UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of report (Date of earliest event reported):
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction of incorporation or organization) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
(Address of principal executive offices) (Zip Code)
(Registrant’s telephone number, include area code)
N/A
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered | ||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
| Item 7.01. | Regulation FD Disclosure. |
Galera Therapeutics, Inc. (the “Company”) from time to time presents and/or distributes to the investment community at various industry and other conferences slide presentations to provide updates and summaries of its business. On September 8, 2021, the Company posted an updated corporate slide presentation in the “Investors” portion of its website at www.galeratx.com. A copy of its current corporate slide presentation is attached to this Current Report on Form 8-K as Exhibit 99.1. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit 99.1.
The information contained in Item 7.01 of this Current Report on Form 8-K (including Exhibit 99.1 attached hereto) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly provided by specific reference in such a filing.
| Item 8.01. | Other Events. |
On September 8, 2021, the Company announced final results from its Phase 1/2 pilot trial of its dismutase mimetic candidate, GC4419, versus placebo, in patients with unresectable or borderline resectable locally advanced pancreatic cancer (LAPC), who are undergoing stereotactic body radiation therapy (SBRT). The results include a minimum of one year of follow up on all 42 patients enrolled in the trial.
In the trial, improvements were observed in overall survival (HR=0.48; 95% CI: 0.20-1.14; p=0.090), progression-free survival (HR=0.46; 95% CI: 0.22-0.98; p=0.040), local tumor control (HR=0.30; 95% CI: 0.08-1.10; p=0.055) and time to distant metastases (HR=0.39; 95% CI: 0.16-0.93; p=0.028). 46% of patients in the active arm were alive at last follow-up (11 out of 24) compared to 33% in the placebo arm (6 out of 18). As previously reported, 29% of patients in the active arm achieved a 30% or greater decrease in primary tumor size (partial response) compared to 11% of patients in the placebo arm. GC4419 was well tolerated, with similar rates of early and late adverse events in the active and placebo arms.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits
The following exhibit relating to Item 7.01 shall be deemed to be furnished, and not filed:
| Exhibit |
Description | |
| 99.1 | Corporate Slide Presentation of Galera Therapeutics, Inc. dated September 8, 2021 | |
| 104 | Cover Page Interactive Data File (embedded within the inline XBRL document) | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| GALERA THERAPEUTICS, INC. | ||||||
| Date: September 8, 2021 | By: | /s/ J. Mel Sorensen, M.D. | ||||
| J. Mel Sorensen, M.D. | ||||||
| President and Chief Executive Officer | ||||||
Transforming radiotherapy for patients with cancer September 2021 Exhibit 99.1
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 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, our plans to prepare for commercialization and a US launch, 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 Annual Report on Form 10-K for the year ended December 31, 2020 filed with the U.S. Securities Exchange Commission (SEC) 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.
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 external beam RT Toxicity Efficacy Galera’s Goal Radioprotection Galera’s Goal Radiosensitization SBRT Stereotactic Body Radiation Therapy @2021 Galera Therapeutics, Inc.
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 cells1 Hydrogen Peroxide (H2O2) is more toxic to cancer cells than normal cells2 @2021 Galera Therapeutics, Inc. 1Sonis S. Drug Design, Development and Therapy 2021:15 1021–1029 2Park WH: Oncol Rep 40: 1787-1794, 2018
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. CA Cancer J Clin 2021;71:7–33 Transforming Radiotherapy Avasopasem Reducing IMRT Toxicity Breakthrough Therapy with Phase 3 Fully Enrolled GC4711 Increasing SBRT Efficacy Large Markets with High Unmet Need Encouraging Survival Data in Pancreatic Cancer Trial1 18 Million New Cancers in World in 20202 (1.9M in US) Severe Oral Mucositis In Head & Neck Cancer Esophagitis in Lung Cancer Pancreatic Cancer Locally Advanced Lung Cancer Locally Advanced Radiotherapy needed by over half of patients with cancer Galera building US commercial team for Avasopasem Launch @2021 Galera Therapeutics, Inc.
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 trial in patients with lung cancer building on avasopasem safety and tolerability findings from SOM trials in patients with HNC 3Trial to assess anti-cancer efficacy of SBRT +/- GC4711; subsequently, intend to assess anti-cancer efficacy of SBRT and checkpoint inhibitor +/- GC4711 4The first SBRT combination trial used GC4419 (avasopasem). Observations from this pilot trial used to guide development of GC4711 in combination with SBRT Phase 2 Phase 3 Topline Data: 4Q 2021 Topline Data: 4Q 2021 SBRT Combo3 Topline Data: 1H 2022 Initial Data: 1H 2022 IMRT induced Esophagitis2 Final Data: 3Q 2021 Initiated Trial: 2Q 2021 SBRT Combo4 ROMAN: Avasopasem vs. Placebo EUSOM: Avasopasem AESOP: Avasopasem GRECO-1: GC4711 vs. Placebo Pilot: GC4419 vs. Placebo GRECO-2: GC4711 vs. Placebo √ Both Trials Fully Enrolled √ √
Reducing IMRT Toxicity
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 Completed & Published3 455 38 60 223 43 Pts @2021 Galera Therapeutics, Inc. 1EUSOM is a single-arm multi-center trial evaluating the safety and efficacy of avasopasem in patients with HNC in Europe 2Phase 2a trial in patients with lung cancer building on avasopasem safety and tolerability findings from SOM trials in patients with HNC 3Anderson CM et al. Int J Radiat Oncol Biol Phys. 2018 Feb 1;100(2):427-435 4Anderson CM et al. J Clin Oncol. 2019;37(34):3256-3265. ROMAN: Avasopasem vs. Placebo EUSOM: Avasopasem AESOP: Avasopasem RP2b: Avasopasem vs. Placebo Ph 1b/2a: Avasopasem
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 Ineffective MASCC Guidelines focus only on symptoms1 Market Research with 150 Radiation Oncologists2 Basic Oral care Opioids, anesthetics Coating agents Benzydamine Anti-inflammatories Only 20% of physicians believe topical agents perform well for oral mucositis 1 No ulcers Erythema & soreness 3 Ulcers Require liquid diet 4 Ulcers Unable to eat or drink 2 Ulcers Able to eat solid diet 1Elad S et al, MASCC/ISOO Clinical Practice Guidelines for the Management of Mucositis Secondary to Cancer Therapy. Cancer 2020;126:4423-4431 2Galera Market Research
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 Patients with Head & Neck Cancer (locally advanced) Receiving standard IMRT and cisplatin over 7 weeks 70% expected to get SOM Primary: Reduction in the incidence of SOM Secondary: Reduction in SOM duration & severity R Randomized 3:2
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 in normal cells from RT burst of superoxide Does not interfere with RT anti-cancer efficacy BTD granted for oral mucositis in February 2018 Based on robust Phase 2b data in 223 patients Enrollment complete Single Phase 3 sufficient for NDA with Phase 2b as supportive
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 Endpoints Patients with Head & Neck Cancer (locally advanced) Receiving standard IMRT and cisplatin over 7 weeks 70% expected to get SOM Primary: Reduction in SOM duration Secondary: Reduction in SOM incidence & severity
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 2019 37:34, 3256-3265 *Secondary endpoints (incidence and severity) have nominal p values compared to placebo Intent-To-Treat (ITT) Population
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 Onset of SOM PLACEBO Arm (45 of 74 Pts had ≥1 visit with SOM) 90MG Avasopasem Arm (35 of 76 Pts had ≥1 visit with SOM) Anderson CM et al. Journal of Clinical Oncology 2019 37:34, 3256-3265
Radiotherapy Efficacy Maintained Over Two Years @2021 Galera Therapeutics, Inc. Final ITT Analysis
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% 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 CM et al. Journal of Clinical Oncology 2019 37:34, 3256-3265
SOM 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 SOM Locally advanced HNC is curable with the standard-of-care IMRT and cisplatin regimen
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.
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 currently infuse drugs1 34% more coordinate with medical oncology to infuse patients Additional 17% can add capabilities to infuse patients 72% Sites with Existing Infusion Capability1 64% Market Patient Share 1Primary market research with 125 IMRT centers in the US
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)
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 to Add Capabilities Total % Sample Distribution 38% 34% 17% 11% Avasopasem Infusion Owner Rad Onc Med Onc Rad Onc - Ease of Coordination Today High High Low Low Likelihood of Prescribing Avasopasem High High High Low Data in above table based on primary research with 125 IMRT centers in the US
US Radiation Oncologists Trending Away from Private Practice @2021 Galera Therapeutics, Inc. 1Data from ASTRO
@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 access Head and neck cancer not a focus for cost control measure Favorable Payer Landscape
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 toxicities in the oral mucosa, please indicate how you might use (maximum %) Product X for the following radiation associated conditions? Galera primary research with 150 Radiation Oncologists
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
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) Supportive care measures: Soft bland diet Prophylactic antifungals Dilation if stricture develops 6 weeks of standard IMRT to ≥ 5 cm of esophagus Will compare esophagitis rate with historical data Asymptomatic Symptoms & altered eating/swallowing Severely altered eating or swallowing Required urgent operative intervention Results in death 1 2 4 3 5 ♦♦♦♦♦ ♦♦♦♦♦ ♦♦♦♦♦ ♦♦♦♦♦ ♦♦♦♦♦ ♦♦♦♦♦
Increasing SBRT Efficacy
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 Data:3Q 2021 Pilot: GC4419 vs. Placebo Phase 1 Next Anticipated Milestone Phase 2 Phase 3 160 71 42 Pts √ 1First SBRT combination trial used GC4419 (avasopasem). Observations from this pilot trial used to guide development of GC4711 in combination with SBRT 2Trial to assess anti-cancer efficacy of SBRT +/- GC4711; subsequently, intend to assess anti-cancer efficacy of SBRT and checkpoint inhibitor +/- GC4711 √
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 increasing for locoregional control of 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, Henry Mancini, Sally Ride, Munsters’ Fred Gwynne, Columnist William Safire, Michal Landon @2021 Galera Therapeutics, Inc.
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) Screened after 4-6 months of chemotherapy Primary: Safety and feasibility of dismutase mimetic with SBRT Secondary: Survival (OS, PFS), Tumor Control (LRC, DMC), Response Rate SBRT + GC4419 90mg x 5 doses SBRT+ Placebo x 5 doses R
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 & Progression-Free Survival HR < 0.4 for Local & Distant Tumor Control Results reinforce the rationale for ongoing GRECO-2 trial
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% / 71% ECOG Performance status 0/1/2 50% / 50% / 0% 50% / 46% / 4% Prior chemo, duration median (range), wks 22 (12.0–36.3) 18 (9.1–67.1) CA19-9 at randomization, median (range) 71 (0.5–5505) 31 (0.3–719) Smokers/Nonsmokers 17% / 83% 8% / 92% CA 19-9 = Carbohydrate Antigen 19-9 is a tumor marker for pancreatic cancer ECOG = Eastern Cooperative Oncology Group Performance Status Criteria
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 67% 46% GI AE 44% 42% Severe AE 0% 0% >90 days after SBRT Any AE 22% 25% GI AE 17% 21% Severe AE 11% 8% AEs Considered related by Investigator to GC/PBO Any TRAE SBRT + PBO SBRT + GC ≤90 days after SBRT Any AE 67% 46% GI AE 44% 42% Severe AE 0% 0% >90 days after SBRT Any AE 17% 21% GI AE 17% 17% Severe AE 11% 4% AE = Adverse Event, GI AE = Gastrointestinal AE No bleeding ulcers by 12-week endoscopy
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 & Distant Tumor Control Partial Response Rate GC29% PBO11% Median OS PFS (mos) GC 17.0 11.2 PBO 13.3 7.1 MedianLRC DMC (mos) GC NR 13.9 PBO 9.6 7.0 Tumor Control LRC DMC Hazard Ratio 0.30 0.39 Survival OS PFS Hazard Ratio 0.48 0.46 *R0 = margins free of microscopic tumor (5/5 patients on GC and 1/2 patients on placebo had clear margins at surgery) LRC = Locoregional Control; DMC = Control of Distant Metastases; PFS = Progression-Free Survival; OS = Overall Survival; NR = Not Reached Surgery GC PBO R0* 5 1
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-month follow-up on all patients, PFS defined as local progression or distant metastasis, not censored for treatment post SBRT
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, not censored for treatment post SBRT Distant Metastases Control – outside RT Field P-value = 0.0279Hazard Ratio = 0.39 Locoregional Control (LRC) – within RT Field P-value = 0.0551Hazard Ratio = 0.30
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 (Response Evaluation Criteria in Solid Tumors)NE = not evaluable (scans not performed post SBRT) R0 = margins free of microscopic tumor (5/5 patients on GC and 1/2 patients on placebo had clear margins at surgery)R1 = positive tumor margins at surgery
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 patients SBRT + GC4711 100mg x 5 doses SBRT+ Placebo x 5 doses GRECO-2 in Pancreatic Cancer 160 Patients Placebo-controlled multicenter trial Locally Advanced Pancreatic Cancer Following 4 months chemotherapy Status: Open & recruiting patients R @2021 Galera Therapeutics, Inc.
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 15,430 Node-Negative NSCLC Peripheral Tumor >3cm Central Tumor <3cm Central Tumor >3cm Surgery ONLY 16% 30% 12% SBRT (+/- other modalities) 81% 67% 85% Other 3% 2% 4%
Corporate Highlights
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 trial in patients with lung cancer building on avasopasem safety and tolerability findings from SOM trials in patients with HNC 3Trial to assess anti-cancer efficacy of SBRT +/- GC4711; subsequently, intend to assess anti-cancer efficacy of SBRT and checkpoint inhibitor +/- GC4711 4The first SBRT combination trial used GC4419 (avasopasem). Observations from this pilot trial used to guide development of GC4711 in combination with SBRT Phase 2 Phase 3 Topline Data: 4Q 2021 Topline Data: 4Q 2021 SBRT Combo3 Topline Data: 1H 2022 Initial Data: 1H 2022 IMRT induced Esophagitis2 Final Data: 3Q 2021 Initiated Trial: 2Q 2021 SBRT Combo4 ROMAN: Avasopasem vs. Placebo EUSOM: Avasopasem AESOP: Avasopasem GRECO-1: GC4711 vs. Placebo Pilot: GC4419 vs. Placebo GRECO-2: GC4711 vs. Placebo √ Both Trials Fully Enrolled √ √
Thank you.
Back-up Slides Mechanistic and Preclinical Data
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
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 Equivalent Doses Sishc, et al., Science Translational Medicine 12 May 2021:Vol. 13, Issue 593
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
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
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