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Sorrento Announces COVISTIX COVID-19 Virus Rapid Antigen Detection Test Detects the Omicron Variant

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  • COVISTIX maintains its ability to detect the Omicron Variant, in addition to detecting SARS-CoV-2 and all of its major variants of concern (VoCs);

  • COVISTIX has the potential to be a “Best-in-Class” rapid COVID-19 virus antigen detection test:

    • Comparative studies with all available EUA-approved COVID-19 virus rapid antigen detection tests demonstrated that COVISTIX significantly outperforms in terms of limit of detection (LOD) of the N proteins and/or live viruses of SARS-CoV-2 and its major VoCs; and

    • In a large in-field real-world clinical study for all-comers including asymptomatic patients, COVISTIX demonstrated approximately 20% higher sensitivity vs. a leading global brand (detailed results can be found at: https://www.medrxiv.org/content/10.1101/2021.09.10.21263410v1);

  • COVISTIX is currently approved and marketed in Mexico, Brazil and is CE marked in Europe;

  • Sorrento is constructing a new US domestic production facility in San Diego, California with an automated assembly line targeting an initial capacity of six (6) million COVISTIX tests per month;

  • Sorrento is also in discussions with multiple US States for incentive packages to further expand its US manufacturing capacity pending strong US and global demand for COVISTIX tests; and

  • Combining OEM and in-house manufacturing capacities, Sorrento is positioning to provide 30 million COVISTIX tests per month in the near term and expand to 50 to 100 million COVISTIX tests monthly to accommodate accelerating demand globally.

SAN DIEGO, Dec. 27, 2021 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) announced today that initial testing of COVISTIX on recombinant N proteins demonstrated its ability to detect the Omicron variant, in addition to detecting the original SARS-CoV-2 virus and its other major VoCs such as the delta and delta-plus strains. The COVISTIX detection levels were similar for all variants. The ease of use and timely detection of Omicron infection was demonstrated by a recent case report of a Mexico patient infected with the Omicron variant detected first with COVISTIX in about 15-minutes test time. This result was confirmed a day later by RT-PCR and sequence verified a few days later to be Omicron infection.

In a laboratory setting, Sorrento has also studied the ability of COVISTIX to detect the Omicron variant compared to other Emergency Use Authorization (EUA) approved, commercially available COVID-19 virus rapid antigen tests. Initial lab results demonstrate that COVISTIX was able to detect the Omicron N protein at a significantly lower level than other commercially available tests. With a difficulty to detect the Omicron N protein at low levels, some of the EUA-approved and marketed rapid tests may have a tough time detecting the Omicron infection at a reasonable sensitivity. False negative readings for infected asymptomatic patients could lead to a false sense of security and the inability to control outbreaks and achieve normal social and business routines.

Sorrento currently has the capacity to produce 30,000,000 COVISTIX tests a month and is currently building up its manufacturing capacity in the US. The company anticipates having a fully automated assembly line capable of producing 6,000,000 COVISTIX units per month up and running in Q1 2022. Pending US and global demand, this capacity could potentially be increased to over 100 million monthly in 2022.

About Sorrento Therapeutics, Inc.

Sorrento is a clinical and commercial stage biopharmaceutical company developing new therapies to treat cancer, pain (non-opioid treatments), autoimmune disease 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”), immuno-cellular therapies (“DAR-T™”), antibody-drug conjugates (“ADCs”), and oncolytic virus (“Seprehvec™”). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including Abivertinib, COVI-AMG™, COVISHIELD™, COVI-MSC™ and COVIDROPS™; and diagnostic test solutions, including COVITRACK™ and COVISTIX™.

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 1B 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 COVISTIX, including its sensitivity and specificity, limit of detection and the speed at which COVISTIX provides results or is able to provide results; COVISTIX’s ability to detect SARS-CoV-2 and its major variants of concern (VoCs), including the Omicron variant; the performance capabilities of COVISTIX, including compared to available EUA-approved COVID-19 virus rapid antigen detection tests; Sorrento’s current and future planned manufacturing capacity for COVISTIX, including the expected timing for expanding capacity and the potential for expanding production in one or more US states based upon state incentives; and Sorrento’s potential position in the diagnostics 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 additional studies and seeking regulatory approval for COVISTIX, including the timing for receipt of any such approval; conducting and receiving results of clinical studies; clinical development risks, including risks in the progress, timing, cost, and results of clinical studies 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; commercial risks related to COVISTIX, including expectations regarding demand for and market acceptance of COVISTIX; expectations regarding maintaining and strengthening its relationships with partners and customers; risks of manufacturing and supplying COVISTIX domestically and globally; risks related to leveraging the expertise of its employees, subsidiaries, affiliates and partners to assist the company in the execution of its COVID-19 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.

Media and Investor Relations Contact
Dorman Followwill
Email: mediarelations@sorrentotherapeutics.com

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

G-MAB™, DAR-T™, Seprehvec™, SOFUSA™, COVI-AMG™, COVISHIELD™, COVIDROPS™, COVI-MSC™, COVITRACK™ and COVISTIX™ are trademarks of Sorrento Therapeutics, Inc.

SEMDEXA™ is a trademark of Semnur Pharmaceuticals, Inc.

ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc.

All other trademarks are the property of their respective owners.

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