Full Press Release Details
TONIX PHARMACEUTICALS HOLDING CORP. 8-K
Tonix Pharmaceuticals
Reports Third Quarter 2023 Financial Results and Operational Highlights
Topline Results from Phase 3 Potentially NDA-Enabling
Study of TNX-102 SL in Fibromyalgia Expected Late December 2023: Centrally-Acting Non-Opioid Analgesic
Topline Results from Phase 2 Proof-of-Concept Study
of TNX-1900 in Chronic Migraine Expected Early December 2023: Intranasal Potentiated Oxytocin
Meaningful Progress Made in Obtaining External
Support for Clinical Trials from U.S. Government Agencies and Other Institutions
Revenue from Marketed Acute Migraine Products:
Zembrace SymTouch (sumatriptan injection) and Tosymra (sumatriptan nasal spray) Included in Third Quarter Financial Statements
CHATHAM, N.J., November 9, 2023 (GLOBE NEWSWIRE)
- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products
and a pipeline of development candidates, today announced financial results for the third quarter ended September 30, 2023, and provided
an overview of recent operational highlights.
"Tonix expects topline results from its Phase
3 fibromyalgia study and Phase 2 chronic migraine study before year end," said Seth Lederman, M.D., Chief Executive Officer of Tonix.
"The Phase 3 RESILIENT trial in fibromyalgia, if successful, is expected to be the final efficacy trial required for submitting
a New Drug Application (NDA) for approval by the U.S. Food and Drug Administration (FDA) for TNX-102 SL (cyclobenzaprine HCl sublingual
tablets). In the Phase 2 proof-of-concept PREVENTION study in chronic migraine of TNX-1900 (intranasal potentiated oxytocin), all patients
have completed their final visit and topline results are expected in early December 2023."
Dr. Lederman continued, "We are continuing
to shift the expense of clinical trials from our operating budget to U.S. government agencies and other institutions through partnerships.
The U.S. Department of Defense (DoD) is supporting the upcoming Phase 2 study of TNX-102 SL in acute stress disorder, being conducted
and sponsored by University of North Carolina (UNC). The U.S. National Institutes of Health (NIH) and National Institute of Allergy and
Infectious Diseases (NIAID), through its Project NextGen, will conduct the Phase 1 study of our vaccine candidate TNX-1800 (modified recombinant
horsepox virus, live vaccine). The National Institute of Drug Abuse (NIDA) is supporting our Phase 2 study of TNX-1300 (recombinant double
mutant cocaine esterase) for cocaine intoxication. Massachusetts General Hospital (MGH) is conducting Phase 2 studies of TNX-1900 in binge
eating disorder and pediatric obesity, and the University of Washington is conducting a Phase 2 study of TNX-1900 in social anxiety disorder.
Finally, we continue to collaborate with MGH on several preclinical non-human primate studies for TNX-1500 (anti-CD40L Fc-modified humanized
monoclonal antibody), currently in a Phase 1 study being conducted by Tonix. These outside collaborations leverage our internal resources
and allow us to progress our clinical programs in a capital efficient manner."
Partnerships with External Funding -
Marketed Products - Recent Highlights
Key Product Candidates* -- Recent Highlights
Central Nervous System (CNS) Pipeline
TNX-102 SL (cyclobenzaprine HCl sublingual
tablets): once-daily at bedtime small molecule for the management of fibromyalgia (FM) - a centrally-acting, non-opioid analgesic.
TNX-102 SL for the treatment of acute
stress reaction (ARS) 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-1900 (intranasal potentiated oxytocin):
small peptide for migraine, craniofacial pain, social anxiety disorder (SAD), insulin resistance and related disorders, and adolescent
obesity and binge eating disorder
TNX-1300 (recombinant double mutant cocaine
esterase): biologic for life-threatening cocaine intoxication
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.
*All of Tonix's product candidates
are investigational new drugs or biologics and none have been approved for any indication.
1Tzabazis A, et al. Cephalalgia. 2016.
2Anand R.P., et al. Nature. 2023. 622,
3Lassiter, G., et al. (2023). TNX-1500, a crystallizable
fragment-modified anti-CD154 antibody, prolongs non-human primate renal allograft survival. American Journal of Transplantation.
4Miura, S., et al. (2023). TNX-1500, a crystallizable
fragment-modified anti-CD154 antibody, prolongs non-human primate cardiac allograft survival. American Journal of Transplantation.
Recent Highlights-Financial
As of September 30, 2023, Tonix had approximately
$6.9 million of cash and cash equivalents, compared to $120.2 million as of December 31, 2022. Additionally, Tonix had inventory totaling
approximately $13.3 million as of September 30, 2023. In August 2023, Tonix received net proceeds of approximately $6.3 million through
a public offering of common stock, after deducting underwriting discount and other offering expenses. Cash used in operations was approximately
$79.7 million for the nine months ended September 30, 2023, compared to $75.8 million for the same period in 2022. Cash used by investing
activities for the nine months ended September 30, 2023 was approximately $28.6 million.
On September 28, 2023, the Company sold 4,050,000
shares of common stock, pre-funded warrants to purchase up to 4,950,000 shares of common stock, and accompanying common A warrants to
purchase 9,000,000 shares of common stock and common B warrants to purchase up to 9,000,000 shares of common stock in a public offering
for net proceeds of approximately $4.0 million, after deducting underwriting discount and other offering expenses. This public offering
closed on October 3, 2023.
Third Quarter 2023 Financial Results
Net product revenue for the third quarter
2023 was approximately $4.0 million. As a reminder, Tonix completed the acquisition of two currently marketed products from Upsher-Smith
Laboratories, LLC on June 30, 2023.
During the three months ended September 30,
2023, Tonix received $0.4 million from NIDA for the TNX-1300 study to treat cocaine intoxication.
R&D expenses for the third quarter 2023
were approximately $21.1 million, compared to $22.2 million for the same period in 2022. This decrease is predominantly due to decreased
non-clinical and manufacturing expenses, offset by an increase in clinical, employee-related and professional expenses.
SG&A expenses for the third quarter 2023
were $8.7 million, compared to $7.4 million for the same period in 2022. The increase was primarily due to sales and marketing associated
with the Company's recently acquired marketed products.
Net loss available to common stockholders
was $28.0 million, or $1.83 per share, basic and diluted, for the third quarter 2023, compared to net loss available to common stockholders
of $29.0 million, or $4.24 per share, basic and diluted, for the same period in 2022. The basic and diluted weighted average common shares
outstanding for the third quarter 2023 was 15,327,558 compared to 6,843,099 shares for the same period in 2022.
Tonix Pharmaceuticals Holding Corp.*
Tonix is a biopharmaceutical company focused on commercializing,
developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering. Tonix Medicines, our commercial
subsidiary, markets Zembrace SymTouch (sumatriptan injection) 3 mg and Tosymra (sumatriptan nasal spray) 10 mg under a
transition services agreement with Upsher-Smith Laboratories, LLC from whom the products were acquired on June 30, 2023. Zembrace SymTouch