Galera Therapeutics, Inc. · OTC:GRTX
Galera Therapeutics — Merger or Acquisition (June 2026)
19 slides from Galera Therapeutics's merger presentation, Jun 2, 2026
Slide 1: OBX-115 engineered TIL cell therapy with regulatable mbIL15 in advanced melanoma
OBX-115 engineered tumor-infiltrating lymphocyte (TIL) cell therapy with regulatable membrane-bound IL15 (mbIL15) in patients with advanced melanoma that has progressed on/after immune checkpoint inhibitors Allison S Betof,1 Jason A Chesney,2 Gino K In,3 Alexander N Shoushtari,4 Tirrell T Johnson,5
Slide 2: Key Takeaways
Key Takeaways 1 2 3 The OBX-115 Promising early Key regimen benefits safety profile is efficacy was observed, may provide a differentiated by with a 67% ORR and meaningful treatment exclusively low-dose potential for durable option to a broader lymphodepletion and deepening patient population and ab
Slide 3: Background
Background 3 • OBX-115 engineered TIL cell therapy expresses regulatable membrane-bound interleukin 15 (mbIL15) via administration of the small-molecule drug acetazolamide (ACZ) • OBX-115 offers several clinical advantages over conventional non-engineered tumor-infiltrating lymphocyte (TIL) cell the
Slide 4: OBX-115 Mechanism of Action
OBX-115 Mechanism of Action ACZ-regulated mbIL15 activates OBX-115 and other immune cells Viral transduction of mbIL15-DRD Tumor Isolated TIL transgene OBX-115 ACZ ligand Patient Antigen-independent expansion & persistence Direct killing of tumor cells OBX-115 Tumor cells IL2Râ Immune cell Trans-act
Slide 5: Agni-01 Single-arm Open-label Phase 1/2 Study
Agni-01 Single-arm Open-label Phase 1/2 Study NCT06060613 On-study Assessment Period Until disease progression, new anticancer therapy, or 2 years after OBX-115 infusion Optional Continuation of Prior Therapy Day 28 Day 42 . Tumor Tissue OBX-115 OBX-115 Infusion Procurement Manufacturing IL2 Day 0 C
Slide 6: OBX-115 Differentiated Manufacturing Process
OBX-115 Differentiated Manufacturing Process Designed to achieve a CD8+ enriched and non-exhausted infusion product Median (range) infused dose: Ex Vivo Manufacturing 83.4 (34.2–100) ×109 cells* OBX-115 Median (range), % N=15 CD8+ T cells† 97.8 (83.6–99.7) Tumor tissue Optimized Activation / mbIL15
Slide 7: Patients Treated with OBX-115 at DL3 / RP2D
15 Patients Treated with OBX-115 at DL3 / RP2D 7 Agni-01 Phase 1/2 Multicenter (N=20 infused*) Phase 1 Phase 2 At DL3/RP2D: (n=11) (n=9) 4 outpatient lymphodepletion 100% of ACZ redosing in DL1+DL2 DL3/RP2D outpatient setting† (n=5) (n=15) DL1 DL2 DL3/RP2D 30 × 109 100 × 109 100 × 109 OBX-115 cell m
Slide 8: Patients Had Difficult-to-treat ICI-refractory Advanced Melanoma
Patients Had Difficult-to-treat ICI-refractory Advanced Melanoma 93% with prior anti–PD-1 combination exposure Baseline Patient and OBX-115 OBX-115 Disease Characteristics (N=15) Treatment Characteristics (N=15) Age, median (range), years 55 (41–78) Lines of prior systemic therapy, median (range)* 2
Slide 9: Strong Early Efficacy in 2L+ Advanced Melanoma
Strong Early Efficacy in 2L+ Advanced Melanoma OBX-115 (N=15) Objective response rate, n (%) 10 (67)* • Median (range) study follow-up: 4.3 months (2.3–16.9) Complete response 2 (13) Partial response 8 (53) • Encouraging efficacy Stable disease 4 (27) • Early data suggest durability of Progressive d
Slide 10: 67% ORR, with SOD Reduction in 80% of Patients
67% ORR, with SOD Reduction in 80% of Patients TTP method Surg Surg Surg Surg Surg CNB* Surg ienc Surg Surg CNB* Surg Surg tionSurg Surg Surg OBX-115 dose 9 94.8 100 55.8 60.9 34.2 99.2 81.6 37.2 77.4 100 86 83.4 89.2 65.7 97.6 (cells × 10 ) ACZ redosing + +—+ + + + + + + + + + + + Patient ID 41 39
Slide 11: Onset and Duration of Responses
Onset and Duration of Responses BRAF- Anti–PD-1 + Prim Pt ACZ redosing† mut Anti–CTLA-4 Resist* ID +—+ 14 - + + 15 - + + 12 - + + 31 - +—9 • Most responses achieved early (Week 6) — + 33 • Responses observed across key disease subsets + +—34—BRAF-mutant - +—38 - + + 37—Anti–PD-1 + anti–CTLA-4 combin
Slide 12: Durable and Deepening Responses
Durable and Deepening Responses Initial ACZ ACZ redosing* 40 41 20 39 13* (%) 0 SOD 1 2 3 6 12 Week18 24 36 48 60 72 Baseline from -20 32‡ Lesion 9 33 -40 12 Target 4 Change in 34 31 -60 11 Complete Response Partial Response Stable Disease -80 38 Progressive Disease Ongoing Response 37 -100 or CR 15
Slide 13: Sustained and Deepening Reduction in Liver Lesion
Sustained and Deepening Reduction in Liver Lesion Patient 31: 44 yr-old with stage IV M1c rectal mucosal melanoma with liver metastases LDH >ULN Prior: Ipi-Nivo (Primary resistant) Low-dose LD CNB TTP (liver) 135 ×109 cells mfg 100 ×109 cells infused No Grade ≥3 TEAEs Day -8 Week 6: PR Week 36: Ongo
Slide 14: TEAEs in ≥20% of Patients
TEAEs in ≥20% of Patients All-grade Grade ≥3 Patients, % 0% 100 10% 80 20% 60 30% 40 40% 20 50% 0 60% 20 70% 40 80% 60 90% 80 100% 100 Hypokalemia AST increased Cytokine release syndrome Hypoalbuminemia Hyponatremia • Grade ≥3 non-hematologic toxicity Hypoxia Nausea was uncommon Fatigue Constipation
Slide 15: TRAE Onset and Severity
TRAE Onset and Severity Initial ACZ ACZ redosing AEs 40 related 30 - 20 eatment Grade 1 Tr Grade 2 of Grade 3 10 Grade 4 Number 0 -10 0 10 20 30 40 50 60 70 80 90 100 110 120 Study Day • TRAEs were mostly Grade ≤2 and occurred in the first 2 weeks after infusion • Longitudinal ACZ redosing was well-
Slide 16: Favorable Cytokine and ctDNA Profiles
Favorable Cytokine and ctDNA Profiles IL15 IL6 ctDNA 600 100 60 Classical CRS range2 ) L L ) 500 to 10 /m /m % g g p p 400 1 ( 40 (BL 5 300 1 IL6 IL 0.1 Normal range1 eVAF, m 20 200 from u r in 0.01 Serum 100 3 Se Normal range LD ACZ ACZ LD ACZ ACZ 0.001 0 0 D14 BL 0 7 14 21 28 BL 0 7 14 21 28 Chang
Slide 17: Conclusions
Conclusions 17 • OBX-115 engineered TIL cell therapy expressing regulatable mbIL15 potentially offers a novel therapeutic intervention for advanced melanoma that has progressed on/after ICI therapy, including ICI-combination–refractory disease – ACZ-driven regulatable mbIL15 expression enables initi
Slide 18: Key Takeaways
Key Takeaways 1 2 3 The OBX-115 Promising early Key regimen benefits safety profile is efficacy was observed, may provide a differentiated by with a 67% ORR and meaningful treatment exclusively low-dose potential for durable option to a broader lymphodepletion and deepening patient population and ab
Slide 19: Thank you
Thank you Patients who participated in this trial, their caregivers, and their families Study-site and sponsor personnel Code Copies are of these for personal slides obtained use only through and may Quick not be Response reproduced (QR) without permission from ASCO® or the author of these slides. P
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