Keros Therapeutics Reports Recent Business Highlights and Fourth Quarter and Full Year 2024 Financial Results

Rhea-AI Summary

Keros Therapeutics (NASDAQ: KROS) reported its Q4 and full-year 2024 financial results, highlighting a net loss of $46.0M for Q4 and $187.4M for the full year. The company's revenue increased to $3.0M in Q4 and $3.6M for 2024, primarily due to a milestone achievement under the Hansoh license agreement.

Research and development expenses rose to $173.6M for 2024, up from $135.3M in 2023, reflecting increased pipeline development activities. The company's cash position was significantly strengthened by a $200M upfront payment from Takeda Pharmaceuticals through an exclusive license agreement for elritercept development.

With cash and cash equivalents of $559.9M as of December 31, 2024, plus the Takeda payment, Keros expects to fund operations into 2029. The company anticipates reporting initial Phase 1 data for KER-065 in healthy volunteers in Q1 2025 and data from the Phase 2 TROPOS trial evaluating cibotercept in pulmonary arterial hypertension patients.

Positive

• $200M upfront payment received from Takeda agreement
• Extended cash runway into 2029
• Revenue increased to $3.6M in 2024 from $0.2M in 2023
• Cash position strengthened to $559.9M from $331.1M YoY

Negative

• Net loss increased to $187.4M in 2024 from $153.0M in 2023
• R&D expenses rose 28% to $173.6M
• G&A expenses increased 17% to $40.8M

Insights

Financial Analyst

Keros Therapeutics has significantly strengthened its financial position through a transformative deal with Takeda Pharmaceuticals, receiving a $200 million upfront payment for elritercept (KER-050) rights. This strategic transaction extends Keros' cash runway into 2029, providing important operational flexibility during a pivotal development period.

The company's financial foundation looks robust with $559.9 million in cash as of December 31, 2024 (up from $331.1 million in 2023). When combined with the Takeda payment, Keros now has approximately $760 million available to fund operations - a substantial war chest for a company with $437 million market capitalization.

Keros' net loss widened to $187.4 million in 2024 (22.5% increase year-over-year), reflecting accelerated investment in clinical programs. The current quarterly burn rate of approximately $46 million suggests an annual cash utilization around $184 million, supporting management's runway projections while allowing for potential pipeline expansion.

The Takeda partnership represents more than just capital - it provides external validation of Keros' TGF-β platform technology while allowing the company to strategically focus resources on wholly-owned assets like KER-065 for neuromuscular diseases and cibotercept for pulmonary arterial hypertension.

Revenue remains minimal at $3.6 million for 2024, primarily from a milestone payment from Hansoh. However, the company's value proposition centers on upcoming clinical catalysts rather than near-term revenue generation. The first quarter of 2025 will be particularly significant with expected initial data from the Phase 1 KER-065 trial potentially enabling advancement into Phase 2 for Duchenne muscular dystrophy, a high-unmet-need indication that could drive substantial value if successful.

Biotech Industry Expert

Keros Therapeutics is advancing a scientifically differentiated platform targeting the TGF-β superfamily of proteins - master regulators involved in tissue homeostasis, immune function, and cell growth. This biological pathway represents a fertile but challenging therapeutic area where Keros has developed specialized expertise.

The recent $200 million Takeda partnership for elritercept provides dual benefits beyond capital: external validation of Keros' scientific approach and the ability to focus internal resources on earlier-stage assets while maintaining significant economics in their lead program. This transaction structure - upfront payment plus undisclosed milestones and royalties - is particularly advantageous given current biotech funding conditions.

The company's pipeline strategy shows intelligent diversification within their core biological expertise:

• Cibotercept (KER-012): Targeting bone morphogenetic protein (BMP) signaling in pulmonary arterial hypertension through the Phase 2 TROPOS trial. PAH represents a $6+ billion market with significant mortality despite available therapies. The upcoming TROPOS data represents a critical catalyst that could position cibotercept as a potential first-in-class therapy addressing underlying disease pathology rather than just symptoms.
• KER-065: Focuses on muscle growth and function via activin inhibition, with Duchenne muscular dystrophy as the initial target. DMD represents a strategic entry into neuromuscular diseases where despite recent approvals (including gene therapies), substantial unmet needs remain for therapies that can preserve or enhance muscle function.

The expanded R&D investment ($173.6 million in 2024) reflects Keros' commitment to generating robust clinical data across multiple programs simultaneously. The Q1 2025 readout from KER-065's Phase 1 study will be particularly informative for determining optimal dosing for efficacy while managing the safety profile - a critical balance for therapies targeting growth factor pathways.

With funding secured into 2029, Keros has unusual flexibility to pursue optimal development paths rather than making compromises based on capital constraints. This positions them well for potential additional partnerships or wholly-owned commercialization depending on clinical outcomes.

LEXINGTON, Mass., Feb. 26, 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 provided a business update and reported financial results for the fourth quarter and full year ended December 31, 2024.

“The efforts over the past year by the team at Keros have positioned us to continue to advance our promising pipeline of novel therapeutics,” said Jasbir S. Seehra, Ph.D., Chair and Chief Executive Officer. “We are excited to report initial data from the ongoing Phase 1 clinical trial of KER-065 in healthy volunteers in the first quarter of 2025, which we believe can inform our advancement into a Phase 2 clinical trial in neuromuscular disease, with our initial focus on Duchenne muscular dystrophy. We continue to expect to report data from the Phase 2 TROPOS trial evaluating cibotercept (KER-012) in patients with pulmonary arterial hypertension, and we plan to evaluate the appropriate development strategy for cibotercept following that data readout.”

Recent Corporate Highlights:

• Cash position strengthened: In February 2025, Keros received a $200.0 million upfront payment pursuant to the exclusive license agreement it entered into with Takeda Pharmaceuticals U.S.A., Inc. (the “Takeda Agreement”) to further develop, manufacture and commercialize elritercept (KER-050) worldwide outside of mainland China, Hong Kong and Macau, which became effective on January 16, 2025. Based on current operating assumptions, the Company expects that its cash and cash equivalents as of December 31, 2024, together with the upfront payment received from the Takeda Agreement, will enable the Company to fund its planned operating expenses and capital expenditure requirements into 2029.
  

2024 Financial Results

Keros reported a net loss of $46.0 million for the fourth quarter and $187.4 million for the year ended December 31, 2024, as compared to a net loss of $40.2 million for the fourth quarter and $153.0 million for the year ended December 31, 2023. The increase in net loss for the fourth quarter and the year was largely due to increased research and development efforts as well as additional investments to support the achievement of Keros' clinical and corporate goals.

Keros generated revenue of $3.0 million for the fourth quarter and $3.6 million for the year ended December 31, 2024 compared to $0.1 million for the fourth quarter and $0.2 million for the year ended December 31, 2023. Revenue in 2024 was largely related to a milestone achieved under Keros' license agreement with Hansoh (Shanghai) Healthtech Co., Ltd. (“Hansoh”).

Research and development expenses were $45.6 million for the fourth quarter and $173.6 million for the year ended December 31, 2024, as compared to $37.5 million for the fourth quarter and $135.3 million for the year ended December 31, 2023. The increase in research and development expenses for the fourth quarter and the year was driven by the continued advancement of the Company's pipeline, notably the TROPOS trial, the ongoing Phase 1 clinical trial of KER-065 and the progression of two Phase 2 clinical trials and the Phase 3 clinical trial of elritercept, as well as an increase in personnel costs and infrastructure to support operations and expansion of the Company's pipeline.

General and administrative expenses were $10.7 million for the fourth quarter and $40.8 million for the year ended December 31, 2024, as compared to $9.1 million and $34.8 million for the fourth quarter and year ended December 31, 2023, respectively. The increase was primarily due to an increase in personnel expenses to support the Company's organizational growth and achievement of its corporate goals, an increase in facilities, supplies and other office expenses due to the growth of the Company's organization and an increase in professional fees.

Keros’ cash and cash equivalents as of December 31, 2024 was $559.9 million compared to $331.1 million as of December 31, 2023. Based on current operating assumptions, Keros expects that its cash and cash equivalents as of December 31, 2024, together with the $200 million upfront payment from the Takeda Agreement, which the Company received in February 2025, will enable the Company to fund its planned operating expenses and capital expenditure requirements into 2029.

About Keros Therapeutics, Inc.

Keros is 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 TGF-ß family of proteins. Keros is a leader in understanding the role of the TGF-ß family of proteins, which are master regulators of the growth, repair and maintenance of a number of tissues, including blood, bone, skeletal muscle, adipose and heart tissue. By leveraging this understanding, Keros has discovered and is developing protein therapeutics that have the potential to provide meaningful and potentially disease-modifying benefit to patients. One of Keros’ product candidates, cibotercept, is being developed for the treatment of pulmonary arterial hypertension and for the treatment of cardiovascular disorders. The Company's second product candidate, KER-065, is being developed for the treatment of neuromuscular diseases. Keros' most advanced product candidate, elritercept, is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndromes and in patients with myelofibrosis.

Cautionary Note Regarding Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as “anticipates,” “believes,” “continue,” “expects,” “enable,” “potential” and “will” or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning: Keros’ expectations regarding its growth, strategy, progress and the design, objectives and timing of its clinical trials for cibotercept and KER-065; the expected timing of data readouts from the Phase 1 clinical trial of KER-065 and the TROPOS trial; Keros’ evaluation of development strategy for cibotercept; and Keros’ expected cash runway. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Keros’ limited operating history and historical losses; Keros’ ability to raise additional funding to complete the development and any commercialization of its product candidates; Keros’ dependence on the success of its product candidates, cibotercept, KER-065 and elritercept; that Keros may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; Keros’ ability to obtain, maintain and protect its intellectual property; and Keros’ dependence on third parties in connection with manufacturing, clinical trials and preclinical studies.

These and other risks are described more fully in Keros’ filings with the Securities and Exchange Commission (“SEC”), including the “Risk Factors” section of the Company’s Quarterly Report on Form 10-Q, filed with the SEC on November 6, 2024, and its other documents subsequently filed with or furnished to the SEC, including the Company’s Annual Report on Form 10-K as of and for the year ended December 31, 2024. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Keros undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Investor Contact:
Justin Frantz
jfrantz@kerostx.com
617-221-6042

KEROS THERAPEUTICS, INC.
Consolidated Statements of Operations
(In thousands, except share and per share data)
(Unaudited)
		THREE MONTHS ENDED DECEMBER 31,								YEAR ENDED DECEMBER 31,
			2024				2023				2024				2023
REVENUE:
Service and other revenue			42				143				550				151
License revenue			3,000				—				3,000				—
Total revenue			3,042				143				3,550				151
OPERATING EXPENSES:
Research and development			(45,631	)			(37,493	)			(173,629	)			(135,258	)
General and administrative			(10,665	)			(9,105	)			(40,754	)			(34,834	)
Total operating expenses			(56,296	)			(46,598	)			(214,383	)			(170,092	)
LOSS FROM OPERATIONS			(53,254	)			(46,455	)			(210,833	)			(169,941	)
OTHER INCOME (EXPENSE), NET:
Research and development incentive income			1,238				2,400				1,238				2,400
Dividend income			6,519				3,756				23,496				14,755
Other income (expense), net			(229	)			56				(954	)			(206	)
Total other income, net			7,528				6,212				23,780				16,949
Loss before income taxes			(45,726	)			(40,243	)			(187,053	)			(152,992	)
Income tax provision			(300	)			—				(300	)			—
Net loss		$	(46,026	)		$	(40,243	)		$	(187,353	)		$	(152,992	)
Net loss attributable to common stockholders—basic and diluted		$	(46,026	)		$	(40,243	)		$	(187,353	)		$	(152,992	)
Net loss per share attributable to common stockholders—basic and diluted		$	(1.14	)		$	(1.34	)		$	(5.00	)		$	(5.20	)
Weighted-average common stock outstanding—basic and diluted			40,337,720				30,126,578				37,437,652				29,447,119

KEROS THERAPEUTICS, INC.
Consolidated Balance Sheets
(In thousands, except share and per share data)
(Unaudited)
	DECEMBER 31,
		2024				2023
ASSETS
CURRENT ASSETS:
Cash and cash equivalents	$	559,931			$	331,147
Accounts receivable		2,742				143
Prepaid expenses and other current assets		26,220				16,003
Total current assets		588,893				347,293
Operating lease right-of-use assets		19,251				15,334
Property and equipment, net		4,237				4,134
Restricted cash		1,449				1,212
Other long term assets		2,056				2,052
Total assets	$	615,886			$	370,025
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES:
Accounts payable	$	4,602			$	5,450
Current portion of operating lease liabilities		1,978				1,005
Accrued expenses and other current liabilities		20,870				17,918
Total current liabilities		27,450				24,373
Operating lease liabilities, net of current portion		16,883				13,439
Total liabilities		44,333				37,812
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS’ EQUITY:
Preferred stock, par value of $0.0001 per share; 10,000,000 shares authorized as of December 31, 2024 and December 31, 2023; no shares issued and outstanding		—				—
Common stock, par value of $0.0001 per share; 200,000,000 authorized as of December 31, 2024 and December 31, 2023; 40,554,705 and 31,841,084 shares issued and outstanding as of December 31, 2024 and December 31, 2023, respectively		4				3
Additional paid-in capital		1,140,328				713,636
Accumulated deficit		(568,779	)			(381,426	)
Total stockholders’ equity		571,553				332,213
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY	$	615,886			$	370,025

FAQ

What was Keros Therapeutics (KROS) net loss for full year 2024?

Keros reported a net loss of $187.4 million for the full year 2024, compared to $153.0 million in 2023.

How much cash did KROS receive from the Takeda agreement in 2025?

Keros received a $200 million upfront payment from Takeda in February 2025 for the exclusive license agreement for elritercept.

What is KROS's cash runway following the Takeda agreement?

With $559.9M in cash as of December 2024 plus the $200M Takeda payment, Keros expects to fund operations into 2029.

How much did KROS's R&D expenses increase in 2024?

R&D expenses increased to $173.6 million in 2024 from $135.3 million in 2023, due to pipeline advancement and infrastructure expansion.

When will KROS report Phase 1 data for KER-065?

Keros expects to report initial data from the Phase 1 trial of KER-065 in healthy volunteers in Q1 2025.