TMCnet News
Keros Therapeutics Reports Recent Business Highlights and Second Quarter 2022 Financial ResultsKER-050 data from ongoing Phase 2 study in patients with lower risk myelodysplastic syndromes demonstrated meaningful responses across both ring sideroblast-positive and non-RS patients; 44% of high transfusion burden patients achieved transfusion independence KER-012 preliminary Phase 1 data exhibited encouraging treatment profile in healthy volunteers with improvements in biomarkers of bone formation with no clinically meaningful changes in red blood cell parameters Strengthened cash position and extended cash runway to fund operations into Q3 2024 LEXINGTON, Mass., Aug. 04, 2022 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. (“Keros” or the “Company”) (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematological, pulmonary, and musculoskeletal disorders with high unmet medical need, today provided a business update and reported financial results for the quarter ended June 30, 2022. “We continued the positive momentum for our pipeline programs into the second quarter of 2022. The clinical data demonstrated the potential of differentiated profiles of KER-050 and KER-012,” said Jasbir S. Seehra, Ph.D., President and Chief Executive Officer. “We shared promising clinical data for KER-050 in patients with MDS demonstrating the potential for transfusion independence in RS+ and non-RS patients and in those patients with high transfusion burden. Additionally, we also presented encouraging initial safety and biomarker data for KER-012 from our Phase 1 study in healthy volunteers. We continue making progress and remain on track to report additional data from both studies later this year.” Recent Program Highlights
Second Quarter 2022 Financial Results Keros reported a net loss of $27.3 million in the second quarter of 2022 as compared to a net loss of $15.6 million in the second quarter of 2021. The increase in net loss for the second quarter was largely due to increased research and development efforts as well as additional infrastructure expenses to support the achievement of Keros' corporate goals. Research and development expenses were $23.3 million for the second quarter of 2022 as compared to $10.0 million for the same period in 2021. The increase of $13.3 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 $7.4 million for the second quarter of 2022 as compared to $5.7 million for the same period in 2021. The increase of $1.8 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, 2022 was $215.6 million compared to $230.0 million as of December 31, 2021. Keros expects that the cash and cash equivalents it had on hand at June 30, 2022 will fund its operating expenses and capital expenditure requirements into the third quarter of 2024. About Keros Therapeutics, Inc. Keros is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematological, pulmonary and musculoskeletal disorders with high unmet medical need. Keros is a leader in understanding the role of the transforming growth factor-beta family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. Keros’ lead protein therapeutic product candidate, KER-050, is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with MDS and in patients with myelofibrosis. Keros’ lead small molecule product candidate, KER-047, is being developed for the treatment of anemia resulting from iron imbalance. Keros’ third product candidate, KER-012, is being developed for the treatment of pulmonary arterial hypertension and for the treatment of disorders associated with bone loss, such as osteoporosis and patients with osteogenesis imperfecta. 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," "expects," "intends," “plans,” “potential,” "projects,” “would” and "future" 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 timing of its clinical trials for KER-047; the potential impact of COVID-19 on Keros’ ongoing and planned preclinical studies, clinical trials, business and operations; 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 lead product candidates, KER-050 and KER-047; 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; Keros’ dependence on third parties in connection with manufacturing, clinical trials and preclinical studies; and risks relating to the impact on Keros' business of the COVID-19 pandemic or similar public health crises. 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 5, 2022, 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: Deepankar Roy KEROS THERAPEUTICS, INC.
Condensed Consolidated Balance Sheets (In thousands, except share and per share data) (Unaudited)
|