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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): November 16, 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 Information.

 

On November 16, 2020, Sorrento Therapeutics, Inc. (“Sorrento”) posted under the “Investors” section of Sorrento’s website at www.sorrentotherapeutics.com an updated corporate presentation. Representatives of Sorrento will use the updated presentation in industry conferences, investor conferences and investor meetings from time to time. 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) Exhibit.

        

99.1 Sorrento Therapeutics, Inc. Corporate Presentation (November 2020).
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:  November 17, 2020 By: /s/ Henry Ji, Ph.D.  
    Name: Henry Ji, Ph.D.  
    Title: Chairman, President and Chief Executive Officer  

 

  

 

 

 

 

 

 

Saving Life TM Medicine November 20 20 NASDAQ : SRNE © 2020 Sorrento Therapeutics, Inc. All Rights Reserved 1 Exhibit 99.1

 

 

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 "estimate," "expect," "intend," "believe," "plan," "anticipate," “potential,” “projected” and other words and terms of similar meaning in connection with any discussion of future operating or financial performance or condition . Sorrento cautions that 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 perfo rmance and/or future results including, without limitation, those relating to the timing fo r 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 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 . 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 substitute for results measured under GAAP and are supplement al to 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, 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 . I nvestors are advised to consult the Company’s filings for a more complete listing of risk factors, contingencies and uncertainties affecting the Company and its business and financial performance . Sorrento® and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc . Forward - Looking Statements and Non - GAAP Financial Information © 2020 Sorrento Therapeutics, Inc. All Rights Reserved 2

 

 

About the COMPANY • Funded and Operational in 2009 • NASDAQ: SRNE • HQ in San Diego, CA 350 Employees including 100+ PhDs & MDs 300,000 SF Research and cGMP Manufacturing Facilities • 5 cGMP Manufacturing Sites (4 USA, 1 China) mAbs, ADC, Plasmid DNA, Cell Therapies, Oncolytic Viruses, and Fill & Finish • 1 FDA Approved Drug ZTlido® (lidocaine topical system)1.8% • Multiple Products in Late - Stage Clinical Development for Pain Management and Cancer © 2020 Sorrento Therapeutics, Inc. All Rights Reserved 3

 

 

Immuno - Oncology Non - Opioid Pain Management © 2020 Sorrento Therapeutics, Inc. All Rights Reserved 4 COVID - 19 COVI - GUARD COVI - AMG SP - 102 DAR - T Abivertinib COVI - DROPS COVI - STIX RTX ZTlido ®

 

 

COVID - 19 Programs 5 © 2020 Sorrento Therapeutics, Inc. All Rights Reserved

 

 

6 Detect Early and Treat Timely Nasal Swab Monitor Infection © 2020 Sorrento Therapeutics, Inc. All Rights Reserved

 

 

7 COVID - 19 Programs Pre - infection Diagnosis Treatment (ascending disease severity) COVI - GeneMAb ™ COVI - TRACE™ COVI - STICK™ COVI - TRACK™ COVI - DROPS™ (STI - 2099 ) COVI - AMG™ (STI - 2020) COVI - GUARD™ (STI - 1499) Abivertinib (STI - 5656) aMSC (STI - 8282) SARS - CoV - 2 STI - 2099 STI - 1499 STI - 2020 STI - 5656 STI - 8282 COVI - TRACE COVI - TRACK COVI - STICK STI - 8472 © 2020 Sorrento Therapeutics, Inc. All Rights Reserved

 

 

COVID - 19 Diagnostics 8 © 2020 Sorrento Therapeutics, Inc. All Rights Reserved

 

 

» Simple: Eliminates laborious extraction step and is designed for potential point - of - care (moderately trained technicians) or at - home use » Accurate: Rapid and highly sensitive platinum colloid - based lateral flow immunoassay to detect SAR - CoV - 2 virus antigens (98% sensitivity, 100% specificity, Low LOD) » Rapid: Expected to produce definitive results in less than 15 minutes » Scalable: Designed to be ideally suited for both single user and high - traffic point - of - care testing (moderate training) or at - home use » Convenient: Simple nasal swab » Offered at Low Cost: Expected to be offered at low cost for mass consumption » Versatile: Platform may be adapted to detect multiple pathogens simultaneously (SARS - CoV - 2, FluA, FluB) » This product has not yet been approved COVI - STIX™ - Sensitive and Simple Virus Antigen Test Nasal Swab © 2020 Sorrento Therapeutics, Inc. All Rights Reserved 9

 

 

COVI - TRACE™ Rapid Point - of - Care SARS - CoV - 2 Virus RNA Test » COVI - TRACE: High Sensitivity and Specificity* » Simple Process: Saliva sample without RNA extraction and no need for complex lab equipment » Colorimetric Reading: red = negative, yellow = positive » In - Field and On - Site Result: ~45 min » Cost Effective: Expected to be offered at low cost for mass consumption » Flexible Platform Technology: can be adapted to other pathogens (virus, bacteria, parasites, fungus) » This product has not yet been approved * https://www.medrxiv.org/content/10.1101/2020.06.13.20129841v1.full.pdf Saliva © 2020 Sorrento Therapeutics, Inc. All Rights Reserved 10

 

 

COVI - TRACK™ Antibody Test Indicating Recent Infection » This rapid (< 8 minutes) SARS - CoV - 2 IgG/IgM antibody test kit is intended for use initially in clinical laboratories and point of care to quickly identify individuals with anti - SARS - CoV - 2 antibodies present » Enable confirmation of protection (self - immunity) with indication of recent or prior infection » This product has not yet been approved 11 © 2020 Sorrento Therapeutics, Inc. All Rights Reserved

 

 

COVID - 19 Therapeutics 12 © 2020 Sorrento Therapeutics, Inc. All Rights Reserved

 

 

G - MAB Library for Discovery of Neutralizing Antibodies Against COVID - 19 © 2020 Sorrento Therapeutics, Inc. All Rights Reserved 13

 

 

14 Treatment by Intramuscular Injection of STI - 2020 - mAb - encoding DNA Plasmid COVI - GeneMAb™ (STI - 8472) (STI - 2020 - encoded by DNA Plasmid) » STI - 2020 - encoded GeneMAb is in development for intramuscular administration to protect against the SARS - CoV - 2 virus and its variant strains » Broad deployment of the GeneMAb could provide an effective method of protecting populations where vaccines do not work as well, including the elderly and the immune compromised » GeneMAb approach permits rapid translation of fully characterized potent neutralizing antibodies into clinical use, which Sorrento believes will be important for responding to potential mutations of SARS - CoV - 2 that may emerge Treated muscle cells secrete STI - 2020 mAb into circulation © 2020 Sorrento Therapeutics, Inc. All Rights Reserved

 

 

COVI - GUARD™ (STI - 1499)* 15 » A potent Anti - SARS - CoV - 2 antibody, COVI - GUARD demonstrated complete neutralization of infection in African green monkey kidney epithelial cells (VERO/E6 cells) in vitro at low concentrations. COVI - GUARD was similarly potent in preclinical studies for neutralization of early pandemic isolates as well as those that have emerged at later stages of the pandemic (D614G - bearing) » COVI - GUARD protects SARS - CoV - 2 - infected hamsters from COVID - 19 - like disease when administered IV immediately following infection » Sorrento has manufactured and released cGMP STI - 1499 to supply ongoing clinical trials. Drug substance production has been scaled to 2000L bioreactors at Sorrento » STI - 1499 IND has been cleared by the FDA and enrollment is currently in progress. Clinical studies to be performed in hospitalized patients as well as healthy individuals » COVI - GUARD Fc region is engineered to eliminate interactions with host Fc receptors, thereby decreasing risk of Antibody Dependent Enhancement (ADE) of SARS - CoV - 2 infection * https://biorxiv.org/cgi/content/short/2020.09.27.316174v1 Hospitalized Patients (moderate symptoms) COVI - GUARD IV © 2020 Sorrento Therapeutics, Inc. All Rights Reserved

 

 

COVI - AMG™ (STI - 2020)* 16 » COVI - AMG engineered for ultra - high potency, with an expected effective dose in humans suitable for IV push administration in an outpatient setting » COVI - AMG administered IV immediately following infection or 12 hours post - infection protects SARS - CoV - 2 - infected hamsters from COVID - 19 - like disease » In preclinical studies, COVI - AMG retains the same characteristics as COVI - GUARD for emerging variants and mitigation of ADE » IND filed for intravenous COVI - AMG to treat i) COVID - 19 patients with mild symptoms and ii) healthy normal individuals to evaluate safety and pharmacokinetics in healthy volunteers » The high potency of the COVI - AMG may translate to more doses per bioreactor manufacturing run, lower cost per dose, and allow for rapid deployment and availability to patients. Sorrento has initiated cGMP manufacturing to produce 100,000 doses, expected to be available early next year, in anticipation of a potential EUA * https://biorxiv.org/cgi/content/short/2020.09.27.316174v1 Outpatient (early symptoms) COVI - AMG IV - Push © 2020 Sorrento Therapeutics, Inc. All Rights Reserved

 

 

COVI - DROPS™ (STI - 2099)* 17 » COVI - DROPS is an intranasal formulation of the highly potent SARS - CoV - 2 neutralizing antibody STI - 2020 » A single intranasal administration of COVI - DROPS prevented disease - associated weight loss in treated hamsters. The impact of the treatment was observed within 24 hours of STI - 2099 treatment, demonstrating unique disease treatment properties as compared to intravenously administered antibodies » COVI - DROPS IND filed for a phase 1 safety and pharmacokinetic study in i) healthy volunteers and ii) outpatients with mild COVID - 19 disease with or without a simultaneous intravenous injection of COVI - AMG™ » Remarkably, animals treated with intranasal COVI - DROPS showed evidence of prevention of disease progression with limited weight loss and reduced duration of disease symptoms as compared to animals treated with intravenous COVI - AMG » The intranasal route is expected to be enabled by the high potency of the antibody and is quite promising against this highly contagious respiratory pathogen » STI - 2099 has the potential to be broadly deployable for early treatment in an outpatient setting and administered immediately upon detection STI - 2020 formulated For intranasal delivery Immediate treatment upon detection of virus infection * https://www.biorxiv.org/content/10.1101/2020.10.28.359836v1 © 2020 Sorrento Therapeutics, Inc. All Rights Reserved

 

 

18 » STI - 5656 is in Phase 2 clinical studies as a treatment of severe COVID - 19 symptoms (ARDS) » STI - 5656 has been shown to be safe and well tolerated at doses up to 600 mg daily in the treatment of non - small cell lung cancer and B cell lymphomas. The dose in the COVID - 19 studies is 100 mg daily » STI - 5656 has shown potent (nanomolar) immunomodulatory activities by inhibiting key pro - inflammatory cytokine production, including IL - 1beta, IL - 6 and TNF - alpha which are present in high levels during “cytokine storm”. The broad - spectrum reduction o f cytokines at nanomolar levels may allow Abivertinib to show success where others have failed » STI - 5656 is an oral treatment and is currently enrolling hospitalized patients with acute respiratory distress symptoms (ARDS) due to COVID - 19 infections Abivertinib (STI - 5656): Severe COVID - 19 - Related Pulmonary Symptoms © 2020 Sorrento Therapeutics, Inc. All Rights Reserved

 

 

19 » aMSC (STI - 8282): Allogeneic culture - expanded adipose - derived Mesenchymal stem cells for the rescue of patients with lung damage and acute respiratory distress syndrome (ARDS) due to COVID - 19 » Preclinical studies have demonstrated that aMSCs may produce a reduction in lung inflammation, fibrosis and edema » The current Phase 1b study anticipates 3 x aMSC IV infusions in subjects with severe COVID - 19 - related ARDS with the hope that treatment will reduce the inflammation and formation of pulmonary alveolar fibrosis and improve pulmonary edema and overall lung function » The study is active at one site and will soon begin enrolling aMSC (STI - 8282) for Patients with Acute Lung Damage © 2020 Sorrento Therapeutics, Inc. All Rights Reserved

 

 

Non - opioid Pain Programs 20 © 2020 Sorrento Therapeutics, Inc. All Rights Reserved

 

 

Lead Marketed Product: ZTlido® 1.8% FDA approved for relief of pain associated with PHN Properties ZTlido® 1.8% Lidoderm® 5% Bioavailability ~45% ~3 + 2% Weight 2 g 14 g Thickness 0.8 mm 1.7 mm Lidocaine content 36 mg 700 mg Adhesive Non - aqueous Water - based ® • ZTlido sales exhibited continuous growth of 26% • Q3 2020 net sales of $7.85 million compared to $5.7 million Q2 2020 © 2020 Sorrento Therapeutics, Inc. All Rights Reserved 21

 

 

SP - 102: Pivotal Phase 3 trial - Over 90% Enrolled If Approved Could be the First Steroid Formulation with an FDA - Approved Label to Treat Lumbar Radicular/Sciatica Pain Potent non - particulate steroid (injectable dexamethasone sodium phosphate gel) ᪵ Viscous g el formulation for extended local release and substantial pain relief ᪵ Pre - filled syringe for epidural use ᪵ Fast acting onset of effect ᪵ Well - tolerated. Key viscous excipient, long history of use including safety ᪵ ᪵ No preservatives, no surfactants, no particulates. Non - opioid and non - addicti ve ᪵ Fast Track Status Received from FDA SP - 102 Product Features © 2020 Sorrento Therapeutics, Inc. All Rights Reserved 22

 

 

Resiniferatoxin (RTX) 23 © 2020 Sorrento Therapeutics, Inc. All Rights Reserved Resiniferatoxin is a potent agonist of the transient receptor potential cation channel sub - family V member 1 (TRPV 1 ) predominantly found in a subpopulation of small C and A delta sensory neurons most often involved in nociception (the transmission of physiological pain), but also identified in cardio - renal and pulmonary modulatory functions . The agonist action of RTX produces a selective and prolonged opening of the TRPV 1 receptor, causing a sustained calcium influx in the cells . This significant cation inward current results in the cytotoxic ablation of the TRPV 1 - positive fibers or neuronal soma . Vanilloid moiety Ester bond Diterpene region

 

 

CLINICAL STUDIES STATUS (2020 COMPLETED ENROLLMENT) OA KNEE PAIN Phase 1b 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. www.clinicaltrials.gov (NCT03542838) Sorrento study (94 enrolled) INTRACTABLE CANCER PAIN Phase 1b study of the intrathecal administration of Resiniferatoxin for treating severe refractory pain associated with advanced cancer. www.clinicaltrials.gov (NCT03226574) NIH study (16 enrolled) INTRACTABLE CANCER PAIN A Multicenter, Open - Label, Phase 1b Study to Assess the Safety and Define the Maximally Tolerated Dose of Epidural Resiniferatoxin Injection for the Treatment of Intractable Pain Associated With Cancer. www.clinicaltrials.gov (NCT00804154) Sorrento study (17 enrolled) 24 © 2020 Sorrento Therapeutics, Inc. All Rights Reserved

 

 

Study Results – Epidural Admin (Cancer Pain) – Study Closed. INTRACTABLE CANCER PAIN A Multicenter, Open - Label, Phase 1b Study to Assess the Safety and Define the Maximally Tolerated Dose of Epidural Resiniferatoxin Injection for the Treatment of Intractable Pain Associated With Cancer www.clinicaltrials.gov (NCT03226574) Sorrento study (17 enrolled at dose levels 0.4, 1, 2, 4, 8, and 15 mcg presented) 25 © 2020 Sorrento Therapeutics, Inc. All Rights Reserved

 

 

Study Results – Intra articular admin (OA Knee Pain). Study Closed. OA KNEE PAIN Phase 1b 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 www.clinicaltrials.gov (NCT03542838) Sorrento study (94 enrolled) 26 © 2020 Sorrento Therapeutics, Inc. All Rights Reserved

 

 

Persistence of Effect past Day 84 (OA Knee Pain) 27 © 2020 Sorrento Therapeutics, Inc. All Rights Reserved

 

 

Immuno - Oncology Programs 28 © 2020 Sorrento Therapeutics, Inc. All Rights Reserved

 

 

Sorrento Immuno - Oncology Toolbox (proprietary) 29 © 2020 Sorrento Therapeutics, Inc. All Rights Reserved

 

 

Core Oncology Pipeline Continues to Progress © 2020 Sorrento Therapeutics, Inc. All Rights Reserved 30

 

 

31 © 2020 Sorrento Therapeutics, Inc. All Rights Reserved ABIVERTINIB (STI - 5656): NSCLC and B Cell Lymphomas » Abivertinib maleate (STI - 5656) is a potent, small molecule third - generation tyrosine kinase inhibitor (TKI) of mutant epidermal growth factor receptor (EGFR) and Bruton tyrosine kinase (BTK) receptor » Abivertinib inhibits the gatekeeper mutation of EGFR; T790M, as well as the common activating mutations (L858R, 19del), and has minimal inhibitory activity against the wild type (WT) receptor, contributing to its observed safety profile » Abivertinib has shown benefit in the treatment of non - small cell lung cancer (NSCLC) and in various B cell lymphomas (BCLs) at doses up to 600 mg daily. One phase 3 study in NSCLC has been completed and is pending final review. A phase 1/2 study in patients with mantle cell lymphoma has been completed as well. Both studies showed promising overall response rates

 

 

32