UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

 

FORM 8-K

 

 

 

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d)

OF THE SECURITIES EXCHANGE ACT OF 1934

 

Date of Report (Date of earliest event reported): June 19, 2019

 

 

 

SORRENTO THERAPEUTICS, INC.

(Exact Name of Registrant as Specified in its Charter) 

 

 
         
Delaware   001-36150   33-0344842

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

4955 Directors Place

San Diego, CA 92121

(Address of Principal Executive Offices) (Zip Code)

 

Registrant’s telephone number, including area code: (858) 203-4100

 

N/A

(Former Name, or Former Address, if Changed Since Last Report)

 

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities Registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol   Name of each exchange on which registered
Common Stock, $0.0001 par value   SRNE   The Nasdaq Stock Market LLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company ¨

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

 

 

 

 

 

 

Item 7.01. Regulation FD Disclosure.

 

On June 19, 2019, Sorrento Therapeutics, Inc. (“Sorrento”) issued a press release providing updates regarding its CD38 immunotherapies. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.

 

On June 19, 2019, Sorrento issued a press release announcing certain results from its Phase 1b clinical trial of resiniferatoxin (RTX) in knee osteoarthritis pain. A copy of the press release is furnished as Exhibit 99.2 to this Current Report on Form 8-K and incorporated herein by reference.

 

The information contained in this Item 7.01 and Exhibits 99.1 and 99.2 hereto are being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any registration statement or other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference to such filing.

 

Item 8.01 Other Information.

 

On June 19, 2019, Sorrento posted under the “Investors” section of Sorrento’s website at www.sorrentotherapeutics.com a corporate presentation regarding its CD38 immunotherapies. Representatives of Sorrento will use the presentation in industry conferences, investor conferences and investor meetings from time to time. A copy of the presentation is filed as Exhibit 99.3 to this Current Report on Form 8-K and incorporated herein by reference.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibit.

 

99.1 Press Release (CD38 Immunotherapies), dated June 19, 2019.
99.2 Press Release (RTX), dated June 19, 2019.
99.3 CD38 Immunotherapies Corporate Presentation.

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  SORRENTO THERAPEUTICS, INC.
     
Date:  June 19, 2019 By: /s/ Henry Ji, Ph.D.
    Name: Henry Ji, Ph.D.
    Title: President and Chief Executive Officer

 

 

 

Exhibit 99.1

 

 

FOR IMMEDIATE RELEASE
June 19th, 2019

Sorrento PROVIDEs updates ON CD38 IMMUNOTHERApiEs and implementation of disruptive GMP manufacturing for “Off-the-shelf” cell therapy

 

·“CD38 Therapeutics” Business Unit formed to focus on development of CD38-directed immunotherapies for potential out-licensing, collaboration and/or other strategic considerations

 

oClinical “Proof-of-Concept” CD38 CAR-T Phase 1 trial progressing and to be concluded in 2019

 

oNext-Gen “Off-the-Shelf” CD38 Dimeric Antigen Receptor (“DAR”)-T cell therapy with IND submission targeted for second half of 2019

 

oCD38 Antibody-Drug Conjugate (“ADC”) IND to be submitted in Q4 2019

 

oCD38-directed immunotherapies demonstrate potent cytotoxicity in preclinical models and against Daratumumab-resistant multiple myeloma patients’ tumor cells in vitro

 

·State-of-the-Art cGMP Facility in San Diego fully operational with manufacturing capacity for thousands of allogeneic cell therapy doses per year thus, drastically reducing treatment cost

 

SAN DIEGO, June 19th, 2019/GlobeNewswire/ — Sorrento Therapeutics, Inc. (NASDAQ: SRNE, "Sorrento") announces today that its Chairman and CEO, Dr. Henry Ji will be discussing the progress made, including innovative higher potency Dimeric Antigen Receptor (“DAR”) technology and allogeneic knock-out/knock-in (“KOKI”) cell therapy manufacturing advances related to its CD38 immunotherapies at upcoming industry conferences, investor conferences and investor meetings. The reference presentation in support of those update discussions has been uploaded to the Sorrento investor relations website and was filed today with the Securities and Exchange Commission (“SEC”) on a Current Report on Form 8-K.

 

Key progress update areas that will be discussed include:

 

Clinical Proof-of-concept Study for Anti-CD38 Autologous CAR-T Cell Therapy

 

The Sorrento suite of anti-CD38 immunotherapies is based on a fully human anti-CD38 antibody mined from the Sorrento G-MAB antibody library. This antibody has demonstrated unique functional binding properties, which make it a promising candidate for therapeutic applications.

 

Dr. Evren Alici’s research team at the Karolinska Institutet and Hospital in Stockholm, Sweden, has generated preclinical data demonstrating that this anti-CD38 antibody can be effectively used in chimeric antigen receptors (“CAR-T”) and antibody-drug conjugates (“ADC”) retaining its anti-tumor activity against multiple myeloma cells obtained from patients who had previously failed anti-CD38 therapy with daratumumab (Darzalex®).

 

 

 

 

The current anti-CD38 CAR construct has also enabled successful manufacturing of autologous CAR-T cells using retrovirus-based cGMP manufacturing processes. The CAR-T cells obtained in this traditional approach have been successfully administered to multiple myeloma patients. Patient recruitment is currently ongoing at two clinical sites and additional sites will be opened in the second half of 2019.

 

“Our CD38 CAR-T program remains an active clinical stage trial with relapsed or refractory multiple myeloma (“RRMM”) patients being dosed and recruitment proceeding as expected. We are particularly proud of our production site at Sorrento in San Diego producing the clinical CD38-CAR-T cells used in our study,” stated Dr. Jerome Zeldis, Chief Medical Officer of Sorrento. “Given the high level of interest in our program, we look forward to publicly discussing our study data later this year.”

 

Next-Generation Anti-CD38 Non-viral KOKI Allogeneic DAR-T Cell Therapy

 

The key components/steps of current state-of-the-art CAR-T cell therapy programs are: a) CAR architecture; b) viral-based transduction of the CAR construct into the T cells; and c) using the patients as their own source for these autologous T cells. Sorrento has developed disruptive next-gen technology platforms to address each of these components/steps. The research and development team at Sorrento has pioneered an allogeneic (“off-the-shelf”) cell therapy technology (KOKI DAR-T) that utilizes healthy donor T cells and genetically (“non-virally”) modifies them with a novel DAR construct (see the public presentation accompanying this press release).

 

Our proprietary design of the dimeric antigen receptor (“DAR”) is based on utilizing the complete antigen-binding fragment (Fab) of the parental antibody. It is generally accepted that Fabs more closely mimic the functional and biophysical properties of natural antibodies. Utilizing the same antibody binding domain sequence, we have compared CAR constructs to their corresponding DAR constructs. Our data showed that the DAR-T cells exhibited a higher cytotoxicity against target-expressing tumor cells as compared to CAR-T cells. In preclinical mouse models, the DAR-T cells demonstrated increased anti-tumor potency as well.

 

Our non-viral KOKI technology may offer several potential benefits over existing virus-based technology, such as transgene-encoding lentiviruses or retrovirus, to introduce antigen receptor constructs into pre-screened healthy donor (allogeneic) T cells. These potential advantages of our non-viral KOKI technology include: a) site-specific integration of transgenes into a pre-selected locus in the T cell genome; b) enhanced clonal expansion of the DAR-T cells; and c) streamlined method for transgene construct production without need for laborious and time-consuming virus production, release and validation processes, resulting in a shorter research and development timelines for IND-enabling activities.

 

Another major drawback of current CAR-T therapy is the reliance on patients’ own T cells (autologous therapy). This leads to delays in treatment (vein-to-vein time of several weeks) and substantial manufacturing costs due to the individual processing of each patient sample. By utilizing healthy donor T cells as the starting point in our KOKI DAR-T cell technology these concerns can be effectively addressed.

 

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Sorrento has developed a robust manufacturing process in which these donor-derived KOKI DAR-T cells are expanded and purified resulting in the production of hundreds of KOKI allogeneic DAR-T cell doses per manufacturing run from a single healthy donor in about 2 weeks. This has the potential to substantially reduce cost of goods sold (“COGS”) and expand access to cell therapy to patients. This KOKI DAR-T manufacturing process will enable Sorrento with its current manufacturing staff to produce in its existing San Diego cGMP facilities the non-viral CD38 DAR-T cells for “off-the-shelf” treatments for thousands of cancer patients per year. Notably, allogeneic cell therapies will enable the execution of global trials and potential commercialization as the shipping logistics and distribution will be simplified. In addition, certain countries’ restrictions on patient cell shipping and processing currently hampering CAR-T cell therapy studies will not prevent patients from receiving KOKI DAR-T cell treatments.

 

“Our first clinical program will be KOKI allogeneic CD38 DAR-T cell therapy. Preclinical data and clinical trial designs will be shared and discussed with the clinical and scientific community as well as investors once the IND has been accepted and the clinical study initiated”, said Dr. Henry Ji, Chairman and CEO of Sorrento. “We are currently applying our KOKI allogeneic DAR technology to our cell therapy program pipeline for multiple hematological and solid tumor indications, including: multiple myeloma, lymphoma, liver cancer, sarcoma, pancreatic cancer and glioma.”

 

Anti-CD38 Antibody-Drug Conjugate STI-6129

 

In keeping with off-the-shelf immunotherapy strategy, Sorrento is developing STI-6129 (or LNDS1001 for China), an anti-CD38 ADC, for which we plan the IND submission in the second half of 2019. Preclinical studies have demonstrated strong anti-tumor activity. Notably, the toxin payload of the ADC is based on our proprietary tubulin inhibitor Duostatin5. The required toxicology studies of the ADC showed a promising safety profile. The manufacturing of the GMP drug substance of the ADC was successfully completed at our facility in Suzhou, China. The clinical drug product will be manufactured at Bioserv, our wholly-owned San Diego-based fill/finish service provider. We anticipate initiation of clinical studies in hematological malignancies and potentially non-oncology indications by the end of 2019.

 

“In total, all of our anti-CD38 immunotherapies have been discovered, developed and manufactured in-house by our outstanding R&D and manufacturing team members. This demonstrates the unique and efficient “turn-key” approach as we are able to perform with our immunotherapy R&D teams utilizing internal expertise and capabilities without being dependent on external service providers,” said Dr. Henry Ji, Chairman and CEO of Sorrento. “We believe that this anti-CD38 therapy suite illustrates the depth and breadth of the disruptive technology platforms we have to attack diseases with high unmet medical need from different angles. Each modality has its unique strengths but when properly sequenced in the clinic by our outstanding clinical development team, we believe substantial benefit potential can be provided to patients, their caretakers and the medical community. We see our CD38 Therapeutics business unit as a model for our vision and will apply this approach to a variety of therapeutic targets, including CD19, BCMA, and CEA.”

 

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About Sorrento Therapeutics, Inc. 

 

Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to turn malignant cancers into manageable and possibly curable diseases. Sorrento's multimodal multipronged approach to fighting cancer is made possible by its extensive array of immuno-oncology platforms, including key assets such as fully human antibodies (“G-MAB library”), clinical-stage immuno-cellular therapies (“CAR-T”), antibody-drug conjugates (“ADC”), and clinical-stage oncolytic virus (“Seprehvir®”). 

 

Sorrento's commitment to life-enhancing therapies for cancer patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule in Resiniferatoxin (“RTX”) and ZTlido®. Resiniferatoxin is completing a Phase 1b trial in terminal cancer patients. ZTlido was approved by US FDA on 02/28/18.

 

For more information visit www.sorrentotherapeutics.com

 

Forward-Looking Statements

 

This press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Sorrento Therapeutics, Inc., under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding the expectations for Sorrento's and its subsidiaries' technologies and product candidates, including the Company’s anti-CD38 cell therapy and CAR, CAR-T, DAR-T and KOKI DAR-T programs and drug products, expected timing for clinical studies and trials and the timing for submitting an IND. Risks and uncertainties that could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: risks related to Sorrento's and its subsidiaries' technologies and prospects, including Sorrento’s anti-CD38 cell therapy and CAR, CAR-T, DAR-T and KOKI DAR-T programs and drug products; risks related to seeking regulatory approvals and conducting clinical trials; and other risks that are described in Sorrento's most recent periodic reports filed with the Securities and Exchange Commission, including Sorrento's Annual Report on Form 10-K for the year ended December 31, 2018, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release except as required by law.

 

# # #

 

Media and Investor Relations

 

Contact: Alexis Nahama, SVP Corporate Development

 

Telephone: 1.858.203.4120

 

Email: mediarelations@sorrentotherapeutics.com

 

# # #

 

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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 Sorrento Therapeutics, Inc.

 

All other trademarks are the property of their respective owners.

 

© 2019 Sorrento Therapeutics, Inc. All Rights Reserved.

 

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Exhibit 99.2

 

 
FOR IMMEDIATE RELEASE
June 19th, 2019

 

sorrento therapeutics UPDATES POSITIVE results of phase 1b RESINIFERATOXIN (rtx) in knee osteoarthritis pain trial

 

·Forty five patients were treated with escalating doses of RTX in the Phase 1b trial to date. Thirty seven patients received RTX and eight patients received saline (pooled as placebo group).
·Most adverse events associated with RTX administration were expected and included pain, hypertension and tachycardia. These events were moderate and resolved in less than a day.
·At the time of update, thirty patients were assessed at day 84 (trial end-point). All dose groups had treatment effect size traditionally considered sufficient for approval by Regulators.
·Further analysis comparing RTX to saline response highlights persistent effect beyond day 84.
·Two dose levels will be further expanded to confirm the final dose for upcoming Phase 3 studies.

 

SAN DIEGO, June 19th, 2019 /GlobeNewswire/ — Sorrento Therapeutics, Inc. (NASDAQ: SRNE, "Sorrento") announced that the Phase 1b study currently in progress has generated positive data and met the day 84 goals set for the resiniferatoxin (RTX) program to advance the investigational drug product into Phase 3 clinical trials.

 

This Phase 1b is a double-blinded, placebo controlled study to assess the safety and preliminary efficacy of intra-articular administration of resiniferatoxin or saline control (as placebo group) for the treatment of moderate to severe pain due to osteoarthritis of the knee. More information can be found at www.clinicaltrials.gov (NCT03542838).

 

Safety Outcomes

 

No dose limiting toxicities were encountered at any dose level studied. Treatment-emergent adverse events (TEAEs) were expected based on the mechanism of action of the drug and included post-injection pain, tachycardia and hypertension; all of which resolved in less than a day.

 

Patients also received standard pre-emptive opiate sedation in anticipation of any procedure related discomfort. Additional treatment cohorts are being recruited, to assess non-opiate pain management methods and fine-tune the ease of drug administration to increase patient comfort, while aiming to limit exposure to opioids.

 

More information related to safety outcomes and observed TEAEs will be communicated at an upcoming conference or through publication at the study conclusion.

 

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Efficacy Outcomes

 

At the time of this update, thirty patients were unblinded at day 84 (trial end-point).

 

The magnitude of the difference in the treatment effect versus saline control (as placebo) at 12 weeks exceeded what is traditionally considered sufficient to support regulatory approval based on either greater than 2 points reduction in WOMAC A1 10-point scale question “pain at walking on flat surface” or greater than 1 point reduction in Numeric Pain Rating Scale (NPRS) using the mixed model for repeated measures (MMRM) analysis (considered a clinically significant pain reduction).

 

In the best performing RTX dose cohort, the WOMAC A1 score at day 84 showed an average of 5.7 points reduction relative to baseline for RTX, and 3.3 points reduction relative to the saline control (as placebo). The difference in the weekly average of the NPRS pain score between control and RTX treated patients using the MMRM analysis was minus 1.0 point at week 4, minus 1.3 at week 8 and minus 1.7 points at week 12, showing a trend towards persistence and strengthening effect size over time.

 

Fast relief (in less than a week) and durability of the effect (over 84 days) confirm the clinical potential of the drug for long-term control of pain associated with osteoarthritis of the knee.

 

The study was designed to follow patients to day 84. Patients were given the option to be followed for a longer period of time. Five RTX treated patients who were evaluated at day 168 showed persistent pain relief. Despite the small number, the observation for these patients suggests treatment persistence: 3 out of 5 reported pain scores of 0 (no pain) from their baseline score of 5 to 8 points, the 4th patient reported a 2 point decrease from baseline, the 5th patient reported a 5 point decrease from baseline (see Table 1).

 

Two doses have been identified as candidates for the pivotal Phase 3 program based on the adverse event profile, magnitude and durability of treatment effect relative to control. In the upcoming months additional patients will be enrolled to confirm which dose will move forward to Phase 3 trials.

 

The two pivotal Phase 3 trials are in advanced planning, with an anticipated first patient enrollment target date in early 2020. Each trial is expected to enroll about 400 patients. The pivotal program will enroll patients from the US and Asia-Pacific. Additional trials will be considered for expanded global registrations, safety exposure and post-approval needs.

 

“Our teams have done an amazing job taking this drug from preclinical IND enabling to pivotal registration trials in less than 2 years. Because of the investigators’ enthusiasm we have experienced for this groundbreaking non-opioid pain therapy in our initial trial, we expect the Phase 3 studies to move very quickly” stated Dr. Henry Ji, Chairman and CEO for Sorrento Therapeutics. “We want to be cautiously optimistic, as we are dealing with a small number of patients so far, but what we see is extremely promising. As we continue on this track, and provided all goes according to plan, RTX has the potential to be on the market by 2022. This is a very ambitious goal that I personally believe is achievable given the quality of the team leading the effort and the performance of the drug so far.”

 

More information related to the efficacy outcomes observed will be communicated at an upcoming conference or through publication at the study conclusion.

 

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Table 1: WOMAC Question A1 “pain at walking” score (0: no pain, 10: worst possible pain) in patients at day 168 post-RTX treatment (partial data from 5 patients with reported pain scores past D84)

 

Patient  Pain Day 0
(score/10)
   Pain Day 84
(score/10)
   Pain Day 168
(score/10)
 
001   5    0    3 
002   8    2    0 
003   5    1    0 
004   7    0    0 
005   7    1    2 

 

About Resiniferatoxin (RTX)

 

A thousand times “hotter” than pure capsaicin (16 Billion Scoville units versus 16M), and with a high affinity for afferent sensory pain nerves, resiniferatoxin binds to TRPV1 receptors present and selectively ablates the nerve endings responsible for pain signals experienced by patients1. Delivered peripherally (into the joint space) the transient nerve ending ablation effect can have profound clinical benefits lasting for months to years (as shown in canine studies2).

 

PTVA-OA-001 is a multicenter, placebo-controlled phase 1b study to assess the safety and define the maximally tolerated dose of resiniferatoxin administered in the knee joint in patients with moderate to severe pain associated with osteoarthritis of the knee. The study is a dose-escalation trial in which cohorts of patients receive increasing doses of resiniferatoxin until the maximum tolerated dose (MTD) is achieved. The primary objective of the study is to evaluate the safety of resiniferatoxin and identify the recommended Phase 3 dose. The secondary objective is to assess the preliminary efficacy of resiniferatoxin measured by assessing changes in the intensity of pain using the A1 score from the WOMAC, a widely used proprietary validated pain questionnaire.

 

Resiniferatoxin is not approved by regulatory authorities. Safety and efficacy have not been established.

 

More information on this trial can be found at www.clinicaltrials.gov (NCT03542838).

 

About Sorrento Therapeutics, Inc. 

 

Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to turn malignant cancers into manageable and possibly curable diseases. Sorrento's multimodal multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as fully human antibodies (“G-MAB™ library”), clinical stage immuno-cellular therapies (“CAR-T”), intracellular targeting antibodies (“iTAbs”), antibody-drug conjugates (“ADC”), and clinical stage oncolytic virus (“Seprehvir®”). 

 

 

 

1 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC398431/

2 Sorrento Therapeutics (Ark Animal Health) internal data (on file)

 

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Sorrento's commitment to life-enhancing therapies for patients is also demonstrated by its effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule, resiniferatoxin (“RTX”), and ZTlido® (lidocaine topical system) 1.8% for the treatment of post-herpetic neuralgia. Resiniferatoxin is completing a phase IB trial in terminal cancer patients and a phase 1B trial in osteoarthritis patients. ZTlido® was approved by the FDA on February 28, 2018.

 

For more information visit www.sorrentotherapeutics.com

 

Forward-Looking Statements

 

This press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Sorrento Therapeutics, Inc., under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding the expectations for Sorrento's and its subsidiaries' technologies and product candidates, including, but, not limited to, resiniferatoxin (RTX) and potential clinical trials and costs associated with those trials, target enrollment dates and the expected timing of RTX being available on the market. Risks and uncertainties that could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: risks related to Sorrento's and its subsidiaries' technologies and prospects, including, but not limited to, RTX; risks related to seeking regulatory approvals and conducting and obtaining results of clinical trials, including, but not limited to, the PTVA-OA-001 study or trial and any prior RTX studies in animals; costs associated with RTX clinical trials, the clinical and commercial success of RTX; the viability and success of using RTX for treatments in certain therapeutic areas, including osteoarthritis (OA) and other risks that are described in Sorrento's most recent periodic reports filed with the Securities and Exchange Commission, including Sorrento's Annual Report on Form 10-K for the year ended December 31, 2018, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release except as required by law.

 

# # #

 

Media and Investor Relations

 

Contact: Alexis Nahama, SVP Corporate Development and Head of the RTX Program.

 

Telephone: 1.858.203.4120

 

Email: mediarelations@sorrentotherapeutics.com

 

# # #

 

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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 Sorrento Therapeutics, Inc. All other trademarks are the property of their respective owners.

 

© 2019 Sorrento Therapeutics, Inc. All Rights Reserved.

 

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Exhibit 99.3

 

CD38 Immunotherapies June 2019 NON - CONFIDENTIAL

   

 

Disclaimer Certain statements contained in this presentation or in other documents of Sorrento Therapeutics, Inc . (the “Company” or “Sorrento”) and of any of its affiliates, along with certain statements that may be made by management of the Company orally in presenting this material are, or may be considered, forward - looking statements” as defined in the Private Securities Litigation Reform Act of 1995 . These statements can be identified by the fact that they do not relate strictly to historic or current facts . They use words such as "expect," "intend," "believe," "plan," "anticipate," “potential”, “projected” and other words and terms of similar meaning in connection with any discussion of future operating or performance or condition . These statements are based upon the current beliefs and expectations of Sorrento’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 Sorrento’s formulations and products and regulatory filings related to the same, may differ from those set forth in the forward - looking statements . Sorrento assumes no obligation to update forward - looking statements as circumstances change . Investors are advised to consult further disclosures that Sorrento makes or has made on related subjects in the Company’s 2018 Annual Report Form 10 - K, which has been filed with the Securities and Exchange Commission (“SEC”) . 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 some of these factors in its SEC filings on Forms 10 - K, 10 - Q and 8 - K, and investors are advised to consult the Company’s filings for a more complete listing 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 . 2 2 © 2019 Sorrento Therapeutics, Inc. All Rights Reserved. NON - CONFIDENTIAL. Do not copy, distribute, or reproduce without express permission. CD38 Immunotherapies – June 2019

   

 

CD38 Immunotherapies 3 3 © 2019 Sorrento Therapeutics, Inc. All Rights Reserved. NON - CONFIDENTIAL. Do not copy, distribute, or reproduce without express permission. CD38 Immunotherapies – June 2019

   

 

CD38 Biology Background › CD38 is a single chain type II transmembrane glycoprotein (45kDa) › CD38 is detectable at low levels in mature lymphocytes or in non - hematopoietic tissues › Highly and ubiquitously expressed on Multiple Myeloma (MM) cells and overexpressed by the majority of Acute Lymphoblastic Leukemia (ALL) as well as on some cases of Acute Myeloid Leukemia (AML) and Non - Hodgkin Lymphoma (NHL) › Daratumumab ( Darzalex ®) is a CD38 - directed cytolytic antibody with anti - myeloma activity and approved for MM indication 4 4 © 2019 Sorrento Therapeutics, Inc. All Rights Reserved. NON - CONFIDENTIAL. Do not copy, distribute, or reproduce without express permission. CD38 Immunotherapies – June 2019

   

 

CD38 Therapeutics Business Unit - Immunotherapy Pipeline › The Business Unit focuses on the development of a CD38 - directed product suite with potential out - licensing, collaboration and/or other strategic considerations › CD38 CAR - T: Phase 1 Clinical Trial – Ongoing › Next - gen CD38 DAR - T Cells are more potent than CD38 CAR - T Cells in preclinical models o “Off - the - Shelf” (allogeneic) centralized scalable manufacturing process o Simplified distribution logistics for immediate infusion o Enabling global clinical trials and commercialization › CD38 ADC has demonstrated strong activity in preclinical models and has completed IND - enabling tox studies › CD38/CD3 BsAb showed potent cytotoxicity in both in vitro and in vivo studies Research IND - enabling Projected IND Phase 1 Phase 2 CAR - T (autologous) ADC H2 2019 DAR - T (allogeneic) H2 2019 CD38/CD3 BsAb H1 2020 5 5 © 2019 Sorrento Therapeutics, Inc. All Rights Reserved. NON - CONFIDENTIAL. Do not copy, distribute, or reproduce without express permission. CD38 Immunotherapies – June 2019

   

 

Anti - CD38 mAb A2 6 6 © 2019 Sorrento Therapeutics, Inc. All Rights Reserved. NON - CONFIDENTIAL. Do not copy, distribute, or reproduce without express permission. CD38 Immunotherapies – June 2019

   

 

CD38 Monoclonal Antibody A2 Possesses Unique CD38 - binding Properties › The anti - CD38 mAb A2 mAb is a fully human antibody selected from our GMAB™ library › CD38A2 and Daratumumab have nanomolar affinities for the CD38 protein › CD38A2 exhibits fast - on/fast - off binding kinetics o Most likely contributing to binding preference against high - expressing CD38 - positive cells, for example myeloma cells › CD38A2 binds to an epitope on the CD38 protein distinct from Daratumumab o A2 is cross - reactive with cynomolgus CD38 while Daratumumab is not o A2 does not inhibit CD38 enzyme function while Daratumumab does o The epitope recognized by A2 is membrane - proximal 7 7 © 2019 Sorrento Therapeutics, Inc. All Rights Reserved. NON - CONFIDENTIAL. Do not copy, distribute, or reproduce without express permission. CD38 Immunotherapies – June 2019

   

 

CD38A2 - based immunotherapies are active against Daratumumab - resistant MM patient tumor cells 8 8 © 2019 Sorrento Therapeutics, Inc. All Rights Reserved. NON - CONFIDENTIAL. Do not copy, distribute, or reproduce without express permission. CD38 Immunotherapies – June 2019

   

 

CD38A2 Immunotherapies are Active Against Dara - refractory MM Patient Tumor Cells Patients: › Cells from 3 Dara - sensitive MM patients were tested › Cells from 6 Dara - resistant MM patients were tested › All patients were MM patients that received Daratumumab 16 mg subcutaneously at least 8 times Studies performed by Dr. Evren Alici (Karolinska Institute/Hospital) 9 9 © 2019 Sorrento Therapeutics, Inc. All Rights Reserved. NON - CONFIDENTIAL. Do not copy, distribute, or reproduce without express permission. CD38 Immunotherapies – June 2019

   

 

Determination of Daratumumab - Responsiveness in MM Patients › Daratumumab resistance was assessed at the end of 8 cycles of treatment. › M - component relative changes in the patients included in the CD38 immunotherapy in vitro experiments are shown. Dara - resistant #1 #2 #4 #5 #6 #3 Patient 10 10 © 2019 Sorrento Therapeutics, Inc. All Rights Reserved. NON - CONFIDENTIAL. Do not copy, distribute, or reproduce without express permission. CD38 Immunotherapies – June 2019

   

 

CD38 - ADCs and Daratumumab Exert Cytotoxicity against Tumor Cells from Dara - Responsive MM Patients › Primary MM cells MACS separated and frozen (5x10e6 cells) › Thawed 6 patients CD138+ fractions o 5 patient samples could be evaluated › Dara samples cultured with 2x10e5 PBMCs (E:T ratio 10) for 24 hours from Day 5 › Each line representing an individual patient sample 11 11 © 2019 Sorrento Therapeutics, Inc. All Rights Reserved. NON - CONFIDENTIAL. Do not copy, distribute, or reproduce without express permission. CD38 Immunotherapies – June 2019

   

 

CD38 - ADCs Exert Cytotoxicity against Tumor Cells from Dara - Resistant MM Patients • Primary MM cells MACS separated and frozen (5x10 e6 cells) • Thawed 6 patients CD138+ fractions • 4 patient samples could be evaluated • Dara samples cultured with 2X10 e5 PBMCs (E:T ratio 10) from Day 5 • Each line representing an individual patient sample 12 12 © 2019 Sorrento Therapeutics, Inc. All Rights Reserved. NON - CONFIDENTIAL. Do not copy, distribute, or reproduce without express permission. CD38 Immunotherapies – June 2019

   

 

CD38 - CAR - T 13 13 © 2019 Sorrento Therapeutics, Inc. All Rights Reserved. NON - CONFIDENTIAL. Do not copy, distribute, or reproduce without express permission. CD38 Immunotherapies – June 2019

   

 

Dose - Dependent In Vivo Anti - Tumor Efficacy of CD38 CAR - T Cells in Multiple Myeloma Model 14 14 © 2019 Sorrento Therapeutics, Inc. All Rights Reserved. NON - CONFIDENTIAL. Do not copy, distribute, or reproduce without express permission. CD38 Immunotherapies – June 2019

   

 

CD38 CAR - T: Phase 1 Clinical Trial - Ongoing › Patients dosed at two US Clinical Sites o Currently continuing enrollment o Additional clinical sites will be activated soon › Manufacturing successfully performed at our CAR - T cGMP facility in San Diego, CA 15 15 © 2019 Sorrento Therapeutics, Inc. All Rights Reserved. NON - CONFIDENTIAL. Do not copy, distribute, or reproduce without express permission. CD38 Immunotherapies – June 2019

   

 

Next - Gen Anti - CD38 KOKI DAR - T 16 16 © 2019 Sorrento Therapeutics, Inc. All Rights Reserved. NON - CONFIDENTIAL. Do not copy, distribute, or reproduce without express permission. CD38 Immunotherapies – June 2019

   

 

From CAR to DAR TM scFv Fab TM Chimeric Antigen Receptor (CAR) scFv - based Dimeric Antigen Receptor (DAR) Fab - based linker Hinge Disulfide bond 17 17 © 2019 Sorrento Therapeutics, Inc. All Rights Reserved. NON - CONFIDENTIAL. Do not copy, distribute, or reproduce without express permission. CD38 Immunotherapies – June 2019

   

 

At Lower Dose (4x10e6 Cells), CD38 DAR - T Cells are more Potent than CD38 CAR - T Cells 18 18 © 2019 Sorrento Therapeutics, Inc. All Rights Reserved. NON - CONFIDENTIAL. Do not copy, distribute, or reproduce without express permission. CD38 Immunotherapies – June 2019

   

 

Illustrative/Potential Comparison of DAR - T Cell and CAT - T Cell cGMP Manufacturing Processes Autologous CAR - T Cell Manufacturing Allogeneic DAR - T Cell Manufacturing 19 19 © 2019 Sorrento Therapeutics, Inc. All Rights Reserved. NON - CONFIDENTIAL. Do not copy, distribute, or reproduce without express permission. CD38 Immunotherapies – June 2019

   

 

Evolution of the Platform from Auto - CAR - T to Allo - DAR - T (drug) Targeting CD38 Clinical Proof - of - Concept CD38 CAR - T Potential Product KOKI CD38 DAR - T Advantages of DAR - T over CAR - T Chimeric Antigen Receptor (CAR) Dimeric Antigen Receptor (DAR) Increased potency Proprietary construct Virally transduced Gene edited Faster development Enhanced clonal expansion Autologous (patients’ own T cells) Allogeneic (healthy donor T cells) “Off - the - Shelf” Centralized scalable manufacturing process Vein - to - vein time (up to 1 month) Pre - manufactured and released DAR - T Cells (dosing upon completion of screening) Simplified distribution logistics On - Demand for immediate infusion Enabling global clinical trials and commercialization 20 20 © 2019 Sorrento Therapeutics, Inc. All Rights Reserved. NON - CONFIDENTIAL. Do not copy, distribute, or reproduce without express permission. CD38 Immunotherapies – June 2019

   

 

Anti - CD38 ADC 21 21 © 2019 Sorrento Therapeutics, Inc. All Rights Reserved. NON - CONFIDENTIAL. Do not copy, distribute, or reproduce without express permission. CD38 Immunotherapies – June 2019

   

 

Anti - CD38 ADC › Product candidate: CD38 - 077 ADC o IND filing: H2 2019 › Antibody (CD38 A2): Identified from Sorrento Therapeutics fully human G - MAB™ library (IgG1) › Payload: Duostatin - 5. Proprietary microtubule inhibitor. Patent application filed › Duostatin - 5 has been used for other partner ADC programs and successfully filed US IND › Conjugation: C - LOCK. Inter - chain Cysteine site - specific conjugation. ▪ Stable covalent, irreversible linker ▪ Re - introduce S - S linkage, better stability ▪ Improved PK Profile ▪ Process fully enable ▪ Platform patent granted 22 22 © 2019 Sorrento Therapeutics, Inc. All Rights Reserved. NON - CONFIDENTIAL. Do not copy, distribute, or reproduce without express permission. CD38 Immunotherapies – June 2019

   

 

CD38A2 - 077 ADC Exerts Strong Anti - tumor Activity in Myeloma Mouse Model 23 23 © 2019 Sorrento Therapeutics, Inc. All Rights Reserved. NON - CONFIDENTIAL. Do not copy, distribute, or reproduce without express permission. CD38 Immunotherapies – June 2019

   

 

CD38/CD3 Bispecific Antibody 24 24 © 2019 Sorrento Therapeutics, Inc. All Rights Reserved. NON - CONFIDENTIAL. Do not copy, distribute, or reproduce without express permission. CD38 Immunotherapies – June 2019

   

 

CD38/CD3 BsAb Mediates CD38 - dependent Cytotoxicity with Sub - nanomolar Potency in vitro › CD38A2/CD3 BsAb shows potent CD38 - dependent tumor cell killing compared to non - specific BsAb control and parental mAb co - administration CD38/CD3 BsAb control BsAb CD38 IgG + CD3 IgG 25 25 © 2019 Sorrento Therapeutics, Inc. All Rights Reserved. NON - CONFIDENTIAL. Do not copy, distribute, or reproduce without express permission. CD38 Immunotherapies – June 2019

   

 

Pilot In vivo Study: Head - to - head Comparison of CD38/CD3 BsAb and CD38 DAR - T Cell Therapy 2 doses of CD38/CD3 BsAb + T cells show potent anti - tumor activity – comparable to 1 dose of CD38 T cell therapy Dose 1 1 µg BsAb + 10 6 T cells/mouse or 10 6 DAR - T cells/mouse Dose 2 1 µg BsAb + 10 6 T cells/mouse 26 26 © 2019 Sorrento Therapeutics, Inc. All Rights Reserved. NON - CONFIDENTIAL. Do not copy, distribute, or reproduce without express permission. CD38 Immunotherapies – June 2019