Core Points - Keros Therapeutics announced the dosing of the first patient in the Phase 3 RENEW clinical trial for elritercept, which triggers a $10 million milestone payment from Takeda under their global license agreement [1][2] - The global license agreement with Takeda, effective January 16, 2025, includes a $200 million upfront cash payment and potential milestones exceeding $1.1 billion, along with tiered royalties on net sales [2] Company Overview - Keros Therapeutics is a clinical-stage biopharmaceutical company focused on developing therapeutics for disorders linked to dysfunctional signaling of the TGF-ß protein family [5] - The company is recognized for its understanding of TGF-ß proteins, which regulate growth and maintenance of various tissues, and is developing protein therapeutics aimed at providing disease-modifying benefits [5] - Keros' lead product candidate, KER-065, targets neuromuscular diseases, while elritercept (KER-050) is focused on treating cytopenias, including anemia and thrombocytopenia in patients with myelodysplastic syndromes and myelofibrosis [5] Clinical Trial Details - The Phase 3 RENEW clinical trial is a global, randomized, double-blind, placebo-controlled study aimed at evaluating the efficacy of elritercept in reducing red blood cell transfusions in adults with transfusion-dependent anemia and varying risk levels of MDS [3]

Cibotercept (KER-012) for Pulmonary Arterial Hypertension (PAH) - A Phase 2 TROPOS trial of Cibotercept in PAH patients is fully enrolled, with dosing continuing in the 1.5 mg/kg treatment arm after halting higher dose arms due to safety review[18] - Topline data from the Phase 2 TROPOS trial is expected in Q2 2025, which will inform the next steps in the development program[18] - In a Phase 1 clinical trial, monthly dosing of Cibotercept for 3 months was generally well-tolerated at doses up to 4.5 mg/kg, with observed changes in bone biomarkers suggesting biological activity from the 0.75 mg/kg dose[24] KER-065 for Neuromuscular Disorders - Keros has deprioritized the development of KER-065 in obesity to focus on neuromuscular disorders[45] - Preclinical data in a mouse model of Duchenne Muscular Dystrophy (DMD) showed that RKER-065 increased utrophin expression and muscle strength[53, 54] - In a preclinical study, co-treatment with prednisolone and RKER-065 in MDX mice increased both muscle mass and strength, as well as trabecular bone and strength[61] - Initial data from a Phase 1 healthy volunteer trial is expected in Q1 2025, which has the potential to inform development of KER-065 in neuromuscular indications, such as DMD[83] Elritercept (KER-050) for Myelodysplastic Syndromes (MDS) and Myelofibrosis (MF) - Keros entered into an exclusive license agreement with Takeda for elritercept, receiving an upfront payment of $200 million and being eligible for over $1.1 billion in milestone payments plus tiered royalties[95] - In an ongoing Phase 2 clinical trial for MDS, elritercept demonstrated an overall response rate of 55.2% (48/87) in the mITT24 population, with 48.3% (42/87) achieving modified IWG 2006 HI-E[114] - In the Phase 2 MDS trial, 39.1% (27/69) of transfusion-independent evaluable patients achieved transfusion independence (TI) for at least 8 weeks[114] - In the Phase 2 MF trial, 40% (8/20) of evaluable patients showed ≥ 10% reduction in spleen size at Week 24[129] - The Phase 3 RENEW trial in MDS is expected to commence in Q1 2025[137]

Core Viewpoint - The significant withhold votes from directors Mary Ann Gray and Alpna Seth highlight a pressing need for change in Keros Therapeutics' capital allocation strategy and governance [1][2][6] Shareholder Sentiment - ADAR1 Capital Management, the largest stockholder, noted that only approximately 34% of outstanding shares voted to elect Dr. Gray and 37% for Dr. Seth, indicating a substantial loss of shareholder confidence and dissatisfaction with the Board's performance [2][6] Company Actions and Responses - The company has recently discontinued the development of cibotercept in pulmonary arterial hypertension and implemented a reduction in headcount, which are seen as positive steps, but insufficient in addressing broader concerns [3][4] - The Board's decision to retain approximately half of its cash balance is criticized, especially given the limited clinical pipeline and commercial prospects [4] Capital Allocation Strategy - There is a call for the Board to return an additional $100 million, totaling $475 million, to shareholders through a special dividend by the end of Q3 2025, and to ensure that shareholders can capture potential cash flow from the Takeda partnership [5] - The lack of clarity regarding the terms, timing, and method of the proposed capital return reflects a disorganized approach to decision-making [4] Future Governance - ADAR1 emphasizes the need for new perspectives in the boardroom to maximize value and indicates a willingness to nominate new directors for the 2026 Annual Meeting if the current strategy persists [6][7]

Financial Data and Key Metrics Changes - The company raised capital in 2024 and plans to return $375 million to shareholders while using the remaining capital to build shareholder value [2][3][58] - The company had $720 million in cash at the end of the third quarter, but this will be significantly reduced after the capital return [61][62] Business Line Data and Key Metrics Changes - The company advanced one asset, elrotircep, through phase two to phase three in partnership with Takeda, receiving $200 million upfront and potential milestones totaling $1.1 billion [4][5] - Development of saboticep was discontinued due to safety signals observed in the phase two study [2][7] - KER065 is currently in development for Duchenne Muscular Dystrophy (DMD), showing increases in lean mass and improvements in bone mineral density during phase one safety studies [18][19] Market Data and Key Metrics Changes - The company is focusing on neuromuscular indications, particularly DMD, as a strategic pivot from obesity due to commercialization potential [26][28] - The competitive landscape in DMD is crowded, but the company believes its product can provide significant benefits by increasing muscle strength and expression of eutrophin [34][35] Company Strategy and Development Direction - The company aims to commercialize its own products rather than becoming a single asset company [28] - There is a focus on understanding the root cause of pericardial effusion related to PAH treatments and exploring opportunities in obesity and other diseases influenced by the TGF beta pathway [55] Management's Comments on Operating Environment and Future Outlook - Management acknowledges the need to understand the mechanism behind increased pericardial effusion in PAH patients before proceeding with further development in that area [16][17] - The company plans to engage with regulators regarding a phase two trial design for DMD, with a focus on patient population and starting doses [42][43] Other Important Information - The company has streamlined its organization and reduced its workforce, resulting in annual savings of approximately $17 million [62] - The strategic review has concluded, with a focus on returning capital to shareholders and investing in the pipeline [59][60] Q&A Session Summary Question: Can you provide an overview of the company's current status and value drivers? - The company is focused on its clinical stage assets, particularly KER065 for DMD, and has returned capital to shareholders while seeking to build value [2][3] Question: What are the key terms of the partnership with Takeda? - The partnership includes an upfront payment of $200 million and potential milestones totaling $1.1 billion, along with royalties [5][6] Question: What safety signals were observed in the saboticep study? - The study was halted due to unexpected pericardial effusions, which were not previously identified in clinical studies [9][10] Question: How does the company plan to approach the DMD indication? - The company plans to conduct trials across all patient populations, focusing on late ambulatory and non-ambulatory patients [39][40] Question: What is the expected cash runway after the capital return? - The cash runway will be significantly reduced, but the company has not yet provided specific guidance on the duration [61][62]

Core Viewpoint - Keros Therapeutics has concluded its strategic alternatives review and plans to return $375 million of excess capital to stockholders while continuing the development of its lead product candidate, KER-065, for neuromuscular diseases, particularly Duchenne muscular dystrophy [1][2]. Group 1: Strategic Review and Capital Return - The Board of Directors unanimously decided to initiate a process to return $375 million of excess capital to stockholders following a comprehensive review of strategic alternatives [1][2]. - The strategic review included evaluating various options such as a potential sale of the company, continued investment in the pipeline, and returning excess capital to stockholders [2]. Group 2: Product Development Focus - Keros is focused on the development of KER-065 for treating neuromuscular diseases, with an initial emphasis on Duchenne muscular dystrophy, reflecting the company's confidence in its potential benefits [2][4]. - The company is also advancing its product candidate elritercept (KER-050) for treating cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndrome and myelofibrosis [4].

Core Insights - Keros Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapeutics targeting disorders linked to dysfunctional signaling of the TGF-ß protein family [3] Company Overview - Keros is recognized as a leader in understanding 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 [3] - The company's lead product candidate, KER-065, is aimed at treating neuromuscular diseases, specifically Duchenne muscular dystrophy [3] - Keros' most advanced product candidate, elritercept (KER-050), is being developed for treating cytopenias, such as anemia and thrombocytopenia, in patients with myelodysplastic syndrome and myelofibrosis [3] Upcoming Events - Keros' Chair and CEO, Jasbir S. Seehra, Ph.D., will participate in a fireside chat at the Goldman Sachs 46th Annual Global Healthcare Conference on June 9, 2025, at 9:20 a.m. Eastern time [1] - A live audio webcast of the presentation will be available, with an archived replay accessible for up to 90 days post-event [2]

Core Viewpoint - Keros Therapeutics has decided to discontinue the development of cibotercept for pulmonary arterial hypertension (PAH) following safety concerns and will undergo corporate restructuring to align with strategic priorities [1][3][5]. TROPOS Trial Results - The TROPOS trial was a Phase 2 clinical trial evaluating cibotercept in combination with background therapy for PAH, which was halted due to observed adverse events, specifically pericardial effusions [2][7]. - The company voluntarily stopped dosing in all treatment arms of the trial after safety reviews indicated new adverse events [2]. Corporate Restructuring - Keros plans to reduce its workforce by approximately 45%, resulting in a total of 85 full-time employees, which is expected to yield annualized cost savings of about $17 million [5][6]. - The restructuring is aimed at aligning operations with ongoing development programs and maximizing stockholder value [6]. Future Development Strategy - The company will evaluate the potential development of cibotercept for other indications after completing a strategic alternative review process [4][6]. - Keros is also exploring various strategic alternatives, including potential sale or business combinations, continued investment in its pipeline, and returning excess capital to stockholders [6]. Company Overview - Keros Therapeutics focuses on developing therapeutics targeting disorders linked to dysfunctional signaling of the TGF-ß family of proteins, with lead candidates including KER-065 for neuromuscular diseases and elritercept for cytopenias [8].

Core Viewpoint - Keros Therapeutics emphasizes the importance of its board in overseeing the strategic review process and urges stockholders to support its director nominees to maximize company value amid challenges posed by ADAR1's campaign [1][2][3]. 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 [10][11]. - The company is advancing several product candidates, including cibotercept for pulmonary arterial hypertension, KER-065 for neuromuscular diseases, and elritercept for cytopenias [10][11]. Board Composition and Strategy - The Keros Board consists of nine independent directors, including four stockholder representatives, bringing diverse expertise in biotechnology, drug development, and capital allocation [7]. - The board is currently engaged in a strategic alternatives review process, which is seen as a constructive step to address shareholder concerns and maximize value [3][8]. Proxy Advisory Firm Recommendations - Glass Lewis & Co. has recommended that Keros stockholders vote "FOR" all three of the company's director nominees, recognizing their qualifications and the board's efforts to enhance stockholder value [1][3]. - The board's decision to retain flexibility through a formal strategic review is viewed as a reasonable approach, contrasting with ADAR1's aggressive campaign [3][5]. Response to ADAR1's Campaign - Keros has responded to claims made by ADAR1, stating that the recent share price decline is primarily due to clinical development risks rather than board mismanagement [3][4]. - The company argues that ADAR1 has not provided compelling evidence against the board members and that the board's actions have been in the best interests of all stockholders [3][6].

Core Viewpoint - ADAR1 Capital Management, the largest stockholder of Keros Therapeutics, is urging the company to disclose the results of its strategic review before the upcoming Annual Meeting of Stockholders on June 4, 2025, to allow stockholders to make informed voting decisions [1][2]. Group 1: Governance Concerns - Institutional Shareholder Services (ISS) has recommended that Keros stockholders WITHHOLD votes from incumbent directors Dr. Mary Ann Gray and Dr. Alpna Seth due to serious concerns regarding the company's governance [1][2]. - ADAR1 believes that the ISS recommendation highlights the need for improved governance and oversight at Keros, advocating for fresh, independent directors [2]. Group 2: Strategic Review and Capital Management - Keros plans to disclose the outcome of its strategic review process five days after the Annual Meeting, which ADAR1 argues is insufficient for stockholders to evaluate the board's decisions [2]. - ADAR1 criticizes the company's cash balance as excessive relative to its clinical opportunities and calls for a significant return of capital before the Annual Meeting [3].

Files Investor Presentation and Issues Open Letter to Stockholders Urges Stockholders to Protect the Value of Their Investment by Voting "FOR" Each of the Company's Highly Qualified Director Nominees LEXINGTON, Mass., May 19, 2025 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. ("Keros", the "Company" 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 s ...