Galera Therapeutics, Inc. · OTC:GRTX
Galera Therapeutics — Investor Presentation (September 2020)
29 slides from Galera Therapeutics's investor presentation, Sep 9, 2020
Slide 1: Transforming Radiotherapy with Dismutase Mimetics
Transforming Radiotherapy with Dismutase Mimetics September 2020 Exhibit 99.1
Slide 2: Disclaimers and Forward-Looking Statements
Disclaimers and 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
Slide 3: Superoxide Dismutase Mimetics – Vision
Superoxide Dismutase Mimetics – Vision 1 Delaney G, Jacob S, Featherstone C, Barton M. The role of radiotherapy in cancer treatment… Cancer. 2005;104:1129-1137 2 Begg AC, Stewart FA, Vens C. Strategies to improve radiotherapy with targeted drugs. Nat Rev Cancer. 2011;11:239-253 IMRT Intensity Modula
Slide 4: Clinical Stage Pipeline
Clinical Stage Pipeline Reducing RT Toxicity IMRT Combos Increasing RT Efficacy SBRT Combos Phase 1 Phase 2 Phase 3 SOM in Head & Neck Cancer Esophagitis in NSCLC (2) SOM in Head & Neck Cancer (1) LAPC (3) NSC Lung Cancer Phase 3 ROMAN Trial PBO vs. avasopasem Phase 2a Trial Single-arm, avasopasem P
Slide 5: Investment Highlights
Investment Highlights Avasopasem In Phase 3 Robust Efficacy in Randomized Phase 2b (n=223) Breakthrough Therapy designation granted by FDA Single Phase 3 sufficient for registration (n450) RT-related Toxicity Radiation-Related Severe Oral Mucositis (SOM) 65,000 patients/year in US get Head & Neck Ca
Slide 6: Dismutase Technology
[Galera Dismutase Technology
Slide 7: Unique Technology: Dismutase Mimetics
Unique Technology Dismutase Mimetics Small Molecule Enzyme Mimetics Mimic human superoxide dismutase (SOD) enzymes Rapidly convert superoxide (O2) to hydrogen peroxide (H2O2) Avasopasem (GC4419) GC4711 Shifts balance in normal & cancer cells from superoxide to hydrogen peroxide
Slide 8: Galera's Dismutase Mimetics
Galera’s Dismutase Mimetics Native SOD Enzymes Native SOD Enzymes Overexpression reduces RT toxicity Large size, immunogenicity & short half-lives limit bioavailability Inactivation/inhibition by reactive oxygen species Small Molecule Mimetics Challenge: suitable small molecule dismutase mimetics Fa
Slide 9: Reducing Toxicity of IMRT (Intensity Modulated Radiotherapy)
Reducing Toxicity of IMRT (Intensity Modulated Radiotherapy)
Slide 10: Oral Mucositis in HNC – Large Unmet Medical Need
Oral Mucositis in HNC – Large Unmet Medical Need SOM and Head & Neck Cancer Can Have Devastating Complications ~65,000 new HNC patients in US/Year ~65% get IMRT & cisplatin as standard-of-care ~70% of patients get SOM (can’t eat) ~20-30% get Grade 4 (can’t eat or drink) No approved drug available Tr
Slide 11: GT-201: 223-Patient Randomized Phase 2b OM Trial
GT-201: 223-Patient Randomized Phase 2b OM Trial Supportive trial to the ROMAN Phase 3 for the NDA Anderson et al, JCO, 2019 Ulcers Requires a liquid diet Ulcers Unable to eat or drink Ulcers Able to eat a solid diet No ulcers Erythema and soreness 3 4 2 1 SEVERE WHO Grading Scale Randomize (1:1:1)
Slide 12: Consistent Efficacy Across All SOM Parameters
Consistent Efficacy Across All SOM Parameters And consistent dose response: 90mg > 30mg Primary endpoint was duration - defined as # days from 1st occurrence of grade 3 or 4 SOM until the 1st event of grade 2 or less (there being no subsequent grade 3 or 4 events.) *Secondary endpoints (incidence an
Slide 13: Efficacy Parameters Better on 90mg arm Compared to Placebo
Efficacy Parameters Better on 90mg arm Compared to Placebo Swimmers plot: each patient who developed at least one SOM episode is represented by a row Grade 4 Grade 3 90 mg GC4419 34% Less Incidence SOM 47% Less Grade 4 OM 92% Shorter Duration SOM Delayed Onset of SOM PLACEBO Arm (45 of 74 Pts had ≥1
Slide 14: Tumor Outcomes Maintained at 2 Years
Tumor Outcomes Maintained - 2 year follow-up Final ITT Analysis OS = Overall Survival, PFS = Progression-Free Survival, LRC = LocoRegional Control, DMF = Free of Distant Metastases Tumor Outcomes Maintained at 2 Years
Slide 15: Safety Summary – Randomized Phase 2b Trial
Safety Summary – Rand. Phase 2b Trial Safety Profile of Both Avasopasem (GC4419) Doses Comparable to Placebo Avasopasem (GC4419) was well tolerated at both doses Most frequent AE’s are those expected with SoC cisplatin – RT regimen Most Frequent AEs (any grade) Placebo (n=72) 30 mg GC4419 (n=73) 90
Slide 16: GT-301: The ROMAN Trial – Phase 3 Confirmatory Trial Enrolling
GT-301: The ROMAN Trial - Phase 3 Confirmatory Trial Enrolling Reduction in Oral Mucositis with Avasopasem Manganese (GC4419) Ulcers Requires a liquid diet Ulcers Unable to eat or drink Ulcers Able to eat a solid diet No ulcers Erythema and soreness 3 4 2 1 SEVERE WHO Grading Scale Randomize (3:2) G
Slide 17: Commercial Considerations
[Galera Commercial Considerations
Slide 18: Large Commercial Opportunity Addressing Clear Unmet Need
Large Commercial Opportunity Addressing Clear Unmet Need Rad Oncs = Radiation Oncologists, SOM = Severe Oral Mucositis 1 Medicare Claims Analysis by Galera in 2019 2Hypothetical Product X for SOM with a similar profile to avasopasem Phase 2b results Galera’s quantitative market research to date incl
Slide 19: OM Substantially Increases Medical Expenses in Patients with HNC
OM Substantially Increases Medical Expenses in Patients with HNC Health economic analysis of patients with HNC receiving RT or chemo/RT 1 Navigant analysis; 40 million member years Pts with OM incur ~$32,000 more of medical expenses within first 6 months of start of RT High Cost Of Oral Mucositis Id
Slide 20: RT-related Mucositis Beyond Head and Neck Cancer
RT-related Mucositis Beyond Head and Neck Cancer 1Galera Market Research (150 Radiation Oncologists) 2 NCI or RTOG grading scales Market Research Question Patients with Other Conditions1 Given the demonstrated ability of Product X to prevent radiation-induced toxicities in the oral mucosa, please in
Slide 21: Increasing SBRT Efficacy (Stereotactic Radiotherapy)
Increasing SBRT Efficacy (Stereotactic Radiotherapy)
Slide 22: Dismutase Mimetics Increase Anti-Cancer Efficacy with High Fraction-Dose RT
Dismutase Mimetics Increase Anti-Cancer Efficacy with High Fraction-Dose RT in Preclinical Models RT with Biological Equivalent Doses Days Post Treatment Days Post Treatment Days Post Treatment Days Post Treatment SBRT Stereotactic Body Radiation Therapy Courtesy of M Story (UTSW) Vehicle Increase R
Slide 23: Increasing Anti-Cancer Efficacy via H2O2
…Increasing Anti-Cancer Efficacy via H2O2 Sishc et al, AACR 2018 Mean Tumor Volume (mm3) Days Post Treatment A vehicle GC4419 18 Gy x 1 RT RT + GC4419 RT + dox RT + GC4419 + dox H1299CAT NSCLC in mice H2O2 Drives Increased Efficacy SBRT Irradiation of human tumor-derived xenografts (H1299CAT) in mic
Slide 24: Target Treatment Population: Pancreatic Cancer
Target Treatment Population Increasing Number of Pancreatic Cancer Patients Diagnosed Each Year 57,000 newly diagnosed/year1 65% of Stage 2: unresectable (UR) or borderline resectable (BR) at Diagnosis 85% of Stage 3: UR or BR at Diagnosis Novel Therapies Needed First Line Treatment is Induction Che
Slide 25: GC4419 + SBRT Pilot Phase 1b/2a in Pancreatic Cancer
GC4419 + SBRT Pilot Phase 1b/2a in Pancreatic Cancer SBRT = Stereotactic Body Radiation Therapy, C Taniguchi & J Herman (MD Anderson), 1LO-ET = Late-Onset Efficacy-Toxicity (Jin IH, Liu S, Thall PF, Yuan Y. J Am Stat Assoc 2014;109:525-36) SBRT Combo Pilot Trial Double-blind, Placebo-controlled, Ran
Slide 26: GC4711 – SBRT Clinical Candidate
GC4711 GC4711 – SBRT Clinical Candidate Same mechanism of action as avasopasem (GC4419), with IV & oral forms NCE with new IP & lyophilized drug product Completed 14-day Phase 1 in healthy volunteers: 15-minute infusion NSCLC Non-Small Cell Lung Cancer (NSCLC) Leading cause of cancer death in US – 1
Slide 27: Summary
Summary
Slide 28: Near-term Potential Catalysts to Drive Future Value
Near-term Potential Catalysts to Drive Future Value 2H2021 Report ROMAN Phase 3 SOM Trial Topline Data 2H 2020 Initiate NSC Lung Cancer Phase 1b/2a Trial Oct 2020 (ASTRO Annual Meeting) Report Phase 1b/2a Pancreatic Cancer Topline Data 1H 2020 Initiated Esophagitis Phase 2a Trial IMRT IMRT SBRT SBRT
Slide 29: Superoxide Dismutase Mimetics – Vision
Superoxide Dismutase Mimetics – Vision 1 Delaney G, Jacob S, Featherstone C, Barton M. The role of radiotherapy in cancer treatment… Cancer. 2005;104:1129-1137 2 Begg AC, Stewart FA, Vens C. Strategies to improve radiotherapy with targeted drugs. Nat Rev Cancer. 2011;11:239-253 IMRT Intensity Modula
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