MALVERN, PA — Galera Therapeutics, Inc. (Nasdaq: GRTX) announced financial results for the second quarter ended June 30, 2020, and provided business updates.
“During the second quarter, we continued to advance the development of our small molecule superoxide dismutase mimetics in clinical trials evaluating their ability to address radiation toxicities and augment the anti-cancer efficacy of radiation,” said Mel Sorensen, M.D., President and CEO of Galera.
“We were pleased to announce the completion of enrollment in our randomized, blinded, placebo-controlled, adaptive Phase 1b/2a trial of avasopasem manganese (GC4419) in combination with stereotactic body radiation therapy (SBRT) for patients with locally advanced pancreatic cancer (LAPC).
“We expect to report topline data from that trial as well as initiate a Phase 1b/2a trial of GC4711 with SBRT in non-small cell lung cancer in the second half of this year. We also remain on track to complete enrollment of the Phase 3 ROMAN trial of avasopasem in the first half of next year and to report topline data from the ROMAN trial in the second half of 2021.”
Second Quarter 2020 and Recent Corporate Highlights
- In July, announced the completion of patient enrollment in the randomized, blinded, placebo-controlled, adaptive Phase 1b/2a clinical trial of avasopasem in combination with SBRT in patients with LAPC. Topline data from this trial are expected in the second half of this year.
- In June, dosed the first patient in a Phase 2a multi-center trial in Europe assessing the safety of avasopasem in patients with head and neck cancer (HNC) undergoing standard-of-care radiotherapy.
- Continued enrollment in the Phase 2a clinical trial of avasopasem to evaluate its ability to reduce the incidence of radiation-induced esophagitis in patients with lung cancer.
- In May, presented new data at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program, which demonstrated statistically significant reductions by avasopasem on markers of chronic kidney disease due to concurrent cisplatin chemoradiation in a retrospective analysis of the completed Phase 2b trial for the reduction of severe oral mucositis in patients with HNC. As a result, the assessment of these markers has been incorporated into the ROMAN Phase 3 trial.
- In May, entered into an amendment to the royalty purchase agreement with Blackstone Life Sciences (Blackstone), which adds $37.5 million in additional funding to the existing $80 million royalty financing commitment that Blackstone (formerly Clarus Ventures) made in 2018. Under the updated agreement terms, Galera agreed to pay Blackstone up to a high single-digit percentage of future commercial royalties from the sales of avasopasem and GC4711 until the total royalty amount achieves an unchanged fixed single-digit multiple of the aggregate financing sum received, upon which the royalty terminates. As partial consideration for the amendment, Galera issued two warrants to Blackstone to purchase an aggregate of 550,661 shares of its common stock at an exercise price of $13.62 per share, each of which will become exercisable upon the receipt by Galera of the applicable specified milestone payment.
- In April, announced the appointment of Linda B. West to its Board of Directors. Ms. West most recently served as Vice President for DuPont Corporate Planning & Analyses, where she led the execution of transformational transactions.
Second Quarter 2020 Financial Highlights
- Research and development expenses were $13.8 million in the second quarter of 2020, compared to $9.5 million for the same period in 2019. The increase was primarily attributable to avasopasem development costs due to increased expenses in the Phase 3 ROMAN trial, additional clinical trials including the Phase 2a trial for the treatment of esophagitis in patients with lung cancer and the Phase 2a multi-center trial in Europe assessing the safety of avasopasem in patients with HNC, and costs associated with manufacturing scale-up activities. Employee-related costs also increased due to increased headcount and share-based compensation expense.
- General and administrative expenses were $3.9 million in the second quarter of 2020, compared to $1.8 million for the same period in 2019. The increase was primarily the result of employee-related costs from increased headcount and share-based compensation expense, and increased insurance, professional fees and other operating costs as a result of becoming a public company.
- Galera reported a net loss of $(18.7) million, or $(0.75) per share, for the second quarter of 2020, compared to a net loss of $(11.6) million, or $(45.30) per share, for the same period in 2019.
- As of June 30, 2020, Galera had cash, cash equivalents and short-term investments of $104.4 million. Galera expects that its existing cash, cash equivalents and short-term investments, together with the expected payments from Blackstone in the amount of $57.5 million upon the achievement of certain clinical enrollment milestones in the ROMAN trial and the anti-cancer program in combination with SBRT under the amended royalty agreement, will enable Galera to fund its operating expenses and capital expenditure requirements into the second half of 2022.
Galera Therapeutics, Inc. is 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.
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