On August 9, 2022 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 second quarter ended June 30, 2022 and provided recent corporate updates (Press release, Galera Therapeutics, AUG 9, 2022, View Source [SID1234617874]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"During this past quarter, we made substantial progress in advancing our product candidates, avasopasem and rucosopasem, across all programs," said Mel Sorensen, M.D., Galera’s President and CEO. "We continue to prepare for submission of an NDA for avasopasem for the treatment of radiotherapy-induced SOM and are on track to submit it by the end of the year. Further, data from our Phase 3 ROMAN trial were presented at multiple prestigious medical conferences, including ASCO (Free ASCO Whitepaper), underscoring the significant unmet need for an FDA-approved treatment option for radiotherapy-induced SOM in patients with head and neck cancer. In addition, we recently announced data from the open-label Phase 1 stage of GRECO-1 investigating rucosopasem in combination with SBRT in patients with NSCLC and are pleased to report that rucosopasem seems to exhibit a favorable benefit-risk profile, with in-field partial responses or stable disease seen in six of the seven patients at six months follow-up."

Recent Corporate Updates

Radiotherapy-Induced Toxicity Programs:

Severe Oral Mucositis (SOM)

The Company remains on track to submit a New Drug Application (NDA) for avasopasem for the treatment of radiotherapy-induced SOM to the U.S. Food and Drug Administration (FDA) by the end of 2022.

An oral presentation on Phase 3 ROMAN data of avasopasem for SOM was given at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting. Avasopasem produced a clinically meaningful reduction in patients’ SOM burden across multiple endpoints, with statistically significant reductions on the primary endpoint of incidence of SOM and the secondary endpoint of number of days of SOM, more than halving the median number of days a patient suffered SOM. Avasopasem also appeared to be well tolerated compared to placebo.

Data from the Phase 3 ROMAN trial of avasopasem for SOM was presented at the Multinational Association of Supportive Care in Cancer (MASCC)/International Society for Oral Oncology (ISOO) Annual Meeting in June 2022.
Esophagitis

The Company reported positive topline data from the open-label, single-arm Phase 2a AESOP trial of avasopasem for the treatment of severe acute radiation-induced esophagitis in patients with lung cancer receiving concurrent chemoradiotherapy. Overall, avasopasem was well tolerated and the incidence of Grade 3 esophagitis was substantially reduced in comparison to expectations based on review of historical data in the literature. No patients experienced Grade 4 or 5 esophagitis at any point during the trial.
Anti-Cancer Programs:

Locally Advanced Pancreatic Cancer (LAPC)

A Trials in Progress poster on the Phase 2b GRECO-2 trial was presented at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting.

Enrollment is ongoing in the 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 is expected in the second half of 2023.
Non-Small Cell Lung Cancer (NSCLC)

The Company recently reported results from the open-label, seven-patient Phase 1 stage of the GRECO-1 trial of rucosopasem in combination with SBRT in patients with NSCLC. Through six months follow-up, in-field partial responses were observed in three patients and stable disease was observed in three others based on RECIST criteria. These include target tumor reductions in five patients of 61%, 58%, 33%, 29% and 27% and one patient with an 8% increase. Preservation of pulmonary lung function was also observed in comparison to expectations based on review of historical data in the literature. Completion of enrollment in the randomized, placebo-controlled Phase 2 stage of this trial is expected in the second half of 2023.
Second Quarter 2022 Financial Highlights

Research and development expenses were $6.7 million in the second quarter of 2022, compared to $16.0 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.

General and administrative expenses were $5.3 million in the second quarter of 2022, broadly consistent with the second quarter of 2021.

Galera reported a net loss of $(14.6) million, or $(0.54) per share, for the second quarter of 2022, compared to a net loss of $(22.4) million, or $(0.88) per share, for the same period in 2021.

As of June 30, 2022, Galera had cash, cash equivalents and short-term investments of $52.0 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 for at least the next twelve months.