Semnur Pharmaceuticals, Inc. · OTC:SMNR
Semnur Pharmaceuticals — SPAC Merger (September 2024)
24 slides from Semnur Pharmaceuticals's SPAC merger presentation, September 2024
Slide 1: Semnur Pharmaceuticals: Getting Back to Normal
Semnur Pharmaceuticals Getting Back to Normal Corporate Presentation Wholly Owned Subsidiary of Scilex Holding Company (NASDAQ: SCLX)
Slide 2: 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 (“Scilex”) orally in presenting this material, are or may be considered “forward
Slide 3: 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 4: History of Semnur Pharmaceuticals
History of Semnur Pharmaceuticals • Semnur was founded in 2013 with Series A $30MM 1 investment from Canaan Partners, Frazier Healthcare, and Vivo Capital. • On March 22, 2019, Scilex Pharmaceuticals Inc. closed a transaction to merge with Semnur Pharmaceuticals, Inc. to form a new company, Scilex H
Slide 5: Semnur Pharmaceuticals Merger with Denali Acquisition Corporation
Semnur Pharmaceuticals Merger with Denali Acquisition Corporation • Semnur Pharmaceuticals, Inc., a Wholly Owned Subsidiary of Scilex Holding Company (Nasdaq: SCLX), and Denali 1 Capital Acquisition Corp. (Nasdaq: DECA) Announce Signing of a Merger Agreement for a Proposed Business Combination. • On
Slide 6: SP-102 Market Opportunity
SP-102 Market Opportunity Developing SP-102 as a non-opioid injectable therapeutic for low back pain Novel viscous gel formulation, optimized for epidural injection Novel biocompatible excipient enables extended local effect On track to be the first and only FDA-approved epidural steroid product Cur
Slide 7: Epidural Steroid Injections (ESI) for Chronic Back Pain
Epidural Steroid Injections (ESI) for Chronic Back Pain One of the Most Common Medical Procedures / Top Pain Procedures Strong Growth Rate, Evidenced by Medicare Procedure Volumes (MM) Medicare Overall ESI Injection Volume1 1 ESIs widely reimbursed as procedure to delay or avoid back surgery 2 Tra
Slide 8: SP-102 Reimbursement – J code Timelines for New Products
SP-102 Reimbursement – J code Timelines for New Products • SP-102 has strong value proposition as the first proven and indicated preservative-free epidural injection for lumbar radiculopathy • Strong case for economic benefits associated with use of epidural steroid injections to defer more complica
Slide 9: Fungal Meningitis Outbreaks with Compounded Steroid Formulations
Fungal Meningitis Outbreaks with Compounded Steroid Formulations Meningitis outbreak caused by compound pharmacy produced steroids for epidural injections, contaminated with Aspergillus fumigatus, infected more than 800 people across 20 states in 2012, 64 of whom died. By Kurt Eichenwald / April 16,
Slide 10: 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 11: SP-102 (SEMDEXA) Toxicology GLP Studies (dogs and pigs)
SP-102 (SEMDEXA) Toxicology GLP Studies (dogs and pigs) • No drug-related effects on any parameter: ECG, Clin obs, BW, Neurology, Clinical pathology & chemistry. • Histopathology: no drug-induced adverse effects, including special stains • Dose dependent PK, both plasma & CSF, cleared by 24 h. • Cor
Slide 12: SP-102 (SEMDEXA) 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 13: SP-102 (SEMDEXA) 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 14: SP-102 (SEMDEXA) C.L.E.A.R. Trial Schema
SP-102 (SEMDEXA) C.L.E.A.R. Trial Schema Inclusion Radicular leg pain episode (4-9 NPRS) MRI confirmed No prior ESI (epidural steroid injection) No opioids or NSAIDs Stable, >4 avg NPRS pain in 21d screening Primary Endpoint Secondaries (W2, W4, W8, W12) Change in mean leg pain Leg pain (NPRS, avg &
Slide 15: SP-102 (SEMDEXA) 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 and
Slide 16: SP-102 (SEMDEXA) 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 to
Slide 17: SP-102 (SEMDEXA) 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, and
Slide 18: SP-102 (SEMDEXA) 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 18
Slide 19: SP-102 Regulatory Discussion(s) to Date
SP-102 Regulatory Discussion(s) to Date 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 CLEAR Trial completed 5 NDA 505(b)(2) application confirmed 6 19
Slide 20: SP-102 Milestones
SP-102 Milestones Open-Label Safety Trial Q4-2024 to 1H-2026 • Open-Label Safety Trial o Up to three SP-102 injections over 24 weeks in Subjects with Lumbosacral Radicular Pain (Sciatica). o All subjects are followed for 24 weeks after the last injection. Trials to enroll ~ 650 subjects to achieve s
Slide 21: Semnur Pharmaceuticals Management Team
Semnur Pharmaceuticals Management Team Jaisim Shah Henry Ji, PhD Dmitri Lissin, MD Steve Lincoln Chief Executive & President Executive Chairman Chief Medical Officer Interim GC and Chief Compliance Officer 25+ years of management 25+ years of experience in the 20+ years in clinical development
Slide 22: Commercial Capabilities of Scilex to Support Pain Specialists and Neurologists
Commercial Capabilities of Scilex to Support Pain Specialists and Neurologists Chief Commercial Officer Analytics & Head of Market Director Sales National Sales Marketing Director Sales Ops Forecasting Director Access Training Director Account Managers Sr PM + Marketing Senior Analyst Regional Field
Slide 23: SEMDEXA (SP-102) Expected to be the First Product Approved to Treat Sciatica
SEMDEXA (SP-102) 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 impr
Slide 24: SP-102 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
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