On November 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 third quarter ended September 30, 2022 and provided recent corporate updates (Press release, Galera Therapeutics, NOV 9, 2022, View Source [SID1234623570]).

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"During the quarter, we added to the package of data supporting our planned avasopasem New Drug Application in radiotherapy-induced severe oral mucositis, which we are on track to submit by the end of the year," said Mel Sorensen, M.D., Galera’s President and CEO. "We presented long-term follow-up data from ROMAN at ASTRO, the major annual radiation oncology conference, affirming what we saw in GT-201, specifically that avasopasem reduced severe oral mucositis while maintaining the clinical benefit of radiation therapy. Moreover, patients were also evaluated for renal function during the one-year follow-up period, and the data showed a 50% reduction in chronic kidney disease, a known cisplatin-related superoxide toxicity."

Dr. Sorensen continued: "Our market research continues to indicate that radiation and medical oncologists treating head and neck cancer view the avasopasem profile favorably and that the majority would prescribe avasopasem if approved by the FDA. The research also indicates that physicians view SOM — the most burdensome side effect of radiation therapy for head and neck cancer — as something best characterized by several key measures. These include not only whether a patient develops SOM, but also how long they suffer from it, when it first develops and whether it worsens into the most severe grade, Grade 4 OM. The meta-analysis of the already positive results from both the ROMAN and GT-201 trials underscores that avasopasem improves SOM across these measures."

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 manganese 90 mg for radiotherapy-induced SOM to the U.S. Food and Drug Administration (FDA) by the end of 2022.

Long-term follow-up data from the ROMAN trial was presented in an oral presentation at the 2022 American Society for Radiation Oncology (ASTRO) Annual Meeting. After one-year follow-up on ROMAN, patients receiving avasopasem in combination with the standard-of-care regimen demonstrated comparable tumor outcomes and overall survival to patients in the placebo arm, showing that avasopasem protected patients with head and neck cancer from SOM without affecting the treatment benefit of standard-of-care chemoradiotherapy.

In a prospectively defined component of the ROMAN long-term follow-up data, also presented at ASTRO, patients treated with avasopasem in combination with radiotherapy and cisplatin had a 10% incidence of chronic kidney disease (CKD) after one year of post treatment follow-up, half the 20% rate in the placebo arm (p=0.0043). This exploratory endpoint was based on mechanism-driven non-clinical studies and a retrospective analysis of GT-201 and suggests avasopasem may offer a further benefit for these patients.

Additionally, a meta-analysis of Galera’s two randomized placebo-controlled trials (ROMAN and GT-201; n=551) was included in the ASTRO presentation, and showed clinically meaningful reductions in the incidence, duration, onset and severity of SOM compared to placebo across both trials.

A poster presentation during ASTRO highlighted the completed Phase 2 EUSOM trial of avasopasem for radiotherapy-induced SOM in Europe.
Esophagitis

Final data from the open-label, single-arm Phase 2 AESOP trial of avasopasem for severe acute radiotherapy-induced esophagitis in patients with lung cancer receiving concurrent chemoradiotherapy were presented at ASTRO. The Company previously reported positive topline data from the trial demonstrating that 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 AESOP trial.
Anti-Cancer Programs:

Locally Advanced Pancreatic Cancer (LAPC)

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

A poster presentation at ASTRO highlighted the ongoing randomized, placebo-controlled Phase 2 stage of the GRECO-1 trial of rucosopasem in combination with SBRT in patients with NSCLC. Completion of enrollment in the Phase 2 stage of this trial is expected in the second half of 2023.
General Corporate Updates:

The Company appointed Eugene P. Kennedy, M.D., F.A.C.S., as Chief Medical Officer. Dr. Kennedy is a renowned Johns Hopkins-trained surgical oncologist and former Chief of Pancreatic and Hepatobiliary Surgery at Thomas Jefferson University with over 15 years’ experience in clinical development and biopharma leadership. He will succeed Jon T. Holmlund, M.D., who plans to retire at the end of this year following the planned submission of the Company’s NDA for avasopasem to the FDA.
Third Quarter 2022 Financial Highlights

Research and development expenses were $8.1 million in the third quarter of 2022, compared to $14.8 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 $4.9 million in the third quarter of 2022, compared to $5.5 million for the same period in 2021. The decrease was primarily attributable to the timing of spend for avasopasem commercial preparations.
Galera reported a net loss of ($16.0) million, or $(0.60) per share, for the third quarter of 2022, compared to a net loss of $(22.6) million, or $(0.86) per share, for the same period in 2021.

As of September 30, 2022, Galera had cash, cash equivalents and short-term investments of $42.8 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 the second half of 2023.