Keros Therapeutics Reports Second Quarter 2024 Financial Results

Rhea-AI Summary

Keros Therapeutics (Nasdaq: KROS) reported its Q2 2024 financial results, showing a net loss of $45.3 million, up from $37.5 million in Q2 2023. The increase was primarily due to expanded R&D efforts and investments in clinical and corporate goals. Research and development expenses rose to $40.5 million from $32.5 million year-over-year, while general and administrative expenses increased to $10.0 million from $8.8 million. Despite the losses, Keros' cash position strengthened to $405.9 million as of June 30, 2024, up from $331.1 million at the end of 2023. The company expects this cash reserve to fund operations into 2027. Keros highlighted positive regulatory and data updates for its elritercept (KER-050) program and strong enrollment in the Phase 2 trial of cibotercept (KER-012) for pulmonary arterial hypertension.

Positive

• Strong cash position of $405.9 million, up from $331.1 million at end of 2023
• Cash runway extended into 2027
• Positive regulatory and data updates for elritercept (KER-050) program
• Strong enrollment in Phase 2 trial of cibotercept (KER-012)

Negative

• Net loss increased to $45.3 million from $37.5 million year-over-year
• Research and development expenses rose to $40.5 million from $32.5 million
• General and administrative expenses increased to $10.0 million from $8.8 million

Financial Analyst

Keros Therapeutics' Q2 2024 results reveal a widening net loss of $45.3 million, up from $37.5 million in Q2 2023. This 20.8% increase in losses is primarily attributed to heightened R&D expenses, which rose by $8 million to $40.5 million. Despite the increased spending, the company's robust cash position of $405.9 million is a positive sign, providing a runway into 2027.

The cash burn rate is a concern, but it's justified by the advancement of their pipeline, particularly the progress in elritercept and cibotercept programs. The 22.6% increase in cash reserves since December 2023 suggests successful fundraising efforts, which is important for a clinical-stage biopharma company. Investors should monitor the pace of clinical trials and potential catalysts that could impact the stock in the near term.

Biotech Research Analyst

Keros' focus on TGF-ß family protein signaling disorders positions it in a promising niche. The positive regulatory updates and data from the elritercept (KER-050) program are encouraging signs of progress. The strong enrollment in the Phase 2 trial of cibotercept (KER-012) for pulmonary arterial hypertension, with completion expected in Q4, could be a significant catalyst.

However, investors should note that despite the progress, Keros remains a clinical-stage company without marketed products. The increased R&D spending of $40.5 million this quarter reflects the company's commitment to advancing its pipeline but also highlights the cash-intensive nature of drug development. The projected cash runway into 2027 provides a comfortable buffer for clinical development, but the path to profitability remains long and uncertain.

LEXINGTON, Mass., Aug. 07, 2024 (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 June 30, 2024.

“Keros continued to build upon the progress of all programs across our pipeline in the second quarter of 2024, as evidenced by our recent positive regulatory and data updates from the elritercept (KER-050) program,” said Jasbir S. Seehra, Ph.D., Chair and Chief Executive Officer. “We continue to be excited by the strong enrollment activity we have seen to date in our Phase 2 clinical trial of cibotercept (KER-012) in patients with pulmonary arterial hypertension and look forward to completing enrollment of that trial in the fourth quarter of this year.”

Second Quarter 2024 Financial Results

Keros reported a net loss of $45.3 million in the second quarter of 2024 as compared to a net loss of $37.5 million in the second quarter of 2023. The increase of $7.8 million for the second quarter was largely due to increased research and development efforts as well as additional investments to support the achievement of Keros’ clinical and corporate goals.

Research and development expenses were $40.5 million for the second quarter of 2024 as compared to $32.5 million for the same period in 2023. The increase of $8.0 million was primarily due to additional research and development efforts, manufacturing activities and personnel expenses to support the advancement of Keros’ pipeline.

General and administrative expenses were $10.0 million for the second quarter of 2024 as compared to $8.8 million for the same period in 2023. The increase of $1.2 million was primarily due to increase in personnel expenses and other external expenses to support Keros’ organizational growth.

Keros’ cash and cash equivalents as of June 30, 2024 was $405.9 million compared to $331.1 million as of December 31, 2023. Keros expects that the cash and cash equivalents it had on hand at June 30, 2024 will enable Keros to fund its operating expenses and capital expenditure requirements into 2027.

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. We are 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, we have discovered and are developing protein therapeutics that have the potential to provide meaningful and potentially disease-modifying benefit to patients. Keros’ lead 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 syndromes and in patients with myelofibrosis. Keros’ second product candidate, cibotercept (KER-012), is being developed for the treatment of pulmonary arterial hypertension and for the treatment of cardiovascular disorders. Keros’ third product candidate, KER-065, is being developed for the treatment of obesity and for the treatment of neuromuscular diseases.

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,” “look forward,” “progress” 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 elritercept and cibotercept, 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, elritercept, cibotercept and KER-065; 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 May 8, 2024, 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 JUNE 30,								SIX MONTHS ENDED JUNE 30,
		2024				2023				2024				2023
REVENUE:
Service and other revenue		37				—				120				—
Total revenue		37				—				120				—
OPERATING EXPENSES:
Research and development		(40,515	)			(32,534	)			(78,773	)			(63,625	)
General and administrative		(9,961	)			(8,803	)			(20,269	)			(16,581	)
Total operating expenses		(50,476	)			(41,337	)			(99,042	)			(80,206	)
LOSS FROM OPERATIONS		(50,439	)			(41,337	)			(98,922	)			(80,206	)
OTHER INCOME (EXPENSE), NET
Dividend income		5,378				3,987				11,184				7,093
Other expense, net		(196	)			(155	)			(633	)			(196	)
Total other income, net		5,182				3,832				10,551				6,897
Net loss	$	(45,257	)		$	(37,505	)		$	(88,371	)		$	(73,309	)
Net loss attributable to common stockholders—basic and diluted	$	(45,257	)		$	(37,505	)		$	(88,371	)		$	(73,309	)
Net loss per share attributable to common stockholders—basic and diluted	$	(1.25	)		$	(1.27	)		$	(2.46	)		$	(2.53	)
Weighted-average common stock outstanding—basic and diluted		36,103,187				29,602,458				35,894,305				28,989,361

KEROS THERAPEUTICS, INC. Condensed Consolidated Balance Sheets (In thousands, except share and per share data) (Unaudited)
	JUNE 30, 2024			DECEMBER 31, 2023
ASSETS
CURRENT ASSETS:
Cash and cash equivalents	405,863			331,147
Accounts receivable	4			143
Prepaid expenses and other current assets	26,847			16,003
Total current assets	432,714			347,293
Operating lease right-of-use assets	14,649			15,334
Property and equipment, net	4,292			4,134
Restricted cash	1,212			1,212
Other long-term assets	2,155			2,052
TOTAL ASSETS	455,022			370,025
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable	6,535			5,450
Current portion of operating lease liabilities	1,096			1,005
Accrued expenses and other current liabilities	13,614			17,918
Total current liabilities	21,245			24,373
Operating lease liabilities, net of current portion	12,861			13,439
Total liabilities	34,106			37,812
STOCKHOLDERS' EQUITY:
Preferred stock, par value of $0.0001 per share; 10,000,000 shares authorized as of June 30, 2024 and December 31, 2023; no shares issued and outstanding	—			—
Common stock, par value of $0.0001 per share; 200,000,000 shares authorized as of June 30, 2024 and December 31, 2023; 36,169,558 and 31,841,084 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively	3			3
Additional paid-in capital	890,710			713,636
Accumulated deficit	(469,797	)		(381,426	)
Total stockholders' equity	420,916			332,213
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	455,022			370,025

FAQ

What was Keros Therapeutics' (KROS) net loss in Q2 2024?

Keros Therapeutics reported a net loss of $45.3 million in the second quarter of 2024.

How much cash does Keros Therapeutics (KROS) have as of June 30, 2024?

Keros Therapeutics had $405.9 million in cash and cash equivalents as of June 30, 2024.

How long does Keros Therapeutics (KROS) expect its current cash to last?

Keros expects its current cash position to fund operating expenses and capital expenditure requirements into 2027.

What is the status of Keros Therapeutics' (KROS) cibotercept (KER-012) clinical trial?

Keros reported strong enrollment activity in its Phase 2 clinical trial of cibotercept (KER-012) in patients with pulmonary arterial hypertension, with enrollment expected to complete in Q4 2024.