OnTarget September

Transcription

1 Therapeutics OnTarget September (c) 2016 Sorrento Therapeutics, Inc. All Rights Reserved.

2 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 by management of the Company orally in presenting this material, may contain forward-looking statements as defined in the Private Securities Litigation Reform Act of These statements can be identified by the fact that they do not relate strictly to historic orcurrent 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 based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties. Statements regarding future action, future performance and/or future results including, without limitation, those relating to the timing for completion, and results of, scheduled or additional clinical trials and the FDA s or other regulatory review and/or approval and commercial launch and sales results (if any) of the Company s formulations and products and regulatory filingsrelated to the same, and receipt 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 been determined on the basis ofmarket 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 size estimates 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. NASDAQ: SRNE 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 prepared in 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 from those 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 someof these factors in its Securities and Exchange Commission ( SEC ) filingson Forms 10-K, 10-Q and 8-K, and investors are advised to consult the Company s filings fora more complete listing 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. All other trademarks and trade names are the property of their respective owners. Logo - (c) 2016 Sorrento Therapeutics, Inc. All Rights Reserved. 2

3 Presentation Summary Company History Core Technologies & Platforms Sorrento Therapeutics Structure Programs and Pipeline Status Partnerships Recent News & Financial Summary Conclusion (c) 2016 Sorrento Therapeutics, Inc. All Rights Reserved. 3

4 Company History Founded Funding and commencement of operations G-MAB Library NASDAQ Listing, Development and Asset Acquisitions - Cynviloq, RTX & ADC License deals with NANT companies Asset Acquisitions - CAR-T, BioSimilars, Intracellular $150M PIPE Financing & Validating License Deal (Servier) (c) 2016 Sorrento Therapeutics, Inc. All Rights Reserved. 4

5 Core Technologies - Antibody Therapeutics - G-MAB Library Proprietary Technology RNA amplification used for library generation Fully Human Antibodies Very High Diversity 2.1 x Distinct Antibodies Highly Successful Screening Hit Rate (100+ targets screened) Difficult Targets Small Peptides &Tumor Neo-epitopes High Value Oncology Targets PD1, PD-L1, CD123, PSMA, CD47 Most Difficult Targets: G Protein-Coupled Receptors (GPCRs) Y G N A G AIP-2 F L S (c) 2016 Sorrento Therapeutics, Inc. All Rights Reserved. 5

6 Core Technologies - Antibody Therapeutics - G-MAB Library G-MAB library: One of the largest fully human antibody libraries More than 10 quadrillion (10 16 ) 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 (c) 2016 Sorrento Therapeutics, Inc. All Rights Reserved. 6

7 Core Technologies - Multi-Faceted Immunotherapy Platform Adoptive Immunotherapy Intracellular Targets c-met ADCs Antibody Drug Conjugates Proprietary Toxins Conjugation Chemistries Secreted Targets PD-L1 Bispecific Abs CAR.NK CAR-T PD-1 Immuno-Oncology (c) 2016 Sorrento Therapeutics, Inc. All Rights Reserved. 7

8 Sorrento Therapeutics Structure Pain Management Scintilla (c) 2016 Sorrento Therapeutics, Inc. All Rights Reserved. 8

9 Programs Sorrento Biologics- Biosimilar /Biobetters (mabs) 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 (c) 2016 Sorrento Therapeutics, Inc. All Rights Reserved. 9

10 Programs Sorrento Biologics- Biosimilar /Biobetters (mabs) Significant Commercial Opportunities Targeting $12 B+ market Significant opportunities for combination therapies Product Generic Target Brand 2014 Global Sales (US$) 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 (c) 2016 Sorrento Therapeutics, Inc. All Rights Reserved. 10

11 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 (c) 2016 Sorrento Therapeutics, Inc. All Rights Reserved. 11

12 Programs - LA Cell - Cell-Penetrating Antibody Delivery 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) (c) 2016 Sorrento Therapeutics, Inc. All Rights Reserved. 12

13 Programs - LA Cell itab Discovery Platform Basic Research Full Discovery Collaborations with Large Pharma Antibody Panning Antibody Modification Functionality Evaluation Developability Assessment Exploratory PK/PD and Biodistribution In Vivo Efficacy Study Tox Study (c) 2016 Sorrento Therapeutics, Inc. All Rights Reserved. 13

14 Programs Antibody-Drug Conjugates Concortis 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 (c) 2016 Sorrento Therapeutics, Inc. All Rights Reserved. 14

15 Programs Pain Management Scintilla Pharmaceuticals 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 (c) 2016 Sorrento Therapeutics, Inc. All Rights Reserved. 15

16 Partnerships Global Immuno-Oncology Partners 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 Therapeutics Sorrento 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 Pharma Lee 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. (c) 2016 Sorrento Therapeutics, Inc. All Rights Reserved. 16

17 Partnerships Global Cellular Therapy and ADC Partners 3SBio TNK 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 Biotech Sorrento 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 Morphotek antibody linked to chemotherapeutic agents using Concortis proprietary ADC Technology. (c) 2016 Sorrento Therapeutics, Inc. All Rights Reserved. 17

18 Recent News 2016 Strategic Accomplishments Moving Sorrento Forward 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 (c) 2016 Sorrento Therapeutics, Inc. All Rights Reserved. 18

19 Financial Summary Recent Items of Financial Significance 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 (c) 2016 Sorrento Therapeutics, Inc. All Rights Reserved. 19

20 Conclusion: Sorrento Therapeutics - OnTarget A Comprehensive Immunotherapy Company with Valuable Technologies and Assets 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 cellular therapies 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 varietyof technologies and assets via internal development, licensing and partnering (c) 2016 Sorrento Therapeutics, Inc. All Rights Reserved. 20

21 Therapeutics Contact Henry Ji, PhD - Presidentand CEO hji@sorrentotherapeutics.com (858) Contact Kevin Herde - EVP and CFO kherde@sorrentotherapeutics.com (858) (c) 2016 Sorrento Therapeutics, Inc. All Rights Reserved. 21