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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): March 20, 2020

 

 

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 Events.

 

On March 20, 2020, Sorrento Therapeutics, Inc. (the “Company”) issued a press release announcing that it has produced a preclinical batch of STI-4398 (COVIDTRAP™), a proprietary protein that is designed to block the SAR-CoV-2 virus from binding and infecting respiratory epithelial cells. A copy of the press release is filed herewith as Exhibit 99.1 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, dated March 20, 2020.

 

 

 

 

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:  March 20, 2020 By: /s/ Henry Ji, Ph.D.  
    Name: Henry Ji, Ph.D.  
    Title: Chairman of the Board, President and Chief Executive Officer  

 

 

 

 

 

Exhibit 99.1

  

  

FOR IMMEDIATE RELEASE

 

March 20, 2020

  

sorrento DEVELOPs STI-4398 (COVIDtrap™ protein) for POTENTIAL prevention and treatment of Sars-cov-2 CORONAVIRUS disease (COVID-19)

 

·COVIDTRAPTM is a proprietary ACE2-Fc protein that binds to the S1 domain of the spike protein of the SARS-CoV-2 virus;
·COVIDTRAP is designed to block the SARS-CoV-2 virus from binding and infecting respiratory epithelial cells, which is expected to effectively interrupt the viral life cycle;
·COVIDTRAP is engineered with a long half-life to provide prophylactic measures for at-risk populations (healthcare workers) with frequent exposure to the SARS-CoV-2 virus;
·COVIDTRAP preserves the ACE2 enzymatic activity, which is important in maintaining normal blood pressure and healthy blood flow into the infected lung tissues when used in advanced COVID-19 patients; and
·STI-4398 is in the cGMP cell line development stage and could be ready for large-scale production in Sorrento’s cGMP facilities in San Diego for human clinical trials and commercialization upon receipt of requisite regulatory approvals.

 

SAN DIEGO, March 20, 2020 /GlobeNewswire/ -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") announced it has produced a preclinical batch of the STI-4398 (COVIDTRAP) protein to immediately commence testing its neutralization and blocking activity in preventing the SARS-CoV-2 virus from infecting ACE2-expressing cells.

 

STI-4398 is a proprietary ACE2 (angiotensin-converting enzyme 2)-Fc fusion protein (COVIDTRAP). The STI-4398 protein binds to the S1 domain of the spike protein, which is expected to block the spike protein of the SARS-CoV-2 virus to bind the ACE2 receptors present on the target respiratory epithelial cells. Without the ability to penetrate target cells, the SARS-CoV-2 virus cannot replicate and spread itself. By interfering with the viral infection cycle, STI-4398 might be the most effective way to prevent an infection to progress to a fully advanced COVID-19 disease. This approach could be ideal in generating passive immunity and shielding at-risk populations, including healthcare providers, the elderly population or patients with compromised immune systems, from developing the COVID-19 disease after viral exposure.

 

The STI-4398 COVIDTRAP preserves the ACE2 enzyme activity in converting angiotensin II to angiotensin 1-7, resulting in reduced vasoconstriction and increased blood flow to the infected lung tissue. It could potentially confer organ protection and lessen severe acute respiratory distress syndrome in COVID-19 patients. Although STI-4398’s primary functionality is to interfere with the viral infection cycle, the COVIDTRAP protein with active ACE2 enzyme may have therapeutic potential for late-stage COVID-19 disease.

 

 

 

 

STI-4398 has been engineered to have a prolonged half-life in the human blood circulation, which may allow it to be used prophylactically to confer short-term and durable passive immunity (with repeated doses) to those that are regularly exposed to the virus (healthcare workers) or are at particular risk following an exposure event (elderly, patients with hypertension or immune-compromised patients).

 

In vitro cell studies for SARS-CoVID-2 virus infection and neutralization are expected to be conducted in the next few weeks in collaboration with world-leading coronavirus experts.

 

Sorrento scientists are in parallel working speedily to generate a stable CHO (Chinese Hamster Ovary) manufacturing cell line that would enable high-yield cGMP production of the COVIDTRAP fusion protein. Sorrento’s approximately 300,000 square feet of state-of-the-art R&D and cGMP facilities in San Diego, CA and Suzhou, China are dedicated to therapeutic antibodies and protein production and cell therapies, as well as its fill-and-finish cGMP facilities. These existing manufacturing infrastructures and capacity are available for rapid and significant scaled-up manufacturing to meet emergency demand following successful human trials. Sorrento currently anticipates it will complete the enabling studies for an expedited IND filing in the next few months.

 

“The COVIDTRAP candidate product developed by our scientists in the past month follows the similar approach we take to developing immune-oncology products for suppressing and/or killing off cancer cells by targeting specific tumor targets on cancer cells. We believe the same approach works for deadly viral diseases,” stated Dr. Henry Ji, Chairman and CEO of Sorrento Therapeutics. “Our immuno-therapy expertise is relevant and applicable to the COVID-19 disease. We are looking forward to quickly demonstrating COVIDTRAP’s safety and efficacy in IND-enabling preclinical studies and clinical trials and make this potentially life-saving medicine available in the fight against the COVID-19 pandemic.”

 

About Sorrento Therapeutics, Inc. 

 

Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to treat cancers. 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”), intracellular targeting antibodies (“iTAbs”), antibody-drug conjugates (“ADC”), and clinical stage oncolytic virus (“Seprehvir®”). 

 

Sorrento's commitment to Saving-LifeTM and Improving-LifeTM medicine and therapy 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 ZTlido® (lidocaine topical system) 1.8% for the treatment of post-herpetic neuralgia. Resiniferatoxin is completing a phase IB trial for intractable pain associated with cancer and a phase 1B trial in osteoarthritis patients. ZTlido® was approved by the FDA on February 28, 2018.

 

 

 

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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 expected timing for the completion of ongoing studies for the treatment of the SARS-CoV-2 virus using STI-4398 COVIDTRAP and data read-outs related thereto; the expected timing for commencing and completing registrational studies and for submitting an IND application for STI-4398 COVIDTRAP for the treatment of the SARS-CoV-2 virus; the therapeutic potential for STI-4398 COVIDTRAP for late-stage COVID-19 disease; STI-4398 COVIDTRAP’s ability to treat and prevent coronaviruses; STI-4398 COVIDTRAP’s expected half-life; the ability of Sorrento’s manufacturing infrastructure and capacity to scale to meet emergency demand; and Sorrento’s potential position in the anti-viral immunity industry. 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', affiliates’ and partners’ technologies and prospects and collaborations with partners, including, but not limited to risks related to conducting pre-clinical trials and seeking IND regulatory approval for STI-4398 COVIDTRAP; conducting and receiving results of clinical trials for STI-4398 COVIDTRAP; the clinical and commercial success of the treatment of the SARS-CoV-2 virus infections using STI-4398 COVIDTRAP; the viability and success of using STI-4398 COVIDTRAP for treatments in anti-viral therapeutic areas, including coronaviruses; 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 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 STI-4398 COVIDTRAP strategies; 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, 2019, 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.

 

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Media and Investor Relations

 

Contact: Alexis Nahama, DVM (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.

 

COVIDTRAP™, Saving-LifeTM and Improving-LifeTM are 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.

 

© 2020 Sorrento Therapeutics, Inc. All Rights Reserved.

 

 

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