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Corporate Presentation29th Annual ROTH ConferenceMarch 13, 2017
Disclaimer
Certain statements contained in this presentation or in other documents of Sorrento Therapeutics, Inc. (the “Company”), along with certain statements that may be made bymanagement of the Company orally in presenting this material, may contain “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. Thesestatements can be identified by the fact that they do not relate strictly to historic or current facts. They use words such as "estimate," "expect," "intend," "believe," "plan," "anticipate,"“projected” and other words and terms of similar meaning in connection with any discussion of future operating or financial performance or condition. These statements are basedupon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties. Statements regarding future action, futureperformance and/or future results including, without limitation, those relating to the timing for completion, and results of, scheduled or addition- al clinical trials and the FDA’s orother regulatory review and/or approval and commercial launch and sales results (if any) of the Company’s formulations and products and regulatory filings related to the same, andreceipt by the Company of milestone and royalty payments may differ from those set forth in the forward-looking statements. Peak sales and market size estimates have beendetermined on the basis of market research and comparable product analysis, but no assurances can be given that such sales levels will be achieved, if at all, or that such market sizeestimates will prove accurate.
The Company assumes no obligation to update forward-looking statements as circumstances change. Investors are advised to consult further disclosures that the Company makes orhas made on related subjects in the Company's Form 10-K, 10-Q and 8-K reports.
In presenting this material or responding to inquiries in connection with a presentation, management may refer to results, projections or performance measures that are not preparedin accordance with U.S. Generally Accepted Accounting Principles (“GAAP”) as reported in the Company’s SEC filings. These results, projections or performance measures are
Non-GAAP measures and are not intended to replace or as a substitute for results measured under GAAP, but rather as supplement to the GAAP reported results.
Because actual results are affected by these and other potential risks, contingencies and uncertainties, the Company cautions investors that actual results may differ materially fromthose expressed or implied in any forward-looking statement. It is not possible to predict or identify all such risks, contingencies and uncertainties. The Company identifies some ofthese factors in its Securities and Exchange Commission (“SEC”) filings on Forms 10-K, 10-Q and 8-K, and investors are advised to consult the Company’s filings for a more completelisting of risk factors, contingencies and uncertainties effecting the Company and its business and financial performance.
Sorrento™, G-MAB™, CAR.TNK™, TNK Therapeutics™, Scintilla Pharmaceuticals™, iTAb™ and the Sorrento logo are trademarks owned by Sorrento Therapeutics, Inc. (NASDAQ: SRNE)
All other trademarks and trade names are the property of their respective owners.
Logo - http://photos.prnewswire.com/prnh/20150105/167173LOGO
2© 2017 Sorrento Therapeutics, Inc. All Rights Reserved
June 2014: License to develop ADCs for upfront + $50mm milestones
September 2015: JV with City of Hope to create LA Cell™ focused on intracellular targeting mAbs (iTAb)
Sorrento Corporate History
3
2006 – 2013 2014 2016 2017
January 2006: Company co-founded by Henry Ji
October 2013: Completed common stock offering + NASDAQ uplisting
November 2016: Announced proposed acquisition of VIRTTU Biologics and their oncolytic virus immunotherapy, Seprehvir® (Phase 2 ready)
November 2016: Closed company acquisition to obtain access to ZTlido™ (NDA re-filing in 2H17)
August 2016: Announced proposed company acquisition to obtain SP-102 for lumbosacral radicular pain (Phase 3 ready)
July 2016: License for Sorrento’s PD-1 mAb STI-A1110 for $27mm upfront + ~$1bn milestones
March 2016: JV to develop checkpoint inhibitors ($10mm from Yuhan & certain mAbs from Sorrento)
August 2015: In-license of 4 biosimilars from Mabtech
October 2014: License for Sorrento’s anti-PD-L1 mAb STI-A1014 in Chinese markets for upfront + $46mm milestones
December 2014: JV to develop next-gen CAR-NK therapy for cancer
March 2015: License for certain antibodies & CAR-NK therapies from Sorrento ($10mm cash & $100mm equity to Sorrento)
June 2009: License for Sorrento’s antibodies in ophthalmology
May 2015: Sale of Cynviloq to NantWorksfor $90mm upfront & $1.2bn+ milestones
September 2013: Acquired IGDRASOL and rights to its lead drug candidate Cynviloq™
October 2013: Acquired Sherrington Pharmaceuticals and its drug candidate RTX
Note: Semnur and VIRTTU acquisitions are pending© 2017 Sorrento Therapeutics, Inc. All Rights Reserved
Sorrento Therapeutics Overview
4
› Novel technology platforms and development programs focused on antibody therapy, cell-based immunotherapy and pain management
› Antibody Therapy (G-MAB™, LA Cell, Concortis, Sorrento Biologics): mAbs for highly coveted IO targets, next-gen intracellular targeting mAbs (iTAb), proprietary ADCs and biosimilars
› Cell-based Immunotherapy (TNK): CAR-T, CAR-NK and oncolytic virus(1) product candidates with human and in vivo proof-of-concept data
› Pain Management (Scilex, Scintilla(1)): Two Phase 3 product candidates for postherpetic neuralgia and lumbosacral radicular pain and Phase 2 product candidate for cancer pain
› G-MAB and LA Cell platforms crucial in generating partnership revenues and proprietary mAb and cell-based immunotherapy (CAR) product candidates
› Potential for product sales from Scilex and Scintilla subsidiaries starting in 2018 and 2020,respectively
› Founded in 2006 and based in San Diego, CA; ~200 FTEs
Partners Subs/JVs
(1)
(1)
Note: (1) Semnur and VIRTTU acquisitions are pending© 2017 Sorrento Therapeutics, Inc. All Rights Reserved
Overview of Sorrento Therapeutics
5
Key Technology Platforms › G-MAB: Extensive library of fully human antibodies› iTAb: Next-gen tech for intracellular targeting mAbs› Proprietary antibody-drug conjugates (ADCs)› Biosimilars / biobetters of marketed mAbs
Lead Product Candidates › G-MAB: PD-L1, PD-1 (IND filings in 2017 / 2018)› iTAb: STAT3, mKRAS G12D & other iTAbs (Preclinical)› Concortis: c-MET & CD25 ADCs (IND filing in 2017 / 2018)› Sorrento Biologics: Erbitux® biosimilar (pre-IND discussions)
Highlights › Source of non-dilutive funding and new pipeline programs
Key Technology Platforms › Branded, non-aqueous pain patch w/ improved adhesion› Differentiated epidural steroid injectable› 1-time injection of non-opioid for cancer pain
Lead Product Candidates› ZTlido pain patch (NDA refiling in mid 2017)› SP-102 for lumbosacral radicular pain (Ph. 3 in 2017)› RTX for intractable cancer pain (Ph. 2 in 2017)
Highlights › Expected ZTlido launch in 2018 & SP-102 launch in 2020
Key Technology Platforms › CAR-T therapy › CAR-NK therapy › Oncolytic virus immunotherapy
Lead Product Candidates › CD38 CAR-T / NK for multiple myeloma (IND enabling
studies)› Seprehvir for solid tumors (Ph. 1b/2)› CAR-T CEA for solid tumors (Ph. 1b)› CD123 CAR-T for acute myeloid leukemia (Preclinical)
Highlights› 3 clinical programs in 2017 w/ promising human & in vivo
proof-of-concept data
Antibody Therapy Cell-Based Immunotherapy Pain Management
G-MAB & LA Cell Concortis™ Sorrento
Biologics™ TNK Therapeutics™ VIRTTU Biologics™ Scilex Pharmaceuticals™
Scintilla Pharmaceuticals™
Notes: Semnur (SP-102) and VIRTTU acquisitions are pending© 2017 Sorrento Therapeutics, Inc. All Rights Reserved
Corporate Structure
6© 2017 Sorrento Therapeutics, Inc. All Rights Reserved
Sorrento Antibody Therapy Business: G-MAB Fully Human Antibody Library
7
Difficult TargetsSmall Peptides & Tumor Neo-epitopes
High Value Oncology TargetsPD1, PD-L1, CD123, CD38, CD47
G Protein-Coupled Receptors(GPCRs)
F
AIP-2
L
SGANGY
One of the Largest Fully Human Antibody Libraries
Highly Successful Screening Hit Rate100+ clinically relevant targets screened
Very High Diversity2.1 x 1016 distinct antibody sequences
Proprietary TechnologyRNA amplification used for library generation
G-MAB
G-MAB has generated multiple strategic partnerships to date with a diversified stream of upfront, milestone and royalty revenues
Source: Total G-MAB deal value per Servier press release dated November 2016© 2017 Sorrento Therapeutics, Inc. All Rights Reserved
Evolution of Antibody Therapy
8
iTAb: Next Wave in Antibody Therapy Intracellular Targeting mAbs
1st Gen AntibodiesMurine mAbs
2nd Gen AntibodiesChimeric, Humanized,
Fully Human mAbs
3rd Gen AntibodiesADCs, Bispecifics, Fc-engineering,
Antibody Fragments
Sold for $5.9bn
Sold for $46.8bn
Sold for $2.4bn
$40.0bn MC
Sold for $2.2bn
Sold for $1.3bn
$1.3bn MC
$701mm MC
$1.4bn MC
$525mm MC
$12.0bn MC
$9.3bn MC
New technologies focused on addressing immunogenicity
Adopted as foundation of front-line treatment for various diseases
Top selling drugs in the market
Re-engineering traditional mAb construct to enhance properties
Shift to precision medicine investment in new mAb targets discovery & BD
Cancer IO mAbs = top priority
Sorrento is at the forefront of the next wave in the antibody market
iTAb addresses fundamental limitation of current therapeutic mAbs (can only target antigens / receptors around the cell surface)
$333bn MC
Note: MC = Market Capitalization as of March 01, 2017; grey-dotted box represents Sorrento’s mAb capabilities© 2017 Sorrento Therapeutics, Inc. All Rights Reserved
Core Technologies and Programs Under Development
9© 2017 Sorrento Therapeutics, Inc. All Rights Reserved
CAR-based Immunotherapies
Antibodies
Intracellular Targeting mAbs (iTAbs)
Biosimilars
Pain Management
› Autologous and allogeneic CAR-T and CAR.NK therapies› Targets include CD38 for Multiple Myeloma, CD123 for Acute Myeloid Leukemia, CEA, and PSMA› IND filings expected in 2017
› PD-1 mAb licensed to Servier for $27.4M upfront and up to ~$1 B in milestones› Other mAbs generated from proprietary G-MAB library are targeting PD-L1, TIM3, VEGFR2, CCR2, CD47, etc.› Next-generation antibody drug conjugates with proprietary toxins, lead program targeting c-MET
› Proprietary platform enables modulation of intracellular targets with antibody therapeutics› Greatly increases druggable space› Licensed from City of Hope, lead targets include STAT3, mutant KRAS, and MYC-MAX
› 4 monoclonal antibodies licensed from Mabtech Limited› Cetuximab (Erbitux®), infliximab (Remicade®), omalizumab (Xolair®), basiliximab (Simulect®)› All have completed Phase III studies in China
› Non-opiate epidural steroid injectable to treat lumbar radiculopathy (pivotal Phase III in 2017)› Ultra-potent TRPV1 agonist neurotoxin for end-stage intractable cancer pain (pivotal Phase II)› Novel anhydrous lidocaine patch to treat post-herpetic neuralgia (FDA resubmission in mid 2017)
Oncolytic Virus Immunotherapy
› Binding term sheet to acquire Virttu Biologics announced November 16, 2016› Lead product, Seprehvir®, is an HSV-based oncolytic virus currently in a Phase I/IIa trial for treatment of
mesothelioma
Sorrento Cell-Based Immunotherapy Business: TNK Therapeutics
10
2017 2018CAR-Based Therapy for Hematological CancersCD38 CAR-T Multiple MyelomaCD38 CAR-NK Multiple MyelomaCD123 CAR-T Acute Myeloid Leukemia CD20 CAR-T Non-Hodgkin’s LymphomaOncolytic Virus ImmunotherapySeprehvir Solid TumorsCAR-Based Therapy for Solid TumorsCEA CAR-T Solid Tumors IL-13R CAR-T GliomaGD3, KIT, PD-L1 CAR-T Solid Tumors
IND Phase 1
IND Phase 1
pre-clinical
Phase 2Phase 1b
pre-clinical IND
Phase 1b Phase 2
Business Overview› New treatment modality using genetically modified human immune cells (T
or NK cells) to attack cancer cells › Antibody-based targeting component (CAR) is expressed on immune cells to
target specific cancer antigens › By leveraging the G-MAB library, has created a robust pipeline of CAR-T and
CAR-NK product candidates › In November 2016, announced the proposed acquisition of VIRTTU Biologics
and its oncolytic virus immunotherapy Seprehvir
Highlights› 3 product candidates expected to be in clinical trials in 2017› Promising human proof-of-concept data for CEA CAR-T› CD38 CAR-T / CAR-NK focus on highly-coveted target for multiple myeloma› Seprehvir offers key advantages vs. other oncolytic viruses: robust data from
100+ patients, intratumoral and systemic delivery, synergistic effect w/ other IO therapies
› Non-binding JV term sheet executed w/ Celularity to create leading, pure-play cell therapy company
Product Candidate Pipeline
IND Phase 1
IND Phase 1
Note: VIRTTU acquisition is pending© 2017 Sorrento Therapeutics, Inc. All Rights Reserved
Anti-CD38 CAR-T Program For Treatment of Multiple Myeloma (MM)
11© 2017 Sorrento Therapeutics, Inc. All Rights Reserved
MM Overview:
› ACS estimated 30,330 new multiple myeloma cases in 2016
› Malignant neoplasm of plasma cells that accumulate in bone marrow, leading to bone destruction and marrow failure
› Still not considered a curable disease, even with recent approvals
Program Overview:
› Leading Anti-CD38 CAR-T program in development for the treatment of multiple myeloma (MM)
› Proprietary second generation anti-CD38 CAR based on a fully human anti-CD38 mAb derived from Sorrento's G-MAB antibody library
› Data has shown efficient killing of multiple myeloma tumor cells in vitro and complete eradication of tumors in a xenograft mouse model of human multiple myeloma
› IND filing in 2017 with first-in-human trials to commence shortly thereafter
Anti-CD38 CAR-T Cells Selectively Lyse CD38 High Expression Cells
Before treatment
1 week after treatment
2 weeks after treatment
3 weeks after treatment
4 weeks after treatment
5 weeks after treatment
6 weeks after treatment
Untreated Mice Anti-CD38 CAR T Treated
Anti-CD38 CAR-T Cells Eradicate CD38 Positive Human Multiple Myeloma in NSG Mice
Seprehvir® - Leading Next-Generation HSV-1 based Oncolytic Virus Immunotherapy
12© 2017 Sorrento Therapeutics, Inc. All Rights Reserved
TRL UL IRL IRS TRSUS
Deleted ICP34.5 Deleted ICP34.5
Seprehvir® (HSV1716) is a Phase II-ready HSV-1 based immuno-oncolytic therapy with over 100 patients treated to date and no adverse events
Designed with the ability to specifically target and destroy tumor cells while also stimulating an anti-tumor T-cell mediated immune response
Ongoing Phase I/IIa in mesothelioma
Ability to be delivered intratumorally and systemically could provide administration advantages versus recently approved HSV-1 oncolytic viral immunotherapy, IMLYGIC™ (Amgen)
Seprehvir® - Safe in Over 100 patients and Three Delivery Routes
13© 2017 Sorrento Therapeutics, Inc. All Rights Reserved
101 patients treated with Seprehvir® in the U.S. and Europe (as of December 2016)
Well tolerated, no toxicity and expected AEs have been mild and transient
Multiple routes of administration: intratumoral, loco-regional, and systemic
HGG48%
HNSCC20%
Melanoma5%
MPM12%
Non-CNS15%
Intratumoral82%
Loco-regional12%
Systemic6%
By Indication By Delivery Route
MPM = Malignant Pleural Mesothelioma, HNSCC = Head and Neck Squamous Cell Carcinoma, HGG = High Grade Gliomas
Highlights from Phase 1b Trial for CEA CAR-T
14
CEA CAR-TPET Scans
Pre-treatment Post CAR-T
CEA CAR-T in Metastatic Liver Cancer Patients
Weeks
#5
#1
#7
#6
#8
#4
20%
0%
40%
60%
80%
100%
Surv
ival
0 20 40 60 80 100 120
ACTIVITY IN HEAVILY PRE-TREATED GROUP (1)
Patient #5 alive >130 weeks Average of 2.5 lines prior chemotherapy Average size of largest tumor = 8.4 cm 4 patients with > 10 liver tumors
Prolonged survival following liver CAR-T infusions. PET scan demonstrates reduction in tumor burden. Expected survival (median < 20 wks) versus 38 mo survival of this heavily pretreated patient with CEA+ colon liver metastases that far exceeds usual survival (2)
Note: Each number in the graph assigned to a patient in the trial
Notes:(1) Junghans et al. Unpublished Data(2) Katz et al, 2015© 2017 Sorrento Therapeutics, Inc. All Rights Reserved
Antibody Therapeutics: Pipeline
15© 2017 Sorrento Therapeutics, Inc. All Rights Reserved
Lead Candidates in Development
› STI-A1014 (PD-L1 mAb)o IND filing in 2017 in CN
› STI-A1110 (PD-1 mAb) with Serviero IND-enabling studies
› STI-A1015 (PD-L1 mAb) with Yuhano IND-enabling studies in KR o US clinical trial initiation expected in 1H18
› c-MET ADCo IND filing expected in 2018
Antibody Therapeutics: Anti-PD-1 Transaction with Servier
› On July 6, 2016 Sorrento announced a license and collaboration agreement with Laboratoires Servier for the development, manufacture and commercialization of products using Sorrento’s fully human immuno-oncology anti-PD-1 mAb STI-A1110
o STI-A1110 was identified and generated using Sorrento’s proprietary G-MAB library platformo Agreement provides Servier with an exclusive worldwide license covering all indications including hematological and solid tumorso Servier obtained full rights and will bear all costs to develop, register and commercialize the products
› Servier is the largest non-listed pharmaceutical company in France with an international presence in 148 countries
› Financial terms of the agreement:o €25 million non-refundable upfront paymento Up to a total of €861 million in various payments based on regulatory and commercial sales milestoneso Sorrento is eligible to receive variable royalties on the sales of all commercialized products ranging from high single-digit to double-
digit percentages
› The anti-PD-1 antibody is in IND-enabling studies
16© 2017 Sorrento Therapeutics, Inc. All Rights Reserved
LA Cell: iTAb (Intracellular Targeting Antibody) Platform
17© 2017 Sorrento Therapeutics, Inc. All Rights Reserved
New Class of Drugs for Unmet Medical Needs
LA Cell’s proprietary iTAb platform enables the ability to modulate intracellular targets with antibody therapeutics, greatly increasing druggable space
› LA Cell’s lead oncology programs focus on key “undruggable” disease targets, such as mutant KRAS, MYC, STAT3
› Potential for application in other indications: inflammation, autoimmune, diabetes, CNS, cardiovascular, and viral infections
Current mAb/protein drugs target extracellular proteins, either secreted or membrane bound
2015 sales$169 billion
< 10% potential druggable space
Current small molecule drugs require defined hydrophobic binding pockets
2015 sales$565 billion
Occupy < 10% potentialdruggable space
iTAb technology enables modified mAbs to penetrate into cell’s cytoplasm and nucleus
LA Cell: Building the Leading Intracellular Targeting Antibody (iTAb) Company
18© 2017 Sorrento Therapeutics, Inc. All Rights Reserved
STAT3
MYC
FOXP3
TAU
KRAS
T-bet
Program
In-Vivo Efficacy Studies
Developability Assessment
Functionality Evaluation
Antibody Panning
Antibody Modification
Antibody Modification
Activities
Lead Optimization
Lead Discovery
Lead Discovery
Lead Discovery
Lead Discovery
Lead Discovery
Stage
19
Sorrento Antibody Therapy Business: Concortis Biotherapeutics (Antibody-Drug Conjugates)
Next-Generation Antibody-Drug Conjugates
› Cytotoxic drugs conjugated to antibodies via chemical linkers
› Site-specific conjugation methods to provide homogenous products
o K-Lock™ and C-Lock™
› Proprietary toxins: tubulin-binding, DNA alkylation & other MoAs
› Lead program: c-MET ADC (CBT-161)
Next Milestone
› IND filing for c-MET ADC expected in 2017 / 2018
© 2017 Sorrento Therapeutics, Inc. All Rights Reserved
20
Sorrento Antibody Therapy Business: Sorrento Biologics (Biosimilars and Biobetters)
Pipeline Overview› Exclusive licensing agreement with Mabtech Limited to develop and commercialize biosimilar antibodies› 4 antibodies to date targeting ~$9B global market:
› All assets have completed Phase 3 clinical trials in China› IND-enabling activities currently in progress
Next Milestone› STI-001 regulatory pathway and discussions with FDA in 2017
Sorrento Antibody Generic Target Brand
Global Sales (2015 WW)
STI-001 Cetuximab EGFR $1.2B
STI-002 Infliximab TNFα $6.6B
STI-003 Basiliximab CD25 $0.2B
STI-004 Omalizumab IgE $0.8B
Total: $8.8B
Sources: SEC filings, Generics and Biosimilars Initiative© 2017 Sorrento Therapeutics, Inc. All Rights Reserved
Sorrento Antibody Therapy Business: Key Near-term Milestones
21
Event Timing
› Potential LA Cell (intracellular mAb) partnership 2017
› STI-001 (Erbitux biosimilar) FDA discussion on regulatory pathway 2017
› IND filing for c-MET ADC 2017 / 2018
› Initiate Phase 1 trial for two PD-L1 mAbs 2017 / 2018
› IND filing for STAT3 iTAb 2018
© 2017 Sorrento Therapeutics, Inc. All Rights Reserved
Scintilla & Scilex Pharmaceuticals: Late-Stage Pain Management Programs
22© 2017 Sorrento Therapeutics, Inc. All Rights Reserved
Asset Overview
Indication
Next Milestones
• Non-opioid-based ultrapotent TRPV1 agonist neurotoxin injectable pain treatment
• End-stage intractable cancer pain (Orphan Status Granted)
• Phase I/II trial trial with NIH
• Pivotal Phase II study targeted for early 2017
• Potential Breakthrough Designation
RTX(resiniferatoxin)
• Anhydrous, single-layer lidocaine patch based on proprietary technology
• Postherpetic neuralgia (“PHN”)
• FDA NDA resubmission expected in mid-2017
• MAA hybrid submission expected in mid-2017
ZTlido™(lidocaine patch 1.8%)
• Non-opiate epidural steroid injectable
• ~10M epidural steroid administrations in US annually
• Lumbar radiculopathy• Phase I/II trial for chronic back pain
completed dosing
• Pivotal Phase III clinical trials planned for 2017
SP-102
Note: Scintilla Pharmaceuticals, Inc. is a subsidiary of Sorrento Therapeutics, Inc. / Semnur acquisitions is pending
Sorrento Pain Management Business: Scilex Pharmaceuticals
23
› ZTlido is a branded, non-aqueous, topical lidocaine patch for pain associated with post-herpetic neuralgia
› Benefits vs. market leader, Lidoderm®, and other pain patches
o Thin, pliable non-aqueous patch w/ 36 mg of drug to deliver therapeutic dose vs. Lidoderm, a thick, aqueous patch w/ 700 mg of drug to deliver therapeutic dose
o Greater adhesion to the skin based on multiple adhesion studies
90% adhesion in 90% of subjects over 12 hours (no marketed patches have such data)
No meaningful impact to PK during and after exercise
o Given less drug required to administer therapeutic dose, provides cost advantage in a largely genericized market
› US Pain patch market(1) = ~$700mm in 2015
o Potential tailwind from significant demand for abuse-deterrent alternatives for pain management
› NDA resubmission expected in mid 2017, with potential approval in 2H 2017 (2 to 6 month review)
In November 2016, Sorrento acquired Scilex Pharmaceuticals and its product candidate ZTlido
Note:(1) Estimate from IMS Health© 2017 Sorrento Therapeutics, Inc. All Rights Reserved
ZTlido: Regulatory Status
24
Submitted NDA based on 505(b)(2) regulatory pathway in 3Q 2015
› 12-hour adhesion trial (ADH-001) confirmed ≥90% adhesion in 90% subjects (n=54)
› Heat and exercise trial (HEX-001) conducted (n=12)
› 3 dermal safety trials (totaling 326 patients) conducted to assess potential irritation, sensitization, photoallergy and phototoxicity
Complete Response Letter received on May 10, 2016
› Type A FDA Meeting held on August 24th
› NDA resubmission planned for mid 2017 w/ additional toxicology and CMC work and one additional PK bioequivalence trial
› In December 2016, announced positive results from new PK bioequivalence trial
› Additional toxicology work completed; additional CMC work near complete
› Potential PDUFA / approval date in 2H 2017 (2 to 6 month review)
ZTlido in the EU – MHRA Scientific Advisory Meeting in February 2016
› MHRA suggested that only bioequivalence PK trial between ZTlido and Versatis® (Grunenthal’s lidocaine patch) was necessary
› Planned MAA filing in mid 2017 w/ potential approval in mid 2018
© 2017 Sorrento Therapeutics, Inc. All Rights Reserved
ZTlido: US Transdermal Market Overview
25
0%
2%
2%
0%
15%
4%
6%
8%
29%
12%
23%
Metabolic
Men's Health
Cancer
Contraception
CNS
NS
Nicotine
Misc*
Hormon
CV
Pain
Current (N = 52)
3%
6%
6%
8%
9%
11%
11%
11%
11%
12%
14%
Metabolic
Men's Health
Cancer
Contraception
CNS
NS
Nicotine
Misc*
Hormon
CV
Pain
Under Development (N = 66) › The transdermal drug delivery market = $12.7bn in 2005; expected to reach $32bn in 2015(1)
› ~52 products make up the current US market; ~66 products under development
› Pain represents one of the largest segments of the transdermal market
› Gel / cream formulation comprises a large portion of the transdermal market for pain
› Patch system also comprises a portion of the transdermal market for pain
o US pain patch market(2) = ~$700mm
o Adoption limited by poor adhesion property
› Potential for new pain patch technology to garner significant market share in light of market demand for abuse deterrent therapies
Notes:(1) www.ncbi.nlm.nih.gov/pmc/articles/PMC2995530(2) Estimate from IMS Health© 2017 Sorrento Therapeutics, Inc. All Rights Reserved
Sorrento Pain Management Business: Scintilla Pharmaceuticals
26
SP-102
Overview
› 1st preservative-free, surfactant-free and particulate-free steroid injectable
› Novel gel formulation to prolong residency time (120 – 150 min vs. 15 min for current injectable steroids)
› Precise, localized epidural administration (1 – 2 vertebrae spread for hrs vs. 7+ vertebrae spread in 15 min)
› Non-opioid w/ novel mechanism for intractable cancer pain› Potential for long-term efficacy w/ single injection › Has shown meaningful reduction in pain, opioid use and
improvement in quality of life (mobility) in Phase 1b proof-of-concept trial
Market Opportunity
› Lumbosacral radicular pain is a progressive disease, often leading to costly back surgery
› Current therapies provide limited pain relief and have serious side effects
› ~10mm epidural steroid injections / year in the US
› > 80% of cancer patients experience uncontrolled cancer-related pain during course of disease
› Chemotherapy induced neuropathic pain in up to ½ of patients› Potential to replace costly invasive treatments (nerve
stimulation, intrathecal opioids, radiotherapy)
Development Status
› Positive Phase 2 human proof-of-concept data› IND filing expected in 1H17› Initiate pivotal Phase 3 trials in 2H 2017› Potential to file NDA w/ 1 Phase 3 trial and launch in 2020
› Positive human proof-of-concept data› IND filed in February 2017› Initiate Phase 1/2 epidural trial in 1H 2017› Orphan drug Designation– potential for NDA filing after 2
Phase 2b trials
RTX
Note: Scintilla Pharmaceuticals, Inc. is a subsidiary of Sorrento Therapeutics, Inc. / Semnur (SP-102) acquisitions is pending© 2017 Sorrento Therapeutics, Inc. All Rights Reserved
Key Near-term Milestones
27
Event Timing
› Initiate Phase 1/2 epidural trial for RTX 1H 2017
› NDA resubmission for ZTlido in US Mid 2017
› MAA submission for ZTlido in EU Mid 2017
› Potential US approval of ZTlido 2H 2017
› Potential EU approval of ZTlido Mid 2018
› Initiate pivotal Phase 3 trial for SP-102 2017
© 2017 Sorrento Therapeutics, Inc. All Rights Reserved
Global Partners: Immuno-Oncology, Cellular Therapy, ADC
28© 2017 Sorrento Therapeutics, Inc. All Rights Reserved
Partner Asset Type Partner Background Partnership Details
Laboratoires Servier Immuno-Oncology • Servier is the largest non-listed pharmaceutical company in France
• License and collaboration agreement for the development, manufacture and commercialization of products using Sorrento’s fully human immuno-oncology anti-PD-1 mAb STI-A1110
Yuhan Corporation Immuno-Oncology• Yuhan Corporation is one of the largest Korean
pharmaceutical companies founded over 80 years ago
• Joint Venture named ImmuneOncia Therapeutics, LLC• Focused on developing and commercializing a number of immune checkpoint
antibodies for hematological malignancies and solid tumors
Lee’s Pharmaceutical Holdings Immuno-Oncology
• Lee’s Pharm is a public biopharma company with over 20 years of operation in China and currently markets 14 products in the PRC
• Sorrento has licensed exclusive rights to Lee’s Pharma to develop and commercialize the fully human anti-PD-L1 mAb STI-A1014 for the greater Chinese market
Morphotek (Eisai) ADC
• Morphotek, a subsidiary of Eisai, Inc., specializes in the development of protein and antibody products through the use of a novel and proprietary gene evolution technology
• Collaboration agreement for Concortis (Sorrento) and Morphotek to generate novel ADCs based on a Morphotek antibody linked to chemotherapeutic agents using Concortis’ proprietary ADC technology
Celularity Cellular Therapy• Celularity is a joint venture utilizing TNK’s CAR
constructs for use in placenta-derived and cord-blood derived cells
• License of product rights to Celularity in exchange for equity
2016 Strategic Accomplishments
Core Technology Validation • Servier PD-1 mAb license validates core G-MAB technology with potential development andcommercial milestones totaling about $1 billion
Pain Management Franchise• Pain management franchise built out and moving forward with internal investments and
acquisitions (SCILEX Pharmaceuticals and Semnur Pharma (pending))• Near-term commercialization opportunity in ZTlido™
• Phase III product in SP-102 & Phase II product in RTX
cGMP Manufacturing• cGMP manufacturing facility operational for:
• Therapeutic antibodies• Cellular therapy programs
Flagship Product Leads
• CD38 CAR-T program for MM & Amyloidosis• CD123 CAR-T program for AML• c-MET ADC program• STAT3 iTAb program• KRASG12D iTAb program• CD47 and TIM3 I-O programs
Seasoned Executive Team
• Henry Ji – President & CEO• Kevin Herde – EVP & CFO• George Ng – EVP & CLO• Jeffrey Su – EVP & COO• Miranda Toledano – EVP of Corporate Development• Jerome “Jerry” Zeldis – CMO and President of Clinical Operations
© 2017 Sorrento Therapeutics, Inc. All Rights Reserved 29
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30© 2017 Sorrento Therapeutics, Inc. All Rights Reserved
(858) 210-3700
9380 Judicial Drive, San Diego, CA 92121