Increasing The Focus on Fibromyalgia

Fibromyalgia Trial Meets All Endpoints

Long COVID Study Did Not Meet Primary Endpoint But Provides Important Data

Focus On CNS Transforms During 2Q23

Robert LeBoyer

Virtual & In-person Roadshows / Conferences

Channelchek Premium. Access more at no cost. 

The site "channelcheck" is opened on the phone

Join the Channelchek Investor Community. Your name, email, zip, and investor type is all it takes to open the door to research reports, favorites tracking, and virtual and in-person roadshows / conferences. Even exclusive investment opps.

Take it to the next level. It doesn’t cost a penny.

Click “Log In” to agree to Channelchek.com <a href="#">Terms of Use</a> and acknowledge that Channelchek.com <a href="#">Privacy Policy</a> applies to you.

Welcome to the Channelchek Investor Community

Informed investors make more money. And it’s all about timing. Get it when it happens.

Inbox Intel from Channelchek.

Healthcare

Biotechnology

Tonix Pharmaceuticals Holding Corp.

Summary.&nbsp;Tonix reported a loss of $34.1 million or ($0.56) per share for 4Q22 and $116.9 million or $(3.27) per share for FY2022. The company reaffirmed its guidance for a 2Q23 announcement of interim analysis for TNX-102 SL the Phase 3 RESILIANT trial in fibromyalgia. The full analysis is expected in 4Q23, one of several additional clinical milestones expected during 2023.&nbsp; Tonix had $120.2 million in cash on December 31.
TNX-102 SL In Fibromyalgia.&nbsp;The RESILIANT Phase 3 trial is a double-blind, placebo controlled study for fibromyalgia.&nbsp; It reached the 50% patient enrollment level in December 2022, with the interim analysis results expected in 2Q23. If successful, the RESILIANT trial could lead to an NDA filing for product approval. Fibromyalgia is a condition with chronic pain, fatigue, and depression that affects between 6 to 12 million adults in the US. Current treatments such as Lyrica, Cymbalta, Savella, pregabalin, and duloxetine are often inadequate and lead to opioid use to relieve pain.
Interim Analysis For Phase 2 PREVAIL Long COVID Trial Expected In 2Q23.&nbsp;&nbsp;During February, BIO (Biotechnology Innovation Organization) sponsored a seminar on Long COVID. There were presentations by government, academic, and industry scientists discussing the cellular mechanisms, clinical symptoms, and potential interventions of Long COVID. One relevant point was that the data shows Long COVID pain symptoms share common mechanisms with fibromyalgia and chronic fatigue syndrome. In our <a href="https://www.channelchek.com/news-channel/biotechnology-industry-report-webcast-highlights-long-covid-symptoms-and-potential-treatments">Research Note published February 23</a>, we discussed the Tonix presentation showing TNX-102 SL can improve the symptoms and disability in Long COVID patients.&nbsp; 
The Phase 2 PREVAIL trial began testing TNX-102 SL in 3Q22, with a primary endpoint of reduction in pain score by NRS (numeric rating scale) and secondary endpoint of reduction in PROMIS (Patient Reported Outcomes Measurement Information System) score for sleep disturbance. The target enrollment is 470 patients at 30 clinical sites in the US. An interim analysis is expected in 2Q23.
Phase 2 PREVENTION Trial Has Begun.&nbsp; In February, Tonix met a clinical milestone when it began enrollment for the Phase 2 PREVENTION trial testing TNX-1900 for prevention of migraine headaches in chronic migraine patients. The trial is a double-blind, placebo controlled trial with an expected enrollment of 300 patients at 25 sites in the US. An interim analysis is planned when the trial reaches 50% enrollment, currently expected in 4Q23.
TNX-1900 is a proprietary, nasally-administered version of oxytocin, a neurologic hormone with multiple actions. During January, Tonix presented preclinical and clinical data that showed delivery to the trigeminal nerve ganglia and the presence of oxytocin receptors in the nerve.&nbsp; These structures have roles in the mechanism of migraine headaches, we believe the data supports the nasal administration and design of the trial. A separate Phase 2 investigator-sponsored trial testing TNX-1900 in obesity-related binge eating disorder is scheduled to start enrollment in 2Q23.
Phase 2 For TNX-601 In MDD Is Expected To Start In 1Q23.&nbsp;The Phase 2 UPLIFT trial in Major Depressive Disorder is expected to begin in 1Q23 testing TNX-601, a formulation of tianeptine hemioxalate for once-daily oral administration. This uses a different mechanism of action than the current drugs for depression. The placebo-controlled trial will treat an estimated 300 patients for 6-weeks. An interim look is planned when the trial reaches 50% enrollment, expected to be in 3Q23.
Phase 2 For TNX-1300 Is Also Planned.&nbsp;Tonix is also in discussions with the FDA to finalize the design of a Phase 2 study for TNX-1300 as a treatment for cocaine intoxication (overdose).&nbsp; Tonix has received Breakthrough Drug designation for TNX-1300, as well as a Cooperative Agreement grant from the National Institute on Drug Abuse (part of the NIH) for the study.
Immunology Program Moves TNX-1500 To Phase 1 In Organ Transplant Rejection.&nbsp;Tonix plans to start a Phase 1 trial testing TNX-1500 prophylaxis to prevent kidney transplant rejection. TNX-1500 is a monoclonal antibody against CD40L in development for prevention of organ transplant rejection, including kidney, heart, and hematopoietic stem cells. The Phase 1 kidney transplant trial is expected to begin in 2Q23, with additional indications continuing in preclinical development.&nbsp;
Conclusion.&nbsp;Tonix has met several clinical development milestones for its late-stage and development pipeline. We look forward to the 2Q announcements of interim results of the Phase 3 RESILIANT and the Phase 2 PREVAIL trial. We are reiterating our Outperform rating and price target of $6.50 per share.

Tonix Pharmaceuticals Holding Corp. (TNXP)

FY2023 Reported – Clinical Milestones Expected In 2Q23

Fundamental Analysis:

Rating: Log in to view

Increasing The Focus on Fibromyalgia (TNXP)

Fibromyalgia Trial Meets All Endpoints (TNXP)

Long COVID Study Did Not Meet Primary Endpoint But Provides Important Data (TNXP)

Focus On CNS Transforms During 2Q23 (TNXP)

Inbox Intel from Channelchek.