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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): January 21, 2022

 

 

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 January 21, 2022, 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 Potent Omicron Neutralizing Antibody (nAb) STI-9167 IV and STI-9199 IN (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.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

99.1 Sorrento Therapeutics, Inc. Corporate Presentation Regarding Sorrento Potent Omicron Neutralizing Antibody (nAb) STI-9167 IV and STI-9199 IN.
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: January 21, 2022 By: /s/ Henry Ji, Ph.D.
    Name: Henry Ji, Ph.D.
    Title: Chairman, President and Chief Executive Officer

 

 

 

 

 

Sorrento Potent Omicron Neutralizing Antibody (nAb) STI - 9167 IV STI - 9199 IN Exhibit 99.1

 

Disclaimer Certain statements contained in this presentation or in other documents of Sorrento Therapeutics, Inc . (the “Company”) and of any of its affiliates, along with certain statements that may be made by management of the Company orally in presenting this material, may contain “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 "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 based upon the current beliefs and expectations of the Company'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 the Company’s formulations and products and regulatory filings related to the same, and receipt by 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 determined on 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 estimates will 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 or has 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 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 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 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 . 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 . 2 © 2022 Sorrento Therapeutics, Inc. All Rights Reserved. Do not copy, distribute, or reproduce without express permission.

 

Discovery of STI - 9167 3 © 2022 Sorrento Therapeutics, Inc. All Rights Reserved. Do not copy, distribute, or reproduce without express permission.

 

STI - 9167 Binding to S1 Domain of SARS - CoV - 2 Variants of Concern (VOCs) 4 Analyte: WA - 1, Delta, or Omicron spike S1 domain Instrument: Biacore T200 © 2022 Sorrento Therapeutics, Inc. All Rights Reserved. Do not copy, distribute, or reproduce without express permission.

 

STI - 9167 Binding Kinetics to Spike S1 Domain Compared to Those of EUA - approved nAbs 5 Analyte: Omicron spike S1 domain Instrument: Biacore T200 © 2022 Sorrento Therapeutics, Inc. All Rights Reserved. Do not copy, distribute, or reproduce without express permission.

 

STI - 9167 Binding to SARS - CoV - 2 VOC Spike Proteins Expressed on HEK293 Cells 6 © 2022 Sorrento Therapeutics, Inc. All Rights Reserved. Do not copy, distribute, or reproduce without express permission.

 

Omicron Variant and Omicron + R346K Mutation Infection Statistics 7 To date: No SARS - CoV - 2 nAb approved or in development has been shown to have potent neutralization activity (≤ 100 ng/ml) against the Omicron + R346K variant © 2022 Sorrento Therapeutics, Inc. All Rights Reserved. Do not copy, distribute, or reproduce without express permission.

 

SARS - CoV - 2 Spike - Pseudotyped VSV Neutralization Assay 8 © 2022 Sorrento Therapeutics, Inc. All Rights Reserved. Do not copy, distribute, or reproduce without express permission.

 

STI - 9167 Superior Neutralization Activities Against Omicron and Omicron+R346K Variants in SARS - CoV - 2 Spike - Pseudotyped VSV Neutralization Assays 9 Variant Lineage STI - 9167 Cilgavimab (AZ) Tixagevimab (AZ) D614G 0.0036 0.0353 0.0056 Omicron (B.1.1.529) 0.0148 9.105 0.6386 Omicron+R346K (B.1.1.529) 0.0239 >10 0.4696 0.001 0.01 0.1 1 10 100 -50 0 50 100 150 D614G Antibody (g/mL) % N e u t r a l i z a t i o n cilgavimab (AZ) tixagevimab (AZ) STI-9167 0.001 0.01 0.1 1 10 100 -50 0 50 100 150 Omicron Antibody (g/mL) % N e u t r a l i z a t i o n cilgavimab (AZ) tixagevimab (AZ) STI-9167 0.001 0.01 0.1 1 10 100 -50 0 50 100 150 Omicron+R436K Antibody (g/mL) % N e u t r a l i z a t i o n cilgavimab (AZ) tixagevimab (AZ) STI-9167 IC50 (ug/mL) © 2022 Sorrento Therapeutics, Inc. All Rights Reserved. Do not copy, distribute, or reproduce without express permission.

 

Neutralization Activity of STI - 9167 in the SARS - CoV - 2 Live Virus Neutralization Assays 10 © 2022 Sorrento Therapeutics, Inc. All Rights Reserved. Do not copy, distribute, or reproduce without express permission.

 

Superior Neutralization Activity of STI - 9167 as Compared to EUA - approved Neutralization Antibodies (nAbs) in the SARS - CoV - 2 Live Omicron Virus Neutralization Assays 11 1 10 100 1000 0 25 50 75 100 Omicron ng/ml F R N T ( % ) Tixagevimab Cilgavimab Bamlanivimab + Etesevimab Sotrovimab STI-9167 Casirivimab + Imdevimab Omicron virus neutralization IC 50 ng/ml STI - 9167 34.4 Tixagevimab 198.9 Cilgavimab 326 Sotrovimab 573.1 Bamlanivimab + Etesevimab > 2000 Casirivimab + Imdevimab > 2000 © 2022 Sorrento Therapeutics, Inc. All Rights Reserved. Do not copy, distribute, or reproduce without express permission.

 

STI - 9167 Neutralizing Activity Following IN or IV Administration in the K18 - hACE2 Transgenic Mouse Model of COVID - 19 12 RSV mAb = negative control RSV mAb = negative control © 2022 Sorrento Therapeutics, Inc. All Rights Reserved. Do not copy, distribute, or reproduce without express permission.

 

STI - 9167 GMP Manufacturing and Clinical Developmental Status 13 x STI - 9167 GMP Master Cell Bank generation completed x IND - enabling preclinical safety and toxicology studies completed • Phase 1 clinical trials planned in healthy individuals and infected patients for both intranasal formulation (COVIDROPS) and intravenous formulation (COVISHIELD) • IND submission in early February x STI - 9167 GMP Drug Product to supply Phase 1/2 studies formulated for intranasal and intravenous dosing has been F/F x Already manufactured enough drug substance for 100,000’s of intranasal doses © 2022 Sorrento Therapeutics, Inc. All Rights Reserved. Do not copy, distribute, or reproduce without express permission.