Full Press Release Details
Tonix Pharmaceuticals
Reports Fourth Quarter and Full Year 2023 Financial Results and Operational Highlights
Positive results from confirmatory Phase 3 RESILIENT
study reported in December 2023 position Tonmya for fibromyalgia for NDA submission second half of 2024; pre-NDA meeting with FDA
scheduled for second quarter 2024
Commercial planning underway, including go-to-market,
supply chain and manufacturing strategies, for U.S. launch of Tonmya, a potential new first-line, centrally-acting, non-opioid analgesic
for the management of fibromyalgia
CHATHAM, N.J., April 1, 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 fourth quarter and full year ended December
31, 2023, and provided an overview of recent operational highlights.
"Our near-term focus is seeking U.S. marketing
approval for Tonmya (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia from the U.S. Food and Drug Administration
(FDA)," said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. "Our pre-NDA meeting with the FDA is scheduled
to take place this quarter and we plan to submit our New Drug Application (NDA) for Tonmya in the second half of 2024. We believe
the positive Phase 3 RESILIENT results reported in December of 2023 together with the positive results from the first Phase 3 RELIEF study
should satisfy the requirements for approval and, if so, would provide the opportunity for Tonix to launch the first FDA-approved drug
for fibromyalgia in more than a decade. We believe the activity of Tonmya on improving pain, sleep quality, fatigue and brain fog in the
RESILIENT study are indicative of the broad-spectrum of activity in fibromyalgia."
Dr. Lederman added, "While Tonix is focusing
its resources on progressing Tonmya toward NDA submission and potential FDA approval, we are seeking partnerships and collaborations on
our pipeline programs from government agencies, non-profit organizations and other biotechnology or pharmaceuticals companies. Tonix has
already shifted portions of our research and development (R&D) expenses to U.S. government agencies and other institutions through
partnerships involving grants and in-kind contributions. These outside collaborations leverage our internal resources, and we believe
they provide a capital efficient strategy for progress."
Selected Product Candidates* -- Recent Highlights
Central Nervous System (CNS) Pipeline
Tonmya (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
TNX-102 SL for the treatment of acute
stress reaction (ASR) and acute stress disorder (ASD), and prophylaxis against development of posttraumatic stress disorder (PTSD)
TNX-102 SL for the treatment of Fibromyalgia-Type
Long COVID, also known as Post-Acute Sequelae of COVID-19 (PASC)
TNX-1300 (recombinant double mutant cocaine
esterase): biologic for life-threatening cocaine intoxication
TNX-1900 (intranasal potentiated oxytocin):
small peptide in development through investigator-initiated studies for bone health in autism, social anxiety disorder (SAD), adolescent
obesity and binge eating disorder
Rare Disease Pipeline
TNX-2900 (intranasal potentiated oxytocin):
small peptide for the treatment of Prader-Willi syndrome (PWS)
TNX-1500 (anti-CD40L Fc-modified humanized
monoclonal antibody): third generation anti-CD40L monoclonal antibody for prophylaxis of organ transplant rejection and treatment of autoimmune
Infectious Disease Pipeline
TNX-1800 (modified recombinant horsepox
virus, live vaccine): potential vaccine to protect against COVID-19 designed to express the SARS-CoV-2 spike protein
TNX-801 (recombinant horsepox virus, live
vaccine): potential vaccine to protect against mpox disease and smallpox.
Broad-spectrum anti-viral programs
Tonix is developing potential broad-spectrum
antiviral drugs in three programs: CD45-targeted therapeutics (TNX-4200), cathepsin inhibitors (TNX-3900) and viral glycan-targeted engineered
biologics (TNX-4000). In 2020, the DoD announced that they are seeking broad spectrum antiviral drugs since it would be hard to predict
which or how many viruses may be deployed on the battlefield.16 Tonix hopes that one or more of our programs may help the DoD
Marketed Products - Recent Highlights
Facilities - Recent Highlights
*All of Tonix's product candidates
are investigational new drugs or biologics and none have been approved for any indication.
1 Bergmans RS, et al. PAIN. 2023. DOI: 10.1097/j.pain.0000000000003110.
2 Fitzcharles M-A, et al. PAIN. 2023.
DOI: 10.1097/j.pain.0000000000003129.
3 Lassiter G., et al. Am J Transplantation.
4 Miura S., et al. Am J Transplantation.
5 Anand, R.P., et al Nature. 622,
393-401 (2023). https://doi.org/10.1038/s41586-023-06594-4
6 Massachusetts General Hospital press release.
March 21, 2024. "World's First Genetically Edited Pig Kidney Transplant into Living Recipient Performed at Massachusetts
(accessed March 29, 2024)
7 Awasthi M, et al. 2023. Vaccines (Basel)
11(11):1682. https://doi:10.3390/vaccines11111682
8 Office of Science and Technology Policy (OSTP).
American Pandemic Preparedness: Transforming Our Capabilities. September 2021
9 National Biodefense Science Board (NBSB). Prioritization
of Product Attribute Categories to Maximize Access for Next Generation COVID-19 Vaccines and Therapeutics. August 2023
10 BARDA Strategic Plan 2022-2026.
RS, et al. Viruses. 2023 26;15(2):356. doi: 10.3390/v15020356
12 U.S. National Academy of Sciences. March 28,
2024. "Consensus Study Report: Future State of Smallpox Medical Countermeasures." https://nap.nationalacademies.org/catalog/27652/future-state-of-smallpox-medical-countermeasures
Commission on Biodefense. (2024). Box the Pox: Reducing the
Risk of Smallpox and Other Orthopoxviruses.
Bipartisan Commission on
Biodefense: Washington, DC. https://biodefensecommission.org/reports/box-the-pox-reducing-the-risk-of-smallpox-and-other-orthopoxviruses/
14 Emanuel, G. NPR. March 27, 2024. "Why
the mpox outbreak in the Democratic Republic of Congo is worrying disease docs." URL: www.npr.org/sections/goatsandsoda/2024/03/27/1239276957/mpox-outbreak-democratic-republic-of-congo-deadlier-strain
et al., BioRxiv 2023.10.25.564033; doi: https://doi.org/10.1101/2023.10.25.564033
16 U.S. Department of Defense. Chemical and Biological
Defense Program. 2022. "Approach for Research, Development, and Acquisition of Medical Countermeasure and Test Products."
U.S. Department of Defense. https://media.defense.gov/2023/Jan/10/2003142624/-1/-1/0/APPROACH-RDA-MCM-TEST-PRODUCTS.PDF
(accessed March 5, 2024)
Recent Highlights-Financial
As of December 31, 2023, Tonix had approximately
$24.9 million of cash and cash equivalents, compared to $120.2 million as of December 31, 2022. Additionally, Tonix had inventory totaling
approximately $13.6 million as of December 31, 2023. Net cash used in operations was approximately $102.0 million for the full year ended
December 31, 2023, compared to $98.1 million for the same period in 2022. Net cash used by investing activities for the full year ended
December 31, 2023 was approximately $29.1 million compared to $48.1 million for the same period in 2022.
In August 2022, the Company announced that
it received a Cooperative Agreement grant from the National Institute on Drug Abuse ("NIDA"), part of the National Institutes