Tonix Pharmaceuticals Announces Presentation at the World Orphan Drug Congress USA

Rhea-AI Summary

Tonix Pharmaceuticals (Nasdaq: TNXP) announced its participation in the World Orphan Drug Congress USA 2022, scheduled for July 11-13. CEO Seth Lederman will present on TNX-2900, an intranasal therapy aimed at treating hyperphagia in adolescents and young adults with Prader-Willi syndrome, on July 11 at 2:00 p.m. ET. Tonix's clinical-stage pipeline includes investigational therapies for various conditions, such as fibromyalgia and Long COVID. The company continues to focus on developing therapeutics across multiple disease areas, enhancing its visibility in the biopharmaceutical sector.

Positive

• Presentation at World Orphan Drug Congress increases visibility.
• Development of TNX-2900 has Orphan-Drug Designation by FDA.
• Diverse pipeline including therapies for fibromyalgia and Long COVID.

Negative

• None.

CHATHAM, N.J., July 06, 2022 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced it will present at the World Orphan Drug Congress USA 2022 being held July 11-13, 2022 at the Hynes Center in Boston, MA. The presentation will take place on Monday, July 11, 2022 at 2:00 p.m. ET.

Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals will deliver a presentation titled, “TNX-2900 (Intranasal Oxytocin + Magnesium) in Development for the Treatment of Hyperphagia in Adolescents and Young Adults with Prader-Willi Syndrome.”

Presentation Details
Date: Monday, July 11, 2022
Time: 2:00 p.m. ET
Conference website: World Orphan Drug Congress USA 2022

A copy of the Company’s presentation will be available under the Presentations tab of the Investors section of the Tonix website at www.tonixpharma.com following the conference.

About Tonix Pharmaceuticals Holding Corp.^*

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the first quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix expects to initiate a Phase 2 study in Long COVID in the third quarter of 2022. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication that is Phase 2 ready and has been granted Breakthrough Therapy Designation by the FDA. TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is expected to enter the clinic with a Phase 2 study in the second half of 2022. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second half of 2022. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox called TNX-801, next-generation vaccines to prevent COVID-19, and a platform to make fully human monoclonal antibodies to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-1850, which are live virus vaccines based on Tonix’s recombinant pox live virus vector vaccine platform.

^*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (the “SEC”) on March 14, 2022, and periodic reports filed with the SEC on or after the date thereof. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 799-8599

Olipriya Das, Ph.D. (media)
Russo Partners
Olipriya.Das@russopartnersllc.com
(646) 942-5588

Peter Vozzo (investors)
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

FAQ

What will Tonix Pharmaceuticals present at the World Orphan Drug Congress USA 2022?

Tonix Pharmaceuticals will present on TNX-2900, a treatment for hyperphagia in adolescents and young adults with Prader-Willi syndrome.

When is Tonix Pharmaceuticals' presentation at the World Orphan Drug Congress?

The presentation is scheduled for July 11, 2022, at 2:00 p.m. ET.

What is TNX-2900 and its significance?

TNX-2900 is an intranasal oxytocin therapy in development for treating hyperphagia in patients with Prader-Willi syndrome, which has received Orphan-Drug Designation from the FDA.

How does Tonix Pharmaceuticals' pipeline look for 2022?

Tonix has a diverse pipeline, including treatments for fibromyalgia, Long COVID, cocaine intoxication, chronic migraines, and infectious diseases.