Semnur Pharmaceuticals, Inc. · OTC:SMNR
Semnur Pharmaceuticals — SPAC Merger (August 2024)
20 slides from Semnur Pharmaceuticals's SPAC merger presentation, August 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 (“Semnur”) 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 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 sciatica Curr
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: 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 9: 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 10: 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 11: 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 12: 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 13: 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 14: 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 15: 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 16: 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 17: SP-102 Milestones
SP-102 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 CLEAR Trial completed 5 NDA 505(b)(2) application confirmed 6 17
Slide 18: SP-102 Milestones: Open-Label Safety Trial
SP-102 Milestones Open-Label Safety Trial H2-2025 to H2-2026 • 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 19: 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
Slide 20: Summary Investment Highlights
Summary Investment Highlights Scilex Launched 3 FDA-approved Non-Opioid Management Products Worldwide Commercial Rights to SP-102 Strong Proprietary Platform with Issued IP and High Barriers to Entry and Replace 5 Scilex Established ReimbursementAccess Blockbuster Potential With Limited Ca