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].

Core Viewpoint - Keros Therapeutics, Inc. is urging stockholders to vote in favor of its three director nominees during the upcoming Annual Meeting, emphasizing the importance of protecting stockholder value amid a strategic review process aimed at maximizing investment returns [2][3][5]. Company Overview - Keros is a clinical-stage biopharmaceutical company focused on developing novel therapeutics targeting disorders linked to dysfunctional signaling of the TGF-ß protein family [21]. - The company has a differentiated clinical pipeline, including three key product candidates: KER-065 for neuromuscular diseases, elritercept (KER-050) for cytopenias, and cibotercept (KER-012) for pulmonary arterial hypertension [6][21]. Strategic Review Process - The Board of Directors is conducting a comprehensive strategic review to evaluate options for maximizing stockholder value, including potential sales, continued investment in the pipeline, or returning excess capital [4][10]. - An interim update on the strategic review process is expected by June 9, 2025 [11]. Director Nominees - Keros recommends stockholders vote "FOR" its three director nominees: Mary Ann Gray, Ph.D., Ran Nussbaum, and Alpna Seth, Ph.D., highlighting their qualifications and experience in the biopharmaceutical industry [3][5][16]. Financial Partnerships - Keros has established a partnership with Takeda Pharmaceuticals, which includes a $200 million upfront payment and potential milestones of up to $1.1 billion, enhancing its financial position and supporting its development goals [11][12]. Clinical Development Updates - KER-065 is advancing to a Phase 2 clinical trial for Duchenne muscular dystrophy (DMD) in early 2026, pending regulatory interactions [6][11]. - Elritercept is being developed for low blood cell counts in patients with myelodysplastic syndromes and myelofibrosis, with significant potential benefits for patients with limited treatment options [12][21]. - Cibotercept's Phase 2 trial (TROPOS) was terminated early due to safety concerns, and the company plans to evaluate its development strategy post-trial [12][21]. Board Composition - The Keros Board consists of nine independent directors, with a significant portion representing stockholder interests, which is higher than the median of its performance peer group [14][15].

Summary of Keros Therapeutics and Tiara Biosciences Conference Calls Keros Therapeutics (KROS) Industry Overview - Keros Therapeutics focuses on the TGF beta pathway, which is crucial for embryogenesis and tissue maintenance. Dysregulation of this pathway is linked to various diseases [3][4]. Core Pipeline - Keros has three main assets: 1. **Aridrocept 50**: A ligand trap for MDS and myelofibrosis, partnered with Takeda, showing promising economics [5]. 2. **Cibodocept**: A trial for pulmonary arterial hypertension (PAH) was terminated early due to safety signals, with top-line data expected soon to determine the next steps [6][10]. 3. **A third ligand trap**: Targets negative regulators of skeletal muscle, enhancing muscle regeneration and improving bone mineral density, suitable for neuromuscular indications [6][7]. Financial and Strategic Challenges - An activist investor has challenged Keros' leadership, prompting the company to explore strategic alternatives to maximize pipeline value [8][10]. - The stock has declined below cash levels, leading to a reassessment of the company's strategy [10]. Clinical Development Insights - Aridrocept is in a Phase 3 trial for MDS, with potential annual sales projected to reach $2 billion if approved for frontline treatment [15][16]. - The company aims to demonstrate that Cibodocept can be effective in PAH, despite recent safety concerns [22][23]. - The CEO emphasizes the importance of patient quality of life and transfusion independence in treatment outcomes [19][21]. Tiara Biosciences Industry Overview - Tiara focuses on small molecule precision medicines, particularly in the FGFR family, with a lead molecule that is FGFR3 selective [34][35]. Unique Platform - The Snap Chemistry Design Platform allows for the development of selective FGFR3 inhibitors, differentiating Tiara from other developers that use pan FGFR inhibitors [35][36]. Clinical Development and Market Potential - Tiara is addressing unmet needs in non-muscle invasive bladder cancer (NMIBC) and achondroplasia, with a focus on oral therapies that can reduce recurrence rates compared to current treatments [39][40]. - The company anticipates generating top-line results from ongoing trials, with a focus on complete response rates as early efficacy signals [44][45]. Competitive Landscape - Tiara's FGFR3 inhibitor is positioned to have a better safety profile compared to existing therapies, with lower rates of adverse effects such as nail toxicity and stomatitis [56][57]. - The company aims to exceed existing benchmarks for height velocity in achondroplasia treatments, targeting an annualized height velocity of 8-8.5 cm [62][53]. Financial Position - Tiara is well-capitalized, with sufficient funds to support operations through 2027, allowing for strategic prioritization of its clinical programs [64][65]. Conclusion - Both Keros Therapeutics and Tiara Biosciences are navigating complex clinical landscapes with innovative therapies aimed at significant unmet medical needs. Keros is focusing on maximizing the value of its pipeline amidst strategic challenges, while Tiara is leveraging its unique platform to differentiate itself in the FGFR inhibitor market.

Core Viewpoint - ADAR1 Capital Management, the largest stockholder of Keros Therapeutics, is advocating for withholding votes on the re-election of two board members at the upcoming Annual Meeting of Stockholders scheduled for June 4, 2025 [1]. Company Overview - ADAR1 Capital Management holds approximately 13.3% of Keros Therapeutics' outstanding shares, indicating a significant stake in the company [1]. - The firm is based in Austin, Texas, and focuses on public and private equity investments in the life sciences and biotechnology sectors [3]. Leadership Background - Dr. Daniel Schneeberger, the founder of ADAR1, has over 20 years of experience in scientific research, healthcare consulting, institutional investing, and executive leadership in the healthcare industry [3]. - The team at ADAR1 consists of experienced professionals with deep medical and scientific expertise, emphasizing their strong track record in biopharmaceutical investing [3].

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 Therapeutics is recognized for its expertise in the TGF-ß protein family, which regulates the growth, repair, and maintenance of various tissues, including blood, bone, skeletal muscle, adipose, and heart tissue [3] - The company is developing several product candidates, including: - Cibotercept (KER-012) for pulmonary arterial hypertension and cardiovascular disorders [3] - KER-065 for neuromuscular diseases [3] - Elritercept (KER-050) for treating low blood cell counts, such as anemia and thrombocytopenia, particularly 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 Bank of America 2025 Global Healthcare Conference on May 13, 2025, at 8:00 p.m. Eastern time [1] - A live audio webcast of the presentation will be available, with an archived replay accessible for up to 90 days [2]

Core Viewpoint - Keros Therapeutics is responding to a misleading press release from ADAR1 Capital Management, emphasizing the importance of stockholder engagement and the ongoing strategic review process to maximize stockholder value [2][5][6] Company Strategy - The Board of Keros is committed to evaluating strategic alternatives, which may include a sale of the company, continued investment in its pipeline, or returning excess capital to stockholders [3][4] - A strategic committee, composed of independent directors, is leading the review process with the assistance of external financial and legal advisors [3][9] Financial Position - Keros has reinforced its strong cash position, enabling funding for clinical programs and operations into 2029 [4] - The exclusive license agreement with Takeda Pharmaceuticals includes a $200 million upfront payment and potential milestones of up to $1.1 billion, providing a recurring capital source [4] Board Composition - The Keros Board consists of nine directors, all independent except for the CEO, with diverse expertise in biotechnology [7] - The Board's Nominating and Corporate Governance Committee is actively seeking directors with complementary skill sets to enhance oversight of the company's strategy [7] Upcoming Meeting - Keros recommends stockholders vote "FOR" its three director nominees at the upcoming 2025 Annual Meeting scheduled for June 4, 2025 [8]