Full Press Release Details
Total net revenue increased approximately 9% to $19.2 million for the third quarter of 2026 compared to the third quarter of 2025
Fortress repaid its credit facility in full in September 2026
A subsidiary of Fortress entered into a license agreement for FB-607, which is currently being evaluated in a randomized, double-blind, placebo-controlled Phase 2 study to assess the safety and efficacy in patients with irritable bowel syndrome with diarrhea
Partnered programs continue to advance, with Crystalys Therapeutics closing a $130 million Series B financing, and royalties generated from ZYCUBO® and UNLOXCYT™
MIAMI, Nov. 13, 2026 (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 income, today announced financial results and recent corporate highlights for the third quarter ended September 30, 2026.
Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, “The third quarter of 2026 reflected continued execution across our diversified portfolio. In September, we repaid in full our credit facility with Oaktree and we also recently announced the in-licensing of FB-607, a novel combination therapy to treat the symptoms of irritable bowel syndrome with diarrhea (“IBS-D”). FB-607 is currently being studied in a randomized, placebo-controlled, Phase 2 trial for IBS-D and we expect to release top-line data in the second half of 2027. Journey Medical continues to build momentum with Emrosi®, with approximately 40,000 in total prescriptions for the third quarter of 2026, supported by continued improvement in the mix of prescriptions reimbursed by health plans. Additionally, in September, anselamimab (formerly CAEL-101) was approved in Japan for the treatment of systemic kappa light chain amyloidosis. With our growing royalty income from ZYCUBO® and UNLOXCYT™, and multiple potential catalysts across our partnered programs, we believe Fortress is well positioned to continue driving long-term value for our shareholders.”
Recent Corporate Highlights1:
Corporate Updates
• Fortress Repays Oaktree Credit Facility in Full. In September 2026, Fortress repaid in full the remaining $15.0 million in outstanding principal under its senior secured credit agreement with Oaktree Fund Administration, LLC (the “Oaktree Agreement”). Upon repayment, all indebtedness under the Oaktree Agreement was satisfied and paid in full, all liens and other security interests in Fortress’ property securing the facility were released and terminated, and the Oaktree Agreement terminated in accordance with its terms. Fortress originally entered into the $50.0 million credit facility in July 2024. Following the repayment, Fortress has no outstanding debt at the parent level.
• Fortress Subsidiary Licenses FB-607 for IBS-D. In the third quarter of 2026, a majority-owned and controlled private subsidiary of Fortress entered into an exclusive licensing agreement with Cedars-Sinai to develop FB-607, a novel drug with the potential to improve care for patients with IBS-D. FB-607 is currently being evaluated in a multi-center, randomized, double-blind, placebo-controlled Phase 2 study to assess the safety and efficacy in patients with IBS-D.
Commercial Portfolio Updates
• Journey Medical Continues to Grow Emrosi®. At the end of March 2025, our partner company Journey Medical Corporation (“Journey Medical”) commercially launched Emrosi® (40mg Minocycline Hydrochloride Modified-Release Capsules, consisting of 10mg immediate release and 30mg extended release pellets), also known as DFD-29, for inflammatory lesions of rosacea. Emrosi® was approved by the FDA in November 2024 and is available by prescription at specialty pharmacy chains. Journey Medical reported that Emrosi® had generated approximately 40,000 prescriptions in the third quarter of 2026. Journey Medical reported net product revenues of $18.9 million for the third quarter of 2026, compared to net product revenues of $17.0 million for the third quarter ended September 30, 2025.
• Royalties. In the third quarter of 2026, Cyprium Therapeutics, Inc. (“Cyprium”) recognized $0.2 million in royalty revenue on net sales of ZYCUBO®, and Fortress recognized $0.1 million in royalty income (contingent consideration) on net sales of UNLOXCYT™.
Clinical Updates
• Crystalys Raises $130M Series B. In July 2026, Crystalys Therapeutics (“Crystalys”) announced a $130 million Series B financing to support the late-stage global clinical development and commercialization preparation for dotinurad. Patients continue to be enrolled in Crystalys’ two randomized, double-blind, multicenter global Phase 3 trials, RUBY and TOPAZ, evaluating dotinurad, a next-generation, once daily oral URAT1 inhibitor with potential for best-in-class safety and efficacy for the treatment of gout, as well as its Phase 2 AMETHYST study in difficult-to-treat gout. Our controlled subsidiary Urica is an equity holder of Crystalys and eligible to receive a 3% royalty on future net sales of dotinurad.
• Anselamimab Receives Approval in Japan. In September 2026, anselamimab (formerly known as CAEL-101) was approved in Japan for the treatment of systemic kappa light chain amyloidosis. Through the sale of Caelum Biosciences, Fortress is eligible to receive commercial milestone payments based on sales and a regulatory milestone payment upon approval by the FDA.
• Other Portfolio Programs Continue to Advance with Potential Upcoming Data and Trial Initiations. Triplex is currently in multiple ongoing clinical trials for cytomegalovirus (CMV) treatment and prevention in solid organ and stem cell transplants, combination trials with CAR T cell therapies for hematologic malignancies. We are exploring the possibility of initiating a clinical trial evaluating MB-109, a combination CAR T cell therapy and oncolytic virus, in the first quarter of 2027 for patients with IL13Rα2-positive recurrent glioblastoma and high-grade astrocytoma.
Financial Results:
• As of September 30, 2026, Fortress’ consolidated cash and cash equivalents totaled $152.2 million, compared to $79.4 million as of December 31, 2025, an increase of $72.8 million year-to-date.
• Fortress’ consolidated cash and cash equivalents totaling $152.2 million as of September 30, 2026 includes $114.1 million attributable to Fortress and the private subsidiaries, $1.5 million attributable to Avenue Therapeutics, $14.3 million attributable to Mustang Bio and $22.3 million attributable to Journey Medical.
• Fortress’ consolidated cash and cash equivalents totaled $79.4 million as of December 31, 2025, and includes $35.2 million attributable to Fortress and private subsidiaries, $2.9 million attributable to Avenue Therapeutics, $17.3 million attributable to Mustang Bio and $24.1 million attributable to Journey Medical.
• Fortress’ consolidated net revenue totaled $19.2 million for the third quarter ended September 30, 2026, $18.9 million of which was generated from our marketed dermatology products. This compares to consolidated net revenue totaling $17.6 million for the third quarter of 2025, $17.0 million of which was generated from our marketed dermatology products.
• Consolidated research and development expenses totaled $1.7 million for the third quarter ended September 30, 2026, compared to $0.2 million for the third quarter ended September 30, 2025.
• Consolidated selling, general and administrative costs were $17.8 million for the third quarter ended September 30, 2026, compared to $17.4 million for the third quarter ended September 30, 2025.
• Consolidated net loss attributable to common stockholders was $(7.9) million, or $(0.23) per share basic and diluted, for the third quarter ended September 30, 2026, compared to net income attributable to common stockholders of $3.7 million, or $0.13 per share basic, and $0.11 per share diluted, for the third quarter ended September 30, 2025.
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 income. The company has a portfolio of multiple marketed prescription pharmaceutical products and 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, Nationwide Children’s Hospital, Columbia University, Dana-Farber Cancer Institute and Sentynl Therapeutics. For more information, visit www.fortressbiotech.com.
Forward-Looking Statements Statements 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; our need for substantial additional funds and uncertainties relating to financings; uncertainty related to the timing and amounts expected to be realized from future milestone, contingent value right, royalty or similar future revenue streams, if at all; 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 product candidates 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 Jaffe Fortress Biotech, Inc. (781) 652-4500 ir@fortressbiotech.com
Media Relations Contact: Tony Plohoros 6 Degrees (908) 591-2839 tplohoros@6degreespr.com
| FORTRESS BIOTECH, INC. AND SUBSIDIARIES Unaudited Condensed Consolidated Balance Sheets ($ in thousands except for share and per share amounts) | ||||||||
| September 30, 2026 | December 31, 2025 | |||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 152,186 | $ | 79,381 | ||||
| Accounts receivable, net | 47,387 | 29,783 | ||||||
| Inventory | 7,772 | 9,624 | ||||||
| Other receivables - related party | 54 | 158 | ||||||
| Prepaid expenses and other current assets | 2,964 | 4,895 | ||||||
| Total current assets | 210,363 | 123,841 | ||||||
| Property and equipment, net | 2,320 | 2,519 | ||||||
| Operating lease right-of-use asset, net | 11,028 | 12,302 | ||||||
| Restricted cash | 1,220 | 1,220 | ||||||
| Equity investments, at fair value | 29,452 | 17,660 | ||||||
| Intangible assets, net | 24,541 | 27,605 | ||||||
| Other assets | 1,291 | 401 | ||||||
| Total assets | $ | 280,215 | $ | 185,548 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable and accrued expenses | $ | 56,628 | $ | 47,125 | ||||
| Income taxes payable | 5,119 | 356 | ||||||
| Common stock warrant liabilities | — | 1 | ||||||
| Operating lease liabilities, short-term | 2,513 | 2,127 | ||||||
| Partner company notes payable, short-term | 7,500 | — | ||||||
| Other current liabilities | — | 135 | ||||||
| Total current liabilities | 71,760 | 49,744 | ||||||
| Notes payable, long-term, net | 18,077 | 52,417 | ||||||
| Operating lease liabilities, long-term | 10,861 | 12,672 | ||||||
| Partner company redeemable perpetual preferred liability | — | 7,085 | ||||||
| Other long-term liabilities | 2,496 | 1,447 | ||||||
| Total liabilities | 103,194 | 123,365 | ||||||
| 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 September 30, 2026 and December 31, 2025, respectively, liquidation value of $25.00 per share | 3 | 3 | ||||||
| Common stock, $0.001 par value, 200,000,000 shares authorized, 33,490,362 and 31,364,094 shares issued and outstanding as of September 30, 2026 and December 31, 2025, respectively | 33 | 31 | ||||||
| Additional paid-in-capital | 789,953 | 783,891 | ||||||
| Accumulated deficit | (629,992 | ) | (734,052 | ) | ||||
| Total stockholders' equity attributed to the Company | 159,997 | 49,873 | ||||||
| Non-controlling interests | 17,024 | 12,310 | ||||||
| Total stockholders' equity | 177,021 | 62,183 | ||||||
| Total liabilities and stockholders' equity | $ | 280,215 | $ | 185,548 |
| FORTRESS BIOTECH, INC. AND SUBSIDIARIES Unaudited CondensedConsolidated Statements of Operations ($ in thousands except for share and per share amounts) | ||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Revenue | ||||||||||||||||
| Product revenue, net | $ | 18,925 | $ | 17,025 | $ | 52,685 | $ | 45,173 | ||||||||
| Other revenue | 234 | 606 | 1,229 | 2,010 | ||||||||||||
| Net revenue | 19,159 | 17,631 | 53,914 | 47,183 | ||||||||||||
| Operating expenses | ||||||||||||||||
| Cost of goods - (excluding amortization of acquired intangible assets) | 5,884 | 5,755 | 18,245 | 15,484 | ||||||||||||
| Amortization of acquired intangible assets | 969 | 1,064 | 3,064 | 3,193 | ||||||||||||
| Research and development | 1,678 | 208 | 3,023 | 12,268 | ||||||||||||
| Selling, general and administrative | 17,821 | 17,415 | 54,519 | 81,670 | ||||||||||||
| Total operating expenses | 26,352 | 24,442 | 78,851 | 112,615 | ||||||||||||
| Loss from operations | (7,193 | ) | (6,811 | ) | (24,937 | ) | (65,432 | ) | ||||||||
| Other income (expense) | ||||||||||||||||
| Interest income | 1,295 | 736 | 3,446 | 1,848 | ||||||||||||
| Interest expense and financing fee | (2,498 | ) | (2,742 | ) | (7,342 | ) | (8,065 | ) | ||||||||
| Gain on sale of priority review voucher, net of expenses | — | — | 158,873 | — | ||||||||||||
| Change in fair value of partner company derivative liability | — | — | (7,085 | ) | — | |||||||||||
| Loss on common stock warrant liabilities | — | (2 | ) | 1 | (399 | ) | ||||||||||
| Gain from deconsolidation of subsidiary | 104 | — | 186 | 27,127 | ||||||||||||
| Other income (expense) | (18 | ) | 17,672 | 11,764 | 17,599 | |||||||||||
| Total other income (expense) | (1,117 | ) | 15,664 | 159,843 | 38,110 | |||||||||||
| Income (loss) before income tax expense | (8,310 | ) | 8,853 | 134,906 | (27,322 | ) | ||||||||||
| Income tax (benefit) expense | (56 | ) | 26 | 5,395 | 196 | |||||||||||
| Net income (loss) | (8,254 | ) | 8,827 | 129,511 | (27,518 | ) | ||||||||||
| Attributable to non-controlling interests | 2,409 | (2,977 | ) | (25,451 | ) | 38,270 | ||||||||||
| Net income (loss) attributable to Fortress | $ | (5,845 | ) | $ | 5,850 | $ | 104,060 | $ | 10,752 | |||||||
| Preferred A dividends cumulated, and Fortress' share of subsidiary deemed dividends | (2,008 | ) | (2,174 | ) | (6,024 | ) | (6,436 | ) | ||||||||
| Net income (loss) attributable to common stockholders | $ | (7,853 | ) | $ | 3,675 | $ | 98,036 | $ | 4,316 | |||||||
| Net income (loss) per common share attributable to common stockholders - basic | $ | (0.23 | ) | $ | 0.13 | $ | 2.94 | $ | 0.16 | |||||||
| Net income (loss) per common share attributable to common stockholders - diluted | $ | (0.23 | ) | $ | 0.11 | $ | 2.51 | $ | 0.14 | |||||||
| Weighted average common shares outstanding - basic | 33,746,832 | 27,244,474 | 33,394,537 | 27,075,216 | ||||||||||||
| Weighted average common shares outstanding - diluted | 33,746,832 | 33,100,961 | 38,997,513 | 30,695,996 |
1 This press release references products being developed or commercialized by Fortress, by Fortress’ private or public subsidiaries (referred to herein as “subsidiaries” or “partner companies”) and by 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.