Galera Therapeutics, Inc. · OTC:GRTX
Galera Therapeutics — Investor Presentation (December 2024)
35 slides from Galera Therapeutics's investor presentation, Dec 31, 2024
Slide 1: Driving Better Outcomes for Breast Cancer Patients
Galera Therapeutics (GRTX) Driving Better Outcomes for Breast Cancer Patients January 2025 Exhibit 99.2
Slide 2: Forward-Looking Statements
Forward-Looking Statements ©2025 Galera Therapeutics, Inc. Certain information contained in this presentation and statements made orally during this presentation relates to or is based on studies, publications, surveys and other data obtained from third-party sources and Galera’s own internal estima
Slide 3: Developing First-in-Class Treatments for Resistant Breast Cancer
©2025 Galera Therapeutics, Inc. Tilarginine (pan-NOS inhibitor) has potential to be first approved therapy in metaplastic breast cancer (MpBC) Fully grant funded Phase 1b/2 trial ongoing in MpBC with nab-paclitaxel and alpelisib (PI3K inhibitor) 4/9 responses seen in Phase 1 portion Next tranche of
Slide 4: Joining Forces to Bring Novel Treatments to Cancer Patients
Galera Therapeutics and Nova Pharma ©2025 Galera Therapeutics, Inc. + Public company with small molecule dismutase mimetics in early trial for hormone-resistant breast cancer Private company with small molecule NOS inhibitor in early trials for advanced and metastatic breast cancer Combined company
Slide 5: Leadership Team
©2025 Galera Therapeutics, Inc. Mel Sorensen, MD President & CEO Galera, Oncopia, Ascenta GSK, Bayer, NCI, Mayo Clinic Judy Schnyder Clinical Operations Galera, Aclaris Andie Collier Regulatory & Quality Galera, Gilead Judy Fox, PhD Drug Development Genentech Sunesis, Chiron Joel Sussman, CPA Chief
Slide 6: Galera's Breast Cancer Trials
Galera’s Breast Cancer Trials ©2025 Galera Therapeutics, Inc. Three Trials Targeting Highly-Resistant forms of Advanced or Metastatic Breast Cancer Tilarginine is L-NMMA (NG-monomethyl-L-arginine), a nitric oxide synthase (NOS) inhibitor, administered IV over 2 hours, with Amlodipine pretreatment TN
Slide 7: Tilarginine in Triple Negative Breast Cancer
Tilarginine in Triple Negative Breast Cancer
Slide 8: Promising Early Results With Tilarginine in TNBC
Promising Early Results With Tilarginine in TNBC ©2025 Galera Therapeutics, Inc. Long-term research with nitric oxide synthase inhibition in cancer has demonstrated potential to translate into the clinic Jenny Chang, MD Breast Oncologist Houston Methodist A research team led by Jenny Chang, M.D., a
Slide 9: Inhibiting NOS Reverses Resistance Mechanisms
Inhibiting NOS Reverses Resistance Mechanisms ©2025 Galera Therapeutics, Inc. NOS drives resistance mechanisms via reversible post-translational modifications (NT & SNO) Chemoresistance cJUN P Resistance to Apoptosis Nitric Oxide (NO) ASK1 NOS Nitric Oxide Synthase Immunosuppression Chemokine T Cell
Slide 10: Tilarginine in Metaplastic Breast Cancer and TNBC
Tilarginine in Metaplastic Breast Cancer and TNBC ©2025 Galera Therapeutics, Inc. We believe resistant TNBC and metaplastic disease are two attractive opportunities with high unmet need Non-Stage IV BC (95%) Metaplastic (1%) Non-Stage IV BC (95%) TNBC (12.6%) Resistant TNBC (26%) Total Estimated Pat
Slide 11: Tilarginine: A Pan-NOS Inhibitor for Breast Cancer
Tilarginine: A Pan-NOS Inhibitor for Breast Cancer ©2025 Galera Therapeutics, Inc. Tilarginine: a well-characterized safety profile across hundreds of patients Preclinical activity seen in TNBC-PDX models as single agent and in combination with chemo and targeted therapies Previous clinical trial ex
Slide 12: Efficacy Signal in Locally Advanced TNBC
Efficacy Signal in Locally Advanced TNBC ©2025 Galera Therapeutics, Inc. Findings from Phase 2 (n=24) portion of tilarginine + taxane trial *After anthracycline (AC)-based therapy Adapted from Chung AW et al. Sci Transl Med. 2021 Dec 15;13(624):eabj5070. doi: 10.1126/scitranslmed.abj5070. Epub 2021
Slide 13: Complete Response from the TNBC Trial
Complete Response from the TNBC Trial ©2025 Galera Therapeutics, Inc. 46-Year-Old Woman with Stage 3 Metaplastic Breast Cancer Patient is alive and well after 3 years Woman with locally-advanced metaplastic breast cancer Stage 3 at diagnosis with disease in lymph nodes Patient received 4 cycles of A
Slide 14: Efficacy in Patient Who Failed Standard of Care
Efficacy in Patient Who Failed Standard of Care ©2025 Galera Therapeutics, Inc. Breast Cancer Specialist affiliated with I-SPY 2 trial tested tilarginine through single patient IND Tilarginine + Abraxane Baseline Post-Therapy Post-surgery pathology report notes a marked treatment effect (Minimal dis
Slide 15: Tilarginine Phase Toxicity Profile
Tilarginine Phase 2 Toxicity Profile ©2025 Galera Therapeutics, Inc. Tilarginine is L-NMMA (NG-monomethyl-L-arginine) is a nitric oxide synthase (NOS) inhibitor, administered IV over 2 hours, with amlodipine pretreatment Amlodipine and aspirin were used as supportive care. Adapted from Chung AW et a
Slide 16: Metaplastic Breast Cancer is First Approval Opportunity
Metaplastic Breast Cancer is First Approval Opportunity ©2025 Galera Therapeutics, Inc. A highly treatment-resistant subset of TNBC with no FDA approved therapies 12 Month Median OS in iNOS high patients1 Rare Subset with High Unmet Need Incidence 1% of all breast cancer2 First classified in 2000 by
Slide 17: Ongoing Fully Funded NIH Trial in Metaplastic Breast Cancer
Ongoing Fully Funded NIH Trial in Metaplastic Breast Cancer ©2025 Galera Therapeutics, Inc. 4/9 patients in Phase 1 portion responded (PR + CR). 7/9 had clinical benefit (PR + CR + SD). *After anthracycline (AC)-based therapy 1Data derived from cBioPortal database of 7548 patients across 12 breast c
Slide 18: Potential Registrational Pathway in Metaplastic Breast Cancer
Potential Registrational Pathway in Metaplastic Breast Cancer ©2025 Galera Therapeutics, Inc. Based on previous rare cancer approvals, one additional randomized trial may be sufficient Participants in this study will receive nab-paclitaxel, alpelisib and tilarginine, administered q3w cycles until di
Slide 19: Indication Expansion Opportunity in Neoadjuvant TNBC
Indication Expansion Opportunity in Neoadjuvant TNBC ©2025 Galera Therapeutics, Inc. 26% of TNBC patients do not have adequate treatment options in the neoadjuvant setting Ctr: paclitaxel; VC: veliparib-carboplatin-paclitaxel; Pembro: pembrolizumab Adapted from Wolf D et al., Redefining breast cance
Slide 20: Avasopasem in HR+ HER2- Breast Cancer
Avasopasem in HR+ HER2- Breast Cancer
Slide 21: Avasopasem Restored Sensitivity to SoC in HR+ Cancers
Avasopasem Restored Sensitivity to SoC in HR+ Cancers ©2025 Galera Therapeutics, Inc. Avasopasem is active preclinically in both HR+ breast cancer and prostate cancer cell lines with AcK68 alteration Avasopasem is cytotoxic to AcK68 HR+ breast tumors and synergizes with CDK4/6 inhibition Avasopasem
Slide 22: Planned Grant Funded Ph1b/2 Trial in HR+ HER2- Breast Cancer
Planned Grant Funded Ph1b/2 Trial in HR+ HER2- Breast Cancer ©2025 Galera Therapeutics, Inc. Opportunity to evaluate ability of dismutase mimetic to reverse resistance to fulvestrant and CDK4/6 inhibitors Avasopasem replaces deactivated AcK68-modified endogenous superoxide dismutase, resolving super
Slide 23: Executive Summary and Key Milestones
©2025 Galera Therapeutics, Inc. Tilarginine potential to be first approved therapy in metaplastic breast cancer (MpBC) Fully grant funded Phase 1b/2 trial ongoing in MpBC with nab-paclitaxel and alpelisib (PI3K inhibitor) 4/9 responses seen in Phase 1 portion Next tranche of data expected end of 202
Slide 24: Capitalization and Cash Position
©2025 Galera Therapeutics, Inc. Cash balance post-financing supports multiple near-term data readouts Cash runway expected into 2026 Galera Therapeutics Capitalization and Cash Position Common Stock As of December 30, 2024 Assuming Conversion of Preferred Stock and Warrants Adjusted Share Count Comm
Slide 25: Financial & Investor Information
Financial & Investor Information ©2025 Galera Therapeutics, Inc. OTC: GRTX In December 2024, Galera entered into a private placement financing Net proceeds of $3M combined with Galera’s net cash of $5.7M is expected to provide cash runway into 2026 On an as-converted basis after accounting for the a
Slide 26: Therapeutics, Inc
Therapeutics, Inc
Slide 27: Other Completed Trials
Other Completed Trials ©2025 Galera Therapeutics, Inc. Two Completed Trials Tilarginine is L-NMMA (NG-monomethyl-L-arginine), a nitric oxide synthase (NOS) inhibitor, administered IV over 2 hours, with Amlodipine pretreatment SBRT is Stereotactic Body Radiotherapy, where high doses are administered
Slide 28: NOS Inhibition Reverses Immune Exclusion of T Cells
NOS Inhibition Reverses Immune Exclusion of T Cells ©2025 Galera Therapeutics, Inc. Excess nitric oxide creates an immunosuppressive tumor microenvironment CD8+ Cells (pink) are excluded from penetrating into the tumor bed by high iNOS expression on tumor edge (red) iNOS inhibition increases CD4 & C
Slide 29: Combining Tilarginine with Immune Checkpoint Blocker
Combining Tilarginine with Immune Checkpoint Blocker ©2025 Galera Therapeutics, Inc. Opportunity to evaluate NOS inhibition in combination with pembrolizumab 1Tcyganov et al., Cancer Cell, 2022; 2) NCT03236935 Patient Population2 12 Patients with refractory solid tumors who are naïve to anti-PD1 the
Slide 30: Avasopasem in Locally Advanced Pancreatic Cancer
Avasopasem in Locally Advanced Pancreatic Cancer
Slide 31: Synergy with High-Dose RT (SBRT)
Synergy with High-Dose RT (SBRT) ©2023 Galera Therapeutics, Inc. High-fraction focal irradiation of human tumor xenografts (H1299 NSCLC) in mice Vehicle Days Post Treatment Days Post Treatment Days Post Treatment Days Post Treatment SBRT Stereotactic Body Radiation Therapy RT with Biological Equival
Slide 32: H2O2 build-up in Cancer Cell Synergy with SBRT
H2O2 build-up in Cancer Cell à Synergy with SBRT ©2023 Galera Therapeutics, Inc. Synergy eliminated with doxycycline-induced catalase in genetically modified H1299CAT cells Preclinical results; Sishc, et al., Science Translational Medicine 12 May 2021:Vol. 13, Issue 593
Slide 33: Proof of Concept Trial in Pancreatic Cancer Completed
Proof of Concept Trial in Pancreatic Cancer ©2023 Galera Therapeutics, Inc. Completed 42-Patient Double-blind, Placebo-controlled, Randomized Trial 60-minute IV infusion before SBRT 4 Centers: MDA, Moffitt, Duke, UTSW Patients with Locally-advanced Pancreatic Cancer (LAPC) Screened after 4-6 months
Slide 34: Final Safety Analysis - Regimen Generally Well Tolerated
Final Safety Analysis - Regimen Generally Well Tolerated ©2025 Galera Therapeutics, Inc. 12-Month Safety Follow-up (% of Patients) AEs Considered related by Investigator to SBRT SBRT + PBO SBRT + AVA ≤90 days after SBRT Any AE 67% 46% GI AE 44% 42% Severe AE 0% 0% >90 days after SBRT Any AE 22% 25%
Slide 35: Efficacy Signal in Locally Advanced Pancreatic Cancer
Efficacy Signal in Locally Advanced Pancreatic Cancer (N=42) ©2025 Galera Therapeutics, Inc. Regimen consisted of radiotherapy (SBRT) + avasopasem vs radiotherapy + placebo 1Adapted from Figure 2 in Taniguchi CM et al, Lancet Oncol 2023; 24: 1387–98 Overall and Progression-Free Survival1 Best in-fie
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