Corporate Presentation th Rodman and Renshaw Global...

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Corporate Presentation 19 th Rodman and Renshaw Global Investment Conference September 11, 2017

Transcript of Corporate Presentation th Rodman and Renshaw Global...

Corporate Presentation19th Rodman and Renshaw Global Investment ConferenceSeptember 11, 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 additional clinical trials and the FDA’s or otherregulatory 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, and receiptby 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 determinedon 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 size estimateswill 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® and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc.

ZTlido™ and G-MAB™ are trademarks owned by Scilex Pharmaceuticals, Inc. and Sorrento, respectively.

Seprehvir®, is a registered trademark of Virttu Biologics Limited, a wholly-owned subsidiary of TNK Therapeutics, Inc. and part of the group of companies owned by SorrentoTherapeutics, Inc.

All other trademarks are the property of their respective owners.

© 2017 Sorrento Therapeutics, Inc. All Rights Reserved.

2© 2017 Sorrento Therapeutics, Inc. All Rights Reserved

Overview of Sorrento Therapeutics

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 › iTAb: STAT3, mKRASG12D & other iTAbs (Preclinical)› Concortis: c-MET & CD38 ADCs › Sorrento Biologics: Erbitux® biosimilar (pre-IND discussions)

Highlights › Source of non-dilutive funding and new pipeline programs

Key Technology Platforms › Branded, non-aqueous lidocaine pain patch w/ better

adhesion› Differentiated non-opioid epidural steroid injectable› One-time injection of non-opioid for intractable cancer pain

Lead Product Candidates› ZTlido pain patch (NDA re-submitted in August, 2017)› SP-102* for lumbosacral radicular pain (Phase III in 2017)› RTX for intractable cancer pain (Phase I in 2017)

Highlights › Expected ZTlido launch in 2018

Key Technology Platforms › CAR-T therapy › CAR-NK therapy › Oncolytic virus immunotherapy

Lead Product Candidates › CD38 CAR-T for multiple myeloma (IND-enabling studies)› Seprehvir for solid tumors (Phase Ib/II)› CEA CAR-T for solid tumors (Phase Ib)

Highlights› 3 clinical programs in 2017 w/ promising human & in vivo

proof-of-concept data

Antibody Therapy Cell-Based Immunotherapy Non-Opioid Pain Management

G-MAB & LA Cell Concortis™ Sorrento

Biologics™ TNK Therapeutics™ VIRTTU Biologics™ Scilex Pharmaceuticals™

Scintilla Pharmaceuticals™

3*Note: SP-102 pending Semnur acquisition© 2017 Sorrento Therapeutics, Inc. All Rights Reserved

Non-Opioid Pain Management Core Pipeline

4© 2017 Sorrento Therapeutics, Inc. All Rights Reserved

Key Pain Programs IND enabling Phase 1 Phase 2 Phase 3 NDA submissionZTlido™ (1.8% lidocaine patch) - relief of pain associated w ith PHN

RTX (resiniferatoxin) - terminal cancer pain - intrathecal route

RTX (resiniferatoxin) - terminal cancer pain - epidural route

ZTlido™ Next Generation Lidocaine Patch

5© 2017 Sorrento Therapeutics, Inc. All Rights Reserved

Pain (Resiniferatoxin): Summary Results from First-In-Human Study (NIH Study)

6© 2017 Sorrento Therapeutics, Inc. All Rights Reserved

7© 2017 Sorrento Therapeutics, Inc. All Rights Reserved

Sorrento Antibody Centric Immuno-Oncology Platforms

Immuno-Oncology Core Pipeline

8© 2017 Sorrento Therapeutics, Inc. All Rights Reserved

Key I/0 Programs IND enabling Phase 1 Phase 2 Phase 3 NDA submissionCD38 CAR-T (Multiple Myeloma)

CEA CAR-T (Metastatic Liver Tumors)

CD38 ADC

CMET ADC

PDL1

Seprehvir® (Solid Tumors)

Combination therapies (synergistic potential under evaluation)

CD38 Franchise: CD38 as Target for CAR-T Immunotherapy of MM

› Type II transmembrane glycoprotein with cyclic ADP ribose hydrolase activity

› Widely found on the surface of lymphoid and myeloid lineages including B, T, NK cells and macrophages

o Expression on B, T, NK cells, and the common myeloid progenitor might pose potential for broad myelotoxicity

› Most resting lymphocytes have low level expression

› High density expression found in:

o Terminally differentiated plasma cells

o Multiple myeloma

o Other B cell malignancies

o All activated lymphoid cells

› Anti-CD38 mAb DARZALEX®(daratumumab) is approved for the treatment of multiple myeloma

o A paradigm shift in clinical results

9© 2017 Sorrento Therapeutics, Inc. All Rights Reserved. HIGHLY CONFIDENTIAL. Do not copy, distribute, or reproduce without express permission.

Sorrento’s Anti-CD38 mAb Has Different Binding Epitope from Daratumumab

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AR2G sensor, coated with Daratumumab, captured CD38, then ran C38A2

CD38A2 binds to an epitope on CD38 that is different from Daratumumab as evident by signal increase

1) Daratumumab immobilized on chip

2) CD38 captured by Daratumumab

3) Wash

4) CD38A2 binding to captured CD38

© 2017 Sorrento Therapeutics, Inc. All Rights Reserved

Anti-CD38 CAR-T Program For Treatment of Multiple Myeloma

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Anti-CD38 CAR-T Cells Selectively Kill CD38 High Expression Cells

© 2017 Sorrento Therapeutics, Inc. All Rights Reserved

Anti-CD38 CAR-T Cells In Xenograft Mouse Model (RPMI8226 MM Tumors)

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T-007 TreatedUntreated Mice

Prior to 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

› On Day -23, immunodeficient NSG mice were infused with human RPMI8226 MM tumor cells

› On Day 0, CAR-T cells were administered i.v.

› In all treated mice, the tumors were eradicated

› 100% of treated mice remained tumor-free until the end of the experiment (150 days)

› All untreated mice had to be sacrificed

Anti-CD38 CAR-T Cells Eradicated CD38 Positive Human Multiple Myeloma in NSG Mice

© 2017 Sorrento Therapeutics, Inc. All Rights Reserved

ADC CD38-136 for Multiple Myeloma (Daudi Cells)

P B S

C D 3 8 -28 6 0

.4m

g /kg

C D 3 8 -28 6 0

.04 m

g /kg

C D 3 8 -13 6 0

.4m

g /kg

C D 3 8 -13 6 0

.04m

g /kg

1 0 4

1 0 5

1 0 6

1 0 7

1 0 8

1 0 9

1 0 1 0

1 0 1 1

1 0 1 2

D a u d i- lu c D a y 4 8

To

tal

Flu

x

[p/s

]

0 2 0 4 0 6 01 0 4

1 0 5

1 0 6

1 0 7

1 0 8

1 0 9

1 0 1 0

1 0 1 1

1 0 1 2

D a y s A fte r T re a tm e n t in itia tio n

To

tal

Flu

x

[p/s

]

D a u d i- lu c

P B S

C D 3 8 -2 8 6 0 .0 4 m g /kg

C D 3 8 -1 3 6 0 .0 4 m g /kg

n = 9

C D 3 8 -2 8 6 0 .4 m g /kg

C D 3 8 -1 3 6 0 .4 m g /kg

At 0.4 mg/kg the ADC CD38-136 demonstrates complete suppression of tumor growth and retains very good anti-tumor activity at 0.04 mg/kg.

13© 2017 Sorrento Therapeutics, Inc. All Rights Reserved

ADC CD38-129 for Multiple Myeloma (Daudi Cells)

0 2 0 4 0 6 01 0 5

1 0 6

1 0 7

1 0 8

1 0 9

1 0 1 0

1 0 1 1

1 0 1 2

D a y s A fte r T re a tm e n t in itia tio n

To

tal

Flu

x

[p/s

]

D a u d i- lu c

P B S

C D 3 8 -1 2 9 0 .0 4 m g /kg

C D 3 8 -3 1 4 0 .0 4 m g /kg

n = 9

C D 3 8 -1 2 9 0 .0 0 4 m g /kg

C D 3 8 -3 1 4 0 .0 0 4 m g /kg

P B S

C D 3 8 -12 9 0

.04m

g /kg

C D 3 8 -12 9 0

.00 4m

g /kg

C D 3 8 -31 4 0

.04m

g /kg

C D 3 8 -31 4 0

.00 4m

g /kg

1 0 5

1 0 6

1 0 7

1 0 8

1 0 9

1 0 1 0

1 0 1 1

1 0 1 2

D a u d i- lu c D a y 4 8

To

tal

Flu

x

[p/s

]

At 0.04 mg/kg the ADC CD38-129 demonstrates complete suppression of tumor growth, while the ADCs exhibit very good anti-tumor activity at 0.004 mg/kg.

14© 2017 Sorrento Therapeutics, Inc. All Rights Reserved

©2017, Sorrento Therapeutics, Inc. ALL RIGHTS RESERVED.

0% 20% 40% 60% 80% 100%

Untreated

ATCCAR-T 1e7CAR-T 1e6

CAR-T 1e6 x3

DARACD38 A2

38-129 3mkg38-129 1mkg x338-129 0.3mkg…

38-136 10mkg38-136 3mkg x338-136 1mkg x3

Normalized Anti-Tumor Activity (%) 1 week after Treatment-20% 0% 20% 40% 60% 80% 100%

Untreated

ATCCAR-T 1e7CAR-T 1e6

CAR-T 1e6 x3

DARACD38 A2

38-129 3mkg38-129 1mkg x3

38-129 0.3mkg x 3

38-136 10mkg38-136 3mkg x338-136 1mkg x3

Normalized Anti-Tumor Activity (%) 2 weeks after Treatment

1 week after treatment 2 weeks after treatment

Anti-Tumor Activity Comparison of Anti-CD38 CAR-T, Antibodies and ADCs

© 2017 Sorrento Therapeutics, Inc. All Rights Reserved 15

Seprehvir: Next-Generation HSV-1 based Oncolytic Virus Immunotherapy

HSV-1 immuno-oncolytic therapy with 100+ patients treated to date

5 Phase I Trials: High Grade Glioma, SCCHN, melanoma, mesothelioma, pediatric neuroblastoma/osteosarcoma

Well tolerated, no toxicity and expected AEs have been mild and transient

Ability to be delivered intratumorally and systemically could provide administration advantages versus recently approved HSV-1 oncolytic viral immunotherapy (Amgen)

Phase II trial in planning phase

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TRL UL IRL IRS TRSUS

Deleted ICP34.5 Deleted ICP34.5

© 2017 Sorrento Therapeutics, Inc. All Rights Reserved

Combination of SEPREHVIR with Anti-PD-1 Antibody Significantly Prolongs Survival in M3-9-M Rhabdomyosarcoma Model

PBS/CTRLPBS/anti-PD1SEPREHVIR/PBSSEPREHVIR/anti-PD1

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Combination therapy of Seprehvir and anti-PD1 mAb exhibits potent anti-tumor activity

© 2017 Sorrento Therapeutics, Inc. All Rights Reserved

Human Ewing Sarcoma A673 xenograft

*athymic mice

Surv

ival

(%)

Days After Initial Treatment

EWS: A673

Days After Initial Treatment

Tum

or V

olum

e (c

m3 )

*Tumor sizes 200-250 mm3

GD2+ human Ewing Sarcoma xenograft modelsTreated with 1x106 PFU Seprehvir or PBS intratumourally on days 0, 3, and 5IP cyclophosphamide for lymphodepletion on day 31x107 GD2-directed human CAR T cells were injected intravenously on day 6

Intra-tumoral SEPREHVIR Improves GD2-CAR-T Cell Anti-tumor Activity

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Combination therapy of Seprehvir and CAR-T cells exhibits potent anti-tumor activity

© 2017 Sorrento Therapeutics, Inc. All Rights Reserved

Strong Evidence of Additional and Synergistic Benefit to Current Therapies Presents Additional Development Opportunities

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© 2017, Sorrento Therapeutics, Inc. ALL RIGHTS RESERVED.

© 2017 Sorrento Therapeutics, Inc. All Rights Reserved

Sorrento Senior Leadership Team

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Name Position(s)

Henry Ji, Ph.D. Chairman, President & Chief Executive Officer

Jerome B. Zeldis, M.D., Ph.D.

Chief Medical Officer & President of Clinical Development

George Ng, J.D. EVP, Chief Administrative Officer

Dean Ferrigno VP Finance and Chief Accounting Officer

Alexis Nahama, DVM VP Corporate Development and President Ark Animal Health

Hui Li, PhD VP Business Development and General Manager China Operations

© 2017 Sorrento Therapeutics, Inc. All Rights Reserved

Gunnar F. Kauffman, Ph.D. Senior Vice President of Immunotherapy & Head of Research and Global Partnerships

Mark Brunswick, Ph.D. VP Regulatory Affairs

Robert Knight, MD VP Clinical Research

Stephen L Klincewicz, DO, MPH, JD VP Pharmacovigilance and Clinical Operations

Bill Farley VP Sales and Business Development

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(858) 203-4100

[email protected]

4955 Directors Place, San Diego, CA 92121

© 2017 Sorrento Therapeutics, Inc. All Rights Reserved