MALVERN, PA — Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company, this week announced financial results for the second quarter ended June 30, 2023, and provided recent corporate updates.
“Following the FDA’s decision on the avasopasem NDA, we have taken decisive steps to extend our cash runway as we seek a Type A meeting with the FDA to discuss the potential path forward for approval,” said Mel Sorensen, M.D., Galera’s President and CEO. “In parallel, enrollment continues in the ongoing GRECO trials of rucosopasem, our anti-cancer candidate, as we investigate the novel compound’s potential to enhance stereotactic body (high daily dose) radiotherapy and extend the lives of patients with deadly cancers.”
Radiotherapy-Induced Severe Oral Mucositis (SOM)
- In August 2023, the Company announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for avasopasem for radiotherapy-induced SOM in patients with head and neck cancer (HNC) undergoing standard-of-care treatment. In the CRL, the FDA communicated that the results from the Phase 3 ROMAN trial together with the supporting data from the GT-201 trial are not sufficiently persuasive to establish substantial evidence of avasopasem’s effectiveness and safety for reducing SOM in patients with HNC. FDA stated that results from an additional clinical trial will be required for resubmission. The Company intends to request a Type A meeting with the FDA to understand the FDA’s rationale for its decision and discuss next steps to support an NDA resubmission seeking approval of avasopasem.
Cisplatin-Related Chronic Kidney Disease
- In June 2023, Galera presented an abstract featuring avasopasem, as part of the Head and Neck Cancer session at the American Society of Clinical Oncology (ASCO) Annual Meeting, which took place June 2-6, 2023, in Chicago, IL. The abstract, titled “One-year reductions in cisplatin-related chronic kidney disease (CKD) in patients with head and neck cancer (HNC) treated with avasopasem manganese: A prespecified analysis from the Phase 3 ROMAN trial,” noted significant improvements in preservation of kidney function compared to placebo based on mean change in estimated Glomerular Filtration Rate, beginning by 3 months through one-year end of follow-up. Reductions in CKD were consistent across cisplatin dosing schedules.
Locally Advanced Pancreatic Cancer (LAPC)
- Enrollment is ongoing in the randomized, placebo-controlled Phase 2b GRECO-2 trial of rucosopasem in combination with SBRT in patients with LAPC. The primary endpoint of the trial is overall survival. Completion of enrollment continues to be anticipated in the first half of 2024, and topline data readout is expected by the end of 2024.
- In May 2023, the FDA granted Orphan Drug Designation for rucosopasem for the treatment of pancreatic cancer.
Non-Small Cell Lung Cancer (NSCLC)
- Enrollment is ongoing in the randomized, placebo-controlled Phase 2 stage of the GRECO-1 trial of rucosopasem in combination with SBRT in patients with NSCLC. Completion of enrollment continues to be anticipated in the second half of 2023, and topline data readout is expected in the second half of 2024.
General Corporate Updates
- In connection with the CRL announcement, on August 9, 2023, the Company further announced it will focus resources on defining the path forward for avasopasem, progressing the ongoing clinical trials for rucosopasem, and concurrently evaluating strategic alternatives, including partnering, for the continued development of avasopasem and rucosopasem. As a result, the Company reduced its workforce by approximately 70%. The plan includes a wind-down of commercial readiness efforts and headcount reductions across several departments.
Second Quarter 2023 Financial Highlights
- Research and development expenses were $7.6 million in the second quarter of 2023, compared to $6.6 million for the same period in 2022. The increase was primarily attributable to an increase in rucosopasem development costs, partially offset by a decrease in avasopasem development costs.
- General and administrative expenses were $9.2 million in the second quarter of 2023, compared to $5.3 million for the same period in 2022. The increase was primarily attributable to avasopasem commercial preparations.
- Galera reported a net loss of $(20.7) million, or $(0.48) per share, for the second quarter of 2023, compared to a net loss of $(14.6) million, or $(0.54) per share, for the same period in 2022.
- As of June 30, 2023, Galera had cash, cash equivalents and short-term investments of $38.8 million. Galera expects that its existing cash, cash equivalents and short-term investments, taking into account the implementation of the reduction in workforce announced in August 2023, will enable Galera to fund its operating expenses and capital expenditure requirements into the second quarter of 2024.
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