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     120  0 Kommentare Sorrento Receives US FDA Clearance to Proceed With Phase 1 Study for STI-2099 (Intranasal COVIDROPS) in Healthy Volunteers and Outpatient Treatment for Newly Diagnosed COVID-19 Positive Patients - Seite 2

    About Sorrento Therapeutics, Inc. 

    Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to treat cancers and COVID-19. Sorrento's multimodal, multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as fully human antibodies (“G-MAB library”), clinical stage immuno-cellular therapies (“CAR-T”, “DAR-T”), antibody-drug conjugates (“ADCs”), and clinical stage oncolytic virus (“Seprehvir”). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including COVIGUARD, COVI-AMG, COVISHIELD, Gene-MAb, COVI-MSC and COVIDROPS; and diagnostic test solutions, including COVITRACK, COVISTIX and COVITRACE.

    Sorrento's commitment to life-enhancing therapies for patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule, resiniferatoxin (“RTX”), and SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (SEMDEXA), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, and to commercialize ZTlido (lidocaine topical system) 1.8% for the treatment of post-herpetic neuralgia. RTX has completed a Phase IB trial for intractable pain associated with cancer and a Phase 1B trial in osteoarthritis patients. SEMDEXA is in a pivotal Phase 3 trial for the treatment of lumbosacral radicular pain, or sciatica. ZTlido was approved by the FDA on February 28, 2018.

    For more information visit www.sorrentotherapeutics.com

    Forward-Looking Statements

    This press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Sorrento Therapeutics, Inc., under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding the therapeutic potential of STI-2099 and STI-2020 and their respective impacts on the SARS-CoV-2 virus; the preclinical and clinical testing of STI-2099 and STI-2020; the potential safety and effectiveness of STI-2099 and STI-2020; the expectation of conducting clinical trials to evaluate STI-2099 alone or in combination with STI-2020; the expected impact STI-2099 and STI-2020 will have against current and future variants of SARS-CoV-2 virus; the potential for STI-2099 to halt infection of the lungs or prevent severe infection; the potential for STI-2099 to prevent hospitalization or accelerate the discharge rate for hospitalized COVID-19 patients; the expected development of additional intranasal antibody formulations that have activity against SARS-CoV-2 virus variants that evade inhibition; and Sorrento’s 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 conducting pre-clinical and clinical studies and seeking regulatory approval for STI-2099, including the timing for receipt of any such approval; conducting and receiving results of clinical trials; 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 COVID-19 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, 2020, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release except as required by law.

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    Sorrento Receives US FDA Clearance to Proceed With Phase 1 Study for STI-2099 (Intranasal COVIDROPS) in Healthy Volunteers and Outpatient Treatment for Newly Diagnosed COVID-19 Positive Patients - Seite 2 FDA granted IND clearance today for the commencement of a Phase 1 safety and pharmacokinetic study for STI-2099 (COVIDROPS) in healthy volunteers and outpatients with mild COVID-19 disease with or without a simultaneous intravenous injection of …