LEXINGTON, Mass., Sept. 08, 2025 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. (“Keros”) (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 presented additional clinical data from its Phase 1 clinical trial of KER-065 in healthy male volunteers at the America ...

Financial Data and Key Metrics Changes - The company reported a strategic review in Q2, resulting in a decision to return $375 million of capital to investors, indicating a focus on KER-065 and the preclinical pipeline [3][40] - As of the last earnings report, the company had $690 million in cash, which after the capital return leaves $315 million, providing a runway into the first half of 2028 [40] Business Line Data and Key Metrics Changes - The most advanced asset, KER-065, is being prioritized after deprioritizing Suborosev due to safety concerns [2][3] - KER-065 is positioned as a muscle bone anabolic with antifibrotic and anti-inflammatory properties, targeting Duchenne muscular dystrophy (DMD) [4][5] Market Data and Key Metrics Changes - The company has restructured to focus on delivering value, reducing its workforce to about half of what it was at the end of the previous year [3] - The market for KER-065 is primarily in muscular dystrophies, with potential expansion into other neuromuscular indications as resources allow [41][42] Company Strategy and Development Direction - The company is focusing on KER-065 as its primary clinical asset while exploring preclinical opportunities for future indications [2][41] - There is a strategic emphasis on sequencing trials rather than running multiple trials in parallel due to limited bandwidth [41] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the skepticism surrounding muscle mass-increasing agents in neuromuscular diseases but emphasized the unique properties of KER-065 that differentiate it from previous failures [8][11] - The company is preparing to submit documents to regulatory bodies for the next phase of trials, indicating a proactive approach to advancing KER-065 [38] Other Important Information - The company is considering a second indication for KER-065 but will prioritize DMD until sufficient resources are available [41] - The partnership with Takeda for elritercept (KER-050) remains a potential source of upside, with ongoing developments in myelofibrosis [49][50] Q&A Session Summary Question: What is the current status of KER-065 and its clinical trials? - Management discussed the focus on KER-065 and the need for an open-label trial to generate proof of concept data earlier [30][41] Question: How does the company plan to return excess capital to investors? - The company is exploring options for capital return, including dividends or share buybacks, and is engaging with advisors to determine the best approach [55] Question: What are the implications of the safety profile observed in KER-065? - Management noted that while there were increases in hemoglobin levels, they were small and manageable, with plans for dose titration to mitigate risks [16][20]

Core Viewpoint - ADAR1 Capital Management, the largest stockholder of Keros Therapeutics, expresses disappointment over the Board's refusal to engage on strategic matters and capital allocation [1][3]. Group 1: Engagement and Communication - ADAR1 previously reached out to Keros' Board to propose an in-person meeting aimed at maximizing stockholder value, especially in light of stockholder dissatisfaction from the 2025 Annual Meeting [2]. - The management team and Board of Keros have declined direct interaction with ADAR1, instead referring them to the Company's financial advisor [3]. Group 2: Valuation and Capital Allocation - ADAR1 believes Keros is undervalued and that its worth is supported by a large cash balance and the net present value of the Takeda partnership for elritercept, suggesting that this value should be distributed to stockholders via a Contingent Value Right (CVR) [4]. - There is concern regarding the lack of updates on the planned return of $375 million in excess capital, with shareholders waiting over two months for a clear plan, specifically urging for a special dividend declaration [6]. Group 3: Future Actions and Board Composition - ADAR1 prefers to collaborate with the Board to realign the Company's strategic direction but warns that if engagement continues to be refused, they will seek to elect new directors at the next Annual Meeting who are willing to listen to stockholder perspectives [7]. - The Company has the potential to create significant long-term value for investors, contingent upon a Board that is open to constructive engagement with stockholders [8].

Core Viewpoint - Keros Therapeutics has received Orphan Drug designation from the FDA for KER-065, aimed at treating Duchenne muscular dystrophy (DMD), highlighting the significant unmet medical need in this area [1][2]. Company Overview - Keros Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel therapeutics targeting disorders linked to dysfunctional signaling of the TGF-ß protein family [5]. - The company is recognized for its expertise in the TGF-ß family of proteins, which are crucial for the growth, repair, and maintenance of various tissues, including blood, bone, skeletal muscle, adipose, and heart tissue [5]. Product Information - KER-065 is a novel ligand trap designed to inhibit the biological effects of myostatin and activin A, promoting skeletal muscle regeneration, increasing muscle size and strength, reducing body fat, and enhancing bone strength [3]. - The product is initially focused on treating DMD, a severe condition characterized by muscle degeneration due to the lack of functional dystrophin protein [4]. Disease Context - Duchenne muscular dystrophy (DMD) is the most common form of muscular dystrophy, leading to muscle degeneration and premature death, affecting approximately one in every 3,500 male births worldwide [4]. - The absence of dystrophin results in increased susceptibility of muscle cells to damage, progressive muscle cell death, and replacement with fibrotic and fatty tissue, ultimately causing loss of muscle strength and function [4]. Regulatory Milestone - The Orphan Drug designation provides Keros with several benefits, including tax credits for clinical testing, waivers or reductions in FDA application fees, and seven years of market exclusivity upon approval [2].

Company Performance - Keros Therapeutics reported a quarterly loss of $0.76 per share, which was better than the Zacks Consensus Estimate of a loss of $1.14, and an improvement from a loss of $1.25 per share a year ago, representing an earnings surprise of +33.33% [1] - The company posted revenues of $18.17 million for the quarter ended June 2025, exceeding the Zacks Consensus Estimate by 135.95%, compared to revenues of $0.04 million in the same quarter last year [2] - Over the last four quarters, Keros Therapeutics has surpassed consensus EPS estimates two times and topped consensus revenue estimates two times [2] Stock Performance - Keros Therapeutics shares have declined approximately 9.1% since the beginning of the year, while the S&P 500 has gained 7.1% [3] - The current consensus EPS estimate for the upcoming quarter is -$1.08 on revenues of $4.37 million, and for the current fiscal year, it is $0.21 on revenues of $219 million [7] Industry Outlook - The Medical - Biomedical and Genetics industry, to which Keros Therapeutics belongs, is currently ranked in the bottom 42% of over 250 Zacks industries, indicating potential challenges ahead [8] - The performance of Keros Therapeutics may be influenced by the overall outlook of the industry, as research shows that the top 50% of Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1 [8]

Core Viewpoint - Keros Therapeutics is discontinuing the development of cibotercept to focus on its key clinical program, KER-065, which is aimed at treating Duchenne muscular dystrophy (DMD) [1][2][4] Strategic Realignment - The company will cease all internal development activities related to cibotercept following the termination of its development in pulmonary arterial hypertension (PAH) due to safety and efficacy data from the TROPOS Phase 2 clinical trial [2] - Keros is reallocating resources to enhance the development of KER-065, which has shown promising results in initial clinical trials [1][4] Leadership Changes - Keros announced several transitions in its Board of Directors and leadership to support its streamlined operational structure [3][5] - Jasbir S. Seehra, Ph.D., will take on the additional role of President while stepping down as Chair of the Board, with Jean-Jacques Bienaimé appointed as the new Chair [5] - Christopher Rovaldi will leave the company, and Lorena Lerner, Ph.D., will be promoted to Chief Scientific Officer [5] Clinical Development Plans - Keros plans to initiate a Phase 2 clinical trial for KER-065 in patients with DMD in the first quarter of 2026, pending positive regulatory interactions [4] - The company has reported initial topline results from the Phase 1 clinical trial of KER-065, achieving key objectives related to safety, tolerability, pharmacokinetics, and pharmacodynamics [4] Financial Results - Keros has released its financial results for the second quarter ended June 30, 2025, which can be accessed on its website [6]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ________________________________________ FORM 10-Q ________________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39264 ________________________________________ ...

Exhibit 99.1 Keros Therapeutics Reports Second Quarter 2025 Financial Results LEXINGTON, Mass., August 6, 2025 (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 reported financial results for the quarter ...

LEXINGTON, Mass., Aug. 06, 2025 (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 reported financial results for the quarter ended June 30, 2025. "The second quarter marked an important point for Keros, ...

Core Viewpoint - Keros Therapeutics, Inc. (KROS) is currently more attractive to value investors compared to Exact Sciences (EXAS) based on various valuation metrics and analyst outlooks [1][3]. Valuation Metrics - KROS has a forward P/E ratio of 70.11, significantly lower than EXAS's forward P/E of 303.06 [5]. - The PEG ratio for KROS is 2.62, while EXAS has a much higher PEG ratio of 10.35, indicating KROS may be undervalued relative to its expected earnings growth [5]. - KROS's P/B ratio stands at 0.81, compared to EXAS's P/B of 3.82, further suggesting KROS is more favorably valued [6]. Analyst Ratings - KROS holds a Zacks Rank of 1 (Strong Buy), while EXAS has a Zacks Rank of 2 (Buy), indicating a stronger earnings estimate revision activity for KROS [3][7]. - The Value grade for KROS is B, whereas EXAS has a Value grade of C, reflecting KROS's superior valuation metrics [6].