Urica Therapeutics, Inc.

PDUFA goal date of November 4, 2024 for DFD-29 for the treatment of inflammatory lesions and erythema of rosacea in adults FDA accepted Biologics License Application resubmission for cosibelimab to treat metastatic or locally advanced cutaneous squamous cell carcinoma; PDUFA goal date of December 28, 2024 MIAMI, Aug. 13, 2024 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty revenue, today announced financial results and recent corporate highlights for the second quarter ended June 30, 2024. Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, “We had a very productive first half of the year and we anticipate an exciting second half, as we have a New Drug Application (“NDA”) and a Biologics License Application (“BLA”) on file with the U.S. Food and Drug Administration (“FDA”) from our diversified portfolio, both with PDUFA goal dates in the fourth quarter, including DFD-29 for rosacea and cosibelimab for metastatic and locally advanced cutaneous squamous cell carcinoma (“cSCC”). Our late-stage candidates could generate up to three regulatory approvals in the next 12 months and a potential fourth BLA submission as early as 2025. Additionally, we had a solid second quarter 2024 of product revenue from our marketed dermatology products of $14.9 million, representing growth of approximately 15% compared to first quarter 2024 product revenues of $13.0 million. We continue to prioritize the development of our candidates and the expansion of our business for long-term success. This involves business development efforts and the growth of additional revenue streams, all aimed at benefiting our shareholders. Our business model provides the potential for significant growth as we acquire new assets and our subsidiary and partner companies grow in value, allowing for the opportunity to collect diversified cashflows such as royalties, milestones, product revenues, cash and stock dividends and through meaningful monetizations.” Recent Corporate Highlights1: Regulatory Updates In March 2024, the FDA accepted the NDA for DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) and set a PDUFA goal date of November 4, 2024. If approved, DFD-29 has the potential to be the new treatment paradigm for the millions of patients suffering from inflammatory lesions and erythema of rosacea. Both double blinded, randomized controlled DFD-29 Phase 3 clinical trials achieved their co-primary and all secondary endpoints with subjects completing the 16-week treatment with no significant safety issues. DFD-29 demonstrated statistical superiority compared to both Oracea capsules and placebo for Investigator’s Global Assessment (IGA) treatment success and the reduction in the total inflammatory lesion count in both clinical trials. Additionally, DFD-29 showed significantly superior reduction in Clinicians Erythema Assessment compared to placebo in both of the Phase 3 clinical trials. DFD-29 is currently in development at our partner company, Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”).In July 2024, the FDA accepted the BLA resubmission for cosibelimab, our investigational anti-PD-L1 antibody, as a treatment for patients with metastatic or locally advanced cSCC who are not candidates for curative surgery or radiation, and set a PDUFA goal date of December 28, 2024. In June 2024, we reached alignment with the FDA on our BLA resubmission strategy for cosibelimab and announced the resubmission of the BLA in July 2024. Cosibelimab is currently in development at our partner company, Checkpoint Therapeutics, Inc. (Nasdaq: CKPT) (“Checkpoint”). Clinical Updates In May 2024, we announced that the last patient had completed dosing in a Phase 1b/2a study evaluating AJ201 in the U.S. for the treatment of spinal and bulbar muscular atrophy (“SBMA”), also known as Kennedy’s Disease. SBMA is a debilitating rare genetic neuromuscular disease primarily affecting men. Topline data for the Phase 1b/2a clinical trial of AJ201 to treat SBMA are currently expected in the second half of 2024. A webcast replay of the Key Opinion Leader event that took place in April 2024 highlighting expert perspectives on SBMA is available on the Events page of Avenue’s website at https://avenuetx.com/. AJ201 is currently in development at our partner company, Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue”).The Phase 2 clinical trial of Triplex, a cytomegalovirus vaccine, for adults co-infected with Human Immunodeficiency Virus (“HIV”) and CMV is now fully enrolled with topline data anticipated in the fourth quarter of 2024. The study aims to show that vaccination with Triplex can safely elicit a CMV-specific immune response and reduce asymptomatic CMV replication in a population of people with HIV on suppressive antiretroviral therapy. The study will also evaluate whether this intervention might reduce chronic inflammation and immune activation, as compared to placebo, and thus, potentially reduce related mortality and morbidity. Triplex is currently in development at our subsidiary company, Helocyte, Inc.In May 2024, we announced that the first patient was dosed in a multi-center, placebo-controlled, randomized Phase 2 study of Triplex, a vaccine for control of CMV, in patients undergoing liver transplantation. The trial will enroll up to 416 CMV seronegative prospective liver transplant recipients and will be conducted across up to 20 nationally recognized transplant centers in the U.S. The trial is funded by a grant from the National Institute of Allergy and Infectious Diseases of the National Institutes of Health that could provide over $20 million in non-dilutive funding. We believe this data set could ultimately be used to support the approval of Triplex in this setting. Other Updates In July 2024, we announced a collaboration to explore the combined therapeutic potential of cosibelimab, our anti-PD-L1 antibody, with GC Cell’s Immuncell-LC, an innovative autologous Cytokine Induced Killer (“CIK”) T cell therapy composed of cytotoxic T lymphocytes and natural killer T cells.In July 2024, our majority owned and controlled subsidiary company, Urica Therapeutics, Inc. (“Urica”), entered into an asset purchase agreement, royalty agreement, and related agreements (collectively, the “Transaction Documents”) with Crystalys Therapeutics, Inc. (“Crystalys”). Crystalys is a Delaware corporation incorporated in 2022 and seeded by leading life sciences institutional investors. Under the Transaction Documents, Urica transferred rights to its URAT1 inhibitor product candidate in development for the treatment of gout, dotinurad, and related intellectual property, licenses and agreements to Crystalys. In return, Crystalys issued to Urica shares of its common stock equal to 35% of Crystalys’ outstanding equity. The Transaction Documents also grant Urica a securitized three percent (3%) royalty on future net sales of dotinurad to be paid by Crystalys, as well as the right to receive nominal cash reimbursement payments for certain clinical and development costs incurred by Urica related to dotinurad.In October 2023, we announced an exclusive worldwide option agreement with City of Hope (“COH”) to license certain intellectual property relating to a CMV/HIV bi-specific Chimeric Antigen Receptor (“CAR”) (collectively, CMV/HIV-CAR) T cell program for the treatment of adults living with HIV, optionally in combination with Triplex. Additionally, the California Institute for Regenerative Medicine awarded a $11.3 million grant to COH to fund a Phase 1 clinical trial involving the CMV/HIV-CAR T. In preclinical studies, administration of the bi-specific CAR T cells followed by administration of a CMV vaccine successfully eradicated HIV, including from latent reservoirs. Commercial Product Updates Journey Medical’s total net revenues for the second quarter ended June 30, 2024 were $14.9 million, compared to total net revenues of $13.0 million for the first quarter ended March 31, 2024. General Corporate: In April 2024, Avenue announced the exercise of warrants for $4.4 million in gross proceeds and a 1-for-75 reverse split of its issued and outstanding common stock.In May and June 2024, Mustang Bio raised approximately $6.5 million across two offerings of its common stock and warrants.In July 2024, Checkpoint raised $12 million in a registered direct offering priced at-the-market under Nasdaq rules.In July 2024, Fortress’ Board of Directors paused the payment of dividends on the Company’s 9.375% Series A Cumulative Redeemable Perpetual Preferred Stock (the “Series A Preferred Stock”) until further notice. The Company believes pausing the dividend is in the best interest of the Company and its stakeholders to maintain financial flexibility ahead of potentially significant inflection points. Dividends on the Series A Preferred Stock accrue in accordance with their terms; the pausing of these dividends will defer approximately $0.7 million in cash dividend payments each month. The Board intends to revisit its decision regarding the monthly dividend regularly and will assess the profitability and cash flow of the Company to determine whether and when the suspension should be lifted.Also in July 2024, Fortress reduced its total debt by entering into a new loan agreement maturing in July 2027 with funds managed by Oaktree Capital Management, L.P. (“Oaktree”), a leading global investment firm. The Company received an initial tranche of $35 million and is eligible to draw an additional $15 million with Oaktree’s consent. In connection with the new loan agreement, the Company repaid its prior term loan with Oaktree of $50 million resulting in a net paydown of $15 million of debt excluding accrued interest and prepayment fees. Financial Results: As of June 30, 2024, Fortress’ consolidated cash and cash equivalents totaled $76.2 million, compared to $83.8 million as of March 31, 2024 and compared to $80.9 million as of December 31, 2023, a decrease of $7.6 million during the quarter and a decrease of $4.7 million year-to-date.Fortress’ consolidated cash and cash equivalents, totaling $76.2 million as of June 30, 2024, includes $38.2 million attributable to Fortress and the private subsidiaries, $4.9 million attributable to Avenue, $5.0 million attributable to Checkpoint, $4.3 million attributable to Mustang Bio and $23.9 million attributable to Journey Medical. Fortress’ consolidated cash and cash equivalents totaled $80.9 million as of December 31, 2023, which included $40.6 million attributable to Fortress and private subsidiaries, $1.8 million attributable to Avenue, $4.9 million attributable to Checkpoint, $6.2 million attributable to Mustang Bio and $27.4 million attributable to Journey Medical. Fortress’ consolidated net revenue totaled $14.9 million for the second quarter ended June 30, 2024, most of which was generated from our marketed dermatology products. This compares to consolidated revenue totaling $17.4 million for the second quarter of 2023, which included $17.0 million in revenue generated from our marketed dermatology products.Consolidated research and development expenses including license acquisitions totaled $12.7 million for the second quarter ended June 30, 2024, compared to $32.1 million for the second quarter ended June 30, 2023.Consolidated selling, general and administrative costs were $20.8 million for the second quarter ended June 30, 2024, compared to $24.4 million for the second quarter ended June 30, 2023.Consolidated net loss attributable to common stockholders was $(13.3) million, or $(0.73) per share, for the second quarter ended June 30, 2024, compared to net loss attributable to common stockholders of $(26.9) million, or $(3.65) per share for the second quarter ended June 30, 2023. About Fortress Biotech Fortress Biotech, Inc. (“Fortress”) is an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty revenue. The company has seven marketed prescription pharmaceutical products and over 20 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. Fortress’ portfolio is being commercialized and developed for various therapeutic areas including oncology, dermatology, and rare diseases. Fortress’ model is focused on leveraging its significant biopharmaceutical industry expertise and network to further expand and advance 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, Nationwide Children’s Hospital and Sentynl. For more information, visit www.fortressbiotech.com. Forward-Looking StatementsStatements in this press release that are not descriptions of historical facts are “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. The words “anticipates,” “believes,” “can,” “continue,” “could,” “estimates,” “expects,” “intends,” “may,” “might,” “plans,” “potential,” “predicts,” “should,” or “will” or the negative of these terms or other comparable terminology are generally intended to identify forward-looking statements. These 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; the ongoing UTRF litigation and our indemnification of Caelum in connection therewith; our need for substantial additional funds and uncertainties 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; our ability to obtain regulatory approval for products under development; our ability to successfully commercialize products for which we receive regulatory approval or receive royalties or other distributions from third parties; our 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) June 30, December 31, 2024 2023 ASSETS Current assets Cash and cash equivalents $76,201 $80,927 Accounts receivable, net 10,465 15,222 Inventory 9,687 10,206 Other receivables - related party 224 167 Prepaid expenses and other current assets 4,649 10,500 Assets held for sale 2,209 — Total current assets 103,435 117,022 Property, plant and equipment, net 3,546 6,505 Operating lease right-of-use asset, net 14,626 16,990 Restricted cash 2,063 2,438 Intangible assets, net 18,658 20,287 Other assets 3,357 4,284 Total assets $ 145,685 $ 167,526 LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) Current liabilities Accounts payable and accrued expenses $68,921 $73,562 Income taxes payable 806 843 Common stock warrant liabilities 172 886 Operating lease liabilities, short-term 2,481 2,523 Partner company convertible preferred shares, short-term, net — 3,931 Partner company installment payments - licenses, short-term, net 3,000 3,000 Other short-term liabilities 163 163 Total current liabilities 75,543 84,908 Notes payable, long-term, net 67,007 60,856 Operating lease liabilities, long-term 15,934 18,282 Other long-term liabilities 1,799 1,893 Total liabilities 160,283 165,939 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 June 30, 2024 and December 31, 2023, respectively, liquidation value of $25.00 per share 3 3 Common stock, $0.001 par value, 200,000,000 shares authorized, 22,587,038 and 15,093,053 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively 23 15 Additional paid-in-capital 739,086 717,396 Accumulated deficit (721,235) (694,870)Total stockholders' equity attributed to the Company 17,877 22,544 Non-controlling interests (32,475) (20,957)Total stockholders' equity (deficit) (14,598) 1,587 Total liabilities and stockholders' equity (deficit) $ 145,685 $ 167,526 FORTRESS BIOTECH, INC. AND SUBSIDIARIESUnaudited Condensed Consolidated Statements of Operations($ in thousands except for share and per share amounts) Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023Revenue Product revenue, net $14,855 $16,961 $27,885 $29,126 Collaboration revenue — 183 — 364 Revenue - related party 41 31 41 66 Other revenue — 211 — 259 Net revenue 14,896 17,386 27,926 29,815 Operating expenses Cost of goods sold - product revenue 6,541 7,767 13,357 14,216 Research and development 12,671 32,139 37,495 67,415 Research and development - licenses acquired — 3 — 4,233 Selling, general and administrative 20,823 24,439 38,777 49,780 Asset impairment 2,649 3,143 2,649 3,143 Total operating expenses 42,684 67,491 92,278 138,787 Loss from operations (27,788) (50,105) (64,352) (108,972) Other income (expense) Interest income 734 715 1,567 1,751 Interest expense and financing fee (2,122) (6,425) (4,724) (10,721)Change in fair value of warrant liabilities — (512) — 6,166 Gain (loss) on common stock warrant liabilities 70 — (597) — Loss from deconsolidation of subsidiaries — (3,369) — (3,369)Other income (expense) 282 395 260 699 Total other income (expense) (1,036) (9,196) (3,494) (5,474)Net loss (28,824) (59,301) (67,846) (114,446) Net loss attributable to non-controlling interests 17,876 34,525 41,481 68,133 Net loss attributable to Fortress $ (10,948) $ (24,776) $ (26,365) $ (46,313) Net loss attributable to common stockholders $ (13,339) $ (26,917) $ (31,199) $ (50,595) Net loss per common share attributable to common stockholders - basic and diluted $(0.73) $(3.65) $(1.76) $(7.14) Weighted average common shares outstanding - basic and diluted 18,316,874 7,377,332 17,736,299 7,086,482 1 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 whom 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.

Fortress is advancing several late-stage clinical assets with two NDA submissions anticipated in second half of 2023 PDUFA goal date of January 3, 2024 set by FDA for cosibelimab to treat metastatic or locally advanced cutaneous squamous cell carcinoma MIAMI, May 15, 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 first quarter ended March 31, 2023. Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, “Fortress and our subsidiaries and partner companies continued advancing our promising clinical-stage drug candidates for a wide range of diseases during the first quarter of 2023. We expect data updates from multiple clinical programs in the coming months, including Phase 3 topline results for DFD-29 to treat papulopustular rosacea (“PPR”) in June of 2023. We also expect to report dose escalation and response data for MB-106, a CD20-targeted, autologous CAR T cell therapy to treat relapsed or refractory B-cell non-Hodgkin lymphomas (“B-NHL”) and chronic lymphocytic leukemia (“CLL”), throughout the year. Dotinurad for the treatment of gout and Triplex for the treatment of cytomegalovirus continue to advance in clinical trials and we anticipate a dotinurad Phase 1 topline data readout in U.S. healthy volunteers in the second quarter of this year.” Dr. Rosenwald continued, “On the regulatory front, we expect the rolling New Drug Application (“NDA”) submission for CUTX-101 to treat Menkes disease to be complete by the end of 2023. We also anticipate filing an NDA for DFD-29 in the second half of 2023 and look forward to the January 3, 2024, Prescription Drug User Fee Act (“PDUFA”) goal date for cosibelimab to treat patients with metastatic or locally advanced cutaneous squamous cell carcinoma (“cSCC”). Overall, it is an exciting time for Fortress as we advance potential treatments for patients in need while focusing on increasing shareholder value.” Recent Corporate Highlights1: Cosibelimab (Anti PD-L1 antibody) Our partner company, Checkpoint Therapeutics, Inc. (Nasdaq: CKPT) (“Checkpoint”), submitted a Biologics License Application (“BLA”) to the FDA for cosibelimab, its investigational anti-PD-L1 antibody, as a treatment for patients with metastatic or locally advanced cSCC who are not candidates for curative surgery or radiation, in January 2023. In March 2023, the FDA accepted the BLA filing for cosibelimab and set a PDUFA goal date of January 3, 2024. In its BLA filing acceptance letter, the FDA indicated that no potential filing review issues have been identified, and that an advisory committee meeting to discuss the application is not currently planned. According to U.S. prescription claims data, in 2021, approximately 11,000 cSCC patients were treated with systemic therapies. As PD-1 inhibitors comprised less than half of patient prescriptions, cSCC remains a disease with a need for more effective and tolerable treatment options, particularly for the significant number of cSCC patients with immunosuppressive conditions or autoimmune diseases. With its unique mechanism of action and compelling safety profile, we believe cosibelimab, if approved, would be uniquely positioned to provide an important new treatment option for cSCC patients that are currently underserved by available therapies.Cosibelimab was sourced by Fortress and is currently in development at Checkpoint. Dotinurad (Urate Transporter (URAT1) Inhibitor) Dotinurad is in development for the treatment of gout. We anticipate topline data from the Phase 1 trial to evaluate dotinurad in healthy volunteers in the United States in the second quarter of 2023 and expect to begin pivotal clinical trials in early 2024.Dotinurad (URECE® tablet) was approved in Japan in 2020 as a once-daily oral therapy for gout and hyperuricemia. Dotinurad was efficacious and well-tolerated in more than 500 Japanese patients treated for up to 58 weeks in Phase 3 clinical trials. The clinical program supporting approval included over 1,000 patients.Dotinurad was sourced by Fortress and is currently in development at Urica. MB-106 (CD20-targeted CAR T Cell Therapy) Mustang Bio, Inc.’s (Nasdaq: MBIO) (“Mustang Bio”) lead clinical candidate is MB-106, a CD20-targeted, autologous CAR T cell therapy to treat relapsed or refractory B-NHL and CLL. MB-106 data to date include an overall response rate of 96% and complete response rate of 75% in a wide range of hematologic malignancies, including Waldenstrom macroglobulinemia (“WM”), in a clinical trial conducted by Mustang Bio’s collaborators at Fred Hutch. In parallel, Mustang Bio’s multicenter, open-label, non-randomized Phase 1/2 clinical trial evaluating the safety and efficacy of MB-106 continues to accrue, and Mustang Bio anticipates escalation to the final dose level in the Phase 1 indolent lymphoma arm in the third quarter of this year. The FDA granted Orphan Drug Designation to MB-106 for the treatment of WM, and Mustang Bio has treated the first WM patient in the indolent lymphoma arm of the trial. Results from this arm are expected to support an accelerated Phase 2 registration strategy for WM, with the first pivotal Phase 2 WM patient potentially to be treated in the first quarter of 2024. In the second quarter of this year, Mustang Bio plans to report safety and efficacy data from the indolent lymphoma arm.Phase 1/2 data from the Fred Hutch clinical trial on MB-106, a CD20-targeted, autologous CAR T cell therapy for patients with relapsed or refractory B-NHL and CLL, will be presented at the European Hematology Association Hybrid Congress (“EHA2023”) taking place June 8-11, 2023, in Frankfurt, Germany and at the International Conference on Malignant Lymphoma (“ICML”) taking place June 13-17, 2023, in Lugano, Switzerland. Data from the WM cohort were selected for poster presentation at EHA2023 and outpatient treatment of follicular lymphoma was selected for oral presentation at ICML.MB-106 was sourced by Fortress and is currently in development at Mustang Bio. CUTX-101 (Copper Histidinate for Menkes disease) Our subsidiary, Cyprium Therapeutics, Inc. (“Cyprium”) has completed two pivotal studies in patients with Menkes disease treated with CUTX-101, copper histidinate (CuHis). In a pre-specified analysis of the studies, a 79% reduction in the risk of death was observed in patients treated within four weeks of birth, compared with a historical control cohort of untreated patients, and median overall survival (OS) was 177.1 months for CUTX-101 compared to 16.1 months for historical control, with a hazard ratio (HR) of (95% CI) = 0.208 (0.094, 0.463) p<0.0001. A 75% reduction in the risk of death was observed in patients treated after four weeks of birth, compared with untreated historical control subjects, and median OS was 62.4 and 17.6 months, respectively; HR (95% CI) = 0.253 (0.119, 0.537); p<0.0001.In 2021, Cyprium signed a Development and Asset Purchase Agreement with Sentynl Therapeutics, Inc. (“Sentynl”), a wholly owned subsidiary of Zydus Lifesciences Ltd., for CUTX-101 to treat Menkes disease. Cyprium is responsible for the development of CUTX-101, and Sentynl will be responsible for commercialization of CUTX-101, as well as progressing newborn screening activities.In December 2021, Cyprium initiated the rolling submission of an NDA to the FDA for CUTX-101, which is ongoing and expected to be completed by the end of 2023.Cyprium will retain 100% ownership over any FDA priority review voucher that may be issued at NDA approval of CUTX-101.CUTX-101 was sourced by Fortress and is currently in development at Cyprium. CAEL-101 (Light Chain Fibril-reactive Monoclonal Antibody for AL Amyloidosis) On October 5, 2021, AstraZeneca plc (“AstraZeneca”) acquired Caelum Biosciences, Inc. (“Caelum”) for an upfront payment of approximately $150 million paid to Caelum shareholders, of which approximately $56.9 million was paid to Fortress, net of Fortress’ $6.4 million portion of the $15 million, 24-month escrow holdback amount and other miscellaneous transaction expenses. The agreement also provides for additional potential payments to Caelum shareholders totaling up to $350 million, payable upon the achievement of regulatory and commercial milestones. Fortress is eligible to receive 42.4% of all potential milestone payments, which, together with the upfront payment, would total up to approximately $212 million.There are two ongoing Phase 3 studies of CAEL-101 for AL amyloidosis. (ClinicalTrials.gov identifiers: NCT04512235 and NCT04504825).2AstraZeneca has estimated that it expects the FDA to accept its BLA submission for review during calendar year 2024.CAEL-101 (anselamimab) was sourced by Fortress and was developed by Caelum (founded by Fortress) until its acquisition by AstraZeneca in October 2021. Triplex (Cytomegalovirus (“CMV”) vaccine) We expect that the Phase 2 clinical trial of Triplex for adults co-infected with HIV and CMV will complete enrollment in the second half of 2023 with topline data anticipated in 2024. The study aims to show potential reduction in intensity of highly active antiretroviral therapy treatment, which is used in up to 1.7 million treated HIV patients.Triplex received a grant from the National Institute of Allergy and Infectious Diseases that could provide over $20 million in non-dilutive funding. This will fund a 420 patient multi-center, placebo-controlled, randomized Phase 2 study of Triplex for control of CMV in patients undergoing liver transplantation and is expected to begin enrollment this year. We believe this data set could ultimately be used to support approval of Triplex in this setting.Triplex is currently the subject of three ongoing clinical trials including: pediatric patients undergoing stem cell transplant; adults co-infected with CMV and HIV; and in combination with a CAR T cell therapy for adults with NHL.Triplex was sourced by Fortress and is currently in development at our subsidiary, Helocyte, Inc. AJ201 In March 2023, we announced that our partner company, Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue”), entered into an exclusive license agreement with AnnJi Pharmaceutical Co., Ltd. for intellectual property related to AJ201, a first-in-class clinical asset currently in a Phase 1b/2a study in the U.S. for the treatment of spinal and bulbar muscular atrophy, also known as Kennedy's Disease. Kennedy’s Disease is a debilitating rare genetic neuromuscular disease primarily affecting men. Although there is a range of cited prevalence rates in the literature, a recent study used genetic analysis to estimate disease prevalence of 1:6,887 males3.AJ201 was sourced by Fortress and is currently in development at Avenue. IV Tramadol In March 2023, Avenue participated in a Type C meeting with the FDA to discuss the proposed study protocol to assess the risk of respiratory depression related to opioid stacking on IV Tramadol compared to IV morphine. The Type C meeting minutes from the FDA indicate that the FDA and Avenue are in agreement with a majority of the proposed protocol items and are in active discussion about remaining open items. The minutes indicate that the FDA also agrees that a successful study will support the submission of a complete response to the second Complete Response Letter for IV Tramadol pending final agreement on a statistical analysis plan and a full review of the submitted data in the complete response as well as concurrence from the Division of Anesthesia, Analgesia and Addiction Products.IV Tramadol was sourced by Fortress and is currently in development at Avenue. In vivo CAR T Platform Technology We continue to collaborate with the Mayo Clinic to potentially revolutionize the delivery of CAR T in patients. The technology has the potential to generate CAR T cells within the patient’s body after two outpatient injections, without the need for traditional ex vivo allogeneic or autologous CAR T cell processing wait time and expense.We anticipate the publication of proof-of-concept research from in vivo animal studies in 2023.The novel CAR T technology was sourced by Fortress and is currently in development at Mustang Bio. Marketed Dermatology Products and Product Candidates Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”), our partner company, markets prescription dermatology products.In January 2023, Journey Medical completed enrollment in its DFD-29 Phase 3 clinical program for the treatment of papulopustular rosacea and achieved the “Last Patient Out” milestone in May 2023. Topline data from the DFD-29 Phase 3 clinical studies are expected in June of 2023. Journey Medical plans to submit its NDA for DFD-29 in the second half of 2023, and an FDA approval decision is anticipated in the second half of 2024. In the Phase 2 clinical trials, DFD-29 (40mg) demonstrated nearly double the efficacy when compared to Oraycea® (European equivalent of Oracea®) on both co-primary endpoints. For the first co-primary endpoint, Investigator’s Global Assessment (“IGA”) treatment success, Oraycea had a 33.33% IGA treatment success rate, while DFD-29 achieved a 66.04% IGA treatment success rate. For the second co-primary endpoint, the change in total inflammatory lesion count, Oraycea had a 10.5 reduction in inflammatory lesions, while DFD-29 achieved a 19.2 reduction in inflammatory lesions. Journey Medical’s total product net revenues were $12.2 million for the first quarter of 2023, compared to first quarter 2022 total product net revenues of $20.8 million. Compared to the prior year period, net sales were primarily impacted by Targadox® generic competition and gross-to-net deductions for Targadox and Ximino®, including returns and managed care rebates. Higher unit sales were seen in Accutane®, Amzeeq®, Zilxi® and Exelderm®, while Qbrexza® volume decreased but was offset by pricing increases. General Corporate: Fortress In February 2023, Fortress completed a registered direct offering priced at-the-market under Nasdaq rules for total gross proceeds of approximately $13.9 million, and a concurrent private placement with investors in the registered direct offering for the pro rata rights to acquire, in the aggregate, securities exercisable into common stock in certain future operating subsidiaries that consummate a specified corporate development transaction within the next five years. Financial Results: To assist our stockholders in understanding our company, we have prepared non-GAAP financial metrics for the three months ended March 31, 2023 and 2022. These metrics exclude the operations of our four public partner companies: Avenue, Checkpoint, Journey Medical and Mustang Bio, as well as any one-time, non-recurring, non-cash transactions. The goal in providing these non-GAAP financial metrics is to highlight the financial results of Fortress’ core operations, which comprise our privately held development-stage entities, as well as our business development and finance functions. As of March 31, 2023, Fortress’ consolidated cash, cash equivalents and restricted cash totaled $154.9 million, compared to $181.0 million as of December 31, 2022, a decrease of $26.1 million during the quarter.On a GAAP basis, Fortress’ net revenue totaled $12.4 million for the first quarter of 2023, which included $12.2 million in net revenue generated from our marketed dermatology products. This compares to net revenue totaling $23.9 million for the first quarter of 2022, which included $20.8 million in net revenue generated from our marketed dermatology products.On a GAAP basis, consolidated research and development expenses including license acquisitions were $39.5 million for the first quarter of 2023, compared to $36.7 million for the first quarter of 2022. On a non-GAAP basis, Fortress research and development expenses were $2.3 million for the first quarter of 2023, compared to $2.8 million for first quarter of 2022.On a GAAP basis, consolidated selling, general and administrative expenses were $25.3 million for the first quarter of 2023, compared to $26.3 million for the first quarter of 2022. On a non-GAAP basis, Fortress selling, general and administrative expenses were $7.0 million, for the first quarter of 2023, compared to $6.2 million for the first quarter of 2022.On a GAAP basis, consolidated net loss attributable to common stockholders was $21.5 million, or $0.21 per share, for the first quarter of 2023, compared to consolidated net loss attributable to common stockholders of $15.8 million, or $0.18 per share for the first quarter of 2022.Fortress’ non-GAAP loss attributable to common stockholders was $6.5 million, or $0.06 per share, for the first quarter of 2023, compared to Fortress’ non-GAAP loss attributable to common stockholders of $5.7 million, or $0.07 per share, for the first quarter of 2022. Use of Non-GAAP Measures:In addition to the GAAP financial measures as presented in our filings with the Securities and Exchange Commission (“SEC”), including our Form 10-Q to be filed on May 15, 2023, the Company, in this press release, has included certain non-GAAP measurements. The non-GAAP net loss attributable to common stockholders is defined by the Company as GAAP net loss attributable to common stockholders, less net losses attributable to common stockholders from our public partner companies Avenue, Checkpoint, Journey Medical and Mustang Bio (“public partner companies”), as well as our former subsidiary, Caelum. In addition, the Company has also provided a Fortress non-GAAP loss attributable to common stockholders which is a modified EBITDA calculation that starts with the non-GAAP loss attributable to common stockholders and removes stock-based compensation expense, non-cash interest expense, amortization of licenses and debt discount, changes in fair values of investment, changes in fair value of derivative liability, and depreciation expense. The Company also provides non-GAAP research and development costs, defined as GAAP research and development costs, less research and development costs of our public partner companies and non-GAAP selling, general and administrative costs, defined as GAAP selling, general and administrative costs, less selling, general and administrative costs of our public partner companies. Management believes each of these non-GAAP measures provide meaningful supplemental information regarding the Company's performance because (i) it allows for greater transparency with respect to key measures used by management in its financial and operational decision-making; (ii) it excludes the impact of non-cash or, when specified, non-recurring items that are not directly attributable to the Company's core operating performance and that may obscure trends in the Company's core operating performance; and (iii) it is used by institutional investors and the analyst community to help analyze the Company's standalone results separate from the results of its public partner companies. However, non-GAAP loss attributable to common stockholders and any other non-GAAP financial measures should be considered as a supplement to, and not as a substitute for, or superior to, the corresponding measures calculated in accordance with GAAP. Further, non-GAAP financial measures used by the Company and the manner in which they are calculated may differ from the non-GAAP financial measures or the calculations of the same non-GAAP financial measures used by other companies, including the Company's competitors. The tables below provide a reconciliation from GAAP to non-GAAP measures: For the three months ended March 31,($ in thousands except for share and per share amounts) 2023 2022 Net loss attributable to common stockholders $(21,537)$(15,760)Net loss attributable to common stockholders - Avenue1 (949) (535)Net loss attributable to common stockholders - Checkpoint2 (1,768) (2,924)Net loss attributable to common stockholders - Journey Medical3 (5,733) (817)Net loss attributable to common stockholders - Mustang Bio4 (3,166) (2,541)Non-GAAP (loss) attributable to common stockholders $(9,921)$(8,943)Stock based compensation 2,870 2,782 Amortization of debt discount 484 357 Depreciation 93 100 Fortress non-GAAP (loss) income attributable to common stockholders $(6,474)$(5,705) Per common share - basic and diluted: Net loss attributable to common stockholders (GAAP) $(0.21)$(0.18)Non-GAAP net loss attributable to common stockholders $(0.10)$(0.10)Fortress non-GAAP (loss) income attributable to common stockholders $(0.06)$(0.07)Fortress non-GAAP (loss) income attributable to common stockholders - diluted Weighted average common shares outstanding - basic and diluted 101,885,648 86,255,142 Avenue net loss for the three months ended March 31, 2023 of $7.5 million net of non-controlling interest ("NCI") of $6.4 million, Master Services Agreement ("MSA") fee to Fortress of $0.1 million, and financing fee to Fortress of $0.1 million; net loss for the three months ended March 31, 2022 of $2.9 million, net of NCI of $2.4 million.Checkpoint net loss for the three months ended March 31, 2023 of $10.5 million net of NCI of $8.4 million, MSA fee to Fortress of $0.1 million, and financing fee to Fortress of $0.2 million; net loss for the three months ended March 31, 2022 of $16.8 million net of NCI of $13.6 million, MSA fee to Fortress of $0.1 million, and financing fee to Fortress of $0.2 million.Journey Medical net loss for the three months ended March 31, 2023 of $10.1 million net of NCI of $4.4 million; net loss for the three months ended March 31, 2022 of $1.4 million net of NCI of $0.5 million and tax expense recognized on a stand-alone basis of $0.1 million.Mustang Bio net loss for the three months ended March 31, 2023 of $16.7 million net of NCI of $13.3 million, Fortress MSA fee of $0.1 million, and Fortress financing fee of $0.1 million; net loss for the three months ended March 31, 2022 of $19.8 million net of NCI of $16.2 million, MSA fee to Fortress of $0.3 million and financing fee to Fortress of $0.8 million. Reconciliation to non-GAAP research and development costs and non-GAAP selling, general and administrative costs: For the three months ended March 31, ($ in thousands) 2023 2022 Research and development1$ 39,506 $ 36,722 Less: Research and development - Avenue2 5,383 1,808 Research and development - Checkpoint 15,826 14,670 Research and development - Journey Medical 2,033 1,266 Research and development - Mustang Bio3 13,938 16,164 Non-GAAP research and development costs$ 2,327 $ 2,814 Selling, general and administrative$ 25,341 $ 26,270 Less: General and administrative - Avenue4 849 1,055 General and administrative - Checkpoint5 2,011 1,922 Selling, general and administrative - Journey Medical 13,292 14,715 General and administrative - Mustang Bio6 2,150 2,402 Non-GAAP selling, general and administrative costs$ 7,039 $ 6,177 Includes Research and development expense and Research and development - licenses acquired expense for the periods presented.Excludes $0.1 million of Fortress MSA expense payable to Fortress for the three months ended March 31, 2023.Excludes $0.1 million of Fortress MSA expense payable to Fortress for the each of the three months ended March 31, 2023 and 2022, respectively.Excludes $0.1 million of Fortress MSA expense and $0.1 million financing fee payable to Fortress for the three months ended March 31, 2023.Excludes $0.1 million of Fortress MSA expense and $0.2 million Fortress financing fee for the three months ended March 31, 2023; and excludes $0.1 million of Fortress MSA expense and $0.2 million Fortress financing fee for the three months ended March 31, 2022.Excludes $0.1 million of Fortress MSA expense and $0.1 million Fortress financing fee for the three months ended March 31, 2023; and $0.1 million of Fortress MSA expense and $0.9 million Fortress financing fee for the three months ended March 31, 2022. About Fortress Biotech Fortress Biotech, Inc. (“Fortress”) is an innovative biopharmaceutical company focused on acquiring, developing and commercializing high-potential marketed and development-stage drugs and drug candidates. The company has eight marketed prescription pharmaceutical products and over 30 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 driven by a world-class business development team that is focused on leveraging its significant biopharmaceutical industry expertise to further expand the company’s portfolio of product opportunities. Fortress has established partnerships with some of the world’s leading academic research institutions and biopharmaceutical companies to maximize each opportunity to its full potential, including 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) March 31, December 31, 2023 2022 ASSETS Current assets Cash and cash equivalents$152,483 $178,266 Accounts receivable, net 27,616 28,208 Inventory 13,278 14,159 Other receivables - related party 636 138 Prepaid expenses and other current assets 8,368 9,661 Total current assets 202,381 230,432 Property, plant and equipment, net 12,194 13,020 Operating lease right-of-use asset, net 19,467 19,991 Restricted cash 2,438 2,688 Intangible asset, net 26,128 27,197 Other assets 943 973 Total assets$ 263,551 $ 294,301 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities Accounts payable and accrued expenses$105,419 $97,446 Deferred revenue 547 728 Income taxes payable 722 722 Common stock warrant liabilities 9,459 13,869 Operating lease liabilities, short-term 2,515 2,447 Partner company term loan, short-term, net 2,318 — Partner company convertible preferred shares, short-term, net 2,937 2,052 Partner company line of credit 3,000 2,948 Partner company installment payments - licenses, short-term, net 2,288 7,235 Other short-term liabilities 268 268 Total current liabilities 129,473 127,715 Notes payable, long-term, net 89,996 91,730 Operating lease liabilities, long-term 21,026 21,572 Partner company installment payments - licenses, long-term, net 1,450 1,412 Other long-term liabilities 1,800 1,847 Total liabilities 243,745 244,276 Commitments and contingencies Stockholders’ equity 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 March 31, 2023 and December 31, 2022, respectively, liquidation value of $25.00 per share 3 3 Common stock, $0.001 par value, 200,000,000 shares authorized, 130,417,161 and 110,494,245 shares issued and outstanding as of March 31, 2023 and December 31, 2022, respectively 130 110 Additional paid-in-capital 693,433 675,841 Accumulated deficit (655,770) (634,233)Total stockholders' equity attributed to the Company 37,796 41,721 Non-controlling interests (17,990) 8,304 Total stockholders' equity 19,806 50,025 Total liabilities and stockholders' equity$ 263,551 $ 294,301 FORTRESS BIOTECH, INC. AND SUBSIDIARIESUnaudited Condensed Consolidated Statements of Operations($ in thousands except for share and per share amounts) Three Months Ended March 31, 2023 2022Revenue Product revenue, net$12,165 $20,796 Collaboration revenue 181 577 Revenue - related party 35 52 Other revenue 48 2,500 Net revenue 12,429 23,925 Operating expenses Cost of goods sold - product revenue 6,449 8,203 Research and development 35,276 36,722 Research and development - licenses acquired 4,230 — Selling, general and administrative 25,341 26,270 Total operating expenses 71,296 71,195 Loss from operations (58,867) (47,270) Other income (expense) Interest income 1,036 142 Interest expense and financing fee (4,296) (2,350)Foreign exchange loss (47) — Change in fair value of warrant liabilities 6,678 — Grant income 351 — Total other income (expense) 3,722 (2,208)Net loss (55,145) (49,478) Net loss attributable to non-controlling interests 33,608 33,718 Net loss attributable to common stockholders$ (21,537) $ (15,760) Net loss per common share attributable to common stockholders - basic and diluted$(0.21) $(0.18) Weighted average common shares outstanding - basic and diluted 101,885,648 86,255,142 1 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.2 Information on clinicaltrials.gov does not constitute part of this release.3 M. Zanovello et al., Unexpected frequency of the pathogenic ARCAG repeat 2 expansion in the general population. Brain, in press (2023).

Fortress expects to file a total of three new drug applications in 2023 Record consolidated net revenue of $75.7 million for full-year 2022 FDA accepted for filing the Biologics License Application for cosibelimab in patients with metastatic or locally advanced cutaneous squamous cell carcinoma; PDUFA goal date of January 3, 2024 Rolling NDA submission for CUTX-101 for the treatment of Menkes disease is expected to be completed in 2023 Topline results from the Phase 3 clinical program of DFD-29 to treat papulopustular rosacea expected in the first half of 2023; NDA submission expected in the second half of 2023 MIAMI, March 30, 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 full-year ended December 31, 2022. Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, “In 2022, we continued to advance our extensive portfolio of multiple clinical-stage programs, several of which are late-stage and pivotal. We also generated record consolidated net revenues of $75.7 million, much of which came from the sales of our eight marketed dermatology products. Our growth continues in 2023, as the U.S. Food and Drug Administration (“FDA”) accepted for filing the Biologics License Application (“BLA”) for cosibelimab earlier this month and we expect to have two New Drug Applications (“NDA”) submitted to the FDA for CUTX-101 for Menkes disease and DFD-29 for rosacea this year. We also anticipate multiple clinical trial initiations, data readouts and regulatory filings across our other development-stage programs. Fortress has also established 25 acquisition companies with expert opinion leaders in multiple therapeutic areas over the past year. These expert opinion leaders will continue to work with our business development team to identify, evaluate and acquire potential best-in-class therapies to form the bases of these new companies. We are focused on licensing assets with proof-of-concept clinical data available in areas with high unmet medical need, which potentially lowers the development uncertainty and associated risk. Our pipeline and structure allow for flexibility and diversified exposure with many product candidates and potentially long-term revenue streams. We expect to achieve multiple milestones this year, and we are confident in our long-term growth prospects as we continue to scale.” 2022 and Recent Corporate Highlights1: Marketed Dermatology Products and Product Candidates Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”), our partner company, currently markets eight prescription dermatology products.Journey Medical’s total net revenues were $73.7 million for the full-year 2022, which includes $71.0 million from their commercial portfolio, compared to full-year 2021 total net revenues of $63.1 million, representing growth of 17%.In January 2023, Journey Medical completed enrollment in its DFD-29 Phase 3 clinical program for the treatment of papulopustular rosacea. Topline data from the two DFD-29 Phase 3 clinical studies are expected to be announced in the first half of 2023. Journey Medical plans to submit the NDA for DFD-29 in the second half of 2023 and an FDA approval decision is anticipated in the second half of 2024. In the Phase 2 clinical trials, DFD-29 (40mg) demonstrated nearly double the efficacy when compared against Oraycea® (European equivalent of Oracea®) on both co-primary endpoints. For the first co-primary endpoint, Investigator’s Global Assessment (“IGA”) treatment success, Oraycea had a 33.33% IGA treatment success rate, while DFD-29 achieved a 66.04% IGA treatment success rate. For the second co-primary endpoint, the change in total inflammatory lesion count, Oraycea had a 10.5 reduction in inflammatory lesions, while DFD-29 achieved a 19.2 reduction in inflammatory lesions. Cosibelimab (Anti PD-L1 antibody) Our partner company, Checkpoint Therapeutics, Inc. (Nasdaq: CKPT) (“Checkpoint”), submitted a BLA to the FDA for cosibelimab, its investigational anti-PD-L1 antibody, as a treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma (“cSCC”) who are not candidates for curative surgery or radiation, in January 2023. In March 2023, the FDA accepted for filing the BLA for cosibelimab and set a Prescription Drug User Fee Act (“PDUFA”) goal date of January 3, 2024. In its BLA filing acceptance letter, the FDA indicated that no potential filing review issues have been identified, and that an advisory committee meeting to discuss the application is not currently planned. According to U.S. prescription claims data, in 2021, approximately 11,000 cSCC patients were treated with systemic therapies. As PD-1 inhibitors comprised less than half of patient prescriptions, cSCC remains a disease with a need for more effective and tolerable treatment options, particularly for the significant number of cSCC patients with immunosuppressive conditions or autoimmune diseases. With its unique mechanism of action and compelling safety profile, we believe cosibelimab, if approved, would be uniquely positioned to provide an important new treatment option for cSCC patients that are currently underserved by available therapies.In January 2022, Checkpoint announced positive topline results from its registration-enabling clinical trial evaluating the safety and efficacy of the anti-PD-L1 antibody, cosibelimab, administered as a fixed dose of 800 mg every two weeks in patients with metastatic cSCC. The study met its primary endpoint, with cosibelimab demonstrating a confirmed objective response rate (“ORR”) of 47.4% (95% CI: 36.0, 59.1) based on independent central review of 78 patients enrolled in the metastatic cSCC cohort using Response Evaluation Criteria in Solid Tumors version 1.1 criteria.In June 2022, we announced that the topline results of Checkpoint’s pivotal trial of cosibelimab in metastatic cSCC were presented at the 2022 American Society of Clinical Oncology Annual Meeting. Data highlights included confirmed ORR by independent central review in the modified intent-to-treat population of 48.7% (95% CI, 37.0-60.4) and 13.2% of patients achieved a complete response in target lesions. Cosibelimab was generally well tolerated with no unexpected safety signals.Also in June 2022, we announced positive interim results from Checkpoint’s pivotal trial of cosibelimab in locally advanced cSCC. As of the March 2022 data cutoff, the confirmed ORR by independent central review in 31 patients was 54.8% (95% CI: 36.0, 72.7).In July 2022, Checkpoint successfully completed two pre-BLA meetings with the FDA (chemistry, manufacturing and controls (“CMC”) and clinical/non-clinical). Based upon favorable interactions with the agency, the January 2023 BLA submission included both the metastatic and locally advanced cSCC indications.Cosibelimab was sourced by Fortress and is currently in development at Checkpoint. Dotinurad (Urate Transporter (URAT1) Inhibitor) In May 2022, our subsidiary company Urica Therapeutics, Inc. (“Urica’”) initiated a Phase 1 clinical trial to evaluate dotinurad in healthy volunteers in the United States. Dotinurad is in development for the treatment of gout. We anticipate topline data from the Phase 1 trial in the first half of 2023 and expect to be in pivotal clinical trials in early 2024.Dotinurad (URECE® tablet) was approved in Japan in 2020 as a once-daily oral therapy for gout and hyperuricemia. Dotinurad was efficacious and well-tolerated in more than 500 Japanese patients treated for up to 58 weeks in Phase 3 clinical trials. The clinical program supporting approval included over 1,000 patients.In October 2022, Urica strengthened its leadership team by appointing Jay D. Kranzler, M.D., Ph.D., as Chairman and Chief Executive Officer, and Vibeke Strand, M.D., MACR, FACP, Adjunct Clinical Professor, Division of Immunology/Rheumatology, Stanford University, to Urica’s Board of Directors.In December 2022, Urica expanded its exclusive license agreement with Fuji Yakuhin Co. Ltd. (“Fuji”) for the development of dotinurad to include the Middle East and North Africa and Turkey territories. The agreement builds upon the exclusive license agreement between Urica and Fuji previously announced in May 2021 to develop dotinurad in the United States, United Kingdom, European Union and Canada.Dotinurad was sourced by Fortress and is currently in development at Urica. MB-106 (CD20-targeted CAR T Cell Therapy) In June 2022, we announced that the FDA granted Orphan Drug Designation to MB-106 for the treatment of Waldenstrom macroglobulinemia (“WM”), a rare type of B-cell non-Hodgkin lymphoma (“B-NHL”). Our partner company Mustang Bio, Inc. (Nasdaq: MBIO) (“Mustang Bio”), which is developing MB-106, plans to treat additional WM patients in the Mustang Bio-sponsored Phase 1 portion of its multicenter trial to potentially support an accelerated Phase 2 strategy for WM.In October 2022, we announced that the first patient was treated in Mustang Bio’s multicenter, open-label, non-randomized Phase 1/2 clinical trial evaluating the safety and efficacy of MB-106, for the treatment of relapsed or refractory B-NHL and chronic lymphocytic leukemia (“CLL”). In 2023, Mustang Bio anticipates dose escalation and reporting response data at major medical meetings.Additionally, in October 2022, we shared interim data from 28 patients treated in the ongoing Phase 1/2 investigator-sponsored clinical trial at Fred Hutch. An ORR of 96% and complete response (“CR”) rate of 75% were observed in a wide range of hematologic malignancies including follicular lymphoma, CLL, diffuse large B-cell lymphoma and WM. Twelve patients have experienced CR for more than 12 months (10 ongoing), including four patients with CR for more than two years and the longest patient with CR at 33 months. Six patients with initial partial response at 28 days post-treatment improved to CR and all remain in ongoing CR. All three patients previously treated with CD19 CAR T cell therapy responded to treatment with MB-106.A favorable safety profile for MB-106 as an outpatient therapy remains, with no cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome ≥ Grade 3 reported to date on this trial. MB-106 continues to generate compelling safety and efficacy data, and the product profile of this autologous CD20-directed CAR T is favorable compared to the approved autologous CD19-directed CAR Ts, which are generating an annualized run rate of $3 billion in net sales, based on reported sales in the third quarter of 2022.MB-106 was sourced by Fortress and is currently in development at Mustang Bio. CUTX-101 (Copper Histidinate for Menkes disease) Our subsidiary, Cyprium Therapeutics, Inc. (“Cyprium) has completed two pivotal studies in patients with Menkes disease treated with CUTX-101, copper histidinate (CuHis). In the studies, a 79% reduction in risk of death was observed in patients treated within four weeks of birth compared with an untreated historical control cohort of patients, and median overall survival (OS) was 177.1 for CUTX-101 compared to 16.1 months historical control, with a hazard ratio (HR) of (95% CI) = 0.208 (0.094, 0.463) p<0.0001. A 75% reduction in the risk of death was also observed in patients treated after four weeks of birth compared with untreated historical control subjects and median OS was 62.4 and 17.6 months, respectively; HR (95% CI) = 0.253 (0.119, 0.537); p<0.0001.In 2021, Cyprium signed a Development and Asset Purchase Agreement with Sentynl Therapeutics, Inc. (“Sentynl”), a wholly owned subsidiary of Zydus Lifesciences Ltd., for CUTX-101 to treat Menkes disease. Cyprium is responsible for the development of CUTX-101 and Sentynl will be responsible for commercialization of CUTX-101, as well as progressing newborn screening activities.In December 2021, Cyprium initiated the rolling submission of an NDA to the FDA for CUTX-101, which is ongoing and expected to be completed in 2023.In March 2022, Cyprium announced positive data on CUTX-101 were presented as a “Top-Rated Abstract” and poster at the 2022 American College of Medical Genetics and Genomics Clinical Genetics Meeting. The abstract can be viewed here.Cyprium will retain 100% ownership over any FDA priority review voucher that may be issued at NDA approval for CUTX-101.CUTX-101 was sourced by Fortress and is currently in development at Cyprium. CAEL-101 (Light Chain Fibril-reactive Monoclonal Antibody for AL Amyloidosis) On October 5, 2021, AstraZeneca plc (“AstraZeneca”) acquired Caelum Biosciences, Inc. (“Caelum”) for an upfront payment of approximately $150 million paid to Caelum shareholders, of which approximately $56.9 million was paid to Fortress, net of Fortress’ $6.4 million portion of the $15 million, 24-month escrow holdback amount and other miscellaneous transaction expenses. The agreement also provides for additional potential payments to Caelum shareholders totaling up to $350 million, payable upon the achievement of regulatory and commercial milestones. Fortress is eligible to receive 42.4% of all potential milestone payments, which together with the upfront payment, would total up to approximately $212 million.There are two ongoing Phase 3 studies of CAEL-101 for AL amyloidosis. (ClinicalTrials.gov identifiers: NCT04512235 and NCT04504825).2AstraZeneca has estimated that it expects the FDA to accept its BLA submission for review during calendar year 2024.CAEL-101 (anselamimab) was sourced by Fortress and was developed by Caelum (founded by Fortress) until its acquisition by AstraZeneca in October 2021. Triplex (Cytomegalovirus (“CMV”) vaccine) We expect that the Phase 2 clinical trial of Triplex for adults co-infected with HIV and CMV will complete enrollment in the second half of 2023 with topline data anticipated in 2024. The study aims to show potential reduction in intensity of highly active antiretroviral therapy treatment (HAART) which is used in up to 1.7 million treated HIV patients.In August 2022, we announced that Triplex received a grant from the National Institute of Allergy and Infectious Diseases that could provide over $20 million in non-dilutive funding. This will fund a 420 patient multi-center, placebo-controlled, randomized Phase 2 study of Triplex for control of CMV in patients undergoing liver transplantation and is expected to begin enrollment this year. The company believes this data set could ultimately be used to support approval of Triplex in this setting.Triplex is currently the subject of four clinical trials including: adults undergoing stem cell transplant; adults co-infected with CMV and HIV; and in combination with a CAR T cell therapy for adults with NHL.Triplex was sourced by Fortress and is currently in development at our subsidiary company, Helocyte, Inc. AJ201 In March 2023, we announced that our partner company, Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue”), entered into an exclusive license agreement with AnnJi Pharmaceutical Co., Ltd. for intellectual property related to AJ201, a first-in-class clinical asset currently in a Phase 1b/2a study in the U.S. for the treatment of spinal and bulbar muscular atrophy (“SBMA”), also known as Kennedy's Disease. Kennedy’s Disease is a debilitating rare genetic neuromuscular disease primarily affecting men. Although there is a range of cited prevalence rates in the literature, a recent study used genetic analysis to estimate disease prevalence of 1:6,887 males3.AJ201 was sourced by Fortress and is currently in development at Avenue. IV Tramadol In September 2022, our partner company Avenue received the official meeting minutes from the FDA regarding a meeting conducted in August 2022, for IV Tramadol. At the meeting, Avenue presented a study design for a single safety clinical trial that Avenue believes could address the concerns regarding risks related to opioid stacking. The FDA stated that the proposed study design appears reasonable and agreed on various study design aspects with the expectation that additional feedback would be provided to Avenue upon review of a more detailed study protocol. Avenue incorporated the FDA’s suggestions from the meeting minutes and submitted a detailed study protocol that could form the basis for the submission of a complete response to the second Complete Response Letter for IV Tramadol.In March 2023, Avenue participated in a Type C meeting with the FDA to discuss the proposed study protocol to assess the risk of respiratory depression related to opioid stacking on IV Tramadol relative to an approved opioid analgesic.IV Tramadol was sourced by Fortress and is currently in development at Avenue. In vivo CAR T Platform Technology We continue to collaborate with the Mayo Clinic to potentially revolutionize the delivery of CAR T in patients. The technology has the potential to generate CAR T cells within the patient’s body after two outpatient injections, without the need for traditional ex vivo allogeneic or autologous CAR T cell processing wait time and expense.We anticipate the publication of proof-of-concept research from in vivo animal studies in 2023.The novel CAR T technology was sourced by Fortress and is currently in development at Mustang Bio. General Corporate: Fortress In April 2022, Fortress participated in a two-day summit hosted by the B. Riley Securities’ Healthcare Equity Research team that featured multiple programs from Fortress’ diversified pipeline. Webcast replays are available on Fortress’ website here. Information on our website does not constitute part of this press release.In July 2022, we announced that David Jin, who has served as Vice President of Corporate Development since May 2020, was also appointed as Chief Financial Officer effective August 16, 2022.In December 2022, Fortress appointed Lucy Lu to its Board of Directors.In February 2023, Fortress completed a registered direct offering priced At-the-Market under Nasdaq rules for total gross proceeds of approximately $13.9 million, and a concurrent private placement with investors in the registered direct offering for the pro rata rights to acquire, in the aggregate, securities exercisable into common stock in certain future operating subsidiaries that consummate a specified corporate development transaction within the next five years. Financial Results: To assist our stockholders in understanding our company, we have prepared non-GAAP financial metrics for the three months and 12 months ended December 31, 2022 and 2021. These metrics exclude the operations of our four public partner companies: Avenue, Checkpoint, Journey Medical and Mustang Bio, as well as any one-time, non-recurring, non-cash transactions. The goal in providing these non-GAAP financial metrics is to highlight the financial results of Fortress’ core operations, which are comprised of our privately held development-stage entities, as well as our business development and finance functions. As of December 31, 2022, Fortress’ consolidated cash, cash equivalents and restricted cash totaled $181.0 million, compared to $210.6 million as of September 30, 2022, and $308.0 million as of December 31, 2021, a decrease of $29.6 million for the fourth quarter and a decrease of $127.0 million for the full year.On a GAAP basis, Fortress’ net revenue totaled $75.7 million for the full year ended December 31, 2022, which included $71.0 million in net revenue generated from our marketed dermatology products. This compares to net revenue totaling $68.8 million for the full year ended 2021, which included $63.1 million in net revenue generated from our marketed dermatology products.On a GAAP basis, consolidated research and development expenses including license acquisitions totaled $134.9 million for the full year ended December 31, 2022, compared to $128.9 million for the full year ended December 31, 2021. On a non-GAAP basis, research and development costs including research and development license acquisitions totaled $11.3 million for the full year ended December 31, 2022, compared to $18.0 million for the full year ended December 31, 2021.On a GAAP basis, consolidated selling, general and administrative costs were $113.7 million for the full year ended December 31, 2022, compared to $86.8 million for the full year ended December 31, 2021. On a non-GAAP basis, selling, general and administrative expenses were $30.6 million for the full year ended December 31, 2022, compared to $28.6 for the full year ended December 31, 2021.On a GAAP basis, consolidated net loss attributable to common stockholders was $(86.6) million, or $(0.97) per share, for the full year ended December 31, 2022, compared to net loss attributable to common stockholders of $(64.7) million, or $(0.79) per share for the full year ended December 31, 2021.Fortress’ non-GAAP loss attributable to common stockholders was $(29.2) million, or $(0.33) per share, for the full year ended December 31, 2022, compared to Fortress’ non-GAAP income attributable to common stockholders of $25.5 million, or $0.31 per share basic and $0.25 per share diluted, for the full year ended December 31, 2021. In 2021, Fortress received initial proceeds from the AstraZeneca acquisition of Caelum. Use of Non-GAAP Measures: In addition to the GAAP financial measures as presented in our filings with the Securities and Exchange Commission (“SEC”), including our Form 10-K to be filed on March 31, 2023, the Company, in this press release, has included certain non-GAAP measurements. The non-GAAP net loss attributable to common stockholders is defined by the Company as GAAP net loss attributable to common stockholders, less net losses attributable to common stockholders from our public partner companies Avenue, Checkpoint, Journey Medical and Mustang Bio (“public partner companies”), as well as our former subsidiary, Caelum. In addition, the Company has also provided a Fortress non-GAAP loss attributable to common stockholders which is a modified EBITDA calculation that starts with the non-GAAP loss attributable to common stockholders and removes stock-based compensation expense, non-cash interest expense, amortization of licenses and debt discount, changes in fair values of investment, changes in fair value of derivative liability, and depreciation expense. The Company also provides non-GAAP research and development costs, defined as GAAP research and development costs, less research and development costs of our public partner companies and non-GAAP selling, general and administrative costs, defined as GAAP selling, general and administrative costs, less selling, general and administrative costs of our public partner companies. Management believes each of these non-GAAP measures provide meaningful supplemental information regarding the Company's performance because (i) it allows for greater transparency with respect to key measures used by management in its financial and operational decision-making; (ii) it excludes the impact of non-cash or, when specified, non-recurring items that are not directly attributable to the Company's core operating performance and that may obscure trends in the Company's core operating performance; and (iii) it is used by institutional investors and the analyst community to help analyze the Company's standalone results separate from the results of its public partner companies. However, non-GAAP loss attributable to common stockholders and any other non-GAAP financial measures should be considered as a supplement to, and not as a substitute for, or superior to, the corresponding measures calculated in accordance with GAAP. Further, non-GAAP financial measures used by the Company and the manner in which they are calculated may differ from the non-GAAP financial measures or the calculations of the same non-GAAP financial measures used by other companies, including the Company's competitors. The tables below provide a reconciliation from GAAP to non-GAAP measures: For the year ended December 31, ($ in thousands except for share and per share amounts) 2022 2021 Net loss attributable to common stockholders $(86,575)$(64,703)Net loss attributable to common stockholders - Avenue1 (587) (822)Net loss attributable to common stockholders - Checkpoint2 (11,415) (9,313)Net loss attributable to common stockholders - Journey Medical3 (17,107) (36,708)Net loss attributable to common stockholders - Mustang Bio4 (13,680) (11,256) Non-GAAP (loss) attributable to common stockholders $(43,786)$(6,605)Stock based compensation 12,706 10,133 Amortization of debt discount 1,532 3,914 Depreciation 385 462 Increase in fair value of investment in Caelum - (39,294)Realization in Caelum investment5 - 56,860 Fortress non-GAAP (loss) income attributable to common stockholders $(29,163)$25,469 Per common share - basic and diluted: Net loss attributable to common stockholders (GAAP) $(0.97)$(0.79)Non-GAAP net loss attributable to common stockholders $(0.49)$(0.08)Fortress non-GAAP (loss) income attributable to common stockholders $(0.33)$0.31 Fortress non-GAAP (loss) income attributable to common stockholders - diluted $(0.33)$0.25 Weighted average common shares outstanding - basic 88,874,519 81,700,220 Weighted average common shares outstanding - diluted 88,874,519 103,604,466 Avenue net loss for the year ended December 31, 2022 of $3.6 million net of non-controlling interest of $2.4 million, Master Services Agreement ("MSA") fee to Fortress of $0.1 million, financing fee and payment-in-kind ("PIK") dividend to Fortress of $0.3 million and $0.3 million, respectively; net loss for the year ended December 31, 2021 of $3.7 million, net of non-controlling interest of $2.9 million.Checkpoint net loss of $62.6 million net of NCI of $48.4 million, MSA fee to Fortress of $0.5 million, financing fee and PIK dividend to Fortress of $0.4 million and $1.9 million, respectively, for the year ended December 31, 2022; and net loss of $56.7 million net of NCI of $39.2 million, MSA fee to Fortress of $0.5 million, financing fee and PIK dividend to Fortress of $1.0 million and $6.6 million, respectively, for the year ended December 31, 2021.Journey Medical net loss for the year ended December 31, 2022 of $29.6 million net of NCI of $12.5 million and tax expense recognized on a stand-alone basis of $0.1 million; and net loss for the year ended December 31, 2021 of $44.0 million net of NCI of $5.7 million and tax expense recognized on a stand-alone basis of $1.6 million.Mustang Bio net loss of $77.5 million net of NCI of $60.8 million, Fortress MSA fee of $1.0 million, and Fortress financing fee and PIK dividend of $0.9 million and $1.1 million, respectively, for the year ended December 31, 2022; and net loss of $66.4 million net of NCI of $48.5 million, MSA fee to Fortress of $0.5 million and financing fee and PIK dividend to Fortress of $1.9 million and $4.2 million, respectively, for the year ended December 31, 2021.Proceeds received from AstraZeneca plc acquisition of Caelum Biosciences, Inc. in October 2021. Reconciliation to non-GAAP research and development costs and non-GAAP selling, general and administrative costs: For the year ended December 31, ($ in thousands) 2022 2021Research and development1 $ 134,877 $ 128,864 Less: Research and development - Avenue2 2,388 1,254Research and development - Checkpoint3 47,940 41,855Research and development - Journey Medical 10,943 16,558Research and development - Mustang Bio4 62,340 51,244Non-GAAP research and development costs $ 11,266 $ 17,953 Selling, general and administrative5 $ 113,656 $ 96,384 Less: General and administrative - Avenue6 5,045 2,484General and administrative - Checkpoint7 7,782 7,005Selling, general and administrative - Journey Medical 59,468 49,373General and administrative - Mustang Bio8 10,795 8,883Non-GAAP selling, general and administrative costs $ 30,566 $ 28,639 Includes Research and development expense and Research and development - licenses acquired expense for the periods presented.Excludes $42,000 of Fortress MSA expense and $0.3 million PIK dividend payable to Fortress for the year ended December 31, 2022.Excludes $1.9 million and $6.6 million of PIK dividend payable to Fortress for the year ended December 31, 2022 and 2021, respectively.Excludes $0.5 million of Fortress MSA expense and $1.1 million PIK dividend payable to Fortress for the year ended December 31, 2022; and excludes $0.3 million of Fortress MSA expense and $4.2 million PIK dividend payable to Fortress for the year ended December 31, 2021.Includes Selling, general and administrative expenses and wire transfer fraud loss for the year ended December 31, 2021.Excludes $42,000 of Fortress MSA expense and $0.3 million of Fortress financing fee for the year ended December 31, 2022.Excludes $0.5 million of Fortress MSA expense and $0.4 million Fortress financing fee for the year ended December 31, 2022; and $0.5 million of Fortress MSA expense and $1.0 million Fortress financing fee for the year ended December 31, 2021.Excludes $0.5 million of Fortress MSA expense and $0.9 million Fortress financing fee for the year ended December 31, 2022; and $0.3 million of Fortress MSA expense and $1.9 million Fortress financing fee for the year ended December 31, 2021. About Fortress Biotech Fortress Biotech, Inc. (“Fortress”) is an innovative biopharmaceutical company focused on acquiring, developing and commercializing high-potential marketed and development-stage drugs and drug candidates. The company has eight marketed prescription pharmaceutical products and over 30 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 driven by a world-class business development team that is focused on leveraging its significant biopharmaceutical industry expertise to further expand the company’s portfolio of product opportunities. Fortress has established partnerships with some of the world’s leading academic research institutions and biopharmaceutical companies to maximize each opportunity to its full potential, including 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 SUBSIDIARIESConsolidated Balance Sheets ($ in thousands except for share and per share amounts) December 31, December 31, 2022 2021 ASSETS Current assets Cash and cash equivalents $178,266 $305,744 Accounts receivable, net 28,208 23,112 Inventory 14,159 9,862 Other receivables - related party 138 678 Prepaid expenses and other current assets 9,661 7,066 Total current assets 230,432 346,462 Property, plant and equipment, net 13,020 15,066 Operating lease right-of-use asset, net 19,991 19,005 Restricted cash 2,688 2,220 Intangible asset, net 27,197 12,552 Other assets 973 1,198 Total assets $294,301 $396,503 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities Accounts payable and accrued expenses $97,446 $90,660 Deferred revenue 728 2,611 Income taxes payable 722 345 Common stock warrant liabilities 13,869 — Operating lease liabilities, short-term 2,447 2,104 Partner company convertible preferred shares, short-term, net 2,052 — Partner company line of credit 2,948 812 Partner company installment payments - licenses, short-term, net 7,235 4,510 Other short-term liabilities 268 — Total current liabilities 127,715 101,042 Notes payable, long-term, net 91,730 42,937 Operating lease liabilities, long-term 21,572 20,987 Partner company installment payments - licenses, long-term, net 1,412 3,627 Other long-term liabilities 1,847 2,033 Total liabilities 244,276 170,626 Commitments and contingencies Stockholders’ equity 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 December 31, 2022 and December 31, 2021, respectively, liquidation value of $25.00 per share 3 3 Common stock, $0.001 par value, 200,000,000 shares authorized, 110,494,245 shares issued and outstanding as of December 31, 2022; 170,000,000 shares authorized, 101,435,505 shares issued and outstanding as of December 31, 2021, respectively 110 101 Additional paid-in-capital 675,841 656,033 Accumulated deficit (634,233) (547,463)Total stockholders' equity attributed to the Company 41,721 108,674 Non-controlling interests 8,304 117,203 Total stockholders' equity 50,025 225,877 Total liabilities and stockholders' equity $294,301 $396,503 FORTRESS BIOTECH, INC. AND SUBSIDIARIESConsolidated Statements of Operations($ in thousands except for share and per share amounts) Year Ended December 31, 2022 2021 Revenue Product revenue, net$70,995 $63,134 Collaboration revenue 1,882 5,389 Revenue - related party 192 268 Other revenue 2,674 — Net revenue 75,743 68,791 Operating expenses Cost of goods sold - product revenue 30,775 32,084 Research and development 134,199 113,240 Research and development - licenses acquired 677 15,625 Selling, general and administrative 113,656 86,843 Wire transfer fraud loss — 9,540 Total operating expenses 279,307 257,332 Loss from operations (203,564) (188,541) Other income (expense) Interest income 1,398 649 Interest expense and financing fee (13,642) (15,308)Foreign exchange loss (89) — Change in fair value of investments — 39,294 Change in fair value of warrant liabilities 1,129 (447)Grant income 1,304 — Total other income (expense) (9,900) 24,188 Loss before income tax expense (213,464) (164,353) Income tax expense 449 473 Net loss (213,913) (164,826) Net loss attributable to non-controlling interests 127,338 100,123 Net loss attributable to common stockholders$(86,575) $(64,703) Net loss per common share attributable to common stockholders - basic and diluted$(0.97) $(0.79) Weighted average common shares outstanding - basic and diluted 88,874,519 81,700,220 1 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 whom 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.2 Information on clinicaltrials.gov does not constitute part of this release.3 M. Zanovello et al., Unexpected frequency of the pathogenic ARCAG repeat 2 expansion in the general population. Brain, in press (2023).