Galera Therapeutics, Inc. · OTC:GRTX
Galera Therapeutics — Investor Presentation (September 2021)
50 slides from Galera Therapeutics's investor presentation, Sep 8, 2021
Slide 1: Transforming radiotherapy for patients with cancer
Transforming radiotherapy for patients with cancer September 2021 Exhibit 99.1
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: Radiation Therapy – Key Role in Cancer Treatment
Radiation Therapy – Key Role in Cancer Treatment Over 50% of all cancer patients receive radiation therapy as part of their treatment IMRT Intensity Modulated Radiation Therapy Low doses for weeks (~2 Gy/day) Most used form of external beam RT High doses for days (>5 Gy/day) Cutting edge form of ext
Slide 4: Galera's Technology: Dismutase Mimetics
Galera’s Technology: Dismutase Mimetics Mechanism of action is to convert RT-induced burst of Superoxide to Hydrogen Peroxide Toxicity Efficacy O2 Shifting the Balance H2O2 Radioprotection of Low Dose RT Radiosensitization of High Dose RT Superoxide (O2) is more damaging to normal cells than cancer
Slide 5: Transforming Radiotherapy
1The first SBRT combination trial used GC4419 (avasopasem). Observations from this pilot trial used to guide development of GC4711 in combination with SBRT 2Global Cancer Statistics. Sung H et al. CA Cancer J Clin 2021;0:1–41 (excluding nonmelanoma skin cancer) 3US Cancer Statistics Siegel RL et al.
Slide 6: Robust Pipeline
Head & Neck Cancer Lung Cancer Pancreatic Cancer Robust Pipeline @2021 Galera Therapeutics, Inc. Phase 1 Next Anticipated Milestone IMRT induced Severe Oral Mucositis1 1EUSOM is a single-arm multi-center trial evaluating the safety and efficacy of avasopasem in patients with HNC in Europe 2Phase 2a
Slide 7: Reducing IMRT Toxicity
Reducing IMRT Toxicity
Slide 8: Radioprotection Programs
Lung Cancer Receiving 6 weeks IMRT & Chemo Head & Neck Cancer Receiving 7 weeks IMRT & Cisplatin Radioprotection Programs Phase 1 Next Anticipated Milestone Phase 2 Phase 3 Esophagitis2 Severe Oral Mucositis1 Topline Data: 4Q 2021 Topline Data: 4Q 2021 Topline Data: 1H 2022 Completed & Published4 Co
Slide 9: 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) 70% Patients Get SOM (Grade 3 or 4 OM) WHO Grading System Current Approaches Lack Efficacy Physicians Consider Topicals Ine
Slide 10: ROMAN Phase 3 Trial – Results this Year
60-minute IV infusion just before IMRT Multicenter (North America) Placebo x 7 weeks Avasopasem 90mg x 7 weeks 455 Patient ROMAN Phase 3 Trial – Results this Year @2021 Galera Therapeutics, Inc. Fully Enrolled Randomized Placebo-Controlled Severe Oral Mucositis Trial Population Treatment Endpoints P
Slide 11: Avasopasem: First-to-Market Potential
Avasopasem: First-to-Market Potential @2021 Galera Therapeutics, Inc. Avasopasem Prevents RT Injury Patients get avasopasem before each RT dose Avasopasem has BTD for Oral Mucositis 455 Patient ROMAN Phase 3 Trial FDA Breakthrough Therapy Designation Data anticipated 4Q 2021 Blocks initiating injury
Slide 12: Phase 2b Trial – Robust Results
60-minute IV infusion just before IMRT Multicenter (North America) Placebo x 7 weeks R Avasopasem 90mg x 7 weeks Avasopasem 30mg x 7 weeks 223 Patient Phase 2b Trial – Robust Results @2021 Galera Therapeutics, Inc. Randomized Placebo-Controlled Severe Oral Mucositis (SOM) Trial Population Treatment
Slide 13: Consistent and Encouraging Results Across SOM Endpoints
Incidence Duration Severity Consistent and Encouraging Results @2021 Galera Therapeutics, Inc. Across SOM Endpoints 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 OM Anderson CM et al. Journal of Clinical Oncology 20
Slide 14: Avasopasem Efficacy Significantly Better than Placebo
Avasopasem Efficacy Significantly Better than Placebo @2021 Galera Therapeutics, Inc. FOLLOW UP POST THERAPY FOLLOW UP POST THERAPY RADIOTHERAPY TREATMENT PERIOD RADIOTHERAPY TREATMENT PERIOD Grade 4 Grade 3 90 mg Avasopasem 34% Less Incidence SOM 47% Less Grade 4 OM 92% Shorter Duration SOM Delayed
Slide 15: Radiotherapy Efficacy Maintained Over Two Years
Radiotherapy Efficacy Maintained Over Two Years @2021 Galera Therapeutics, Inc. Final ITT Analysis
Slide 16: Safety Results Comparable to Placebo
Safety Results Comparable to Placebo @2021 Galera Therapeutics, Inc. Avasopasem Generally Well Tolerated Most Frequent AEs (any grade) Placebo (n=72) 30 mg Avasopasem (n=73) 90 mg Avasopasem (n=72) Lymphopenia 89% 92% 88% Nausea 75% 68% 82% Fatigue 69% 60% 65% Oropharyngeal pain 64% 63% 61% Constipa
Slide 17: SOM Market Opportunity
SOM Market Opportunity [Galera
Slide 18: 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 19: Head and Neck Cancer Can Affect Anyone
Head and Neck Cancer Can Affect Anyone Babe Ruth, Lana Turner, Jamie Dimon, Ulysses S. Grant, Sigmund Freud, Humphrey Bogart, Grover Cleveland, Eddie Van Halen Sammy Davis Jr., George Harrison, Michael Douglas, Ann Richards, Tony Gwynn @2021 Galera Therapeutics, Inc.
Slide 20: Concentrated Physician Population
Concentrated Physician Population @2021 Galera Therapeutics, Inc. 700 5,000 Radiation Oncologists in U.S 2,500 Radiotherapy Treatment Sites Top centers where >80% HNC patients are treated Initial Sales Focus SOM is most burdensome side effect of curative IMRT + cisplatin regimen 38% IMRT centers cur
Slide 21: Where Patients with Head & Neck Cancer are Treated
Where Patients with Head & Neck Cancer are Treated @2021 Galera Therapeutics, Inc. 76% Treated in only 29% Zip Code areas Galera Market Research (122 Zip Codes are 0)
Slide 22: Most Centers Have Ability to Infuse Today
Most Centers Have Ability to Infuse Today @2021 Galera Therapeutics, Inc. 72% Radiotherapy Sites Have Existing Infusion Capability Adoption Archetype Determinants A Rad Oncs Have Current Capabilities B Med Oncs Administer Infusions for Rad Onc C Rad Oncs Need to Add Capabilities D Rad Oncs Unlikely
Slide 23: US Radiation Oncologists Trending Away from Private Practice
US Radiation Oncologists Trending Away from Private Practice @2021 Galera Therapeutics, Inc. 1Data from ASTRO
Slide 24: Favorable Payer Landscape
@2021 Galera Therapeutics, Inc. $40,000 Additional medical expenses incurred by patients who develop OM $15-25K Indicative price of full course of therapy based on initial payer research Step Edits Unlikely High unmet need with limited treatment options Price strategy intended to optimize patient ac
Slide 25: Beyond Oral Mucositis: Other RT-Related Toxicities
Beyond Oral Mucositis: Other RT-Related Toxicities @2021 Galera Therapeutics, Inc. Physicians view oral mucositis 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 toxic
Slide 26: Esophagitis in Lung Cancer
Esophagitis in Lung Cancer @2021 Galera Therapeutics, Inc. 2,500,000 Global NSCLC Incidence 175,000 50,000 US Patients Diagnosed each year US Patients at Risk for RT-related Esophagitis Initial Target Population Locally advanced NSCLC frequently treated with IMRT and chemotherapy
Slide 27: Esophagitis: Major Unmet Need in Lung Cancer
Esophagitis: Major Unmet Need in Lung Cancer @2021 Galera Therapeutics, Inc. Common Side Effect of Chemoradiotherapy (IMRT x 6 weeks) 50% Patients Get Grade 2+ Esophagitis RTOG Grading System Current Approaches Lack Efficacy AESOP Trial Design No established drug therapy Phase 2 Trial (n=60) Support
Slide 28: Increasing SBRT Efficacy
Increasing SBRT Efficacy
Slide 29: Radiosensitizer Programs
Pancreatic Cancer1 Locally Advanced Receiving 5 days SBRT after 4-6 months chemo Lung Cancer2 Locally Advanced Receiving 5 days SBRT Radiosensitizer Programs @2021 Galera Therapeutics, Inc. Initial Data: 1H 2022 Initiated Trial: 2Q 2021 GRECO-1: GC4711 vs. Placebo GRECO-2: GC4711 vs. Placebo Final D
Slide 30: Pancreatic Cancer
Pancreatic Cancer @2021 Galera Therapeutics, Inc. 500,000 Global Incidence 60,000 18,000 US Patients Diagnosed each year Patients with Unresectable Locally Advanced Tumors Initial Target Population High Unmet Medical Need With Limited Therapeutic Options 5-year survival rate is only ~10% SBRT use in
Slide 31: People We Have Lost to Pancreatic Cancer
People We Have Lost to Pancreatic Cancer Pavarotti, Donna Reed, Dizzy Gillespie, Cardinal Bernardin, Eiko Ishioka, Bonanza’s Pernell Roberts, Joan Crawford Ben Gazzara, Alex Trebek, Alan Bates, Jack Benny, Dr. Sydney Salmon, Billy Paul, Rand Pausch (last lecture) Ruth Bader Ginsburg, John Lewis, Hen
Slide 32: Proof of Concept Trial in Pancreatic Cancer
Proof of Concept Trial in Pancreatic Cancer @2021 Galera Therapeutics, Inc. 42-Patient Double-blind, Placebo-controlled, Randomized Trial 60-minute IV infusion before SBRT 4 Centers: MDA, Moffitt, Duke, UTSW Population Treatment Endpoints Patients with Locally-advanced Pancreatic Cancer (LAPC) Scree
Slide 33: Proof of Concept Trial in Pancreatic Cancer – Final Analysis
Proof of Concept Trial in Pancreatic Cancer – Final Analysis @2021 Galera Therapeutics, Inc. 42-Patient Double-blind, Placebo-controlled, Randomized Trial SBRT and SBRT+GC combination generally well tolerated Improvements observed across all evaluated efficacy endpoints HR < 0.5 for Overall & Progre
Slide 34: Final Analysis of Safety & Efficacy
Final Analysis of Safety & Efficacy @2021 Galera Therapeutics, Inc. Minimum of One Year Follow-up on All Patients Baseline Characteristics Placebo (n=18) GC4419 (n=24) Median age (range), yrs 68 (48–82) 72 (41–83) Male / Female 39% / 61% 67% / 33% Borderline resectable / Unresectable 11% / 89% 29% /
Slide 35: Final Safety Analysis - Regimen Generally Well Tolerated
Final Safety Analysis - Regimen Generally Well Tolerated @2021 Galera Therapeutics, Inc. 12-Month Safety Follow-up (% of Patients) Similar SBRT Toxicity Across Arms No Early or Late Toxicity Signal for GC AEs Considered related by Investigator to SBRT SBRT + PBO SBRT + GC ≤90 days after SBRT Any AE
Slide 36: Final Efficacy Analysis – Improvements Across All Parameters
Final Efficacy Analysis – Improvements Across All Parameters @2021 Galera Therapeutics, Inc. Encouraging hazard ratios across all endpoints Survival Tumor Control Response 2.5-fold Increase in Response Rate Hazard Ratios Below 0.5 Overall & Progression-Free Survival Hazard Ratios Below 0.4 Local & D
Slide 37: Improved Overall and Progression-Free Survival
Improved Overall and Progression-Free Survival @2021 Galera Therapeutics, Inc. 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 = 0.0396Hazard Ratio = 0.46 P-value = 0.0899Hazard Ratio = 0.48 Minimum 12-mont
Slide 38: Improved Control of Both Local and Distant Disease
Improved Control of Both Local and Distant Disease @2021 Galera Therapeutics, Inc. Median LRC on GC arm not yet reached at data cut-off; Increased median DMC by 100% Minimum 12-month follow-up on all patients, HR = Hazard Ratio DMC and LRC defined as distant metastasis or local regional progression,
Slide 39: Partial Response Rate Increased 2.5-fold
Partial Response Rate Increased 2.5-fold @2021 Galera Therapeutics, Inc. Best Local Response with follow-up of at least 12 months on all patients (ITT, n=42) SBRT + GC SBRT + PBO PR1: 29% (7 of 24 patients) PR1: 11% (2 of 18 patients) R0 R0 R0 R0 R0 R0 R1 NE NE 1Partial response per modified RECIST
Slide 40: Galera's Radiosensitization Trials
Galera’s Radiosensitization Trials Galera Radiotherapy Efficacy Cancer Optimization GRECO-1 in Lung Cancer SBRT + GC4711 100mg x 5 doses SBRT+ Placebo x 5 doses R 71 Patients Placebo-controlled multicenter trial Locally Advanced NSC Lung Cancer Large & central tumors Status: Open & recruiting patien
Slide 41: SBRT for Non-Small Cell Lung Cancer
SBRT for Non-Small Cell Lung Cancer @2021 Galera Therapeutics, Inc. 42,000 Receive SBRT Today SBRT is an established treatment for central and large peripheral NSCLC tumors 2,500,000 Global NSCLC Incidence 175,000 55,100 US Patients Diagnosed each year Node-Negative NSCLC All SBRT 14,600 12,120 15,4
Slide 42: Corporate Highlights
Corporate Highlights
Slide 43: Robust Pipeline
Head & Neck Cancer Lung Cancer Pancreatic Cancer Robust Pipeline @2021 Galera Therapeutics, Inc. Phase 1 Next Anticipated Milestone IMRT induced Severe Oral Mucositis1 1EUSOM is a single-arm multi-center trial evaluating the safety and efficacy of avasopasem in patients with HNC in Europe 2Phase 2a
Slide 44: Thank you.
Thank you.
Slide 45: Back-up Slides Mechanistic and Preclinical Data
Back-up Slides Mechanistic and Preclinical Data
Slide 46: Protection from Lethal Radiation Exposure Observed in Preclinical Studies
Protection from Lethal Radiation Exposure @2021 Galera Therapeutics, Inc. Observed in Preclinical Studies – Total Body Irradiation (8.5 Gy) to Mice Thompson, et al., Free Radical Research, 44(5):529-540, 2010
Slide 47: Synergy with High-Dose RT (SBRT)
Synergy with High-Dose RT (SBRT) @2021 Galera Therapeutics, Inc. High-fraction focal irradiation of human tumor xenografts (H1299 NSCLC) in mice Vehicle Days Post Treatment Days Post Treatment Days Post Treatment Days Post Treatment SBRT Stereotactic Body Radiation Therapy RT with Biological Equival
Slide 48: H2O2 build-up in Cancer Cell – Synergy with SBRT
H2O2 build-up in Cancer Cell à Synergy with SBRT @2021 Galera Therapeutics, Inc. Synergy abrogated with doxycycline-induced catalase in genetically modified H1299CAT cells Sishc, et al., Science Translational Medicine 12 May 2021:Vol. 13, Issue 593
Slide 49: Pancreatic Tumor Model – Synergy with SBRT
Pancreatic Tumor Model à Synergy with SBRT @2021 Galera Therapeutics, Inc. 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
Slide 50: Enhanced Checkpoint Inhibitor Activity in Vivo
Enhanced Checkpoint Inhibitor Activity in Vivo @2021 Galera Therapeutics, Inc. GC4419 enhances tumor response to SBRT + anti-PD-L1, PD-1 or CTLA-4 – within and outside RT field LLC syngeneic lung tumor model Galera data on file
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