Sorrento Therapeutics, Inc. · OTC:SRNE
Sorrento Therapeutics — SPAC Merger (December 2021)
57 slides from Sorrento Therapeutics's SPAC merger presentation, Dec 13, 2021
Slide 1: Scilex Holding Company: Innovative Leader in Non-Opioid Pain Therapeutics
C C on f on f i i den t de n t i i a l a l : : F F o r or I I n n t t e e r r na l nal S S C C I I L E L E X X P P h ha r ar m m a c a c eu t eu t i i c c a l a l s s U U s e se O n On l l y y 1 1 Scilex Holding Company Innovative Leader in Non - Opioid Pain Therapeutics December 2021 Exhibit 99.1
Slide 2: Safe Harbor Statements
THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION THAT IS THE PROPERTY OF THE COMPANY . NEITHER THIS DOCUMENT, NOR THE PROPRIETARY INFORMATION CONTAINED HEREIN, SHALL BE PUBLISHED, REPRODUCED, COPIED, DISCLOSED OR USED FOR ANY OTHER PURPOSE, OTHER THAN THE REVIEW AND CONSIDERATION OF THIS DOCUMENT . Sa
Slide 3: Industry and Market Data; Important Information
THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION THAT IS THE PROPERTY OF THE COMPANY . NEITHER THIS DOCUMENT, NOR THE PROPRIETARY INFORMATION CONTAINED HEREIN, SHALL BE PUBLISHED, REPRODUCED, COPIED, DISCLOSED OR USED FOR ANY OTHER PURPOSE, OTHER THAN THE REVIEW AND CONSIDERATION OF THIS DOCUMENT . un
Slide 4: Important Information and Where to Find It
THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION THAT IS THE PROPERTY OF THE COMPANY . NEITHER THIS DOCUMENT, NOR THE PROPRIETARY INFORMATION CONTAINED HEREIN, SHALL BE PUBLISHED, REPRODUCED, COPIED, DISCLOSED OR USED FOR ANY OTHER PURPOSE, OTHER THAN THE REVIEW AND CONSIDERATION OF THIS DOCUMENT . In
Slide 5: Participants in Solicitation; Non-Solicitation
THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION THAT IS THE PROPERTY OF THE COMPANY . NEITHER THIS DOCUMENT, NOR THE PROPRIETARY INFORMATION CONTAINED HEREIN, SHALL BE PUBLISHED, REPRODUCED, COPIED, DISCLOSED OR USED FOR ANY OTHER PURPOSE, OTHER THAN THE REVIEW AND CONSIDERATION OF THIS DOCUMENT . Sc
Slide 6: Agenda
Agenda 1) Scilex Holding Corporate Overview 2) ZTlido® 1.8% Update 3) SP - 102 (S EMDEXA ) for Lumbar Radicular Pain / Sciatica 4) SP - 103 (3X ZTlido) for Low Back Pain 5) DBR Low Dose Naltrexone (LDN) for Fibromyalgia 6) Company Summary Scilex Holding Company
Slide 7: Corporate Overview
Scilex Holding Company C onf i dent i a l : F or Inte r nal S C IL E X P ha r m a c eut i ca l s U se On l y 1 0 Corporate Overview Scilex Holding Company
Slide 8: Business Combination with Vickers Vantage Corp I
Scilex Holding Company Vickers Strengths Strong deal structuring, investing and M&A experience within the fin - tech space Significant private and public investment experience History of working within highly regulated industries requiring vast and rigorous due diligence efforts Necessary experience
Slide 9: Management Team
Name Position(s) Experience Jaisim Shah CEO & President ▪ 2 5 + years of management experience in large Pharma and Biotech ▪ Lead commercialization of multiple blockbusters Rituxan ® , Abilify ® , Pegasys®, BuSpar ® , Tequin ▪ CEO, Semnur Pharma; CBO , Elevation; CBO , PDL BioPharma; VP , Bristol -
Slide 10: Best-in-Class Non-Opioid Pain Therapeutics Pipeline
Platform Program IND P h as e 1 P h as e 2 P h ase3 P i v o t al NDA Approved U p c o m in g M il es t o n es N on - O p i o i d P a i n M a n a g e m e n t ZTlido ® 1 . 8 % (Postherpetic Neuralgia - PHN) Laun c h e d U S October 2018 SP - 102 (S EMDEXA ) (Lumbar Radicular / Sciatica Pain) P i vot a
Slide 11: 2021 Scilex Business Update
Scilex Holding Company 2021 Scilex Business Update In April 2021, Scilex received a supplemental new drug application ( sNDA ) approval from the FDA for ZTlido to expand the label for use in water stress conditions In 2020, ZTlido had US net sales ~$27MM, which represents a ~35% growth rate YoY 2019
Slide 12: Target Physicians Concentrated in High Volume Clinics
15,000 - 20,000 T arget P hysician s C onsist of a M ix of Health Care S pecialists, Focus in H igh V olume C linics Source: Campbell Alliance Market Research; Clinical Guidelines: Lumbar Disk Herniation with Radiculopathy. NA Spine Society, 2012. http://www.guideline.gov/content.aspx?id=46414. Prim
Slide 13: Headquarters and Satellite Office
Scilex Holding Company Headquarters - 960 San Antonio Road, Palo Alto CA 94303 - Satellite Office: 4955 Directors Place, San Diego, CA 92121 Scilex Holding Company
Slide 14: ZTlido 1.8% for Post-Herpetic Neuralgia (PHN)
Scilex Holding Company C onf i dent i a l : F or Inte r nal S C IL E X P ha r m a c eut i ca l s U se On l y 1 0 Scilex Pharmaceuticals ZTlido 1.8% for Post - Herpetic Neuralgia (PHN) Scilex Holding Company
Slide 15: Marketed Product: ZTlido 1.8%
US FDA APPROVAL – FEBRUARY 2018 COMMERCIAL LAUNCH – OCTOBER 2018 Marketed Product: ZTlido® 1.8% (FDA approved for relief of pain associated with PHN ) Lidocaine Patch Market Overview >3 .5 million prescriptions per year More than 129 million prescription lidocaine patches were sold in the US in 2020
Slide 16: Lidocaine Patches are as Efficacious as Gabapentinoids
Scilex Holding Company Lidocaine Patches are as Efficacious as Gabapentinoids
Slide 17: ZTlido Annual TRx & NRx
Scilex Holding Company 91,421 129,384 120,542 199,144 0 50,000 100,000 150,000 200,000 250,000 2019 2020 ZTlido Annual TRx & NRx NRx TRx ZTlido strong prescription growth continued at faster pace than market through 2020, despite COVID - 19 pandemic impact +65.2 YoY ∆ +41.5% YoY ∆ 2,024,976 2,196,55
Slide 18: ZTlido Gross Sales YTD 2021 vs 2020
$38.5 MM $51.8 MM $0.0 $10.0 $20.0 $30.0 $40.0 $50.0 $60.0 YTD 2020 (Jan-Oct) YTD 2021 (Jan-Oct) ZTlido Gross Sales YTD '21 vs '20 (Jan - Oct) ZTlido YTD Sales Performance Comparison +35 % ∆ Scilex Holding Company
Slide 19: ZTlido Reimbursement Market Access Update
Scilex Holding Company ZTlido Reimbursement Market Access Update: Preferred Lido patch on Medi - Cal from Jan 1. Negotiating with CVS ZTlido Market Access continuing to improve Sources: MMIT, Scilex Analysis, lives in Millions 298 Preferred 55 CVS/Aetna Commercial 58.6 ESI Commercial 38.6 Optum Rx/U
Slide 20: ZTlido Global Intellectual Property
ZTlido Global Intellectual Property Family 1 – Expiring in 2031 ● U.S. 9,283,174 – Non - aqueous patch comprising lidocaine – Orange Book listed ● U.S. 9,925,264 – Methods of treating pain using patch – Orange Book listed ● U.S. 9,931,403 – Non - aqueous patch comprising lidocaine – Orange Book list
Slide 21: ZTlido Summary
ZTlido sales continue s to show impressive growth 2 years after launch (growth of 35% in 2020, projected strong growth in 2021) Effective September 1, 2021, ZTlido ® (lidocaine topical system) 1.8% has been added to multiple formularies, including two national PBMs (United Health and Optum Rx), a na
Slide 22: SEMDEXA for Lumbar Radicular Sciatica Pain
Scilex Holding Company C onf i dent i a l : F or Inte r nal S C IL E X P ha r m a c eut i ca l s U se On l y 1 0 SP - 102 (S EMDEXA) for Lumbar Radicular Sciatica Pain Scilex Holding Company
Slide 23: Epidural Steroid Injections: Among Most Common Procedures
Epidural Steroid Injections One of the Most Common Medical Procedures and Top Pain Procedure in the U.S. • ESIs widely reimbursed as procedure to delay or avoid back surgery • Transforaminal ESI route (used in C.L.E.A.R. trial) majority of procedures Common Surgical Procedures (thousands) (1) Strong
Slide 24: Current Problem: Multi-Modal Pain Management and Opioid Abuse
“ Consultants, ASA members, and ASRA members strongly agree that eipidural steroid injections with or without local anesthetics should be used for radicular pain or radiculopathy.” - American Society of Anesthesiology Practice Guidelines for Chronic Pain Management 3 Prescription opioid abuse is at
Slide 25: Important Environmental Factors: Fungal Meningitis Outbreak
Important Environmental Factors Fungal Meningitis Outbreak with ESI (2013 - 14) Scilex Holding Company
Slide 26: CDC Data: Drug Overdose Deaths Top 100K
CDC Data: Drug Overdose Deaths Top 100K for First Time 26 Scilex Holding Company
Slide 27: SEMDEXA Product Profile
Well - tolerated. Key viscous excipient, long h i s t or y o f u s e i n c l ud i n g s a f e t y and safer repeat injections Fast acting onset of effect with less spread Potent non - particulate steroid (injectable dexamethasone sodium phosphate viscous gel) Pre - filled syringe for epidura
Slide 28: SEMDEXA – Product Development & Regulatory
C onf i dent i a l : F or Inte r nal S C IL E X P ha r m a c eut i ca l s U se On l y 2 7 SEMDEXA – Product Development & Regulatory Scilex Holding Company
Slide 29: Preclinical Supporting Studies
Preclinical Supporting Studies Hydrodynamic Animal Study All tox studies completed concurrence with FDA pre - IND meeting ● No toxicology red flags in either species (dog & pig) after both single and repeat dosing No drug - related toxicity with SP - 102, local (spinal area) or systemic (including b
Slide 30: Phase 1/2 Trial in Patients with Radicular Pain
- 80 . 0% - 60 . 0% - 40 . 0% - 20 . 0% 0 . 0% 20 . 0 % 0 7 1 4 2 1 2 8 3 5 Phase 1/2 Open - Label Crossover Study in Patients with Radicular Pain (PK/PD Bridging) Mean change from baseline in pain scores (N=12) 42 49 56 Days following SP - 102 injection SP - 102 single e p i du r a l i n j ec t i o
Slide 31: Phase 2 Repeat Dose Trial
NPRS: Numeric Pain Rating Scale • Clinical Response (over 50% pain reduction) with Average Leg Pain • Greater effect with second treatment, demonstrating added benefit • Cortisol Suppression Time is not extended by repeat dose • No interference with clinical decision of repeat dose administration SP
Slide 32: Pivotal Phase 3 C.L.E.A.R. Trial Topline Results
Scilex Holding Company SP - 102 Pivotal Phase 3 C.L.E.A.R. Trial Topline Results
Slide 33: C.L.E.A.R. Phase 3 Trial Objectives
SP - 102 C.L.E.A.R. Phase 3 Trial Objectives Primary objective: ● Evaluate the analgesic effect on average leg pain (as measured by the Numeric Pain Rating Scale in the affected leg) following a single transforaminal (TF) injection of SP - 102 compared to an intramuscular injection of placebo over 4
Slide 34: C.L.E.A.R. Phase 3 Trial Design
Phase 3 SP - 102 C.L.E.A.R. Trial Design 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 Change in mean leg pain (NPRS) over first 4 weeks Secondaries (W2, W4, W
Slide 35: C.L.E.A.R. Trial Sample Size and Statistical Analysis Plan
Phase 3 SP - 102 C.L.E.A.R. Trial – Sample Size Statistical Analysis Plan ● The sample size provides 90% power to detect a 1 - point difference in change from Baseline in the mean NPRS average daily leg pain score in the affected leg over 4 weeks between the 2 treatment groups. ● The sample size was
Slide 36: C.L.E.A.R. Trial Primary Endpoint Comparison vs. Placebo
Phase 3 SP - 102 C.L.E.A.R. Trial – Primary Endpoint Comparison: SP - 102 vs. Placebo Over 4 Weeks, LS Mean (SE) - 1.08 (0.17) 95% CI - 1.42, - 0.75 p - value <0.001*** -3 -2.5 -2 -1.5 -1 -0.5 0 0.5 Week 1 Week 2 Week 3 Week 4 Numeric Pain Rating Scale, LS Mean Change in Average Daily Pain in Affect
Slide 37: Oswestry Disability Index
Oswestry Disability Index The gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. Contains 10 topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, soc
Slide 38: C.L.E.A.R. Trial Key Secondary Endpoints
C.L.E.A.R. Trial – Key Secondary Endpoints Comparison: SP - 102 vs. Placebo At Week 4, LS Mean (SE) - 6.28 (1.494) 95% CI - 9.22, - 3.34 p - value <0.001*** SP - 102 (N=154) Placebo (N=189) Number of subjects with repeat injection of SP - 102 (%) 70 (46%) 126 (67%) Time (days) to Repeat Injection 25
Slide 39: C.L.E.A.R. Trial Adverse Events
C.L.E.A.R. Trial – Adverse Events SP - 102/SP - 102 PBO/SP - 102 SP - 102/none PBO/none (N=104) (N=130) (N=98) (N=69) Subjects, n(%) Events Subjects, n(%) Events Subjects, n(%) Events Subjects, n(%) Events Any TEAE 34 (32.7) 72 41 (31.5) 73 25 (25.5) 46 14 (20.3) 23 Any TEAE >3% Incidence Headache 7
Slide 40: C.L.E.A.R. Trial Conclusions
Phase 3 SP - 102 C.L.E.A.R. Trial - Conclusions The trial met primary and key secondary endpoints with statistical significance Demonstrated clear safety profile of SP - 102 Achieved all study objectives Next steps in 2022 ● Apply for Breakthrough Therapy Designation with FDA ● Request pre - NDA mee
Slide 41: Manufacturing: Commercial Supply Chain in Place
Commercial supply chain in place ▪ API : Dexamethasone sodium phosphate supplier in place ▪ Novel excipient : Supply from leading commercial provider, 20 - year supply agreement for specific type for use ▪ Drug product : Commercial manufacturer in place, FDA experienced with biocompatible excipient,
Slide 42: SEMDEXA Global Intellectual Property
SP - 102 ( SEMDEXA ) Global Intellectual Property Patent family expiring in 2036 ● U.S. 10,117,938 - methods of treating inflammation and/or pain ● U.S. 10,500,284 – composition of matter and syringe ● U.S. 11,020,485 – composition of matter ● 1 pending U.S. application Ex - U.S. applications in AT
Slide 43: Summary (SEMDEXA)
Summary SP - 102 (SEMDEXA) N o FDA approved products to treat Sciatica/chronic back pain. All currently used off - label products have FDA warnings not to use Scilex will meet with FDA to discuss NDA filing for SEMDEXA in 2022 Breakthrough Designation filing with Phase 3 results in 2022 Priority Rev
Slide 44: SEMDEXA – Commercial Strategy & Outlook
C onf i dent i a l : F or Inte r nal S C IL E X P ha r m a c eut i ca l s U se On l y 3 4 SEMDEXA – Commercial Strategy & Outlook Scilex Holding Company
Slide 45: SEMDEXA Overall Physician Impression
Source: “Lumbar Radiculopathy Market Opportunity” Quantitative Research (Nov’17); Cognitive Consulting SEMDEXA Overall Physician Impression Scilex Holding Company
Slide 46: SEMDEXA Broad Potential for Life Cycle Management
SEMDEXA – Broad Potential for Life Cycle Management ▪ Carpel Tunnel ▪ Trigger Point Injections ▪ Injections for Knee, Shoulders, Wrists, Ankles, Joints ▪ Cervical Radiculopathy ▪ K ne e A r t hr i t is ▪ Hip and Knee Replacements ▪ Complex Regional Pain Syndromes (CRPS) ▪ Lumbar Spinal Stenosis ▪ Ac
Slide 47: Reimbursement Scenario
SP - 102 Reimbursement Scenario SP - 102 is expected to be used in the Office setting as well as in Ambulatory Surgical Centers and Hospital Outpatient clinics Scilex expects SP - 102 to secure favorable pricing and reimbursement due to its strong product profile, meeting important unmet medical nee
Slide 48: Intellectual Property and Barriers to Competition
Intellectual Property P r op r i eta r y E xc i p i e n t Complex Manufacturing Process & Know - How for Pre - Filled Viscous Gel Full Nonclinical Safety & Clinical Package Likely Required by F D A f o r a n y A l te r n at e Fo r m u l a t i on • SP - 102 Method of Use: US Patent issued (2036 expir
Slide 49: Summary – SEMDEXA
Market with high unmet need & no FDA approved products to treat sciatica pain Scilex will meet with FDA to discuss NDA for S EMDEXA in 2022 and pursue B reakthrough D esignation and P riority R eview applications SEMDEXA is a potential blockbuster product with market potential of $3 - 5 billion in p
Slide 50: SP-103 for Low Back Pain & Delayed Release LDN for Fibromyalgia
C on f i d e n t i a l : F or Inte r nal S C ILEX Pha r m a c e ut i c a l s U se On l y 31 SP - 103 for Low Back Pain & Delayed Release LDN for Fibromyalgia Scilex Holding Company
Slide 51: SP-103 Next-Generation 5.4% Lidocaine Topical System
x 3x drug load (108 mg vs 36 mg lidocaine) x Triple strength localized dose of lidocaine x Expected same superior adhesion and efficient formulation x Expect to initiate Phase 2 trial by January 2022 x For the treatment of acute low back pain – a substantially larger opportunity than PHN SP - 103 Ne
Slide 52: SP-104 Delayed Burst Low Dose Naltrexone for Fibromyalgia
SP - 104 Delayed Burst Low Dose Naltrexone (LDN) – Fibromyalgia Fibromyalgia is a long - term condition that causes pain all over the body and affects ~2% of general population ( 5 - 8 million patients, 80 - 90% women) Low Dose Naltrexone (LDN) efficacy well documented • Routinely used off - label t
Slide 53: Summary
C onf i dent i a l : F or Inte r nal S C IL E X P ha r m a c eut i ca l s U se On l y 4 6 S umm a r y Scilex Holding Company
Slide 54: Acute/Chronic Pain: Major Global Healthcare Problem
Acute/Chronic Pain Major Global Healthcare Problem • Pain is reported in about 90% of the global population • 94% report pain in their back or lower back • 69% of people endure long - lasting pain which negatively impacts quality of life S ou r c e : Gl oba l P a i n I nde x S u mm a r y R epo r t .
Slide 55: Best-in-Class Non-Opioid Pain Therapeutics Pipeline
Platform Program IND P h as e 1 P h as e 2 P h ase3 P i v o t al NDA Approved U p c o m in g M il es t o n es N on - O p i o i d P a i n M a n a g e m e n t ZTlido ® 1 . 8 % (Postherpetic Neuralgia - PHN) Laun c h e d U S October 2018 SP - 102 (S EMDEXA ) (Lumbar Radicular / Sciatica Pain) P i vot a
Slide 56: Epidural Steroid Injection Market is a Huge Opportunity
Epidural Steroid Injections (ESIs) Market are a Huge Opportunity for a Potential Blockbuster Like SP - 102 Osteoarthritis intra - articular injection products Post - operative acute pain local anesthetic products 4M+ procedures / year 8M+ procedures / year 12M+ procedures / year Chronic low back pai
Slide 57: Scilex Holding Summary
Scilex Holding Summary Commercial non - opioid pain management company with 3 clinical stage programs in large markets with very high unmet need Launched rapidly growing ZTlido (lidocaine topical system 1.8%) in 2018 with in - house commercial and sales team Semnur Pharma merged with Scilex in 2019