MALVERN, PA — Galera Therapeutics, Inc. (NASDAQ: GRTX) this week unveiled its financial results for the third quarter of 2023, alongside a series of significant corporate updates that signal a strategic shift for the company.
Mel Sorensen, M.D., Galera’s President and CEO, announced the discontinuation of the GRECO trials in an effort to conserve cash and maximize shareholder value. “Given the considerable time and investment required for additional clinical trials, we find it prudent to explore strategic options,” said Sorensen.
This announcement comes after the U.S. FDA issued a Complete Response Letter (CRL) for avasopasem manganese (avasopasem), a treatment for radiotherapy-induced Severe Oral Mucositis (SOM) in patients with head and neck cancer, in August 2023. The FDA cited insufficient data from the Phase 2b GT-201 and Phase 3 ROMAN trials, necessitating an additional trial for NDA resubmission.
Following a Type A meeting with the FDA in September 2023, Galera received official minutes reiterating the requirement for an additional Phase 3 trial. However, conducting another trial is not feasible with current resources, prompting the exploration of strategic alternatives.
In terms of financial highlights, Galera reported a net loss of $(15.1) million, or $(0.33) per share, for the third quarter of 2023. This compares to a net loss of $(16.0) million, or $(0.60) per share, for the same period in 2022.
Research and development expenses were $6.1 million in the third quarter of 2023, down from $8.1 million for the same period in 2022. General and administrative expenses were slightly up at $5.0 million in the third quarter of 2023, compared to $4.9 million for the same period in 2022.
The company also implemented a workforce reduction of 70% in August 2023 and engaged Stifel, Nicolaus & Company, Inc. to review strategic alternatives for the company and its portfolio of dismutase mimetics. These alternatives may include mergers, asset sales, divestiture, licensing arrangements, or other strategic transactions.
As of September 30, 2023, Galera’s cash, cash equivalents, and short-term investments stood at $28.4 million. The company expects that this will fund its operating expenses and capital expenditure requirements into 2025, taking into account the discontinuation of the GRECO-1 and GRECO-2 trials.
Additional details can be found on the official Galera Therapeutics website.
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