 Completed Enrollment of Randomized, Blinded, Placebo-controlled Trial of GC4419 in Combination with Radiotherapy in Locally Advanced Pancreatic Cancer; Topline Data Readout Expected in 2H20 Phase 3 ROMAN Trial Remains on Track for Completion of Enrollment in 1H21MALVERN, Pa., Aug. 10, 2020 GLOBE NEWSWIRE -- 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, today 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 1b2a 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 1b2a 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 1b2a 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.About Galera TherapeuticsGalera 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. Galeras lead product candidate is avasopasem manganese GC4419, a highly selective small molecule superoxide dismutase SOD mimetic initially being developed for the reduction of radiation-induced severe oral mucositis SOM. Avasopasem is being studied in the Phase 3 ROMAN trial for its ability to reduce the incidence and severity of SOM induced by radiotherapy in patients with locally advanced head and neck cancer HNC, its lead indication. It is also being studied in a Phase 2a multi-center trial in Europe assessing the safety of avasopasem in patients with HNC undergoing standard-of-care radiotherapy, a Phase 2a trial for its ability to reduce the incidence of esophagitis induced by radiotherapy in patients with lung cancer and in a randomized Phase 12 trial in combination with stereotactic body radiation therapy SBRT in patients with locally advanced pancreatic cancer. The FDA granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of SOM induced by radiotherapy. Galera is developing a second product candidate, GC4711, specifically for use in combination with SBRT, which successfully completed Phase 1 trials in healthy volunteers. Galera is headquartered in Malvern, PA. For more information, please visit StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding expectations surrounding our growth and the continued advancement of our product pipeline, the potential, efficacy, and regulatory and clinical development of Galeras product candidates, plans and timing for the commencement of and the release of data from Galeras clinical trials, expected payments from Blackstone, and the sufficiency of Galeras cash, cash equivalents and short-term investments. These forward-looking statements are based on managements current expectations. 