Galera Therapeutics, Inc. · OTC:GRTX
Galera Therapeutics — Investor Presentation (October 2022)
48 slides from Galera Therapeutics's investor presentation, Oct 26, 2022
Slide 1: Transforming radiotherapy for patients with cancer
Exhibit 99.2 Transforming radiotherapy for patients with cancer October 2022
Slide 2: Forward-Looking Statements
Forward-Looking Statements 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 estimates and research. While Galera b
Slide 3: Radiation Therapy – Key Role in Cancer Treatment
Efficacy Radiation Therapy – Key Role in Cancer Treatment 1 1.9 million new cancers annually in US; over 50% of patients receive radiation therapy as part of their treatment SBRT IMRT Stereotactic Body Radiation Therapy Intensity Modulated Radiation Therapy Low doses for weeks High doses for days (~
Slide 4: Galera's Technology: Dismutase Mimetics
Efficacy Galera’s Technology: Dismutase Mimetics Mechanism of action is to convert RT-induced burst of Superoxide to Hydrogen Peroxide Rucosopasem (GC4711) Avasopasem (GC4419) Superoxide Shifts balance in normal & cancer cells (O ) is more 2 from superoxide to hydrogen peroxide damaging to normal ce
Slide 5: Transforming Radiotherapy
Transforming Radiotherapy Potential to improve both sides of the therapeutic index Avasopasem Rucosopasem Reducing IMRT Toxicity Increasing SBRT Efficacy Ø Severe Oral Mucositis in Head & Neck Cancer (HNC)Ø Locally Advanced Pancreatic Cancer (LAPC) Ø Esophagitis in Lung CancerØ Non-Small Cell Lung C
Slide 6: Clinical Stage Pipeline
Clinical Stage Pipeline Phase 1 Phase 2 Phase 3 Trial Status/Anticipated Milestones Radioprotection ROMAN: AVA vs. Placebo (n=455) NDA Submission by Y/E 2022 4 GT-201: AVA vs. Placebo (n=223) Completed & Published 1 Head & Neck Cancer (SOM) EUSOM: AVA (n=38) Completed in 2021 5 Ph 1b/2a AVA (n=43) C
Slide 7: Reducing IMRT Toxicity
Reducing IMRT Toxicity 7
Slide 8: Severe Oral Mucositis in Head & Neck Cancer
Severe Oral Mucositis in Head & Neck Cancer 1 The most burdensome toxicity of standard-of-care chemoradiotherapy (radiotherapy & cisplatin) 70% Patients Get SOM Current Approaches Physicians Consider (Grade 3 or 4 OM) Lack Efficacy Topicals Ineffective WHO Scale Criteria for MASCC Guidelines focus M
Slide 9: Avasopasem: First-to-Market Potential for Severe Oral Mucositis
Avasopasem: First-to-Market Potential for Severe Oral Mucositis Achieved statistical significance in two randomized trials in patients with head and neck cancer Phase 1 Phase 2 Phase 3 Trial Status/Anticipated Milestones Avasopasem Clinical Trials ROMAN: AVA vs. Placebo (n=455) NDA Submission by Y/E
Slide 10: Comparison of Galera's Two Placebo-Controlled Trials
Comparison of Galera’s Two Placebo-Controlled Trials Both GT-201 and ROMAN were double-blind placebo-controlled randomized trials GT-201 Phase 2b Similarities ROMAN Phase 3 N=223 N=455 • SoC IMRT + Cisplatin Avasopasem 90mg x 7 weeks Avasopasem 90mg x 7 weeks • 60-minute IV infusion Avasopasem 30mg
Slide 11: Most Frequent Adverse Events on the Two Randomized Trials
Most Frequent Adverse Events on the Two Randomized Trials Avasopasem 90mg appears generally well tolerated (all grades and causes) 1 2,3 ROMAN GT-201 0% 20% 40% 60% 80% 100% 0% 20% 40% 60% 80% 100% Lymphopenia Lymphopenia Nausea Nausea Fatigue Fatigue Oropharyngeal pain Oropharyngeal Pain Constipati
Slide 12: Most Frequent Grade 3+ AEs on the Two Randomized Trials
Most Frequent ≥ Grade 3 AEs on the Two Randomized Trials Avasopasem 90mg appears generally well tolerated 1 2,3 ROMAN GT-201 0% 20% 40% 60% 80% 100% 0% 20% 40% 60% 80% 100% Lymphopenia Lymphopenia Leukopenia Leukopenia Neutropenia Neutropenia Dysphagia Dysphagia Oropharyngeal pain Anemia Anaemia Dec
Slide 13: Multiple Efficacy Parameters Define the Patient Burden of SOM
Multiple Efficacy Parameters Define the Patient Burden of SOM Incidence doesn’t tell full story; real patient examples from ROMAN 1° endpoint 2° endpoints Exploratory OM evaluation 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 è 10 Gyè 20 Gyè 30 Gyè 40 Gyè 50 Gyè 60 Gyè65–70 Follow-up Cumulative RT SOM # D
Slide 14: ROMAN Results (ITT n=407)
ROMAN Results (ITT n=407) Reductions across SOM endpoints; statistical significance on the primary & median days SOM secondary endpoint SOM Incidence SOM Days Grade 4 OM Incidence SOM Onset Reduction Reduction Reduction Delay in in SOM in median in incidence of median days st 16% 56% 27% 29% inciden
Slide 15: Incidence Reduced at All Landmarks of Radiation Therapy
Incidence Reduced at All Landmarks of Radiation Therapy Both before and after primary endpoint at end of IMRT – all patients Primary Endpoint Relative Reduction 45% 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 80% 70% 71% 64% 60% 58% 58% 54% 50% 45% 40% 42% 30% 32% 28%
Slide 16: GT-201 Results (n=223)
GT-201 Results (n=223) Consistent and encouraging results across SOM endpoints – ITT Population SOM Incidence SOM Days Grade 4 OM Incidence SOM Onset Reduction Reduction Delay in Reduction in SOM in median in incidence of median days st 34% 92% 47% 56% incidence days of SOM Grade 4 OM to 1 SOM 30% 7
Slide 17: Combined Meta-analysis of the Two Randomized Trials (n=551)
Combined Meta-analysis of the Two Randomized Trials (n=551) Avasopasem SOM improvement consistent across trials and key parameters SOM Incidence SOM Days Grade 4 OM Incidence SOM Onset Reduction Reduction Delay in Reduction in SOM in median in incidence of median days st 19% 58% 32% 28% incidence da
Slide 18: Avasopasem Reduced Narcotic and Feeding Tube Usage
Avasopasem Reduced Narcotic and Feeding Tube Usage Reductions in SOM with avasopasem appeared to decrease utilization in ROMAN trial Narcotics Gastrostomy (Feeding) Tubes Reduction Reduction Reduction in Reduction in usage in usage for in placements overall 13% 13% 19% 21% after RT start OM pain aft
Slide 19: ROMAN Long-term Outcomes: Tumor Control & Survival
ROMAN Long-term Outcomes: Tumor Control & Survival 1 Overlapping 95% confidence intervals at 1 year; consistent with GT-201 tumor outcomes ROMAN Phase 3 – Tumor Outcomes at 1 Year 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 97% 95% 93% 88% 98% 94% 97% 96% 0% OS PFS LRC DMFS PBO (n=166) AVA (n=241) =95%
Slide 20: ROMAN Long-Term Outcomes: Cisplatin Renal Endpoints
ROMAN Long-Term Outcomes: Cisplatin Renal Endpoints 2 Avasopasem halved Chronic Kidney Disease (CKD) at 1 year; a predefined endpoint (CKD <60 mL/min/1.73m ) Previous Scientific Data CKD @ 1 Year on ROMAN Cisplatin Renal Gr. 3+ AEs AKI↓Mg↑Cr • Superoxide drives cisplatin Acute Kidney Injury hypomagn
Slide 21: Plan to Submit Avasopasem NDA by End of 2022
Plan to Submit Avasopasem NDA by End of 2022 • No FDA-approved treatments for radiotherapy-induced SOM • Avasopasem has Breakthrough Therapy and Fast Track Designations • Productive interactions with FDA • NDA will be based on statistically significant, clinically meaningful data from two placebo-co
Slide 22: SOM Market Opportunity
SOM Market Opportunity
Slide 23: Head and Neck Cancer – Large Market Opportunity
Head and Neck Cancer – Large Market Opportunity 1 Severe Oral Mucositis is >$1B total market opportunity in the US 650,000 Global Head & Neck Cancer Incidence Initial 65,630 Target US Patients Diagnosed each year Population 42,000 US Patients at Risk for RT-related SOM Locally advanced HNC is curabl
Slide 24: Concentrated Physician Population
Concentrated Physician Population SOM is most burdensome side effect of curative IMRT + cisplatin regimen 5,000 Radiation Oncologists in US Initial 2,500 Sales Radiotherapy Focus Treatment Sites 700 Top centers where >80% HNC patients are treated ©2022 Galera Therapeutics, Inc. 24
Slide 25: Most Centers Have Ability to Infuse Avasopasem Today
Most Centers Have Ability to Infuse Avasopasem Today 72% Radiotherapy Sites Have Existing Infusion Capability Adoption Archetype Determinants A B C D Rad Oncs Have Med Oncs Administer Rad Oncs Need to Rad Oncs Unlikely to Current Capabilities Infusions for Rad Onc Add Capabilities Add Capabilities T
Slide 26: Beyond Oral Mucositis: Other RT-Related Toxicities
Beyond Oral Mucositis: Other RT-Related Toxicities Physicians view SOM data as potentially applicable to other radiation-related toxicities 150 Rad Oncs were asked the following: Given the demonstrated ability of Product X to prevent radiation-induced toxicities in the oral mucosa, please indicate h
Slide 27: Esophagitis in Lung Cancer
Esophagitis in Lung Cancer 2,500,000 Global NSCLC Incidence Initial 175,000 Target US Patients Diagnosed each year Population 50,000 US Patients at Risk for RT-related Esophagitis Locally advanced NSCLC frequently treated with IMRT and chemotherapy ©2022 Galera Therapeutics, Inc. 27
Slide 28: Esophagitis: Major Unmet Need in Lung Cancer
Esophagitis: Major Unmet Need in Lung Cancer Common Side Effect of Chemoradiotherapy (IMRT x 6 weeks) 1 50-60% Get Grade 2+ Current Approaches AESOP Trial Design 2,3 20-30% Get Grade 3+ Lack Efficacy in Lung Cancer 4 NCI Grading for esophagitis No established drug therapy Single-arm Phase 2 Trial 1
Slide 29: Esophagitis Trial (AESOP)
Esophagitis Trial (AESOP) Low incidence of Grade 3+ esophagitis with avasopasem compared to literature Trial Design AESOP Results Safety AE profile consistent with chemoradiotherapy Patients and Treatment (Per Protocol n=29) 0% 20% 40% 60% 80% 100% 2 Esophagitis Incidence by Grade • Single-arm Phase
Slide 30: Increasing SBRT Efficacy
Increasing SBRT Efficacy
Slide 31: Clinical Stage Pipeline
Clinical Stage Pipeline Phase 1 Phase 2 Phase 3 Trial Status/Anticipated Milestones Radioprotection ROMAN: AVA vs. Placebo (n=455) NDA Submission by Y/E 2022 4 GT-201: AVA vs. Placebo (n=223) Completed & Published 1 Head & Neck Cancer (SOM) EUSOM: AVA (n=38) Completed in 2021 5 Ph 1b/2a AVA (n=43) C
Slide 32: Synergy with High-Dose RT (SBRT)
Synergy with High-Dose RT (SBRT) High-fraction focal irradiation of human tumor xenografts (H1299 NSCLC) in mice RT with Biological Equivalent Doses Vehicle Days Post Treatment Days Post Treatment Days Post Treatment Days Post Treatment SBRT Stereotactic Body Radiation Therapy Sishc, et al., Science
Slide 33: H2O2 build-up in Cancer Cell – Synergy with SBRT
H O build-up in Cancer Cell à Synergy with SBRT 2 2 CAT Synergy eliminated with doxycycline-induced catalase in genetically modified H1299 cells Sishc, et al., Science Translational Medicine 12 May 2021:Vol. 13, Issue 593 ©2022 Galera Therapeutics, Inc. 33
Slide 34: Pancreatic Tumor Model – Synergy with SBRT
Pancreatic Tumor Model à Synergy with SBRT Marked synergy of Dismutase Mimetic with 12 Gray Radiotherapy PANC-1 PDAC xenograft Sishc, et al., Science Translational Medicine 12 May 2021:Vol. 13, Issue 593 ©2022 Galera Therapeutics, Inc. 34
Slide 35: Pancreatic Cancer High Unmet Medical Need
Pancreatic Cancer High Unmet Medical Need With Limited Therapeutic Options 500,000 Global Incidence Initial 60,000 Target US Patients Diagnosed each year Population 18,000 Patients with Unresectable Locally Advanced Tumors 5-year survival rate is only ~10% SBRT use increasing for locoregional contro
Slide 36: Proof of Concept Trial in Pancreatic Cancer
Proof of Concept Trial in Pancreatic Cancer Completed 42-Patient Double-blind, Placebo-controlled, Randomized Trial Population Treatment Endpoints • Patients with Locally-advanced • Primary: Safety and feasibility of SBRT + GC4419 90mg x 5 doses Pancreatic Cancer (LAPC) dismutase mimetic with SBRT R
Slide 37: Final Analysis of Safety & Efficacy
Final Analysis of Safety & Efficacy Minimum of One Year Follow-up on All Patients Baseline Characteristics Placebo GC4419 (n=18) (n=24) Median age (range), yrs 68 (48–82) 72 (41–83) Male / Female 39% / 61% 67% / 33% Borderline resectable / Unresectable 11% / 89% 29% / 71% ECOG Performance status 0/1
Slide 38: Final Safety Analysis - Regimen Generally Well Tolerated
Final Safety Analysis - Regimen Generally Well Tolerated 12-Month Safety Follow-up (% of Patients) Similar SBRT Toxicity Across Arms No Early or Late Toxicity Signal for GC AEs Considered related SBRT SBRT AEs Considered related by SBRT SBRT by Investigator to SBRT + PBO + GC Investigator to GC/PBO
Slide 39: Partial Response Rate Increased 2.5-fold
Partial Response Rate Increased 2.5-fold Best Local Response with follow-up of at least 12 months on all patients (ITT, n=42) SBRT + GC SBRT + PBO 40% 30% 20% 10% R0 R0 R0 R1 NE NE 0% R0 R0 R0 -10% -20% -30% 1 1 PR : 29% (7 of 24 patients) PR : 11% (2 of 18 patients) -40% -50% -60% 1 Partial respons
Slide 40: Improved Control of Both Local and Distant Disease
Improved Control of Both Local and Distant Disease Median LRC on GC arm not yet reached at data cut-off; Increased median DMC by 100% Locoregional Control (LRC) Distant Metastases Control – within RT Field – outside RT Field P-value = 0.0551 Hazard Ratio = 0.30 P-value = 0.0279 Hazard Ratio = 0.39 M
Slide 41: Improved Overall and Progression-Free Survival
Improved Overall and Progression-Free Survival 46% (11/24) alive on GC arm at last follow up compared to 33% (6/18) on placebo Overall Survival (OS) Progression-Free Survival (PFS) P-value = 0.0899 Hazard Ratio = 0.48 P-value = 0.0396 Hazard Ratio = 0.46 Minimum 12-month follow-up on all patients, P
Slide 42: Final Efficacy Analysis – Improvements Across All Parameters
Final Efficacy Analysis – Improvements Across All Parameters Encouraging hazard ratios across all endpoints Hazard Ratios Below 0.5 Hazard Ratios Below 0.4 2.5-fold Increase in Overall & Progression-Free Local & Distant Tumor Response Rate Survival Control Survival Tumor Control Response Median OS P
Slide 43: GRECO-2 Trial of Rucosopasem + SBRT in LAPC
GRECO-2 Trial of Rucosopasem + SBRT in LAPC Galera Radiotherapy Efficacy Cancer Optimization Rucosopasem 100mg IV or placebo administered over 15 mins <3 hrs before SBRT (5 fractions of 10 Gy each) • Multicenter, double-blinded, placebo-controlled trial • 160 patients, 1:1 randomization N=160 SBRT +
Slide 44: SBRT for Non-Small Cell Lung Cancer
SBRT for Non-Small Cell Lung Cancer SBRT is an established treatment for central and large peripheral NSCLC tumors 2,500,000 Global NSCLC Incidence All SBRT 14,600 12,120 15,430 Node- Peripheral Central Central Negative Tumor Tumor Tumor NSCLC >3cm <3cm >3cm Surgery 42,000 175,000 16% 30% 12% ONLY R
Slide 45: GRECO-1 Trial of Rucosopasem + SBRT in NSCLC
GRECO-1 Trial of Rucosopasem + SBRT in NSCLC Galera Radiotherapy Efficacy Cancer Optimization GRECO-1 Trial Phase 1 Results • Rucosopasem + SBRT was well tolerated in Phase 1 with fatigue, cough & Rucosopasem 100mg IV or placebo over 15 mins nausea most frequent adverse events (common in patients re
Slide 46: Corporate Highlights
Corporate Highlights
Slide 47: Clinical Stage Pipeline
Clinical Stage Pipeline Phase 1 Phase 2 Phase 3 Trial Status/Anticipated Milestones Radioprotection ROMAN: AVA vs. Placebo (n=455) NDA Submission by Y/E 2022 4 GT-201: AVA vs. Placebo (n=223) Completed & Published 1 Head & Neck Cancer (SOM) EUSOM: AVA (n=38) Completed in 2021 5 Ph 1b/2a AVA (n=43) C
Slide 48: Thank you.
Thank you.
Galera Therapeutics — Investor Presentation (October 2022) on 6ix