On November 10, 2021 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 third quarter ended September 30, 2021 and provided recent corporate updates (Press release, Galera Therapeutics, NOV 10, 2021, View Source [SID1234595118]).
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"We are well-positioned financially to continue advancing our dismutase mimetic candidate rucosopasem (GC4711) in combination with stereotactic body radiation therapy (SBRT) in our randomized Phase 2 GRECO trials, with the goal of increasing the anti-cancer effectiveness of SBRT in patients with lung and pancreatic cancer," said Mel Sorensen, M.D., Galera’s President and CEO. "We have already observed improved tumor outcomes and survival when combining one of our dismutase mimetics with SBRT in our randomized, placebo-controlled, proof-of-concept trial in patients with locally advanced pancreatic cancer, reported in September. We look forward to reporting initial data evaluating rucosopasem in lung cancer in the first half of next year."
Dr. Sorensen continued: "Following the recent announcement of topline results of the Phase 3 ROMAN trial, we are continuing to analyze the data and evaluating next steps for avasopasem. While ROMAN did not achieve statistical significance in the primary endpoint of reducing SOM incidence, avasopasem was generally well tolerated and more than halved the number of days patients experienced this severe side effect resulting from radiation therapy."
Recent Corporate Updates
Anti-Cancer Programs:
Locally Advanced Pancreatic Cancer (LAPC)
The Company reported final data from the Phase 1/2 pilot trial of avasopasem in combination with SBRT in patients with unresectable or borderline resectable LAPC. In this proof-of-concept trial, relative improvements were observed in overall survival, progression-free survival, local tumor control and time to distant metastases. 46% of patients in the active arm were alive at last follow-up (11 out of 24) compared to 33% in the placebo arm (6 out of 18).
Enrollment is ongoing in the Phase 2b, 160-patient randomized, multicenter, placebo-controlled GRECO-2 trial of rucosopasem, Galera’s second dismutase mimetic product candidate, in combination with SBRT in patients with LAPC. The primary endpoint of the trial is overall survival.
Non-Small Cell Lung Cancer (NSCLC)
Enrollment is ongoing in the Phase 1/2 GRECO-1 trial of rucosopasem in combination with SBRT in patients with NSCLC. The Company expects to report initial data from this trial in the first half of 2022.
Radiotherapy-Induced Toxicity Programs:
Severe Oral Mucositis (SOM)
The Company reported topline data from the Phase 3 ROMAN trial of avasopasem for the reduction of SOM in patients with locally advanced head and neck cancer (HNC) undergoing standard-of-care radiotherapy. The Company announced that the trial did not meet its primary endpoint of reduction in the incidence of SOM. Consistent with the Phase 2b trial, the data showed relative reduction across all key SOM endpoints, including more than halving the median duration of SOM.
The Company expects to report topline data from the Phase 2a EUSOM multicenter trial of avasopasem in Europe in patients with HNC undergoing standard-of-care radiotherapy in the fourth quarter of 2021.
Esophagitis
Enrollment is ongoing in the Phase 2a AESOP trial of avasopasem evaluating its ability to reduce the incidence of esophagitis induced by radiotherapy in patients with lung cancer. The Company expects to report topline data in the first half of 2022.
Third Quarter 2021 Financial Highlights
Research and development expenses were $14.8 million in the third quarter of 2021, compared to $12.1 million for the same period in 2020. The increase was primarily attributable to rucosopasem development costs and an increase in contractor and consultant expense associated with the avasopasem SOM program.
General and administrative expenses were $5.5 million in the third quarter of 2021, compared to $3.9 million for the same period in 2020. The increase was primarily attributable to employee-related costs from increased headcount and share-based compensation expense, increased expenses related to preparation for potential commercialization of avasopasem, and increased insurance expense and professional fees.
Galera reported a net loss of $(22.6) million, or $(0.86) per share, for the third quarter of 2021, compared to a net loss of $(17.1) million, or $(0.69) per share, for the same period in 2020.
As of September 30, 2021, Galera had cash, cash equivalents and short-term investments of $88.7 million. Galera expects that its existing cash, cash equivalents and short-term investments will enable Galera to fund its operating expenses and capital expenditure requirements into 2023, assuming limited future development and commercial activities for avasopasem during this period. These assumptions may change as a result of many factors currently unknown to the Company, including without limitation the results of further analyses of data from the ROMAN trial and potential next steps for the Company’s radiotherapy-induced toxicity programs.