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

Tonmya Presentations From Previous and Upcoming Trials

Increasing The Focus on Fibromyalgia

Fibromyalgia Trial Meets All Endpoints

Robert LeBoyer

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Tonix Pharmaceuticals Holding Corp.

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5th View Registration

Summary. Tonix announced successful Phase 3 RESILIENT trial data in late December. This is the second positive trial for Tonmya (TNX-102 SL) in fibromyalgia, giving the company the two trials required to support an NDA for approval. Since that time, Tonix has been shifting its focus toward filing the NDA for Tonmya approval. It has also has raised capital and plans lower R&amp;D expenses to ensure sufficient cash through the start of Tonmya sales.
We attribute the decline in TNXP over the past year to the perception of risk in the RESILIENT clinical trial and the need to raise capital in a difficult financing environment. The June 2023 acquisition of two drugs for migraine headache transformed Tonix into an operating company, adding a foundation to build a marketing program for Tonmya. However, we believe it may have been seen as increasing risk and dependance on the RESILIENT trial. 
The RESILIENT clinical data showed strong benefits in its primary and secondary endpoints, the product acquisition has been completed, and the company has raised capital. We believe the risk of these events has passed and expect an NDA filing in 2H24. In view of this progress, we have revised our earnings estimates and price target while maintaining our Outperform rating.
Tonix Will Focus On Products For CNS Disorders and Reduce Expenses. Tonix has developed a broad pipeline of products that grew from its original work in neurology and immunology. This led to clinical trials and academic collaborations in infectious disease, biodefense, and immunology. The companyâ€™s focus over the next year will be on the NDA filing and premarketing activities for Tonmya. The large trials have been completed and no new ones are scheduled, allowing us to reduce our clinical expense estimates. We expect the company to continue developing additional indications for Tonmya and its pipeline products through sources of non-dilutive funding, such as sponsored trials and academic collaborations.
Tonix Continues To Develop Products For CNS Disorders. In June 2023, the company acquired two migraine drugs, Zebrace (sumatriptan) and Tosymra (sumatriptan nasal spray), with a salesforce that calls on neurologists. The acquisition brought personnel and expertise in several areas, including sales, marketing, reimbursement, and supply chain management. This provides a foundation to develop a sales force in CNS products that could be expanded to market Tonmya to rheumatologists, neurologists, and primary care physicians.
We See Large Potential Opportunity For Tonmya In Fibromyalgia. Tonix has two studies that show positive endpoints that include pain reduction, fatigue, and sleep improvement. These symptoms are currently treated with drugs developed for other conditions that address some fibromyalgia symptoms, such as Lyrica (pregabalin) to treat neurological pain or Cymbata and Savella (SNRI drugs) to treat the depression and overall malaise. 
Many patients have insufficient response to therapy, do not respond, or cannot tolerate the side effects. The current drugs were developed for other indications and only affect some symptoms, so that patients are often dissatisfied with the results. Many rotate through several drugs or take drug combinations.&nbsp;
Fibromyalgia Has An Estimated Patient Population of Over 10 Million Patients.&nbsp;Tonmya was developed to address the symptoms of fibromyalgia with strong effects on all major symptoms. It has a unique mechanism of action that facilitates restorative sleep and acts on neurotransmitter receptors, producing a broad effect on many symptoms. We believe Tonmyaâ€™s differentiated mechanism of action and strong data would fit with patientsâ€™ need for new therapies.&nbsp;The patient population with fibromyalgia is estimated at over 10 million adults, with an estimated 22 million prescriptions to address its symptoms.&nbsp;
RESILIENT Trial Showed High Statistical Significance In Its Endpoints. The Phase 3 RESILIENT trial testing Tonmya (TNX-102 SL) in fibromyalgia reported results in December 2023. The trial endpoints were based on the primary symptoms of chronic pain, non-restorative sleep, and fatigue. The data were consistent with the Phase 3 RELIEF study, providing Tonix with two positive Phase 3 trials to support an NDA for approval. 
 
Study Design and Results
The Phase 3 RESILIENT study was a double-blind placebo-controlled study enrolling 457 fibromyalgia patients at 33 clinical sites. Patients received either placebo or one 2.8mg tablet for the first two weeks, followed by two tablets (5.6mg total) for the remaining 12 weeks. The primary endpoint was reduction in pain severity score compared with placebo. Secondary endpoints included sleep quality, reducing fatigue, overall symptoms and function.
Primary Pain Endpoint Was Met With High Statistical Significance. The data shows pain scores for the two groups began to separate soon after starting therapy, reaching a p-value of (p&lt;0.01) in about one week. The pain score differences widened over the 14-week duration of the study, reaching an effect size of 0.38 with (p&lt;0.001). Patients showing at least 30% pain reduction reached 45.9% for the treatment group and 27.1% for the placebo group (p&lt;0.001). 
Figure 1. Pain Scores For TNX-102 SL vs. Placebo The pain scores began to show significant differences at week 1, and increased over the 14 weeks of the study.
<img decoding="async" src="https://www.noblelinx.com/x/research/images/reports/resiliantpainscoresapr24.jpg" style="width: 564px;height: 275px" /> 
 
Source: Tonix Pharmaceutical Holdings, Inc.

 
Figure 2. Responder Analysis Favors TNX-102 SL. Patient Showing a 30% reduction in pain reached 45.9% compared with 27.1% for the placebo group.
<img decoding="async" src="https://www.noblelinx.com/x/research/images/reports/resiliantresponders.jpg" style="width: 543px;height: 299px" /> 
 
Source: Tonix Pharmaceutical Holdings, Inc. 
 
Figure 3. The RESILIANT Trial met all of its secondary endpoints. 
 
<img decoding="async" src="https://www.noblelinx.com/x/research/images/reports/resiliantsecondary.jpg" style="width: 552px;height: 308px" />
Source: Tonix Pharmaceutical Holdings, Inc.
An NDA Is Expected In 2H24. Tonix now has two Phase 3 studies to support an NDA filing for approval. We assume the application takes about 6 to 9 months to compile and is submitted in 2H24.&nbsp; Allowing for a standard review time of about 10 months for review would estimated approval in 3Q25 to 4Q25, followed by the first full year of revenues in 2026. 
 
Our models are intentionally conservative to allow time for product launch and modest initial uptake in the first quarters of sales. We assume patients refill prescriptions, with increased sales and market penetration to follow. We also believe news of an effective treatment could lead to increased patient awareness and expansion of the market, although we have not increased our target population at this time.
We Have Reduced Our Net Losses For FY2025-26. The clinical trial expenses related to the Phase 3 RESILIENT trial have ended. In FY2024, R&amp;D expenses will reflect the cost of filing the NDA and some small Phase 2 trials. Grant-funded trials and academic collaborations will continue, but no large late-stage clinical trials are planned. 
 
Conclusion. We believe TNXP has passed through several high-risk periods over the past year. The acquisition of the two migraine products has transformed Tonix into an operating company, with strong results from the Phase 3 RESILIENT trial gave it a product to drive sales in FY2025-26. We believe the stock is trading at a large discount to its fair value and reiterate our Outperform rating with an adjusted price target of $1.50 per share.

Tonix Pharmaceuticals Holding Corp. (TNXP)

Increasing The Focus on Fibromyalgia

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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.