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TONIX PHARMACEUTICALS HOLDING CORP.[TNXP]

Date Filed : Jul 27, 2021

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EX-99.012ex99-1.htmPRESS RELEASE

TONIX PHARMACEUTICALS HOLDING CORP. 8-K

 

Exhibit 99.01

 

 

Tonix Pharmaceuticals Announces Agreementto Acquire Infectious Disease R&D Facility to Accelerate Development of Vaccines and Antiviral Drugs

 

R&D Facility in Frederick, MD is Expectedto Provide Internal Capacity to Discover and Develop Vaccines and Antiviral Drugs Against COVID-19, its Variants and Other InfectiousDiseases

 

Facility, Currently Owned and Operated byTonix Partner Southern Research, has Housed Research Relating to Tonix’s COVID-19 Vaccine Candidate, TNX-1800 and Smallpoxand Monkeypox Vaccine Candidate, TNX-801

 

 

CHATHAM, N.J., July 27, 2021 – TonixPharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announcedthe signing of a Purchase and Sale Agreement to acquire an approximately 48,000 square foot research and development (R&D)facility in Frederick, MD to support Tonix’s expanding infectious disease pipeline, including TNX-1800, a live replicatingviral vaccine designed to protect against COVID-19, TNX-801, a live vaccine designed to protect against smallpox and monkeypox,and TNX-3500, a small molecule antiviral to inhibit replication of SARS-CoV-2.

 

Tonix agreed to purchase the R&D facilityfrom Southern Research, a research collaboration partner for TNX-1800 and TNX-801 development. The facility currently operatesat biosafety level 2 (BSL-2) containment. Pending transfer and approval of relevant permits, Tonix expects the transaction to closeand the facility to be operational in the fourth quarter of 2021. Southern Research plans to consolidate its research activitiesat its Birmingham, AL campus. Tonix and Southern Research plan to continue those aspects of their collaboration on the developmentof vaccines and antivirals that are ongoing at the Birmingham, AL campus.

 

“The Fredrick facility will bea major expansion of our R&D capabilities,” stated Seth Lederman, M.D., President and Chief Executive Officer of Tonix.“We believe this facility will ensure adequate resources and capacity to support and grow our pipeline of vaccines and antiviraltherapeutics. In addition, we view control of in-house facilities as a strategic capability to ensure the speed and efficiencywith which we can develop vaccines and antiviral products in the future against known, emerging or novel pathogens.”

Dr. Lederman continued, “WhileCOVID-19 has the appearance of being controlled in certain geographic centers, reports of increasing infections in both unvaccinatedand vaccinated individuals, primarily related to new variants, have led to new mask mandates and restrictions in parts of the U.S.as well as new lockdowns and other restrictions in Europe and elsewhere. These concerning trends point to an urgent need for morerobust vaccine technology and better overall preparedness. The COVID-19 pandemic revealed weaknesses in the U.S. domestic capabilityto conduct infectious disease R&D and produce vaccines and therapeutics, particularly in the setting of an interrupted globalsupply chain. We believe our planned capabilities at the Frederick facility will provide greatly needed domestic resources. Thefacility is ideally located in Maryland’s ’biotech corridor’, which is rich in highly skilled talent, and isalso close to the center of the U.S. biodefense research community.”

Josh Carpenter, PhD, Chief ExecutiveOfficer of Southern Research stated, “We are delighted that Tonix will be acquiring the Frederick research campus. This isanother chapter in a robust partnership that will be made even stronger. We have enjoyed partnering with Tonix on TNX-1800 andTNX-801 vaccine projects and look forward to continued collaboration on these projects, as well as TNX-3500 with work performedat our Birmingham campus.”

 
 

 

Tonix’s Fredrick R&D facilitywill complement its Advanced Development Center (ADC) being constructed in New Bedford, MA and the Commercial Manufacturing Center(CMC) that Tonix is planning in Hamilton, MT. The ADC will house laboratories dedicated to process analytical development and pilotmanufacturing of its vaccine candidates. The CMC is expected to support commercial scale manufacturing of vaccine products.

 

Tonix Pharmaceuticals HoldingCorp.

Tonix is a clinical-stage biopharmaceuticalcompany focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human diseaseand alleviate suffering. Tonix’s portfolio is primarily composed of central nervous system (CNS) and immunology product candidates.The Company’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addictionconditions. Tonix’s lead CNS candidate, TNX-102 SL1, is in mid-Phase 3 development for the management of fibromyalgia.Tonix’s immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression,cancer, and autoimmune diseases. Tonix’s lead vaccine candidate, TNX-18002, is a live replicating vaccine basedon the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix reported positiveefficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-8012, live horsepox virus vaccine forpercutaneous administration, is in development to protect against smallpox and monkeypox. TNX-35003 (sangivamycin) isa small molecule antiviral drug in the pre-IND stage of development.

 

1TNX-102 SL is an investigationalnew drug and has not been approved for any indication.

2TNX-1800 and TNX-801are investigational new biologics and have not been approved for any indication.

3TNX-3500 is an investigationalnew drug at the pre-IND stage of development and has not been approved for any indication.

 

This press release and further informationabout Tonix can be found at www.tonixpharma.com.

 

About Southern Research

 

Founded in 1941, Southern Research (SR) is an independent, 501(c)(3)nonprofit affiliated with the University of Alabama at Birmingham. SR is an applied scientific research organization with morethan 400 scientists and engineers working across four divisions: CRO services, Drug Discovery, Energy Storage, and Engineering.SR has supported the pharmaceutical, biotechnology, defense, aerospace, environmental, and energy industries. SR works on behalfof the National Institutes of Health, the U.S. Department of Defense, the U.S. Department of Energy, NASA and other major aerospacefirms, utility companies, and other external academic, industry and government agencies. SR pursues entrepreneurial and collaborativeinitiatives to develop and maintain a pipeline of intellectual property and innovative technologies that positively impact real-worldproblems. SR has numerous ongoing drug discovery programs, which encompass drug discovery programs to combat various forms of cancer,Alzheimer’s, schizophrenia, opioid use disorder, human immunodeficiency virus, disease, Parkinson’s, tuberculosis,influenza, and others. SR’s strong history, which includes nearly 80 years of successful collaborations to solve complexproblems, has led to the discovery of seven FDA-approved cancer drugs—a number rivaling any other U.S. research institute.Furthermore, experts at SR are well-equipped to assist with the challenging landscapes of drug design and development technologiesand market viability. SR is headquartered in Birmingham, Alabama.

 

 
 

 

Further information about SR can be found at https://southernresearch.org

 

Forward Looking Statements

Certain statements in this press release areforward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identifiedby the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,”“expect,” and “intend,” among others. These forward-looking statements are based on Tonix's current expectationsand actual results could differ materially. There are a number of factors that could cause actual events to differ materially fromthose indicated by such forward-looking statements. These factors include, but are not limited to, the development of R&D facilities,risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertaintiescaused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates;our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third partypayor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. Aswith any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercializationof new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should readthe risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the Securitiesand Exchange Commission (the “SEC”) on March 15, 2021, and periodic reports filed with the SEC on or after the datethereof. All Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements.The information set forth herein speaks only as of the date thereof.

 

Contacts

Jessica Morris (corporate)

Tonix Pharmaceuticals

investor.relations@tonixpharma.com

(862) 904-8182

 

Olipriya Das, Ph.D. (media)

Russo Partners

Olipriya.Das@russopartnersllc.com

(646) 942-5588

 

Peter Vozzo (investors)

Westwicke/ICR

peter.vozzo@westwicke.com

(443) 213-0505

 

 

 

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