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At Tonix: Two Key Medical Catalysts Before Year End

Tonix Pharmaceuticals

(Nasdaq: TNXP)
52-Week Range: $0.39-$5.38
Average Daily Volume: 24 Million

With $67 million in pro forma cash at June 30, 2020, Tonix Pharmaceuticals (TNXP) is closing in on topline data from two important programs that address unmet needs in billion-dollar medical categories.

#1: By year end, Tonix expects to release topline data from a pivotal Phase 3 registration trial in fibromyalgia. Positive results would move Tonix one step closer to tapping into the nearly $9 billion fibromyalgia drug market created by Lyrica and Cymbalta. Now that both are generic, the dollar value of the market has decreased but the patients have not disappeared –in fact, if anything, their numbers have increased. Despite their searing success, both Lyrica and Cymbalta (and their generic versions) have well-known treatment-limiting side effects. Results from two large prior trials suggest Tonix’s sublingual bedtime candidate may offer a large advantage in tolerability, on top of promising efficacy.

#2: Also before year end: Tonix expects to release data from advanced non-human primate challenge studies of its lead Covid-19 T cell eliciting vaccine candidate utilizing a live attenuated virus vector. Tonix’s decision to develop T cell vs. antibody eliciting vaccines puts it in a race alongside Merck, the only other US company developing Covid-19 vaccines with a similar approach.

Condensed Overview

Tonix CEO Seth Lederman, MD covers highlights of the company’s product strategy and the status of its two lead programs – a Phase 3 candidate in fibromyalgia, and a T cell eliciting Covid-19 vaccine now in SARS-CoV-2 challenge studies with non-human primates.
(Approximate running time: 9 minutes)

TNXP At A Glance

Additional details on Tonix’s registration-directed clinical strategy in fibromyalgia, and why a live attenuated virus is Tonix’s – and also Merck’s—technology of choice for a Covid-19 vaccine designed to confer long term immunity, and prevent forward expression, or contagion, an absolute requirement to prevent the spread of any virus. Based on current data, antibody eliciting vaccines currently in the clinic cannot make these claims.

Corporate Presentation

Tonix Corporate Presentation
(PowerPoint)

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www.tonixpharma.com

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Important notice, please read: The information and statistical data contained herein may contain forward-looking statements that reflect the company’s intentions, expectations, assumptions, or beliefs concerning future events, including, but not limited to, expectations with respect to FDA and other regulatory bodies approval of new products, technology, and product development milestones, the ability of the company to leverage its product development and negotiate favorable collaborative agreements, the commencement of sales, the size of market opportunities with respect to the company’s product candidates and sufficiency of the company’s cash flow for future liquidity and capital resource needs and other risks identified in the Risk Factor Section of the company’s Annual Report on Form 10-K and any subsequent reports filed with the SEC. We do not undertake to advise you as to any change in this information. The forward-looking statements are qualified by important factors that could cause actual results to differ materially from those in the forward-looking statements. In addition, significant fluctuations in quarterly results may occur as a result of varying milestone payments and the timing of costs and expenses related to the company’s research and development programs. This is not a solicitation of any offer to buy or sell. Redington, Inc. is paid by subject company as an investor relations advisor, and its employees or members of their families may from time to time own an equity interest in companies mentioned herein.