EX-99.2

EX-99.2 3 d927839dex992.htm EX-99.2 EX-99.2

Transforming Radiotherapy with Dismutase Mimetics May 2020 Exhibit 99.2

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. While Galera believes these third-party sources to be reliable as of the date of this presentation, it has not independently verified, and makes no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. While Galera believes its internal research is reliable, such research has not been verified by any independent source. This presentation contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our clinical results and other future conditions. All statements other than statements of historical facts contained in this presentation, including statements regarding future results of operations and financial position, business strategy, the safety, efficacy, regulatory and clinical progress, and therapeutic potential of current and prospective product candidates, plans and timing for the commencement of and the release of data from clinical trials, the anticipated direct and indirect impact of COVID-19 on Galera's business and operations, planned clinical trials and preclinical activities, potential product approvals and related commercial opportunity, current and prospective collaborations, and timing and likelihood of success, plans and objectives of management for future operations, are forward-looking statements. The words ”may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “estimate,” “believe,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The information in this presentation, including without limitation the forward-looking statements contained herein, represent our views as of the date of this presentation. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. The forward-looking statements in this presentation involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the drug development process and the regulatory approval process, our reliance on third parties over which we may not always have full control, and other important risks and uncertainties that are described in Galera’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2020 filed with the U.S. Securities and Exchange Commission (SEC), Annual Report on Form 10-K for the year ended December 31, 2019 and Galera’s other filings with the SEC. New risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. Whenever the Company uses the terms “transform radiotherapy” or “transforming radiotherapy” in this presentation, it is referring to its mission statement.

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 Intensity Modulated RT Reducing IMRT Toxicity Severe Oral Mucositis Head & Neck Cancer (SOM in HNC) Esophagitis NSC Lung Cancer (NSCLC) Normal tissue toxicity limits optimal radiotherapy treatment of tumor Phase 3 ROMAN Phase 2 Trial Increasing SBRT Efficacy Pancreatic Cancer Locally Advanced (LAPC) Lung Cancer Oligometastatic (NSCLC) Radiotherapy is SoC for many local tumors but need remains for greater efficacy Phase 1b/2a SBRT Combo Phase 1b/2a SBRT Combo SBRT Stereotactic Body RT Rapid elimination of Superoxide (O2) Increase H2O2 in tumors Over half of cancer patients receive radiotherapy as part of their care1, 2 Transforming Radiotherapy with Dismutase Mimetics

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 Cancer SOM most burdensome side-effect: 70% of patients Focused Commercial Opportunity Galera Intends to Commercialize in US ~60% treatments in ~500 centers Current SOM treatments are marginally effective ~40 reps for the 4,000 radiation oncologists in U.S. 1 COVID-19 has delayed the initiation of the Phase 2a multi-center trial in Europe in patients with head and neck cancer indefinitely. This trial was expected to enroll up to 70 patients and contribute to the safety database for avasopasem for SOM in HNC. As a result, in order to maintain the size of the safety database, the ROMAN trial target enrollment has been increased to 450 patients.

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 topline data 2H2020 Select Phase 1/2 formulation Severe Oral Mucositis(1) Esophagitis(2) Pancreatic Cancer(3) Lung Cancer GC4711 Initiate GC4711 Phase 1b/2a 2H2020 (1)We also plan to conduct a Phase 2a multi-center trial in Europe assessing the safety of 90 mg avasopasem (GC4419) in patients with HNC undergoing standard-of-care radiotherapy. COVID-19 has delayed the initiation of the trial indefinitely. We will continue to monitor and assess the COVID-19 pandemic in Europe regarding the initiation of the trial in Europe. (2)Phase 2a trial in patients with lung cancer building on avasopasem (GC4419) safety and tolerability findings in patients with HNC SOM studies. (3)Observations from our Phase 1b/2a pilot trial of avasopasem (GC4419) in combination with SBRT in patients with LAPC whose tumor cannot be resected will be used to help develop GC4711 to increase the anti-cancer efficacy of SBRT.

Dismutase Technology

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

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 Stimulation of NOX, etc. Inflammatory response RT-induced superoxide overwhelms SODs, resulting in normal tissue damage Dismutase Activity SOD Galera 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 rates & high selectivity for superoxide Firmly hold manganese in macrocyclic ring Stable, safe & suitable for manufacturing Dismutase Mimetics Core Structure Pentaaza Macrocycles Small Molecule Dismutase Mimetics with Attractive Drug Characteristics Comparable to native SODs (2x107 molecules per sec) Interact with superoxide alone, not other reactive oxygen species Firmly hold Mn atom in macrocyclic ring Well-tolerated preclinically and clinically Efficient & cost-effective manufacturing process Speed Selectivity Stability Safety Synthesis

Reducing Toxicity of IMRT (Intensity Modulated Radiotherapy)

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 Treatment Approach Recommended for HNC OM due to RT? Basic oral care ✔ Anti-microbials, coating agents, anesthetics, & analgesics (0.2% morphine mouthwash) ✔ Anti-inflammatories, benzydamine ? Low level laser & other light therapy ? Cryotherapy for 5-FU chemotherapy O Natural & other agents O Current Treatments are Marginally Effective 42,000 receive IMRT WHO Grading Scale 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 Dehydration & Malnutrition Often requiring PEG tube feeding Pain Often severe pain requiring opioids Treatment interruption Each week of treatment delay decreases tumor control by >10% Increased economic burden OM Dx à ~$32,000 in additional medical expenses in first 6 months from RT start MASCC / ISOO Guidelines for HNC OM

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) GC4419 90mg x 7 weeks GC4419 30mg x 7 weeks Placebo x 7 weeks Treatment Avasopasem (GC4419) 90mg, 30mg, or placebo 60 minute IV infusion, Mon-Fri. Ending <60 mins pre-RT Population Patients with HNC Locally-advanced, squamous cell Eligible for SoC – 7 weeks IMRT + cisplatin Stratification Factors Tumor HPV Status: positive or negative Cisplatin Schedule: q3wks or weekly Endpoints Primary – Reduction in median duration of SOM – WHO Grades 3 & 4 Secondary – Reduction in incidence and severity of SOM at pre-specified timepoints Exploratory – Time to SOM onset Tumor outcomes (2 year follow-up) Locoregional control, distant mets, PFS, OS Trial Design

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 and severity ) have nominal p values compared to placebo ITT = Intent-To-Treat population (n=223) DURATION 92% Reduction in median days of SOM 90 mg vs. Placebo p=0.024 INCIDENCE 34% Reduction through all RT 90 mg vs. Placebo p=0.009* SEVERITY 47% Reduction in Incidence of Grade 4 OM 90 mg vs. Placebo p=0.045*

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 visit with SOM) 90MG Avasopasem (GC4419) Arm (35 of 76 Pts had ≥1 visit with SOM)

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

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 GC4419 (n=72) Lymphopenia 89% 92% 88% Nausea 75% 68% 82% Fatigue 69% 60% 65% Oropharyngeal pain 64% 63% 61% Constipation 53% 59% 64% Radiation skin injury 47% 51% 53% Vomiting 47% 52% 49% Dysgeusia (taste) 49% 55% 43% Dysphagia 43% 42% 47% Weight decreased 35% 40% 44% Oral candidiasis 29% 45% 43% Leukopenia 39% 37% 39% % Anderson et al, JCO, 2019

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) GC4419 90mg x 7 weeks Placebo x 7 weeks Treatment Avasopasem (GC4419) 90mg or placebo 60 minute IV infusion, Mon-Fri Ending <60 mins pre-RT Population Patients with Head & Neck Cancer Locally-advanced, squamous cell Eligible for SoC – 7 weeks IMRT + cisplatin Stratification Factors Surgery Status: post-op or definitive Cisplatin Schedule: q3wks or weekly Endpoints Primary – Reduction in incidence of SOM – WHO Grades 3 & 4 Secondary – Reductions in severity of SOM and number of days of SOM experienced Tumor outcomes2 – LRC, DM-free, PFS, OS Trial Design (n450 pts)1 1 COVID-19 has delayed the initiation of the Phase 2a multi-center trial in Europe in patients with head and neck cancer indefinitely. This trial was expected to enroll up to 70 patients and contribute to the safety database for avasopasem for SOM in HNC. As a result, in order to maintain the size of the safety database, the ROMAN trial target enrollment has been increased to 450 patients. 2 LRC = locoregional control, DM-free = free of distant mets, PFS = Progression-Free Survival, OS = Overall Survival

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 indicate how you might use (maximum %) Product X for the following radiation associated conditions? Mucositis of Esophagus Radiotherapy-related Esophagitis in Lung Cancer Galera’s HNC trials seen by radiation oncologists as supportive for esophagitis1 ~50,000 lung cancer patients are treated with RT, 50% get ≥ Grade 2 esophagitis2 Effects: inability to swallow, severe pain, ulceration, bleeding & hospitalization Compendial Listing Phase 2 to support Compendial Listing post-Approval for SOM Single-arm Phase 2a trial in 60 patients w/ locally-advanced lung cancers Standard IMRT to ≥ 5 cm of esophagus (30 fractions, 2Gy/day x5 for 6 weeks) Post approval for SOM in HNC, plan to seek compendial listing in U.S.

Commercial Considerations

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 (GC4419) for oral mucositis Rad Oncs report severe oral mucositis is most burdensome side effect of HNC RT treatment 70% of patients get SOM (Grades 3 & 4) with standard-of-care RT & 20-30% get Grade 4 Current approaches inadequate – while frequently used, only 1 in 5 believe they are useful Patients with OM incur ~$32,000 more in medical expenses in first 6 months from start of RT ~2,500 radiotherapy sites in US ~60% of patients are treated in ~500 centers1 Market research suggests rad oncs view OM data as representative of efficacy in esophagitis 220 Rad Oncs in market research SOM clear unmet need SOM common & costly OM data representative for all mucositis Targeted salesforce In U.S. Focused commercial infrastructure Evaluating options for commercialization outside U.S. ~40 reps for the 4,000 radiation oncologists in U.S. ~$32,000 5% of Rad Oncs 70% get SOM ~40 Reps 4,000 Rad Oncs

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.S. Radiation Oncologists) % MDs that rated these attributes as a 6 or 7 on a 7-point scale Product Performance Product Attribute Importance & Topical Performance Efficacy in preventing/reducing OM is most important product attribute Only 19-21% MDs believe topical agents perform well in preventing or reducing mucositis

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 Identified patients with locally advanced Head & Neck Cancer, treated with RT +/-chemo Longitudinal claims analysis1 assessing costs over a six month period Compared healthcare expenses of patients with & without oral mucositis Included both in-patient and out-patient expenses associated with a claim

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, please indicate how you might use (maximum %) Product X for the following radiation associated conditions? Potential Usage in Other Radiation Associated Conditions Maximum % of Patients with Other Conditions Other RT-related Mucositis Avasopasem (GC4419) for other RT-related Toxicities Over 50% cancer patients will get RT at some time in their treatment Several major cancers treated with RT (lung, prostate, breast) Largest potential usage for radiation induced esophagitis (out of conditions below)

Increasing SBRT Efficacy (Stereotactic Radiotherapy)

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 Focal irradiation of human tumor xenografts (H1299 NSCLC) in mice RT anti-cancer synergy of avasopasem (GC4419) increases with bigger RT fractions Bigger fraction à More O2 à More 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 Engineered to overexpress catalase (disposes of H2O2) when induced by doxycycline Overexpressing catalase blocks synergy with RT by removing avasopasem (GC4419)-generated H2O2 Tumor tissue H2O2 reduced when doxycycline added to RT + avasopasem (GC4419)

…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-4 Also appeared to reduce metastasis & increase response in unirradiated secondary tumors

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 Cancer (LAPC) 3rd leading cause of cancer death in US – 45,750 deaths in 2019 One year survival is 20% & 5-year survival is ~5% Placebo-controlled, Adaptive Trial: Escalating SBRT Dose (LO-ET Method1) both arms 48 Patient Pilot Trial Trial status as of August 2019 Single-Center: 19 patients treated Numerical differences in favor of avasopasem (GC4419) arm in PFS, local tumor response rate & overall response rate Data is preliminary, not yet audited, & subject to change Now Multi-Center, targeting 29 more patients R Evaluated at 2, 3, 6 & 12 months Screened After 6 months of induction Chemo SBRT + GC4419 x 5 doses SBRT + Placebo x 5 doses 1° Objective is MTD of SBRT (at 12 months) 2° Objectives include Progression-Free Survival (PFS) Overall Response Rate at 90 days

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-cancer/current-treatment-landscape--and-emerging-therapies-for-pancreatic-cancer ©2020 National Cancer Data Base (NCDB) - Commission on Cancer (CoC) - Saturday, January 4, 2020 - http://oliver.facs.org/BMPub/index.cfm Pancreatic Cancer 2018: US (World) Diagnoses 55k (459k) Deaths 44k (432k) 2/3rds Dx age > 65 5-Yr Survival (US) = 9.3% (2009-15)

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 deaths in 2019 SBRT commonly used for smaller peripheral tumors Lung toxicity limits use in larger or centrally-located tumors Pilot Study Phase 1b/2a in NSCLC with GC4711 + SBRT 1st Stage: 5 fractions of SBRT +/- GC4711 2nd Stage: 5 fractions of SBRT + checkpoint inhibitor +/- GC4711 Endpoints include safety, acute pneumonitis (DLCO2) & PFS GC4711 + SBRT Combination in NSC Lung Cancer 1 2019 SEER Data 2 DLCO = diffusing capacity of the lung for carbon monoxide

Summary

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) GC4711 New Drug Application Commercialization FUTURE POTENTIAL Avasopasem (GC4419) Avasopasem (GC4419)