Keros Therapeutics, Inc. (KROS) SEC Filings & Earnings Calls

Clinical trial risk; elritercept is still in development and may not succeed.

“ELRiSE MF is a Phase 3, multicenter, double-blind, randomized trial to compare the efficacy and safety of elritercept to placebo in patients with myelofibrosis and anemia on concurrent ruxolitinib therapy.” · word for word

Clinical trial risk: Phase 2 trial is early-stage; no efficacy/safety data available; initial data not expected until H1 2027

“Initial data expected in the first half of 2027” · word for word

Small buyback relative to cash; may signal limited investment opportunities.

“$5M buyback vs $257.6M cash; company is pre-revenue biotech.”

No revenue; reliant on cash reserves and clinical success.

“No revenue in Q2 2026; net loss of $28.7M.”

Clinical trial failure risk

“In January 2025, we announced the early termination of our Phase 2 clinical trial evaluating cibotercept in patients with pulmonary arterial hypertension... based on an ongoing safety review due to the unanticipated observation of pericardial effusion adverse events in the trial.” · word for word

Capital need risk

“We will need substantial additional funding in order to complete the development and commence commercialization of our product candidates.” · word for word

Dependence on collaborations

“In the event that the license agreement we entered into with Takeda... is terminated, we may not receive any additional fees or milestone payments under that agreement.” · word for word

Dependence on Takeda partnership for elritercept development and commercialization; milestone payments contingent on clinical progress.

“Under the terms of the global license agreement with Takeda ... Keros received a $200 million upfront cash payment ... and is eligible to receive development, commercial and sales milestones” · word for word

CFO departure may signal internal issues, though stated as voluntary and no disagreement.

“Resignation was voluntary and not the result of any disagreement with the Company on any matter relating to accounting practices, financial statements, internal controls.”

Revenue concentration risk from Takeda partnership; no new license revenue in Q1 2026

“License revenue $0 in Q1 2026 vs $195.4M in Q1 2025”

Clinical-stage biotech with no approved products; depends on pipeline success

“Keros is a clinical-stage biopharmaceutical company... no approved products”

Clinical trial failure risk

“We are heavily dependent on the success of our product candidates, which are in clinical development. If we are unable to advance our current or future product candidates through clinical trials, obtain marketing approval and ultimately commercialize any product candidates we develop, or experience significant delays in doing so, our business will be materia” · word for word

Need for additional capital

“We will need substantial additional funding in order to complete the development and commence commercialization of our product candidates. Failure to obtain this necessary capital when needed may force us to delay, reduce or eliminate certain of our product development or research operations.” · word for word

Safety/adverse events risk

“Our product candidates may be associated with serious adverse, undesirable or unacceptable side effects or other properties or safety risks, which may delay or halt their clinical development, or prevent marketing approval.” · word for word

Clinical pipeline concentration risk

“We made the strategic decision to exclusively prioritize the clinical advancement of our lead product candidate, rinvatercept... we discontinued all material internal development activities related to cibotercept (KER-012).” · word for word

Cibotercept program failure

“This decision follows the previously announced termination of the development of cibotercept in pulmonary arterial hypertension ('PAH'), following the analysis of all available safety and efficacy data from the TROPOS Phase 2 clinical trial in patients with PAH.” · word for word

Key executive departure

“Mr. Rovaldi ceased serving as our President and Chief Operating Officer, effective August 18, 2025.” · word for word

Shareholder concentration and large block repurchase

“the ADAR1 Parties and the Pontifax Parties sold all of the shares of common stock beneficially owned by them, being an aggregate of 10,176,595 shares of common stock, to us at a per share purchase price of $17.75 per share, for an aggregate purchase price of $180.6 million.” · word for word

Cash burn rate high; cash runway only into H1 2028; no new revenue sources beyond Takeda license.

“Cash decreased from $559.9M to $287.4M; cash runway into H1 2028.”

Clinical-stage dependency; no approved products; pipeline risk for rinvatercept and elritercept.

“Forward-looking statements highlight risks of delays, competition, and dependence on product candidates.”

Clinical development risk

“We will not generate any revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval for one or more of our product candidates.” · word for word

Funding dependency

“We will need substantial additional funding to support our operating activities as we advance our product candidates through clinical development, seek regulatory approval and prepare for and, if any of our product candidates are approved, proceed to commercialization.” · word for word

Reimbursement uncertainty

“If reimbursement is not available, or is available only to limited levels, we may not be able to successfully commercialize our product candidates.” · word for word

Board transition may signal governance changes but no immediate risk.

Forward-looking statements with typical clinical and regulatory risks.

“Risks include limited operating history, need for additional funding, clinical trial delays.”

Clinical-stage company with no approved products

“Company is clinical-stage; revenue dependent on license agreements.”

Dependence on Takeda partnership

“Significant revenue from Takeda license; partner advancing elritercept.”

Clinical trial failure risk

“In January 2025, we announced the early termination of our Phase 2 clinical trial evaluating cibotercept in patients with PAH, which we refer to as the TROPOS trial, based on an ongoing safety review due to the unanticipated observation of pericardial effusion adverse events in the trial.” · word for word

Dependence on collaboration revenue

“Revenue we generate from our collaborations with Takeda and Hansoh (Shanghai) Healthtech Co., Ltd., or Hansoh, and any future collaboration arrangements may not be sufficient to sustain our operations.” · word for word

Need for additional capital

“We will need substantial additional funding in order to complete the development and commence commercialization of our product candidates.” · word for word