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LEXINGTON, Mass., Jan. 29, 2024 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. (“Keros” or “we”) (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 three abstracts will be presented from the KER-012 program at the Pulmonary Vascular Research Institute (“PVRI”) 2024 Annual Congress, to be held from January 31 through February 3, 2024. Clinical Presentations “Development of KER-012, a Novel Investigational Activin Receptor Type IIB Ligand Trap with High Activin/GDF Specificity and Target Engagement for the Treatment of Pulmonary Arterial Hypertension: Rationale and Design of the TROPOS Phase 2 Study” Presenter: Marc Humbert, M.D., Ph.D., Professor of Respiratory Medicine at the Université Paris-SaclayDate: February 2, 2024Presentation Time: 4:30 - 6:00 p.m. GMT “Administration of KER-012 to Healthy Post-Menopausal Women Elicited Biomarker Changes Suggesting Anti-Inflammatory and Anti-Fibrotic Effects That Target the Pathophysiology of Pulmonary Arterial Hypertension” Presenter: M. Kathryn Steiner, M.D., KerosDate: February 2, 2024Presentation Time: 4:30 - 6:00 p.m. GMT Preclinical Presentation “RKER-012, A Novel Modified ActRIIB Ligand Trap, Reduced Pulmonary Vascular Pathology in a Rat Model of Pulmonary Arterial Hypertension” Presenter: Keith Babbs, Ph.D., KerosDate: February 2, 2024Presentation Time: 4:20 p.m. GMT About TROPOS TROPOS is a randomized, double-blind, placebo-controlled, global Phase 2 clinical trial to evaluate KER-012 in combination with background therapy in patients with pulmonary arterial hypertension (“PAH”). The primary objective of this trial is to evaluate the effect of KER-012 on pulmonary hemodynamics compared to placebo in participants on background PAH therapy. The key secondary objective of this trial is to evaluate the effect of KER-012 on exercise capacity compared to placebo on participants on background PAH therapy. About KER-012 KER-012 is designed to bind to and inhibit the signaling of TGF-β ligands that stimulate smooth muscle hypertrophy and fibrosis, including activin A, activin B and myostatin. Keros believes that KER-012 has the potential to increase the signaling of bone morphogenic protein (“BMP”) pathways through this inhibition of activin A and activin B signaling, and consequently treat diseases such as PAH that are associated with reduced BMP signaling due to inactivating mutations in the BMP receptors. KER-012 is being developed for the treatment of PAH and for the treatment of cardiovascular disorders. 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. We are a leader in understanding the role of the TGF-ß family of proteins, which are master regulators of the growth, repair and maintenance of blood cells and a number of tissues, including bone, skeletal muscle, adipose and heart tissue. By leveraging this understanding, we have discovered and are developing large and small molecules that have the potential to provide meaningful and potentially disease-modifying benefit to patients. Keros’ lead protein therapeutic product candidate, KER-050 (elritercept), is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndromes and in patients with myelofibrosis. Keros’ second product candidate, KER-012, is being developed for the treatment of PAH and for the treatment of cardiovascular disorders. Keros’ third product candidate, KER-065, is being developed for the treatment of obesity and for the treatment of neuromuscular diseases. 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 “would” and “future” or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning: Keros’ presentation plans for the upcoming PVRI 2024 Annual Congress. 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, KER-050, KER-012 and KER-065; 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 Keros’ Quarterly Report on Form 10-Q, filed with the SEC on November 6, 2023, and its other documents subsequently filed with or furnished to the SEC. 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 Frantzjfrantz@kerostx.com 617-221-6042

- Taldefgrobep is a novel myostatin inhibitor with the potential to be an important therapy for neuromuscular disorders and metabolic diseases including obesity. - Taldefgrobep monotherapy significantly reduced fat and increased lean muscle mass in an obese mouse model; potential body composition changes relevant to individuals living with overweight and obesity. - Biohaven presented an analysis supporting change in waist circumference as a strong correlate for weight loss, suggesting potential alternative endpoints for obesity studies. NEW HAVEN, Conn., Oct. 16, 2023 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) ("Biohaven"), announced the presentation of preclinical data demonstrating the ability of taldefgrobep alfa to significantly reduce fat mass while increasing lean mass in an obese mouse model. Separately, data supporting the correlation between change in waist circumference and change in total body weight among adults living with overweight and obesity treated with approved anti-obesity medications were reported. Both sets of data were presented on October 15, 2023 at The Obesity Society's annual ObesityWeek conference held in Dallas, TX. Poster 210: Correlation Between Reduction in Total Body Weight and Change in Waist Circumference Poster 211: Taldefgrobep Alfa Reduces Fat and Increases Muscle in an Obese Mouse Model The poster presentations hightlight the potential benefit of taldefgrobep in the treatment of adults living with overweight and obesity and suggest anthropometric measures of central obesity, such as waist circumference or waist-to-height ratio, may be considered as effective alternative estimations of therapeutic effect. In a mouse model of diet-induced obesity, untreated mice exhibited an increase in fat mass of 31%, while the taldefgrobep-treated mice demonstrated increases in lean mass of 25% from baseline (p£.0.001; Figure 1) and lost 11% of their baseline fat (p£.0.001; Figure 2) compared to vehicle (placebo) treated mice. Insulin and leptin levels were consistently lower in taldefgrobep-treated mice compared to untreated. There was no difference in food intake over time across the taldefgrobep and untreated mice, counter to what has been observed with incretin mimetics (e.g., semaglutide) which are consistently associated with a reduction in energy intake. "The disease of obesity is a public health crisis for which alternative treatment options remain necessary. With the unprecedented amount of weight loss generated by the latest anti-obesity medications, it is important that we carefully consider the quality of resulting body composition changes, including the degree of lean muscle loss. Taldefgrobep's differentiated mechanism offers the potential for a meaningful reduction in fat mass, the primary pathogenic tissue in obesity, while increasing lean mass. These body changes are unique relative to all approved anti-obesity medications which achieve reductions in total body weight based on a composite of fat mass loss and lean muscle mass loss, the latter of which may pose important adverse long-term health consequences" said Peter Ackerman, M.D., Vice President and Clinical Lead for Metabolic Disorders at Biohaven. A Phase 2 obesity study with taldefgrobep is planned for 2024. Full posters will be available on the Posters and Presentations page at: . Irfan Qureshi, MD, Chief Medical Officer at Biohaven, commented, "Together these posters support the development of taldefgrobep as a novel therapy for the treatment of overweight and obesity that can result in significant fat loss while increasing lean mass. This is a paradigm-shift from traditional obesity therapies that focus on overall weight loss despite significant difficult to reverse loss in muscle mass." About Taldefgrobep alfa Taldefgrobep alfa (BHV-2000) is a fully human recombinant protein designed to specifically designed to bind to myostatin (GDF-8) and inhibit the signaling of both myostatin and activin A, both key regulators of muscle and adipose tissue. Taldefgrobep binds myostatin. The myostatin-taldefgrobep complex then acts as an Activin 2a/2b receptor antagonist. Anti-myostatin therapy has a novel mechanism of action that may reduce fat mass, increase lean mass, and improve other metabolic parameters. About Biohaven Biohaven is a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies for people with debilitating neurological and neuropsychiatric diseases, including rare disorders. Biohaven is advancing a pipeline of best-in-class therapies for diseases with little or no treatment options, leveraging its proven drug development capabilities and proprietary platforms, including Kv7 ion channel modulation for epilepsy and neuronal hyperexcitability; glutamate modulation for obsessive-compulsive disorder and spinocerebellar ataxia and myostatin inhibition for neuromuscular diseases. Biohaven's portfolio of early- and late-stage product candidates also includes discovery research programs focused on TRPM3 channel activation for neuropathic pain and CD-38 antibody recruiting, bispecific molecules for multiple myeloma. More information about Biohaven is available at . Forward-looking Statements This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including "believe", "may" and "will" and similar expressions, are intended to identify forward-looking statements. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of Biohaven's management about taldefgrobep alfa as treatment for patients with neuromuscular or obesity disorders. Investors are cautioned that any forward-looking statements, including statements regarding the future development, timing and potential marketing approval and commercialization of development candidates are not guarantees of future performance or results and involve substantial risks and uncertainties. Additional important factors to be considered in connection with forward-looking statements are described in Biohaven's filings with the Securities and Exchange Commission, including within the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations". The forward-looking statements are made as of the date of this new release, and Biohaven does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Biohaven Contact: Jennifer Porcelli Vice President, Investor Relations [email protected] 201-248-0741 Mike Beyer Sam Brown Inc. [email protected] 312-961-2502 SOURCE Biohaven Ltd.

- Taldefgrobep alfa is the only myostatin inhibitor in clinical development that targets both myostatin and activin A signaling, two key regulators of muscle mass and adipose tissue - RESILIENT, the pivotal clinical trial in spinal muscular atrophy, was designed to test the efficacy and safety of taldefgrobep alfa as adjunctive therapy to increase muscle in SMA patients treated with standard of care nusinersen, risdiplam or onasemnogene abeparvovec-xioi NEW HAVEN, Conn., Sept. 14, 2023 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) ("Biohaven"), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range of rare and common diseases, today announced completing enrollment in RESILIENT, the Phase 3 pivotal study of taldefgrobep alfa in spinal muscular atrophy (SMA). Lindsey Lair, MD, Biohaven Vice President, Clinical Development Lead for the SMA program stated, "We are thrilled to complete enrollment in this pivotal trial for SMA as it brings us one step closer to advancing a novel muscle targeting therapy for patients with SMA. Despite recent advances in SMA genetic treatments, patients still experience weakness and impairments in quality of life that can be alleviated by enhancing muscle mass and function, on top of what is delivered by current standard of care treatments." Dr. Lair added, "Our team has been inspired by the entire global SMA community of clinicians, patients and family members – we are particularly grateful to the patients and investigators who helped us complete enrollment ahead of our timelines." Taldefgrobep is an investigational, muscle-targeted recombinant protein with the potential to enhance muscle mass and strength in people living with SMA when used in combination with other approved treatments. Taldefgrobep targets myostatin, a natural protein that limits skeletal muscle growth. Myostatin inhibition is a potential therapeutic strategy for children and adults with a range of neuromuscular conditions for whom active myostatin can limit the skeletal muscle growth needed to achieve developmental and functional milestones. RESILIENT is a Phase 3 placebo-controlled, double-blind trial designed to evaluate the efficacy and safety of taldefgrobep at 48 weeks as an adjunctive therapy for participants who are already taking a stable dose of nusinersen, risdiplam and/or have a history of treatment with onasemnogene abeparvovec-xioi, compared to placebo. The study is not restricted nor limited to patients based on ambulatory status or classification of SMA. Taldefgrobep was granted EU Orphan Drug Designation, along with both Fast Track and Orphan Drug Designation by the US FDA. "While we have had good progress with current therapies, a high unmet need for safe and effective supportive treatments for SMA remains, as many patients still experience significant weakness and reduced levels of functioning. We appreciate the partnership of investigators, patients, and researchers to expedite the development of new efficacious therapies that will work in combination with current options to help restore muscle strength and function," said Kenneth Hobby, President, Cure SMA. Biohaven targeted randomizing approximately 180 patients in this global trial conducted in 9 countries. The primary objective is to determine the safety and efficacy of taldefgrobep alfa compared to placebo after 48 weeks of subcutaneous administration as determined by change from baseline in the 32 item Motor Function Measure (MFM-32) total score. Additional details about the trial can be found at SMATrials.com or . About Taldefgrobep alfa Taldefgrobep alfa (BHV-2000) is a fully human recombinant protein specifically designed to inhibit the signaling of myostatin and activin A; two key regulators of muscle and adipose tissue. Taldefgrobep binds myostatin and acts as an Activin 2b receptor antagonist. Taldefgrobep's novel mechanism of action offers the potential for meaningful reductions in fat mass, increased lean mass, and improvements in multiple metabolic parameters. About Spinal Muscular Atrophy (SMA) Spinal muscular atrophy (SMA) is a rare genetic neurodegenerative disorder characterized by the loss of motor neurons, atrophy of the voluntary muscles of the limbs and trunk and progressive muscle weakness that is often fatal and typically diagnosed in young children. The underlying pathology of SMA is caused by insufficient production of the SMN (survival of motor neuron) protein, essential for the survival of motor neurons, and is encoded by two genes, SMN1 and SMN2. Globally, SMA affects approximately 1 in 11,000 births, and about 1 in every 50 individuals is a genetic carrier. About Biohaven Biohaven is a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies for people with debilitating neurological and neuropsychiatric diseases, including rare disorders. Biohaven is advancing a pipeline of therapies for diseases with little or no treatment options, leveraging its proven drug development capabilities and proprietary platforms, including Kv7 ion channel modulation for epilepsy and neuronal hyperexcitability; glutamate modulation for obsessive-compulsive disorder and spinocerebellar ataxia and myostatin inhibition for neuromuscular diseases. Biohaven's portfolio of early- and late-stage product candidates also includes discovery research programs focused on TRPM3 channel activation for neuropathic pain and CD-38 antibody recruiting, bispecific molecules for multiple myeloma. More information about Biohaven is available at . Forward-looking Statements This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including "believe", "may" and "will" and similar expressions, are intended to identify forward-looking statements. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of Biohaven's management about taldefgrobep alfa as treatment for patients with neuromuscular disease. Investors are cautioned that any forward-looking statements, including statements regarding the future development, timing and potential marketing approval and commercialization of development candidates are not guarantees of future performance or results and involve substantial risks and uncertainties. Additional important factors to be considered in connection with forward-looking statements are described in Biohaven's filings with the Securities and Exchange Commission, including within the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations". The forward-looking statements are made as of the date of this new release, and Biohaven does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Biohaven Contact: Jennifer Porcelli Vice President, Investor Relations [email protected] 201-248-0741 Mike Beyer Sam Brown Inc. [email protected] 312-961-2502 SOURCE BIOHAVEN LTD