Tonix Pharmaceuticals Holding Corp. announced data presented at an oral Keynote Talk at the Vaccine Congress 2024 held June 24-25, 2024 in Prague, Czech Republic. The presentation titled, "A New Live Virus, One Dose Vaccine Platform for Mpox, Smallpox and COVID-19", detailed the Company's vaccine platform, including TNX-801 (horsepox, live virus) vaccine for preventing mpox (formerly known as monkeypox) and smallpox and TNX-1800 (horsepox expressing SARS-CoV-2 spike protein) for protecting against COVID-19.

TNX-801 and TNX-1800 are live replicating attenuated vaccines based on horsepox that are believed to provide immune protection with better tolerability than modern vaccinia viruses. In the presentation, Tonix highlighted positive preclinical efficacy data, demonstrating that TNX-801 protected non-human primates against lethal challenge with intratracheal Clade 1 monkeypox virus3. TNX-801 also has the potential to be used as a viral vector platform, for which recombinant versions can be developed to protect against other infectious diseases.

Tonix developed TNX-1800 as a vaccine to protect against COVID-19. The presentation noted that the global mpox outbreak, which commenced in 2022, has affected over 90,000 persons in countries where mpox had previously not been endemic, including Europe and the US. The keynote presentation also included preclinical data for TNX-1800, demonstrating immunity and tolerability.

TNX-1800 was selected by the NIH's Project NextGen for inclusion in clinical trials as part of a select group of next generation COVID-19 vaccine candidates with the intent to identify promising vaccine platforms. NIH plans to conduct a Phase 1 trial and cover the full cost, while Tonix provides the vaccine candidate. Tonix's development portfolio is focused on central nervous system (CNS) disorders. Tonix's priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia.

Tonmya has not been approved for any indication. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of products; risks related to the failure of the company's products; risks related to the Company's vaccine platform, and the company's vaccine platform, including the company's vaccine platform, which is designed to provide long-term protection from mpox and smallpox and TNX -1800 (horsepox expressing Sars-CoV-2 spike proteins) for protecting against COVID.

Tonix Medicines, company's commercial subsidiary, markets Zembrace®? SymTouch®? (sumatriptan injection) 3 mg and Tosymra®?

(sumatript an nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults. Tonix's product development candidates are investigational new drugs or biologics and have not been approved for any indication; Tonmya?? is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromy fibromyalgia.

Tonmy a has not been approved for any indications. There are a number of factor that could cause actual events to vary materially from those indicated by suchforward-looking statements. These factors includes, but are not limited to the failure to obtain FDAclearances or approvals and noncompliance With FDA regulations; risks related to The failure to successfully market any of its products; risks related to the company's products; risks associated to the failure to successfully market all of its products; risks related of its products; risks related.