Full Press Release Details
Tonix Pharmaceuticals 8-K
Tonix Pharmaceuticals
Reports Fourth Quarter and Full Year 2021 Financial Results and Operational Highlights
Immunology and CNS Programs Entering the Clinic
in 2022 for Organ Transplantation, Cocaine Intoxication, Fibromyalgia, PTSD, Migraine Headache and Binge Eating Disorder
Covid-19 Programs Include Upcoming Phase 2 Trial
in Long Covid, Results of First-in-Human T Cell Immunity Skin Test and New Versions of Our Live Virus Covid-19 Vaccine That Express Spike
Proteins From the Omicron and BA.2 Variants
Expansion of Internal Research and Development Capabilities
Underway to Accelerate Infectious Disease Programs and Prepare for Future Pandemic Responses
Orphan-Drug Designation Granted for TNX-2900 (Intranasal
Potentiated Oxytocin) for Prader-Willi Syndrome
Cash and Cash Equivalents Totaled Approximately
$179 Million at December 31, 2021
CHATHAM, NJ, March 14, 2022 (GLOBE NEWSWIRE) -
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced
financial results for the fourth quarter and full year ended December 31, 2021, and provided an overview of recent operational highlights.
"2021 was an important year for Tonix as we
delivered on several important milestones to advance our rich pipeline of immunology, central nervous system (CNS) and infectious disease
product candidates," said Seth Lederman, M.D., Chief Executive Officer of Tonix. "Our diversified pipeline was built through
internal research and development, business development and strategic collaborations. Already in 2022, we have shared results of animal
studies of monoclonal antibody TNX-1500 in organ transplantation and announced FDA's award of Orphan-Drug designation for TNX-2900
for Prader Willi syndrome. We look forward to pharmacogenomic analyses, in conjunction with topline data, for the Phase 3 RALLY study
of TNX-102 SL in fibromyalgia in the first quarter of 2022."
Dr. Lederman continued, "Through acquisitions
and the continued buildout of in-house R&D capabilities, Tonix is strengthening its capabilities to develop a broad infectious disease
portfolio of product candidates, led by TNX-801 which is a live virus vaccine for smallpox and monkeypox, that is based on horsepox, which
is our recombinant pox virus platform (RPV). Also based on the RPV are next-generation vaccine candidates to prevent Covid-19, including
TNX-1840 and TNX-1850 which are live virus vaccines designed to express the omicron and BA.2 variants of the spike protein. We look forward
to starting a Phase 2 study of TNX-102 SL for Long Covid and reporting topline data from the ongoing first-in-human study of TNX-2100,
a diagnostic skin test for T cell immunity to SARS-CoV-2, in the first half of 2022."
Gregory Sullivan, M.D., Chief Medical Officer of Tonix
said, "In 2022, we expect to initiate several clinical trials. We intend to start a Phase 1 study of TNX-1500, a humanized monoclonal
antibody with several potential indications including the prevention of organ transplant rejection and treatment of autoimmune disorders.
Within our CNS pipeline, we expect to start a Phase 2 study of FDA Breakthrough Therapy-designated product candidate TNX-1300 (recombinant
cocaine esterase) for cocaine intoxication in the emergency room setting. We also expect to start three trials for TNX-102 SL (sublingual
cyclobenzaprine) including: a confirmatory Phase 3 study for the management of fibromyalgia, a Phase 2 study for the treatment of PTSD,
and a Phase 2 study for the treatment of Long Covid. Finally, in 2022 we intend to start a Phase 2 study of TNX-1900 for the treatment
of migraine and an investigator-initiated Phase 2 study of TNX-1900 for binge eating disorder."
Recent Highlights-Key Product Candidates*
TNX-1500 (anti-CD40L monoclonal antibody):
third generation monoclonal antibody for prophylaxis of organ transplant rejection and treating autoimmune disorders.
TNX-1700 (stabilized recombinant trefoil
factor 2, or rTFF2): biologic for gastric and colorectal cancers
Central Nervous System (CNS) Pipeline
TNX-1300 (recombinant double mutant cocaine
esterase): biologic for life-threatening cocaine intoxication
TNX-102 SL (cyclobenzaprine HCl sublingual
tablets): small molecule for the management of fibromyalgia (FM)
TNX-102 SL for the treatment of Posttraumatic
Stress Disorder (PTSD)
TNX-102 SL for the treatment of Long Covid,
also known as Post-Acute Sequelae of COVID-19 (PASC)
TNX-1900 (intranasal potentiated oxytocin):
small peptide for migraine, craniofacial pain, insulin resistance and related disorders, and binge eating disorder
TNX-2900 (intranasal potentiated oxytocin):
small peptide for the treatment of Prader-Willi syndrome (PWS)
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.
Infectious Disease Pipeline
TNX-801 (live horsepox virus vaccine for
percutaneous administration): smallpox and monkeypox vaccine 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 a single-administration vaccine to elicit T cell immunity
TNX-3500 (sangivamycin): antiviral inhibitor
of SARS-CoV-2 for the treatment of COVID-19 and potential other viral disorders
TNX-3600: COVID-19 therapeutic; fully human
monoclonal antibody platform
TNX-3700: COVID-19 mRNA vaccine candidate
using a zinc nanoparticle (ZNP) formulation
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.
2021 Highlights-Facilities and Corporate
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.
Recent Highlights--Financial
As of December 30, 2021, Tonix had $178.7 million of cash and
cash equivalents, compared to $77.1 million as of December 31, 2020. Subsequent to December 31, 2021, the Company sold 15.6 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 $4.3 million. Additionally, the Company sold 22.0 million shares of common stock under the Purchase Agreement with Lincoln
Park for net proceeds of approximately $4.5 million.
Cash used in operations was approximately $75.6
million for the full year ended December 31, 2021, compared to $48.6 million for the full year ended December 31, 2020. The increase in
primarily due to an increase in research and development (R&D) and general and administrative (G&A) activities, described below.
Fourth Quarter 2021 Financial Results
R&D expenses for the fourth quarter of
2021 were $22.3 million, compared to $12.1 million for the same period in 2020. This increase is predominately due to increased clinical
expenses of $1.9 million, increased manufacturing expenses of $2.1 million, non-clinical expenses of $2.4 million, employee-related expenses
of $2.3 million and regulatory/legal expenses of $0.6 million. We expect R&D expenses to increase during 2022 as we move our clinical
development programs forward and continue to invest in our development pipeline.
G&A expenses for the fourth quarter of
2021 were $7.3 million, compared to $4.9 million for the same period in 2020. The increase is primarily due to employee-related expenses