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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): August 9, 2021

 

 

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 8.01 Other Information.

 

On August 9, 2021, Sorrento Therapeutics, Inc. (the “Company”) posted under the “Investors” section of the Company’s website at www.sorrentotherapeutics.com a corporate presentation providing an overview of the Company’s proprietary mRNA vaccine development program for COVID-19 (the “Presentation”). A copy of the Presentation is filed as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.

 

On August 9, 2021, the Company issued a press release announcing that it has posted the Presentation under the “Investors” section of the Company’s website at www.sorrentotherapeutics.com. A copy of the press release is filed herewith as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

        

99.1 Sorrento Therapeutics, Inc. Corporate Presentation Regarding SARS-CoV-2 Vaccine Countermeasures (August 2021)
99.2 Press Release, dated August 9, 2021.
104 Cover Page interactive Data File, formatted in Inline Extensible Business Reporting Language (iXBRL).

 

 

 

 

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:  August 9, 2021 By: /s/ Henry Ji, Ph.D.
    Name: Henry Ji, Ph.D.
    Title: Chairman, President and Chief Executive Officer

 

 

 

 

 

  

SARS - CoV - 2 Vaccine Countermeasures August 20 21 NASDAQ : SRNE © 2021 Sorrento Therapeutics, Inc. All Rights Reserved 1 Exhibit 99.1

 

 

2 © 2021 Sorrento Therapeutics, Inc. All Rights Reserved

 

 

HQ in San Diego, CA ~ 700 Employees worldwide ~100 Employees with PhDs & MDs >5 00,000 SF Research and cGMP Manufacturing Facilities 1 FDA Approved Drug ZTlido ® (lidocaine topical system)1.8% NASDAQ: SRNE 7 cGMP Manufacturing Sites (5 USA, 2 China) mAbs, Small Molecule, ADC, Plasmid DNA, Lymphatic Drug Delivery Device, Cell Therapies, Oncolytic Viruses, and Fill & Finish Multiple Products in Late - Stage Clinical Development for Pain Management, Immune - Oncology and COVID - 19 © 2021 Sorrento Therapeutics, Inc. All Rights Reserved 3

 

 

TARGETING THE EMERGING PANDEMIC STRAINS OF SARS - CoV - 2 4 As new pandemic strains emerge, Sorrento is developing vaccine solutions in response to these changes. • Thermostable Nucleic Acid - based Platforms • Needle - Free Lymphatic Delivery of mRNA - Encoded Spike Antigens Virus mutations identified in emerging strains o Messenger RNA © 2021 Sorrento Therapeutics, Inc. All Rights Reserved

 

 

STI mRNA Vaccine: mRNAs Encode SARS - CoV - 2 Variant Spike Proteins Dead Dead Daniel Wrapp et al. Science 2020;367:1260 - 1263 Spike protein: • the main target for neutralizing antibodies • binds to hACE2 to initiate infection Spike Protein SARS - CoV - 2 Variant of Concern Spike Proteins Spike 3’ UTR 5’ UTR — AAAAAAAA CAP Poly (A) tail S1 S2 Coronavirus mRNA © 2021 Sorrento Therapeutics, Inc. All Rights Reserved TM* *TM: transmembrane domain 5

 

 

Sorrento COVID - 19 mRNA Vaccine Candidate Target Product Profile Room temperature Storage condition Immunogen Sorrento Washington Alpha Gamma Delta Administration Needle - free Lymphatic Drug Delivery (LDD) ( Sofusa ® MuVaxx Ρ ) © 2021 Sorrento Therapeutics, Inc. All Rights Reserved Intramuscular injection or Beta 6

 

 

© 2021 Sorrento Therapeutics, Inc. All Rights Reserved Spike 3’ UTR 5’ UTR — AAAAAAAA C A P mRNA Spike 3’ UTR 5’ UTR — AAAAAAAA C A P Spike 3’ UTR 5’ UTR — AAAAAAAA C A P Spike 3’ UTR 5’ UTR — AAAAAAAA C A P Spike 3’ UTR 5’ UTR — AAAAAAAA C A P DNA Washington Alpha Beta Gamma Delta IVT LNP formulation Needle - Free Lymphatic Drug Delivery (LDD) ( Sofusa ® MuVaxx Ρ ) Intramuscular injection Sorrento MultiValent mRNA Vaccine Production and Administration 7

 

 

Mode of Action of mRNA Coronavirus Vaccine Dead Dead Spike 3’ UTR 5’ UTR — AAAAAAAA CAP CD4 T cell CD8 T cell B cell Antigen Presenting Cell Neutralizing Antibodies Cell Mediated Immunity LNP mRNA Formulation Enters Cell © 2021 Sorrento Therapeutics, Inc. All Rights Reserved 8

 

 

Designer mRNA: Spike Protein Cleavage Site Mutation Increases the Surface Expression of mRNAs © 2021 Sorrento Therapeutics, Inc. All Rights Reserved Washington Alpha Beta Gamma Spike protein antibody Delta RBD S1/S2 cleavage site Mutation S1 S2 Wild - type mRNA Designer Mutant mRNA Cleavage Site mutation designed to allow for increased vaccine safety over use of wild - type mRNA Day 3 after transfection into HEK293T cells TM* *TM: transmembrane domain 9

 

 

Needle - Free Lymphatic Drug Delivery (LDD) ( Sofusa ® MuVaxx Ρ ) Generates Anti - SARS - CoV - 2 Immune Responses at a 1 m g Dose Similar to Those Achieved Following Intramuscular Injection (IM) of 10 m g *Needle - Free Lymphatic Drug Delivery (LDD) ( Sofusa ® MuVaxx Ρ ) © 2021 Sorrento Therapeutics, Inc. All Rights Reserved 10 mRNA Formulated Administered DAY 0 Measured Mouse Serum IgG Competitor IM (10 m g) STI IM (10 m g) STI IM (1 m g) STI LDD* (1 m g) Anti - Spike S1 Antibody Response IM or by MuVaxx in SARS - CoV - 2 Spike S1 ELISA DAY 7 DAY 14

 

 

* STI LNP and STI LNP Lyophilized are different formulations, Same mRNA, different compositions © 2021 Sorrento Therapeutics, Inc. All Rights Reserved In Vivo Comparabililty Study for Lyophilized Spike - mRNA - LNP (IM 1 m g) Day 7 Day 14 10 2 10 3 10 4 10 5 A n t i - S 1 I g G ( n g / m L ) STI LNP STI LNP-Lyophilized 11 mRNA Formulated Administered DAY 0 Measured Mouse Serum IgG IM in SARS - CoV - 2 Spike S1 ELISA DAY 7 DAY 14

 

 

Sorrento Needle - Free Delivery Technology Designed to Maximize Immunization Efficiency Lymphatic vessels Brachial LN (1) Iwasaki et al., “Adaptive Immunity”, BioRender.com, 2020 Lymph nodes are the primary organs for generating adaptive immune responses as dendritic cells activate T and B cells. Thus, del ivering therapeutics directly toward lymph nodes (versus most common method of delivery into muscle tissue or blood) presents an opportunity to potentially im prove current vaccines. Lymph Nodes provide specialized microenvironment in order to orchestrate immune responses © 2021 Sorrento Therapeutics, Inc. All Rights Reserved Sofusa ® MuVaxx TM 12

 

 

Sorrento cGMP mRNA Manufacturing for Clinical Trials and Commercialization • 7 cGMP Manufacturing Sites (5 USA, 2 China) • Unique process utilizing automation to ensure consistent repeatability, quality control and on - demand manufacturing © 2021 Sorrento Therapeutics, Inc. All Rights Reserved 13

 

 

Sorrento mRNA Vaccine Solutions • Sofusa ® MuVaxx Ρ platform is designed to improve immune responses following COVID vaccines vs. subcutaneous and intradermal injections. • Established micro - fabrication and large - scale DNA and mRNA GMP manufacturing in place to supply COVID - 19 vaccine campaigns © 2021 Sorrento Therapeutics, Inc. All Rights Reserved • Potential for hundreds of millions of vaccine doses to be delivered to underserved populations without the need for frozen temperature storage and transportation • Sorrento has developed an innovative SARS - CoV - 2 vaccine strategy to address the current global public health demand 14

 

 

Exhibit 99.2

 

 

FOR IMMEDIATE RELEASE

 

August 9, 2021

 

Sorrento unveils overview oF its multivalent mRNA covid-19 vaccine development program

 

SAN DIEGO, August 9, 2021 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento"), a clinical and commercial stage biopharmaceutical company developing new therapies to treat cancer, pain and COVID-19, announced today the availability of a presentation on its corporate website to provide an overview of Sorrento’s proprietary mRNA vaccine development program for COVID-19.

 

Highlights of the presentation include:

 

·MultiValent COVID Vaccine candidate comprised of proprietary designer Spike-encoding mRNAs designed to elicit cellular and humoral immunity against the early WA-1 virus as well as the predominant variants of concern (VOCs), Alpha, Beta, Gamma, Delta, and Lambda.

  

· mRNA construct engineered to remove a furin cleavage site in the native spike protein. This cleavage site could potentially lead to spike protein being cleaved off the cells expressing the protein and then entering the circulation.

  

·Thermostable mRNA lipid nanoparticle (LNP) formulation that potentially allows for provision of vaccine doses without the need for frozen storage after time of manufacture during transport and prior to dose administration.

  

·Development of equipotent lyophilized dose forms that may further enhance the potential for vaccine delivery to underserved populations due to cold-chain storage and transportation issues.

  

·Micro-epidermal infusion patch device potentially elicits a superior immune response thought to be due to the direct lymphatic dose delivery. MultiValent COVID Vaccine administered via Sorrento’s proprietary Sofusa® MuVaxx™ system achieved equivalent serum IgG responses at one tenth of the dose compared to intramuscular administration in mice based on preclinical studies.

 

The presentation can be viewed at: https://investors.sorrentotherapeutics.com/events-and-presentations/presentations

 

 

 

 

About Sorrento Therapeutics, Inc.

 

Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to treat cancers and COVID-19. 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”, “DAR-T™”), antibody-drug conjugates (“ADCs”), and clinical stage oncolytic virus (“Seprehvir™”). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including COVIGUARD™, COVI-AMG™, COVISHIELD™, Gene-MAb™, COVI-MSC™ and COVIDROPS™; and diagnostic test solutions, including COVITRACK™, COVISTIX™ and COVITRACE™.

 

Sorrento's commitment to life-enhancing therapies for patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule, resiniferatoxin (“RTX”), and SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (SEMDEXA™), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, and to commercialize ZTlido® (lidocaine topical system) 1.8% for the treatment of post-herpetic neuralgia. RTX has completed a Phase IB trial for intractable pain associated with cancer and a Phase 1B trial in osteoarthritis patients. SEMDEXA is in a pivotal Phase 3 trial for the treatment of lumbosacral radicular pain, or sciatica. 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 technologies and product candidates, including, but, not limited to, its MultiValent COVID Vaccine candidate and its potential effectiveness against the WA-1 virus and variants of concern, including the Alpha, Beta, Gamma, Delta and Lambda variants; the potential for Sorrento’s engineered mRNA construct to reduce levels of spike protein in circulation; the potential advantages of the MultiValent COVID Vaccine, including maintaining stability without the need for frozen storage and transportation requirements; the potential for enhancing delivery to underserved populations by developing lyophilized dose forms that eliminate certain storage and transportation limitations; and the potential benefits of administering the MultiValent COVID Vaccine with the Sofusa MuVaxx system, including eliciting a superior immune response and achieving equivalent IgG responses at a lower dose compared to intramuscular administration. 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 technologies and prospects, including, but not limited to risks related to seeking regulatory approval for a MultiValent COVID Vaccine candidate; clinical development risks, including risks in the progress, timing, cost, and results of clinical trials and product development programs; risk of difficulties or delays in obtaining regulatory approvals; risks that clinical study results may not meet any or all endpoints of a clinical study and that any data generated from such studies may not support a regulatory submission or approval; risks that prior test, study and trial results may not be replicated in future studies and trials; risks of manufacturing and supplying drug product; risks related to leveraging the expertise of its employees, subsidiaries, affiliates and partners to assist Sorrento in the execution of its therapeutic antibody product candidate strategies; risks related to the global impact of COVID-19; 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, 2020, 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, DVM (SVP Corporate Development)

Email: mediarelations@sorrentotherapeutics.com

 

# # #

 

Sorrento® and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc.

 

G-MAB™, DAR-T™, SOFUSA™, MuVAXX™, COVIGUARD™, COVI-AMG™, COVISHIELD™, Gene-MAb™, COVIDROPS™, COVI-MSC™, COVITRACK™, COVITRACE™ and COVISTIX™ are trademarks of Sorrento Therapeutics, Inc.

 

SEMDEXA™ is a trademark of Semnur Pharmaceuticals, Inc.

 

ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc.

 

All other trademarks are the property of their respective owners.

 

©2021 Sorrento Therapeutics, Inc. All Rights Reserved.