Climb Bio, Inc. · NASDAQ:CLYM
Climb Bio — Eliem Therapeutics — Investor Presentation (November 2021)
29 slides from Climb Bio's investor presentation, Nov 8, 2021
Slide 1: Clinical Stage Neurology Company Focused on Neuronal Excitability Disorders
Clinical Stage Neurology Company Focused on Neuronal Excitability Disorders Corporate Presentation | November 2021
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains forward-looking statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this presentation, including statements regarding our future financial condition, results of operat
Slide 3: Investment highlights
Highly experienced management team Clinical and preclinical pipeline based on clinically validated mechanisms of action Two clinically differentiated lead product candidates with top-line data readouts across five indications over next 24 months ~$170M* cash runway to late 2023 allows for top line d
Slide 4: Powered by Successful and Talented Executives from Pioneering Organizations
Powered by Successful and Talented Executives from Pioneering Organizations General Management, Commercial & Corporate Development Research & Development Valerie Morisset, PhD EVP R&D and Chief Scientific Officer Joanne Palmer, PhD Chief Development Officer Amy Chappell, MD Chief Medical Officer Rob
Slide 5: Eliem is Developing Novel Therapies With Multiple Opportunities to Address Interrelated Diseases
Eliem is Developing Novel Therapies With Multiple Opportunities to Address Interrelated Diseases Approaching interrelated disease states with multiple MOAs Innovating within clinically validated mechanisms of action Multiple “pipeline-in-a-product” opportunities ETX-810 ETX-155 Kv7 Chronic Pain Epil
Slide 6: Eliem Pipeline: Four Programs with Clinically Validated MOAs and Multiple Upcoming Clinical Catalysts
Eliem Pipeline: Four Programs with Clinically Validated MOAs and Multiple Upcoming Clinical Catalysts Product Candidate (Mechanism) Lead indications Preclinical Phase 1 Phase 2 Anticipated Clinical Milestones ETX-810 (PEA prodrug) Diabetic peripheral neuropathic pain Topline Phase 2a data (1H 2022)
Slide 7: ETX-810 Anticipated Milestones
ETX-810 Anticipated Milestones Diabetic Peripheral Neuropathic Pain (DPNP) Phase 2a Data 1H 2022 Lumbosacral Radicular Pain (LSRP) Phase 2a Data 1H 2022
Slide 8: Chronic Pain: Large Commercial Opportunity with High Unmet Need
Chronic Pain: Large Commercial Opportunity with High Unmet Need ETX-810 Current Treatment Paradigm ETX-810 has opportunity to be preferred 2nd line monotherapy or used in combination <50% of patients achieve ≥50% reduction in pain significant residual pain Significant tolerability issues (e.g., di
Slide 9: ETX-810: Prodrug of PEA, an Endogenous Bioactive Lipid
ETX-810: Prodrug of PEA (palmitoylethanolamide), an Endogenous Bioactive Lipid Acting as a Master Regulator of Neuroinflammation and Pain Signaling ETX-810 Petrosino and Di Marzo, Br J Pharmacol. 2017 174:1349 ETX-810 is being developed to restore PEA levels to reduce persistent neuroinflammation an
Slide 10: Clinical Validation of PEA: Compelling Body of Evidence in Chronic Pain
Clinical Validation of PEA: Compelling Body of Evidence Highlighting PEA’s Activity and Tolerability in Chronic Pain ETX-810 Paladini et al, Pain Physician, 2016, 19:11-24 Artukoglu et al, Pain Physician, 2017, 20:353-362 From Cymbalta (duloxetine) meta-analyses in chronic pain: Osani et al, Korean
Slide 11: Clinical Validation of PEA: Two Large Placebo-Controlled Studies
Clinical Validation of PEA: Two Large Placebo-Controlled Studies Demonstrate Clinical Activity and Dose-Dependent Response ETX-810 Guida et al, DOLOR, 2010; 25:35-42 Post-hoc analysis of Guida low back pain study by Cruccu et al, CNS & Neurological Disorders - Drug Targets, 2019; 18:491-495 Steels e
Slide 12: ETX-810: Opportunity to Be a First-in-Class PEA Prescription Therapeutic
ETX-810: Opportunity to Be a First-in-Class PEA Prescription Therapeutic for Chronic Pain ETX-810 Prodrug Program Rationale Program Goals Clear dose response in PEA RCTs Opportunity to enhance exposure Develop new chemical entity (NCE) through prodrug approach Optimize PK of bioactive PEA Maximize p
Slide 13: ETX-810 Has an Improved PK Profile and 3X Higher Exposure
ETX-810 Has an Improved PK Profile and 3X Higher Exposure Compared to Dietary Supplement PEA ETX-810 Prodrug pharmacokinetics results in higher PEA concentration over time and 3x exposure improvement PEA concentration over time PEA exposure 600mg PEA Dietary supplement 1000 mg ETX-810 (= 490 mg PEA)
Slide 14: Encouraging Tolerability in Phase 1 Study
Encouraging Tolerability in Phase 1 Study With All AEs Being Mild and at Similar Rates as Placebo, With No Discontinuations ETX-810 * same subjects participated in both the 150mg fasted and fed dosing conditions Highly differentiated Phase 1 tolerability profile for a chronic pain drug Participants
Slide 15: ETX-810: Two Phase 2a Proof of Concept Studies Now Enrolling
ETX-810: Two Phase 2a Proof of Concept Studies Now Enrolling With Topline Data Expected 1H 2022 ETX-810 Implementing clinical development strategies to refine patient population and limit placebo effect Lumbosacral Radicular Pain (LSRP) Diabetic Peripheral Neuropathic Pain (DPNP) NCT04778592 NCT0468
Slide 16: Aiming to Develop a NCE with Desired Clinical Profile for the Chronic Pain Market
Aiming to Develop a NCE with Desired Clinical Profile to Address the Large Chronic Pain Market ETX-810 * Decision Resources Group estimated chronic pain 2028 prevalence by indication, February 2021 A novel chronic pain therapy with a desirable product profile is a multibillion dollar opportunity Com
Slide 17: ETX-155 Anticipated Milestones
ETX-155 Anticipated Milestones Photosensitive Epilepsy Data Expected 1H 2022 Major Depressive Disorder Topline Phase 2a Expected 1H 2023 Perimenopausal Depression Topline Phase 2a Expected 1H 2023
Slide 18: ETX-155: A Differentiated Neuroactive Steroid GABAA Positive Allosteric Modulator
ETX-155: A Differentiated Neuroactive Steroid GABAA Positive Allosteric Modulator ETX-155 Dual potent activity at synaptic and extrasynaptic GABAA receptors, with high intrinsic efficacy Well tolerated at exposure levels that have translated to clinical efficacy for other GABAA PAMs No clinically me
Slide 19: Clinical Development Focused on Depressive Disorders and Focal Onset Seizure
Clinical Development Focused on Depressive Disorders and Focal Onset Seizure – Large Markets With Considerable Unmet Need ETX-155 Perimenopausal Depression (PMD) Estimated annual prevalence (US+EU) MoA Rationale Unmet Needs Reduced GABA levels increased MDD severity1 Clinically validated (SAGE-217
Slide 20: ETX-155 Differentiation: Longer Half-Life, No Food Effect, Favorable Bioavailability
Company Molecule GABAAR Activity Pharmacokinetics Half-life Oral Bioavailability Clinical Validation (positive RCT) Synaptic Extra-synaptic Food effect Half-life Oral Bioavailability MDD PPD or PMD Epilepsy ETX-155 No ~40 hrs ~70% (tablet) 1H 2023 1H 2023 2024 SAGE-217 (zuranolone) Yes 14-18 hrs 68%
Slide 21: Phase 1 Study in Healthy Subjects: Excellent PK and Safety Profile
Phase 1 Study in Healthy Subjects: Excellent Pharmacokinetics and Safety & Tolerability Profile with No Severe or Serious Adverse Events ETX-155 ETX-155 Phase 1 Repeat-Dose Results Favorable pharmacokinetics Steady state reached at day 8 ~40-hour half-life at steady state 60 mg evening dosing was we
Slide 22: ETX-155 Does Not Have a Clinically Meaningful Food Effect
ETX-155 Does Not Have a Clinically Meaningful Food Effect: Potential to Impact Efficacy, Safety, and Compliance ETX-155 has not been assessed in a head-to-head study against PRAX-114, SAGE-217, or ganaxolone, and the study designs and analytical methods for all four product candidates may be differe
Slide 23: Progressing ETX-155 in Epilepsy: Phase 1b Photosensitive Epilepsy Trial
Progressing ETX-155 in Epilepsy: Phase 1b Proof-of-Concept Trial in Photosensitive Epilepsy (PSE) to De-risk Focal Onset Seizure Study ETX-155 Study Details Rationale Design: Phase 1b, single-center, randomized, double-blind, placebo-controlled, 2-sequence crossover study Objective: Provide evidence
Slide 24: Progressing ETX-155 in Depressive Disorders: Two Phase 2a RCTs
Progressing ETX-155 in Depressive Disorders: Two Phase 2a RCTs of ETX-155 in MDD and PMD, with Topline Data Anticipated in 1H 2023 ETX-155 Screening Outpatient Treatment Follow-up 28 days Week 14 days 1 2 3 4 ETX-155 60 mg tablets qd x 28 days Placebo qd x 28 days MDD Phase 2a ~80 subjects 12 US sit
Slide 25: ETX-155: Potentially Clinically Differentiated Oral Neuroactive Steroid
ETX-155: Potentially Clinically Differentiated Oral Neuroactive Steroid in Markets with Significant Unmet Needs ETX-155 Improve Efficacy Leverage absence of food effect & significantly longer half-life ETX-155 Opportunities Unmet Needs Improve Tolerability Highly encouraging CNS AE rates in healthy
Slide 26: Kv7.2/3 Program: Developing a Differentiated Kv7.2/3 Opener
Kv7.2/3 Program: Developing a Differentiated Kv7.2/3 Opener For Multiple Neuronal Excitability Indications Kv7 IND-enabling studies anticipated to initiate 1H 2022 Opportunity across multiple indication areas Epilepsy Chronic Pain Depression Kv7 Eliem Kv7 Program Goal Kv7 Opportunity Program Status
Slide 27: Multiple Catalysts and Value-Creating Milestones Across Pipeline
Multiple Catalysts and Value-Creating Milestones Across Pipeline – Existing Cash Runway Through Five Topline Data Catalysts 2H 2021 1H 2022 2H 2022 1H 2023 Ph 1b PSE Topline data Ph 2a DPNP Ph 2a LSRP Ph 2a MDD ETX-810 ETX-155 Ph 2a PMD Ph 2 FOS Preclinical Kv7 program IND-enabling studies GAD progr
Slide 28: Investment highlights
Highly experienced management team Clinical and preclinical pipeline based on clinically validated mechanisms of action Two clinically differentiated lead product candidates with top-line data readouts across five indications over next 24 months ~$170M* cash runway to late 2023 allows for top line d
Slide 29: For more information: www.eliemtx.com
For more information: www.eliemtx.com InvestorRelations@eliemtx.com
Eliem Therapeutics — Investor Presentation (November 2021) on 6ix