Sorrento Therapeutics, Inc. announces a $4.6 Million U.S. Government contract from the NIAID for a Sensitive, Reusable, and Rapid Diagnostic Platform for Pandemic Preparedness

SAN DIEGO, June 13, 2023 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (OTC: SRNEQ, "Sorrento") today announces it has been awarded a $4.6 million contract from the National Institute of Allergy and Infectious Diseases, a part of the National Institutes of Health (NIH) for the development of in vitro diagnostics for biodefense, antimicrobial resistant infections and emerging infectious diseases. The award shows NIAID’s support for the development of promising quantitative diagnostics technologies for detection of signatures from biothreat pathogens as well as pathogens causing emerging or reemerging infectious diseases, and for pandemic preparedness.

The purpose of the contract is to develop a diagnostic platform for rapid and sensitive detection of proteins and other biomolecules that improves existing rapid testing devices (RTDs). Current diagnostic RTDs have long development timelines and low clinical sensitivity. Sorrento and Virex Health, LLC (Virex Health), a wholly owned subsidiary of Sorrento, plan to develop an adaptable diagnostic platform which is highly sensitive and cost-effective for multiple pathogens. This approach leverages the expertise of Sorrento to rapidly select and produce highly specific antibodies from its proprietary G-MAB™ library targeting viral and bacterial antigens, combined with a chemical detection approach and the existing infrastructure of the glucometer industry.

Virex Health has developed a proprietary technology for electrochemical detection of bioanalytes (virus, proteins, and small molecules) using the similar electronic device requirements employed in reusable glucometers and has reformulated the chemistry contained on the test strip to detect pathogens. In so doing, Virex Health leverages an existing infrastructure that produces tens of millions of devices per year. The objective is to address the needs of rapid detection for biodefense and new emerging infectious disease preparedness. At the conclusion of the contract, Sorrento and Virex Health intend to deliver a rapid, sensitive, accurate and scalable diagnostic capable of being readily deployed in response to an emergent or reemergent threat. “Once the diagnostic platform is developed, our unique approach can be quickly transferred to other pathogens and deployed when needed on a large scale,” said Scott Schaus, Ph.D., Co-founder and Chief Technology Officer for Virex Health.

“We are pleased to accept this award and collaboration with the U.S. Government to ensure that, as a society, we are better prepared for the next pandemic. This award validates our unique approach of combining antibody development and electrochemical-based diagnostics for a rapid response to save lives and manage infectious disease outbreaks,” stated Henry Ji, Ph.D., Chairman and CEO of Sorrento.

"This project has been funded in whole or in part with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N93023C00024".

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 next-generation tyrosine kinase inhibitors ("TKIs"), 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 STI-1558 and COVI-MSC™, and diagnostic test solutions, including COVIMARK^™.

Sorrento's commitment to life-enhancing therapies for patients is also demonstrated by our effort to advance a 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 postherpetic neuralgia (PHN). RTX has been cleared for a Phase II trial for intractable pain associated with cancer and a Phase II trial in osteoarthritis patients. Positive final results from the Phase III Pivotal Trial C.L.E.A.R. Program for SEMDEXA™, its novel, non-opioid product for the treatment of lumbosacral radicular pain (sciatica), were announced in March 2022. ZTlido^® was approved by the FDA on February 28, 2018.

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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 products, technologies and prospects, the development of a diagnostic platform for rapid and sensitive detection of proteins or other biomolecules that improves on existing rapid testing devices and that is adaptable, highly sensitive and cost-effective, Sorrento’s unique approach and its platform’s transferability to other pathogens, Sorrento’s and Virex Health’s ability to address the needs of rapid detection for biodefense and new emerging infectious disease preparedness and the delivery of a rapid, sensitive, accurate and scalable diagnostic capable of being readily deployed in response to an emergent or reemergent threat. 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 technologies and prospects, including, but not limited to risks related to safety and efficacy of STI-1558 and seeking regulatory approval for STI-1558; clinical development risks, including risks in the progress, timing, cost, and results of clinical trials and product development programs; risks related to Sorrento’s multiple ascending dose (MAD) Phase 1 Study with STI-1558; 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, including those for STI-1558, may not be replicated in continuing or 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 product candidates’ strategies; risks related to the global impact of COVID-19; risks relating to the voluntary proceedings under Chapter 11 in the Bankruptcy Court (the "Chapter 11 Cases"), Sorrento's ability to continue operating in the ordinary course while the Chapter 11 Cases are pending, the timing and outcome of the Chapter 11 Cases, Sorrento's ability to obtain timely approval by the Bankruptcy Court of the motions filed in the Chapter 11 Cases, employee attrition and Sorrento's ability to retain senior management and other key personnel due to the distractions and uncertainties of the Chapter 11 Cases, Sorrento's ability to maintain relationships with suppliers, customers, employees and other third parties and regulatory authorities as a result of the Chapter 11 Cases, the Bankruptcy Court's rulings in the Chapter 11 Cases, the length of time that Sorrento will operate under Chapter 11 protection and the continued availability to Sorrento of operating capital during the pendency of the Chapter 11 Cases, risks associated with any third party motions in the Chapter 11 Cases, increased administrative and legal costs related to the chapter 11 process, exposure to potential litigation and inherent risks involved in a bankruptcy process, the potential adverse effects of the Chapter 11 Cases on Sorrento's liquidity or results of operations, or Sorrento's ability to timely file its periodic reports or meet periodic reporting requirements with the SEC; 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, 2022 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^® and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc.

G-MAB™, DAR-T™, Seprehvec™, SOFUSA™, COVISHIELD™, COVIDROPS™, COVI-MSC™, COVIMARK™, Fujovee™ and Ovydso™ are trademarks of Sorrento Therapeutics, Inc.

SEMDEXA™ (SP-102) is a trademark of Semnur Pharmaceuticals, Inc. A proprietary name review by the FDA is planned.

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

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