Galecto, Inc. (NASDAQ: GLTO), a clinical-stage biotechnology company, has announced a strategic shift to focus on oncology and liver diseases following its acquisition of global rights to GB3226, a novel dual inhibitor targeting acute myeloid leukemia (AML). The company reported this development alongside its full-year 2024 financial results on March 19, 2025.
The acquisition of GB3226 (formerly BRM-1420) from Bridge Medicines represents a significant milestone in Galecto's strategic realignment. This dual ENL-YEATS and FLT3 inhibitor is designed to address multiple genetic subsets of AML, a blood cancer with significant unmet medical needs.
"The acquisition of global rights to GB3226 provides us with an opportunity to develop a unique approach to AML that has the potential to significantly improve outcomes for the AML patient population," said Dr. Hans Schambye, CEO of Galecto. "GB3226 has shown strong potential in preclinical studies, showing activity against a range of AML-driving mutations, including those commonly associated with resistance and relapse."
Novel Dual Mechanism of Action
GB3226's dual mechanism of action differentiates it from existing therapies. The compound is designed to provide rapid therapeutic effect through FLT3 inhibition while promoting sustained response via ENL-YEATS inhibition. This approach could potentially address resistance mechanisms that often limit the efficacy of current AML treatments.
Preclinical data has demonstrated GB3226's superior efficacy compared to both FLT3 and menin inhibitors in animal models. Additionally, the compound has shown additive or synergistic activity when combined with standard-of-care treatments, suggesting potential for combination therapy approaches.
The company is advancing GB3226 toward an Investigational New Drug (IND) application submission to the FDA, expected in Q1 2026.
Ongoing Clinical Development
In parallel with the GB3226 program, Galecto continues to advance its galectin-3 inhibitor, GB1211. The Providence Portland Medical Center's Earle A. Chiles Research Institute has initiated a Phase 2 investigator-initiated trial of GB1211 in combination with pembrolizumab (Keytruda®) for patients with metastatic melanoma and head and neck squamous cell carcinoma.
This trial builds on previous research suggesting that galectin-3 inhibition may enhance the efficacy of immune checkpoint inhibitors by modulating the tumor microenvironment and potentially overcoming resistance mechanisms.
Financial Position and Outlook
As of December 31, 2024, Galecto reported cash and cash equivalents of approximately $14.2 million. The company anticipates these funds will support operating expenses and capital requirements into 2026, including the planned IND submission for GB3226.
Research and development expenses decreased significantly to $6.4 million for 2024, compared to $23.8 million in 2023, primarily due to discontinued clinical trial activities and reduced chemistry, manufacturing, and control operations.
The company recorded $4.4 million in acquired in-process research and development costs related to the Bridge Medicines asset purchase. General and administrative expenses also decreased to $10.5 million in 2024 from $12.7 million in 2023.
Net loss for 2024 was $21.4 million, or $(18.53) per basic and diluted share, compared to $38.3 million, or $(36.08) per share, in the prior year.
Leadership Expansion
To support its strategic realignment, Galecto has strengthened its leadership team. Matthew Kronmiller, formerly Bridge Medicine's Chief Executive Officer, has joined Galecto as Executive Vice President of Strategy and Chief Business Officer. Additionally, Dr. Amy Wechsler has been appointed to the Board of Directors, bringing valuable biotech leadership experience.
AML Treatment Landscape
AML is an aggressive blood cancer characterized by the rapid growth of abnormal myeloid cells in the bone marrow and blood. The disease affects approximately 20,000 new patients annually in the United States, with a five-year survival rate of only about 29%.
Current treatment approaches include chemotherapy, targeted therapies, and stem cell transplantation. However, resistance and relapse remain significant challenges, particularly in patients with specific genetic mutations.
GB3226's dual targeting approach aims to address these challenges by simultaneously inhibiting two key pathways involved in AML pathogenesis. The ENL-YEATS inhibition targets epigenetic mechanisms that drive leukemic cell growth, while FLT3 inhibition addresses a common mutation found in approximately 30% of AML patients.
Future Directions
Dr. Schambye emphasized the company's commitment to advancing GB3226 into clinical development rapidly while maintaining focus on transformative treatments for cancer and liver diseases.
"With a strengthened pipeline and a clear strategic focus, we look forward to advancing these promising therapies for patients in need," he stated.
The company's pipeline now consists of first-in-class small molecule drug candidates targeting cancer and fibrosis signaling pathways, including GB3226 for AML, GB1211 in combination with checkpoint inhibitors for various oncology indications, and GB1211 for the treatment of liver cirrhosis.
As Galecto advances these programs, additional capital will be required to support future clinical development of both the GB3226 and GB1211 programs beyond the current funding horizon.
