0001664710FALSE00016647102025-11-052025-11-050001664710us-gaap:CommonStockMember2025-11-052025-11-050001664710us-gaap:PreferredStockMember2025-11-052025-11-05
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): November 5, 2025
Keros Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
| | | | | | | | | | | | | | |
| | | | |
| 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:
| | | | | |
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| | | | | |
| ☐ | 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)) |
| | | | | |
| ☐ | 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:
| | | | | | | | | | | | | | |
| | | | |
| 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 November 5, 2025, Keros Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 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
| | | | | | | | |
| | |
| Exhibit | | |
| No. | | Description |
| | |
| 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.
| | | | | | | | |
| | |
| KEROS THERAPEUTICS, INC. |
| |
| By: | | /s/ Jasbir Seehra |
| | Jasbir Seehra, Ph.D. Chief Executive Officer |
Dated: November 5, 2025
Keros Therapeutics Reports Third Quarter 2025 Financial Results
LEXINGTON, Mass., November 5, 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 September 30, 2025.
“We are excited that our partner Takeda plans to advance elritercept into a Phase 3 clinical trial to evaluate elritercept in the first-line setting in myelodysplastic syndromes,” said Jasbir S. Seehra, Ph.D., President and Chief Executive Officer. “We are pleased with the continued progress of both our partner and our internal pipeline, as we advance toward initiating a Phase 2 clinical trial of KER-065 in patients with Duchenne muscular dystrophy.”
Third Quarter 2025 Financial Results
Keros reported a net loss of $7.3 million in the third quarter of 2025 as compared to a net loss of $53.0 million in the third quarter of 2024. The decrease of $45.7 million was largely due to revenue recognized 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 $19.5 million for the third quarter of 2025 as compared to $49.2 million for the same period in 2024. The decrease of $29.7 million was primarily due to the transition of elritercept-related research and development expenses to Takeda.
General and administrative expenses were $10.1 million for the third quarter of 2025 as compared to $9.8 million for the same period in 2024. The increase of $0.3 million was primarily due to an increase in other 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 September 30, 2025 was $693.5 million compared to $559.9 million as of December 31, 2024. Based on current operating assumptions, Keros expects that its cash and cash equivalents as of September 30, 2025, less $375.0 million of excess capital that the Company's Board of Directors has determined to return to stockholders, will enable Keros to fund its 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 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. Keros’ lead product candidate, KER-065, is being developed for the treatment of neuromuscular diseases, with an initial focus on Duchenne muscular dystrophy. 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 “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 for KER-065; Takeda's plans to advance elritercept into a Phase 3 clinical trial; 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, 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 August 6, 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.
Contacts
Investor Contact:
Justin Frantz
jfrantz@kerostx.com
617-221-6042
Media Contact:
Mahmoud Siddig / Adam Pollack / Viveca Tress
Joele Frank, Wilkinson Brimmer Katcher
212-355-4449
KEROS THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations
(In thousands, except share and per share data)
(Unaudited)
| | | | | | | | | | | | | | | | | | | | | | | |
| THREE MONTHS ENDED SEPTEMBER 30, | | NINE MONTHS ENDED SEPTEMBER 30, |
| 2025 | | 2024 | | 2025 | | 2024 |
| REVENUE: | | | | | | | |
| Service and other revenue | 4,262 | | | 388 | | | 38,321 | | | 508 | |
| License revenue | 10,000 | | | — | | | 205,355 | | | — | |
| Total revenue | 14,262 | | | 388 | | | 243,676 | | | 508 | |
| OPERATING EXPENSES: | | | | | | | |
| Research and development | (19,519) | | | (49,225) | | | (111,731) | | | (127,998) | |
| General and administrative | (10,127) | | | (9,820) | | | (35,106) | | | (30,089) | |
| Total operating expenses | (29,646) | | | (59,045) | | | (146,837) | | | (158,087) | |
| INCOME (LOSS) FROM OPERATIONS | (15,384) | | | (58,657) | | | 96,839 | | | (157,579) | |
| OTHER INCOME (EXPENSE), NET | | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| Dividend income | 6,933 | | | 5,793 | | | 20,845 | | | 16,977 | |
| Other expense, net | (253) | | | (92) | | | (812) | | | (725) | |
| Total other income, net | 6,680 | | | 5,701 | | | 20,033 | | | 16,252 | |
| Income (loss) before income taxes | (8,704) | | | (52,956) | | | 116,872 | | | (141,327) | |
| Income tax (provision) benefit | 1,424 | | | — | | | (6,397) | | | — | |
| Net income (loss) | $ | (7,280) | | | $ | (52,956) | | | $ | 110,475 | | | $ | (141,327) | |
| | | | | | | |
| Net income (loss) attributable to common stockholders — basic and diluted | $ | (7,280) | | | $ | (52,956) | | | $ | 110,475 | | | $ | (141,327) | |
| | | | | | | |
| Weighted-average shares of common stock outstanding — basic | 40,623,364 | | | 37,590,727 | | | 40,598,777 | | | 36,463,906 | |
| Weighted-average shares of common stock outstanding — diluted | 40,623,364 | | | 37,590,727 | | | 41,202,371 | | | 36,463,906 | |
| | | | | | | |
| Net income (loss) per share of common stock — basic | $ | (0.18) | | | $ | (1.41) | | | $ | 2.72 | | | $ | (3.88) | |
| Net income (loss) per share of common stock — diluted | $ | (0.18) | | | $ | (1.41) | | | $ | 2.68 | | | $ | (3.88) | |
KEROS THERAPEUTICS, INC.
Condensed Consolidated Balance Sheets
(In thousands, except share and per share data)
(Unaudited)
| | | | | | | | | | | |
| SEPTEMBER 30,
2025 | | DECEMBER 31,
2024 |
| ASSETS | | | |
| CURRENT ASSETS: | | | |
| Cash and cash equivalents | 693,472 | | | 559,931 | |
| Accounts receivable | 3,492 | | | 2,742 | |
| | | |
| Prepaid expenses and other current assets | 22,343 | | | 26,220 | |
| | | |
| | | |
| Total current assets | 719,307 | | | 588,893 | |
| Operating lease right-of-use assets | 17,463 | | | 19,251 | |
| Property and equipment, net | 4,564 | | | 4,237 | |
| Restricted cash | 1,449 | | | 1,449 | |
| Other long-term assets | — | | | 2,056 | |
| TOTAL ASSETS | 742,783 | | | 615,886 | |
| LIABILITIES AND STOCKHOLDERS' EQUITY | | | |
| CURRENT LIABILITIES: | | | |
| Accounts payable | 2,298 | | | 4,602 | |
| Current portion of operating lease liabilities | 2,318 | | | 1,978 | |
| Accrued expenses and other current liabilities | 15,174 | | | 20,870 | |
| Deferred revenue | 155 | | | — | |
| Current tax liability | 4,147 | | | — | |
| Total current liabilities | 24,092 | | | 27,450 | |
| Operating lease liabilities, net of current portion | 15,111 | | | 16,883 | |
| | | |
| | | |
| Total liabilities | 39,203 | | | 44,333 | |
| | | |
| STOCKHOLDERS' EQUITY: | | | |
| Preferred stock, par value of $0.0001 per share; 10,000,000 shares authorized as of September 30, 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 September 30, 2025 and December 31, 2024, respectively; no shares issued and outstanding | | | |
| Common stock, par value of $0.0001 per share; 200,000,000 shares authorized as of September 30, 2025 and December 31, 2024; 40,632,164 and 40,554,705 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively | 4 | | | 4 | |
| Additional paid-in capital | 1,161,880 | | | 1,140,328 | |
| Accumulated deficit | (458,304) | | | (568,779) | |
| Total stockholders' equity | 703,580 | | | 571,553 | |
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | 742,783 | | | 615,886 | |