SRNE Sorrento Therapeutics Inc.

7.09
-0.62  -8%
Previous Close 7.71
Open 7.66
52 Week Low 1.45
52 Week High 19.39
Market Cap $1,855,719,740
Shares 261,737,622
Float 256,951,109
Enterprise Value $2,214,447,065
Volume 11,660,749
Av. Daily Volume 27,201,837
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
SP-102
Lumbosacral radicular pain (sciatica)
Phase 3
Phase 3
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.

Drug Pipeline

Drug Stage Notes
Anti-CD38 CAR-T
Multiple Myeloma
Phase 1
Phase 1
Phase 1 trial ongoing.
Resiniferatoxin
OsteoArthritis (OA) Knee Pain
Phase 1b
Phase 1b
Phase 1b data released September 28, 2020. Last patient follow up due 1Q 2021. Phase 2 trial to commence 2020.
Resiniferatoxin
Intractable Pain Associated with Cancer
Phase 1b
Phase 1b
Phase 1b data released September 22, 2020.
STI-1499 (COVI-GUARD)
COVID-19
Phase 1
Phase 1
Phase 1 trial planned.
Abivertinib
COVID-19
Phase 2
Phase 2
Phase 2 trial to be initiated.
CYNK-001
COVID-19 Coronavirus
Phase 1/2
Phase 1/2
Phase 1/2 trial to commence immediately - noted April 2, 2020.
STI-4398
Coronavirus COVID-19
Phase 1
Phase 1
Phase 1 IND filing due to be filed in the coming months - noted March 20, 2020.
ZTlido (lidocaine patch 1.8%)
Pain associated with post-herpetic neuralgia (PHN)
Approved
Approved
Approval announced February 28, 2018.

Latest News

    • Phase 2 clinical trials of Abivertinib now cleared to proceed in both Brazil and the U.S.
    • Studies are complementary and address both dose duration and disease stage
    • Rapid enrollment expected for both geographies

    SAN DIEGO, Oct. 14, 2020 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (NASDAQ:SRNE, "Sorrento"))) today announced receipt of clearance from the Brazilian regulatory agency (ANVISA) to proceed with a Phase 2 clinical trial of Abivertinib in mild, moderate and severe COVID-19 patients.

    The Brazil study is a Phase 2, Randomized, Double-Blind, Placebo-controlled Study of the Safety and Efficacy of STI-5656 (Abivertinib Maleate) in Subjects Hospitalized Due to COVID-19, particularly looking at the potential clinical benefits of the drug…

    • Phase 2 clinical trials of Abivertinib now cleared to proceed in both Brazil and the U.S.

    • Studies are complementary and address both dose duration and disease stage
    • Rapid enrollment expected for both geographies



    SAN DIEGO, Oct. 14, 2020 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (NASDAQ:SRNE, "Sorrento"))) today announced receipt of clearance from the Brazilian regulatory agency (ANVISA) to proceed with a Phase 2 clinical trial of Abivertinib in mild, moderate and severe COVID-19 patients.

    The Brazil study is a Phase 2, Randomized, Double-Blind, Placebo-controlled Study of the Safety and Efficacy of STI-5656 (Abivertinib Maleate) in Subjects Hospitalized Due to COVID-19, particularly looking at the potential clinical benefits of the drug associated with its broad ability (mode of action) to reduce inflammatory cytokine storm. The dose to be tested is the same as in the U.S. Phase 2 trial, but the trial protocol in Brazil includes patients at earlier stages of the disease, with a drug administration regimen of only 7 days (versus 14 days for more advanced patients in the U.S.).

    The Brazilian study is expected to rapidly enroll 400 patients. The rapid projected enrollment pace is made possible by the recent partnership established between Sorrento and a leading local clinical research organization (Synova Health) with access to high quality medical centers throughout the country.

    A broad clinical development strategic alignment between Sorrento and local medical systems, including with the city of Rio de Janeiro, will also help accelerate site initiation and access to potential patients for additional Sorrento studies currently being evaluated by ANVISA.

    BR Protocol DesignU.S. Protocol Design
    Mild, Moderate and Severe COVID-19 patientsSevere COVID-19 patients
    Any hospitalized patientICU non-ventilated
    N=400 randomized 3:1 (Abivertinib to placebo)N=80 randomized 1:1 (Abivertinib to placebo)
    100 mg QD x 7 days100 mg QD x 14 days
    Duration 45 daysDuration 94 days
    Primary endpoint:

    % discharged from hospital by Week 4
    Primary endpoint:

    % alive and free of respiratory failure at Week 4

    "We are very satisfied with the progress made in Brazil so far," stated Dr. Henry Ji, Chairman and CEO of Sorrento Therapeutics. "By targeting some of the geographies currently most impacted by COVID-19, we are able to implement a synergistic program to answer questions about safety and efficacy of our drug candidates in helping patients, while potentially accelerating enrollment timelines, reducing overall cost and opening up collaboration opportunities with local companies."

    The study is referenced with ANVISA (Brazilian authority) under Process nº 25351.105670/2020-14, Reference n° 3380614/20-4

    Brazilian Clinical Study details can be found at:

    https://clinicaltrials.gov/ct2/show/NCT04528667?term=abivertinib&draw=2&rank=3

    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"), antibody-drug conjugates ("ADCs"), and clinical stage oncolytic virus ("Seprehvir®", "Seprehvec™"). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including COVIDTRAP™, ACE-MAB™, COVI-MAB™, COVI-GUARD™, COVI-SHIELD™, COVI-AMG™ and T-VIVA-19™; and diagnostic test solutions, including COVI-TRACK™, COVI-STIX™ and COVI-TRACE™.

    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 ZTlido® (lidocaine topical system) 1.8% for the treatment of post-herpetic neuralgia. RTX has completed a phase 1B 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.

    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 Abivertinib, including the safety, tolerability and demonstrated efficacy thereof; the potential ability of Abivertinib to reduce inflammatory cytokine activity; expected rapid enrollment of clinical trials in the U.S. and Brazil; the protocol design for both the U.S. and Brazilian clinical trials; the synergistic potential of the U.S. and Brazil clinical trials; and the ability of a synergistic program to potentially accelerate enrollment timelines, reduce overall cost and create collaboration opportunities with local companies . 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 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 the company in the execution of its therapeutic product candidates 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, 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.

    Contact

    Alexis Nahama, DVM (SVP Corporate Development)

    Email:

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

    G-MAB™, COVI-GUARD™, COVI-SHIELD™, COVI-AMG™, COVIDTRAP™, T-VIVA-19™, COVI-MAB™, ACE-MAB™, COVI-TRACK™, COVI-STIX™ and COVI-TRACE™ are trademarks of Sorrento Therapeutics, Inc.

    ZTlido® is a trademark owned by Scilex Pharmaceuticals Inc.

    All other trademarks are the property of their respective owners.

    © 2020 Sorrento Therapeutics, Inc. All Rights Reserved.

    Primary Logo

    View Full Article Hide Full Article
  1. SAN DIEGO, Oct. 12, 2020 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (NASDAQ:SRNE, ", Sorrento", ))) announced today that it has entered into an exclusive license agreement with Personalized Stem Cells, Inc. (PSC) to acquire global rights to its adipose derived mesenchymal stem cells (MSCs) for patients suffering from acute respiratory distress syndrome (ARDS) associated with COVID-19, which have been cleared for a Phase 1 clinical trial by the FDA.

    The study is a single arm, non-randomized Phase 1 study of the safety and preliminary efficacy of an adipose-derived allogeneic MSC product candidate. The outcome data will be compared to contemporaneous non-enrolled patients at the same clinical site(s) as the enrolled patients. The primary…

    SAN DIEGO, Oct. 12, 2020 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (NASDAQ:SRNE, ", Sorrento", ))) announced today that it has entered into an exclusive license agreement with Personalized Stem Cells, Inc. (PSC) to acquire global rights to its adipose derived mesenchymal stem cells (MSCs) for patients suffering from acute respiratory distress syndrome (ARDS) associated with COVID-19, which have been cleared for a Phase 1 clinical trial by the FDA.

    The study is a single arm, non-randomized Phase 1 study of the safety and preliminary efficacy of an adipose-derived allogeneic MSC product candidate. The outcome data will be compared to contemporaneous non-enrolled patients at the same clinical site(s) as the enrolled patients. The primary objective is to evaluate the safety of intravenous infusion of allogeneic adipose stem cells in patients with COVID-19 and in respiratory distress. The secondary objective is to evaluate a set of safety and efficacy outcome variables to give guidance regarding the risk/benefit ratio in patients with COVID-19 respiratory distress.

    More information on the Phase 1 trial can be found at:

    https://clinicaltrials.gov/ct2/show/NCT04486001?term=coronastem&draw=2&rank=1

    Sorrento will be assuming responsibility for executing the Phase 1 trial, which is targeted to enroll about 20 hospitalized COVID-19 patients in California. Pending the results of the Phase 1 trial, Sorrento expects to expand into Phase 2 trials in multiple relevant geographies as may be determined in consultation with applicable regulatory authorities.

    Stem cells have been demonstrated to support resolution of symptoms in multiple disease settings and have the potential to reduce the long-term effects associated with pulmonary tissue damage for these patients. More information on the potential use and benefits of MSCs for patients with COVID-19 can be found in the recently published review at:

    https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-020-02380-2

    Stem cells represent a treatment modality with high potential to help in the fight against COVID-19 as a stand-alone therapy or in synergy with other product candidates in Sorrento's pipeline, including small molecules (abivertinib or salicyn-30) and neutralizing antibodies (STI-1499 or STI 2020).

    Until a time where early treatments are more readily available, it is important to provide patients severely afflicted with COVID-19 multimodal solutions that can help increase survival, reduce the time spent in the hospital and reduce long-term sequelae. The long-term lingering effects of COVID-19 on the body can persist for months after patients leave the hospital, especially for patients that received ventilator support. Shortness of breath, difficulty doing simple tasks and pulmonary fibrosis are among the common complaints of long-term effects of the disease on COVID-19 patients leaving the ICU.

    Dr. Robert Harman, CEO of PSC stated, "We are delighted to be working with a company such as Sorrento, that has the vision and expertise to take our program through the next steps in the clinical development process. Sorrento saw the translational value of our decades of work in animal health and has acknowledged the extensive manufacturing and regulatory work we have done in bringing human cell lines to a Phase 1 FDA clearance. We are looking forward to collaborating on this initiative and beyond."

    Dr. Henry Ji, Chairman and CEO of Sorrento stated, "Stem cells were a missing piece in our comprehensive portfolio of potential solutions against COVID-19. We now cover multiple stages of the continuum of care from prevention to potential therapeutic solutions for the most advanced stages of the disease. With PSC's Phase 1 product candidate, we hope to move quickly through the next clinical trials, and, if successful, be able to provide a supportive therapy that may save the lives of the most advanced patients and may also ensure patients who have to undergo intensive care can benefit from a therapy with the potential to minimize the long-term effects of the disease due to the lung damage created by the virus early in the infection."

    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™", "Seprehvec™"). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including COVIDTRAP™, ACE-MAB™, COVI-MAB™, COVI-GUARD™, COVI-SHIELD™, COVI-AMG™ and T-VIVA-19™; and diagnostic test solutions, including COVI-TRACK™, COVI-STIX™ and COVI-TRACE™.

    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 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. 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 safety and efficacy of an adipose-derived allogeneic MSC product in patients with COVID-19 and in respiratory distress; the clinical testing of an adipose-derived allogeneic MSC product; the expected enrollment of the Phase 1 trial; the potential commencement of any future clinical trials for an adipose-derived allogeneic MSC product; the ability of an adipose-derived allogeneic MSC product to work as a stand-alone therapy or in synergy with our other product candidates; the ability of an adipose-derived allogeneic MSC product to support healing and reduce the long-term effects associated with pulmonary tissue damage for COVID-19 patients; our ability to provide a supportive therapy for COVID-19 patents using an adipose-derived allogeneic MSC product; the ability of an adipose-derived allogeneic MSC product to potentially save lives of COVID-19 patients and to potentially minimize the long-term effects of COVID-19; our ability to cover all stages of the continuum of care for COVID-19; and our potential position in the antiviral 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 seeking regulatory approval for any adipose-derived allogeneic MSC product; 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 COVID-19 therapeutic 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, 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.

    Media and Investor Relations

    Contact: Alexis Nahama, DVM (SVP Corporate Development)

    Telephone: 1.858.203.4120

    Email:

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

    G-MAB™, COVI-GUARDTM, COVI-SHIELD™, COVI-AMG™, COVIDTRAP™, T-VIVA-19™, COVI-MAB™, ACE-MAB™, COVI-TRACK™, COVI-STIX™ and COVI-TRACE™ are trademarks of Sorrento Therapeutics, Inc.

    ZTlido® is a trademark owned by Scilex Pharmaceuticals Inc.

    All other trademarks are the property of their respective owners.

    © 2020 Sorrento Therapeutics, Inc. All Rights Reserved. 

    Primary Logo

    View Full Article Hide Full Article
  2. SAN DIEGO, Oct. 09, 2020 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (NASDAQ:SRNE, "Sorrento"))) today released details about its upcoming COVID-19 Pipeline Update call and webcast on October 13th, 2020.

    Title:
    Sorrento Therapeutics COVID-19 Pipeline Update, R&D Discussion and Management Q&A

    Conference ID: 2066037
    Date of call: 10/13/2020
    Time of call: 16:30 Eastern Time
    Expected Duration: 60 minutes + questions (analysts and general public)

    For registered analysts and pre-certified participants:

    Toll Free Number: (833) 665-0715

    For other participants (webcast, with ability to submit questions during the session):

    https://edge.media-server.com/mmc/p/tun863t9

    Management participants will include:
    Dr. Henry Ji, Chairman…

    SAN DIEGO, Oct. 09, 2020 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (NASDAQ:SRNE, "Sorrento"))) today released details about its upcoming COVID-19 Pipeline Update call and webcast on October 13th, 2020.

    Title:

    Sorrento Therapeutics COVID-19 Pipeline Update, R&D Discussion and Management Q&A



    Conference ID: 2066037

    Date of call: 10/13/2020

    Time of call: 16:30 Eastern Time

    Expected Duration: 60 minutes + questions (analysts and general public)

    For registered analysts and pre-certified participants:

    Toll Free Number: (833) 665-0715

    For other participants (webcast, with ability to submit questions during the session):

    https://edge.media-server.com/mmc/p/tun863t9

    Management participants will include:

    Dr. Henry Ji, Chairman and CEO

    Dr. Mark Brunswick, SVP and Head of Regulatory and Quality

    Dr. Robert Allen, SVP, Antiviral and Oncolytic Immunotherapy Development

    Dr. Mike Royal, Chief Medical Officer

    Dr. Alexis Nahama, SVP of Corporate Development

    R&D Day Agenda:

     Strategic Outlook (Dr. Henry Ji)

    Therapeutic Pipeline – Clinical Stage (Management)

    • STI-1499 (neutralizing antibody)
    • STI-5656 (abivertinib)

    Therapeutic Pipeline – IND enabling Stage (Management)

    • STI-2020 (affinity matured STI-1499)
    • STI-2099 (encoded plasmid DNA expressing STI-2020)

    Therapeutic Discovery (Dr. Henry Ji)

    • Neutralizing antibody cocktail (COVI-SHIELD™)
    • Bispecific Neutralizing antibodies
    • STI-2030 (Salicyn-30)
    • STI-4398 (COVIDTRAP™: ACE2 receptor decoy protein)
    • STI-3333 (T-VIVA-19™: protein-based vaccine)
    • I-Cell vaccine delivery platform

    Diagnostics (Management)

    • COVI-TRACK™: IgG/IgM Antibody Test
    • COVI-TRACE™: HP-LAMP Molecular Detection Test
    • COVI-STIX™: Viral Antigen Test

    The webcast will be available on the Sorrento Therapeutics' website for 30 days at www.sorrentotherapeutics.com.

    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®", "Seprehvec™"). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including COVIDTRAP™, ACE-MAB™, COVI-MAB™, COVI-GUARD™, COVI-SHIELD™, COVI-AMG™ and T-VIVA-19™; and diagnostic test solutions, including COVI-TRACK™, COVI-STIX™ and COVI-TRACE™.

    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 ZTlido® (lidocaine topical system) 1.8% for the treatment of post-herpetic neuralgia. RTX has completed a phase 1B 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.

    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 Sorrento's pipeline and plans with respect to its strategic outlook and clinical and pre-clinical COVID-19 programs, its COVID-19 therapeutic and diagnostic product candidates and pipeline, and its proprietary technology platforms. 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, including, but not limited to 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 the company in the execution of its therapeutic and diagnostic product candidates' 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, 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.

    Contact

    Alexis Nahama, DVM (SVP Corporate Development)

    Email:

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

    G-MAB™, COVI-GUARD™, COVI-SHIELD™, COVI-AMG™, COVIDTRAP™, T-VIVA-19™, COVI-MAB™, ACE-MAB™, COVI-TRACK™, COVI-STIX™ and COVI-TRACE™ are trademarks of Sorrento Therapeutics, Inc.

    ZTlido® is a trademark owned by Scilex Pharmaceuticals Inc.

    All other trademarks are the property of their respective owners.

    © 2020 Sorrento Therapeutics, Inc. All Rights Reserved.

    Primary Logo

    View Full Article Hide Full Article
    • In preclinical studies, Salicyn-30, a small molecule, demonstrated potent in-vitro viral load reduction of 3-4 log in SARS-CoV-2 infection model in normal healthy VERO E6 cells.

    • Salicyn-30 displays a novel mechanism of inhibition of SARS-CoV-2, with potential additive benefits when used in a multi-modal therapy approach.

    • Salicyn-30 can potentially be administered orally alone and will be tested in combination with Sorrento's potent STI-1499 and affinity matured STI-2020 neutralizing antibodies.

    SAN DIEGO, Oct. 07, 2020 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (NASDAQ:SRNE, ", Sorrento", ))) announced today that it has discovered a small molecule termed Salicyn-30 that demonstrated a potent 3-4 log reduction of SARS-CoV-2 virus infection…

    • In preclinical studies, Salicyn-30, a small molecule, demonstrated potent in-vitro viral load reduction of 3-4 log in SARS-CoV-2 infection model in normal healthy VERO E6 cells.



    • Salicyn-30 displays a novel mechanism of inhibition of SARS-CoV-2, with potential additive benefits when used in a multi-modal therapy approach.



    • Salicyn-30 can potentially be administered orally alone and will be tested in combination with Sorrento's potent STI-1499 and affinity matured STI-2020 neutralizing antibodies.

    SAN DIEGO, Oct. 07, 2020 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (NASDAQ:SRNE, ", Sorrento", ))) announced today that it has discovered a small molecule termed Salicyn-30 that demonstrated a potent 3-4 log reduction of SARS-CoV-2 virus infection in an in vitro virus infection experiment.

    Since the beginning of the COVID-19 pandemic, Sorrento has developed a program targeting the entire continuum of care (for prevention, early treatment and rescue therapies) to manage COVID-19 disease. It is Sorrento's belief that multi-modal therapies will naturally follow the approval of effective single therapies, regardless of individual drug potential.

    Using a drug repurposing strategy, Sorrento has been looking for compounds that could synergistically supplement its current antibody program and, in that process, screened a collection of salicylanilide compounds of interest from a library of molecules developed upon a chemical scaffolding known as salicylanilides. In preliminary preclinical experiments, comparative data generated thus far demonstrates Salicyn-30 may be more effective than another salicylanilide, niclosamide, a small molecule previously used to treat tapeworm infection, which has recently entered clinical trials (NCT04372082) to examine its effectiveness against COVID-19.

    Drug repurposing for other diseases has gained widespread attention in recent years as several such drugs have been approved by the FDA. Moreover, in the global emergency of the COVID-19 pandemic, this is one of the strategies being implemented by both major pharma and academic efforts.

    Sorrento's intent on examining a salicylanilide library as a starting point for targeting COVID-19 (and potentially other coronaviruses) is grounded upon the concept that drug repurposing, is generally cost and time effective, with the potential for high returns and relatively low risk. Sorrento's unique approach goes beyond identifying an anti-viral drug through repurposed molecule screening and is aimed at finding an optimal small molecule candidate that could be further developed for its potential to enhance the proprietary pipeline of clinical stage neutralizing antibodies.

    Salicyn-30 will be developed initially as a stand-alone therapy to potentially reduce viral load in severely affected patients. In parallel, its potential in combination with Sorrento's antibodies currently in development will be validated, both for synergistic efficacy but also to ensure that the safety of the combination therapy is established prior to human trials.

    Dr. Henry Ji, Sorrento's Chairman and CEO, stated, "Salicyn-30 has shown exceptional therapeutic potential, it is orally available and has greater systemic exposure besides being more potent than other salicylanilide niclosamides in preclinical trials to date. We see high potential value for this new small molecule inhibitor of SARS-CoV-2 either as a standalone therapeutic or used in conjunction with the proprietary neutralizing antibodies (nAbs) STI-1499 and affinity matured STI-2020 being developed by our Company. Our ultimate goal is to be able to provide patients with solutions at each stage of the COVID-19 disease continuum and ensure all the therapeutic solutions we put forward work well together and enhance each other."

    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®", "Seprehvec™"). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including COVIDTRAP™, ACE-MAB™, COVI-MAB™, COVI-GUARD™, COVI-SHIELD™, COVI-AMG™ and T-VIVA-19™; and diagnostic test solutions, including COVI-TRACK™, COVI-STIX™ and COVI-TRACE™.

    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 ZTlido® (lidocaine topical system) 1.8% for the treatment of post-herpetic neuralgia. RTX has completed a phase 1B 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.

    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 Sorrento's pipeline and plans with respect to its clinical and pre-clinical COVID-19 programs, including Salicyn-30, STI-1499 and STI-2020; the potential for Salicyn-30 to be used as a standalone therapeutic or multi-modal therapy for the treatment of COVID-19; the potential method for administration of Salicyn-30; the belief that multi-modal therapies will naturally follow the approval of effective single therapies; Salicyn-30's potency and its potency relative to other salicylanilide niclosamides; time efficiencies associated with drug repurposing, as well as the potential for high returns and relatively low risk associated therewith; the potential for Salicyn-30, STI-1499 and STI-2020 to work together and enhance each other; the potential for Salicyn-30 to reduce viral load and Sorrento's COVID-19 therapeutic and diagnostic product candidates and pipeline goals. 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, including, but not limited to 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 the company in the execution of its therapeutic and diagnostic product candidates' 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, 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.

    Contact

    Alexis Nahama, DVM (SVP Corporate Development)

    Email:

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

    G-MAB™, COVI-GUARDTM, COVI-SHIELD™, COVI-AMG™, COVIDTRAP™, T-VIVA-19™, COVI-MAB™, ACE-MABTM, COVI-TRACK™, COVI-STIX™ and COVI-TRACE™ are trademarks of Sorrento Therapeutics, Inc.

    ZTlido® is a trademark owned by Scilex Pharmaceuticals Inc.

    All other trademarks are the property of their respective owners.

    © 2020 Sorrento Therapeutics, Inc. All Rights Reserved.

    Primary Logo

    View Full Article Hide Full Article
    • Preliminary Q3 2020 net sales of ZTlido® of approximately $7.2 million, quarter-over-quarter growth of 26% compared to $5.7MM in Q2-2020 despite the continued impact of COVID-19 pandemic.
    • The Phase 3 pivotal trial investigating SP-102 non-opioid therapy for lumbosacral radicular pain/ sciatica is over 90% enrolled and top-line data is expected to be announced by Q2-2021, despite the ongoing COVID-19 pandemic, which delayed or put on hold hundreds of other clinical trials around the world.
    • SP-102 could potentially be the first FDA approved epidural steroid product for the treatment of sciatica with the potential to replace the current 10 to 11 million off-label epidural steroid injections administered each year in the U.S.

    PALO ALTO, Calif., Oct…

    • Preliminary Q3 2020 net sales of ZTlido® of approximately $7.2 million, quarter-over-quarter growth of 26% compared to $5.7MM in Q2-2020 despite the continued impact of COVID-19 pandemic.
    • The Phase 3 pivotal trial investigating SP-102 non-opioid therapy for lumbosacral radicular pain/ sciatica is over 90% enrolled and top-line data is expected to be announced by Q2-2021, despite the ongoing COVID-19 pandemic, which delayed or put on hold hundreds of other clinical trials around the world.
    • SP-102 could potentially be the first FDA approved epidural steroid product for the treatment of sciatica with the potential to replace the current 10 to 11 million off-label epidural steroid injections administered each year in the U.S.

    PALO ALTO, Calif., Oct. 07, 2020 (GLOBE NEWSWIRE) -- Scilex Holding Company ("Scilex"), a majority-owned subsidiary of Sorrento Therapeutics, Inc. (NASDAQ:SRNE, ", Sorrento", ))), today announced continuous sales growth in ZTlido® from quarter to quarter in 2020. Scilex expects third quarter 2020 ZTlido® net sales to grow 26% to approximately $7.2MM, compared to $5.7MM in Q2-2020. The preliminary third quarter 2020 net sales information presented in this press release is based on Scilex's current expectations and may be adjusted as a result of, among other things, completion of customary quarterly review procedures.

    Scilex's SP-102 (SEMDEXA™) is currently being evaluated in a pivotal Phase 3 clinical trial in the U.S. to evaluate patients with lumbosacral radicular pain/sciatica. The trial is expected to complete enrollment in the fourth quarter of 2020 and top-line data is expected in the second quarter of 2021.   Scilex intends to use the results from this pivotal Phase 3 trial to discuss with U.S. health authorities the basis for licensure application to the U.S. Food and Drug Administration (FDA) for this high unmet need indication where no treatments have been approved and which is responsible for millions of people suffering in the U.S. alone. Scilex has extensive clinical and pre-clinical data (including multiple Phase 2 clinical trials) with the novel viscous formulation of SP-102, which was designed to provide extended local effect for sciatica patients. The robust data collected over the course of the company's multi-year clinical development program will be presented to the U.S. FDA as part of a new drug application.  

    The CLEAR ("Corticosteroid Lumbar Epidural Analgesia for Radiculopathy") clinical study is a randomized, double-blind, placebo-controlled Phase 3 trial that is expected to enroll 400 patients with lumbosacral radicular pain at 40+ sites across the U.S. The primary endpoint of the study is mean change in the Numeric Pain Rating Scale (NPRS) for leg pain with SP-102 epidural injection compared to intramuscular injection of placebo over four weeks. The secondary endpoints include other measures of pain at 4 and 12 weeks as well as time to repeat injection of SP-102, safety and function. The study includes an open-label extension to build the safety database of patients treated with SP-102.   "We are anxiously awaiting a new injectable formulation of dexamethasone and registration for treatment of radicular pain based on results of a large, randomized placebo-controlled multi-center trial. If approved by the FDA, SP-102 would be the first corticosteroid for epidural injections addressing safety issues with steroid medications, currently used off-label, and an important addition to armamentarium of interventional pain physicians," said Dr. Steve Cohen, Chief of Pain Medicine and Professor of Anesthesiology & Critical Care Medicine, Neurology and Physical Medicine & Rehabilitation, Johns Hopkins School of Medicine, and Professor of Anesthesiology and Physical Medicine & Rehabilitation, Walter Reed National Military Medical Center, Uniformed Services University of the Health Sciences.

    SP-102 is a novel, non-opioid injectable viscous gel formulation in development for the treatment of lumbosacral radicular pain, containing no neurotoxic preservatives, surfactants, solvents or particulates. The SP-102 formulation is administered by epidural injection. Based on preclinical and clinical studies conducted to date, it extends the residency time at the site of injection and has not demonstrated the safety concerns that led the FDA to issue a class warning on the currently off-label use of injectable corticosteroids to include information about the risk of serious neurologic events with epidural steroid injections (ESIs).

    "Lumbosacral radicular pain, otherwise known as sciatica, is commonly treated by off-label epidural steroid injections. There are an estimated ten to eleven million epidural steroid injections administered per year in the U.S. alone and there are no approved steroids for epidural injections.2 The clinical results for the pivotal Phase 3 trial for SP-102 will be a seminal milestone for Scilex and may provide encouraging news for the many millions of people who are confronting debilitating radicular pain/sciatica. We believe that SP-102 could be the first FDA-approved epidural steroid product for patients suffering from this common, painful condition," said Jaisim Shah, President and Chief Executive Officer of Scilex.

    In 2019, the overall estimated number of ESI procedures in the U.S. was 11.6 million across all Medicare and private coverage patients, with lumbar radiculopathy / sciatica procedures comprising approximately 88% of all ESIs administered. Despite widespread utilization of ESIs, concerns persist in the market about particulate steroids and potential side effect and safety concerns (e.g., stroke) from current off-label use. As a result, a significant unmet medical need exists within the market for a potent, non-particulate ESI formulation that demonstrated safety and effectiveness in controlled clinical trial evaluations.1  

    In the U.S., more than 30 million people live with low back and radicular pain, with this population expected to grow as the population ages.4,5 Many patients experience moderate to severe pain with intolerance and/or inadequate response to current analgesic therapies such as opioids and nonsteroidal anti-inflammatory drugs (NSAIDs).6,7 There is a great need for highly effective analgesic medications to provide patient relief without the toxicity and tolerability challenges of NSAIDs and opioids.5 Opioid prescriptions account for about 40 percent of the chronic pain market and carry a well-known risk of abuse and misuse, underscoring the need for alternative pain therapies without the medical and societal challenges.5,8

    Chronic pain affects 100 million, or almost one- in-three, Americans9, with nearly 33 million patients suffering from lower back pain in the U.S.10, and costs the United States approximately $560 to $635 billion annually., Government agencies, physicians, patients, and payers are looking for alternatives to opioids to reduce the risk of dependency or addiction, and serious side effects (such as respiratory depression and constipation), while still offering potent solutions for people living with chronic pain.

    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®", "Seprehvec™"). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including COVIDTRAP™, ACE-MAB™, COVI-MAB™, COVI-GUARD™, COVI-SHIELD™, COVI-AMG™ and T-VIVA-19™; and diagnostic test solutions, including COVI-TRACK™, COVI-STIX™ and COVI-TRACE™.

    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 ZTlido® (lidocaine topical system) 1.8% for the treatment of post-herpetic neuralgia. RTX has completed a phase 1B 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. SP-102 is undergoing a Phase 3 pivotal trial for the treatment of lumbosacral radicular pain/sciatica.

    For more information visit www.sorrentotherapeutics.com

    About Scilex Holding Company.

    Scilex Holding Company, a majority-owned subsidiary of Sorrento Therapeutics, Inc. (NASDAQ:SRNE), is a commercial-stage, non-opioid pain management company focused on the development and commercialization of topical and injectable therapies.  Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with moderate to severe chronic pain.  Scilex launched its first commercial product in October 2018 and is developing its late-stage pipeline, which includes a pivotal Phase 3 candidate and a Phase 2 candidate.  Its commercial product, ZTlido® (lidocaine topical system) 1.8%, or ZTlido, is a prescription lidocaine topical product approved by the U.S. Food and Drug Administration for the relief of pain associated with postherpetic neuralgia, which is a form of post-shingles nerve pain.  Scilex's two product candidates are SP-102 (10 mg, dexamethasone sodium phosphate viscous gel), or SEMDEXA™, a Phase 3, novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, and SP-103 (lidocaine topical system) 5.4%, or SP-103, a Phase 2, next-generation, triple-strength formulation of ZTlido, for the treatment of chronic low back pain.

    Forward-Looking Statements

    This press release and any statements made for and during any presentation or meeting concerning the matters discussed in this press release contain forward-looking statements related to Sorrento Therapeutics, Inc. and its subsidiaries, including but not limited to Scilex Holding Company, Scilex Pharmaceuticals, Inc. and Semnur Pharmaceuticals, Inc. under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are 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 completing enrollment for the Phase 3 trial for SP-102; expected third quarter 2020 ZTlido® net sales; the expected timing for receipt of top-line data for the Phase 3 trial for SP-102; discussions with the FDA and health authorities regarding any new drug application for SP-102; clinical trial endpoints; expectations that SP-102 may be the first FDA-approved epidural steroid product for the treatment of sciatica; the outcome of the data from a clinical trial for SP-102; Scilex Holding's prospects; future clinical trials and the results thereof and market and patient population trends.  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 the completion of the customary quarterly financial statement review procedures; clinical development risks, including risks in the progress, timing, cost, and results of clinical trials and product development programs; risks that prior test, study and trial results may not be replicated in future studies and trials; risks that SP-102 may not meet all endpoints of the clinical study and that the data may not support an NDA submission; risks of difficulties or delays in obtaining regulatory approvals and risks related to the global impact of COVID-19. 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 may be required by law.

    Media and Investor Relations

    Contact: Alexis Nahama, SVP Corporate Development

    Telephone: 1.858.203.4120

    Email:

    Website: www.sorrentotherapeutics.com

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

    G-MAB™, COVI-GUARDTM, COVI-SHIELD™, COVI-AMG™, COVIDTRAP™, T-VIVA-19™, COVI-MAB™, ACE-MABTM, COVI-TRACK™, COVI-STIX™ and COVI-TRACE™ are trademarks of Sorrento Therapeutics, Inc.

    ZTlido® is a trademark owned by Scilex Pharmaceuticals Inc.

    All other trademarks are the property of their respective owners.

    © 2020 Sorrento Therapeutics, Inc. All Rights Reserved.

    References

    (1)    Syneos Health Consulting; Syneos is a leading management consulting firm specializing in life sciences industry

    (2)    NEJM July 3, 2014 Editorial: Epidural Glucocorticoid Injections in Patients with Lumbar Spinal Stenosis; Gunnar B.J. Andersson, M.D., Ph.D.

    (3)    Institute of Medicine, National Center for Health Statistics, and Datamonitor December 2009

    (4)    Decisions Resources Group. Chronic Pain: Disease Landscape and Forecast. 2016; 76 & 80

    (5)    Decisions Resources Group. Chronic Pain: Disease Landscape and Forecast. 2016; 40

    (6)    Decisions Resources Group. Chronic Pain: Disease Landscape and Forecast. 2016; 62

    (7)    Decisions Resources Group. Chronic Pain: Disease Landscape and Forecast. 2016; 62

    (8)    Decisions Resources Group. Chronic Pain: Disease Landscape and Forecast. 2016; 8

    (9)    2015 NIH Report: David B. Reuben, Anika A. H. Alvanzo, Takamaru Ashikaga, G. Anne Bogat, Christopher M. Callahan, Victoria Ruffing, David C. Steffens. National Institutes of Health Pathways to Prevention Workshop: The Role of Opioids in the Treatment of Chronic Pain. Annals of Internal Medicine, 2015; DOI: 10.7326/M14-2775

    (10) Decision Resources Group (2016)

    Primary Logo

    View Full Article Hide Full Article
View All Sorrento Therapeutics Inc. News