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Tonix Pharmaceuticals Plans Vaccine Development and Manufacturing Facility in Hamilton

Tonix Plans to Bring Jobs, Join Bioscience Cluster in Bitterroot Valley

Facility Planned to Produce Vaccines at Commercial Scale, Including Those Under Development for Covid-19

HAMILTON, MONTANA (DECEMBER 23, 2020) – New Jersey-based Tonix Pharmaceuticals Holding Corp.(Nasdaq: TNXP) (Tonix or The Company) closed on an approximately 44-acre parcel of land on Old Corvallis Road in Hamilton, Montana. The sale took place on December 17, 2020.

The site is intended to become the home of a vaccine production facility and it is expected to create a number of professional and support jobs. The site is large enough to accommodate additional buildings in the future and Tonix hopes for expansion on the site over time. Such expansion would result in more jobs and economic growth in the coming years.

Construction timing for the Tonix facility is dependent on planning and permitting, but groundbreaking may occur as early as first quarter 2022.

Tonix CEO on Future

“We’re excited to be part of Montana’s growing bioscience community,” said Seth Lederman, M.D., the co-founder and chief executive officer of Tonix. “The COVID-19 pandemic exposed weaknesses in domestic vaccine development and manufacturing capabilities. Tonix seeks to be a leader in the re-domestication of American vaccine development and production. We believe it is critical to bring these capabilities and high-tech jobs back to the U.S. both to finish the fight against the COVID-19 pandemic and to prepare for potential future pandemics.  After the pandemic, we believe that it’s likely COVID-19 will become endemic. That means humans will have to co-exist with COVID-19 and it will be a constant threat that can only be managed by maintaining a vaccinated population. To manage COVID-19 in the future, we need a next generation COVID-19 vaccine that can be part of the standard childhood immunizations, like MMR for mumps, measles and rubella. We expect that such a vaccine will be a live-virus vaccine, because of their potential to provide durable protection and block transmission.”

Dr. Lederman continued, “The planned Montana facility reflects our commitment to the development of our vaccines and, along with the recent announcement of our new Advanced Development Center in Massachusetts, takes us a step closer to controlling and vertically integrating more of our development and manufacturing activities. While we applaud the recent successes and Emergency Use Authorizations of the first-generation COVID-19 vaccines, we believe that Tonix’s live replicating viral vector vaccine technology in development remains an important initiative given all the unanswered questions about those vaccines due to the novelty of their underlying technology. Specifically, it is unknown whether the first-generation vaccines provide durable protection (for example a year after vaccination), protect against death, or block forward transmission. Tonix’s lead COVID-19 vaccine candidate TNX-1800, is based on the backbone of the smallpox vaccine developed by Edward Jenner more than 200 years ago, which led to the eradication of smallpox. TNX-1800 has been designed to have several important features including one shot dosing, ability to elicit a ‘take’ biomarker for T cell protection, stability during transport and storage, and scalability of manufacturing.”

Broad Support from Governor-elect Gianforte and U.S. Senators Tester, Daines

U.S. Senators Jon Tester and Steve Daines and Governor-elect Greg Gianforte have shown broad support of Montana’s bioscience industry.

“Good news for Hamilton! It’s great to see Montana leading in the bioscience industry which will help support Montana jobs and end our reliance on other countries for critical vaccines and prescription drugs,” said Senator Steve Daines.

Senator Jon Tester echoed the sentiment, noting, “Montanans are hard workers and I am pleased to see more manufacturing jobs come to our state. The growing bioscience industry in Montana is good for our economy and will improve our public health.”

Tonix joins the U.S. National Institutes of Health’s Rocky Mountain Laboratories (RML) in Hamilton, which is an internationally recognized leader in vaccine development and virology research.  GlaxoSmithKline (GSK) also has a vaccine manufacturing facility in Hamilton.

“It’s no surprise that the bioscience industry is thriving in Montana,” said Governor-elect Gianforte. “We have an unmatched work ethic. We’re problem solvers. And we do it all from one of the most beautiful places in the world.”

Tonix intends to follow and maintain GMP (Good Manufacturing Practices) at the planned Hamilton facility. GMP assures all federal, state, and international safety and production standards are met with operations of the facility.

The Tonix sale meets goals set in Ravalli County’s growth policy. The policy encourages economic development and expanded employment opportunities. The Bessenyey/Van Tuyn family sold the parcel to Tonix. Sterling Commercial Real Estate Advisors brokered the sale.

“As we saw with this deal, collaboration is the key to robust economic opportunity in Montana,” said Matt Mellott, lead broker with Sterling CRE. “Ravalli County officials, Julie Foster with the Ravalli County Economic Authority and the local seller all played critical roles in moving this project forward.”

Tonix is developing a potential COVID-19 vaccine, TNX-1800 (modified horsepox virus), for which it expects efficacy animal data in the first quarter of 2021.

Tonix in Hamilton

About Tonix Pharmaceuticals

Tonix Pharmaceuticals Holding Corp. is a clinical-stage biopharmaceutical company committed to discovering and developing new therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases.

Our mission is to improve the lives of patients by identifying, researching and developing promising therapies which have the potential to address needs not currently fulfilled by existing products.

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For information on this release, please contact Sarah Knobel. For information on available land in Montana, contact Advisor Matt Mellott.