Therapeutics
OnTarget
September - 2016
(c) 2016 Sorrento Therapeutics, Inc. All Rights Reserved.
Disclaimer NASDAQ: SRNEIn presenting this material or responding to inquiries in connection with a presentation, management may refer to results, projections or perfor-mance measures that are not prepared in accordance with U.S. GenerallyAccepted Accounting Principles (“GAAP”) as reported in the Company’sSEC filings.These results, projections or performance measures areNon-GAAP measures and are not intended to replace or as a substitute for results measured under GAAP, but rather as supplement to the GAAPreported results.
Because actual results are affected by these and other potential risks, con-tingencies and uncertainties, the Company cautions investors that actualresults may differ materially from those expressed or implied in anyforward-looking statement. It is not possible to predict or identify all suchrisks, contingencies and uncertainties. The Company identifies some ofthese factors in its Securities and Exchange Commission (“SEC”) filings onForms 10-K, 10-Q and 8-K, and investors are advised to consult the Compa-ny’s filings for a more complete listing of risk factors, contingencies anduncertainties effecting the Company and its business and financial perfor-mance.
Sorrento™, G-MAB™, CAR.TNK™, TNK Therapeutics™, Scintilla Pharmaceuticals™, iTAb ™ and the Sorrento logo are trademarks owned by Sorrento Therapeutics, Inc.
All other trademarks and trade names are the property of their respective owners.
Logo - http://photos.prnewswire.com/prnh/20150105/167173LOGO
Certain statements contained in this presentation or in other documents ofSorrento Therapeutics, Inc. (the “Company”), along with certain statements that may be made by management of the Company orally in presentingthis material, may contain “forward-looking statements”as defined in thePrivate Securities Litigation Reform Act of 1995. These statements can beidentified by the fact that they do not relate strictly to historic or currentfacts. They use words such as "estimate," "expect," "intend," "believe," "plan,""anticipate,"“projected”and other words and terms of similar meaning inconnection with any discussion of future operating or financial perfor-mance or condition. These statements are based upon the current beliefsand expectations of the Company's management and are subject to signifi-cant risks and uncertainties. Statements regarding future action, future performance and/or future results including, without limitation, thoserelating to the timing for completion, and results of, scheduled or addition-al clinical trials and the FDA’s or other regulatory review and/or approvaland commercial launch and sales results (if any) of the Company’s formula-tions and products and regulatory filings related to the same, and receiptby the Company of milestone and royalty payments may differ from thoseset forth in the forward-looking statements. Peak sales and market size estimates have been determined on the basis of market research andcomparable product analysis, but no assurances can be given that suchsales levels will be achieved, if at all, or that such market size estimates willprove accurate.
The Company assumes no obligation to update forward-looking state-ments as circumstances change. Investors are advised to consult further disclosures that the Company makes or has made on related subjects inthe Company's Form 10-K, 10-Q and 8-K reports.
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Presentation Summary
Company History
Core Technologies & Platforms
Sorrento Therapeutics Structure
Programs and Pipeline Status
Partnerships
Recent News & Financial Summary
Conclusion
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Company History
2006 - Founded2009 - Funding and commencement of operations2010 - G-MAB Library2013 - NASDAQ Listing, Development and Asset Acquisitions
- Cynviloq, RTX & ADC 2014 - License deals with “NANT” companies2015 - Asset Acquisitions
- CAR-T, BioSimilars, Intracellular2016 - $150M PIPE Financing & Validating License Deal (Servier)
Core Technologies - Antibody Therapeutics - G-MAB Library
Difficult TargetsSmall Peptides &Tumor Neo-epitopes
High Value Oncology TargetsPD1, PD-L1, CD123, PSMA, CD47
Most Difficult Targets:G Protein-Coupled Receptors (GPCRs)
Y G N A G
L S
F
AIP-2
Proprietary TechnologyRNA amplification used for library generation
Highly SuccessfulScreening Hit Rate
(100+ targets screened)Fully Human Antibodies
Very High Diversity2.1 x 1016 Distinct Antibodies
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G-MAB library:• One of the largest fully human antibody libraries • More than 10 quadrillion (1016) distinct antibody
sequences • Over 100 clinically-relevant targets• Leading candidates in development are STI-A1110
(PD-1), STI-A1014 (PD-L1) and STI-600 (TIM3)
Bispecific Antibodies:• Targeting two different receptors in
combination on the same cell
Core Technologies - Antibody Therapeutics - G-MAB Library
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ADCsAntibody Drug ConjugatesProprietary ToxinsConjugation Chemistries
SecretedTargets
BispecificAbs
Immuno-Oncology
AdoptiveImmunotherapy
CAR-TCAR.NK
Intracellular Targets
Core Technologies - Multi-Faceted Immunotherapy Platform
PD-1
PD-L1
c-MET
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Sorrento Therapeutics Structure
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Pain Management
Scintilla
Programs – Sorrento Biologics- Biosimilar /Biobetters (mAbs)
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Sorrento Biologics Program Summary:• Exclusive licensing agreement with Mabtech Limited to develop and commercialize biosimilar
antibodies, 4 to date:• Erbitux® (STI-001, cetuximab), • Remicade® (STI-002, infliximab), • Simulect® (STI-003, basiliximab)• Xolair® (STI-004, omalizumab)
• All have completed Phase 3 clinical studies in China
• IND-enabling activities in progress
Next Milestone:• STI-001 regulatory pathway and discussions with MHRA (UK) / FDA (US) agencies – 1H 2017
Significant Commercial Opportunities
• Targeting $12 B+ market
• Significant opportunities forcombination therapies
Programs – Sorrento Biologics- Biosimilar /Biobetters (mAbs)
Product Generic Target Brand 2014 GlobalSales (US$)
STI-001 Cetuximab EGFR Erbitux $1.9B
STI-002 Infliximab TNFα Remicade $0.9B
STI-003 Basiliximab CD25 Simulect $114M
STI-004 Omalizumab IgE Xolair $1.1B
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Programs - CAR-T & CAR-pNK - TNK Therapeutics
Chimeric Antigen Receptor (CAR) Based Immunotherapies
Program Summary:• Autologous and allogeneic CAR-T and CAR.NK therapies
• Leading autologous clinical candidates in development are: • T-001 (Anti-CEA CAR-T) • T-002 (Anti-PSMA CAR-T)• T-007 (Anti-CD38 CAR-T for Multiple Myeloma)
Next Milestone:• Corporate IND filing 1H 2017
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Novel Breakthrough Intracellular Targeting Antibody -iTab™
• Modulation of intracellular targets with antibody therapeutics will greatly increase druggable space
• Specific modification of antibodies enables efficient cellular internalization, intracellular target recognition
• Broad range of indications, e.g. oncology, infectious diseases, and inflammation
• Leading preclinical targets include: Stat3 (oncology & inflammation), mutant KRAS (oncology), MYC (oncology), and FoxP3 (immuno-oncology)
• Useful for other modalities (proteins, peptides, nucleic acids)
Programs - LA Cell - Cell-Penetrating Antibody Delivery
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Tox StudyIn Vivo
Efficacy StudyExploratory PK/PD and
Biodistribution
Developability Assessment
Functionality Evaluation
Antibody Modification
Antibody Panning
Programs - LA Cell – iTAb Discovery Platform
Basic Research – Full Discovery – Collaborations with Large Pharma
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Programs – Antibody-Drug Conjugates – Concortis
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Next Generation Antibody-Drug Conjugates
• Cytotoxic drugs conjugated to antibodies via chemical linkers• Site-specific conjugation methods to provide homogenous products:
• K-Lock™ & C-Lock™• Proprietary Toxins: tublin-binding, DNA alkylation & other MOAs• Lead program: c-Met ADC (CBT-161) • Next Milestone : IND in 2017
Scintilla Pharmaceuticals –Subsidiary Focused on Pain Management
RTX (resiniferatoxin)• Non-opioid-based pain treatment that selectively binds to the TRPV-1 receptor and
creates an ultra-potent agonist signal that leads to calcium influx induced apoptosis of TRPV-1 nerve cells, resulting in a selective ablation
• Completed Phase 1/2 trial with the NIH • Next Milestone : Pivotal phase 2 study targeted for early in 2017
ZTlido™ (lidocaine patch 1.8%) – Pending Acquisition of SCILEX• Being developed for the treatment of postherpetic neuralgia (PHN)• Next Milestone : FDA interactions on going for potential 2017 action date
Epidural Steroid – Pending Acquisition of Semnur Pharmaceuticals• Semnur's lead product is a non-opiate epidural steroid injectable for chronic back pain• Being developed for the treatment of lumbosacral radicular pain• Next Milestone : Phase 3 clinical trials planned for 2017
Programs – Pain Management – Scintilla Pharmaceuticals
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Laboratoires Servier Servier, the largest non-listed pharmaceutical company in France, announced a license and collaboration agreement for the development, manufacture and commercialization of products using Sorrento's fully human immuno-oncology anti-PD-1 monoclonal antibody (mAb) STI-A1110.
ImmuneOncia TherapeuticsSorrento and Yuhan Corporation have entered into an agreement to form a joint venture company, ImmuneOncia Therapeutics, LLC, to develop and commercialize a number of immune checkpoint antibodies against undisclosed targets for both hematological malignancies and solid tumors.
Lee’s PharmaLee’s Pharma has licensed exclusive rights from Sorrento to develop and commercialize the fully human anti-PD-L1 monoclonal antibody (mAb) STI-A1014 for the greater Chinese market, including Mainland China, Hong Kong, Macau, and Taiwan.
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Partnerships – Global Immuno-Oncology Partners
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3SBioTNK Therapeutics has an agreement to enter into a joint venture with Shenyang Sunshine Pharmaceutical Company Ltd (3SBio) to develop and commercialize proprietary immunotherapies, including those developed from, including or using TNK's CAR-T technology targeting CEA positive cancers.
CHA BiotechSorrento Therapeutics, Inc. has an agreement to enter a joint venture with CHA Biotech Co., LTD to develop and commercialize proprietary CAR modified cellular therapies based on CBT's Activated Killer Cell (AKC) technology and five of Sorrento's CARs for all disease conditions, including oncology and infectious diseases.
Morphotech (Eisai)Concortis Biosystems, Inc. has entered into a collaboration agreement to generate novel antibody drug conjugates (ADCs) based on a Morphotekantibody linked to chemotherapeutic agents using Concortis’ proprietary ADC Technology.
Partnerships – Global Cellular Therapy and ADC Partners
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Recent News
• Validation of core technology with Servier license• Potential development and commercial milestones total nearly $1 billion
• Moving pain management franchise forward with internal investments and acquisitions
• cGMP manufacturing facility operational for therapeutic antibodies and cellular therapy programs
• Entered strategic partnerships in cellular therapy with 3SBio and CHA Bio agreements
• Hired Jerome “Jerry” Zeldis M.D. Ph.D., former Celgene CMO, as CMO and President of Clinical Operations
2016 Strategic Accomplishments Moving Sorrento Forward
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Financial Summary
• Completed $150 million PIPE capital funding
• Received $27.5 million from Servier up-front license fee
• Completed stock swap transaction with NantKwest shares
• Swapped SRNE shares with NK shares (marketable securities) plus $15.6 million cash
• Bought back 7.9 million SRNE shares and retired 0.5 million warrants
• 57.6 million common shares outstanding• 7.8 million shares held in treasury stock for potential future issuance
Recent Items of Financial Significance
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Conclusion: Sorrento Therapeutics - OnTarget
• Recognized leader in therapeutic antibody technologies and discoveries
• Comprehensive portfolio of novel immunotherapy technologies and product candidates
• Clinical-stage biosimilars antibodies have substantial market potential
• Unique technologies and partnerships to enable impactful advances in cellulartherapies
• Focusing on core priorities in each program area and moving lead candidates towards key milestones in 2017
• Strategic optionality - value creation possibilities across a wide variety oftechnologies and assets via internal development, licensing and partnering
A Comprehensive Immunotherapy Company with Valuable Technologies and Assets
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Therapeutics
ContactHenry Ji, PhD - President and CEO
[email protected](858) 668-6923
ContactKevin Herde - EVP and CFO
[email protected](858) 210-3736
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