Keros Therapeutics Reports Recent First Quarter 2025 Financial Results
- Net income of $148.5M in Q1 2025, compared to $43.1M loss in Q1 2024
- Strong cash position of $720.5M, up from $559.9M in December 2024
- Cash runway extended into 2029
- Successful Phase 1 trial results for KER-065
- Revenue boost from Takeda Pharmaceuticals license agreement
- Increased R&D expenses by $10.5M year-over-year
- Higher G&A expenses, up $0.2M from previous year
Insights
Keros transforms financial position with $148.5M quarterly profit, extending cash runway to 2029 through Takeda licensing deal.
Keros Therapeutics has achieved a remarkable financial transformation in Q1 2025, reporting net income of $148.5 million compared to a $43.1 million loss in Q1 2024—a $191.6 million improvement. This dramatic shift stems primarily from revenue recognized through their license agreement with Takeda Pharmaceuticals, representing significant validation of their TGF-β platform technology.
The company's cash position has strengthened substantially to $720.5 million, up from $559.9 million at year-end 2024. This robust treasury now extends their operational runway into 2029, providing approximately four years of funding—an exceptionally strong position for a clinical-stage biotech. This financial cushion provides critical strategic flexibility for pipeline advancement without near-term financing pressure.
Operating expenses show disciplined growth with R&D expenses at $48.7 million (up $10.5 million year-over-year) reflecting increased clinical development activities, while G&A expenses remained nearly flat at $10.5 million. The mention of the Board's ongoing review of strategic alternatives suggests potential corporate developments beyond organic growth, possibly including partnerships or acquisition opportunities. Their strengthened financial position enhances negotiating leverage for any such transactions.
Keros advances KER-065 toward Phase 2 with successful Phase 1 results while approaching critical cibotercept PAH data readout in Q2 2025.
Keros has reported initial topline results from the Phase 1 trial of KER-065 that met key objectives, though specific efficacy endpoints or biomarker data weren't disclosed. This positive language typically suggests a favorable safety profile and preliminary signals supporting the drug's mechanism of action. The company's plans to advance to Phase 2 by Q1 2026 following regulatory discussions indicates confidence in the compound's potential.
The most immediate catalyst in their clinical pipeline is the upcoming Phase 2 TROPOS trial data for cibotercept (KER-012) in pulmonary arterial hypertension (PAH), expected in Q2 2025. This represents a significant near-term value inflection point, as PAH remains a serious condition with substantial unmet needs despite available therapies. The company's statement about evaluating an "appropriate development strategy" following this readout suggests they're considering various scenarios depending on the data's strength.
Keros' focus on targeting dysfunctional signaling of the TGF-β family of proteins represents a mechanistically differentiated approach. This pathway has broad therapeutic potential across multiple disease states but has historically presented development challenges. Success in modulating this pathway could potentially address underlying disease mechanisms rather than just symptoms, particularly in conditions like PAH where pathological vascular remodeling plays a central role.
LEXINGTON, Mass., May 06, 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 reported financial results for the quarter ended March 31, 2025.
“In the first quarter, we reported initial topline results from the Phase 1 clinical trial of KER-065 that met key objectives and yielded valuable insights. These findings position us well as we prepare to engage with regulators with the aim of advancing KER-065 to a Phase 2 clinical trial in the first quarter of 2026,” said Jasbir S. Seehra, Ph.D., Chair and Chief Executive Officer. “As our Board of Directors continues its review process to evaluate strategic alternatives to enhance stockholder value for the Company, we remain focused on the execution of our strategy and advancing the development of our pipeline of novel therapeutics. We expect to report data in the second quarter of 2025 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.”
First Quarter 2025 Financial Results
Keros reported a net income of
Research and development expenses were
General and administrative expenses were
Keros’ cash and cash equivalents as of March 31, 2025 was
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. Keros’ second product candidate, KER-065, is being developed for the treatment of neuromuscular diseases. Keros’ most advanced product candidate, elritercept (KER-050), is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndrome 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 “enable,” “expects” 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 strategy, progress and timing of its clinical trials and data readouts for cibotercept and KER-065; statements concerning the intended benefits of the strategic review process; 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: whether the objectives of the strategic alternative review process will be achieved; the terms, structure, benefits and costs of any strategic transaction; the timing of any transaction and whether any transaction will be consummated at all; the risk that the strategic alternatives review and its announcement could have an adverse effect on the ability of the Company to retain and hire key personnel and maintain relationships with partners, suppliers, employees, shareholders and other business relationships and on its operating results and business generally; the risk the strategic alternatives review could divert the attention and time of the Company’s management; the risk of any unexpected costs or expenses resulting from the review; the risk of any litigation relating to the review; 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 Annual Report on Form 10-K, filed with the SEC on February 26, 2025, and its other documents subsequently filed with or furnished to the SEC. 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. Condensed Consolidated Statements of Operations (In thousands, except share and per share data) (Unaudited) | |||||||
| THREE MONTHS ENDED MARCH 31, | |||||||
| 2025 | 2024 | ||||||
| REVENUE: | |||||||
| Service and other revenue | 15,891 | 83 | |||||
| License revenue | 195,355 | — | |||||
| Total revenue | 211,246 | 83 | |||||
| OPERATING EXPENSES: | |||||||
| Research and development | (48,709 | ) | (38,258 | ) | |||
| General and administrative | (10,497 | ) | (10,308 | ) | |||
| Total operating expenses | (59,206 | ) | (48,566 | ) | |||
| INCOME (LOSS) FROM OPERATIONS | 152,040 | (48,483 | ) | ||||
| OTHER INCOME (EXPENSE), NET | |||||||
| Dividend income | 6,792 | 5,806 | |||||
| Other expense, net | (338 | ) | (437 | ) | |||
| Total other income, net | 6,454 | 5,369 | |||||
| Income (loss) before income taxes | 158,494 | (43,114 | ) | ||||
| Income tax provision | (10,043 | ) | — | ||||
| Net income (loss) | $ | 148,451 | $ | (43,114 | ) | ||
| Net income (loss) attributable to common stockholders—basic and diluted | $ | 148,451 | $ | (43,114 | ) | ||
| Weighted-average shares of common stock outstanding — basic | 40,559,355 | 35,685,422 | |||||
| Weighted-average shares of common stock outstanding — diluted | 41,021,325 | 35,685,422 | |||||
| Net income (loss) per share of common stock — basic | $ | 3.66 | $ | (1.21 | ) | ||
| Net income (loss) per share of common stock — diluted | $ | 3.62 | $ | (1.21 | ) | ||
| KEROS THERAPEUTICS, INC. Condensed Consolidated Balance Sheets (In thousands, except share and per share data) (Unaudited) | |||||
| MARCH 31, 2025 | DECEMBER 31, 2024 | ||||
| ASSETS | |||||
| CURRENT ASSETS: | |||||
| Cash and cash equivalents | 720,541 | 559,931 | |||
| Accounts receivable | 17,291 | 2,742 | |||
| Prepaid expenses and other current assets | 21,677 | 26,220 | |||
| Total current assets | 759,509 | 588,893 | |||
| Operating lease right-of-use assets | 18,667 | 19,251 | |||
| Property and equipment, net | 4,473 | 4,237 | |||
| Restricted cash | 1,449 | 1,449 | |||
| Other long-term assets | 463 | 2,056 | |||
| TOTAL ASSETS | 784,561 | 615,886 | |||
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||
| CURRENT LIABILITIES: | |||||
| Accounts payable | 6,636 | 4,602 | |||
| Current portion of operating lease liabilities | 2,102 | 1,978 | |||
| Accrued expenses and other current liabilities | 17,290 | 20,870 | |||
| Deferred revenue | 3,308 | — | |||
| Current tax liability | 10,043 | — | |||
| Total current liabilities | 39,379 | 27,450 | |||
| Operating lease liabilities, net of current portion | 16,311 | 16,883 | |||
| Total liabilities | 55,690 | 44,333 | |||
| STOCKHOLDERS' EQUITY: | |||||
| Preferred stock, par value of | — | — | |||
| Common stock, par value of | 4 | 4 | |||
| Additional paid-in capital | 1,149,195 | 1,140,328 | |||
| Accumulated deficit | (420,328 | ) | (568,779 | ) | |
| Total stockholders' equity | 728,871 | 571,553 | |||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | 784,561 | 615,886 | |||
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