Elritercept

March 09, 2026 -- Keros Therapeutics, Inc. (“Keros” or the “Company”) (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta (“TGF-ß”) family of proteins, today announced that it has entered into an agreement with the Massachusetts General Hospital (“MGH”) for the design of a Phase 2 clinical trial evaluating rinvatercept in patients with amyotrophic lateral sclerosis (“ALS”) within the Healey ALS MyMatch program (“ALS MyMatch”), led by the Sean M. Healey & AMG Center for ALS at Mass General Brigham. The collaboration is in response to the Healey & AMG Center’s call for applications for the ALS MyMatch program. The ALS MyMatch program is accelerating the development of new therapies for ALS by harnessing the power of biomarker-driven personalized trial approaches. By integrating comprehensive genetic and biofluid markers, the program matches subgroups of ALS individuals to various experimental therapies based on their disease markers. ALS MyMatch is an ongoing series of early-stage Phase 1b/2a clinical trials aimed at deepening the understanding of biological effects of experimental products and identifying the optimal population for future later-stage Phase 2/3 clinical trials. “We are proud to be selected to the ALS MyMatch program to collaborate with the Healey & AMG Center at Mass General,” said Jasbir S. Seehra, Ph.D., President and Chief Executive Officer of Keros. “Rinvatercept represents a potentially novel approach to treat patients with ALS. Based on the data we have generated to date, we believe there is a strong scientific rationale for the potential of rinvatercept to preserve muscle strength and function and improve quality of life in patients with ALS.” “ALS is a serious, progressive disorder with need of additional treatment options,” said Merit Cudkowicz, M.D., M.Sc., director of the Sean M. Healey & AMG Center for ALS, executive director of the Neuroscience Institute at Mass General Brigham, and the Julieanne Dorn Professor of Neurology at Harvard Medical School. “We look forward to partnering with Keros to evaluate rinvatercept within the ALS MyMatch program, bringing us closer to our goal of finding additional treatments for those battling ALS.” Healey ALS MyMatch is a multi-site, collaborative initiative that currently brings together four trial-ready, high enrolling ALS research centers and is a Network of Excellence for ALS (NEALS) affiliated program. Research centers include Mass General in Boston; University of Minnesota in Minneapolis, Minn.; Northwestern University in Evanston, Ill.; and Nova Southeastern University in Fort Lauderdale, Fla. ALS MyMatch has partnered with the Acceleration Centers of Enrollment (ACE) program, a community-driven philanthropic partnership program focused on expediting start up and recruitment at study centers. Additional trials and high performing sites will be added as the program grows. The Sean M. Healey & AMG Center for ALS at Mass General Brigham, launched in 2018, brings together a global network of scientists, physicians, nurses, foundations, federal agencies and people living with ALS, their loved ones, and caregivers to accelerate the pace of ALS therapy discovery and development. Rinvatercept is a novel ligand trap comprised of a modified ligand-binding domain derived from activin receptor type IIA and activin receptor type IIB that is fused to the portion of the human antibody known as the Fc domain. Rinvatercept is designed to act as a ligand trap and inhibit the biological effects of myostatin and activin A, which are negative regulators of muscle and bone mass and strength, to improve skeletal muscle regeneration, increase muscle size and strength, inhibit and reduce fibrosis, inhibit inflammation, reduce fat accumulation and improve bone health through bone anabolic mechanisms. We are developing rinvatercept for the treatment of Duchenne muscular dystrophy and for the treatment of ALS. Keros is a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signaling of the TGF-ß family of proteins. Keros is a leader in understanding the role of the TGF-ß family of proteins, which are master regulators of the growth, repair and maintenance of a number of tissues, including skeletal muscle, bone, adipose, heart tissue and blood. By leveraging this understanding, Keros has discovered and is developing protein therapeutics that have the potential to provide meaningful and potentially disease-modifying benefit to patients. Keros’ lead product candidate, rinvatercept, is being developed for the treatment of Duchenne muscular dystrophy and for the treatment of ALS. Keros’ most advanced product candidate, elritercept, is being developed for the treatment of cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndrome and in patients with myelofibrosis. The content above comes from the network. if any infringement, please contact us to modify.

LEXINGTON, Mass., March 04, 2026 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. (“Keros” or the “Company”) (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta (“TGF-ß”) family of proteins, today provided a business update and reported financial results for the fourth quarter and full year ended December 31, 2025. “The previous year was an important period of transition for the Company, during which we sharpened our strategic priorities,” said Jasbir S. Seehra, Ph.D., President and Chief Executive Officer. “With that foundation in place, our attention is firmly on execution – advancing rinvatercept into a Phase 2 clinical trial in patients with Duchenne muscular dystrophy (“DMD”) and engaging regulators on the design of a Phase 2 clinical trial in patients with amyotrophic lateral sclerosis (“ALS”). With a strong foundation in place, our focus remains on bringing potential meaningful benefit to patients and creating long-term value for our stockholders.” Recent Corporate Highlights: Board and leadership changes: In February 2026, Keros announced the appointment of Charles Newton to its board of directors, effective March 9, 2026. Concurrent with Mr. Newton joining Keros’ Board of Directors, Carl Gordon, Ph.D., C.F.A., will step down as a director of the Company. Esther Cho, J.D., Senior Vice President, General Counsel, was promoted to Chief Legal Officer, effective February 24, 2026. Selected Anticipated Program Milestones: Rinvatercept for the treatment of DMD and for the treatment of ALS: The Company expects to commence a Phase 2 clinical trial of rinvatercept in patients with DMD in the second quarter of 2026. The Company plans to engage regulators on the design of a Phase 2 clinical trial of rinvatercept in patients with ALS in the second half of 2026. 2025 Financial Results Keros reported a net loss of $23.5 million for the fourth quarter and net income of $87.0 million for the year ended December 31, 2025, as compared to a net loss of $46.0 million for the fourth quarter and a net loss of $187.4 million for the year ended December 31, 2024. The decrease in net loss for the fourth quarter and the net income for the year was largely due to revenue related to Keros’ license agreement with Takeda Pharmaceuticals U.S.A., Inc. (“Takeda”), partially offset by research and development efforts as well as additional investments to support the achievement of Keros’ clinical and corporate goals. Research and development expenses were $17.9 million for the fourth quarter and $129.6 million for the year ended December 31, 2025, as compared to $45.6 million for the fourth quarter and $173.6 million for the year ended December 31, 2024. The decrease in research and development expenses for the fourth quarter and the year was primarily due to the transition of elritercept-related research and development expenses to Takeda. General and administrative expenses were $11.7 million for the fourth quarter and $46.8 million for the year ended December 31, 2025, as compared to $10.7 million for the fourth quarter and $40.8 million for the year ended December 31, 2024. The increase in general and administrative expenses for the year was primarily due to an increase in external expenses, partially offset by a decrease in compensation costs, including stock-based compensation costs, in connection with a reduction in headcount. Keros’ cash and cash equivalents as of December 31, 2025 was $287.4 million compared to $559.9 million as of December 31, 2024. The decrease in cash and cash equivalents for the year was primarily driven by Keros’ share repurchase with certain stockholders and cash tender offer. Based on current operating assumptions, Keros expects that its cash and cash equivalents as of December 31, 2025 will enable the Company to fund its planned operating expenses and capital expenditure requirements into the first half of 2028. About Keros Therapeutics, Inc. Keros is a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signaling of the TGF-ß family of proteins. Keros is a leader in understanding the role of the TGF-ß family of proteins, which are master regulators of the growth, repair and maintenance of a number of tissues, including skeletal muscle, bone, adipose, heart tissue and blood. By leveraging this understanding, Keros has discovered and is developing protein therapeutics that have the potential to provide meaningful and potentially disease-modifying benefit to patients. Keros’ lead product candidate, rinvatercept, is being developed for the treatment of DMD and for the treatment of ALS. Keros’ most advanced product candidate, elritercept, is being developed for the treatment of cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndrome and in patients with myelofibrosis. Cautionary Note Regarding Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as “anticipates,” “believes,” “continue,” “expects,” “enable,” “potential” and “will” or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning: Keros’ expectations regarding its growth, strategy, progress and the design, objectives and timing of its clinical trials for rinvatercept, including its regulatory plans; and Keros’ expected cash runway. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Keros’ limited operating history and historical losses; Keros’ ability to raise additional funding to complete the development and any commercialization of its product candidates; Keros’ dependence on the success of its product candidates, rinvatercept and elritercept; that Keros may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; Keros’ ability to obtain, maintain and protect its intellectual property; and Keros’ dependence on third parties in connection with manufacturing, clinical trials and preclinical studies. These and other risks are described more fully in Keros’ filings with the Securities and Exchange Commission (“SEC”), including the “Risk Factors” section of the Company’s Quarterly Report on Form 10-Q, filed with the SEC on November 5, 2025, and its other documents subsequently filed with or furnished to the SEC, including the Company’s Annual Report on Form 10-K as of and for the year ended December 31, 2025. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Keros undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Investor Contact: Justin Frantz jfrantz@kerostx.com 617-221-6042 Media Contact: Mahmoud Siddig / Adam Pollack / Brooks Hussey Joele Frank, Wilkinson Brimmer Katcher (212) 355-4449 KEROS THERAPEUTICS, INC. Consolidated Statements of Operations (In thousands, except share and per share data) (Unaudited) THREE MONTHS ENDED DECEMBER 31, YEAR ENDED DECEMBER 31, 2025 2024 2025 2024 REVENUE: Service and other revenue 385 42 38,706 550 License revenue — 3,000 205,355 3,000 Total revenue 385 3,042 244,061 3,550 OPERATING EXPENSES: Research and development (17,912 ) (45,631 ) (129,643 ) (173,629 ) General and administrative (11,743 ) (10,665 ) (46,849 ) (40,754 ) Total operating expenses (29,655 ) (56,296 ) (176,492 ) (214,383 ) INCOME (LOSS) FROM OPERATIONS (29,270 ) (53,254 ) 67,569 (210,833 ) OTHER INCOME (EXPENSE), NET: Research and development incentive income — 1,238 — 1,238 Dividend income 4,022 6,519 24,867 23,496 Other income (expense), net 273 (229 ) (539 ) (954 ) Total other income, net 4,295 7,528 24,328 23,780 Income (loss) before income taxes (24,975 ) (45,726 ) 91,897 (187,053 ) Income tax provision 1,514 (300 ) (4,883 ) (300 ) Net income (loss) $ (23,461 ) $ (46,026 ) $ 87,014 $ (187,353 ) Net income (loss) attributable to common stockholders—basic and diluted $ (23,461 ) $ (46,026 ) $ 87,014 $ (187,353 ) Weighted-average common stock outstanding—basic 27,198,653 40,337,720 37,221,211 37,437,652 Weighted-average common stock outstanding—diluted 27,198,653 40,337,720 37,859,106 37,437,652 Net income (loss) per share of common stock — basic $ (0.86 ) $ (1.14 ) $ 2.34 $ (5.00 ) Net income (loss) per share of common stock — diluted $ (0.86 ) $ (1.14 ) $ 2.30 $ (5.00 ) KEROS THERAPEUTICS, INC. Consolidated Balance Sheets (In thousands, except share and per share data) (Unaudited) DECEMBER 31, 2025 2024 ASSETS CURRENT ASSETS: Cash and cash equivalents $ 287,415 $ 559,931 Accounts receivable 3,567 2,742 Prepaid expenses and other current assets 22,202 26,220 Current income tax receivable 2,250 — Total current assets 315,434 588,893 Operating lease right-of-use assets 16,841 19,251 Property and equipment, net 4,297 4,237 Restricted cash 1,449 1,449 Other long term assets — 2,056 TOTAL ASSETS $ 338,021 $ 615,886 LIABILITIES AND STOCKHOLDERS’ EQUITY CURRENT LIABILITIES: Accounts payable $ 1,967 $ 4,602 Current portion of operating lease liabilities 2,408 1,978 Accrued expenses and other current liabilities 16,039 20,870 Total current liabilities 20,414 27,450 Operating lease liabilities, net of current portion 14,475 16,883 Total liabilities 34,889 44,333 COMMITMENTS AND CONTINGENCIES STOCKHOLDERS’ EQUITY: Preferred stock, par value of $0.0001 per share; 10,000,000 shares authorized as of December 31, 2025 and December 31, 2024; no shares issued and outstanding — — Series A junior participating preferred stock, par value of $0.0001 per share; 500,000 and no shares authorized as of December 31, 2025 and December 31, 2024, respectively; no shares issued and outstanding — — Common stock, par value of $0.0001 per share; 200,000,000 authorized as of December 31, 2025 and December 31, 2024; 40,670,466 issued and 19,543,706 outstanding as of December 31, 2025 and 40,554,705 shares issued and outstanding as of December 31, 2024 4 4 Treasury stock, at cost; 21,126,760 and no shares as of December 31, 2025 and December 31, 2024, respectively (384,558 ) — Additional paid-in capital 1,169,451 1,140,328 Accumulated deficit (481,765 ) (568,779 ) Total stockholders’ equity 303,132 571,553 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $ 338,021 $ 615,886