Galera Therapeutics Reports Statistically Significant Results in a 223-Patient Phase 2b Trial of GC4419 for Severe Oral Mucositis in Patients with Head and Neck Cancer

• Achieved primary endpoint against placebo (p=0.024) demonstrating a statistically significant and clinically meaningful reduction of 92 percent in the duration of severe oral mucositis (SOM)

Secondary Endpoints Consistent with Primary Endpoint

• GC4419 reduced the incidence of SOM through completion of radiotherapy by 34 percent (p=0.009)

• GC4419 also achieved a 36 percent reduction in the overall incidence of SOM through 60 Gy of radiation (p=0.010)

• GC4419 reduced the incidence of debilitating Grade 4 oral mucositis (OM) by 47 percent (p=0.045)

MALVERN, PA, December 18, 2017 (GLOBE NEWSWIRE) — Galera Therapeutics, Inc. today reported positive results from its Phase 2b clinical trial for its lead drug candidate, GC4419 for severe oral mucositis (SOM) in patients with head and neck cancer receiving chemoradiation. In the intent-to-treat population, the 90 milligram (mg) dose of GC4419 met its primary … Continued

Galera Therapeutics Announces Promising Innovative Medicines Designation from the United Kingdom’s Medicines and Healthcare Products Regulatory Agency for GC4419 for the Reduction of Oral Mucositis in Head and Neck Cancer Patients

MALVERN, PA, July 31, 2017 — Galera Therapeutics, Inc., a clinical stage biotechnology company announced today that GC4419 has received a Promising Innovative Medicines (PIM) designation in the United Kingdom (UK) by the Medicines and Healthcare Products Regulatory Agency (MHRA) for the reduction of the duration or incidence of radiation and chemotherapy induced severe oral … Continued

Galera Therapeutics Completes Enrollment in Phase 2b Clinical Trial with Lead Compound GC4419 for Treatment of Oral Mucositis

Company expects to report topline results in 4Q 2017

MALVERN, PA, June 15, 2017 — Galera Therapeutics, Inc. announced today that it has completed enrollment in its phase 2b clinical trial evaluating the efficacy, safety and tolerability of GC4419 as a treatment for reducing the incidence and duration of oral mucositis (OM) in head and neck cancer patients receiving chemoradiation therapy. GC4419 is a … Continued

Galera Therapeutics Expands Series B to $57 Million

Sofinnova Ventures joins existing lead investors NEA, Novartis Venture Fund and Novo Ventures

MALVERN, PENNSYLVANIA – November 28, 2016– Galera Therapeutics, Inc., a clinical-stage biotechnology company developing transformational new treatments for cancer patients, announced today it has received $15 million in funding from new investor Sofinnova Ventures, bringing its Series B financing total to $57 million. Sofinnova joins existing investors New Enterprise Associates, Novartis Venture Fund, Novo Ventures, … Continued

Galera Therapeutics Announces Presentation of One-year Follow-up Data From a Phase 1b/2a Study of GC4419 in the Reduction of Severe Oral Mucositis

Data Presented at the American Society of Radiation Oncology Annual Meeting

MALVERN, PA – September 27, 2016 – Galera Therapeutics, Inc., a clinical-stage biotechnology company developing new treatments for cancer patients, today announced the presentation of final data, including one-year tumor control, from a Phase 1b/2a clinical trial of GC4419, an investigational drug candidate for the reduction of severe chemoradiation-induced oral mucositis (OM), in an oral … Continued

Galera Therapeutics Announces Presentation at ASCO of Positive Results From Study of GC4419 for the Reduction of Severe Oral Mucositis

MALVERN, PA – June 6, 2016 – Galera Therapeutics, Inc., a clinical-stage biotechnology company developing new treatments for cancer patients, today announced the presentation of data from a Phase 1b/2a clinical trial of GC4419, an investigational drug candidate for the reduction of chemoradiotherapy-induced oral mucositis (OM), at the American Society of Clinical Oncology (ASCO) Annual … Continued

Galera Therapeutics Increases Series B Financing to $42 Million

Funding to Support Development of Clinical Stage Dismutase Mimetics in the Treatment of Cancer Patients

MALVERN, PA – February 3, 2016 – Galera Therapeutics, Inc., a clinical-stage biotech developing new treatments for cancer patients, announced today it has received an additional $5 million in funding from Enso Ventures to bring its Series B financing total to $42 million. Enso Ventures joins existing investors New Enterprise Associates, Novartis Venture Fund, Novo … Continued

Galera Therapeutics Announces Fast Track Designation of GC4419 for Prevention of Oral Mucositis

Enrolls First Patients in Late-Stage Trial of GC4419 in Head and Neck Cancer Patients

MALVERN, PA – January 7, 2016 – Galera Therapeutics, Inc., today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for GC4419, an investigational drug candidate, for the reduction of severity and incidence of radiation and chemotherapy induced oral mucositis (OM). Galera also announced today that it has begun enrolling … Continued

Galera Therapeutics Raises $37 Million in Series B Financing

Funding to Support Development of Clinical Stage Dismutase Mimetics in the Treatment of Cancer Patients

MALVERN, PA – October 14, 2015 – Galera Therapeutics, Inc., a clinical-stage biotech developing new treatments for cancer patients, announced today it has completed a $37 million Series B financing. The proceeds of the financing will be used to advance the development of Galera’s selective dismutase mimetics, including progressing lead candidate GC4419 into a Phase … Continued

Galera Therapeutics Raises $11 Million in Series A Financing

Funding to Support Clinical Development of Therapeutics for Fibrosis and Cancer
Galera Names Mel Sorensen, M.D. New President and CEO; Robert Beardsley, Ph.D., Executive Chair

MALVERN, Pa. and ST. LOUIS , Mo.– December 11, 2012 – Galera Therapeutics, Inc., a biotechnology company focused on the development of breakthrough drugs targeting oxygen metabolic pathways in cancer, fibrosis and other human diseases, today announced an $11 million Series A venture capital financing. The round is co-led by New Enterprise Associates (NEA) and … Continued