Tonix Announces Positive Pre-NDA Meeting – NDA Submission On Schedule

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Increasing The Focus on Fibromyalgia

Fibromyalgia Trial Meets All Endpoints

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Tonix Pharmaceuticals Holding Corp.

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Summary.&nbsp;&nbsp;During 2Q23, Tonix acquired two currently marketed products for migraine headaches that turn it into an operating company with product sales. These products fit with its new focus on CNS drugs and its four clinical trials expected to announce topline results before the end of 2023.&nbsp;The company&nbsp;reported a loss of $28.4 million or $(2.68) per share, and a cash balance of $25.6 million in cash on June 30, 2023.
Two CNS Products Have Been Acquired. In June, Tonix acquired two migraine headache products containing sumatriptan with delivery technologies. Zembrace SymTouch is an injectable sumatriptan packaged with an autoinjector for ease of use. Tosymra is a sumatriptan nasal spray with a permeation enhancer for rapid absorption. These products had about $30 million in sales in the previous 12 months, and bring a CNS sales force and customer base for Tonixâ€™s future CNS products.
New Products Fit With Pipeline Products. In 4Q23, Tonix is expecting to announce top-line results from its Phase 3 RESILIENT trial testing TNX-102 SL in fibromyalgia. If successful, Tonix would have two trials to support an application for FDA approval. 
TNX-1900 Is Expected To Report Results In 4Q. Tonix is also expecting to announce data from its Phase 2 PREVENTION trial testing TNX-1900 in chronic migraine headache during 4Q23. This is the first indication for TNX-1900, a proprietary form of oxytocin formulated for nasal delivery. 
Three additional investigator-initiated trial (IIT) indications for TNX-1900 also began in 2Q23. The Phase 2 STROBE trial began began treating patients for binge eating disorder, while The Phase 2 POWER trial began in childhood obesity. Both trials are being conducted at Massachusetts General Hospital. A Phase 2 testing TNX-1900 in social safety learning in social anxiety disorder (SAD) began a proof-of-concept study at the University of Washington.
Results From Two Phase 2 Studies Are Expected To Be Announced. Immediate release tianeptine has been used as a twice-daily antidepressant in Europe for over 30 years. TNX-601 ER is an extended release formulation being testing in Major Depressive Disorder. The Phase 2 UPLIFT trial&nbsp;is a placebo-controlled trial with 6 weeks of once-daily dosing expected to report results in the fourth quarter of 2023. The primary endpoint is mean change from baseline in the MADRS (Montgomery-Asberg depression rating scale) at week 6. Results from the Phase 2 PREVAIL study testing TNX-102 SL in Long COVID are also expected to be announced in 3Q23.
As discussed in our<a href="https://www.channelchek.com/research-reports/25887"> Research Note on May 30</a>, studies on the mechanism of action for TNX-601 showed that the original compound contains two racemic forms of tianeptine. One form acts to restore neuroplasticity and neurogenesis while the other causes side effects. This has led to the development of TNX-4300, a purified version of isomer that acts on neurological pathways, for mood disorders and degenerative neurological conditions.
Phase 2 Is Expected To Begin For TNX-1300.&nbsp;Tonix is planning to start a Phase 2 trial testing TNX-1300 for emergency treatment of cocaine intoxication in 3Q23. This indication has been granted Breakthrough Therapy designation by the FDA and has received a grant from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health.
Immunology Products Progress To Clinical Trials. TNX-1500 is a monoclonal antibody against CD40L in development for prevention of kidney transplant rejection. The IND became effective in 2Q23, and a Phase 1 study is expected to begin in 3Q23. Additional indications under consideration include autoimmune diseases.
Conclusion. Tonix has focused its pipeline on CNS indications and acquired two products that can provide the foundation for commercialization of its new products. We expect the stock to be driven by results from the four clinical trials due to report data over 3Q23 and 4Q23. We are reiterating our Outperform rating and $10 price target.&#8212;&#8212;&#8212;- page break &#8212;&#8212;&#8212;- 
 
Figure 1.&nbsp; Tonix Product Pipeline Chart.&nbsp;Shaded indications are expected to report results before year-end 2023.
 <img decoding="async" src="https://www.noblelinx.com/x/research/images/reports/pipeline2q23.jpg" style="width: 574px;height: 275px" /> 
 
Source: Tonix Pharmaceutical Holdings, Inc filings.

Tonix Pharmaceuticals Holding Corp. (TNXP)

Focus On CNS Transforms During 2Q23

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Tonix Announces Positive Pre-NDA Meeting – NDA Submission On Schedule (TNXP)

Tonmya Presentations From Previous and Upcoming Trials (TNXP)

Increasing The Focus on Fibromyalgia (TNXP)

Fibromyalgia Trial Meets All Endpoints (TNXP)

Inbox Intel from Channelchek.