Galera Therapeutics, Inc. · OTC:GRTX
Galera Therapeutics — Technical Presentation (December 2021)
18 slides from Galera Therapeutics's technical presentation, Dec 14, 2021
Slide 1: ROMAN Phase 3 Trial Update
ROMAN Phase 3 Trial Update December 14, 2021 Exhibit 99.2
Slide 2: Forward-Looking Statements
Forward-Looking Statements @2021 Galera Therapeutics, Inc. Certain information contained in this presentation and statements made orally during this presentation relates to or is based on studies, publications, surveys and other data obtained from third-party sources and Galera’s own internal estima
Slide 3: Executive Summary
Executive Summary @2021 Galera Therapeutics, Inc. Corrected ROMAN Phase 3 topline results: achieved statistical significance on primary endpoint Corrected topline Phase 3 ROMAN data demonstrate primary endpoint achieved statistical significance in reducing the incidence of severe oral mucositis (p=0
Slide 4: Head and Neck Cancer – Large Market Opportunity
Head and Neck Cancer – Large Market Opportunity @2021 Galera Therapeutics, Inc. 650,000 Global Head & Neck Cancer Incidence 65,630 42,000 US Patients Diagnosed each year US Patients at Risk for RT-related SOM Initial Target Population Severe Oral Mucositis is most burdensome side effect – 70% get SO
Slide 5: Severe Oral Mucositis in Head & Neck Cancer
Severe Severe Oral Mucositis in Head & Neck Cancer @2021 Galera Therapeutics, Inc. The most burdensome toxicity of standard-of-care chemoradiotherapy (radiotherapy & cisplatin)2 70% Patients Get SOM (Grade 3 or 4 OM) WHO Grading System Current Approaches Lack Efficacy Physicians Consider Topicals In
Slide 6: Avasopasem: First-to-Market Potential for Severe Oral Mucositis
Avasopasem: First-to-Market Potential for Severe Oral Mucositis @2021 Galera Therapeutics, Inc. Achieved statistical significance in two randomized trials in patients with head and neck cancer Avasopasem Prevents RT Injury Patients get avasopasem before each RT dose Breakthrough Therapy Designation
Slide 7: Similarities Comparison of Galera's Phase 2b & Phase 3 Trials
Similarities ROMAN Phase 3 Comparison of Galera’s Rand. Phase 2b & ROMAN Phase 3 @2021 Galera Therapeutics, Inc. Two Double-blinded Placebo-controlled Randomized Trials Rand. Phase 2b N=223 Placebo x 7 weeks R Avasopasem 90mg x 7 weeks Avasopasem 30mg x 7 weeks N=455 Placebo x 7 weeks Avasopasem 90m
Slide 8: Results from Randomized Phase 2b (n=223)
Incidence Duration Severity Results from Rand. Phase 2b (n=223) @2021 Galera Therapeutics, Inc. Consistent and encouraging results across SOM endpoints – ITT Population p=0.024* p=0.009 p=0.045 34% 92% 47% Reduction in SOM incidence Reduction in median days of SOM Reduction in incidence of Grade 4 O
Slide 9: Randomized Phase 2b: Most Frequent Adverse Events
Randomized Phase 2b: Most Frequent Adverse Events @2021 Galera Therapeutics, Inc. Avasopasem 90mg appears generally well-tolerated Adverse Events1,2 (all grades & causes) Adverse Events1,2 ≥ Grade 3 1Intent-to-Treat (ITT) population: 73 patients on placebo; 72 patients on 90mg avasopasem 2Anderson C
Slide 10: Results from ROMAN Phase 3 (n=455)
Results from ROMAN Phase 3 (n=455) @2021 Galera Therapeutics, Inc. Reductions across SOM endpoints; statistical significance on the primary & SOM duration secondary endpoint SOM Incidence SOM Duration Grade 4 OM 16% 56% 27% Reduction in SOM incidence Reduction in median days of SOM Reduction in inci
Slide 11: Avasopasem also appears to delay the onset of SOM
Avasopasem also appears to delay the onset of SOM @2021 Galera Therapeutics, Inc. Time to onset of SOM was an exploratory endpoint Onset of SOM Placebo Avasopasem 25% Delay in median days to 1st SOM p=0.002
Slide 12: Incidence Reduced at All Landmarks of Radiation Therapy
Incidence Reduced at All Landmarks of Radiation Therapy @2021 Galera Therapeutics, Inc. Both before and after primary endpoint at end of IMRT – all patients Relative Reduction 46% 45% 39% 28% 16% 18% P value p=0.030 p=0.001 p<0.001 p=0.002 p=0.045 p=0.012 ITT population Primary Endpoint
Slide 13: Greater Reductions with Full Treatment
Greater Reductions with Full Treatment @2021 Galera Therapeutics, Inc. Patients with full courses of IMRT & avasopasem demonstrated a greater relative reduction in SOM incidence 46% 32% 20% 21% p<0.0001 p=0.001 p=0.016 p=0.005 Relative Reduction 39% 28% 16% 18% P value p<0.001 p=0.002 p=0.045 p=0.01
Slide 14: ROMAN: Most Frequent Adverse Events
ROMAN Phase 3: Most Frequent Adverse Events @2021 Galera Therapeutics, Inc. Avasopasem 90mg appears generally well-tolerated, consistent with Phase 2b Adverse Events1 (all grades, all causes) Adverse Events1 ≥Grade 3 1ITT population: 166 patients on placebo; 241 on 90mg avasopasem
Slide 15: European Safety Trial (EUSOM) – Similar results to ROMAN P3
European Safety Trial (EUSOM) – Similar results to ROMAN P3 @2021 Galera Therapeutics, Inc. Safety was primary endpoint; efficacy was secondary (n=38) Head & Neck Cancer 7 weeks of IMRT and cisplatin 35 doses of avasopasem 41% oral cavity (vs. 16% in P3) 54% oropharyngeal (vs. 80% in P3) 81% male, M
Slide 16: Key Conclusions: Data
Key Conclusions: ROMAN Phase 3 Data @2021 Galera Therapeutics, Inc. Achieved statistical significance on primary endpoint of reduction in SOM incidence (p=0.045) Achieved statistical significance (p=0.002) on secondary endpoint of SOM duration – 56% relative reduction Greater reductions in SOM incid
Slide 17: Executive Summary
Executive Summary @2021 Galera Therapeutics, Inc. Corrected ROMAN Phase 3 topline results: achieved statistical significance on primary endpoint Corrected topline Phase 3 ROMAN data demonstrate primary endpoint achieved statistical significance in reducing the incidence of severe oral mucositis (p=0
Slide 18: Q&A
Q&A [Galera
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