Galera Therapeutics, Inc. · OTC:GRTX
Galera Therapeutics — Investor Presentation (May 2020)
33 slides from Galera Therapeutics's investor presentation, May 12, 2020
Slide 1: Transforming Radiotherapy with Dismutase Mimetics
Transforming Radiotherapy with Dismutase Mimetics May 2020 Exhibit 99.2
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 – Development Targets
Superoxide Dismutase Mimetics – Development Targets 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 Int
Slide 4: Investment Highlights
Investment Highlights Lead Product in Phase 3 Robust Efficacy in Randomized Phase 2b (n=223) Breakthrough Therapy designation Single Phase 3 sufficient for registration (n450)1 Substantial Unmet Medical Need Radiation-Related Severe Oral Mucositis (SOM) 65,000 patients/year in US get Head & Neck Can
Slide 5: Clinical Stage Pipeline
Preclinical Phase 1 Phase 2 Phase 3 Clinical Stage Pipeline Next Anticipated Milestone Reducing Toxicity Avasopasem Manganese (GC4419) with IMRT Increasing Anti-Cancer Efficacy GC4711 with SBRT(3) Oral Delivery Complete ROMAN enrollment 1H2021 ROMAN Phase 3 topline data 2H2021 GC4419 Phase 1b/2a top
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: Radiation & Superoxide
Radiation & Superoxide Superoxide (O2) Produced by every cell as part of cellular respiration & substrate for HOCl. Highly toxic & leads to cell death. SOD enzymes evolved to rapidly convert O2 to H2O2 (10-7 seconds) Radiation Radiation Produces bursts of superoxide, causing Radiolysis of water Stim
Slide 9: Galera's Dismutase Mimetics
Galera’s Dismutase Mimetics Natural SOD Enzymes Limitations of Natural SOD Enzymes Large size prevents entry into cells Immunogenicity & short half-lives Inactivation/inhibition by reactive oxygen species Small Molecule Mimetics Challenge: suitable small molecule dismutase mimetics Fast catalytic ra
Slide 10: Reducing Toxicity of IMRT (Intensity Modulated Radiotherapy)
Reducing Toxicity of IMRT (Intensity Modulated Radiotherapy)
Slide 11: 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 12: 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 13: 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 14: 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 15: 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 16: 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 as expected with Standard Cisplatin – RT Regimen Most Frequent AEs (any grade) Placebo (n=72) 30 mg GC4419 (n=73) 90 mg
Slide 17: GT-301: The ROMAN Phase 3 Confirmatory Trial
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) GC
Slide 18: 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 19: Commercial Considerations
[Galera Commercial Considerations
Slide 20: 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 Galera’s quantitative market research to date includes ~5% of US radiation oncologists Support significant, rapid uptake of avasopasem (
Slide 21: Topical Agents Perform Poorly in Efficacy Attributes
Product Importance Rated in importance when choosing an oral mucositis treatment Topical Performance Rated on usefulness for treating oral mucositis Topical Agents Perform Poorly in Efficacy Attributes Physicians seek therapy to prevent/reduce the toxicity of radiation Galera Market Research (150 U.
Slide 22: 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 23: Physicians View Oral Mucositis Data as Applicable to Other Toxicities
Physicians View Oral Mucositis Data as Potentially Applicable to Other Radiation-Related Toxicities Galera Market Research (150 U.S. Radiation Oncologists) Question Patients with Other Conditions Given the demonstrated ability of Product X to prevent radiation-induced toxicities in the oral mucosa,
Slide 24: Increasing SBRT Efficacy (Stereotactic Radiotherapy)
Increasing SBRT Efficacy (Stereotactic Radiotherapy)
Slide 25: Dismutase Mimetics Increase Anti-Cancer Efficacy with High Fraction-Dose RT
Dismutase Mimetics Increase Anti-Cancer Efficacy with High Fraction-Dose RT 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 Radiotherapy Efficacy F
Slide 26: Increase Anti-Cancer Efficacy via H2O2
…Increase 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 mice
Slide 27: Also Enhance Immuno-Radiotherapy
…Also Enhance Immuno-Radiotherapy Courtesy of M Story (UTSW) Days Mean Tumor Vol. (mm3) 2000 1500 500 0 0 10 20 30 40 1000 Increase IO + SBRT Efficacy SBRT + Checkpoint Inhibitor therapy of syngeneic tumors (LLC) in mice Avasopasem (GC4419) enhances tumor response to SBRT + anti-PD-L1, PD-1 or CTLA-
Slide 28: Avasopasem + SBRT Pilot Phase 1b/2a in Pancreatic Cancer
Avasopasem (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) Pancreatic Cancer Locally-Advanced Pancreatic C
Slide 29: Potential Eligible Pancreatic Cancer Population
Potential Eligible Pancreatic Cancer Population * Stage at diagnosis; **5 yr survivorship by stage; surwww.seer.cancer.gov/statfacts/html/pancreas.html & https://onlinelibrary.wiley.com/doi/full/10.3322/caac.21492 https://www.ajmc.com/journals/supplement/2019/managed-care-considerations-pancreatic-c
Slide 30: 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 Completing Phase 1 in healthy volunteers: 15-minute infusion NSCLC Non-Small Cell Lung Cancer (NSCLC) Leading cause of cancer death in US – 142,670
Slide 31: Summary
Summary
Slide 32: 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 2H 2020 Report Phase 1b/2a Pancreatic Cancer Topline Data 1H 2020 Initiated Esophagitis Phase 2a Trial IMRT IMRT SBRT SBRT Avasopasem (GC4419) GC4
Slide 33: Superoxide Dismutase Mimetics – Development Targets
Superoxide Dismutase Mimetics – Development Targets 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 Int
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