophylactic tocilizumab or dexamethasone. Outpatient administration was allowed and found to be feasible. MB-106 CAR T-cell expansion and persistence in patients was demonstrated. The FDA granted Orphan Drug Designation to MB-106 for the treatment of WM, and results from this arm of the multicenter trial are expected to support an accelerated Phase 2 registration strategy for WM, with the first pivotal Phase 2 patient with WM to be treated potentially in 2024. Mazyar Shadman, M.D., M.P.H., Study Chair, Associate Professor and physician at Fred Hutch and University of Washington, also presented data from the ongoing Fred Hutch Phase 1/2 clinical trial specific to two B-cell non-Hodgkin lymphoma cohorts, FL and WM. In the FL data cohort (n=20), an overall response rate (“ORR”) of 95% was seen, of which 80% of patients experienced a complete response and 15% had a partial response. The complete response patients include a patient who was previously treated with a CD19-directed CAR T-cell therapy. Of the six patients who experienced cytokine release syndrome (“CRS”), only one had Grade 2, while the remaining five had Grade 1. Ten patients continue to experience complete response for more than 10 months, four patients have experienced complete response for more than two years (all ongoing), and the first patient enrolled has sustained complete response for more than 3 years. In the WM cohort (n=6), all of whom had received prior Bruton tyrosine kinase inhibitor, two patients experienced complete response, one of whom continues to be in complete response at more than 22 months; 1 patient experienced a very good partial response; and 1 patient experienced a partial response. No patients experienced CRS or ICANS greater than Grade 2. None of the six patients with WM has needed to start new therapy for their disease. MB-109 (IL13Rα2-targeted CAR T-cells + HSV-1 oncolytic virus for recurrent glioblastoma): In October 2023, Mustang announced that the FDA accepted the Company’s IND to initiate a Phase 1 open label, multicenter clinical trial to assess the safety, tolerability and efficacy of MB-109, a novel combination of MB-101 (IL13Rα2‐targeted CAR T-cell therapy) and MB-108 (HSV-1 oncolytic virus), for the treatment of recurrent GBM and high-grade astrocytoma. Mustang is evaluating plans to initiate the clinical trial and request orphan drug designation for GBM, subject to resource allocation, in 2024. As previously reported, preclinical data presented at the American Association for Cancer Research (“AACR”) Annual Meeting 2022 supported this combination therapy to optimize results to treat recurrent GBM. The combination leverages MB-108 to make cold tumors “hot,” thereby potentially improving the efficacy of MB-101 CAR T-cell therapy. In March 2024, data from the Phase 1 trial evaluating MB-101 IL13Rα2-targeted CAR T-cells in high-grade glioma were published in Nature Medicine. MB-101 was well tolerated and 50% of patients achieved stable disease or better, with two partial responses and two complete responses in high grade glioma patients. The two patients who achieved complete response both had high levels of intratumoral CD3+ T-cells pre-therapy (i.e., “hot” tumors), and their responses lasted 7.5 and 66+ months, respectively. In the cohort with dual intratumoral (ICT)/ intraventricular (ICV) delivery and an optimized manufacturing process there was a ~70% improvement in median overall survival (10.2 months) compared to the expected survival rate of six months in this patient population. In Vivo CAR-T Technology Platform: Mustang continues to collaborate with the Mayo Clinic to progress our exclusively licensed novel in vivo CAR-T technology platform that may be able to transform the administration of CAR-T therapies and has the potential to be used as an off-the-shelf therapy. Mustang anticipates the publication of proof-of-concept research in a murine tumor model in 2024. MB-117 and MB-217 Lentiviral Gene Therapies for X-Linked Severe Combined Immunodeficiency (XSCID): In 2024, the first patients are expected to be treated in both new investigator-sponsored trials for newborns diagnosed with XSCID and for previously transplanted patients with XSCID. These trials with MB-117 and MB-217, respectively, are planned by our partners and will test a modified version of the current lentiviral vector. About Mustang Bio Mustang Bio, Inc. is 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. Mustang aims to acquire rights to these technologies by licensing or otherwise acquiring an ownership interest, to fund research and development, and to outlicense or bring the technologies to market. Mustang has partnered with top medical institutions to advance the development of CAR-T therapies across multiple cancers, as well as lentiviral gene therapies for severe combined immunodeficiency. Mustang’s common stock is registered under the Securities Exchange Act of 1934, as amended, and Mustang files periodic reports with the U.S. Securities and Exchange Commission (“SEC”). Mustang was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). For more information, visit Forward‐Looking Statements This press release contains “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, each as amended. Such statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. These forward-looking statements, include, but are not limited to, any statements relating to our growth strategy and product development programs, including the timing of and our ability to make regulatory filings such as INDs and other applications and to obtain regulatory approvals for our product candidates, statements concerning the potential of therapies and product candidates and any other statements that are not historical facts. Actual events or results may differ materially from those described in this press release due to a number of risks and uncertainties. Risks and uncertainties include, among other things, risks related to the satisfaction of the conditions necessary to transfer the lease of Mustang’s manufacturing facility and receive the contingent payment in connection with Mustang’s sale of its manufacturing facility in the anticipated timeframe or at all; whether the purchaser of Mustang’s manufacturing facility is able to successfully perform its obligation to produce Mustang’s products under the manufacturing services agreement on a timely basis and to acceptable standards; disruption from the sale of Mustang’s manufacturing facility making it more difficult to maintain business and operational relationships; negative effects of the announcement or the consummation of the transaction on the market price of Mustang’s common stock; significant transaction costs; the development stage of Mustang’s primary product candidates, our ability to obtain, perform under, and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; risks relating to the timing of starting and completing clinical trials; uncertainties relating to preclinical and clinical testing; 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 Part I, Item 1A, “Risk Factors,” in our Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q, and our other filings we make with the SEC. 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 required by applicable law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Company Contacts: Jaclyn Jaffe and Nicole McCloskey Mustang Bio, Inc. (781) 652-4500 ir@mustangbio.com MUSTANG BIO, INC. Balance Sheets (in thousands, except for share and per share amounts) December 31, December 31, 2023 2022 ASSETS Current Assets: Cash and cash equivalents $ 6,234 $ 75,656 Other receivables - related party - 36 Other receivables 3,879 263 Prepaid expenses and other current assets 1,233 2,897 Total current assets 11,346 78,852 Property, plant and equipment, net 3,218 8,440 Fixed assets - construction in process 29 951 Restricted cash 750 1,000 Other assets 833 261 Operating lease right-of-use asset, net 1,566 2,918 Total Assets $ 17,742 $ 92,422 LIABILITIES AND STOCKHOLDERS’ EQUITY Current Liabilities: Accounts payable and accrued expenses $ 14,017 $ 13,731 Payables and accrued expenses - related party 834 766 Operating lease liabilities - short-term 520 612 Total current liabilities 15,371 15,109 Deferred income 270 270 Note payable, long-term, net - 27,436 Operating lease liabilities - long-term 1,978 3,334 Total Liabilities 17,619 46,149 Stockholders’ Equity Preferred stock ($0.0001 par value), 2,000,000 shares authorized, 250,000 shares of Class A preferred stock issued and outstanding as of December 31, 2023 and 2022, respectively — — Common stock ($0.0001 par value), 200,000,000 shares authorized as of December 31, 2023 and 2022, respectively Class A common shares, 845,385 shares issued and outstanding as of December 31, 2023 and 2022, respectively — — Common shares, 8,374,869 and 7,100,111 shares issued and outstanding as of December 31, 2023 and 2022, respectively 1 11 Common stock issuable, 419,089 and 187,134 shares as of December 31, 2023 and 2022, respectively 591 1,109 Additional paid-in capital 380,502 374,522 Accumulated deficit (380,971 ) (329,369 ) Total Stockholders’ Equity 123 46,273 Total Liabilities and Stockholders’ Equity $ 17,742 $ 92,422 MUSTANG BIO, INC. Statements of Operations (in thousands, except for share and per share amounts) For the year ended December 31, 2023 2022 Operating expenses: Research and development $ 40,513 $ 62,475 Research and development – licenses acquired 527 1,474 Gain on the sale of property and equipment (1,466 ) — General and administrative 9,686 12,210 Total operating expenses 49,260 76,159 Loss from operations (49,260 ) (76,159 ) Other income (expense) Other income 917 1,304 Interest income 850 689 Interest expense (4,109 ) (3,359 ) Total other income (expense) (2,342 ) (1,366 ) Net Loss $ (51,602 ) $ (77,525 ) Net loss per common share outstanding, basic and diluted $ (6.00 ) $ (10.09 ) Weighted average number of common shares outstanding, basic and diluted 8,604,104 7,684,508

Total consolidated net revenue was $34.8 million in the third quarter of 2023, a 100% increase from total consolidated net revenue of $17.4 million in the second quarter of 2023 Fortress is advancing several late-stage clinical assets with three potential NDA and BLA submissions to FDA through year-end of 2024 across our portfolio1, including a NDA submission for DFD-29 to treat rosacea, anticipated around year-end of 2023 MIAMI, Nov. 14, 2023 (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 financial results and recent corporate highlights for the third quarter ended September 30, 2023. Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, “In the third quarter of 2023, Fortress and our partner companies and subsidiaries continued to advance our diverse portfolio of drug candidates. Our total consolidated net revenue this quarter was $34.8 million, which includes an upfront payment of $19 million that Journey Medical received upon entering into an exclusive license agreement with Maruho for commercialization of Qbrexza® in additional territories in Asia. We’re looking forward to multiple significant near-term milestones, including potentially up to four New Drug Application (“NDA”) and Biologics License Application (“BLA”) submissions to the U.S. Food and Drug Administration (“FDA”) between 2023 and 2025, one of which is a NDA for DFD-29 to treat rosacea around the end of this year. We are also anticipating the PDUFA goal date of January 3, 2024, for cosibelimab, our investigational anti-PD-L1 antibody, as a treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma (“cSCC”).” Recent Corporate Highlights2: Marketed Dermatology Products Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”), our partner company, primarily focuses on selling and marketing of prescription dermatology products.In September 2023, Journey Medical entered into an exclusive license agreement with Maruho Co., Ltd. (“Maruho”), a Japanese company specializing in dermatology as well as Journey’s exclusive licensing partner that developed and is commercializing Qbrexza® (Rapifort®) in Japan. Under the terms of the Agreement, Journey Medical received a $19 million nonrefundable upfront payment and granted Maruho an exclusive license to develop and commercialize Qbrexza (glycopyrronium tosylate hydrate) for the treatment of hyperhidrosis in South Korea, Taiwan, Hong Kong, Macau, Thailand, Indonesia, Malaysia, Philippines, Singapore, Vietnam, Brunei, Cambodia, Myanmar and Laos (the “Territory”). Maruho is responsible for all development and commercialization costs for the program throughout the Territory.Journey Medical’s total net revenues in the third quarter of 2023 were $34.5 million, an increase of $18.4 million, or 114%, compared to total net revenues of $16.1 million in the third quarter of 2022.Journey Medical’s total product net revenues were $15.3 million for the third quarter of 2023, compared to third quarter 2022 total product net revenues of $16.0 million. Fortress, through its subsidiaries, partner companies and partners, has a broad and diverse pipeline of clinical-stage programs being evaluated in over 20 ongoing clinical trials. We look forward to potential filings of up to four NDA and BLA submissions from 2023 through 2025, including: DFD-29 – modified release oral minocycline for rosaceaCosibelimab – anti-PD-L1 antibody for solid tumorsCUTX-101 – copper histidinate for Menkes diseaseCAEL-101 – light chain fibril-reactive monoclonal antibody for AL amyloidosis We also expect to continue to advance our early-to-mid-clinical-stage candidates, some of which may begin pivotal trials during the next twelve to eighteen months, including: Dotinurad – urate transporter (URAT1) inhibitor for gout and hyperuricemiaIV tramadol – intravenous small molecule for acute post-operative painMB-106 – CD20-targeted CAR-T cell therapy for hematologic malignanciesTriplex – multi-antigen, modified vaccinia Ankara-based (MVA) vaccine for cytomegalovirus (CMV)MB-117 – ex vivo lentiviral gene therapy for newborns with XSCID (X-linked severe combined immunodeficiency)MB-217 – ex vivo lentiviral gene therapy for previously transplanted children and young adults with XSCIDAJ201 – Nrf1 and Nrf2 activator, androgen receptor degradation enhancer for spinal and bulbar muscular atrophy (SBMA), also known as Kennedy’s DiseaseBAER-101 – GABAA α2/3 positive allosteric modulator for refractory epilepsiesMB-109 – IL13Rα2-targeted CAR-T cell therapy combined with HSV-1 oncolytic virus for recurrent glioblastoma and high-grade astrocytomas General Corporate: In November 2023, Fortress raised approximately $10.0 million in gross proceeds in a public offering.In October 2023, Fortress effected a 1-for-15 reverse stock split of its issued and outstanding common stock to bring the Company into compliance with Nasdaq’s minimum bid price requirement for continued listing. Financial Results: As of September 30, 2023, Fortress’ consolidated cash, cash equivalents and restricted cash totaled $74.7 million, compared to $89.2 million as of June 30, 2023, a decrease of $14.5 million during the quarter.Fortress’ consolidated cash, cash equivalents and restricted cash, totaling $74.7 million as of September 30, 2023, includes $37.7 million attributable to Fortress and private subsidiaries, $0.2 million attributable to Avenue, $1.8 million attributable to Checkpoint, $10.3 million attributable to Mustang Bio and $24.7 million attributable to Journey Medical.Subsequent to the end of the third quarter, in November 2023, Fortress raised approximately $10.0 million in gross proceeds in a public offering and Avenue raised approximately $5.0 million in gross proceeds in a public offering. In addition, in October 2023, Checkpoint raised approximately $11.1 million in gross proceeds from the exercise of warrants and Mustang Bio raised approximately $4.4 million in gross proceeds in a registered direct offering.Fortress’ consolidated net revenue totaled $34.8 million for the third quarter of 2023, which included $15.3 million in net product revenue generated from our marketed dermatology products. This compares to consolidated net revenue totaling $16.5 million for the third quarter of 2022, which included $16.0 million in net product revenue generated from our marketed dermatology products.Consolidated research and development expenses including license acquisitions were $20.3 million for the third quarter of 2023, compared to $29.9 million for the third quarter of 2022.Consolidated selling, general and administrative expenses were $21.7 million for the third quarter of 2023, compared to $30.1 million for the third quarter of 2022.Consolidated net loss attributable to common stockholders was $7.1 million, or $0.94 per share, for the third quarter of 2023, compared to consolidated net loss attributable to common stockholders of $24.5 million, or $4.11 per share for the third quarter of 2022. About Fortress Biotech Fortress Biotech, Inc. (“Fortress”) is an innovative biopharmaceutical company focused on efficiently acquiring, developing and commercializing or monetizing promising therapeutic products and product candidates. The company has eight marketed prescription pharmaceutical products and over 25 programs in development at Fortress, at its majority-owned and majority-controlled partners and subsidiaries and at partners and subsidiaries 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 focused on leveraging its significant biopharmaceutical industry expertise and network 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 AstraZeneca, City of Hope, Fred Hutchinson Cancer Center, St. Jude Children’s Research Hospital, Nationwide Children’s Hospital and Sentynl. For more information, visit www.fortressbiotech.com. Forward-Looking StatementsThis 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, ability to generate shareholder value, ability of our products to receive necessary approvals, including FDA approval, ability of our products and therapies to help patients 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; financing and strategic agreements and relationships; our need for substantial additional funds and uncertainty relating to financings; our ability to identify, acquire, close and integrate product candidates successfully and on a timely basis; our ability to attract, integrate and retain key personnel; the early stage of products under development; 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; the ability to secure and maintain third-party manufacturing, marketing and distribution of our and our partner companies’ products and product candidates; 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, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. 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 Contact:Jaclyn JaffeFortress Biotech, Inc.(781) 652-4500ir@fortressbiotech.com Media Relations Contact:Tony Plohoros6 Degrees(908) 591-2839tplohoros@6degreespr.com FORTRESS BIOTECH, INC. AND SUBSIDIARIESUnaudited Condensed Consolidated Balance Sheets ($ in thousands except for share and per share amounts) September 30, December 31, 2023 2022 ASSETS Current assets Cash and cash equivalents$72,307 $178,266 Accounts receivable, net 7,989 28,208 Inventory 11,024 14,159 Other receivables - related party 165 138 Prepaid expenses and other current assets 6,341 9,661 Total current assets 97,826 230,432 Property, plant and equipment, net 6,854 13,020 Operating lease right-of-use asset, net 17,507 19,991 Restricted cash 2,438 2,688 Intangible asset, net 21,102 27,197 Other assets 4,822 973 Total assets$ 150,549 $ 294,301 LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) Current liabilities Accounts payable and accrued expenses$81,406 $97,446 Income taxes payable 84 — Common stock warrant liabilities 5,430 13,869 Operating lease liabilities, short-term 2,413 2,447 Partner company convertible preferred shares, short-term, net 3,797 2,052 Partner company line of credit — 2,948 Partner company installment payments - licenses, short-term, net 3,000 7,235 Other short-term liabilities 1,221 1,718 Total current liabilities 97,351 127,715 Notes payable, long-term, net 45,791 91,730 Operating lease liabilities, long-term 18,944 21,572 Partner company installment payments - licenses, long-term, net — 1,412 Other long-term liabilities 1,706 1,847 Total liabilities 163,792 244,276 Commitments and contingencies Stockholders’ equity (deficit) Cumulative redeemable perpetual preferred stock, $0.001 par value, 15,000,000 authorized, 5,000,000 designated Series A shares, 3,427,138 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively, liquidation value of $25.00 per share 3 3 Common stock, $0.001 par value, 200,000,000 shares authorized, 8,937,587 and 7,366,283 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively 9 7 Additional paid-in-capital 702,253 675,944 Accumulated deficit (685,591) (634,233)Total stockholders' equity attributed to the Company 16,674 41,721 Non-controlling interests (29,917) 8,304 Total stockholders' equity (deficit) (13,243) 50,025 Total liabilities and stockholders' equity (deficit)$ 150,549 $ 294,301 FORTRESS BIOTECH, INC. AND SUBSIDIARIESUnaudited Condensed Consolidated Statements of Operations($ in thousands except for share and per share amounts) Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022Revenue Product revenue, net$15,279 $16,043 $44,405 $55,074 Collaboration revenue 182 364 546 1,518 Revenue - related party 31 48 97 118 Other revenue 19,260 73 19,519 2,629 Net revenue 34,752 16,528 64,567 59,339 Operating expenses Cost of goods sold - product revenue 6,429 7,221 20,645 23,057 Research and development 20,288 29,855 87,702 99,707 Research and development - licenses acquired 60 47 4,293 48 Selling, general and administrative 21,733 30,139 71,512 85,457 Asset impairment — — 3,143 — Total operating expenses 48,510 67,262 187,295 208,269 Loss from operations (13,758) (50,734) (122,728) (148,930) Other income (expense) Interest income 547 419 2,296 711 Interest expense and financing fee (2,534) (3,393) (13,255) (8,897)Change in fair value of warrant liabilities 4,542 — 10,708 — Other income 620 648 (2,049) 648 Total other income (expense) 3,175 (2,326) (2,300) (7,538)Loss before income tax expense (10,583) (53,060) (125,028) (156,468) Income tax expense 141 — 142 — Net loss (10,724) (53,060) (125,170) (156,468) Net loss attributable to non-controlling interests 5,679 30,549 73,812 96,841 Net loss attributable to Fortress (5,045) (22,511) (51,358) (59,627) Preferred A dividends declared and paid (2,008) (2,008) (6,024) (6,024)Net loss attributable to common stockholders $ (7,053) $ (24,519) $ (57,382) $ (65,651) Net loss per common share attributable to common stockholders - basic and diluted$(0.94) $(4.11) $(7.94) $(11.15) Weighted average common shares outstanding - basic and diluted 7,498,653 5,961,663 7,231,004 5,886,131 _______________1 Includes CAEL-101, an asset in development at Caelum Biosciences (a former subsidiary now 100% owned by AstraZeneca’s Alexion) with respect to which Fortress remains eligible to receive substantial milestone payments.2 The development programs depicted in this press release include product candidates in development at Fortress, at Fortress’ private subsidiaries (referred to herein as “subsidiaries”), at Fortress’ public subsidiaries (referred to herein as “partner companies”) and at entities with which one of the foregoing parties has a significant business relationship, such as an exclusive license or an ongoing product-related payment obligation (such entities referred to herein as “partners”). The words “we”, “us” and “our” may refer to Fortress individually, to one or more of our subsidiaries and/or partner companies, or to all such entities as a group, as dictated by context.