Financial Performance - The net loss for the year ended December 31, 2024, was $187.4 million, with an accumulated deficit of $568.8 million as of the same date [592]. - Total revenue for the year ended December 31, 2024, was $3.55 million, a significant increase from $151,000 in 2023 and no revenue in 2022 [620]. - The net loss for the year ended December 31, 2024, was $187.4 million, compared to a net loss of $153.0 million in 2023 [620]. - The company reported net losses of $187.4 million, $153.0 million, and $104.7 million for the years ended December 31, 2024, 2023, and 2022, respectively, with an accumulated deficit of $568.8 million as of December 31, 2024 [631]. Cash and Liquidity - As of December 31, 2024, the company had cash and cash equivalents of $559.9 million, which, along with a $200 million upfront payment from Takeda Pharmaceuticals, is expected to fund operations into 2029 [596]. - Cash and cash equivalents totaled $559.9 million as of December 31, 2024, which, along with a $200.0 million upfront payment from a license agreement, is expected to fund liquidity requirements into 2029 [634]. - The company experienced a net increase in cash and cash equivalents of $229.0 million for the year ended December 31, 2024 [637]. - The company had cash and cash equivalents of $559.9 million as of December 31, 2024, compared to $331.1 million as of December 31, 2023, indicating a significant increase in liquidity [662]. - The company has no outstanding debt subject to interest rate variability as of December 31, 2024, mitigating interest rate risk related to debt [663]. Revenue Generation - The company has not generated any revenue from product sales since its inception in 2015, as none of its product candidates have been approved for commercialization [587]. - The company does not expect to generate revenue from product sales until successful development and regulatory approval of its product candidates, which may take several years [632]. - The company has recognized $3.0 million in revenue from a development milestone related to the Hansoh Agreement for the year ended December 31, 2024 [603]. - The company’s revenue consists solely of payments received related to research collaborations and licensing of intellectual property [653]. Expenses - Research and development expenses rose to $173.6 million in 2024, up from $135.3 million in 2023, reflecting an increase of $38.4 million primarily due to higher program-related costs [622]. - General and administrative expenses increased to $40.8 million in 2024, compared to $34.8 million in 2023, driven by higher personnel and professional fees [626]. - The company expects to incur significant expenses related to developing its internal commercialization capability if any product candidates receive regulatory approval [593]. - The company anticipates significant increases in operating expenses related to research and development as it advances clinical trials and preclinical activities [634]. - The company expects research and development expenses to continue increasing as new clinical trials are initiated and ongoing trials progress [613]. Financing Activities - The company has entered into an ATM Sales Agreement allowing for the issuance and sale of up to $250 million of common stock, with approximately $228.6 million raised as of December 31, 2024 [589][590]. - A public offering in January 2024 raised approximately $151.1 million from the sale of 4,025,000 shares at a price of $40.00 per share [591]. - The company generated net cash provided by financing activities of $391.8 million for the year ended December 31, 2024, primarily from a public offering and sales under the ATM Program [643]. - The company has sold a total of 4,290,096 shares of common stock under the ATM Program for net proceeds of approximately $228.6 million during the year ended December 31, 2024 [633]. Risks and Uncertainties - Economic uncertainties, including inflation and rising interest rates, may adversely affect the company's operating results and financial position [598]. - The company is subject to risks that could affect its ability to access additional capital, which may impact its research and development programs [636]. Development and Licensing - The company is developing multiple product candidates, including elritercept for cytopenias and cibotercept for pulmonary arterial hypertension [586]. - The company has licensing agreements with Takeda and Hansoh, with potential milestone payments of up to $370 million and $144 million, respectively, based on development and sales achievements [608][603]. - Contractual obligations include milestone payments ranging from $50,000 to $10.0 million under the MGH Agreement, with royalties on sales ranging from low-single digits to mid-single digits [647]. - The company has deprioritized the KER-047 program, leading to changes in the reporting of related expenses [625]. Accounting and Estimates - Revenue recognition is based on ASC 606, with revenue recognized when customers obtain control of promised goods or services [653]. - The company estimates accrued research and development expenses based on known facts and circumstances, with no material adjustments to prior estimates reported [658]. - Stock-based compensation expense is recognized based on fair value, with the Black-Scholes option-pricing model used for valuation [659]. - The company has not entered into investments for trading or speculative purposes, focusing on capital preservation with short-term maturities [662]. - The company evaluates its estimates and assumptions on an ongoing basis, acknowledging that actual results may differ from these estimates [651]. - The company’s investment portfolio is conservative, and it does not expect a one percentage point change in interest rates to materially affect its operating results or cash flows [662].

Financial Performance - Keros reported a net loss of $46.0 million for Q4 2024, compared to a net loss of $40.2 million in Q4 2023, and a total net loss of $187.4 million for the year, up from $153.0 million in 2023 [4]. - Revenue for Q4 2024 was $3.0 million, significantly increasing from $0.1 million in Q4 2023, with total revenue for the year at $3.6 million compared to $0.2 million in 2023 [5]. - General and administrative expenses for Q4 2024 were $10.7 million, up from $9.1 million in Q4 2023, reflecting increased personnel and operational costs [7]. - The total operating expenses for 2024 were $214.4 million, compared to $170.1 million in 2023, driven by increased R&D and administrative costs [15]. Research and Development - Research and development expenses rose to $45.6 million in Q4 2024 from $37.5 million in Q4 2023, totaling $173.6 million for the year, up from $135.3 million in 2023 [6]. - The company expects to report initial data from the Phase 1 clinical trial of KER-065 in Q1 2025, with plans to advance into a Phase 2 trial focusing on Duchenne muscular dystrophy [2]. - Keros anticipates data from the Phase 2 TROPOS trial for cibotercept (KER-012) in patients with pulmonary arterial hypertension, which will inform future development strategies [2]. Cash and Assets - Keros' cash and cash equivalents increased to $559.9 million as of December 31, 2024, compared to $331.1 million at the end of 2023, bolstered by a $200 million upfront payment from Takeda Pharmaceuticals [9]. - Keros' total assets as of December 31, 2024, were $615.9 million, a significant increase from $370.0 million at the end of 2023 [17]. - The company plans to fund its operating expenses and capital requirements into 2029 based on current cash positions and the recent Takeda agreement [3].

Core Viewpoint - Keros Therapeutics, Inc. is advancing its clinical pipeline with promising data expected from ongoing trials, while also strengthening its financial position through a significant licensing agreement with Takeda Pharmaceuticals [1][2][3]. Financial Performance - Keros reported a net loss of $46.0 million for Q4 2024 and $187.4 million for the full year, compared to a net loss of $40.2 million and $153.0 million for the same periods in 2023, primarily due to increased R&D expenses [4]. - Total revenue for Q4 2024 was $3.0 million, up from $0.1 million in Q4 2023, and for the full year, revenue was $3.6 million compared to $0.2 million in 2023, largely driven by a milestone under a license agreement with Hansoh [5][13]. - Research and development expenses rose to $45.6 million for Q4 2024 and $173.6 million for the full year, compared to $37.5 million and $135.3 million in 2023, reflecting ongoing clinical trials and increased operational costs [6]. - General and administrative expenses increased to $10.7 million for Q4 2024 and $40.8 million for the full year, up from $9.1 million and $34.8 million in 2023, due to organizational growth and higher operational costs [7]. Cash Position - As of December 31, 2024, Keros had cash and cash equivalents of $559.9 million, an increase from $331.1 million in 2023, bolstered by a $200 million upfront payment from the Takeda Agreement, which is expected to fund operations into 2029 [8][3]. Clinical Development - Keros is focused on advancing its pipeline, with initial data from the Phase 1 trial of KER-065 expected in Q1 2025, targeting neuromuscular diseases, particularly Duchenne muscular dystrophy [2]. - The company anticipates reporting data from the Phase 2 TROPOS trial for cibotercept (KER-012) in patients with pulmonary arterial hypertension, with plans to evaluate its development strategy post-data readout [2]. Company Overview - Keros Therapeutics specializes in developing therapeutics targeting disorders linked to dysfunctional TGF-ß signaling, with a focus on conditions such as pulmonary arterial hypertension and neuromuscular diseases [9].

Core Viewpoint - Keros Therapeutics, Inc. is under investigation for potential securities fraud and unlawful business practices following significant stock price declines related to safety concerns in its clinical trials [1][2][3]. Group 1: Company Actions and Stock Performance - On December 12, 2024, Keros announced a voluntary halt in dosing for certain treatment arms in the TROPOS trial due to safety concerns, resulting in a stock price drop of $50.22 per share, or 73.15%, closing at $18.43 [2]. - On January 15, 2025, Keros further halted all dosing in the TROPOS trial based on ongoing safety reviews, leading to an additional stock price decline of $2.06 per share, or 16.51%, closing at $10.42 [3]. Group 2: Legal Investigation - Pomerantz LLP is investigating claims on behalf of Keros investors regarding potential securities fraud or other unlawful practices by the company and its officers or directors [1].

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 [1][3] - The company will participate in a fireside chat at the Guggenheim SMID Cap Biotech Conference on February 6, 2025 [1] Company Overview - Keros Therapeutics is recognized for its expertise in the TGF-ß protein family, which regulates growth, repair, and maintenance of various tissues including blood, bone, skeletal muscle, adipose, and heart tissue [3] - The company is developing several product candidates: - 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, including anemia and thrombocytopenia, in patients with myelodysplastic syndrome and myelofibrosis [3]

Keros Therapeutics Stock Performance - Keros Therapeutics (KROS) shares have plunged 80.9% in the past three months and 79.8% over the past year, significantly underperforming the industry's 12% decline [1][4] Cibotercept (KER-012) Clinical Trial Update - The company voluntarily halted dosing in the mid-stage TROPOS study of cibotercept (KER-012) for pulmonary arterial hypertension (PAH) due to unexpected adverse pericardial effusion events [1][2] - Initially suspended dosing in the 3 mg/kg and 4.5 mg/kg treatment arms, later extended to include the 1.5 mg/kg and placebo arms [3] - The TROPOS study is being concluded ahead of schedule, with top-line data expected in Q2 2025 [5] Other Pipeline Candidates - Elritercept (KER-050) is in two ongoing phase II studies for myelodysplastic syndromes (MDS) and myelofibrosis, with a planned phase III RENEW study for transfusion-dependent anemia [8][9] - KER-065 is in phase I development for obesity and neuromuscular diseases, with top-line data expected in Q1 2025 and a proof-of-concept study planned in obese patients [10] Industry Comparison - Castle Biosciences (CSTL) shares have declined 16.3% in three months, with 2024 earnings estimates increasing from 34 to 39 cents per share [12] - BioMarin Pharmaceutical (BMRN) shares have lost 11.9% in three months, with 2024 earnings estimates improving from $3.28 to $3.29 per share [13] - CytomX Therapeutics (CTMX) shares have declined 22.4% in three months, with 2024 loss estimates remaining at 5 cents per share [14]

Company Overview - Keros Therapeutics, Inc. (KROS) shares increased by 5.1% to close at $11.41, following a significant trading volume compared to normal sessions, despite a 36.6% loss over the past four weeks [1] Recent Developments - The global development and commercialization license agreement with Takeda for elritercept became effective on January 16, 2025, with Takeda set to make an upfront payment of $200 million to Keros Therapeutics, potentially contributing to the recent share price rally [2] Financial Expectations - Keros Therapeutics is expected to report a quarterly loss of $0.93 per share, reflecting a year-over-year increase of 30.6%, while revenues are projected to be $105.25 million, a substantial increase of 75078.6% from the same quarter last year [3] - The consensus EPS estimate for the quarter has been revised 2.7% higher in the last 30 days, indicating a positive trend that may lead to price appreciation [4] Industry Context - Keros Therapeutics operates within the Zacks Medical - Biomedical and Genetics industry, where another company, Revolution Medicines, Inc. (RVMD), experienced a 0.3% decline to $40.16, with a return of -8.3% over the past month [4]

Core Viewpoint - Keros Therapeutics, Inc. is under investigation for potential securities fraud and unlawful business practices following significant stock price declines related to safety concerns in its clinical trials [1][2][3]. Group 1: Company Actions and Stock Performance - On December 12, 2024, Keros announced a voluntary halt in dosing for certain treatment arms in the TROPOS trial due to safety concerns, leading to a stock price drop of $50.22 per share, or 73.15%, closing at $18.43 [2]. - On January 15, 2025, Keros further halted all dosing in the TROPOS trial based on ongoing safety reviews, resulting in an additional stock price decline of $2.06 per share, or 16.51%, closing at $10.42 [3]. Group 2: Legal Investigation - Pomerantz LLP is investigating claims on behalf of Keros investors regarding potential securities fraud or other unlawful business practices by the company and its officers or directors [1].

Core Viewpoint - The article discusses an ongoing investigation related to Keros Therapeutics, Inc. (KROS) and highlights potential financial losses incurred by investors due to the company's actions [1] Group 1 - The investigation is being conducted by Levi & Korsinsky, focusing on whether Keros Therapeutics misled investors regarding its financial performance and business prospects [1] - Investors who have lost money on Keros Therapeutics are encouraged to contact the law firm for assistance in the investigation [1] - The article emphasizes the importance of understanding the implications of the investigation for current and potential investors in Keros Therapeutics [1]

Core Viewpoint - Keros Therapeutics, Inc. (KROS) is currently under investigation by Bronstein, Gewirtz & Grossman, LLC, which is encouraging stockholders to reach out for more information regarding the investigation [1] Group 1 - The investigation pertains to potential violations of securities laws by Keros Therapeutics [1] - Stockholders are being urged to contact the firm to understand the implications of the investigation [1] - The investigation may impact the stock performance and investor sentiment towards Keros Therapeutics [1]