Climb Bio, Inc. · NASDAQ:CLYM
Climb Bio — Eliem Therapeutics — Investor Presentation (March 2022)
34 slides from Climb Bio's investor presentation, Mar 29, 2022
Slide 1: Clinical Stage Neurology Company Focused on Neuronal Excitability Disorders
Clinical Stage Neurology Company Focused on Neuronal Excitability Disorders Corporate Presentation | March 28, 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: Rethinking Treatment for Nervous System Disorders
Highly experienced management team Clinical and preclinical pipeline based on clinically validated mechanisms of action Rethinking treatment for Two clinically differentiated lead product candidates with top-line nervous system data readouts across five indications over next 24 months disorders ~$16
Slide 4: Powered by Successful and Talented Executives from Pioneering Organizations
Powered by Successful and Talented Deep expertise in neuroscience Executives from Pioneering Organizations research, clinical development and commercialization • Lyrica, Neurontin, Trobalt, Vyepti, Vixotrigine, Nimotop, Aptiom, Lunesta, General Management, Commercial & Corporate Development Geodon L
Slide 5: Developing Novel Therapies With Multiple Opportunities to Address Interrelated Diseases
Eliem is Developing Novel Therapies With Multiple Opportunities to Address Interrelated Diseases Chronic Pain Approaching interrelated disease states with ETX-810 multiple MOAs ETX-155 Kv7 Innovating within clinically validated mechanisms of action Depression Epilepsy / Anxiety ETX-155 ETX-155 Kv7 K
Slide 6: Eliem Pipeline: Four Programs with Clinically Validated MOAs
Eliem Pipeline: Four Programs with Clinically Validated MOAs and Multiple Upcoming Clinical Catalysts Product Candidate Anticipated Clinical Lead indications Preclinical Phase 1 Phase 2 Phase 3 (Mechanism) Milestones Topline Phase 2a Diabetic peripheral neuropathic pain data (1H 2022) ETX-810 (PEA p
Slide 7: Anticipated Milestones
Anticipated Milestones Diabetic Peripheral Neuropathic Pain (DPNP) ETX-810 Phase 2a Data 1H 2022 Lumbosacral Radicular Pain (LSRP) Phase 2a Data 2H 2022
Slide 8: Chronic Pain: Large Commercial Opportunity with High Unmet Need
Chronic Pain: Large Commercial Opportunity with High Unmet Need Current Treatment Paradigm Unmet Need >36m • <50% of patients achieve ?50% reduction in pain ? significant residual pain 1st line Antidepressants • Significant tolerability issues (e.g., dizziness, nausea, US+EU (e.g., Cymbalta) somnole
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 Reduced PEA levels hypothesized in PEA is a master regulator of neuroinflammation and chronic pain pathology1 pain signaling with a pleiotropic mechanis
Slide 10: Clinical Validation of PEA: Compelling Body of Evidence
Clinical Validation of PEA: Compelling Body of Evidence Highlighting PEA’s Activity and Tolerability in Chronic Pain PEA in Chronic Pain Meta-Analyses of PEA Chronic Pain Clinical Studies Reference Key Conclusions >2,500 patients treated with PEA in >35 published clinical studies of PEA Paladini 201
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 Guida 20101 – Low back pain / sciatica Steels 20193 – Knee osteoarthritis N=636, PEA monotherapy 300 mg / 600 mg vs placebo, N=111, PEA monotherapy 300 mg / 600 mg vs placebo, 2
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 Program Rationale ETX-810 Absorption • Clear dose response in PEA RCTs • Opportunity to enhance exposure • Develop new chemical entity (NCE) Ester prodrug Protected PEA Hydrolysis in Active PEA through prodrug
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 Prodrug pharmacokinetics results in higher PEA concentration over time and 3x exposure improvement PEA concentration over time PEA exposure 80 400 1000 mg ETX-810 (delivering 490 mg PEA) 600 mg PEA dietary s
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 SAD Study (n=60) MAD Study (n=20) ETX-810 Placebo ETX-810 1000mg ETX-810 500mg BID Placebo Adverse Event Adverse Event (50-1200mg) (n=48*) (n=12) BID (n=8) (n=8) (n=4) Any AE 2
Slide 15: ETX-810: Two Phase 2a Proof of Concept Studies
ETX-810: Two Phase 2a Proof of Concept Studies With Topline Data Expected in 2022 Diabetic Peripheral Neuropathic Pain (DPNP) Objectives: 4 Weeks Study + 1 Week Follow up Fully enrolled • Demonstrate clinically meaningful R ETX-810 (1000mg BID) Anticipated topline data improvement in neuropathic pai
Slide 16: ~10 Million Treated Patients in DPNP and LSRP Indications in the US
There are a total of ~10 million treated patients in the DPNP and LSRP indications in the US DPNP LSRP Diabetes overall prevalence 34.2 M Chronic LBP overall prevalence 32.4 M DPNP overall prevalence 9.6 M Neuropathic pain in chronic LBP 13.7 M DPNP diagnosis rate 4 468 .6 M Chronic LBP diagnosis ra
Slide 17: ~60% of Treated US Patient Opportunity Is in 2nd Line and Beyond
~60% of the treated US patient opportunity is in 2nd line and beyond (2L+) Treated patient opportunity by LOT DPNP Total 2L+ • <50% of patients achieve ?50% Line 1 Line 2 Line 3 Line 4+ reduction in pain ? significant % Pts 59% (40%) (27%) (19%) (14%) residual pain across all lines • Significant tol
Slide 18: A $15B+ Branded Opportunity Exists in LoT2+
A $15B+ branded opportunity exists in LoT2+ Drug Branded Dollar Both Cymbalta and Lyrica achieved Treated Opportunity >$1B in US peak sales in pain DPNP ~3.0 M ~$5 B Peak year: 2013 Assumptions: Pain revenue: ~$1.3B ? 60% LOT2+ LSRP ~7.0 M 195 Average DoT ~$11 B ? ~$ WAC Peak year: 2018 ? 5000 Pain
Slide 19: Each 10% Share of LoT2+ Patients Is a $1.5B+ Opportunity
Each 10% share of the LoT2+ patients is a $1.5B+ opportunity Percentage of Patients in LoT2+ across DPNP and LSRP Opportunity 11% Opioids 43% • ~40%+ of patients are taking Total Branded Patients opioids consistently Opportunity = $16B of 31% Anti-Epileptics / Anti-Depressants Share of Lot2+ patient
Slide 20: Target 70% of the Market with a Field Team of ~500-550
We believe we can target 70% of the market (~75k HCPs) with a field team of ~500-550 HCP Universe Top specialties across DPNP & LSRP by NRx volume 8% PM & R LSRP 8% DPNP PAIN MEDICINE 10% 17k 31k 27k 14% ANESTHESIOLOGY NRx % INTERNAL MEDICINE 34% FAMILY MEDICINE ~75k unique HCPs
Slide 21: Aiming to Develop a NCE to Address the Large Chronic Pain Market
Aiming to Develop a NCE with Desired Clinical Profile to Address the Large Chronic Pain Market Target Profile for a New Chronic Pain Treatment Commercial Opportunity Non-opioid, with no abuse liability 2028 US+EU Forecast: ~50m 2nd line or later drug-treated chronic pain patients Novel mechanism of
Slide 22: Anticipated Milestones
Anticipated Milestones Photosensitive Epilepsy ETX-155 Data Expected 1H 2022 Major Depressive Disorder Topline Phase 2a Expected 2H 2023 Perimenopausal Depression Topline Phase 2a Expected 2H 2023
Slide 23: ETX-155: A Differentiated Neuroactive Steroid GABAA Positive Allosteric Modulator
ETX-155: A Differentiated Neuroactive Steroid GABAA Positive Allosteric Modulator Clinical validation for MOA (GABAA PAM) Dual potent activity at synaptic and extrasynaptic GABAA receptors, with high intrinsic efficacy No clinically meaningful food effect Convenient once-daily dosing with ~40-hr hal
Slide 24: 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 Major Depressive Perimenopausal Epilepsy / Focal Disorder (MDD) Depression (PMD) Onset Seizure (FOS) • Reduced GABA levels ? • Reduced neurosteroid levels ? • GABAergic deficits
Slide 25: ETX-155 Differentiation: Longer Half-Life, Lack of Food Effect
ETX-155 Differentiation: Significantly Longer Half-Life, Lack of Food Effect, Favorable Bioavailability and Broad GABAAR Activity GABAAR Clinical Validation Pharmacokinetics Activity (positive RCT) Company Molecule Extra- Synaptic Food effect Half-life Oral Bioavailability MDD PPD or PMD Epilepsy sy
Slide 26: Phase 1 Study in Healthy Subjects: Excellent PK and Safety
Phase 1 Study in Healthy Subjects: Excellent Pharmacokinetics and Safety & Tolerability Profile 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 pharmacokinetic
Slide 27: 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 GABAA PAM class Presence of a food effect may impact: Efficacy 3.5 Cmax AUC(0-t) Exposure reduced or increased if medication not 3 3.0x taken with food 2.5 2
Slide 28: Progressing ETX-155 in Epilepsy: Phase 1b Trial in Photosensitive Epilepsy
Progressing ETX-155 in Epilepsy: Phase 1b Proof-of-Concept Trial in Photosensitive Epilepsy (PSE) to De-risk Focal Onset Seizure Study Rationale Study Details PSE is characterized by a photoparoxysmal response (PPR) Design: Phase 1b, single-center, randomized, double-blind, triggered by light stimul
Slide 29: 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 2H 2023 Screening Outpatient Treatment Follow-up Primary Endpoint (both PMD and MDD studies) Week 28 days 14 days Change from baseline in HAMD17 1 2 3 4 over days 3, 8, 15, 22,
Slide 30: ETX-155: Potentially Clinically Differentiated Oral Neuroactive Steroid
ETX-155: Potentially Clinically Differentiated Oral Neuroactive Steroid in Markets with Significant Unmet Needs Unmet Needs ETX-155 Opportunities Depressive Disorders Improve Efficacy Leverage absence of food effect & significantly longer half-life Slow onset of efficacy (~6+ wks) Improve Tolerabili
Slide 31: 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 Chronic Pain Human genetic validation and safety Strong clinical validation in pain and epilepsy Program Stat
Slide 32: Multiple Catalysts and Value-Creating Milestones Across Pipeline
Multiple Catalysts and Value-Creating Milestones Across Pipeline – Existing Cash Runway Through Five Topline Data Catalysts Anticipated Catalysts and Key Milestones 1H 2022 2H 2022 1H 2023 2H 2023 Ph 2a DPNP Topline Ph 2b Dose Range Finding data ETX-810 Ph 2a LSRP Topline data Potential Ph 2b Dose R
Slide 33: Rethinking Treatment for Nervous System Disorders
Highly experienced management team Clinical and preclinical pipeline based on clinically validated mechanisms of action Rethinking treatment for Two clinically differentiated lead product candidates with top-line nervous system data readouts across five indications over next 24 months disorders ~$16
Slide 34: For more information
For more information: www.eliemtx.com InvestorRelations@eliemtx.com
Eliem Therapeutics — Investor Presentation (March 2022) on 6ix