Scilex Holding Company · NASDAQ:SCLX
Scilex — Merger or Acquisition (September 2024)
22 slides from Scilex's merger presentation, Sep 3, 2024
Slide 1: Corporate Presentation
Corporate Presentation’
Slide 2: Safe Harbor Statements Forward-Looking Statement
oemnur Safe Harbor Statements Forward-Looking Statement: jarmaceuticals™ Normal Ca SISOS EAGIASEH IS COPTATS PSST SS POSCAGTR YS WI COAST TTOGOR Ta Ty Bs TES By MAARGUTOATT Ser Paracas (SOM) resenng ts mata, ar or may be consred oaresooking tatomersThese stoners canbe nied by he fact tat hey Gort ea
Slide 3: Safe Harbor Statements Forward-Looking Statement
Safe Harbor Statements Forward-Looking Statement: *k fo Normal ‘Atari Registration Satements dele etlectve bythe SEC he pony sttemantpoepectu wl be sent tall Dena sharealders a fa eer date for the meeting of Dena shareholders tobe ‘statis or vot on he proposed bushes combraton Dena aoe ae docamens r
Slide 4: History of Semnur Pharmaceuticals
History of Semnur Pharmaceuticals Getting Back to Normal + Semnur was founded in 2013 with Series A $30MM 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
Slide 5: Semnur Pharmaceuticals Merger with Denali Acquisition Corporation
Semnur Pharmaceuticals Merger with Denali Acquisition Corporation 2k fo Normal + Semnur Pharmaceuticals, Inc., a Wholly Owned Subsidiary of Scilex Holding Company (Nasdaq: SCLX), and Denali Capital Acquisition Corp. (Nasdaq: DECA) Announce Signing of a Merger Agreement for a Proposed Business Combin
Slide 6: Market Opportunity
SP-102 Market Opportunity Getting Back to Normal Developing SP-102 as a non-opioid injectable therapeutic for sciatica Novel biocompatible excipient enables extended local effect On track to be the first FDA-approved epidural steroid product for sciatica ‘Currently used products are off-label and co
Slide 7: Epidural Steroid Injections (ESI) for Chronic Back Pain
oemnur Pharmaceuticals™ Epidural Steroid Injections (ESI) for Chronic Back Pain Getting Back to Normal One of the Most Common Medical Procedures / Top Pain Procedures ‘Strong Growth Rate, Evidenced by Medicare Procedure Volumes (MM) Medicare Overall ESI Injection Volumet ESIs widely reimbursed as pr
Slide 8: Fungal Meningitis Outbreaks with Compounded Steroid Formulations
Fungal Menin: Formulations Outbreaks with Compounded Steroid Getting Back to Normal 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. Newsweek mA
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: (SEMDEXA) Pharmacokinetic Bridging Trial
SP-102 (SEMDEXA) Pharmacokinetic Bridging Trial Getting Back to Normal + Epidural SP-102 injection was well tolerated 0 1021 ‘ 2 =r + Not associated with greater systemic Reeeweeset decanetusone shan dexamethasone exposure than IV dexamethasone Femteactoicuorpin at the same dose 10 mg (Reference Lis
Slide 11: (SEMDEXA) Phase 2: Repeat Dose PD trial
SP-102 (SEMDEXA) Phase 2: Repeat Dose PD trial Getting Back to Normal * The repeat injection had similar effects on Repeat Epidural njectons of SP-102 cortisol suppression time (~5 days), glucose (Denametiatone Sedum Phosphate injectable ‘Get in Subjects with LmbosaeralRadclopahy levels and WBC coun
Slide 12: (SEMDEXA) C.L.E.A.R. Trial Schema
SP-102 (SEMDEXA) C.L.E.A.R. Trial Schema Getting Back to Normal socio ES el Gr Resear log pan (oNPRS) uRtcontimes No prior ES! a, (cpa _ es] stood ss fel | | Primary Endooint ‘change in mean leg pain Lega (NPRS, avg & wos ain), (NPRS) over fest weeks csabaty (ODI), meta repeatinjecion
Slide 13: (SEMDEXA) C.L.E.A.R. Trial Met Primary Endpoint
SP-102 (SEMDEXA) C.L.E.A.R. Trial Met Primary Endpoin| (Corticosteroid Lumbar Epidural Analgesia in Radiculopathy) Getting Back to Normal Primary Endpoint + Largest prospective, double-blind, randomized study in imary Endpoint (mit) Sciatica (n=401) ‘Change in Average Daily Pain in Affected Leg + Th
Slide 14: (SEMDEXA) C.L.E.A.R. Trial Secondary Endpoint
SP-102 (SEMDEXA) C.L.E.A.R. Trial Secondary Endpoint: (ITT) Getting Back to Normal * Key Secondary Endpoint + The Oswestry Disability Index (ODI) - gold standard for measuring degree of disability and estimating ¢ juality of life, contains 10 topics Concerning intensity of pain, lifting, ability to
Slide 15: (SEMDEXA) C.L.E.A.R. Trial Effect Duration and Safety
SP-102 (SEMDEXA) C.L.E.A.R. Trial — Effect Duration and Safety Getting Back to Normal SP-102 Time to Repeat Injection (Return of > Primary Eapoint, “Allowance for Open-Label Repeat injection of P-102 + SP-102 showed continued reduction of pain beyond one month, and the median time to open-label repe
Slide 16: (SEMDEXA) C.L.E.A.R. Safety Summary
SP-102 (SEMDEXA) C.L.E.A.R. Safety Summary Getting Back to Normal + 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 ‘SPAO
Slide 17: Milestones
SP-102 Milestones Getting Back to Normal Toxicology program complete Pharmacokinetic bridge established to Reference Listed Drug Phase lI, additional PK / PD / Safety of repeat injection trial completed CLEAR Trial completed NDA 505(b)(2) application confirmed
Slide 18: Milestones
SP-102 Milestones Getting Back to Normal Open-Label Safety Trial @4-2024 to 1H-2026 + Open-Label Safety Trial ‘© Uptothree SP.102 injections over 24 weeks in Subjects wih Lumbosacral Raicular Pain (Sciatic). © Allsubjct are fallowed for 24 weeks ater the last nycton, © _ Tiats to enrott ~ 650 subjec
Slide 19: Scilex Commercial Capabilities to Launch SP-102
Scilex Commercial Capabilities to Launch SP-102 Chief Commercial Offi Analytics & Director Sales. Forecasting Director, Training Marketing Director ‘Account Managers '& Support Staff 7 ‘St PM + Marketing Senior Analyst ‘Support (N=3) Regional Field Trainers (N=6) Senior Analyst *k fo Normal National
Slide 20: SEMDEXA (SP-102) Expected to be the First Product Approved to Treat Sciatica
SEMDEXA (SP-102) Expected to be the First Product Semnur Approved to Treat Sciatica Pharmaceuticals’ Getting Back to Normal » SP-102 is a preservative free, surfactant free and particulate free viscous gel formulation of dexamethasone for sciatica (lumbosacral radicular pain) + Extended local effect
Slide 21: Semnur Pharmaceuticals Management Team
Semnur Pharmaceuticals Management Team Semnur Jaisim Shah Chit Executive & President ‘erence nage Pra snd ‘Son exact at Rech, 5, ise: POL ‘Suresh Khemani ‘peters ate nay r Y Henry Ji, PhD xeautve Chakman + 251 yursot expnance nde Seltincgy nate scanesaisey rd Subs Des cout eae “merperne mses sun Dmi
Slide 22: Summary Investment Highlights
oemnur Summary Investment Highlights Pharmaceuticals™ Getting Back to Normal Scilex Launched 3 FDA-approved Non-Opioid Management Products Worldwide Commercial Rights to SP-102 Strong Proprietary Platform and Replace Issued IP and High Barriers to Entry Scilex Established ReimbursementAccess Blockbu
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