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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 4, 2026
Keros Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
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| Delaware | | 001-39264 | | 81-1173868 |
(state or other jurisdiction of incorporation) | | (Commission File Number) | | (I.R.S. Employer Identification No.) |
| |
1050 Waltham Street, Suite 302 Lexington, Massachusetts | | 02421 |
| (Address of principal executive offices) | | (Zip Code) |
Registrant’s telephone number, including area code: (617) 314-6297
Not applicable
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| | | | | |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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| Title of each class | | Trading Symbol | | Name of each exchange on which registered |
| Common Stock, $0.0001 par value per share | | KROS | | The Nasdaq Stock Market LLC |
| Preferred Share Purchase Rights | | N/A | | The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On March 4, 2026, Keros Therapeutics, Inc. (the “Company”) issued a press release announcing its recent business highlights and financial results for the quarter and year ended December 31, 2025. A copy of the press release is furnished hereto as Exhibit 99.1 and is incorporated herein by reference.
The information in this Item 2.02, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section. The information contained in this Item 2.02 and in the accompanying exhibit is not incorporated by reference in any filing of the Company under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
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| | |
| Exhibit | | |
| No. | | Description |
99.1 | | Press Release dated March 4, 2026. |
| 104 | | Cover Page Interactive Data File (the cover page XBRL tags are embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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| KEROS THERAPEUTICS, INC. |
| |
| By: | | /s/ Jasbir Seehra |
| | Jasbir Seehra, Ph.D. Chief Executive Officer |
Dated: March 4, 2026
Keros Therapeutics Reports Recent Business Highlights and Fourth Quarter and Full Year 2025 Financial Results
LEXINGTON, Mass., March 4, 2026 (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, 2025.
“The previous year was an important period of transition for the Company, during which we sharpened our strategic priorities,” said Jasbir S. Seehra, Ph.D., President and Chief Executive Officer. “With that foundation in place, our attention is firmly on execution – advancing rinvatercept into a Phase 2 clinical trial in patients with Duchenne muscular dystrophy (“DMD”) and engaging regulators on the design of a Phase 2 clinical trial in patients with amyotrophic lateral sclerosis (“ALS”). With a strong foundation in place, our focus remains on bringing potential meaningful benefit to patients and creating long-term value for our stockholders.”
Recent Corporate Highlights:
•Board and leadership changes:
◦In February 2026, Keros announced the appointment of Charles Newton to its board of directors, effective March 9, 2026. Concurrent with Mr. Newton joining Keros’ Board of Directors, Carl Gordon, Ph.D., C.F.A., will step down as a director of the Company.
◦Esther Cho, J.D., Senior Vice President, General Counsel, was promoted to Chief Legal Officer, effective February 24, 2026.
Selected Anticipated Program Milestones:
•Rinvatercept for the treatment of DMD and for the treatment of ALS:
◦The Company expects to commence a Phase 2 clinical trial of rinvatercept in patients with DMD in the second quarter of 2026.
◦The Company plans to engage regulators on the design of a Phase 2 clinical trial of rinvatercept in patients with ALS in the second half of 2026.
2025 Financial Results
Keros reported a net loss of $23.5 million for the fourth quarter and net income of $87.0 million for the year ended December 31, 2025, as compared to a net loss of $46.0 million for the fourth quarter and a net loss of $187.4 million for the year ended December 31, 2024. The decrease in net loss for the fourth quarter and the net income for the year was largely due to revenue related to Keros’ license agreement with Takeda Pharmaceuticals U.S.A., Inc. (“Takeda”), partially offset by research and development efforts as well as additional investments to support the achievement of Keros’ clinical and corporate goals.
Research and development expenses were $17.9 million for the fourth quarter and $129.6 million for the year ended December 31, 2025, as compared to $45.6 million for the fourth quarter and $173.6 million for the year ended December 31, 2024. The decrease in research and development expenses for the fourth quarter and the year was primarily due to the transition of elritercept-related research and development expenses to Takeda.
General and administrative expenses were $11.7 million for the fourth quarter and $46.8 million for the year ended December 31, 2025, as compared to $10.7 million for the fourth quarter and $40.8 million for the year ended December 31, 2024. The increase in general and administrative expenses for the year
was primarily due to an increase in external expenses, partially offset by a decrease in compensation costs, including stock-based compensation costs, in connection with a reduction in headcount.
Keros’ cash and cash equivalents as of December 31, 2025 was $287.4 million compared to $559.9 million as of December 31, 2024. The decrease in cash and cash equivalents for the year was primarily driven by Keros’ share repurchase with certain stockholders and cash tender offer. Based on current operating assumptions, Keros expects that its cash and cash equivalents as of December 31, 2025 will enable the Company to fund its planned operating expenses and capital expenditure requirements into the first half of 2028.
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 skeletal muscle, bone, adipose, heart tissue and blood. 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. Keros’ lead product candidate, rinvatercept, is being developed for the treatment of DMD and for the treatment of ALS. Keros’ most advanced product candidate, elritercept, is being developed for the treatment of 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 “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 rinvatercept, including its regulatory plans; 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, rinvatercept 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 5, 2025, 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, 2025. 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
Media Contact:
Mahmoud Siddig / Adam Pollack / Brooks Hussey
Joele Frank, Wilkinson Brimmer Katcher
(212) 355-4449
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, |
| | 2025 | | 2024 | | 2025 | | 2024 |
REVENUE: | | | | | | | | |
Service and other revenue | | 385 | | | 42 | | | 38,706 | | | 550 | |
License revenue | | — | | | 3,000 | | | 205,355 | | | 3,000 | |
Total revenue | | 385 | | | 3,042 | | | 244,061 | | | 3,550 | |
OPERATING EXPENSES: | | | | | | | | |
Research and development | | (17,912) | | | (45,631) | | | (129,643) | | | (173,629) | |
General and administrative | | (11,743) | | | (10,665) | | | (46,849) | | | (40,754) | |
Total operating expenses | | (29,655) | | | (56,296) | | | (176,492) | | | (214,383) | |
INCOME (LOSS) FROM OPERATIONS | | (29,270) | | | (53,254) | | | 67,569 | | | (210,833) | |
OTHER INCOME (EXPENSE), NET: | | | | | | | | |
| | | | | | | | |
Research and development incentive income | | — | | | 1,238 | | | — | | | 1,238 | |
| | | | | | | | |
Dividend income | | 4,022 | | | 6,519 | | | 24,867 | | | 23,496 | |
Other income (expense), net | | 273 | | | (229) | | | (539) | | | (954) | |
Total other income, net | | 4,295 | | | 7,528 | | | 24,328 | | | 23,780 | |
Income (loss) before income taxes | | (24,975) | | | (45,726) | | | 91,897 | | | (187,053) | |
Income tax provision | | 1,514 | | | (300) | | | (4,883) | | | (300) | |
Net income (loss) | | $ | (23,461) | | | $ | (46,026) | | | $ | 87,014 | | | $ | (187,353) | |
Net income (loss) attributable to common stockholders—basic and diluted | | $ | (23,461) | | | $ | (46,026) | | | $ | 87,014 | | | $ | (187,353) | |
| | | | | | | | |
Weighted-average common stock outstanding—basic | | 27,198,653 | | | 40,337,720 | | | 37,221,211 | | | 37,437,652 | |
Weighted-average common stock outstanding—diluted | | 27,198,653 | | | 40,337,720 | | | 37,859,106 | | | 37,437,652 | |
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Net income (loss) per share of common stock — basic | | $ | (0.86) | | | $ | (1.14) | | | $ | 2.34 | | | $ | (5.00) | |
Net income (loss) per share of common stock — diluted | | $ | (0.86) | | | $ | (1.14) | | | $ | 2.30 | | | $ | (5.00) | |
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KEROS THERAPEUTICS, INC.
Consolidated Balance Sheets
(In thousands, except share and per share data)
(Unaudited)
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| DECEMBER 31, |
| 2025 | | 2024 |
| | | |
ASSETS | | | |
CURRENT ASSETS: | | | |
Cash and cash equivalents | $ | 287,415 | | | $ | 559,931 | |
Accounts receivable | 3,567 | | | 2,742 | |
Prepaid expenses and other current assets | 22,202 | | | 26,220 | |
| | | |
| | | |
Current income tax receivable | 2,250 | | | — | |
Total current assets | 315,434 | | | 588,893 | |
Operating lease right-of-use assets | 16,841 | | | 19,251 | |
Property and equipment, net | 4,297 | | | 4,237 | |
| | | |
Restricted cash | 1,449 | | | 1,449 | |
Other long term assets | — | | | 2,056 | |
TOTAL ASSETS | $ | 338,021 | | | $ | 615,886 | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | | | |
CURRENT LIABILITIES: | | | |
Accounts payable | $ | 1,967 | | | $ | 4,602 | |
Current portion of operating lease liabilities | 2,408 | | | 1,978 | |
| | | |
Accrued expenses and other current liabilities | 16,039 | | | 20,870 | |
| | | |
Total current liabilities | 20,414 | | | 27,450 | |
Operating lease liabilities, net of current portion | 14,475 | | | 16,883 | |
| | | |
| | | |
Total liabilities | 34,889 | | | 44,333 | |
COMMITMENTS AND CONTINGENCIES | | | |
STOCKHOLDERS’ EQUITY: | | | |
Preferred stock, par value of $0.0001 per share; 10,000,000 shares authorized as of December 31, 2025 and December 31, 2024; no shares issued and outstanding | — | | | — | |
Series A junior participating preferred stock, par value of $0.0001 per share; 500,000 and no shares authorized as of December 31, 2025 and December 31, 2024, respectively; no shares issued and outstanding | — | | | — | |
Common stock, par value of $0.0001 per share; 200,000,000 authorized as of December 31, 2025 and December 31, 2024; 40,670,466 issued and 19,543,706 outstanding as of December 31, 2025 and 40,554,705 shares issued and outstanding as of December 31, 2024 | 4 | | | 4 | |
Treasury stock, at cost; 21,126,760 and no shares as of December 31, 2025 and December 31, 2024, respectively | (384,558) | | | — | |
Additional paid-in capital | 1,169,451 | | | 1,140,328 | |
Accumulated deficit | (481,765) | | | (568,779) | |
Total stockholders’ equity | 303,132 | | | 571,553 | |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 338,021 | | | $ | 615,886 | |
