Full Press Release Details
Tonix Pharmaceuticals Holding Corp. - 8-K
Pharmaceuticals Reports First Quarter 2024 Financial Results and Operational Highlights
track to submit NDA in the second half of 2024 for Tonmya for fibromyalgia;
meeting with FDA scheduled for second quarter 2024
planning continues for U.S. launch of Tonmya, a potential new first-line, centrally-acting, non-opioid analgesic for the management of
N.J., May 13, 2024 (GLOBE NEWSWIRE) - Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated
biopharmaceutical company with marketed products and a pipeline of development candidates, today announced financial results for the
first quarter ended March 31, 2024, and provided an overview of recent operational highlights.
near-term priority continues to be the submission of our New Drug Application (NDA) for Tonmya (cyclobenzaprine HCl sublingual
tablets) for the management of fibromyalgia, while continuing to build out our commercial strategy for the anticipated product launch
in the event of FDA approval, which we currently estimate to occur in the second half of 2025," said Seth Lederman, M.D., Chief
Executive Officer of Tonix.
Lederman added, "The well-known treatment-limiting side effects of the three currently approved drugs have led to widespread patient
dissatisfaction, creating what we believe is a significant opportunity for a new therapeutic. Tonmya has a differentiated mechanism of
action and is generally free of common side effects associated with the currently approved products, including weight gain, fatigue,
insomnia, increased blood pressure, gastrointestinal issues or sexual dysfunction. As such, we believe Tonmya, if approved, could become
the treatment of choice for the approximately 10 million people in the U.S. suffering the debilitating effects of fibromyalgia."
Company is also advancing other key pipeline programs including those for immunology, obesity, eating disorders, infectious and rare
diseases, many through a capital efficient strategy involving partnerships, grants and in-kind contributions.
Highlights - Key Product Candidates*
Nervous System (CNS) Pipeline
(also known as TNX-102 SL; cyclobenzaprine HCl sublingual tablets): a centrally-acting, non-opioid, small molecule analgesic taken once-daily
at bedtime for the management of fibromyalgia (FM).
| In January 2024, Tonix presented additional safety and tolerability data from the pivotal Phase 3 RESILIENT study that showed Tonmya treatment was not associated with increases in systolic or diastolic blood pressure or body weight, nor were there any reported sexual side effects. The Company had previously announced in December 2023 that the Phase 3 RESILIENT study, a registration-quality, double-blind, placebo-controlled study evaluating Tonyma met its pre-specified primary endpoint in the second of two positive Phase 3 clinical trials, significantly reducing daily pain compared to placebo (p-value=0.00005) in participants with fibromyalgia. Statistically significant and clinically meaningful results were also seen in all pre-specified key secondary endpoints including those related to improving sleep quality, reducing fatigue, and improving patient global ratings and overall fibromyalgia symptoms and function. Tonmya was well tolerated with an adverse event profile comparable to prior studies and no new safety signals observed. In addition, Tonmya therapy showed activity on improving female sexual function relative to placebo with a nominal p-value=0.010 by the Changes in Sexual Functioning Questionnaire short-form, female version. | |
| Tonix plans to submit an NDA to the FDA in the second half of 2024 for Tonmya for the management of fibromyalgia. In February 2024, Tonix announced the engagement of Rho, Inc. as our contract research organization (CRO) to support NDA submission. | |
| In February 2024, Tonix announced statistically significant results from its clinical pharmacokinetic (PK) bridging study of Tonmya in healthy adult male and female ethnic Japanese and Chinese volunteers. Results indicate that key PK parameters of cyclobenzaprine are comparable in ethnic Japanese and Chinese volunteers to Caucasian volunteers from a prior PK study. Tonmya was generally well tolerated in the ethnic Japanese and Chinese healthy volunteers. The company expects these data to fulfill the requirement for a bridging study, and enables Tonix to rely on Phase 3 studies RESILIENT and RELIEF results to support regulatory filings for clinical studies in Japan and China where cyclobenzaprine is a new chemical entity (NCE). Tonix holds issued patents for market exclusivity rights of Tonmya in Japan, China, Hong Kong and Taiwan. | |
| In March 2024, Tonix announced the selection of two contract manufacturing organizations (CMOs), including Almac Pharma Services, as dual supply sources for the potential launch and commercialization of Tonmya in the U.S. | |
| In March 2024, Tonix selected EVERSANA, a leading provider of commercialization services to the global life sciences industry, to support the launch strategy and commercial planning of Tonmya in the U.S. | |
| Tonix presented additional efficacy data from RESILIENT at the 6 th International Congress on Controversies in Fibromyalgia in Brussels, Belgium, March 7-8, 2024. The data showed that Tonmya treatment resulted in an improvement in cognitive dysfunction, or brain fog', measured by the change in the Fibromyalgia Impact Questionnaire-Revised (FIQ-R) memory item. The FIQ-R cognitive item showed nominal improvement in Tonmya-treated patients vs placebo-treated patients with a nominal p-value=0.001 and effect size of 0.31. |
SL for the treatment of acute stress reaction (ASR) and acute stress disorder (ASD), and prophylaxis against development of posttraumatic
stress disorder (PTSD)
| In February 2024, the Company announced the FDA cleared the Investigational New Drug (IND) application for the Phase 2 investigator-initiated OASIS trial to evaluate TNX-102 SL in reducing the severity of ASR and the frequency of ASD and PTSD. The trial is sponsored by the University of North Carolina Institute for Trauma Recovery and supported by a $3 million grant from the U.S. Department of Defense, which was awarded in September 2023. The proposed Phase 2, Optimizing Acute Stress Reaction Interventions with TNX-102 SL (OASIS) study will examine the safety and efficacy of TNX-102 SL to reduce adverse posttraumatic neuropsychiatric sequelae among patients presenting to the emergency department (ED) after a motor vehicle collision. The study will enroll approximately 180 trauma survivors at ED study sites in the U.S. Participants will be randomized in the ED to receive a two-week course of either TNX-102 SL 5.6 mg or placebo. | |
| Tonix anticipates the Phase 2 OASIS trial will initiate in the second quarter of 2024. |
SL for the treatment of Fibromyalgia-Type Long COVID, also known as Post-Acute Sequelae of COVID-19 (PASC)
(recombinant double mutant cocaine esterase): biologic for life-threatening cocaine intoxication
| Tonix expects to initiate a Phase 2 clinical study of TNX-1300 for the treatment of cocaine intoxication in emergency rooms in the second quarter of 2024. In 2022, Tonix was awarded a Cooperative Agreement grant from the National Institutes of Health (NIH)'s National Institute of Drug Abuse (NIDA) to support development of TNX-1300. | |
| TNX-1300 has been granted Breakthrough Therapy designation by the FDA. |
(intranasal potentiated oxytocin): small peptide in development through investigator-initiated studies for adolescent obesity, binge
eating disorder, bone health in autism and social anxiety disorder (SAD).
(intranasal potentiated oxytocin): small peptide for the treatment of Prader-Willi syndrome (PWS)
(anti-CD40L Fc-modified humanized monoclonal antibody): third generation anti-CD40L monoclonal antibody for prophylaxis of organ transplant
rejection and treatment of autoimmune disorders.
Products - Recent Highlights
of Tonix's product candidates are investigational new drugs or biologics and none have been approved for any indication.
is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia.
Tonmya has not been approved for any indication.
Bergmans RS, et al. PAIN. 2023. DOI: 10.1097/j.pain.0000000000003110.
Fitzcharles M-A, et al. PAIN. 2023. DOI: 10.1097/j.pain.0000000000003129.
Lassiter G., et al. Am J Transplantation. 2023. https://doi.org/10.1016/j.ajt.2023.03.022
Miura S., et al. Am J Transplantation. 2023. https://doi.org/10.1016/j.ajt.2023.03.025
Massachusetts General Hospital press release. March 21, 2024. "World's First Genetically Edited Pig Kidney Transplant
into Living Recipient Performed at Massachusetts General Hospital." www.massgeneral.org/news/press-release/worlds-first-genetically-edited-pig-kidney-transplant-into-living-recipient
(accessed March 29, 2024)
Anand, R.P., et al Nature. 622, 393-401 (2023). https://doi.org/10.1038/s41586-023-06594-4
Stoico, N. Boston Globe. May 11, 2023. "Mass Man who received first kidney transplant from genetically engineered
pig has died, family says".
Highlights - Financial
of March 31, 2024, Tonix had $7.0 million of cash and cash equivalents, compared to $24.9 million as of December 31, 2023. Net cash used
in operations was approximately $17.6 million for first quarter 2024, compared to net cash used in operations of $32.9 million for the
same period in 2023.
April 1, 2024, the Company closed a financing with existing healthcare-focused institutional investors for upfront gross proceeds of
approximately $4.4 million through a registered direct offering.
Quarter 2024 Financial Results
product revenue for the first quarter 2024 was approximately $2.5 million. Net product revenue consisted of combined net sales of Zembrace
SymTouch and Tosymra , which were acquired from Upsher-Smith Laboratories, LLC on June 30, 2023. Cost of Sales for the first
quarter 2024 was approximately $1.7 million.
and development expenses for the first quarter 2024 were $12.9 million, compared to $26.5 million for the same period in 2023. This decrease
is predominantly due to decreased clinical, non-clinical and manufacturing expenses.
and administrative expenses for the first quarter 2024 were $9.3 million, compared to $7.4 million for the same period in 2023. The increase
was primarily due to sales and marketing and the transition services expenses associated with the Company's recently acquired marketed
products offset by a decrease in financial reporting expenses.
loss was $(14.9) million, or $(0.18) per share, basic and diluted, for the first quarter 2024, compared to net loss of $(33.0) million,
or $(3.21) per share, basic and diluted, for the same period in 2023. The basic and diluted weighted average common shares outstanding
for the first quarter 2024 was 80,879,108 compared to 10,268,500 shares for the same period in 2023.
Pharmaceuticals Holding Corp.*
is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent
human disease and alleviate suffering. Tonix's development portfolio is focused on central nervous system (CNS) disorders. Tonix's
priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya1, a product candidate
for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being
developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix's CNS portfolio includes TNX-1300 (cocaine
esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix's immunology development
portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized
monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment
of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines,
our commercial subsidiary, markets Zembrace SymTouch (sumatriptan injection) 3 mg and Tosymra (sumatriptan nasal spray)
10 mg for the treatment of acute migraine with or without aura in adults.
product development candidates are investigational new drugs or biologics and have not been approved for any indication.
is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia.
Tonmya has not been approved for any indication.
SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.
press release and further information about Tonix can be found at www.tonixpharma.com.
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; risks related to the failure to successfully market
any of our products; 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, 2023, as filed with the Securities and Exchange Commission (the "SEC") on April
1, 2024, 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.
PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS