Semnur Pharmaceuticals, Inc. · OTC:SMNR
Semnur Pharmaceuticals — Investor Presentation (August 2024)
25 slides from Semnur Pharmaceuticals's investor presentation, Aug 1, 2024
Slide 1: Semnur Pharmaceuticals: Getting Back to Normal
Semnur Pharmaceuticals Getting Back to Normal Corporate Presentation (OTC: SMNR) Majority Owned Subsidiary of Scilex Holding Company (NASDAQ: SCLX)
Slide 2: SP-102 (SEMDEXA) Opportunity
SP-102 (SEMDEXA) Opportunity • Market Opportunity • Unmet needs • Product Profile • Clinical Development • Reimbursement • Sales Forecast 2
Slide 3: Safe Harbor Statements Forward-Looking Statements
Safe Harbor Statements Forward-Looking Statements Certain statements contained in this corporate presentation (this “Presentation”), along with certain statements that may be made by management of Semnur Pharmaceuticals (“Semnur”) orally in presenting this material, are or may be considered “forward
Slide 4: Safe Harbor Statements Forward-Looking Statements
Safe Harbor Statements Forward-Looking Statements After the Registration Statement is declared effective by the SEC, the proxy statement/prospectus will be sent to all Denali shareholders as of a record date for the meeting of Denali shareholders to be established for voting on the proposed business
Slide 5: SP-102 (SEMDEXA) Market Opportunity
SP-102 (SEMDEXA) Market Opportunity Developing SP-102 as a non-opioid injectable therapeutic for sciatica Novel viscous gel formulation, optimized for epidural injection Novel biocompatible excipient enables extended local effect On track to be the first FDA-approved epidural steroid product for sci
Slide 6: Epidural Steroid Injections Are One of the Most Common Medical Procedures in the U.S.
Epidural Steroid Injections Are One of the Most Common Medical Procedures in the U.S. Common Surgical Strong Growth Rate, Evidenced by 1 Procedures (thousands) (1) Medicare Procedure Volumes Epidural Steroid Injections 10,000 All cardiac interventions 7,500 Operations of the GI system 6,000 Knee art
Slide 7: SP-102 (SEMDEXA) Epidemiology—Overview
SP-102 (SEMDEXA) Epidemiology—Overview Lumbar Radiculopathy is a subtype of Low Back Pain characterized by debilitating pain usually requiring medical intervention. Treatment Funnel for ESI Treatment of Lumbar Radiculopathy ~80% of Americans will experience low back pain in their lifetime (~250 mi
Slide 8: Expected to be the First Product Approved to Treat Sciatica
SP-102 (SEMDEXA) Expected to be the First Product Approved to Treat Sciatica • SP-102 is a preservative free, surfactant free and particulate free viscous gel formulation of dexamethasone for sciatica (lumbosacral radicular pain). • Extended local effect provides durable pain relief and significant
Slide 9: Differentiated Product Profile & Positioning
SP-102 Differentiated Product Profile & Positioning Depo-Medrol Dexameth- Kenalog Celestone Important Treatment Attributes SP-102 (triamcinolone) (methylprednis- asone (betamethasone) 1 olone) FDA-approved for lumbosacral – – – – radicular pain Robust clinical data demonstrating safety – – – – a
Slide 10: Coverage – Public Payers Overview
SP-102 (SEMDEXA) Coverage – Public Payers Overview LR ESI products are covered by public payers (Medicare, Medicaid, and Medicare Advantage) as a physician-administered drug. Public Payer Coverage Physician-administered Drug Overview Pharmacy Benefits Medical Benefits Physician-administered drug i
Slide 11: Forecast: Patient Visit – ESI Volume Analysis
SP-102 (SEMDEXA) Forecast Patient Visit – ESI Volume Analysis The number of ESIs performed in ambulatory surgical centers (ASCs) is higher than that in other settings/physician specialties in 2018. Average Injection Number by HCP Specialty (2018)1 Key Points On average, ~60% of total physicians pe
Slide 12: Currently Used Off-Label Steroids
Off-Label Steroids Bolded Warning Against Epidural Use Drug Formulation Potential Issues The safety and effectiveness of epidural administration • Methylprednisolone acetate of corticosteroids have not been established and Currently Used Depomedrol • Contains polyethylene glycol + benzyl corticoster
Slide 13: SEMDEXA – Broad Potential for Life Cycle Management
SEMDEXA – Broad Potential for Life Cycle Management 1 Physicians indicated there is potential opportunity for spontaneous use of SEMDEXA outside of lumbar radiculopathy which could represent an additional upside of ~50-200%* over LR 2 Additional Uses Carpel Tunnel Hip and Knee Replacements Tri
Slide 14: History of Serious Spinal Adverse Events Associated with ESIs
History of Serious Spinal Adverse Events Associated with ESIs: Resulting FDA Warning in All Injectable Corticosteroid Product Labels 1997-2014 90 serious (including fatal) neurological events following ESIs reported to FAERS 2014 FDA required warning for all injectable corticosteroid product labels
Slide 15: Pharmacokinetic Bridging Trial
SP-102 (SEMDEXA) Pharmacokinetic Bridging Trial • Epidural SP-102 injection was well tolerated • Not associated with greater systemic dexamethasone exposure than IV dexamethasone at the same dose 10 mg (Reference Listed Drug) • Equivalent AUC • Lower mean plasma Cmax (~ 50% lower) • Both treatments
Slide 16: Phase 2: Repeat Dose PD trial
SP-102 (SEMDEXA) Phase 2: Repeat Dose PD trial • The repeat injection had similar effects on cortisol suppression time (~5 days), glucose levels and WBC count. No cumulative effect. • There were no SAEs or discontinuations due to adverse events. • SP-102 provided prolonged pain relief, with prelimin
Slide 17: Confidential, not for distribution
Confidential, not for distribution 24
Slide 18: C.L.E.A.R. Trial Schema
SP-102 (SEMDEXA) C.L.E.A.R. Trial Schema Confidential, not for distribution 25
Slide 19: C.L.E.A.R. Trial Met Primary Endpoint
SP-102 (SEMDEXA) C.L.E.A.R. Trial Met Primary Endpoint (Corticosteroid Lumbar Epidural Analgesia in Radiculopathy) Primary Endpoint (mITT) • Largest prospective, double-blind, randomized study in Sciatica (n=401) Change in Average Daily Pain in Affected Leg 0.5 • The trial met primary, key secondary
Slide 20: C.L.E.A.R. Trial Secondary Endpoints (ITT)
SP-102 (SEMDEXA) C.L.E.A.R. Trial Secondary Endpoints (ITT) • Key Secondary Endpoint • The Oswestry Disability Index (ODI) - gold standard for measuring degree of disability and estimating quality of life, contains 10 topics concerning intensity of pain, lifting, ability to care for oneself, ability
Slide 21: C.L.E.A.R. Trial – Effect Duration and Safety
SP-102 (SEMDEXA) C.L.E.A.R. Trial – Effect Duration and Safety SP-102 Time to Repeat Injection (Return of Moderate-Severe Pain) Month 1 Month 2 Month 3 Month 4 Month 5 Primary Endpoint Allowance for Open-Label Repeat Injection of SP-102 • SP-102 showed continued reduction of pain beyond one month, a
Slide 22: C.L.E.A.R. Safety Summary
SP-102 (SEMDEXA) C.L.E.A.R. Safety Summary • No AEs of special interest (paraplegia, hematoma, infection) • No SAEs related to drug or injection procedure • No meaningful differences in physical examinations, vital signs, or laboratory parameters between treatment groups Confidential, not for distri
Slide 23: SP-102 Key Milestones
SP-102 Key Milestones 1 Toxicology program complete 2 Pharmacokinetic bridge established to Reference Listed Drug 3 Phase II, additional PK / PD / Safety of repeat injection trial completed 4 Phase III CLEAR Trial completed 5 NDA 505(b)(2) application confirmed 6 6 Additional Phase III design confir
Slide 24: Research Paper: Long-acting dexamethasone viscous gel for radicular pain
8L+AWA DAHON ABEA QIAVO/YOAROM ISA LIA YPOOALICOHOGOAU MVE XOMOUDINXPOHISGBZ3UTIM + 8YNOILWNCSZ LAB Hd GIINUG Aq UrEd/uDS'AMy'sjeUUNO!// GAY Woy PaPEOLMOG #Z0zIP1/90 vO Research Paper PAIN 00 (2024) 1-12 PAIN = A randomized, placebo-controlled trial of long-acting dexamethasone viscous gel delivered
Slide 25: Summary Investment Highlights
Summary Investment Highlights Huge Unmet Needs Without Approved Products to Treat for Sciatica Worldwide Commercial Rights to SP-102 Strong Proprietary Platform with Issued IP and High Barriers to Entry 5 Established ReimbursementAccess Blockbuster Potential With Limited Capital Required f
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