On March 8, 2023 Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, reported financial results for the fourth quarter and year ended December 31, 2022 and provided recent corporate updates (Press release, Galera Therapeutics, MAR 8, 2023, View Source [SID1234628302]).
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"2023 is a pivotal year for Galera, as we received Priority Review designation for our NDA for avasopasem, and we look forward to continuing productive discussions with the FDA over the coming months," said Mel Sorensen, M.D., Galera’s President and CEO. "Avasopasem has the potential to be the first FDA-approved drug to reduce SOM, a debilitating radiotherapy-induced toxicity, in head and neck cancer patients undergoing standard-of-care treatment. Each year approximately 43,500 U.S. patients with HNC are at high risk of developing SOM as a result of their cancer treatment. Following our recent financing, we believe that we are well-equipped to build out our operations and expand our commercial leadership team in preparation for potential approval of avasopasem in the second half of the year."
Recent Corporate Updates
Radiotherapy-Induced Toxicity Programs:
Severe Oral Mucositis (SOM)
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In December 2022, the Company submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for avasopasem manganese (avasopasem) for radiotherapy-induced SOM in patients with head and neck cancer (HNC) undergoing standard-of-care treatment. There are currently no FDA-approved drugs to reduce SOM for these patients.
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On February 15, 2023, the Company announced that the FDA accepted for filing and granted priority review to the NDA for avasopasem. With Priority Review designation, the Prescription Drug User Fee Act (PDUFA) target date assigned by the FDA for the NDA is August 9, 2023. The FDA indicated in its acceptance of filing letter that it is not planning to hold an advisory committee meeting on the application.
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Data from the Phase 3 ROMAN trial is scheduled to be presented by Dr. Carryn Anderson, MD, Clinical Associate Professor of Radiation Oncology at the University of Iowa, at the European
Congress on Head and Neck Oncology (ECHNO), taking place March 8-11, 2023, in Lisbon, Portugal. The presentation will include a generalized pairwise comparisons (GPC) analysis, a statistical method to assess the net treatment benefit of avasopasem compared to placebo.
Esophagitis
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In May 2022, the Company announced topline results from the open-label, single-arm Phase 2a AESOP trial evaluating avasopasem for its potential to reduce the incidence of radiotherapy-induced esophagitis in patients with lung cancer. The results demonstrated that avasopasem was generally well tolerated and substantially reduced the incidence of severe esophagitis in patients with lung cancer receiving chemoradiotherapy compared to expectations based on review of historical data in the literature. Based on these data, Galera intends to pursue a strategy for avasopasem, if approved for the reduction of SOM, to support the use of avasopasem to reduce radiotherapy-induced esophagitis in patients with lung cancer as a medically accepted indication in published drug compendia.
Anti-Cancer Programs:
Locally Advanced Pancreatic Cancer (LAPC)
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Enrollment is ongoing in the randomized, placebo-controlled Phase 2b GRECO-2 trial of rucosopasem in combination with stereotactic body radiation therapy (SBRT) in patients with LAPC. The primary endpoint of the trial is overall survival. The Company continues to anticipate completion of enrollment in the second half of 2023.
Non-Small Cell Lung Cancer (NSCLC)
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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. The Company continues to anticipate completion of enrollment in the second half of 2023.
General Corporate Updates
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On February 17, 2023, the Company completed a registered direct offering, which resulted in the issuance and sale of 14,320,000 shares of common stock and warrants to purchase up to 14,320,000 shares of common stock at a combined offering price of $2.095 per share and accompanying warrant, generating gross proceeds of $30 million. The warrants have an exercise price of $1.97 per share of common stock, are exercisable immediately following their issuance and will expire five years from the date of issuance. The Company received net proceeds of approximately $27.7 million from this offering, after deducting placement agent fees and offering expenses.
Fourth Quarter 2022 Financial Highlights
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Research and development expenses were $8.1 million in the fourth quarter of 2022, compared to $9.2 million for the same period in 2021. The decrease was primarily attributable to a decrease in avasopasem development costs, partially offset by an increase in rucosopasem development costs.
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General and administrative expenses were $5.0 million in the fourth quarter of 2022, compared to $5.3 million for the same period in 2021. The decrease was primarily attributable to the timing of spend for avasopasem commercial preparations.
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Galera reported a net loss of $(16.2) million, or $(0.58) per share, for the fourth quarter of 2022, compared to a net loss of $(16.8) million, or $(0.64) per share, for the same period in 2021.
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As of December 31, 2022, Galera had cash, cash equivalents and short-term investments of $31.6 million. Galera expects that its existing cash, cash equivalents and short-term investments, together with the net proceeds from its February 2023 registered direct offering, will enable Galera to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2023.
Full Year 2022 Financial Highlights
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Research and development expenses were $31.0 million for the year ended December 31, 2022, compared to $52.4 million for the year ended December 31, 2021. The decrease was primarily attributable to a decrease in avasopasem development costs and decreased manufacturing expenses, partially offset by an increase in rucosopasem development costs.
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General and administrative expenses were $20.2 million for the year ended December 31, 2022, compared to $21.0 million for the year ended December 31, 2021. The decrease was primarily attributable to the timing of spend for avasopasem commercial preparations.
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Galera reported a net loss of $(62.2) million, or $(2.30) per share, for the year ended December 31, 2022, compared to a net loss of $(80.5) million, or $(3.12) per share, for the year ended December 31, 2021.