Lexicon Pharmaceuticals, Inc. · NASDAQ:LXRX
Lexicon Pharmaceuticals — Investor Day (2025)
35 slides from Lexicon Pharmaceuticals's investor day presentation, 2025
Slide 1: LX9211: Changing the Paradigm for Treatment of Neuropathic Pain
LX9211 Changing the Paradigm for Treatment of Neuropathic Pain 1
Slide 2: Agenda
Agenda Overview of massive treatment gap in Neuropathic Pain (10 mins) Mike Exton, PhD; Director and Chief Executive Officer LX9211: Potential innovative solution for DPNP (20 mins) Suma Gopinathan, PhD; VP, Clinical Development and LX9211 Lead Expert panel discussion on the latest in Pain Managemen
Slide 3: Overview of massive treatment gap in neuropathic pain
Overview of massive I have been suffering for almost 20 years treatment gap in with painful diabetic neuropathy that has gotten progressively worse. In addition to neuropathic pain unrelenting pain that has limited my mobility, it is depressing that I'm unable to enjoy something as simple as playing
Slide 4: Neuropathic pain: A chronic condition with significant unmet need
Neuropathic pain: A chronic condition with significant unmet need Definition Nerve pain that occurs when the nervous system malfunctions or gets damaged 1 Causes of Neuropathic Pain (NP) Only 30% of patients with Diabetes Chemotherapy Multiple sclerosis neuropathic pain achieve partial pain manageme
Slide 5: Significant quality of life impact
Unsatisfied market with substantial impact to quality of life for patients Significant quality of life impact Sensation, Falls, Loss of daily Ulcers, Pain, Lack of sleep balance loss fractures function amputations depression 5
Slide 6: Little innovation over the past 20 years
Amitriptyline Oral tricyclic anti-depressant - spontaneous use for many years Oral SNRI Oral long-acting opioid There has been little 1961 2004 2012 innovation over the past 20 years, and an intensifying need for novel and effective non-opioid 2004 2020 therapeutic options 1994 Gabapentin Oral antic
Slide 7: Pain management evolves from single to polypharmacy as DPNP progresses
Pain management evolves from single to polypharmacy as diabetic peripheral neuropathic pain (DPNP) progresses ~60% DPNP patients treated go on to switch or add therapies1 Cycle of trial and failure Uncontrolled Therapy Added on Stable Therapy switched Controlled Prescribed single agent Symptom onset
Slide 8: DPNP is highly prevalent and rapidly growing
DPNP is highly prevalent and rapidly growing Disease Awareness ~13M diagnosed DPNP Investment across industry to Patients educate on DPNP Market Reinvigoration Educational efforts to improve standard of care in DPNP ~9M diagnosed DPNP Patients Non-Opioid, Novel Options Introduction of new therapies
Slide 9: Unique potential advantages of LX9211 from our continuing clinical development program
Unique potential advantages of LX9211 from our continuing clinical development program Novel, non-opioid treatment option Clinically and statistically significant reductions compared to placebo Qualify dose, oral monotherapy or in combination with standard of care 9
Slide 10: LX9211: Potential innovative solution for DPNP
LX9211: Potential It's heartbreaking to see my innovative solution for husband suffering. He is often up during the night, crying out from DPNP the pain in his legs and feet, which affects the quality of life for both of us. Suma Gopinathan, PhD VP, Clinical Development and LX9211 Lead - First-hand
Slide 11: AAK1 is a novel target for neuropathic pain
AAK1 is a novel target for neuropathic pain Novel, non-opioid target for treating neuropathic pain Neuropathic Pain Inhibits reuptake and recycling of neurotransmitters involved in pain signaling and spasticity Validated using a genetic knockout Treatment with model, preclinical studies, and human L
Slide 12: Broad therapeutic potential backed by data in range of neuropathies and spasticity
Broad therapeutic potential backed by data in range of neuropathies and spasticity Preclinical Efficacy Clinical Proof of Concept Neuropathic Pain Diabetic Peripheral Neuropathic Pain Postherpetic Neuralgia Chemotherapy-Induced Neuropathic Pain Lumbosacral Radiculopathy Multiple Sclerosis Pain Spast
Slide 13: RELIEF-DPN-1 Study Overview
RELIEF-DPN-1 Study Overview 13
Slide 14: Proof of concept RELIEF-DPN-1 study in patients with DPNP
Proof of concept RELIEF-DPN-1 study in patients with DPNP Patient Run in period Double-Blind Treatment Period Safety Follow-up Population 2-week 6-week 5-week LX9211 100/10 mg (n = 106) • Patients with T1DM or T2DM Placebo LX9211 200/20 mg (n = 106) Placebo • Moderate to severe pain R • Allowed to r
Slide 15: Statistically significant reduction in ADPS in RELIEF-DPN-1 Phase 2 study
Meaningful and statistically significant reduction in ADPS in placebo-controlled RELIEF-DPN-1 Phase 2 study LX9211 LX9211 Placebo* (100/10 mg) (200/20 mg) 0 LS Mean Change from Baseline -0.7 -1 Δ = -0.7 -1.3 -1.4 p-value = 0.007 p-value = 0.03 -2 ADPS: average daily pain score; SOC: standard of care
Slide 16: Most common adverse events from RELIEF-DPN1
Most common adverse events from RELIEF-DPN1 PLACEBO 100 mg/10 mg 200 mg/20 mg TOTAL Adverse Event (N = 107) n (%) (N = 106) n (%) (N = 106) n (%) (N = 319) n (%) Dizziness 2 (1.9) 16 (15.1) 29 (27.4) 47 (14.7) Headache 4 (3.7) 9 (8.5) 10 (9.4) 23 (7.2) Nausea 3 (2.8) 9 (8.5) 12 (11.3) 24 (7.5) Findi
Slide 17: RELIEF-PHN-1 Study Overview
RELIEF-PHN-1 Study Overview 17
Slide 18: RELIEF-PHN-1 study design in patients with PHN
RELIEF-PHN-1 study design in patients with PHN Patient Run in period Treatment Period Safety Follow-up Population 2-week 6-week 5-week LX9211 200/20 mg (n = 38) • Moderate to severe pain Placebo Placebo • Allowed to remain on R background PHN medication Placebo (n = 41) Day 1 Week 6 Week 11 PHN: Pos
Slide 19: Achieved proof of concept in placebo-controlled RELIEF-PHN-1
Achieved proof of concept in placebo-controlled RELIEF-PHN-1 Placebo LX9211 n = 41 n = 38 0 LS Mean Change from Baseline -1 -1.6 -2 Δ = -0.80 -2.4 -3 p-value = 0.12 LX9211 = LX9211, 200 mg/20 mg; ADPS: average daily pain score PHN: Postherpetic neuralgia Source: Vinik, 2014 19
Slide 20: PROGRESS Study Overview
PROGRESS Study Overview pharmaceuticals
Slide 21: PROGRESS study is designed to be patient-centric and powered for success
PROGRESS study is designed to be patient-centric and powered for success Pragmatic design led to rapid, early, and above capacity enrollment Key Design elements 2-week run-in Placebo-controlled Patient population Patient selection No loading dose • Type 1 and 2 • Diagnosed using MNSI Training in pai
Slide 22: PROGRESS Phase 2b study enrollment complete
PROGRESS Phase 2b study enrollment complete Patient Run in period Treatment Period Safety Follow-up Population 2-week 8-week 4-week LX9211 10 mg • Patients with T1DM or T2DM LX9211 20 mg • Moderate to severe pain Placebo • Allowed to remain on R LX9211 20 mg for 7 days/10 mg thereafter background st
Slide 23: Goals for top-line data
Goals for top-line data Achieve similar or better efficacy Removal of loading dose improves tolerability Target Target Phase3 3 Phase start start inin 2025 2025 Identify single dose to take into placebo-controlled Phase 3 studies Reaffirm pragmatic design 23
Slide 24: Expert panel on the latest in pain management for DPNP
Expert panel on the latest The first pain and the worst pain in pain management for was my feet feeling like they were DPNP caught on fire, almost burning. Often, I would wake up at night and not be able to go back to sleep. Moderated by Craig Granowitz, MD, PhD - RELIEF-DPN-1 trial patient SVP and
Slide 25: Objectives of today's panel discussion
Objectives of today’s panel discussion Educate on Understand Review Discuss clinical neuropathic pain patient journey the current trials in and specifically treatment neuropathic pain DPNP landscape, pros and cons 25
Slide 26: Discussion on neuropathic pain: Panelists
Discussion on neuropathic pain Panelists Rodica Pop-Busui, Steve Edelman, MD Suma Gopinathan, Craig Granowitz, MD, PhD PhD MD, PhD Jordan Schnitzer Chair in Diabetes | Professor of Medicine, the Division of VP, Clinical Development SVP and Chief Medical Officer Professor of Medicine and Division Hea
Slide 27: Key Takeaways
Key Takeaways Mike Exton, PhD Director and Chief Executive Officer 27
Slide 28: Introducing Pilavapadin
Introducing Pilavapadin “pill-uh-vap-uh-din” A potential treatment for DPNP 28
Slide 29: Unique potential advantages of pilavapadin
Unique potential advantages of pilavapadin New and Novel Proof of Concept no approved options for clinically and statistically significant neuropathic pain in over 2 decades reductions compared to placebo Oral Once Daily Non-Opioid monotherapy or in combination MOA distinct from current with standar
Slide 30: A clear need and opportunity in the DPNP treatment landscape
A clear need and opportunity in the DPNP treatment landscape DPNP impacts 25%1 of diabetes patients 60% of patients Have tried multiple ~9 Million treatments Patients with DPNP as of 20 years 2024 Since last innovative treatment 1) CDC National Diabetes Statistics Report 2024. Du SH, Zheng YL, Zhang
Slide 31: 2025 Year Ahead
2025 Year Ahead pharmaceuticals
Slide 32: Multiple potential catalysts for value creation in 2025
Company Overview Multiple potential catalysts for value creation in 2025 ATTRACTIVE DEVELOPMENT LEAN, AGILE NEAR-TERM ASSETS EXPERTISE ORGANIZATION CATALYSTS • Diversified pipeline • Clinical drug • Full focus as a • Pilavapadin Ph. 2b platform potential development expertise development company top
Slide 33: A portfolio of potential "pipelines in a pill"
A portfolio of potential “pipelines in a pill” 2025 2026 2027 2028 2029 Pilavapadin Ph3 Initiation Q1 PDUFA Approval Diabetic Peripheral Neuropathic Pain (DPNP) Ph3 planning / execution 2028 Approval Postherpetic Neuralgia (PHN) Ph2 planning / execution 2029 Approval MS Spasticity Sotagliflozin ex-U
Slide 34: Q&A
Q&A Rodica Pop-Busui, MD, PhD Steve Edelman, MD Mike Exton, PhD Craig Granowitz, MD, PhD Suma Gopinathan, PhD 34
Slide 35: Thank You
Thank You pharmaceuticals