Tonix Pharmaceuticals (NASDAQ: TNXP), a fully integrated biopharmaceutical company with marketed products and a pipeline of development candidates, is reporting that the World Health Organization’s (“WHO”) preferred target product profile (“TPP”) aligns with the characteristics of its proprietary TNX-801 (horsepox, live virus) vaccine; Tonix is developing the vaccine for mpox (formerly known as monkeypox). WHO released the TPP at the Mpox Research and Innovation Scientific Conference, which was held Aug. 29–30, 2024,

According to the announcement, key elements of the WHO draft TPP include single-dose, durable protection, administration without special equipment and stability at ambient temperature.

“The characteristics of TNX-801 align with the draft TPP released at the WHO-sponsored Mpox Research and Innovation Scientific Conference,” said Tonix Pharmaceuticals CEO Seth Lederman, MD, in the press release. “The recent WHO declaration of a Public Health Emergency of International Concern (‘PHEIC’) underscores the urgent need for new vaccines to control this outbreak and save lives. We have been motivated to develop TNX-801 because single-dose vaccines simplify logistics of administration, achieve higher coverage by reducing vaccinee dropout between doses and allow for case-contact or ‘ring’ strategies to vaccinate the contacts of confirmed mpox patients.”

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About Tonix Pharmaceuticals Holding Corp.

Tonix is a fully integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s priority is to submit a New Drug Application (“NDA”) to the FDA in October 2024 for TNX-102 SL, a product candidate for which two statistically significant phase 3 studies have been completed for the management of fibromyalgia. The FDA has granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction. Tonix recently announced the U.S. Department of Defense (“DoD”), Defense Threat Reduction Agency (“DTRA”) awarded it a contract for up to $34 million over five years in an Other Transaction Agreement (“OTA”) to develop TNX-4200 small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. For more information about the company, please visit www.TonixPharma.com.

NOTE TO INVESTORS: The latest news and updates relating to TNXP are available in the company’s newsroom at https://ibn.fm/TNXP

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