Climb Bio, Inc. · NASDAQ:CLYM
Climb Bio — Eliem Therapeutics — Investor Presentation (October 2022)
24 slides from Climb Bio's investor presentation, Oct 5, 2022
Slide 1: Clinical Stage Neurology Company Focused on Neuronal Excitability Disorders
Exhibit 99.2 Clinical Stage Neurology Company Focused on Neuronal Excitability Disorders Corporate Presentation | October 5, 2022
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: Highly experienced management team; clinical and preclinical pipeline; cash runway into 2025
Highly experienced management team Clinical and preclinical pipeline based on clinically validated mechanisms of action Rethinking Two differentiated programs in depression and epilepsy with treatment for expansion opportunities in chronic pain nervous system disorders ~$130M* cash runway into 2025
Slide 4: Deep expertise in neuroscience
Deep expertise in neuroscience Powered by successful and talented research, clinical development executives from pioneering organizations and commercialization • Lyrica, Neurontin, Trobalt, Vyepti, Vixotrigine, Nimotop, Aptiom, Lunesta, Geodon General Management, Commercial & Corporate Development L
Slide 5: Addressing multiple interrelated diseases with two distinct, clinically validated mechanisms of action
Addressing multiple interrelated diseases with two distinct, clinically validated mechanisms of action Approaching interrelated disease states with Depression distinct MOAs (GABA PAM and Kv7.2/3) A / Anxiety Innovating within clinically validated mechanisms of action ETX-155 Kv7 Chronic Pain Epileps
Slide 6: Eliem Pipeline: Two programs with clinically validated MOAs
Eliem Pipeline: Two programs with clinically validated MOAs intended to address large markets Product Candidate Lead indications Preclinical Phase 1 Phase 2 Phase 3 (Mechanism) Major depressive disorder Positioned for Phase 2a (MDD) initiation in Q1 2023 ETX-155 (GABA receptor PAM) A Epilepsy Kv7 Pr
Slide 7: Proof of concept Phase 2a trial in MDD
Proof of concept Phase 2a trial in Major Depressive Disorder (MDD) ETX-155 positioned for Q1 2023 initiation 7
Slide 8: ETX-155: A differentiated neuroactive steroid GABA positive allosteric modulator
ETX-155: A differentiated neuroactive steroid GABA positive allosteric modulator A Clinical validation for MOA (GABA PAM) A Dual potent activity at synaptic and extrasynaptic GABA receptors, with high intrinsic efficacy A No clinically meaningful food effect Convenient once-daily dosing with ~40-hr
Slide 9: Clinical development focused on MDD with opportunity to expand into other large markets
Clinical development focused on MDD with opportunity to expand into other large markets with considerable unmet need Proof of concept planned Potential future indication opportunities Major Depressive Perimenopausal Epilepsy / Focal Disorder (MDD) Depression (PMD) Onset Seizure (FOS) • Reduced GABA
Slide 10: ETX-155 Differentiation: Similar dual GABA-A R potency with differentiated pharmacokinetics
ETX-155 Differentiation: Similar dual GABA R potency to clinically validated A GABA PAMs, with differentiated pharmacokinetics A GABA R Clinical Validation A Pharmacokinetics (positive RCT) Potency Company Molecule Extra- Synaptic Food effect Half-life MDD PPD Epilepsy synaptic No ~40 hrs - - - ETX-
Slide 11: 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 Reported Fed/Fasted Ratios for GABA PAM class Presence of a food effect may impact: A Efficacy Cmax AUC(0-t) 3.5 Exposure reduced or increased if medication not taken with food 3 3.0x 2.9x
Slide 12: Phase 1 Study in Healthy Subjects: Encouraging safety and tolerability profile
Phase 1 Study in Healthy Subjects: Encouraging safety & tolerability profile observed with no severe or serious adverse events Most common treatment-emergent AEs ETX-155 Phase 1 Repeat-Dose Results (In ≥10% of ETX-155 treated subjects across repeat dose studies) • Favorable pharmacokinetics 7-day Re
Slide 13: Analysis of ETX-155 pharmacokinetic profile confirmed comparable 60mg exposures
Analysis of ETX-155 pharmacokinetic profile confirmed comparable 60mg exposures obtained with different batches, enabling path forward in Phase 2a MDD trial Original Phase 1 studies PSE study findings (April ‘22) Extensive Investigation • SAD (5-200mg, n=6 active/cohort) • Proof-of-concept model in
Slide 14: At steady-state, modeled exposures of ETX-155 60mg and 75mg are within therapeutic range
At steady-state, modeled exposures of ETX-155 60mg and 75mg doses are well within the therapeutic range Modeled 60mg and 75mg ETX-155 AUC at steady state 0-24 Preclinical Robust ED range (3 mg/kg) Mean: 2810 Benchmark zuranolone modeled AUC for 0-24 30mg and 50mg capsules at steady state* Mean: 2248
Slide 15: Positioned to progress ETX-155 into Phase 2a RCT in MDD in Q1 2023
Positioned to progress ETX-155 into Phase 2a RCT in MDD in Q1 2023 with topline data expected in mid-2024 Screening Outpatient Treatment Follow-up Primary Endpoint Week 28 days 14 days Change from baseline in HAMD17 1 2 3 4 over days 4, 8, 15, 22, and 29 Secondary Endpoints ETX-155 qd x 28 days MDD
Slide 16: ETX-155 Market Opportunity
ETX-155 Market Opportunity 16
Slide 17: One-third of the US MDD treated patient opportunity is in 2nd line and beyond
nd One-third (7M) of the US MDD treated patient opportunity is in 2 line and beyond US Epidemiology, 2030 estimates Reference branded MDD drug peak sales Drug Class Peak Sales Peak Year Diagnosed and Drug-treated 21M MDD patients Lexapro SSRI $3.0B 2011 Effexor SNRI $2.7B 2008 Zoloft SSRI $2.6B 2005
Slide 18: Zuranolone precedent: GABA-A PAM efficacy in line with approved MDD drugs
Zuranolone precedent GABA PAM efficacy in line with approved MDD drugs, A achieving statistical significance and ~50% reduction in HAMD17 despite smaller delta to placebo Estimated Mean HAMD17 at Mean HAMD17 change from Baseline end of treatment Year of Baseline Duration of Drug: Study* Reference St
Slide 19: Zuranolone precedent suggests potential GABA-A PAM advantages relative to existing ADTs
Zuranolone precedent suggests potential GABA PAM advantages relative to existing A ADTs: would be attractive in a “direct to patient” commercial marketplace Background Potential Differentiation Points • SSRI’s treatment duration undefined – many • “Treat depressive episode”: zuranolone uses a patien
Slide 20: ETX-155: Being Developed as a Potentially Clinically Differentiated Oral Neuroactive Steroid
ETX-155: Being Developed as a Potentially Clinically Differentiated Oral Neuroactive Steroid ETX-155 Opportunities Improve Efficacy: Increasing AUC • Absence of clinically meaningful food effect • Significantly longer half-life • Higher exposures observed at well tolerated doses Improve Tolerability
Slide 21: Kv7 Opener: pre-candidates identified, IND-enabling safety studies planned Q1 2023
Pre-candidates identified IND-enabling safety studies planned for Kv7 Opener Q1 2023 21
Slide 22: 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 Opportunity Eliem Kv7 Program Goal Maintain efficacy with improved tolerability Human genetic validation and safety Strong clinical validation in pain and Program Status epilepsy (retigabin
Slide 23: Highly experienced management team; clinical and preclinical pipeline; cash runway into 2025
Highly experienced management team Clinical and preclinical pipeline based on clinically validated mechanisms of action Rethinking Two differentiated programs in depression and epilepsy with treatment for expansion opportunities in chronic pain nervous system disorders ~$130M* cash runway into 2025
Slide 24: For more information
For more information: www.eliemtx.com InvestorRelations@eliemtx.com
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