Sorrento Therapeutics : Report of unscheduled material events or corporate event

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	(Commission	(IRS Employer
of Incorporation)	File Number)	Identification No.)
	4955 Directors Place
	San Diego, CA 92121
	(Address of Principal Executive Offices) (Zip Code)
	Registrant's telephone number, including area code: [phone]
	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-commencementcommunications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
• Pre-commencementcommunications 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.

1. Press Release (CD38 Immunotherapies), dated June 19, 2019.
2. Press Release (RTX), dated June 19, 2019.
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

• • Clinical "Proof-of-Concept" CD38 CAR-T Phase 1 trial progressing and to be concluded in 2019
  • Next-Gen"Off-the-Shelf" CD38 Dimeric Antigen Receptor ("DAR")-T cell therapy with IND submission targeted for second half of 2019
  • CD38 Antibody-Drug Conjugate ("ADC") IND to be submitted in Q4 2019
  • CD38-directedimmunotherapies demonstrate potent cytotoxicity in preclinical models and against Daratumumab-resistant multiple myeloma patients' tumor cells in vitro
• State-of-the-ArtcGMP 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-GenerationAnti-CD38Non-viral KOKI Allogeneic DAR-T Cell Therapy

The key components/steps of current state-of-the-artCAR-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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