UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 7.01 | Regulation FD Disclosure. |
On October 26, 2022, Galera Therapeutics, Inc. (the “Company”) issued a press release announcing the presentation of one-year tumor and renal function outcomes data from its Phase 3 ROMAN trial of avasopasem manganese 90 mg for radiotherapy-induced severe oral mucositis (SOM), as well as topline results from a recently completed meta-analysis of the ROMAN and GT-201 SOM trial results, at the 2022 American Society for Radiation Oncology (ASTRO) Annual Meeting. The press release also announces that final data from the Company’s Phase 2 AESOP trial of avasopasem for radiotherapy-induced esophagitis were also presented in a separate session and that, in addition, poster presentations during ASTRO highlighted the completed Phase 2 EUSOM trial of avasopasem for SOM in Europe and the ongoing GRECO-1 trial of rucosopasem for non-small cell lung cancer. A copy of the press release is attached to this Current Report on Form 8-K (“Form 8-K”) as Exhibit 99.1.
On October 26, 2022, the Company posted an updated corporate slide presentation in the “Investors” portion of its website at www.galeratx.com. A copy of that corporate slide presentation is attached to this Form 8-K as Exhibit 99.2. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit 99.2.
The information contained in Item 7.01 of this Form 8-K (including Exhibit 99.1 and Exhibit 99.2 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 October 26, 2022, the Company announced the presentation of the one-year tumor and renal function outcomes data from its Phase 3 ROMAN trial of avasopasem manganese 90 mg for radiotherapy-induced severe oral mucositis (SOM), as well as topline results from a recently completed meta-analysis of the ROMAN and GT-201 SOM trial results at the 2022 American Society for Radiation Oncology (ASTRO) Annual Meeting.
Highlights from the Phase 3 ROMAN data presented at ASTRO:
| • | After one-year follow-up, patients with locally advanced head and neck cancer treated with avasopasem in combination with the standard-of-care regimen (intensity-modulated radiation therapy (IMRT) + cisplatin) demonstrated comparable tumor outcomes and overall survival to patients in the placebo arm. |
| • | Patients treated with avasopasem in combination with IMRT + cisplatin had a 10 percent incidence of chronic kidney disease (CKD) after one year of post treatment follow-up, compared to 20 percent of patients in the placebo arm (p=0.0043). CKD (eGFR <60) is a known toxicity risk with cisplatin for these patients and the results highlight success on a predefined exploratory endpoint of renal function. The prospective exploration of this potential benefit of avasopasem was driven by published preclinical data and a post hoc assessment of patients from the GT-201 trial presented at the 2020 American Society of Clinical Oncology (ASCO) annual meeting. |
In addition to the ROMAN long-term endpoints, a meta-analysis of the Company’s two randomized placebo-controlled trials (ROMAN and GT-201; n=551) was included in the ASTRO presentation; these results reinforced that avasopasem therapy resulted in clinically meaningful reductions in radiotherapy-induced SOM, including a significant reduction in the incidence (19% reduction; p=0.0053), duration (58% reduction in the median number of days of SOM; p=0.0002), onset (28% delay in the median number of days to first SOM; p=0.0005) and severity (32% reduction in the incidence of Grade 4 oral mucositis; p=0.0102) of SOM compared to placebo.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits
Exhibits 99.1 and 99.2 relating to Item 7.01 shall be deemed to be furnished, and not filed:
| Exhibit |
Description | |
| 99.1 | Press Release of Galera Therapeutics, Inc. issued October 26, 2022 | |
| 99.2 | Corporate Presentation of Galera Therapeutics, Inc. dated October 26, 2022 | |
| 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: October 26, 2022 | By: | /s/ J. Mel Sorensen, M.D. | ||||
| J. Mel Sorensen, M.D. | ||||||
| President and Chief Executive Officer | ||||||
Exhibit 99.1
Galera Announces Presentation of Phase 3 ROMAN Long-term Follow-up Data at 2022 American Society for Radiation Oncology (ASTRO) Annual Meeting
Tumor outcomes and overall survival maintained in patients with HNC at one-year
Cisplatin-related chronic kidney disease reduced by 50% in avasopasem patients compared to placebo at one-year
Meta-analysis of ROMAN and GT-201 (Phase 2b) supports efficacy across trials and key SOM endpoints
Company remains on track to submit NDA to the U.S. FDA for avasopasem for radiotherapy-induced severe oral mucositis by end of 2022
MALVERN, Pa. – October 26, 2022 – Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced the presentation of one-year tumor and renal function outcomes data from its Phase 3 ROMAN trial of avasopasem manganese 90 mg for radiotherapy-induced severe oral mucositis (SOM), as well as topline results from a recently completed meta-analysis of the ROMAN and GT-201 SOM trial results, at the 2022 American Society for Radiation Oncology (ASTRO) Annual Meeting. Final data from its Phase 2 AESOP trial of avasopasem for radiotherapy-induced esophagitis were also presented today in a separate session. In addition, poster presentations during ASTRO highlighted the completed Phase 2 EUSOM trial of avasopasem for SOM in Europe and the ongoing GRECO-1 trial of rucosopasem for non-small cell lung cancer. The presentations and posters are currently available in the ASTRO digital program.
Highlights from the Phase 3 ROMAN data presented at ASTRO:
| • | After one-year follow-up, patients with locally advanced head and neck cancer treated with avasopasem in combination with the standard-of-care regimen (intensity-modulated radiation therapy (IMRT) + cisplatin) demonstrated comparable tumor outcomes and overall survival to patients in the placebo arm. |
| • | Patients treated with avasopasem in combination with IMRT + cisplatin had a 10 percent incidence of chronic kidney disease (CKD) after one year of post treatment follow-up, compared to 20 percent of patients in the placebo arm (p=0.0043). CKD (eGFR <60) is a known toxicity risk with cisplatin for these patients and the results highlight success on a predefined exploratory endpoint of renal function. The prospective exploration of this potential benefit of avasopasem was driven by published preclinical data and a post hoc assessment of patients from the GT-201 trial presented at the 2020 American Society of Clinical Oncology (ASCO) annual meeting. |
“The ROMAN one-year follow-up data show that avasopasem can protect head and neck cancer patients from severe oral mucositis without affecting the treatment benefit of standard-of-care chemoradiotherapy,” said Dr. Carryn Anderson, Clinical Associate Professor of Radiation Oncology at the University of Iowa. “Treatment with avasopasem also significantly reduced the likelihood of patients developing cisplatin-related chronic kidney disease compared to placebo at one-year follow-up, suggesting avasopasem can reduce cisplatin renal toxicities and greatly improve patient quality of life.”
In addition to the ROMAN long-term endpoints, a meta-analysis of Galera’s two randomized placebo-controlled trials (ROMAN and GT-201; n=551) was included in Dr. Anderson’s ASTRO presentation; these results reinforced that avasopasem therapy resulted in clinically meaningful reductions in radiotherapy-induced SOM, including a significant reduction in the incidence, duration, onset and severity of SOM compared to placebo.
“The data presented today affirm our belief that avasopasem is providing real benefit for patients with head and neck cancer undergoing the current standard of care,” said Mel Sorensen, M.D., Galera’s President and CEO. “We look forward to submitting the NDA to the FDA by the end of 2022 with the intention of bringing avasopasem to patients as the first FDA-approved drug for radiotherapy-induced SOM.”
About Severe Oral Mucositis (SOM)
Approximately 42,000 patients with head and neck cancer undergo standard-of-care radiotherapy every year in the U.S. and are at risk of experiencing SOM. In patients with head and neck cancer, radiotherapy is a mainstay of treatment. Approximately 70 percent of patients receiving radiotherapy for head and neck cancer develop SOM, defined by the inability to eat solid food or drink liquids. The impact on patients who develop SOM is substantial, particularly when hospitalization and/or surgical placement of PEG tubes to maintain nutrition and hydration are required. SOM can adversely affect cancer treatment outcomes by causing interruptions in radiotherapy, which may compromise the otherwise good prognosis for tumor control in many of these patients. There is currently no drug approved to prevent or treat SOM for these patients.
About Avasopasem
Avasopasem manganese (avasopasem, or GC4419) is a selective small molecule dismutase mimetic in development for the reduction of radiotherapy-induced severe oral mucositis (SOM) in patients with locally advanced head and neck cancer (HNC) and for the reduction of radiotherapy-induced esophagitis in patients with lung cancer. The FDA has granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of SOM induced by radiotherapy, with or without systemic therapy.
About Galera Therapeutics
Galera Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutic candidates that have the potential to transform radiotherapy in cancer. Galera’s selective dismutase mimetic product candidate avasopasem manganese (avasopasem, or GC4419) is being evaluated for radiotherapy-induced toxicities. The
Company’s second product candidate, rucosopasem manganese (rucosopasem, or GC4711), is in clinical-stage development to augment the anti-cancer efficacy of stereotactic body radiation therapy in patients with non-small cell lung cancer and locally advanced pancreatic cancer. Galera is headquartered in Malvern, PA. For more information, please visit www.galeratx.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding: the expectations surrounding the continued advancement of Galera’s product pipeline; the potential safety and efficacy of Galera’s product candidates and their regulatory and clinical development; the timing of the submission of an NDA for avasopasem for the treatment of radiotherapy-induced severe oral mucositis (SOM) in patients with locally advanced head and neck cancer with the FDA; the ability of avasopasem to protect head and neck cancer patients from SOM without affecting the treatment benefit of standard-of-care chemoradiotherapy; the ability of avasopasem to reduce cisplatin renal toxicities and improve patient quality of life; and the Company’s ability to achieve its goal of transforming radiotherapy in cancer treatment with its selective dismutase mimetics. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause Galera’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: Galera’s limited operating history; anticipating continued losses for the foreseeable future; needing substantial funding and the ability to raise capital; Galera’s dependence on avasopasem manganese (GC4419); uncertainties inherent in the conduct of clinical trials; difficulties or delays enrolling patients in clinical trials; the FDA’s acceptance of data from clinical trials outside the United States; undesirable side effects from Galera’s product candidates; risks relating to the regulatory approval process; failure to capitalize on more profitable product candidates or indications; ability to receive or maintain Breakthrough Therapy Designation or Fast Track Designation for product candidates; failure to obtain regulatory approval of product candidates in the United States or other jurisdictions; ongoing regulatory obligations and continued regulatory review; risks related to commercialization; risks related to competition; ability to retain key employees and manage growth; risks related to intellectual property; inability to maintain collaborations or the failure of these collaborations; Galera’s reliance on third parties; the possibility of system failures or security breaches; liability related to the privacy of health information obtained from clinical trials and product liability lawsuits; unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives; environmental, health and safety laws and regulations; the impact of the COVID-19 pandemic on Galera’s business and operations, including preclinical studies and clinical trials, and general economic conditions; risks related to ownership of Galera’s common stock; the possibility of Galera’s common stock being delisted from The Nasdaq Global Market; and significant costs as a result of operating as a public company. These and other important factors discussed under the caption “Risk Factors” in Galera’s Annual Report on Form 10-K for the year ended December 31, 2021 filed with the U.S. Securities and Exchange Commission (SEC) and Galera’s other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any forward-looking statements speak only as of the date of this press release and are based on information available to Galera as of the date of this release, and Galera assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.
###
Investor Contacts:
Christopher Degnan
Galera Therapeutics, Inc.
610-725-1500
cdegnan@galeratx.com
William Windham
Solebury Strategic Communications
646-378-2946
wwindham@soleburystrat.com
Media Contact:
Zara Lockshin
Solebury Strategic Communications
330-417-6250
zlockshin@soleburystrat.com
Exhibit 99.2 Transforming radiotherapy for patients with cancer October 2022
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 been 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 timing thereof, and therapeutic potential of current and prospective product candidates, plans and timing for the commencement of, and the release of data from, clinical trials, plans and timing for the submission of applications for marketing approval to regulatory authorities, our plans to prepare for commercialization and a U.S. 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, 2021 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. ©2022 Galera Therapeutics, Inc. 2
Efficacy Radiation Therapy – Key Role in Cancer Treatment 1 1.9 million new cancers annually in US; over 50% of patients receive radiation therapy as part of their treatment SBRT IMRT Stereotactic Body Radiation Therapy Intensity Modulated Radiation Therapy Low doses for weeks High doses for days (~2 Gy/day) (>5 Gy/day) Most used form of external beam RT Cutting edge form of external beam RT Galera’s Goal Galera’s Goal Radioprotection Radiosensitization 1 SEER data for 2020 ©2022 Galera Therapeutics, Inc. 3 Toxicity
Efficacy Galera’s Technology: Dismutase Mimetics Mechanism of action is to convert RT-induced burst of Superoxide to Hydrogen Peroxide Rucosopasem (GC4711) Avasopasem (GC4419) Superoxide Shifts balance in normal & cancer cells (O ) is more 2 from superoxide to hydrogen peroxide damaging to normal cells Hydrogen than cancer 1 Peroxide (H O ) cells 2 2 is more toxic to cancer cells than 2 normal cells Radioprotection Radiosensitization of Low Dose RT of High Dose RT 1 Sonis S. Drug Design, Development and Therapy 2021:15 1021–1029 2 Park WH: Oncol Rep 40: 1787-1794, 2018 ©2022 Galera Therapeutics, Inc. 4 Toxicity
Transforming Radiotherapy Potential to improve both sides of the therapeutic index Avasopasem Rucosopasem Reducing IMRT Toxicity Increasing SBRT Efficacy Ø Severe Oral Mucositis in Head & Neck Cancer (HNC)Ø Locally Advanced Pancreatic Cancer (LAPC) Ø Esophagitis in Lung CancerØ Non-Small Cell Lung Cancer (NSCLC) 1 2 positive randomized placebo-controlled trials in HNC Encouraging survival data in pancreatic cancer trial • GT-201 Phase 2b (n=223) GRECO trials evaluating SBRT + rucosopasem – • ROMAN Phase 3 (n=455) Enrollment expected to complete 2H 2023 • GRECO-1 in NSCLC NDA submission planned by end of 2022 • GRECO-2 in LAPC • FDA Breakthrough Therapy Designation (BTD) 1 The first SBRT combination trial used GC4419 (avasopasem). Observations from this pilot trial used to guide development of rucosopasem in combination with SBRT. ©2022 Galera Therapeutics, Inc. 5
Clinical Stage Pipeline Phase 1 Phase 2 Phase 3 Trial Status/Anticipated Milestones Radioprotection ROMAN: AVA vs. Placebo (n=455) NDA Submission by Y/E 2022 4 GT-201: AVA vs. Placebo (n=223) Completed & Published 1 Head & Neck Cancer (SOM) EUSOM: AVA (n=38) Completed in 2021 5 Ph 1b/2a AVA (n=43) Completed & Published 2 Lung Cancer (Esophagitis) AESOP: AVA in NSCLC Completed in 2022 Radiosensitization GRECO-2: RUCO vs. Placebo Enrollment to Complete 2H2023 3 Pancreatic Cancer Locally Advanced Pilot: AVA vs. Placebo (n=42) Completed in 2021 Lung Cancer GRECO-1: RUCO vs. Placebo Enrollment to Complete 2H2023 Locally Advanced Severe Oral Mucositis = SOM 1 EUSOM was a single-arm multi-center trial evaluating the safety and efficacy of avasopasem in patients with HNC in Europe. Avasopasem = AVA 2 Phase 2a trial that evaluated incidence of esophagitis in patients with lung cancer receiving standard-of-care chemoradiation. Rucosopasem = RUCO 3 First SBRT combination trial was a pilot & used avasopasem (AVA). Subsequent SBRT trials combine rucosopasem (RUCO) with SBRT. Intensity Modulated RT = IMRT 4 Anderson CM et al. J Clin Oncol. 2019;37(34):3256-3265. Stereotactic Body RT = SBRT 5 Anderson CM et al. Int J Radiat Oncol Biol Phys. 2018 Feb 1;100(2):427-435. ©2022 Galera Therapeutics, Inc. 6
Reducing IMRT Toxicity 7
Severe Oral Mucositis in Head & Neck Cancer 1 The most burdensome toxicity of standard-of-care chemoradiotherapy (radiotherapy & cisplatin) 70% Patients Get SOM Current Approaches Physicians Consider (Grade 3 or 4 OM) Lack Efficacy Topicals Ineffective WHO Scale Criteria for MASCC Guidelines focus Market Research with 150 2 1 Oral Mucositis principally on symptoms Radiation Oncologists Severe • Basic Oral care • Only 20% of physicians • Opioids, anesthetics believe topical agents 1 2 3 4 No ulcers Ulcers Ulcers Ulcers • Coating agents perform well for oral Erythema Able to eat Require Unable to • Benzydamine mucositis & soreness solid diet liquid diet eat or drink • Anti-inflammatories • Laser and other light therapy 1 Galera Market Research 2 Elad S et al, MASCC/ISOO Clinical Practice Guidelines for the Management of Mucositis Secondary to Cancer Therapy. Cancer 2020;126:4423-4431 ©2022 Galera Therapeutics, Inc. 8
Avasopasem: First-to-Market Potential for Severe Oral Mucositis Achieved statistical significance in two randomized trials in patients with head and neck cancer Phase 1 Phase 2 Phase 3 Trial Status/Anticipated Milestones Avasopasem Clinical Trials ROMAN: AVA vs. Placebo (n=455) NDA Submission by Y/E 2022 3 GT-201: AVA vs. Placebo (n=223) Completed & Published 1 Head & Neck Cancer (SOM) 7 weeks IMRT & Cisplatin EUSOM: AVA (n=38) Completed in 2021 4 Ph 1b/2a AVA (n=43) Completed & Published 2 Lung Cancer (Esophagitis) AESOP: AVA in NSCLC Completed in 2022 6 weeks IMRT & Chemo Avasopasem has FDA Breakthrough Therapy Designation based on GT-201 results 1 EUSOM was a single-arm multi-center trial evaluating the safety and efficacy of avasopasem in patients with HNC in Europe. 2 Phase 2a trial that evaluated incidence of esophagitis in patients with lung cancer receiving standard-of-care chemoradiation. 3 Anderson CM et al. J Clin Oncol. 2019;37(34):3256-3265. 4 Anderson CM et al. Int J Radiat Oncol Biol Phys. 2018 Feb 1;100(2):427-435. ©2022 Galera Therapeutics, Inc. 9
Comparison of Galera’s Two Placebo-Controlled Trials Both GT-201 and ROMAN were double-blind placebo-controlled randomized trials GT-201 Phase 2b Similarities ROMAN Phase 3 N=223 N=455 • SoC IMRT + Cisplatin Avasopasem 90mg x 7 weeks Avasopasem 90mg x 7 weeks • 60-minute IV infusion Avasopasem 30mg x 7 weeks R just before IMRT R Randomized 3:2 • WHO Grading Placebo x 7 weeks Placebo x 7 weeks • Multicenter in North America (~90% US) Endpoints Endpoints • Patients with Head & Neck Cancer (locally advanced) • Primary: Reduction in SOM • Primary: Reduction in the • Same inclusion / exclusion duration incidence of SOM criteria • Secondary: Reduction in SOM • Secondary: Reduction in SOM incidence & severity duration & severity ©2022 Galera Therapeutics, Inc. 10
Most Frequent Adverse Events on the Two Randomized Trials Avasopasem 90mg appears generally well tolerated (all grades and causes) 1 2,3 ROMAN GT-201 0% 20% 40% 60% 80% 100% 0% 20% 40% 60% 80% 100% Lymphopenia Lymphopenia Nausea Nausea Fatigue Fatigue Oropharyngeal pain Oropharyngeal Pain Constipation Constipation Dysgeusia Radiation skin injury Dry mouth Vomiting Radiation skin injury Dysphagia PBO PBO Vomiting Dysgeusia AVA AVA Weight decreased Weight decreased Leukopenia Oral candidiasis Dysphagia Leucopenia Dehydration Diarrhea Dehydration Decreased appetite Neutropenia Decreased appetite Headache Headache Tinnitus Neutropenia Tinnitus Oral candidiasis 2 1 Intent-to-Treat (ITT) population: 72 patients on placebo; 72 patients on 90mg avasopasem ITT population: 166 patients on placebo; 241 on 90mg avasopasem 3 Anderson CM et al. Journal of Clinical Oncology 2019 Dec 1; 37(34): 3256-3265 ©2022 Galera Therapeutics, Inc. 11
Most Frequent ≥ Grade 3 AEs on the Two Randomized Trials Avasopasem 90mg appears generally well tolerated 1 2,3 ROMAN GT-201 0% 20% 40% 60% 80% 100% 0% 20% 40% 60% 80% 100% Lymphopenia Lymphopenia Leukopenia Leukopenia Neutropenia Neutropenia Dysphagia Dysphagia Oropharyngeal pain Anemia Anaemia Decreased appetite Decreased appetite Hyponatremia PBO PBO Nausea Nausea AVA AVA Hypokalaemia Dehydration Fatigue Hypokalemia Febrile neutropenia Oropharyngeal pain Dehydration Vomiting Hypertension Febrile neutropenia Radiation skin injury Hypertension Syncope Hyperglycemia 2 1 ITT population: 166 patients on placebo; 241 on 90mg avasopasem Intent-to-Treat (ITT) population: 72 patients on placebo; 72 patients on 90mg avasopasem 3 AE = Adverse Event Anderson CM et al. Journal of Clinical Oncology 2019 Dec 1; 37(34): 3256-3265 ©2022 Galera Therapeutics, Inc. 12
Multiple Efficacy Parameters Define the Patient Burden of SOM Incidence doesn’t tell full story; real patient examples from ROMAN 1° endpoint 2° endpoints Exploratory OM evaluation 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 è 10 Gyè 20 Gyè 30 Gyè 40 Gyè 50 Gyè 60 Gyè65–70 Follow-up Cumulative RT SOM # Days of Grade 4 Days to incidence SOM incidence onset 0 0 2 2 2 2 2 2 2 2 2 2 2 2 2 2 0 0 0 - - - A B 0 0 0 0 0 0 0 0 0 0 0 1 1 3 0 0 1 7 0 46 ROMAN C patient 0 0 2 2 3 2 2 2 2 2 2 2 0 0 2 2 1 3 0 17 examples D 0 0 0 0 3 3 3 3 3 3 3 3 3 3 3 3 1 44 0 16 E 0 0 0 1 2 3 3 4 4 4 4 4 4 4 4 3 1 45 1 20 OM=oral mucositis; RT=radiation therapy Anderson CM, Lee C, Kelley JR, et al. ROMAN: Phase 3 trial of avasopasem manganese (GC4419) for severe oral mucositis (SOM) in patients receiving chemoradiotherapy (CRT) for locally advanced, nonmetastatic head and neck cancer (LAHNC). Presented at ASCO Annual Meeting, June 3, 2022. ©2022 Galera Therapeutics, Inc. 13
ROMAN Results (ITT n=407) Reductions across SOM endpoints; statistical significance on the primary & median days SOM secondary endpoint SOM Incidence SOM Days Grade 4 OM Incidence SOM Onset Reduction Reduction Reduction Delay in in SOM in median in incidence of median days st 16% 56% 27% 29% incidence days of SOM Grade 4 OM to 1 SOM 70% 20 35% 60 18 33% 60% 64% 18 30% p=0.002** p=0.045* 16 50 p=0.052 49 50% 54% 25% 14 40 24% 12 40% 20% 38 10 30 p=0.002* 30% 15% 8 8 20 6 20% 10% 4 10 10% 5% 2 0% 0 0% 0 Placebo Avasopasem Placebo Avasopasem Placebo Avasopasem Placebo Avasopasem *Statistical significance per statistical analysis plan for this Phase 3 trial **Time to Onset was an exploratory endpoint Anderson CM, Lee C, Kelley JR, et al. ROMAN: Phase 3 trial of avasopasem manganese (GC4419) for severe oral mucositis (SOM) in patients receiving chemoradiotherapy (CRT) for locally advanced, nonmetastatic head and neck cancer (LAHNC). Presented at ASCO Annual Meeting, June 3, 2022. ©2022 Galera Therapeutics, Inc. 14
Incidence Reduced at All Landmarks of Radiation Therapy Both before and after primary endpoint at end of IMRT – all patients Primary Endpoint Relative Reduction 45% 45% 39% 28% 16% 18% P value p=0.030 p=0.001 p<0.001 p=0.002 p=0.045 p=0.012 80% 70% 71% 64% 60% 58% 58% 54% 50% 45% 40% 42% 30% 32% 28% 20% 17% 16% 10% 9% 0% ≤ 30 Gy ≤ 40 Gy ≤ 50 Gy ≤ 60 Gy Thru IMRT Post IMRT PBO (n=166) AVA (n=241) ITT population; ROMAN trial Anderson CM, Lee C, Kelley JR, et al. ROMAN: Phase 3 trial of avasopasem manganese (GC4419) for severe oral mucositis (SOM) in patients receiving chemoradiotherapy (CRT) for locally advanced, nonmetastatic head and neck cancer (LAHNC). Presented at ASCO Annual Meeting, June 3, 2022. ©2022 Galera Therapeutics, Inc. 15
GT-201 Results (n=223) Consistent and encouraging results across SOM endpoints – ITT Population SOM Incidence SOM Days Grade 4 OM Incidence SOM Onset Reduction Reduction Delay in Reduction in SOM in median in incidence of median days st 34% 92% 47% 56% incidence days of SOM Grade 4 OM to 1 SOM 30% 70 20 70% 30% p=0.080 18 19 60 25% 65% 60% 61 16 60% 50 14 50% 20% 50 p=0.009 21% 12 p=0.045 40 40% 43% 15% 10 39 16% 30 30% 8 10% 8 6 20 20% 4 5% p=0.024* 10 10% 2 1.5 0% 0 0% 0 Placebo 30mg 90mg Placebo 30mg 90mg Placebo 30mg 90mg Placebo 30mg 90mg *Statistical significance per statistical analysis plan for this trial Anderson CM et al. Journal of Clinical Oncology 2019 Dec 1; 37(34): 3256-3265 ©2022 Galera Therapeutics, Inc. 16
Combined Meta-analysis of the Two Randomized Trials (n=551) Avasopasem SOM improvement consistent across trials and key parameters SOM Incidence SOM Days Grade 4 OM Incidence SOM Onset Reduction Reduction Delay in Reduction in SOM in median in incidence of median days st 19% 58% 32% 28% incidence days of SOM Grade 4 OM to 1 SOM 70% 20 35% 60 18 19 p=0.0005 64% 60% 30% 32% 50 p=0.0053 16 50 50% 25% 14 52% p=0.0102 40 12 39 40% 20% 22% 10 30 p=0.0002 30% 15% 8 8 20 6 20% 10% 4 10 10% 5% 2 0% 0 0% 0 Placebo Avasopasem Placebo Avasopasem Placebo Avasopasem Placebo Avasopasem Note: Nominal p values for all endpoints, calculated according to prespecified statistical analysis plan (SAP) for the meta-analysis; 238 patients on placebo; 313 patients on 90mg avasopasem Anderson CM, Lee C, Kelley JR, et al.. Tumor Outcomes for ROMAN: Phase 3 Trial of Avasopasem Manganese (GC4419) for Severe Oral Mucositis (SOM) in Patients Receiving Chemoradiotherapy (CRT) for Locally Advanced Head and Neck Cancer (LAHNC). Presented at ASTRO Annual Meeting, October 26, 2022. ©2022 Galera Therapeutics, Inc. 17
Avasopasem Reduced Narcotic and Feeding Tube Usage Reductions in SOM with avasopasem appeared to decrease utilization in ROMAN trial Narcotics Gastrostomy (Feeding) Tubes Reduction Reduction Reduction in Reduction in usage in usage for in placements overall 13% 13% 19% 21% after RT start OM pain after RT start utilization 80% 70% 50% 35% 45% 70% 60% 30% 40% 40% 60% 55% 50% 25% 61% 35% 26% 35% 48% 50% 30% 40% 20% 48% 21% 25% 40% 30% 15% 20% 30% 15% 20% 10% 20% 10% 10% 5% 10% 5% 0% 0% 0% 0% Placebo Avasopasem Placebo Avasopasem Placebo Avasopasem Placebo Avasopasem ITT population; ROMAN trial Saunders D, Lee CM, Kelley JR, et al. ROMAN: Phase 3 trial of avasopasem to reduce chemoradiotherapy (CRT)-related severe oral mucositis (SOM) in patients with head and neck cancer (HNC). Presented at Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology Annual Meeting, June 23-25, 2022. ©2022 Galera Therapeutics, Inc. 18
ROMAN Long-term Outcomes: Tumor Control & Survival 1 Overlapping 95% confidence intervals at 1 year; consistent with GT-201 tumor outcomes ROMAN Phase 3 – Tumor Outcomes at 1 Year 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 97% 95% 93% 88% 98% 94% 97% 96% 0% OS PFS LRC DMFS PBO (n=166) AVA (n=241) =95% CI OS = overall survival, PFS = progression-free survival, LRC = locoregional control, DMFS = distant metastasis-free survival. 95% Confidence Intervals for each endpoint. Anderson CM, Lee C, Kelley JR, et al.. Tumor Outcomes for ROMAN: Phase 3 Trial of Avasopasem Manganese (GC4419) for Severe Oral Mucositis (SOM) in Patients Receiving Chemoradiotherapy (CRT) for Locally Advanced Head and Neck Cancer (LAHNC). Presented at ASTRO Annual Meeting, October 26, 2022. ©2022 Galera Therapeutics, Inc. 19
ROMAN Long-Term Outcomes: Cisplatin Renal Endpoints 2 Avasopasem halved Chronic Kidney Disease (CKD) at 1 year; a predefined endpoint (CKD <60 mL/min/1.73m ) Previous Scientific Data CKD @ 1 Year on ROMAN Cisplatin Renal Gr. 3+ AEs AKI↓Mg↑Cr • Superoxide drives cisplatin Acute Kidney Injury hypomagnesemia Incr. Creatinine 25% nephrotoxicity 6% - Mapuskar, Redox Biol 2021 20% 5.4% 5% 20% • Avasopasem preclinically 4% prevented cisplatin 15% acute kidney injury 3.6% 3% 3.3% - Mapuskar, Antioxid 2018 p=0.0043 10% 10% 2.4% 2% • Retrospective analysis of 5% 1% 1.2% Phase 2b patient subset 0.8% suggested CKD prevention 0% 0% - Steinbach, ASCO 2020 PBO (n=149) AVA (n=202) PBO (n=166) AVA (n=241) ITT population; CKD defined by Nat. Kidney Foundation as eGFR (estimated Glomerular Filtration Rate) < 60 mL/min/1.73 m2 (approx. the % of normal kidney function that is working) Anderson CM, Lee C, Kelley JR, et al.. Tumor Outcomes for ROMAN: Phase 3 Trial of Avasopasem Manganese (GC4419) for Severe Oral Mucositis (SOM) in Patients Receiving Chemoradiotherapy (CRT) for Locally Advanced Head and Neck Cancer (LAHNC). Presented at ASTRO Annual Meeting, October 26, 2022. ©2022 Galera Therapeutics, Inc. 20
Plan to Submit Avasopasem NDA by End of 2022 • No FDA-approved treatments for radiotherapy-induced SOM • Avasopasem has Breakthrough Therapy and Fast Track Designations • Productive interactions with FDA • NDA will be based on statistically significant, clinically meaningful data from two placebo-controlled randomized trials: ROMAN and GT-201 • ROMAN results presented in oral presentations at 2022 ASCO (June), MASCC (June), and ASTRO (October) annual meetings • NDA submission planned by end of 2022 NDA=New Drug Application; FDA=U.S. Food and Drug Administration; ASCO=American Society of Clinical Oncology; MASCC=Multinational Association of Supportive Care in Cancer; ASTRO=American Society for Radiation Oncology ©2022 Galera Therapeutics, Inc. 21
SOM Market Opportunity
Head and Neck Cancer – Large Market Opportunity 1 Severe Oral Mucositis is >$1B total market opportunity in the US 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 is curable with the standard-of-care IMRT and cisplatin regimen Source: Globocan & US SEER Data in CA Cancer J Clin 2021 1 Based on 42,000 US patients and branded supportive care price analogs ©2022 Galera Therapeutics, Inc. 23
Concentrated Physician Population SOM is most burdensome side effect of curative IMRT + cisplatin regimen 5,000 Radiation Oncologists in US Initial 2,500 Sales Radiotherapy Focus Treatment Sites 700 Top centers where >80% HNC patients are treated ©2022 Galera Therapeutics, Inc. 24
Most Centers Have Ability to Infuse Avasopasem 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 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 ©2022 Galera Therapeutics, Inc. 25
Beyond Oral Mucositis: Other RT-Related Toxicities Physicians view SOM 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 ©2022 Galera Therapeutics, Inc. 26
Esophagitis in Lung Cancer 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 ©2022 Galera Therapeutics, Inc. 27
Esophagitis: Major Unmet Need in Lung Cancer Common Side Effect of Chemoradiotherapy (IMRT x 6 weeks) 1 50-60% Get Grade 2+ Current Approaches AESOP Trial Design 2,3 20-30% Get Grade 3+ Lack Efficacy in Lung Cancer 4 NCI Grading for esophagitis No established drug therapy Single-arm Phase 2 Trial 1 Asymptomatic Supportive care measures: • 6 weeks of standard IMRT to ≥ 5 cm of esophagus 2 Symptoms & altered eating/swallowing • Soft bland diet ♦♦♦♦♦ ♦♦♦♦♦ ♦♦♦♦♦ ♦♦♦♦♦ ♦♦♦♦♦ ♦♦♦♦♦ 3 Severely altered eating or swallowing • Prophylactic antifungals Required urgent operative intervention 4 • Will compare esophagitis • Dilation if stricture develops Results in death rate with historical data 5 1 3 Palma, DA. (2013). Int J Radiation Oncol Biol Phys, Vol. 87 (4), 690-696. RTOG 9410. Curran, WJ et al. (2011). J Natl Cancer Inst, 103:1452–1460 (cisplatin + vinblastine). 2 4 LAMP Study. Belani, CP et al. (2005). J Clin Oncol, 23:5883-5891 (carboplatin + paclitaxel chemo). NCI Common Toxicity Criteria 5.0. ©2022 Galera Therapeutics, Inc. 28
Esophagitis Trial (AESOP) Low incidence of Grade 3+ esophagitis with avasopasem compared to literature Trial Design AESOP Results Safety AE profile consistent with chemoradiotherapy Patients and Treatment (Per Protocol n=29) 0% 20% 40% 60% 80% 100% 2 Esophagitis Incidence by Grade • Single-arm Phase 2a open-label trial Fatigue Weeks of IMRT Nausea 1 2 3 4 5 6 • Patients with lung cancer (NSCLC or SCLC) Dysphagia Gr. 2 - 10% 17% 38% 48% 45% Gr. 3 - - 3% - - 3% • Standard-of-care chemoradiotherapy over 6 Vomiting Gr. 4-5 - - - - - - weeks (60 Gy IMRT) + avasopasem 90mg Cough Dizziness • Grade 3 esophagitis was much less than • Eligibility criteria required ≥5 cm (≥20%) of Constipation in comparable trial results the esophagus in the radiotherapy field Oropharyngeal pain • Most patients free of Grade 3 for most Ø Patients who get ≥60 Gy to ≥17% of their Diarrhea weeks of treatment—no Grade 4 or 5 esophagus are considered at highest risk: 59% Hypotension 1 risk of grade ≥2 and 22% of grade ≥3 esophagitis Trial Pt # CXRT Arms Grade Headache 3+4 Leukopenia Pt # Disposition Catheter site pain AESOP 29 CT+RT 7% Dyspnea 39 Enrolled (Safety) 74 CT à CT+RT 19% LAMP Lymphopenia 3 Study 92 RT+CT à CT 28% 35 Full Chemoradiation (6 weeks) Paresthesia RTOG 193 CT+RT 22% 4 29 Per Protocol AVA (≥5 weeks) AEs >20% (n=39) 9410 3 1 Palma, DA. (2013). Int J Radiation Oncol Biol Phys, Vol. 87 (4), 690-696. LAMP Study. Belani, CP et al. (2005). J Clin Oncol, 23:5883-5891 (carboplatin + paclitaxel chemo). 2 4 RTOG 9410. Curran, WJ et al. (2011). J Natl Cancer Inst, 103:1452–1460 (cisplatin + vinblastine). NCI Common Toxicity Criteria 5.0. 29
Increasing SBRT Efficacy
Clinical Stage Pipeline Phase 1 Phase 2 Phase 3 Trial Status/Anticipated Milestones Radioprotection ROMAN: AVA vs. Placebo (n=455) NDA Submission by Y/E 2022 4 GT-201: AVA vs. Placebo (n=223) Completed & Published 1 Head & Neck Cancer (SOM) EUSOM: AVA (n=38) Completed in 2021 5 Ph 1b/2a AVA (n=43) Completed & Published 2 Lung Cancer (Esophagitis) AESOP: AVA in NSCLC Completed in 2022 Radiosensitization GRECO-2: RUCO vs. Placebo Enrollment to Complete 2H2023 3 Pancreatic Cancer Locally Advanced Pilot: AVA vs. Placebo (n=42) Completed in 2021 Lung Cancer GRECO-1: RUCO vs. Placebo Enrollment to Complete 2H2023 Locally Advanced Severe Oral Mucositis = SOM 1 EUSOM was a single-arm multi-center trial evaluating the safety and efficacy of avasopasem in patients with HNC in Europe. Avasopasem = AVA 2 Phase 2a trial that evaluated incidence of esophagitis in patients with lung cancer receiving standard-of-care chemoradiation. Rucosopasem = RUCO 3 First SBRT combination trial was a pilot & used avasopasem (AVA). Subsequent SBRT trials combine rucosopasem (RUCO) with SBRT. Intensity Modulated RT = IMRT 4 Anderson CM et al. J Clin Oncol. 2019;37(34):3256-3265. Stereotactic Body RT = SBRT 5 Anderson CM et al. Int J Radiat Oncol Biol Phys. 2018 Feb 1;100(2):427-435. ©2022 Galera Therapeutics, Inc. 31
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, et al., Science Translational Medicine 12 May 2021:Vol. 13, Issue 593 ©2022 Galera Therapeutics, Inc. 32
H O build-up in Cancer Cell à Synergy with SBRT 2 2 CAT Synergy eliminated with doxycycline-induced catalase in genetically modified H1299 cells Sishc, et al., Science Translational Medicine 12 May 2021:Vol. 13, Issue 593 ©2022 Galera Therapeutics, Inc. 33
Pancreatic Tumor Model à Synergy with SBRT 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 ©2022 Galera Therapeutics, Inc. 34
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 is only ~10% SBRT use increasing for locoregional control of pancreatic cancer ©2022 Galera Therapeutics, Inc. 35
Proof of Concept Trial in Pancreatic Cancer Completed 42-Patient Double-blind, Placebo-controlled, Randomized Trial Population Treatment Endpoints • Patients with Locally-advanced • Primary: Safety and feasibility of SBRT + GC4419 90mg x 5 doses Pancreatic Cancer (LAPC) dismutase mimetic with SBRT R SBRT+ Placebo x 5 doses • Screened after 4-6 months of • Secondary: Survival (OS, PFS), chemotherapy Tumor Control (LRC, DMC), Response Rate • 60-minute IV infusion before SBRT • 4 Centers: MDA, Moffitt, Duke, UTSW ©2022 Galera Therapeutics, Inc. 36
Final Analysis of Safety & Efficacy Minimum of One Year Follow-up on All Patients Baseline Characteristics Placebo GC4419 (n=18) (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 ©2022 Galera Therapeutics, Inc. 37
Final Safety Analysis - Regimen Generally Well Tolerated 12-Month Safety Follow-up (% of Patients) Similar SBRT Toxicity Across Arms No Early or Late Toxicity Signal for GC AEs Considered related SBRT SBRT AEs Considered related by SBRT SBRT by Investigator to SBRT + PBO + GC Investigator to GC/PBO + PBO + GC Any AE 67% 46% Any AE 67% 46% ≤90 days ≤90 days after GI AE 44% 42% after GI AE 44% 42% SBRT SBRT Severe AE 0% 0% Severe AE 0% 0% Any AE 22% 25% Any AE 17% 21% >90 days >90 days after GI AE 17% 21% after GI AE 17% 17% SBRT SBRT Severe AE 11% 8% Severe AE 11% 4% • No bleeding ulcers by 12-week endoscopy AE = Adverse Event, GI AE = Gastrointestinal AE ©2022 Galera Therapeutics, Inc. 38
Partial Response Rate Increased 2.5-fold Best Local Response with follow-up of at least 12 months on all patients (ITT, n=42) SBRT + GC SBRT + PBO 40% 30% 20% 10% R0 R0 R0 R1 NE NE 0% R0 R0 R0 -10% -20% -30% 1 1 PR : 29% (7 of 24 patients) PR : 11% (2 of 18 patients) -40% -50% -60% 1 Partial 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 ©2022 Galera Therapeutics, Inc. 39
Improved Control of Both Local and Distant Disease Median LRC on GC arm not yet reached at data cut-off; Increased median DMC by 100% Locoregional Control (LRC) Distant Metastases Control – within RT Field – outside RT Field P-value = 0.0551 Hazard Ratio = 0.30 P-value = 0.0279 Hazard Ratio = 0.39 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 ©2022 Galera Therapeutics, Inc. 40
Improved Overall and Progression-Free Survival 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 = 0.0899 Hazard Ratio = 0.48 P-value = 0.0396 Hazard Ratio = 0.46 Minimum 12-month follow-up on all patients, PFS defined as local progression or distant metastasis, not censored for treatment post SBRT ©2022 Galera Therapeutics, Inc. 41
Final Efficacy Analysis – Improvements Across All Parameters Encouraging hazard ratios across all endpoints Hazard Ratios Below 0.5 Hazard Ratios Below 0.4 2.5-fold Increase in Overall & Progression-Free Local & Distant Tumor Response Rate Survival Control Survival Tumor Control Response Median OS PFS (mos) Median LRC DMC (mos) Partial Response Rate GC 17.0 11.2 GC NR 13.9 GC 29% PBO 13.3 7.1 PBO 9.6 7.0 PBO 11% Survival OS PFS Tumor Control LRC DMC Surgery GC PBO Hazard Ratio 0.48 0.46 Hazard Ratio 0.30 0.39 R0* 5 1 *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 ©2022 Galera Therapeutics, Inc. 42
GRECO-2 Trial of Rucosopasem + SBRT in LAPC Galera Radiotherapy Efficacy Cancer Optimization Rucosopasem 100mg IV or placebo administered over 15 mins <3 hrs before SBRT (5 fractions of 10 Gy each) • Multicenter, double-blinded, placebo-controlled trial • 160 patients, 1:1 randomization N=160 SBRT + Rucosopasem x 5 doses • Locally Advanced Pancreatic Cancer (LAPC) – >30 sites in R (n=160) unresectable or borderline resectable, non-metastatic US, Canada, EU & UK SBRT + Placebo x 5 doses • ECOG Performance 0-2 • Must have 6 weeks or more of chemotherapy (FOLFIRINOX or Gemcitabine doublet regimen) • Primary Endpoint: Overall Survival • Stratified for borderline resectable vs. unresectable • Secondary Endpoints: PFS, LRC, TDM, surgical resection, in-field response rate, acute & late toxicity PFS = Progression-Free Survival; LRC = Locoregional Control; TDM = Time to Distant Metastasis ©2022 Galera Therapeutics, Inc. 43
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 Receive US Patients Diagnosed each year SBRT SBRT (+/- other 81% 67% 85% Today modalities) Other 3% 2% 4% 55,100 Node-Negative NSCLC ©2022 Galera Therapeutics, Inc. 44
GRECO-1 Trial of Rucosopasem + SBRT in NSCLC Galera Radiotherapy Efficacy Cancer Optimization GRECO-1 Trial Phase 1 Results • Rucosopasem + SBRT was well tolerated in Phase 1 with fatigue, cough & Rucosopasem 100mg IV or placebo over 15 mins nausea most frequent adverse events (common in patients receiving RT) before each SBRT fraction • Pulmonary function preserved: 1 - No Grade 2-4 declines in DLCO (RTOG scale) with rucosopasem 2 - Historical expectation 7-12% in prospective trial evaluating effect of SBRT + Rucosopasem lung SBRT on pulmonary function (4-5 fractions, n=127) • Target tumor volume at 6 months post SBRT + Rucosopasem, as follows: Phase I R Phase 2 (n=66) 50% SBRT + Placebo n=7 47% 30% 10% 8%* • Patients with central and/or large NSCLC tumors -10% • Single-arm open label Phase 1 stage complete -27% -29% -33% -30% • Multicenter, double-blinded, placebo-controlled Phase 2 stage actively enrolling; anticipate completion of enrollment in 2H2023 -58% -50% -61% • SBRT Dose Schedule: -70% 5.1cm 1.8cm 3.3cm 2.8cm 2.7cm 1.5cm 1.1cm - Phase 1: 5 fractions x 10 Gy Baseline Tumor Size at Screening - Phase 2: 5 x 10 Gy or 3 x 18 Gy * Measurement at 3 months, target lesion unevaluable at 6 months; progressed out of RT field at 6 months; only patient with prior chemotherapy 1 DLCO is the diffusing capacity of the lung for carbon monoxide, a measurement of the lung's ability to transfer gas from inspired air to the bloodstream. 2 Stone B, Mangona VS, Johnson MD et.al. Changes in pulmonary function following image-guided stereotactic lung radiotherapy. J Thorac Oncol. 2015;10: 1762–1769 ©2022 Galera Therapeutics, Inc. 45
Corporate Highlights
Clinical Stage Pipeline Phase 1 Phase 2 Phase 3 Trial Status/Anticipated Milestones Radioprotection ROMAN: AVA vs. Placebo (n=455) NDA Submission by Y/E 2022 4 GT-201: AVA vs. Placebo (n=223) Completed & Published 1 Head & Neck Cancer (SOM) EUSOM: AVA (n=38) Completed in 2021 5 Ph 1b/2a AVA (n=43) Completed & Published 2 Lung Cancer (Esophagitis) AESOP: AVA in NSCLC Completed in 2022 Radiosensitization GRECO-2: RUCO vs. Placebo Enrollment to Complete 2H2023 3 Pancreatic Cancer Locally Advanced Pilot: AVA vs. Placebo (n=42) Completed in 2021 Lung Cancer GRECO-1: RUCO vs. Placebo Enrollment to Complete 2H2023 Locally Advanced Severe Oral Mucositis = SOM 1 EUSOM was a single-arm multi-center trial evaluating the safety and efficacy of avasopasem in patients with HNC in Europe. Avasopasem = AVA 2 Phase 2a trial that evaluated incidence of esophagitis in patients with lung cancer receiving standard-of-care chemoradiation. Rucosopasem = RUCO 3 First SBRT combination trial was a pilot & used avasopasem (AVA). Subsequent SBRT trials combine rucosopasem (RUCO) with SBRT. Intensity Modulated RT = IMRT 4 Anderson CM et al. J Clin Oncol. 2019;37(34):3256-3265. Stereotactic Body RT = SBRT 5 Anderson CM et al. Int J Radiat Oncol Biol Phys. 2018 Feb 1;100(2):427-435. ©2022 Galera Therapeutics, Inc. 47
Thank you.