Full Press Release Details
Tonix Pharmaceuticals Holding Corp. 8-K
Tonix Pharmaceuticals
Reports First Quarter 2022 Financial Results and Operational Highlights
Fibromyalgia Phase 3 Trial of TNX-102 SL Enrollment
Initiated; Results from Interim Analysis Expected First Quarter 2023
Long COVID IND Cleared for TNX-102 SL; Phase 2 Trial
Expected to Initiate Second Quarter 2022
Three Additional CNS Programs Expected to Initiate
Phase 2 Studies in 2022: TNX-1300 for Cocaine Intoxication, TNX-1900 for Chronic Migraine and TNX-102 SL for PTSD
FDA Granted Orphan-Drug Designation for TNX-2900
for Treatment of Prader-Willi Syndrome
Organ Transplantation Phase 1 Study of TNX-1500
Expected to Initiate Second Half 2022
Cash and Cash Equivalents Totaled Approximately
$140 Million at March 31, 2022
CHATHAM, N.J., May 9, 2022 (GLOBE NEWSWIRE) -
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced
financial results for the first quarter ended March 31, 2022, and provided an overview of recent operational highlights.
"Tonix is making meaningful strides developing
our rich portfolio of high impact product candidates," said Seth Lederman, M.D., Chief Executive Officer of Tonix. "By the
end of this year, we expect to have five central nervous system (CNS) programs in the clinic, led by our most advanced program, TNX-102
SL (cyclobenzaprine HCl sublingual tablets) for fibromyalgia, which is in mid-Phase 3 development. Enrollment has begun for TNX-102 SL
in a registration-enabling-Phase 3 clinical trial. TNX-102 SL trials in Long COVID and PTSD are also expected to initiate enrollment in
the second quarter of 2022."
Dr. Lederman continued, "Long COVID is a growing
problem because it is a chronic condition experienced by approximately 30% of people who recover from COVID-19. There is no currently
approved treatment for this condition. We recently reported data from a retrospective observational study of U.S. adults that shows that
35% of Long COVID sufferers who experience multi-site pain are turning to addictive opioids. We are excited to study TNX-102 SL for this
condition, since TNX-102 SL is a centrally-acting, non-addictive analgesic which is intended for chronic use. We look forward to starting
our Phase 2 study for Long COVID with multi-site pain imminently."
Gregory Sullivan, M.D., Chief Medical Officer of
Tonix said, "We are excited by the opportunities ahead for our rich pipeline of CNS, rare disease, immunology and infectious disease
product candidates. TNX-1300 (recombinant double mutant cocaine esterase) is expected to start enrolling in a Phase 2 trial in the second
quarter of 2022 for emergency department treatment of cocaine intoxication, and TNX-1900 (intranasal potentiated oxytocin) is expected
to enter the clinic in the second half of 2022 for the prevention of migraines in chronic migraineurs. In addition to the CNS programs,
we expect to begin a Phase 1 study of TNX-1500, a monoclonal antibody targeting CD40 ligand, also known as CD154, which will initially
be developed to prevent organ transplant rejection and, ultimately, to treat autoimmune conditions. We continue to progress our infectious
disease portfolio, which is led by our smallpox vaccine, TNX-801 (live horsepox virus vaccine). We are also developing the live-virus
vectored COVID-19 vaccines, TNX-1840 and TNX-1850 that are designed to express the spike proteins from the omicron and BA.2 variants,
Recent Highlights-Key Product Candidates*
Central Nervous System (CNS) Pipeline
TNX-102 SL (cyclobenzaprine HCl sublingual
tablet): small molecule for the management of fibromyalgia (FM)
TNX-102 SL for the treatment of Long COVID,
also known as Post-Acute Sequelae of COVID-19 (PASC)
TNX-102 SL for the treatment of Posttraumatic
Stress Disorder (PTSD)
TNX-1300 (recombinant double mutant cocaine
esterase): biologic for life-threatening cocaine intoxication
TNX-1900 (intranasal potentiated oxytocin):
small peptide for migraine, craniofacial pain, insulin resistance and related disorders, and binge eating disorder
TNX-601 CR (tianeptine oxalate and naloxone
controlled-release tablets): small molecule for the treatment of major depressive disorder, PTSD and neurocognitive dysfunction associated
with corticosteroid use.
Rare Disease Pipeline
TNX-2900 (intranasal potentiated oxytocin):
small peptide for the treatment of Prader-Willi syndrome (PWS)
TNX-1500 (anti-CD40L monoclonal antibody):
third generation monoclonal antibody for prophylaxis of organ transplant rejection and treatment of autoimmune disorders.
Infectious Disease Pipeline
TNX-801 (live horsepox virus vaccine for
percutaneous administration): vaccine against smallpox and monkeypox designed as a single-administration vaccine to elicit T cell immunity
TNX-1840 /-1850 (live virus vaccines based
on Tonix's recombinant pox virus vector): COVID-19 vaccines designed as single-administration vaccines to elicit T cell immunity
TNX-3700: COVID-19 mRNA vaccine candidate
using a zinc nanoparticle (ZNP) formulation
TNX-2300: Live virus vaccine based on a
bovine parainfluenza virus vector to protect against COVID-19
TNX-2100 (diagnostic skin test): SARS-CoV-2
epitope peptide mixtures for intradermal administration to measure the delayed-type hypersensitivity (DTH) reaction to SARS-CoV-2
*All of Tonix's product candidates
are investigational new drugs or biologics and have not been approved for any indication.
J.G., Robertson, M.J., Barros- lvarez, X. et al. The oxytocin signaling complex reveals a molecular switch for cation
dependence. Nat Struct Mol Biol (2022). https://doi.org/10.1038/s41594-022-00728-4
2Noyce, RS, et al. Synthetic Chimeric Horsepox Virus (scHPXV)
Vaccination Protects Macaques from Monkeypox* Presented as a poster at the American Society of Microbiology BioThreats Conference - January
29, 2020, Arlington, VA. (https://content.equisolve.net/tonixpharma/media/10929ac27f4fb5f5204f5cf41d59a121.pdf
3Noyce RS, et al. Construction
of an infectious horsepox virus vaccine from chemically synthesized DNA fragments. PLoS One. 2018 Jan 19;13(1): e0188453.
4Clarke KE, et al. Seroprevalence of Infection-Induced
SARS-CoV-2 Antibodies - United States, September 2021-February 2022. MMWR Morb Mortal Wkly Rep 2022;71:606-608. DOI: http://dx.doi.org/10.15585/mmwr.mm7117e3
Recent Highlights--Financial
As of March 31, 2022, Tonix had $140.4 million of cash and cash
equivalents, compared to $178.7 million as of December 31, 2021. Subsequent to March 31, 2022, the Company sold 33.9 million shares of
common stock in at-the-market offerings (ATM) sales under a Sales Agreement with A.G.P./Alliance Global Partners, for net proceeds of
approximately $6.8 million. Additionally, the Company sold 13.0 million shares of common stock under the Purchase Agreement with Lincoln
Park for net proceeds of approximately $2.0 million.
Cash used in operations was approximately
$31.1 million for the first quarter ended March 31, 2022, compared to $21.1 million for the first quarter ended March 31, 2021. The increase
in primarily due to an increase in research and development (R&D) expense, general and administrative (G&A) expense, and increases
in working capital. Capital expenditures were approximately $20.2 million for the first quarter ending March 31, 2022 compared to $0.5
million for the first quarter ended March 31, 2021. The increase was primarily due to the continued buildout of the Advanced Development
Center in North Dartmouth, Mass.
First Quarter 2022 Financial Results
R&D expenses for the first quarter of 2022
were $18.4 million, compared to $15.3 million for the same period in 2021. This increase is predominately due to employee-related expenses
and non-clinical expenses. We continue to expect R&D expenses to increase during 2022 as we move our clinical development programs
forward and invest in our development pipeline.
G&A expenses for the first quarter of 2022
were $8.0 million, compared to $5.4 million for the same period in 2021. The increase is primarily due to employee-related expenses.