Full Press Release Details
Tonix Pharmaceuticals Holding Corp. 8-K
Tonix Pharmaceuticals
Reports Fourth Quarter and Full Year 2022 Financial Results and Operational Highlights
Interim Analysis of Registration-Enabling Phase
3 Fibromyalgia Trial of TNX-102 SL Expected Second Quarter 2023; Topline Data Expected Fourth Quarter 2023
Potentially Pivotal Phase 2 Trials of TNX-1900 in
Chronic Migraine and TNX-601 ER in Depression Scheduled for Interim Analyses in Fourth Quarter 2023
Potentially Pivotal Phase 2 Fibromyalgia-Type Long
COVID Study Enrolling
Cash and Cash Equivalents Totaled Approximately
$120.2 Million at December 31, 2022
CHATHAM, N.J., March 13, 2023 (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, 2022, and provided an overview of recent operational highlights.
"Our clinical activity is at a high point in
the Company's history, and we believe it is setting the stage for a year of significant accomplishments across an expanded portfolio
of novel pharmaceutical candidates designed to serve major unmet medical needs," said Seth Lederman, M.D., Chief Executive Officer
"We are pleased with the progress of our current
Phase 3 program in fibromyalgia, and we are looking forward to the results of a planned interim analysis due next quarter, followed by
topline results in the fourth quarter of this year. If successful, we believe it will be the second and final adequate and well-controlled
efficacy trial required for filing a New Drug Application (NDA) for approval by the U.S. Food and Drug Administration (FDA)", he
added. "Moreover, we believe we have satisfied all the other clinical and non-clinical requirements for an NDA."
Dr. Lederman added, "Patients and caregivers
alike report widespread dissatisfaction with the three currently approved drugs for fibromyalgia-Lyrica , Cymbalta , and
Savella , and generic pregabalin and duloxetine--, switching back and forth between them, and too often taking off-label products,
including addictive opiates. Fibromyalgia affects between six and 12 million adults in the U.S. according to the American Pain Association,
and there hasn't been a new FDA drug approval in the category in more than a dozen years."
Dr Lederman continued, "Our recently expanded
late-stage clinical programs include four potentially pivotal Phase 2 trials. Two are currently enrolling, one in Long COVID and the other
in chronic migraine. The two others - one in depression and the other in cocaine intoxication - are due to start enrolling.
We expect to initiate enrollment in the depression study by the end of March, followed by the cocaine intoxication study in the second
quarter of this year."
"In summary", he concluded, "these
programs, together with several others in earlier development, represent a diverse portfolio of programs with multiple opportunities for
value creation in 2023 and beyond."
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 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, insulin resistance and related disorders, and obesity-associated binge eating disorder
TNX-601 ER (tianeptine hemioxalate extended-release
tablets): a once-daily orally-administered small molecule for the treatment of major depressive disorder (MDD), Posttraumatic Stress Disorder
(PTSD), and neurocognitive dysfunction associated with corticosteroid use.
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 monoclonal antibody):
third generation anti-CD40L 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 to protect against smallpox and mpox designed as a single-administration vaccine to elicit T cell
*All of Tonix's product candidates
are investigational new drugs or biologics and none have been approved for any indication.
Recent Highlights-Corporate and Other
Recent Highlights-Financial
As of December 31, 2022, Tonix had $120.2 million of cash and
cash equivalents, compared to $178.7 million as of December 31, 2021. Net proceeds from financing activities were approximately $87.8
million for full year 2022, compared to $212.5 million for the full year 2021.
Since January 1, 2023, the Company repurchased 15,700,269 shares
of common stock under a $12.5 million share purchase program at prices ranging from $0.44 to $1.38 for a gross aggregate cost of approximately
In January 2023, the Board of Directors approved a new $12.5 million
share repurchase program. Since January 1, 2023, the Company repurchased 1,000,000 shares of common stock under this share repurchase
program at $1.14 for a gross aggregate cost of $1.1 million.
Cash used in operations was approximately $98.1
million for the full year 2022, compared to $75.6 million for the full year 2021. The increase in cash outlays was primarily due to an
increase in research and development (R&D) and general and administrative (G&A) activities, described below.
Cash used by investing activities for the years
ended December 31, 2022, and 2021 was approximately $48.1 million and $35.3 million, respectively, related to the purchase of property
Fourth Quarter 2022 Financial Results
R&D expenses for the fourth quarter 2022
were $24.7 million, compared to $22.3 million for the same period in 2021. The increase is predominately due to increased employee-related,
facility and laboratory expenses. We expect R&D expenses to increase during 2023 as we move our clinical development programs forward
and invests in our development pipeline.
G&A expenses for the fourth quarter 2022
were $8.1 million, compared to $7.3 million for the same period in 2021. The increase is primarily due to increased employee-related and
financial reporting expenses.
Net loss available to common stockholders was
$34.1 million, or $0.56 per share, basic and diluted, for the fourth quarter 2022, compared to net loss of $29.6 million, or $2.08 per
share, basic and diluted, for the same period in 2021. The basic and diluted weighted average common shares outstanding for the fourth
quarter 2022 was 61,379,692 compared to 14,230,897 shares for the same period in 2021.
Full Year 2022 Financial Results
R&D expenses for the full year 2022 were
$81.9 million, compared to $68.8 million for the same period in 2021. The increase is predominately due to increased employee-related,
facility and laboratory expenses. We expect R&D expenses to increase during 2023 as we move our clinical development programs forward
and invest in our development pipeline.
G&A expenses for the full year 2022 were
$30.2 million, compared to $23.5 million for the same period in 2021. The increase is primarily due to increased employee-related and
financial reporting expenses.
Net loss available to common stockholders was
$116.9 million, or $3.27 per share, basic and diluted, for the full year 2022, compared to net loss of $92.3 million, or $8.10 per share,
basic and diluted, for the same period in 2021. The basic and diluted weighted average common shares outstanding for full year 2022 was
35,739,057 compared to 11,387,308 shares for the same period in 2021.
Tonix Pharmaceuticals Holding Corp.*
Tonix is a clinical-stage biopharmaceutical company
focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix's