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Corporate Presentation September, 2017 V092117

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Page 1: Sorrento Therapeutics, Inc.sorrentotherapeutics.com/wp-content/uploads/2013/... · Peak sales and market size estimates have been determined on the basis of market research and comparable

Corporate Presentation

September, 2017

V092117

Page 2: Sorrento Therapeutics, Inc.sorrentotherapeutics.com/wp-content/uploads/2013/... · Peak sales and market size estimates have been determined on the basis of market research and comparable

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

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3© 2017 Sorrento Therapeutics, Inc. All Rights Reserved

Sorrento Antibody Centric Immuno-Oncology Platform

Bi-Specific mAbs

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I/O Strategic Approach (Tic Tac Toe)

4© 2017 Sorrento Therapeutics, Inc. All Rights Reserved

Multiple Myeloma Modality and Target Matrix

Effective monotherapies (Multiple Myeloma)

Multimodal synergistic potential

Exponential asset value (combination therapy)

SRNE active MM projects

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Financial Opportunity

5© 2017 Sorrento Therapeutics, Inc. All Rights Reserved

Historical Deal Values for

Multiple Myeloma Modalities

(1) Janssen-GenMab

(2) Amgen-Xencor

(3) Celgene-EngMab

(4) Celgene-Sutro

(5) Celgene-BlueBird

(6) Celgene-Inhibrx

(7) Celgene-AstraZeneca

(8) Pfizer-Merck

Page 6: Sorrento Therapeutics, Inc.sorrentotherapeutics.com/wp-content/uploads/2013/... · Peak sales and market size estimates have been determined on the basis of market research and comparable

Immuno-Oncology Core Program Pipeline

6© 2017 Sorrento Therapeutics, Inc. All Rights Reserved

Key I/0 Programs IND enabling Phase 1 Phase 2 Phase 3 NDA submission

CD38 CAR-T (Multiple Myeloma) *CEA CAR-T (Metastatic Liver Tumors) *CD38 ADC *CMET ADC

PDL1

Seprehvir® (Solid Tumors) *

Combination therapies (synergistic potential under evaluation)

* Program ready to move to next phase. No additional studies required at this time.

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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

› Validated target with approval DARZALEX®(daratumumab) for the treatment of multiple myeloma

7© 2017 Sorrento Therapeutics, Inc. All Rights Reserved. HIGHLY CONFIDENTIAL. Do not copy, distribute, or reproduce without express permission.

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

8

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

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

9

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

© 2017 Sorrento Therapeutics, Inc. All Rights Reserved

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

10

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

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ADC CD38-129 for Multiple Myeloma (Daudi Cells)

At 0.04 mg/kg the ADC CD38-129 demonstrates complete suppression of tumor growth.

11© 2017 Sorrento Therapeutics, Inc. All Rights Reserved

PB

S

CD

38-1

29 0

.04m

g/k

g

CD

38-1

29 0

.004m

g/k

g

CD

38-3

14 0

.04m

g/k

g

CD

38-3

14 0

.004m

g/k

g

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

]

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ADC CD38-136 for Multiple Myeloma (Daudi Cells)

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.

12© 2017 Sorrento Therapeutics, Inc. All Rights Reserved

PB

S

CD

38-2

86 0

.4m

g/k

g

CD

38-2

86 0

.04 m

g/k

g

CD

38-1

36 0

.4m

g/k

g

CD

38-1

36 0

.04m

g/k

g

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

]

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STAT3 iTAb (internalizing Targeting Antibody) Antitumor Activity

13© 2017 Sorrento Therapeutics, Inc. All Rights Reserved

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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

14

TRL UL IRL IRS TRSUS

Deleted ICP34.5 Deleted ICP34.5

© 2017 Sorrento Therapeutics, Inc. All Rights Reserved

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Combination SEPREHVIR / Anti-PD-1 Antibody Prolongs Survival in M3-9-M Rhabdomyosarcoma Model

PBS/CTRL

PBS/anti-PD1

SEPREHVIR/PBS

SEPREHVIR/anti-PD1

15

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

© 2017 Sorrento Therapeutics, Inc. All Rights Reserved Scientific Reports | 7: 2396 | DOI:10.1038/s41598-017-02503

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Pain Strategic Approach: The ‘Hard Wired’ System

16© 2017 Sorrento Therapeutics, Inc. All Rights Reserved

Non-Opioids

(Intractable) Neuropathic PainInitiated or caused by primary lesion or dysfunction in the

nervous system

(Progressive) Nociceptive Pain Caused by activity in neural pathways in response to

potentially tissue-damaging stimuli

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Non-Opioid Pain Management Core Pipeline

17© 2017 Sorrento Therapeutics, Inc. All Rights Reserved

* Program ready to move to next phase. No additional studies required at this time.

Key Pain Programs IND enabling Phase 1 Phase 2 Phase 3 NDA submission

ZTlido™ (1.8% lidocaine patch) - relief of pain associated w ith PHN

RTX (resiniferatoxin) - terminal cancer pain - intrathecal route (NIH)

RTX (resiniferatoxin) - terminal cancer pain - epidural route (SRNE)

RTX (resiniferatoxin) - severe arthritis pain - intra-articular (SRNE) *

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ZTlido™ Next Generation Lidocaine Patch

18© 2017 Sorrento Therapeutics, Inc. All Rights Reserved

NDA submission complete. PDUFA response expected by 02/28/18

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ZTlido™ Next Generation Lidocaine Patch

19© 2017 Sorrento Therapeutics, Inc. All Rights Reserved

Linear Plot of Mean Plasma Lidocaine Patch 1.8%Concentration vs Time with Physical Exercise and Normal Conditions

Time (Hours)

0 5 10 15 20 25 30 35 40 45 50

Mean P

lasm

a L

idocain

e C

oncentr

ation (

ng/m

L)

0

20

40

60

80

100

Normal conditions Exercise conditions

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Sorrento’s Resiniferatoxin (RTX) for Non-Opioid Control of Previously Intractable Pain

o Ultrapotent, highly specific TRPV1 agonist that selectively and

permanently ablates afferent neurons (“molecular neurolysis”).

o Targeted single injection via epidural (EP), intrathecal (IT) or regional

(IA, IP, PC) approach for long-term or permanent control of

previously intractable pain.

o Meaningful non-opioid analgesia with concomitant opioid

reduction and improvement in functional outcomes.

o Additional long-term benefits linked to disease modifying effect

(through neurogenic inflammation feedback loop interruption).

o Alteration of heat & pain sensation in the targeted area with no

adverse effects on normal perception, sensation or coordination.

20© 2017 Sorrento Therapeutics, Inc. All Rights Reserved. NON-CONFIDENTIAL.

September 2017

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Pain (Resiniferatoxin): Novel Class Potent Transient Receptor Vanilloid-1 Agonist (TRPV1A)

21© 2017 Sorrento Therapeutics, Inc. All Rights Reserved

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Pain (Resiniferatoxin): Novel Class Potent Transient Receptor Vanilloid-1 Agonist (TRPV1A)

22© 2017 Sorrento Therapeutics, Inc. All Rights Reserved

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Pain (Resiniferatoxin): Canine Validation Studies (translational to humans)

23© 2017 Sorrento Therapeutics, Inc. All Rights Reserved

Osteosarcoma pain (single intrathecal administration)

Brown et al, Anesthesiol 2005

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Pain (Resiniferatoxin): Canine Validation Studies (translational to humans)

24© 2017 Sorrento Therapeutics, Inc. All Rights Reserved

Arthritis pain (single intra-articular injection) Open Label Study (7 dogs with OA pain).

• Intra-articular RTX application (10mcg).

• Day 7 assessment, pain interference and pain severity scores

significantly improved (CBPI scale).

• Severity score significantly improved 21 days after treatment

• Effect sustained in dogs a median of 150 days post

resiniferatoxin injection (range 58 to 730 days).

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Sorrento’s Resiniferatoxin (RTX) for Pain Control (Human Studies)

o Phase 1B – Terminal Cancer Pain (intrathecal administration)

• NIH collaboration, open-label, dose escalation safety study, >6/10

NRS (severe pain) and Pain not controlled by standard Treatments

• 12 patients treated (prior to clinical hold: NIH pharmacy issues

unrelated to the drug)

• Hold lifted. Expected to finalize enrollment and conclude study 2Q18

o Phase 1B – Terminal Cancer Pain (epidural administration)

• Open label Phase 1b single dose escalation safety study for adult

subjects with intractable pain associated with cancer in any area

below the mid thoracic level, an average worst pain score >6 on the

NPRS (Numeric Pain Rating Scale)

• 2 clinical sites to initiate enrollment 4Q17 (Brigham, Duke University)

o Phase 1 – Safety and Efficacy of intra-articular administration in

patients suffering from chronic osteoarthritic pain and scheduled for

total knee replacement.

• Open label Phase 1 single dose escalation safety study for adult

subjects

• 1 initial clinical site to initiate enrollment 2Q187 (IND submission

1Q18)

25© 2017 Sorrento Therapeutics, Inc. All Rights Reserved. NON-CONFIDENTIAL.

September 2017

NIH Phase I Study (intrathecal administration)

12 patients with

advanced cancer

(43-61 years old)

Improved pain and

increased activity with

reduced opioids

3 non or

poorly

ambulatory

patients able

to become

ambulatory

Clinically meaningful

reduction in pain after

single RTX injection

No

unexpected

adverse

events

MTD not reached with 1

mL RTX over 2 min via

infusion pump

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Sorrento Strategic Vision (Executive Summary)

26

Immuno-Oncology Strategy:Build successful cancer treatments through proprietary multimodal multipronged therapeutic approaches

› Acquire novel and promising immuno-oncology assets› Enhance and develop monotherapy assets from early stage to clinical validation› Uncover synergistic potential of proprietary monotherapies to build novel cancer therapeutic combination approaches

5 immuno-oncology assets in our development portfolio (G-MABs™, CAR-T, ADCs, iTAbs, Oncolytic Virus)

Pain Management Strategy:Address currently intractable pain in ways that preserve a patients ability to maintain normal life routines

› Address cancer pain without opioids and their unwanted deleterious effects› Provide delivery systems that maximize drug effect, improve safety or significantly add convenience for patients

2 pain management assets in our development portfolio (ZTlido™, Resiniferatoxin)

© 2017 Sorrento Therapeutics, Inc. All Rights Reserved

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Sorrento’s Rich Technology Asset Base (Executive Summary)

Key Technology Assets

› Extensive library of fully human antibodies (G-MAB™)

› Biosimilars / Bio-better naked antibodies

› Intracellular targeting Abs (iTAbs)

› Antibody-drug conjugates (ADCs)

Lead Product Candidates – Development programs

› PD-L1, PD-1

› CD38 ADC, CMET ADC

› STAT3, mKRASG12D (iTABs)

› Erbitux® biosimilar (pre-IND FDA discussions)

Highlights / Upcoming Milestones

› Licensing opportunities (non-dilutive capital)

› 3Q18 CD38 ADC IND filing

› 2018 CMET ADC IND filing

Key Technology Assets

› TRPV1 Agonist - Neuron Ablating Agent (resiniferatoxin)

› Non-aqueous adhesive pain patch (lidocaine)

› Non-opioid epidural steroid injectable (novel formulation)*

Lead Product Candidates – Development programs

› RTX epidural for intractable cancer pain

› RTX intra-articular for arthritis pain

› Lidocaine for relief of pain from PHN

› Lumbosacral radicular pain (Phase III in 2017)*

Highlights / Upcoming Milestones

› 4Q17 ZTlido MAA (Europe submission)

› 1Q18 ZTlido PDUFA response on NDA submission

› 1Q18 Epidural RTX cancer pain phase (1st patient)

› 2Q18 Intrathecal RTX (NIH) phase 1 (last patient)

› 1Q18 Intra-articular RTX arthritis IND submission

Key Technology Assets

› CAR-T therapy

› CAR-NK therapy

› CAR-PNK therapy

› Oncolytic virus immunotherapy

Lead Product Candidates – Development programs

› CD38 CAR-T for multiple myeloma (IND-enabling studies)

› CEA CAR-T for solid tumors (Phase Ib)

› Seprehvir for solid tumors (Phase Ib/II)

Highlights / Upcoming Milestones

› Licensing opportunity for CD38 platform (CAR-T)

› 4Q17 IND CD38 CAR-T

› 2018 Phase II CEA CAR-T

Immuno-Oncology Platform Non-Opioid Pain Management

G-MAB™

LA CellConcortis™

Sorrento

Biologics™TNK Therapeutics™ VIRTTU Biologics™

Scilex

Pharmaceuticals™

Scintilla

Pharmaceuticals™

27*Note: SP-102 pending Semnur acquisition

© 2017 Sorrento Therapeutics, Inc. All Rights Reserved

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Sorrento’s Senior Leadership Team

28

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, Chief Legal Officer

Dean FerrignoVP Finance

and Chief Accounting Officer

Alexis Nahama, DVMVP Corporate Development

and President Ark Animal Health

Hui Li, PhDVP Business Development

and General Manager China Operations

© 2017 Sorrento Therapeutics, Inc. All Rights Reserved

Name Position(s)

Gunnar F. Kaufmann, Ph.D. Senior Vice President of Immunotherapy,

Head of Research and Global Partnerships

Mark Brunswick, Ph.D. VP Regulatory Affairs and Quality

Robert Knight, MD Sr VP Clinical Research

Stephen L Klincewicz, DO, MPH, JD

VP Pharmacovigilance

and Clinical Operations

Bill Farley VP Sales and Business Development

Ken Takeshita, MD Sr VP Clinical Research

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29

(858) 203-4100

[email protected]

4955 Directors Place, San Diego, CA 92121

© 2017 Sorrento Therapeutics, Inc. All Rights Reserved