Core Viewpoint - Mustang Bio, Inc. has announced a definitive agreement for the issuance and sale of 6,130,000 shares of common stock at a price of $0.41 per share, along with unregistered warrants to purchase an equal number of shares, aimed at raising approximately $2.5 million for working capital and general corporate purposes [2][5]. Group 1: Offering Details - The gross proceeds from the offering are expected to be approximately $2.5 million before deducting fees and expenses [2]. - The offering includes a registered direct offering and a concurrent private placement of unregistered warrants [5]. - The unregistered warrants will have an exercise price of $0.41 per share and will expire five years from the date of stockholder approval [6]. Group 2: Regulatory Information - The unregistered warrants and underlying shares have not been registered under the Securities Act and may not be resold in the U.S. without an effective registration statement or applicable exemption [3]. - The shares offered in the registered direct offering are being made under a "shelf" registration statement previously filed with the SEC [7]. Group 3: Company Overview - Mustang Bio is a clinical-stage biopharmaceutical company focused on developing cell therapies for difficult-to-treat cancers [9]. - The company aims to acquire rights to medical technologies, fund research and development, and partner with leading medical institutions to advance CAR-T therapies [9].

All patients were heavily pretreated/refractory to BTK inhibitors, and only one patient has started new anti-WM treatment after MB-106 Overall response rate of 90% in cohort with durable responses observed; one patient remains in complete remission at 31 months Outpatient administration was allowed and found to be feasible Currently no FDA-approved CAR-T treatments for WM Data presented at the European Hematology Association 2024 Hybrid Congress WORCESTER, Mass., June 17, 2024 (GLOBE NEWSWIRE) -- Mustang Bi ...

Company Overview - Fortress Biotech, Inc. 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 [3] - The company has seven marketed prescription pharmaceutical products and over 20 programs in development across various therapeutic areas including oncology, dermatology, and rare diseases [3] - Fortress has established partnerships with leading academic research institutions and biopharmaceutical companies such as AstraZeneca, City of Hope, Fred Hutchinson Cancer Center, Nationwide Children's Hospital, and Sentynl to maximize opportunities [3] Upcoming Events - Lindsay A. Rosenwald, M.D., Chairman, President, and CEO of Fortress, will participate in a fireside chat at the Alliance Global Partners' Virtual Healthcare Company Showcase on May 21, 2024, at 4:20 p.m. ET [1] - A replay of the fireside chat will be available on Fortress' website for approximately 30 days following the meeting [2]

PART I. FINANCIAL INFORMATION [Unaudited Condensed Consolidated Financial Statements](index=7&type=section&id=Item%201.%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section presents Fortress Biotech's unaudited condensed consolidated financial statements for Q1 2024, detailing financial position, performance, and cash flows [Unaudited Condensed Consolidated Balance Sheets](index=7&type=section&id=Unaudited%20Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2024, Fortress Biotech reported total assets of **$164.6 million**, a slight decrease from **$167.5 million** at December 31, 2023, resulting in a total stockholders' deficit of **$3.9 million** Condensed Consolidated Balance Sheet Data (in thousands) | | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Total Current Assets** | $116,548 | $117,022 | | **Total Assets** | **$164,645** | **$167,526** | | **Total Current Liabilities** | $87,696 | $84,908 | | **Total Liabilities** | **$168,582** | **$165,939** | | **Total Stockholders' Equity (Deficit)** | **($3,937)** | **$1,587** | [Unaudited Condensed Consolidated Statements of Operations](index=8&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations) For Q1 2024, net revenues increased to **$13.0 million**, with loss from operations narrowing to **$36.6 million** due to reduced R&D and SG&A expenses, leading to a net loss attributable to Fortress of **$15.4 million** Condensed Consolidated Statements of Operations (in thousands, except per share data) | | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | **Net Revenue** | $13,030 | $12,429 | | **Total Operating Expenses** | $49,596 | $71,296 | | **Loss from Operations** | ($36,566) | ($58,867) | | **Net Loss** | ($39,023) | ($55,145) | | **Net Loss Attributable to Fortress** | ($15,417) | ($21,537) | | **Net Loss Per Common Share** | ($1.03) | ($3.47) | [Unaudited Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities improved to **$25.4 million** in Q1 2024, with **$27.9 million** provided by financing activities, resulting in a net increase in cash of **$2.5 million** Summary of Cash Flows (in thousands) | | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | **Net cash used in operating activities** | ($25,387) | ($43,220) | | **Net cash used in investing activities** | $0 | ($5,000) | | **Net cash provided by financing activities** | $27,859 | $22,187 | | **Net increase (decrease) in cash** | $2,472 | ($26,033) | | **Cash, cash equivalents and restricted cash at end of period** | $85,837 | $154,921 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=13&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) These notes detail Fortress Biotech's business model, significant accounting policies, debt, equity, and segment performance, along with liquidity and subsequent events - Fortress operates as a biopharmaceutical company focused on acquiring and advancing assets through subsidiaries and partner companies, including Avenue, Checkpoint, Journey, and Mustang. The parent company's cash of **$43.9 million** is considered sufficient to fund its operations for at least the next 12 months, but additional funding will be needed for broader development and regulatory activities[41](index=41&type=chunk)[43](index=43&type=chunk)[45](index=45&type=chunk) - In May 2024, Mustang and uBriGene executed a National Security Agreement with CFIUS, agreeing to abandon the previously planned sale of Mustang's Worcester manufacturing facility to uBriGene[60](index=60&type=chunk) Total Debt Outstanding (in thousands) | Debt Instrument | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Oaktree Note | $50,000 | $50,000 | | SWK Term Loan | $15,000 | $15,000 | | Less: Discount on notes payable | ($3,580) | ($4,144) | | **Total notes payable** | **$61,420** | **$60,856** | - In January 2024, Fortress closed a registered direct offering, raising net proceeds of approximately **$10.2 million**[101](index=101&type=chunk) - Subsequent to the quarter end, in April 2024, Avenue effected a 1-for-75 reverse stock split. In May 2024, Avenue raised approximately **$4.4 million** in gross proceeds through a warrant inducement transaction[140](index=140&type=chunk)[141](index=141&type=chunk)[142](index=142&type=chunk) - Subsequent to the quarter end, in April 2024, Mustang reduced its workforce by approximately **81%**. In May 2024, Mustang raised approximately **$3.3 million** in net proceeds from a public offering[145](index=145&type=chunk)[146](index=146&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=44&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's Q1 2024 financial performance, highlighting increased net revenue, significantly reduced operating expenses, and a strong liquidity position [Overview and Recent Events](index=44&type=section&id=Overview%20and%20Recent%20Events) Fortress Biotech's Q1 2024 saw a **5%** net revenue increase to **$13.0 million**, alongside key pipeline updates and successful financing activities across the company and its partners - **Cosibelimab:** Following a CRL from the FDA due to issues at a third-party manufacturer, Checkpoint plans to resubmit the BLA mid-year 2024[160](index=160&type=chunk) - **DFD-29:** The FDA accepted the NDA for this rosacea treatment, setting a PDUFA goal date of November 4, 2024[160](index=160&type=chunk) - **CUTX-101:** The rolling NDA submission for this Menkes disease treatment is ongoing and expected to be completed by partner Sentynl in 2024[158](index=158&type=chunk) - **IV Tramadol:** Avenue reached an agreement with the FDA on the Phase 3 safety study protocol and plans to initiate the study subject to financing[162](index=162&type=chunk) - **Corporate Financing:** In Q1 2024, Fortress raised **~$11.0M**, and Checkpoint raised **~$14.0M**. Post-quarter, Avenue raised **~$4.4M** and Mustang raised **~$4.0M**[170](index=170&type=chunk) [Results of Operations](index=52&type=section&id=Results%20of%20Operations) Q1 2024 net revenue increased **5%** to **$13.0 million**, while total operating expenses decreased **30%** to **$49.6 million**, significantly improving the loss from operations to **$36.6 million** Comparison of Results of Operations (in thousands) | | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | Change (%) | | :--- | :--- | :--- | :--- | | **Net Revenue** | $13,030 | $12,429 | 5% | | **Cost of Goods Sold** | $6,816 | $6,449 | 6% | | **Research & Development** | $24,839 | $35,276 | (30)% | | **R&D - Licenses Acquired** | $0 | $4,230 | (100)% | | **Selling, General & Administrative** | $17,941 | $25,341 | (29)% | | **Loss from Operations** | ($36,566) | ($58,867) | 38% | - The decrease in R&D spending was mainly due to reduced personnel and program costs at Mustang (**$10.2M decrease**) and lower BLA-related expenses at Checkpoint (**$7.3M decrease**), partially offset by a **$5.9M increase** at Journey for DFD-29 filing fees and milestones[187](index=187&type=chunk) - The decrease in SG&A expenses was primarily driven by a **$4.9M reduction** at Journey due to cost reduction initiatives in sales and marketing[193](index=193&type=chunk) [Liquidity and Capital Resources](index=56&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2024, the company held **$83.8 million** in cash and cash equivalents, with management deeming it sufficient for at least the next 12 months of operations, supported by **$27.9 million** from financing activities Cash and Cash Equivalents by Entity (in millions) as of March 31, 2024 | Entity | Cash & Cash Equivalents | | :--- | :--- | | Fortress & private subsidiaries | $43.9 | | Checkpoint | $11.2 | | Mustang | $1.3 | | Journey | $24.1 | | Avenue | $3.2 | | **Total** | **$83.8** | - The company and its subsidiaries have actively raised capital through at-the-market programs and registered direct offerings. In Q1 2024, Fortress raised net proceeds of **~$10.2M** from a direct offering and **$0.9M** from its ATM program[207](index=207&type=chunk)[208](index=208&type=chunk) - Partner companies also secured financing in Q1 2024, with Checkpoint raising **~$12.8M** in a direct offering, Avenue raising **~$4.5M** from a warrant inducement, and Journey raising **$1.5M** from its ATM program[211](index=211&type=chunk)[214](index=214&type=chunk)[216](index=216&type=chunk) [Quantitative and Qualitative Disclosures About Market Risks](index=62&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risks) As a "smaller reporting company," Fortress Biotech, Inc. is not required to provide the information for this item - The company is a "smaller reporting company" and is therefore not required to provide quantitative and qualitative disclosures about market risks[220](index=220&type=chunk) [Controls and Procedures](index=62&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded the company's disclosure controls and procedures were effective as of March 31, 2024, with no material changes in internal control over financial reporting during the quarter - The principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective as of March 31, 2024[221](index=221&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that materially affected, or are reasonably likely to materially affect, internal controls[222](index=222&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=62&type=section&id=Item%201.%20Legal%20Proceedings) There were no material developments in legal proceedings during the quarter, with the company noting its indemnification obligation for Caelum in the ongoing UTRF Litigation, scheduled for trial in September 2024 - Fortress has an indemnification obligation to its former subsidiary Caelum in a lawsuit brought by The University of Tennessee Research Foundation (UTRF) regarding alleged trade secret misappropriation[119](index=119&type=chunk) - Fortress's indemnification is capped at the amount of acquisition proceeds it received (**~$57 million**) and may be offset against future payments from the acquirer, AstraZeneca. The company believes the amount in escrow (**$15 million**) is sufficient to cover anticipated costs and has not accrued a liability[119](index=119&type=chunk) - A trial for the UTRF Litigation is scheduled for September 2024, pending a motion for summary judgment[119](index=119&type=chunk) [Risk Factors](index=64&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant investment risks, encompassing drug development, financing, revenue dependence, business strategy, third-party reliance, and regulatory compliance [Risks Inherent in Drug Development](index=64&type=section&id=Risks%20Inherent%20in%20Drug%20Development) The company faces substantial risks in drug development, including high failure rates in clinical trials, intense competition, and potential delays or terminations of studies - Most product candidates are in early development stages, requiring substantial capital and time, with a high risk of failure in clinical trials or at the regulatory approval stage[227](index=227&type=chunk) - The company faces intense competition from larger pharmaceutical companies with greater resources, which may develop more effective or cheaper treatments, rendering Fortress's candidates obsolete[241](index=241&type=chunk)[245](index=245&type=chunk) - Delays, suspensions, or terminations of clinical trials can occur for numerous reasons, including patient enrollment difficulties, safety issues, or regulatory holds, which would increase costs and hinder development[234](index=234&type=chunk)[239](index=239&type=chunk) [Risks Pertaining to the Need for and Impact of Existing and Additional Financing Activities](index=73&type=section&id=Risks%20Pertaining%20to%20the%20Need%20for%20and%20Impact%20of%20Existing%20and%20Additional%20Financing%20Activities) Fortress has a history of operating losses and requires substantial additional funding, with its ability to raise capital limited by existing debt covenants and SEC rules, leading to potential R&D curtailment and stockholder dilution - The company has a history of operating losses (**$39.0M** for Q1 2024) and an accumulated deficit of **$710.3 million** as of March 31, 2024, with losses expected to continue[262](index=262&type=chunk) - Substantial additional funding is required for R&D, commercialization, and acquisitions. The company's ability to raise capital through shelf registrations is limited by the SEC's "baby shelf rules" due to its public float being under **$75 million**[272](index=272&type=chunk)[276](index=276&type=chunk)[277](index=277&type=chunk) - Existing debt, such as the Oaktree Note, contains restrictive covenants that limit the company's ability to incur more debt, make certain investments, and pay dividends, potentially hindering growth opportunities[259](index=259&type=chunk)[261](index=261&type=chunk) [Risks Pertaining to Our Existing Revenue Stream from Journey Medical Corporation](index=81&type=section&id=Risks%20Pertaining%20to%20Our%20Existing%20Revenue%20Stream%20from%20Journey%20Medical%20Corporation) The company's revenue heavily relies on Journey's dermatology products, which face risks from generic competition and dependence on favorable managed care formulary inclusion and third-party payor reimbursement - The vast majority of operating income is expected to come from Journey's dermatology products. Any setbacks related to supply, demand, manufacturing, or competition for these products could significantly impair financial results[282](index=282&type=chunk) - A significant portion of Journey's sales comes from products without patent protection (e.g., Accutane, Targadox), making them vulnerable to generic competition, which can lead to intense price pressure and loss of market share[283](index=283&type=chunk)[284](index=284&type=chunk)[285](index=285&type=chunk) - Sales depend on reimbursement from third-party payors and inclusion in managed care formularies. Failure to secure favorable formulary status or adequate reimbursement levels could negatively impact product utilization and market share[291](index=291&type=chunk)[292](index=292&type=chunk) [Risks Pertaining to our Business Strategy, Structure and Organization](index=87&type=section&id=Risks%20Pertaining%20to%20our%20Business%20Strategy%2C%20Structure%20and%20Organization) The company's business model, involving complex collaborations and acquisitions, creates financial risks through subsidiary guarantees and potential conflicts of interest due to shared officers and concentrated ownership - The strategy of entering into collaborations or divestitures (like with Caelum and Cyprium) is complex and may reduce business scope or fail to consummate, impairing asset value[305](index=305&type=chunk)[306](index=306&type=chunk) - Fortress acts as a guarantor and/or indemnitor for certain obligations of its subsidiaries, which could require substantial payments based on the actions of those entities[312](index=312&type=chunk)[313](index=313&type=chunk) - Shared officers and directors across Fortress and its partner companies could create conflicts of interest regarding corporate opportunities and transactions[317](index=317&type=chunk) [Risks Pertaining to Reliance on Third Parties](index=93&type=section&id=Risks%20Pertaining%20to%20Reliance%20on%20Third%20Parties) Fortress heavily relies on third parties for manufacturing, clinical trials, and R&D, introducing risks of non-compliance, delays, and disputes that could significantly hinder product development and commercialization - The company depends heavily on third-party manufacturers for preclinical, clinical, and commercial supply. Any failure by these manufacturers to comply with cGMP or other regulations could halt trials and sales[327](index=327&type=chunk)[328](index=328&type=chunk) - Reliance on third-party CROs to conduct clinical trials is critical. If these parties fail to meet deadlines, adhere to protocols, or comply with GCP, clinical data may be deemed unreliable, delaying or preventing regulatory approval[334](index=334&type=chunk)[337](index=337&type=chunk)[338](index=338&type=chunk) - Collaborative relationships are difficult to establish and manage. Partners may not commit sufficient resources or may prioritize other projects, and disputes can terminate agreements, jeopardizing development programs[342](index=342&type=chunk)[344](index=344&type=chunk) [Risks Pertaining to Intellectual Property and Potential Disputes with Licensors Thereof](index=99&type=section&id=Risks%20Pertaining%20to%20Intellectual%20Property%20and%20Potential%20Disputes%20with%20Licensors%20Thereof) The company's success depends on maintaining patent protection, much of which is in-licensed, exposing it to risks of litigation, validity challenges, and licensor disputes that could jeopardize product development and commercialization - The company's ability to commercialize products depends on maintaining sufficient patent protection, which is uncertain and subject to challenges, invalidation, or circumvention by competitors[348](index=348&type=chunk)[352](index=352&type=chunk) - The majority of intellectual property is in-licensed from third parties. Any dispute with these licensors over terms, payments, or diligence obligations could adversely affect the ability to develop and commercialize the applicable product candidates[366](index=366&type=chunk)[367](index=367&type=chunk) - The company may be sued for infringing third-party intellectual property rights, which could be costly, time-consuming, and result in being forced to obtain licenses, pay substantial damages, or abandon product candidates[364](index=364&type=chunk)[365](index=365&type=chunk) [Risks Pertaining to the Commercialization of Product Candidates](index=108&type=section&id=Risks%20Pertaining%20to%20the%20Commercialization%20of%20Product%20Candidates) Even with regulatory approval, products face significant commercialization risks, including uncertain market acceptance, potential product liability claims, and ongoing regulatory scrutiny that could lead to marketing restrictions or withdrawal - Approved products may not achieve broad market acceptance, which depends on factors like efficacy, safety, cost-effectiveness, and competition. Failure to gain acceptance will limit revenue[372](index=372&type=chunk)[373](index=373&type=chunk) - The company faces potential product liability exposure from clinical trials and commercial sales. Successful claims could result in substantial liabilities, reputational harm, and limit commercialization[376](index=376&type=chunk) - Approved products are subject to ongoing regulatory requirements. Later discovery of problems or failure to comply can result in restrictions, recalls, fines, or withdrawal of marketing approval[380](index=380&type=chunk)[381](index=381&type=chunk) [Risks Pertaining to Legislation and Regulation Affecting the Biopharmaceutical and Other Industries](index=113&type=section&id=Risks%20Pertaining%20to%20Legislation%20and%20Regulation%20Affecting%20the%20Biopharmaceutical%20and%20Other%20Industries) The company's business is subject to extensive and evolving healthcare laws and regulations, with compliance costs and potential penalties, while legislative efforts to control healthcare costs could negatively impact drug pricing and profitability - The company is subject to complex healthcare laws (e.g., Anti-Kickback Statute, False Claims Act), and non-compliance can lead to criminal sanctions, civil penalties, and exclusion from government healthcare programs[384](index=384&type=chunk) - Healthcare reform measures, particularly those aimed at containing drug costs like the Inflation Reduction Act of 2022, could reduce prices and reimbursement for products, adversely affecting profitability[299](index=299&type=chunk)[301](index=301&type=chunk) - If the company's holdings of minority interests in other entities expand, it may become subject to regulation under the Investment Company Act of 1940, which would incur significant compliance costs[388](index=388&type=chunk) [General and Other Risks](index=115&type=section&id=General%20and%20Other%20Risks) This section covers a range of general business risks, including cybersecurity threats, reliance on key personnel, potential for employee misconduct, stock price volatility, and challenges in managing growth - The business is vulnerable to computer system failures and cyber-attacks. A 2021 incident at Journey resulted in a **$9.5 million** misdirection of funds, highlighting the financial and reputational risks[390](index=390&type=chunk)[392](index=392&type=chunk) - The company's success depends on retaining key officers and employees. Competition for qualified personnel is intense, and their loss could adversely affect the business[397](index=397&type=chunk) - The company has previously failed to meet Nasdaq's minimum bid price requirement. Future non-compliance with listing standards could result in the delisting of its securities, which would decrease market liquidity and price[423](index=423&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=127&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[425](index=425&type=chunk) [Defaults Upon Senior Securities](index=127&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - None[426](index=426&type=chunk) [Mine Safety Disclosures](index=127&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - None[427](index=427&type=chunk) [Other Information](index=127&type=section&id=Item%205.%20Other%20Information) The company reported no other information required to be disclosed in this item - None[428](index=428&type=chunk) [Exhibits](index=127&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including corporate governance documents, agreements related to recent financing activities, and certifications by the CEO and CFO - Exhibits filed include certifications from the CEO and CFO (Exhibits 31.1, 31.2, 32.1, 32.2) and documents related to the December 2023 Securities Purchase Agreement and Placement Agency Agreement (Exhibits 10.1, 10.2)[432](index=432&type=chunk)

[Q1 2024 Overview and Corporate Highlights](index=1&type=section&id=Fortress%20Biotech%20Reports%20First%20Quarter%202024%20Financial%20Results%20and%20Recent%20Corporate%20Highlights) [CEO's Statement](index=1&type=section&id=CEO's%20Statement) The CEO highlighted **7% product revenue growth** in Q1 2024, driven by flagship products, alongside key regulatory milestones and anticipated approvals - Product revenue grew **7% year-over-year** in Q1, primarily driven by **over 20% growth** in flagship products Qbrexza and Accutane[2](index=2&type=chunk) - The company's late-stage pipeline may yield up to **three regulatory approvals** within the next 12 months, with a potential fourth BLA filing as early as 2025[1](index=1&type=chunk)[2](index=2&type=chunk) - Multiple data readouts are anticipated in 2024, including topline data for AJ201, Phase 1b data for dotinurad, and Phase 2 data for Triplex[2](index=2&type=chunk) [Recent Corporate Highlights](index=2&type=section&id=Recent%20Corporate%20Highlights) Significant pipeline progress reported, encompassing regulatory milestones, clinical advancements, commercial performance, and financing [Regulatory Milestones and Updates](index=2&type=section&id=Regulatory%20Milestones%20and%20Updates) Fortress achieved key regulatory milestones, including DFD-29 NDA acceptance, CUTX-101 submission, and planned cosibelimab BLA resubmission - The FDA accepted the New Drug Application (NDA) for DFD-29 for treating rosacea, with a PDUFA goal date of **November 4, 2024**[1](index=1&type=chunk)[6](index=6&type=chunk) - The rolling NDA submission for CUTX-101 is ongoing and expected to be completed in **2024**[6](index=6&type=chunk) - Following a Complete Response Letter (CRL) for cosibelimab citing third-party manufacturing issues, a BLA resubmission is targeted for **mid-year 2024**[6](index=6&type=chunk) - Partner AstraZeneca estimates it may submit the BLA for CAEL-101 for AL amyloidosis for FDA review as early as **2025**[6](index=6&type=chunk) [Clinical Updates](index=2&type=section&id=Clinical%20Updates) Several clinical programs advanced, including Triplex Phase 2 enrollment, new Triplex study initiation, and anticipated dotinurad data - The Phase 2 clinical trial of Triplex in adults co-infected with HIV and CMV is fully enrolled, with topline data expected in **Q4 2024**[6](index=6&type=chunk) - The first patient was dosed in a multi-center Phase 2 study of Triplex for CMV control in liver transplant patients, funded by an NIH grant of **over $20 million**[2](index=2&type=chunk)[6](index=6&type=chunk) - Data from the ongoing Phase 1b clinical trial of dotinurad for gout and hyperuricemia is expected in **mid-2024**[2](index=2&type=chunk)[6](index=6&type=chunk) [Commercial Product Updates](index=2&type=section&id=Commercial%20Product%20Updates) Journey Medical reported **$13.0 million** in total revenues for Q1 2024, representing a **7% increase** year-over-year Journey Medical Total Revenues | Company | Metric | Q1 2024 | Q1 2023 | Change | | :--- | :--- | :--- | :--- | :--- | | Journey Medical | Total Revenues | $13.0 million | $12.2 million | +7% | [General Corporate](index=3&type=section&id=General%20Corporate) Fortress and partner companies completed several financing activities in early 2024, securing significant capital - In January 2024, Fortress raised gross proceeds of approximately **$11.0 million** in a registered direct offering[9](index=9&type=chunk) - Partner companies Checkpoint and Avenue raised approximately **$14.0 million** and **$5.0 million**, respectively, in January 2024[9](index=9&type=chunk) - Subsequent to Q1, in May 2024, Avenue raised approximately **$4.4 million** and Mustang raised approximately **$4.0 million**[9](index=9&type=chunk) [Financial Results](index=3&type=section&id=Financial%20Results) [First Quarter 2024 Financial Performance](index=3&type=section&id=First%20Quarter%202024%20Financial%20Performance) Fortress reported **$13.0 million** in Q1 2024 net revenue, reduced operating expenses, and a net loss of **$17.7 million** Key Financial Highlights | Financial Metric | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | **Consolidated Net Revenue** | $13.0 million | $12.4 million | | **R&D Expenses** | $24.8 million | $39.5 million | | **SG&A Costs** | $17.9 million | $25.3 million | | **Net Loss (to common stockholders)** | $(17.7) million | $(23.5) million | | **Net Loss per Share** | $(1.03) | $(3.47) | Consolidated Cash Position | Cash Position | March 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | **Consolidated Cash** | $85.8 million | $83.4 million | [Financial Statements](index=5&type=section&id=Financial%20Statements) [Unaudited Condensed Consolidated Balance Sheets](index=5&type=section&id=Unaudited%20Condensed%20Consolidated%20Balance%20Sheets) Fortress Biotech reported total assets of **$164.6 million**, liabilities of **$168.6 million**, and a stockholders' deficit of **$3.9 million** Condensed Consolidated Balance Sheet Summary | Balance Sheet Item ($ in thousands) | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $83,774 | $80,927 | | Total Assets | $164,645 | $167,526 | | Total Liabilities | $168,582 | $165,939 | | Total stockholders' equity (deficit) | $(3,937) | $1,587 | [Unaudited Condensed Consolidated Statements of Operations](index=6&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations) For Q1 2024, the company reported **$13.0 million** net revenue, reduced operating expenses, and an improved net loss of **$17.7 million** Condensed Consolidated Statements of Operations Summary | Statement of Operations ($ in thousands) | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Net revenue | $13,030 | $12,429 | | Total operating expenses | $49,596 | $71,296 | | Loss from operations | $(36,566) | $(58,867) | | Net loss attributable to common stockholders | $(17,731) | $(23,545) | | Net loss per common share | $(1.03) | $(3.47) |

Core Viewpoint - Fortress Biotech and its subsidiary Helocyte are advancing the development of Triplex, a vaccine aimed at preventing and treating cytomegalovirus (CMV) in liver transplant recipients, with the first patient dosed in a Phase 2 clinical trial funded by a $9 million NIH/NIAID grant, expected to receive an additional $12 million over the next four years [1][2][3]. Company Overview - Fortress Biotech is focused on acquiring and advancing biopharmaceutical assets to enhance long-term shareholder value through product revenue, equity holdings, and dividend and royalty revenue, with seven marketed products and over 20 programs in development [6]. - Helocyte is a clinical-stage company developing immunotherapies for cancer and infectious diseases, including CMV and HIV, with a significant focus on transplant recipients who are at high risk for CMV complications [5]. Clinical Trial Details - The Phase 2 trial, named "CMV vaccine in Orthotopic Liver Transplant" (COLT), involves up to 416 CMV seronegative liver transplant recipients to evaluate the safety and efficacy of two doses of Triplex [2]. - The primary objective is to assess the impact of pre-transplant Triplex vaccination on the duration of CMV antiviral therapy within the first 100 days post-transplant [2]. Triplex Vaccine Information - Triplex is a recombinant Modified Vaccinia Ankara viral vector vaccine designed to induce a robust T cell response to CMV, with previous studies indicating it is safe, well-tolerated, and highly immunogenic [4]. - The vaccine is currently involved in multiple ongoing clinical trials for various transplant indications and HIV, with plans for additional studies, including a Phase 2 trial for kidney transplant recipients [4]. Market Context - CMV poses significant risks in organ transplantation, with over 46,000 organ transplants performed in the U.S. in 2023, primarily kidney and liver transplants, highlighting the unmet medical need for effective therapies [5].

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

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

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

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