Keros Therapeutics Reports Recent Business Highlights and Fourth Quarter and Full Year 2023 Financial Results
- Keros made clinical progress in its pipeline with Phase 2 trials for KER-012 and KER-050.
- The company closed a public offering to strengthen its cash position, expecting funding into 2027.
- Keros reported increased net losses due to R&D investments, with revenue from a technology transfer agreement with Hansoh.
- The company's cash and equivalents stood at $331.1 million as of December 31, 2023.
- Increased net losses reported for Q4 and full year 2023 compared to the previous year.
- Research and development expenses increased significantly for the year ended December 31, 2023.
- General and administrative expenses also rose in Q4 and full year 2023.
- No revenue was generated for the year ended December 31, 2022.
Insights
The reported financial results for Keros Therapeutics indicate a significant increase in both quarterly and annual net losses, principally attributed to escalated research and development (R&D) expenses. This uptick in R&D spending is consistent with the company's efforts to advance its clinical pipeline, notably the progression of its Phase 2 clinical trials and the initiation of a Phase 1 trial. The strategic allocation of funds towards R&D is a common practice within the biopharmaceutical industry, especially for companies like Keros that are in the clinical stage and have no marketed products. Investors typically expect these companies to operate at a loss while investing heavily in the development of their drug candidates.
From a financial perspective, the successful capital raise through a public offering, resulting in a strengthened cash position, is noteworthy. This cash infusion, amounting to approximately $331.1 million in cash and cash equivalents, provides the company with a runway into 2027, which is a positive signal to investors regarding the company's financial stability and its ability to sustain operations without the immediate need for further financing. However, the dilutive effect of the common stock offering on existing shareholders cannot be overlooked, as it may impact the stock's value in the short term.
Keros Therapeutics' focus on disorders related to the transforming growth factor-beta (TGF-ß) family of proteins represents a niche but potentially significant area in the biopharmaceutical field. The progression to Phase 2 clinical trials for KER-050 in myelodysplastic syndromes (MDS) and myelofibrosis and the advancement of KER-012 in pulmonary arterial hypertension (PAH) suggest promising therapeutic potential. The move into Phase 3 trials for KER-050 in MDS is particularly important, as it signifies a pivotal step towards potential commercialization.
Engagement with regulators on the design of the planned Phase 3 clinical trial is a critical phase in drug development, as it sets the stage for the studies that will ultimately support marketing approval if successful. The anticipation of additional data from ongoing trials in 2024 is likely to be a significant catalyst for both the medical community and investors, as it will provide further insights into the safety and efficacy of the drug candidates. The initiation of a Phase 1 trial for KER-065 for obesity and neuromuscular diseases expands the company's pipeline diversity, potentially addressing high-impact medical conditions with unmet needs.
The biopharmaceutical sector is highly competitive and driven by innovation, with investors closely watching clinical trial progress and regulatory interactions. Keros Therapeutics' update indicates a proactive approach in advancing their pipeline, which is essential for maintaining investor interest and confidence. The company's focus on diseases like MDS, myelofibrosis, PAH and potentially obesity and neuromuscular diseases, targets markets with significant patient populations and high unmet medical needs.
The timing of anticipated milestones, such as the engagement with regulators and the reporting of additional data, is crucial as these events can heavily influence the company's market valuation. The reported increase in general and administrative expenses reflects the company's growth and may be viewed positively if it translates into efficient management and successful execution of its strategic goals. Overall, Keros' activities and financial health are closely aligned with industry norms for a clinical-stage biopharmaceutical company and will likely be of interest to stakeholders monitoring the sector for emerging opportunities.
LEXINGTON, Mass., Feb. 28, 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 provided a business update and reported financial results for the fourth quarter and full year ended December 31, 2023.
“In 2023, Keros made continued clinical progress across our pipeline, including commencing our Phase 2 clinical trial evaluating KER-012 in patients with pulmonary arterial hypertension (“PAH”) and presenting exciting data from our two ongoing Phase 2 clinical trials of KER-050, one in patients with myelodysplastic syndromes (“MDS”) and one in patients with myelofibrosis,” said Jasbir S. Seehra, Ph.D., President and Chief Executive Officer. “We continue to build on that momentum in 2024, as highlighted by the advancement of our third clinical asset, KER-065, into a Phase 1 healthy volunteer clinical trial at the beginning of this year. We look forward to providing updates from the KER-050 and KER-012 programs in the first half of this year.”
Recent Corporate Highlights:
- Cash position strengthened: The Company closed an underwritten public offering of 4,025,000 shares of common stock on January 8, 2024, at a public offering price of
$40.00 per share, inclusive of the underwriters’ exercise in full of their option to purchase up to an additional 525,000 shares of common stock at the public offering price (the “January 2024 Offering”). The Company expects that its cash and cash equivalents as of December 31, 2023, together with the net proceeds from the January 2024 Offering, will enable the Company to fund its planned operating expenses and capital expenditure requirements into 2027.
Selected Anticipated Program Milestones:
- KER-050 (elritercept) for the treatment of ineffective hematopoiesis to address cytopenias:
- Engage with regulators on the design of the planned Phase 3 clinical trial of KER-050 in patients with MDS in the first half of 2024
- Report additional data from Part 2 of the ongoing Phase 2 clinical trial of KER-050 in patients with MDS in the second and fourth quarters of 2024
- Report additional data from the ongoing Phase 2 clinical trial of KER-050 in patients with myelofibrosis in the second and fourth quarters of 2024
- KER-012 for the treatment of PAH and for the treatment of cardiovascular disorders:
- Provide an update on enrollment of the ongoing Phase 2 clinical trial evaluating KER-012 in patients with PAH (the “TROPOS trial”) in the first half of 2024
- Report initial data from the ongoing Phase 2 open-label biomarker trial of KER-012 in patients with chronic heart failure with preserved injection and in such patients with reduced ejection fraction in the second half of 2024
- KER-065 for the treatment of obesity and for the treatment of neuromuscular diseases:
- Report initial data from the ongoing Phase 1 clinical trial in healthy volunteers in the first quarter of 2025
- Report initial data from the ongoing Phase 1 clinical trial in healthy volunteers in the first quarter of 2025
2023 Financial Results
Keros reported a net loss of
Keros generated revenue of
Research and development expenses were
General and administrative expenses were
Keros’ cash and cash equivalents as of December 31, 2023 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. 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, KER-050 (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. Keros’ second product candidate, KER-012, is being developed for the treatment of PAH 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 “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 KER-050, KER-012 and KER-065, 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, KER-050, KER-012 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 November 6, 2023, 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. Consolidated Statements of Operations (In thousands, except share and per share data) (Unaudited) | ||||||||||||||||
| THREE MONTHS ENDED DECEMBER 31, | YEAR ENDED DECEMBER 31, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| REVENUE: | ||||||||||||||||
| Service and other revenue | 143 | — | 151 | — | ||||||||||||
| Total revenue | 143 | — | 151 | — | ||||||||||||
| OPERATING EXPENSES: | ||||||||||||||||
| Research and development | (37,493 | ) | (24,867 | ) | (135,258 | ) | (87,265 | ) | ||||||||
| General and administrative | (9,105 | ) | (7,093 | ) | (34,834 | ) | (27,525 | ) | ||||||||
| Total operating expenses | (46,598 | ) | (31,960 | ) | (170,092 | ) | (114,790 | ) | ||||||||
| LOSS FROM OPERATIONS | (46,455 | ) | (31,960 | ) | (169,941 | ) | (114,790 | ) | ||||||||
| OTHER INCOME (EXPENSE), NET: | ||||||||||||||||
| Interest expense, net | — | — | — | (1 | ) | |||||||||||
| Research and development incentive income | 2,400 | — | 2,400 | 7,081 | ||||||||||||
| Dividend income | 3,756 | 2,301 | 14,755 | 3,644 | ||||||||||||
| Other income (expense), net | 56 | (59 | ) | (206 | ) | (613 | ) | |||||||||
| Total other income (expense), net | 6,212 | 2,242 | 16,949 | 10,111 | ||||||||||||
| Loss before income taxes | (40,243 | ) | (29,718 | ) | (152,992 | ) | (104,679 | ) | ||||||||
| Income tax provision | — | — | — | — | ||||||||||||
| Net loss | $ | (40,243 | ) | $ | (29,718 | ) | $ | (152,992 | ) | $ | (104,679 | ) | ||||
| Net loss attributable to common stockholders—basic and diluted | $ | (40,243 | ) | $ | (29,718 | ) | $ | (152,992 | ) | $ | (104,679 | ) | ||||
| Net loss per share attributable to common stockholders—basic and diluted | $ | (1.34 | ) | $ | (1.09 | ) | $ | (5.20 | ) | $ | (4.15 | ) | ||||
| Weighted-average common stock outstanding—basic and diluted | 30,126,578 | 27,326,726 | 29,447,119 | 25,241,030 | ||||||||||||
| KEROS THERAPEUTICS, INC. Consolidated Balance Sheets (In thousands, except share and per share data) (Unaudited) | |||||||
| DECEMBER 31, | |||||||
| 2023 | 2022 | ||||||
| ASSETS | |||||||
| CURRENT ASSETS: | |||||||
| Cash and cash equivalents | $ | 331,147 | $ | 279,048 | |||
| Accounts receivable | 143 | — | |||||
| Prepaid expenses and other current assets | 16,003 | 6,719 | |||||
| Total current assets | 347,293 | 285,767 | |||||
| Operating lease right-of-use assets | 15,334 | 15,548 | |||||
| Property and equipment, net | 4,134 | 2,021 | |||||
| Restricted cash | 1,212 | 1,327 | |||||
| Other long term asset | 2,052 | 2,118 | |||||
| Total assets | $ | 370,025 | $ | 306,781 | |||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
| CURRENT LIABILITIES: | |||||||
| Accounts payable | $ | 5,450 | $ | 3,339 | |||
| Current portion of operating lease liabilities | 1,005 | 455 | |||||
| Accrued expenses and other current liabilities | 17,918 | 12,753 | |||||
| Total current liabilities | 24,373 | 16,547 | |||||
| Operating lease liabilities, net of current portion | 13,439 | 12,811 | |||||
| Total liabilities | 37,812 | 29,358 | |||||
| COMMITMENTS AND CONTINGENCIES | |||||||
| STOCKHOLDERS’ EQUITY: | |||||||
| Preferred stock, par value of | — | — | |||||
| Common stock, par value of | 3 | 2 | |||||
| Additional paid-in capital | 713,636 | 505,855 | |||||
| Accumulated deficit | (381,426 | ) | (228,434 | ) | |||
| Total stockholders’ equity | 332,213 | 277,423 | |||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 370,025 | $ | 306,781 | |||
FAQ
What clinical progress did Keros make in its pipeline?
How did Keros strengthen its cash position?
Why did Keros report increased net losses?
What was Keros' cash and equivalents as of December 31, 2023?
