DTRA Awards Leidos Project to Conduct Clinical Trials for COVID-19 Therapeutics

Leidos to use new clinical trial prototype enhancing flexibility and speed

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Feb 25, 2021, 08:00 ET

RESTON, Va., Feb. 25, 2021 /PRNewswire/ -- Leidos (NYSE: LDOS), a FORTUNE® 500 science and technology leader, was recently awarded a new project agreement by the Defense Threat Reduction Agency (DTRA) to conduct clinical studies of therapeutics for treating COVID-19. The cost-plus-fixed-fee agreement was awarded through the Medical CBRN Defense Consortium. It holds a base value of $22 million and a base period of performance of 24 months.

"This award reinforces our commitment to fighting this deadly pandemic," said Liz Porter, Leidos Health Group president. "We are proud to conduct these clinical trials and support our customers' mission to develop life-saving drugs, vaccines and therapeutics for the men and women of our armed forces."

Through this contract, Leidos will use a new clinical trial prototype to enable real-time data collection, which will support rapid initiation, amendment and evaluation of studies. Leidos will use the prototype to simultaneously conduct two clinical studies using new drug combinations to treat COVID-19. The studies will seek safe and effective doses and regimens for coronavirus patients. The trials will also pursue enhancements to military success by improving long-term lung function and reducing neurocognitive deficits caused by COVID-19.

The Leidos trial prototype aims to enable quicker evaluations and improvements as the study evolves. It uses an electronic data capture system to collect, evaluate and assess symptom severity as well as clinical outcomes in real-time for patients. This could enable the trial's data and safety monitoring board to quickly evaluate potential safety signals or evidence of efficacy. The prototype is also designed to analyze the need for additional patients to show statistical significance. These evaluations could improve potential Phase 3 studies and demonstrate efficacy using the selected drug combination.

Leidos is collaborating with Personal Health Insights, Inc., Syneos Health and SCOPE International USA, Inc., on this prototype project.

About Leidos

Leidos is a Fortune 500® information technology, engineering, and science solutions and services leader working to solve the world's toughest challenges in the defense, intelligence, homeland security, civil, and health markets. The company's 39,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Va., Leidos reported annual revenues of approximately $12.30 billion for the fiscal year ended January 1, 2021. For more information, visit www.Leidos.com.

Statements in this announcement, other than historical data and information, constitute forward-looking statements that involve risks and uncertainties. A number of factors could cause our actual results, performance, achievements, or industry results to be very different from the results, performance, or achievements expressed or implied by such forward-looking statements. Some of these factors include, but are not limited to, the risk factors set forth in the company's Annual Report on Form 10-K for the period ended January 1, 2021, and other such filings that Leidos makes with the SEC from time to time. Due to such uncertainties and risks, readers are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date hereof.