Galera Therapeutics, Inc. · OTC:GRTX
Galera Therapeutics — Investor Presentation (April 2021)
44 slides from Galera Therapeutics's investor presentation, Apr 28, 2021
Slide 1: Transforming radiotherapy for patients with cancer
Exhibit 99.1 Transforming radiotherapy for patients with cancer April 2021Exhibit 99.1 Transforming radiotherapy for patients with cancer April 2021
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: Transforming radiotherapy by reducing side effects and increasing anti-cancer efficacy
Toxicity Transforming radiotherapy by reducing side effects and increasing anti-cancer efficacy Over 50% of Cancer Patients Receive Radiotherapy 3 EfficacyToxicity Transforming radiotherapy by reducing side effects and increasing anti-cancer efficacy Over 50% of Cancer Patients Receive Radiotherapy
Slide 4: Reducing Toxicity
Toxicity REDUCING TOXICITY In radiotherapy Galera shifts the balance from normal tissue-damaging high levels of superoxide…. 4Toxicity REDUCING TOXICITY In radiotherapy Galera shifts the balance from normal tissue-damaging high levels of superoxide…. 4
Slide 5: While Increasing Efficacy
… W HI L E I NCRE A S I NG E F F I CA CY to potentially tumor-toxic high levels of hydrogen peroxide. 5 Efficacy… W HI L E I NCRE A S I NG E F F I CA CY to potentially tumor-toxic high levels of hydrogen peroxide. 5 Efficacy
Slide 6: Transforming Radiotherapy
Transforming Radiotherapy Reducing Increasing Large Market IMRT Toxicity SBRT Efficacy Opportunities In Phase 3 with Breakthrough Encouraging Survival Data High Unmet Medical Need & Therapy Designation in Pancreatic Cancer Trial Limited Therapeutic Options Severe Oral Mucositis Pancreatic Cancer Rad
Slide 7: Robust Pipeline
Robust Pipeline Phase 1 Phase 2 Phase 3 Next Anticipated Milestone Head & Neck ROMAN: Avasopasem vs. Placebo Topline Data: 2H 2021 IMRT induced Cancer Severe Oral 1 Mucositis EUSOM: Avasopasem Topline Data: 2H 2021 IMRT induced Lung AESOP: Avasopasem Topline Data: 1H 2022 2 Esophagitis Cancer SBRT G
Slide 8: Reducing IMRT Toxicity
Toxicity Reducing IMRT Toxicity 8Toxicity Reducing IMRT Toxicity 8
Slide 9: Randomized 223 Patient Phase 2b Trial – Robust Results
Randomized 1:1:1 223 Patient Phase 2b Trial – Robust Results Randomized Placebo-Controlled Severe Oral Mucositis (SOM) Trial Avasopasem 90mg x 7 weeks R Avasopasem 30mg x 7 weeks Placebo x 7 weeks Stratification • Tumor HPV status: + / - • Cisplatin schedule: qwk / q3wk Tumor Outcomes Population Tre
Slide 10: Consistent and Encouraging Results Across SOM Endpoints
Consistent and Encouraging Results Across SOM Endpoints SOM Incidence SOM Duration SOM Severity Reduction in Reduction in Reduction in incidence median days incidence of 34% 47% 92% Grade 4 70% 20 30% 18 60% 25% 16 50% 14 p=0.009* 20% 12 40% p=0.045* 10 15% 30% 8 10% 20% 6 4 10% p=0.024 5% 2 0% 0 0%
Slide 11: Avasopasem Efficacy Significantly Better than Placebo
Avasopasem Efficacy Significantly Better than Placebo PLACEBO Arm (45 of 74 Pts had ≥1 visit with SOM) 90MG Avasopasem Arm (35 of 76 Pts had ≥1 visit with SOM) RADIOTHERAPY TREATMENT PERIOD FOLLOW UP POST THERAPY RADIOTHERAPY TREATMENT PERIOD FOLLOW UP POST THERAPY 90 mg Avasopasem • 34% Less Incide
Slide 12: Radiotherapy Efficacy Results Maintained Over Two Years
Radiotherapy Efficacy Results Maintained Over Two Years 100% 90% 91% 91% 91% 90% 89% 89% 87% 86% 85% 80% 77% 77% 76% 70% 60% 50% 40% 30% 20% 10% 0% Overall Survival (OS) Progression-Free Survival (PFS) Locoregional Control (LRC) Free of Distant Mets (DMF) PBO 30 mg 90 mg Final ITT Analysis; 2-Year F
Slide 13: Safety Results Comparable to Placebo
Safety Results Comparable to Placebo Avasopasem Generally Well Tolerated Most Frequent AEs Placebo 30 mg 90 mg Avasopasem Avasopasem (any grade) (n=72) (n=73) (n=72) 100 Lymphopenia 89% 92% 88% 99% 97% 97% 90 95% 95% 94% Nausea 75% 68% 82% 80 Fatigue 69% 60% 65% 70 60 Oropharyngeal pain 64% 63% 61%
Slide 14: Randomized 450 Patient Phase 3 Trial – Results this Year
Randomized 3:2 450 Patient Phase 3 Trial – Results this Year Avasopasem 90mg x 7 weeks Randomized Placebo-Controlled Severe Oral Mucositis Trial R Placebo x 7 weeks Stratification • Surgery status: + / - before Rx • Cisplatin schedule: qwk / q3wk Tumor Outcomes Population Treatment Endpoints • Survi
Slide 15: SOM Market Opportunity
SOM Market OpportunitySOM Market Opportunity
Slide 16: Head and Neck Cancer – Large Market Opportunity
Head and Neck Cancer – Large Market Opportunity Severe Oral Mucositis is most burdensome side effect – 70% get SOM 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 curable w
Slide 17: 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 17Head and Neck Cancer Can Affect Anyone Babe Ruth, Lana Turner,
Slide 18: Avasopasem: First-to-Market Potential
Avasopasem: First-to-Market Potential Current Approaches Rad Oncs Consider Avasopasem is Lack Efficacy Topicals Ineffective Disease Modifying MAASC Guidelines focus Market Research with 150 Only Breakthrough Therapy 1 2 3 only on symptoms Radiation Oncologists Designation for SOM • Only 20% of physi
Slide 19: Concentrated Physician Population
Concentrated Physician Population SOM is Most Burdensome Side Effect of Curative IMRT + Cisplatin Regimen 5,000 72% Radiation Oncologists Sites with Existing 1 in U.S Infusion Capability Initial 2,500 64% Sales Radiotherapy Focus Market Patient Share Treatment Sites 700 Top centers where >80% HNC Pa
Slide 20: Where Patients with Head & Neck Cancer are Treated
Where Patients with Head & Neck Cancer are Treated 76% Treated in only 29% Zip Code Areas Galera Market Research (122 Zip Codes are 0) 20Where Patients with Head & Neck Cancer are Treated 76% Treated in only 29% Zip Code Areas Galera Market Research (122 Zip Codes are 0) 20
Slide 21: Most IMRT Centers Have Ability to Infuse Today
Most IMRT Centers Have Ability to Infuse 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 Avasopa
Slide 22: US Radiation Oncologists Trending Away from Private Practice
US Radiation Oncologists Trending Away from Private Practice 53% 41% 38% 31% 17% 11% Private Practice Hospital Academic/University 2012 2017 1 Data from ASTRO 22US Radiation Oncologists Trending Away from Private Practice 53% 41% 38% 31% 17% 11% Private Practice Hospital Academic/University 2012 201
Slide 23: Favorable Payer Landscape
Favorable Payer Landscape Price strategy intended to $40,000 optimize patient access Additional medical expenses incurred Head and neck cancer not a focus for cost by patients who develop OM control measure $15-25K Step Edits Unlikely Indicative price of full course of therapy High unmet need with l
Slide 24: Esophagitis in Lung Cancer
Esophagitis in Lung Cancer 50% patients get Grade 2 or worse 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 24Esophagitis in
Slide 25: Increasing SBRT Efficacy
Increasing SBRT Efficacy EfficacyIncreasing SBRT Efficacy Efficacy
Slide 26: 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 27: Pancreatic Cancer: High Unmet Medical Need With Limited Therapeutic Options
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 only ~10% SBRT use increasing for locoregional control o
Slide 28: Design Pilot Trial in Pancreatic Cancer
Design Pilot Trial in Pancreatic Cancer 42-Patient Double-blind, Placebo-controlled, Randomized Trial SBRT + GC4419 90mg x 5 doses R SBRT+ Placebo x 5 doses 42 Patients Single Multi Center Center Placebo N=8 N=10 GC4419 N=11 N=13 >1 Year >6 Months Population Treatment Endpoints Follow-Up Follow-Up •
Slide 29: Highlights of Current Analysis
Highlights of Current Analysis Follow-up through at least 6 months on all patients Surgical Resection • 5/24 on GC All with clear tumor margins • 2/18 on PBO 1 with clear tumor margins 85% Increase in 2.5-fold Increase in 2-fold Increase in Overall Survival Response Rate Time to Metastases Hazard Ra
Slide 30: Median Overall Survival Increased 85%
Median Overall Survival Increased 85% Encouraging hazard ratios for both OS and PFS 1 Overall Survival (OS) Progression-Free Survival (PFS) Median OS GC 20.1 Mos PBO 10.9 Mos Hazard Ratio = 0.4 Hazard Ratio = 0.4 1 PFS defined as local progression or distant metastasis; not censored for treatment po
Slide 31: Partial Response Rate Increased 2.5-fold
Partial Response Rate Increased 2.5-fold Best Local Response with follow-up through at least 6 months on all patients (ITT, n=42) SBRT + GC SBRT + PBO 40% 30% 20% 10% NE R0 R0 R0 NE R1 0% R0 R0 R0 -10% -20% -30% PR*: 29% (7 of 24 patients) PR*: 11% (2 of 18 patients) -40% -50% -60% R0 R1 = Surgical
Slide 32: Time to Distant Metastases Increased 2-fold And Improved Locoregional Control
Time to Distant Metastases Increased 2-fold And Improved Locoregional Control Distant Metastases Control Locoregional Control (LRC) – outside RT Field – within RT Field Median DMC GC 13.9 Mos PBO 7.0 Mos Hazard Ratio = 0.3 Hazard Ratio = 0.3 Patients censored for cancer progression or death (not for
Slide 33: Regimen Generally Well Tolerated
Regimen Generally Well Tolerated Toxicity reports through first 90 days after SBRT (ITT, n=42) Placebo Avasopasem Acute Adverse Events (up to 90 days post SBRT) (n=18) (n=24) Grade 3+ AEs 4 (22%) 6 (25%) 1 Grade 3 Gastrointestinal AEs 2 (11%) 2 (8%) 1 No bleeding ulcers by 12-week endoscopy, no GI t
Slide 34: GRECO-1 Next Steps
GRECO-1 Next Steps SBRT + GC4711 100mg x 5 doses R SBRT+ Placebo x 5 doses • Placebo-controlled multicenter trial • Locally Advanced NSC Lung Cancer – Proof o1. f Efficacy results from blinded controlled trial consistent with large & central tumors Concept preclinical studies that showed synergy wit
Slide 35: 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 36: Corporate Highlights
Corporate HighlightsCorporate Highlights
Slide 37: Robust Pipeline
Robust Pipeline Phase 1 Phase 2 Phase 3 Next Anticipated Milestone Head & Neck ROMAN: Avasopasem vs. Placebo Topline Data: 2H 2021 IMRT induced Cancer Severe Oral 1 Mucositis EUSOM: Avasopasem Topline Data: 2H 2021 IMRT induced Lung AESOP: Avasopasem Topline Data: 1H 2022 2 Esophagitis Cancer SBRT G
Slide 38: Back-up Slides: Mechanistic and Preclinical Data
Back-up Slides Mechanistic and Preclinical DataBack-up Slides Mechanistic and Preclinical Data
Slide 39: Differential Effect of Dismutase Mimetics
Efficacy Differential Effect of Dismutase Mimetics Conversion of superoxide to hydrogen peroxide leverages inherent tissue differences Hydrogen Superoxide Shifting the Peroxide (O ) is more 2 (H O ) is Balance 2 2 damaging more toxic H O 2 2 to normal to cancer cells than cells than cancer normal 1
Slide 40: Protection from Lethal Radiation Exposure Observed in Preclinical Studies
Protection from Lethal Radiation Exposure Observed in Preclinical Studies – Total Body Irradiation (8.5 Gy) to Mice Thompson, et al., Free Radical Research, 44(5):529-540, 2010 40Protection from Lethal Radiation Exposure Observed in Preclinical Studies – Total Body Irradiation (8.5 Gy) to Mice Thomp
Slide 41: 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 BJ et al, Proc.
Slide 42: H2O2 build-up in Cancer Cell Synergy with SBRT
H O build-up in Cancer Cell à Synergy with SBRT 2 2 CAT Synergy abrogated with doxycycline-induced catalase in genetically modified H1299 cells Sishc BJ et al, AACR, 2018 42H O build-up in Cancer Cell à Synergy with SBRT 2 2 CAT Synergy abrogated with doxycycline-induced catalase in genetically modi
Slide 43: 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 BJ et al, AACR Pancreatic Cancer, 2019 43Pancreatic Tumor Model à Synergy with SBRT Marked synergy of Dismutase Mimetic with 12 Gray Radiotherapy PANC-1 PDAC xenograft
Slide 44: Enhanced Checkpoint Inhibitor Activity in Vivo
Enhanced Checkpoint Inhibitor Activity in Vivo GC4419 enhanced 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 44Enhanced Checkpoint Inhibitor Activity in Vivo GC4419 enhanced tumor response to SBRT + anti-PD-L1, PD
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