Onkure Therapeutics, Inc. · NASDAQ:OKUR
Onkure Therapeutics — Reneo Pharmaceuticals — Merger or Acquisition (May 2024)
25 slides from Onkure Therapeutics's merger presentation, May 13, 2024
Slide 1: Merger Announcement May 2024
Exhibit 99.2 Merger Announcement May 2024 WRITING THE NEXT CHAPTER IN PRECISION MEDICINES FOR PATIENTS WITH CANCER
Slide 2: Forward-Looking Statements
Legends Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, express or implied statements regarding the structure, timing and comple
Slide 3: Legends (Cont.): Additional Information and Where to Find It
Legends (Cont.) Additional Information and Where to Find It The information herein does not purport to be all-inclusive or contain all the information that may be required to make a full analysis of Reneo, OnKure, the combined company or the Proposed Transactions. Readers should each make their own
Slide 4: Merger of OnKure and Reneo
Merger of OnKure and Reneo • Transaction Summary ‐ Merger with OnKure, Inc., a privately held clinical-stage biopharmaceutical company focused on the development of novel precision medicines in oncology ‐ Upon close, Reneo Pharmaceuticals is expected to be renamed “OnKure Therapeutics, Inc.” (NASDAQ
Slide 5: Developing Innovative Precision Medicines for Patients
Developing Innovative Precision Medicines for Patients Backed by an experienced team with decades of success FOCUS STRATEGY TEAM Target well-validated oncogenes Advance highly oncogene- A team with remarkable capability, with untapped therapeutic selective inhibitors to enable a proven track record,
Slide 6: Leadership Team with Proven Experience
Leadership Team with Proven Experience Board of Directors Tony Nicholas • Isaac Manke Piscopio, Ph.D. Saccomano, Ph.D. President and Co-Founder and Head of R&D Acorn BioVentures Chief Executive Officer • Andrew Phillips Aleksia Therapeutics, Inc. Nexo Therapeutics, Inc • R. Michael Carruthers Samuel
Slide 7: An Emerging Pipeline Well-Positioned for Clinical Success
An Emerging Pipeline Well-Positioned for Clinical Success Current Next Anticipated Program/Target Initial Indication Discovery Preclinical Phase 1 Status Milestone OKI-219 Phase 1 Early phase 1 data H1047R Breast cancer PI3Ka PIKture-01 Trial enrolling (Q4 2024) selective inhibitor PI3Ka Select cand
Slide 8: PI3Ka: The Most Commonly Mutated Oncogene with Significant Unmet Opportunity
PI3Ka: The Most Commonly Mutated Oncogene with Significant Unmet Therapeutic Opportunity H1047R PI3Ka : the most MUT Targeting PI3Ka is a Large 1 common hotspot mutation Opportunity Present in ~4% of all human cancers and 2 ~15% of Breast Cancers PI3Ka mutation is highly prevalent in Breast Cancer H
Slide 9: PI3Ka Inhibitors: Potential As Backbone Therapy in Combinations
MUT HER2 PI3Ka Inhibitors: Potential As Backbone Therapy in Combinations ADCs with Approved Agents in Her2 mAb Her2-inhibitors Breast Cancer PI3Kai PI3Ka AKTi CDK4/6i AKT SERMs SERDs Estrogen AI Receptor Cancer Cell Survival & • SERM (Selective estrogen receptor modulator) Cell Cycle Transcription •
Slide 10: OKI-219: A PI3Ka Mutant Selective Inhibitor | At A Glance
OKI-219: A PI3Ka Mutant Selective Inhibitor | At A Glance OKI-219 has the potential to establish a favorable market position st in adjuvant and 1 line treatments in HR+ MBC Efficacy Safety Dosing OKI-219 shows preclinical OKI-219 has been well OKI-219 has potential efficacy at low doses in tolerated
Slide 11: Next-Gen PI3Kα Mutant Targeting Competitive Landscape
Next-Gen PI3Kα Mutant Targeting Competitive Landscape Mutant-Selectivity is Necessary to Drive Improved Efficacy and Safety ATP Site Competitive Inhibitors H1047R PI3Kα Inhibitors • Approved: Alpelisib • Under review: Inavolisib • Phase 1: OKI-219 & LOXO • Highly selective with wide therapeutic inde
Slide 12: Existing PI3Ka Drugs have Limited Efficacy
Existing PI3Ka Drugs have Limited Efficacy MUT • Optimal activity of PI3Ka inhibition requires prolonged target coverage 30X Selective Mutation-Targeting May WT • Toxicity of inhibiting PI3Ka may limit ability to get Optimize Efficacy and Safety optimal target coverage Theoretical illustration • Sig
Slide 13: Non-Selective PI3K Inhibitors: AE Profile is Challenging
Non-Selective PI3K Inhibitors: AE Profile is Challenging Propose that a well-tolerated mutant-selective PI3K inhibitor may enable use in both adjuvant and metastatic settings Alpelisib (PI3Ki) Capivasertib (AKTi) Inavolisib (PI3Ki) RLY-2608* Sample Size 284 155 60 43 All grades All grades All grades
Slide 14: Mutation Selective Inhibition Leads to Superior Efficacy & Safety in Mouse Studies
Mutation Selective Inhibition Leads to Superior Efficacy & Safety in Mouse Preclinical Studies H1047R OKI-219 Drives Regressions in PI3Kα With No Changes in Glucose Homeostasis Mutant Heterozygous Tumors Insulin Changes after 600 T47D ER+HER2- MBC 21 Days of Dosing (H1047R +/-) 6 6 ** 400 4 4 200 2
Slide 15: OKI-219 Demonstrated Brain Penetrance in Preclinical Studies
OKI-219 Demonstrated Brain Penetrance in Preclinical Studies OKI-219 is highly brain OKI-219 shows strong activity in CNS models, penetrant equivalent to systemic Rat Brain Free Drug Micro-Dialysis 100 xxT47D-Luciferase xxT47D-Luciferase S.C. Flank Brain 2500 400 10 2000 300 1500 1 200 1000 30mpk fr
Slide 16: Regressions with standard of care drugs in MBC Models
Regressions with standard of care drugs in MBC Models Regressions Overcoming OKI-219 shows low-dose activity in Tucatinib Resistance combination with SERDs xxT47D ER+HER2- (H1047R-/+) 1500 HCC1954 1000 1000 750 500 500 250 0 0 0 10 20 30 40 50 0 10 20 30 Day Day Vehicle Control OKI-219 25mg/kg + Cam
Slide 17: OKI-219: A Preclinical Safety Profile Supports a Wide Clinical Therapeutic Window
OKI-219: A Preclinical Safety Profile Supports a Wide Clinical Therapeutic Window • Generally well tolerated in 28-day Rat and Dog toxicology studies when dosed to 1 g/kg per day ‐ Exposure increases were largely proportional to dose ‐ Signals were predominately non-adverse, monitorable, and reversi
Slide 18: Positioning OKI-219 for Competitive and Expeditious Path to NDA
Positioning OKI-219 for Competitive and Expeditious Path to NDA Rapid Regulatory Therapeutic Enrollment Differentiation Strategy Design Ph1 to move Identify indications with Enable Seamless path quickly to RP2D minimal competition to Ph3 from FIH Study Enroll sites in EU/Asia, in Address new FDA Pro
Slide 19: PIKture-01 Trial Design
PIKture-01 Trial Design Early data expected Q4 2024 Phase 1 | Advance Solid Tumor and Advance MBC NCT06239467 Design Includes Dose Optimization N=4-7 • Part A - investigate escalating Backfill doses of OKI-219 mono- (High Dose) OKI-219 Dose Ranging (n=24) therapy Single Agent Tumor Agnostic Backfill
Slide 20: OKI-219 Strategy: Combine with Best-in-Class Targeted Agents
OKI-219 Strategy: HER2 Combine with Best- Trastuzumab (Roche) in-Class Targeted Pertuzamab (Roche) Agents Across Tucatinib (Pfizer) Breast Cancer OKI-219 PI3K OnKure PI3Ka Franchise LOXO-783 Ribociclib (Novartis) AKT Palbociclib (Pfizer) Fulvestrant (generic) Abemaciclib (Lilly) Camizestrant (AZ) Ve
Slide 21: PI3K Mutated HR+ MBC: A Major Market Opportunity
PI3K Mutated HR+ MBC: A Major Market Opportunity H1047R PI3Ka Mutated HR+ Breast Cancer: Significant Unmet Need Current & Near-Term HR+ accounts for ~70% Treatable US 1 2 of all BrCa cases Treatments Population OKI-219: Targeted for Development Across Adjuvant & MBC NONE Adjuvant ~19K OKI-219 is des
Slide 22: OKI-219's Development Opportunity
OKI-219’s Development Opportunity The Potential to Reach Across Multiple Lines of Therapies H1047R PI3Ka Mutant Selective Drugs: Development into Poorly Served Markets Current & Near- OKI-219 Development Opportunities Term Treatments (Start in Metastatic and advance to Adjuvant) NONE OKI-219 vs. Pla
Slide 23: Vision for OnKure's PI3K H1047X Portfolio
Vision for OnKure’s PI3K H1047X Portfolio OKI-219 Best-in-Class Active in Alpelisib / Best-in-class enabled CNS-Penetrant Safety/Efficacy/ Inavolisib Resistant development in Convenience metastatic Breast Cancer Next Generation Compound Attributes: to Maintain Efficacy and Next Gen Selectivity of OK
Slide 24: Summary: OnKure is Developing Innovative Precision Medicines
Summary: OnKure is Developing Innovative Precision Medicines for Patients Focused team with remarkable Mutation-specific approach to a success in precision medicine validated target (PI3Ka) in a large patient population Supported by POC PIKture-01 trial initiated; early committed investors data expe
Slide 25: Writing the Next Chapter in Precision Medicines for Patients with Cancer
WRITING THE NEXT CHAPTER IN PRECISION MEDICINES FOR PATIENTS WITH CANCER
Reneo Pharmaceuticals — Merger or Acquisition (May 2024) on 6ix