Keros Therapeutics, Inc. (KROS) revealed its financial results for the quarter ended June 30th, 2023 along with delivering a comprehensive business update. The clinical-stage biopharmaceutical company is honed-in on developing and commercializing novel therapeutics to address a vast range of disorders tied to abnormal TGF-ß signaling. With the goal of treating those in need, Keros remains committed to their mission.
We are thrilled to announce our plans to advance KER-065 — an activin receptor ligand trap which increases bone and muscle density, boosts fat metabolism and reduces fibrosis — into a Phase 2 clinical trial in patients suffering from Duchenne muscular dystrophy (“DMD”). This promising development marks a crucial next step in our mission to provide treatments for debilitating diseases with an unmet need.
Additionally, Keros is making progress with our Phase 2 trial of KER-012 in PAH patients. Our pipeline is fueled by a deep understanding of the TGF-ß family of proteins, which drives our passion to develop effective, differentiated therapies.
Recent Program Highlights
- KER-050 for the treatment of ineffective hematopoiesis to address cytopenias
- Keros has initiated dosing for Cohort 4 of its Phase 2 clinical trial of KER-050 in myelofibrosis-associated cytopenias. This will be administered as both a combination and monotherapy at a dosage strength of 4.5 mg/kg, as recommended by the Safety Review Committee. Keros expects to share dose escalation data and launch Part 2 of the trial in the latter half of 2023.
- KER-047 for the treatment of functional iron deficiency
- Keros is advancing a novel approach to treat myelodysplastic syndromes (“MDS”) and myelofibrosis with functional iron deficiency – a Phase 2 clinical trial. Early indications of success could potentially be available by the first half of 2024, bringing a much needed hope and relief to individuals suffering from these diseases.
- KER-012 for the treatment of PAH and for the treatment of cardiovascular disorders
- Keros is excited to announce that the U.S. Food and Drug Administration has cleared its investigational new drug application to conduct a groundbreaking Phase 2 clinical trial. The trial, known as the TROPOS trial, seeks to evaluate KER-012 in combination with background therapy in patients suffering from Pulmonary Arterial Hypertension (PAH) in a randomized, double-blind, placebo-controlled study across the globe. This marks a major milestone in Keros’ efforts to help those coping with this debilitating condition.
- Tomorrow, August 8, 2023, the Company is hosting an exciting conference call and webcast at 8:00 a.m. Eastern time to give insights on the TROPOS trial design. Don’t miss this great opportunity to get to the heart of what this experimental process entails!
- KER-065 for the treatment of neuromuscular disease
- Keros, a biotechnology company, is developing KER-065, a novel Activin receptor type II ligand trap, to treat neuromuscular diseases such as Duchenne Muscular Dystrophy (DMD). Selected from its proprietary library of ligand traps, KER-065 holds the potential to become a breakthrough therapy for these debilitating conditions.
- The Company is set to embark on an exciting journey next year when it commences a Phase 1 clinical trial for its potential new treatment, KER-065. This randomized, double-blind, placebo-controlled trial will evaluate the safety and tolerability of doses both single and multiple, testing it on a group of healthy volunteers. The results of this trial are eagerly anticipated in the first quarter of 2024.
Second Quarter 2023 Financial Results
Keros experienced a worrying net loss of $37.5 million in the second quarter of 2023, an increase of $10.2 million from the net loss in the second quarter of 2022. This significant hike was largely attributed to the company’s increased investments in research and development and other corporate objectives.
For the second quarter of 2023, research and development expenses amounted to a staggering $32.5 million – a $9.3 million increase from the same period in 2022. This rise was mainly attributed to increased efforts in research, development, and manufacturing projects, in addition to personnel expenses associated with Keros’ potential pipeline.
In the second quarter of 2023, our general and administrative expenses rose by $1.4 million, from $7.4 million to $8.8 million. This increase was mainly driven by greater personnel costs and the increased investments we made in external resources to support our ongoing expansive growth.
Keros was able to increase its cash and cash equivalents to $322.0 million as of June 30, 2023, up significantly from $279.0 million from the end of 2022. With this strong balance of capital, the company will be well-positioned to finance its operations and capital needs through the fourth quarter of 2025.
About Keros Therapeutics, Inc.
Keros is revolutionizing the way we treat a whole range of disorders through its focus on TGF-ß family of proteins. These master regulators control the growth, repair, and maintenance of blood cells, bone, skeletal muscle, adipose and heart tissue.
Our passion for understanding the power of these proteins has guided us to develop large and small molecule therapeutic products such as KER-050 for anemia and thrombocytopenia, KER-047 for functional iron deficiency, KER-012 for pulmonary arterial hypertension and cardiovascular disorders, and KER-065 for neuromuscular diseases, with a particular focus on DMD. By tapping into the natural healing power of the TGF-ß family of proteins, Keros is unlocking pathways to meaningful results for a range of patients.
Cautionary Note Regarding Forward-Looking Statements
Keros is blazing a new trail in the treatment of cancer with its novel therapeutics, KER-050, KER-047, KER-012, and KER-065. If Keros’ developments are successful, it expects to revolutionize the healthcare industry and enable meaningful progress for those affected by cancer.
The investments made and expected clinical trials of the product candidates will be integral to realizing the progress; however, various risks, such as Keros’ limited operating history and its ability to maintain and protect its intellectual property, may delay or derail the efforts. With that said, Keros is dedicated to its mission and remains confident that its plans for growth, strategy and the commercialization of its product candidates will ultimately manifest.
Keros faces a range of risks that could affect our performance and prospects, which can be found in full detail in the Company’s filings with the Securities and Exchange Commission. However, these risks do not lessen our commitment to staying up-to-date with the latest regulatory and market developments, and making sure that all decisions are made with our long-term success in mind. We strive to stay ahead of the curve and remain committed to taking calculated risks for the benefit of our shareholders and our future.