Full Press Release Details
Tonix Pharmaceuticals Holding Corp. 8-K
Pharmaceuticals Reports Fourth Quarter and Full Year 2020 Financial Results and Operational Highlights
Positive Phase 3 RELIEF Study Results for TNX-102 SL 5.6 mg in Fibromyalgia
Analysis Results from Second Confirmatory Phase 3 Study, RALLY, Expected in Third Quarter 2021: Interim Cohort Enrolled
Data from Animal Studies of COVID-19 Vaccine Candidate, TNX-1800, Expected in First Quarter 2021
1 Safety Study in Humans of TNX-1800 Expected to Start in Second Half 2021
December 31, 2020, Cash and Cash Equivalents Totaled $77.1 Million;
$110 Million in Gross Proceeds Raised Subsequent to Year-End
NJ, March 15, 2021 (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, 2020, and provided an overview of recent operational highlights.
continue to make progress across our development programs and are steadily advancing our diverse pipeline of CNS and immunology
product candidates," said Seth Lederman, M.D., President and Chief Executive Officer. "In 2021, we expect to deliver
on several important milestones. Following on the success of our first pivotal Phase 3 fibromyalgia study, RELIEF, we look forward
to reporting interim and topline data from a second potentially pivotal Phase 3 fibromyalgia study, RALLY, this year. We recently
reported that we achieved enrollment of the first 50 percent of participants in RALLY, which we expect will be the interim analysis
cohort. We also expect to report preclinical efficacy data from our COVID-19 vaccine candidate this quarter and start a Phase
1 study in humans in the second half of this year. Finally, we expect to initiate new clinical trials this year for several other
programs including a Phase 2 cocaine intoxication trial, Phase 2 migraine trial, and a proof-of-concept study for the skin test
for COVID-19 exposure to measure T cell immunity."
SL (cyclobenzaprine HCl sublingual tablets): small molecule product candidate for management of fibromyalgia
(live attenuated vaccine based on Tonix's horsepox virus vector, TNX-801): COVID-19 vaccine candidate designed as a single-administration
vaccine to elicit T cell immunity
| In November 2020, the Company announced results following vaccination of non-human primates with TNX-1800 in COVID-19 models to measure safety and the immune response to the SARS-CoV-2 Spike protein. Data demonstrated that TNX-1800 at a low dose induces a strong immune response to SARS-CoV-2 in non-human primates, with all eight animals manifesting "takes", a skin reaction which is a validated biomarker of functional T cell immunity. | |
| Efficacy results from a study of TNX-1800 in which non-human primates were vaccinated with TNX-1800 and challenged with live SARS-CoV-2 are expected in the first quarter of 2021. | |
| A Phase 1 safety study using TNX-1800 in humans is anticipated to start in the second half of 2021, pending Investigational New Drug (IND) clearance from the FDA. |
(diagnostic skin test): SARS-CoV-2 epitope peptide mixtures for intradermal administration to measure the delayed-type hypersensitivity
(DTH) reaction to SARS-CoV-2
| Based on guidance from the FDA the Company plans to file an IND in the second quarter of 2021 and initiate clinical trials in the second half of 2021. The Company has already manufactured peptides under cGMP. TNX-2100 is designed to measure functional, or meaningful, in vivo T cell immunity to SARS-CoV-2. T cell immunity to SARS-CoV-2 persists longer than antibody immunity, is sometimes present in the absence of a measurable antibody response and is believed to provide an important element of protection against serious COVID-19 illness after infection with SARS-CoV-2. TNX-2100 is a test comprising three different mixtures of synthetic peptides (TNX-2110, -2120 and -2130), which are designed to represent different protein components of the SARS-CoV-2 virus. | |
| Tonix's proposed skin test has the potential to serve as: 1) a biomarker for cellular immunity and protective immunity; 2) a method to stratify participants in COVID-19 vaccine trials by immune status; 3) an endpoint in COVID-19 vaccine trials, and 4) a biomarker of durability of vaccine protection. |
(intranasal potentiated oxytocin): small peptide product candidate for migraine, craniofacial pain, insulin resistance and related
| Tonix intends to submit an IND application to the FDA in the second quarter of 2021 and is targeting to start a Phase 2 study of TNX-1900 for the prophylactic treatment of chronic migraine in the U.S. in the third quarter of 2021. A Phase 2 trial under an investigator-initiated IND was completed in the U.S. using TNX-1900 prior to Tonix's acquisition of the program. | |
| In June 2020, Tonix acquired the assets of Trigemina, Inc., including the rights to develop TNX-1900 for migraine and craniofacial pain. In December 2020, Tonix acquired an exclusive license to the University of Geneva's technology for using oxytocin to treat insulin resistance and related syndromes, including obesity. This license allows Tonix to expand its intranasal potentiated oxytocin development program into cardiometabolic syndromes, which include insulin resistance, impaired glucose tolerance, and obesity. |
(novel formulation of intranasal potentiated oxytocin): small peptide product candidate for the treatment of Prader-Willi syndrome
| In February 2021, Tonix announced an agreement whereby the Company has licensed technology using oxytocin-based therapeutics for the treatment of Prader-Willi syndrome from Inserm, the French National Institute of Health and Medical Research. The co-exclusive license allows Tonix to expand its intranasal potentiated oxytocin development program to a new indication. | |
| Prader-Willi syndrome is an orphan disease that occurs in approximately one in 15,000 births, and is recognized as the most common genetic cause of life-threatening childhood obesity, affecting males and females with equal frequency and all races and ethnicities. There is currently no approved treatment for either the suckling (breastfeeding) deficit in infants or the obesity and hyperphagia in older children associated with Prader-Willi syndrome. Tonix plans to submit applications to the FDA for Orphan Drug and Fast Track designations for TNX-2900. |
(recombinant double mutant cocaine esterase): biologic product candidate for life-threatening cocaine intoxication
(monoclonal antibody anti-CD154): third generation monoclonal antibody as a potential first line monotherapy for preventing or
treating organ transplant rejection and treating autoimmune disorders
*All Tonix product candidates are investigational new drugs or biologics and have not been approved for any indication.
of December 31, 2020, Tonix had $77.1 million of cash and cash equivalents, compared to $11.2 million as of December 31, 2019.
Cash used in operations was approximately $48.6 million for the full year ended December 31, 2020, compared to $26.7 million for
full year ended December 31, 2019. The increase in cash used in operations resulted principally from an increase in research and
development and general and administrative activities as defined below.
the year ended December 31, 2020, net proceeds from financing activities were $123.1 million, predominantly from the sale of common
stock and exercise of warrants. In January 2021, the Company sold 50,000,000 shares of common stock at $0.80 per share, priced
at-the-market, for gross proceeds of approximately $40 million, and net proceeds of approximately $36.9 million, after deducting
the underwriting discount and other offering expenses. In February 2021, the Company sold 58,333,334 shares of common stock at
$1.20 per share in a registered direct public offering, priced at-the-market, for gross proceeds of approximately $70 million,
and net proceeds of approximately $65.0 million, after deducting the underwriting discount and other offering expenses.
Quarter 2020 Financial Results
and development expenses for the fourth quarter of 2020 were $12.1 million, compared to $5.7 million for the same period in 2019.
This increase is predominantly due to two Phase 3 studies ongoing during this time for TNX-102 SL for fibromyalgia as well as
the development of potential COVID-19 vaccine candidate, TNX-1800, which was not in development in 2019.
and administrative expenses for the fourth quarter of 2020 were $4.9 million, compared to $3.0 million for the same period in
2019. The increase is primarily due to an increase in financial reporting expenses, patent prosecution and maintenance costs and
an increase in headcount.
loss available to common stockholders was $17.0 million, or $0.10 per share, basic and diluted, for the fourth quarter of 2020,
compared to net loss of $11.2 million, or $2.86 per share, basic and diluted, for the fourth quarter of 2019. The basic and diluted
weighted average common shares outstanding for the fourth quarter of 2020 was 163,873,489, compared to 3,912,800 shares for the
Year 2020 Financial Results
and development expenses for full year 2020 were $36.2 million, compared to $18.2 million for the same period in 2019. This increase
is predominantly due to the timing of development milestones related to the Phase 3 RELIEF and RALLY studies in fibromyalgia in
2020, increased activities for the development of potential vaccine candidates, TNX-1800 and TNX-801 as well as the Trigemina
and administrative expenses for full year 2020 were $14.4 million, compared to $10.6 million for the same period in 2019. The
increase is primarily due to an increase in legal fees, patent prosecution and maintenance costs, financial reporting expenses
and increased employee headcount.
loss available to common stockholders was $52.2 million, or $0.55 per share, basic and diluted, for full year 2020, compared to
net loss available to common stockholders of $31.1 million, or $19.33 per share, basic and diluted, for full year 2019. The basic
and diluted weighted average common shares outstanding for full year 2020 was 94,591,715, compared to 1,608,568 shares for full
Tonix Pharmaceuticals Holding Corp.
is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and
biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central
nervous system (CNS) and immunology product candidates. The CNS portfolio includes both small molecules and biologics to treat
pain, neurologic, psychiatric and addiction conditions. Tonix's lead CNS candidate, TNX-102 SL1, is in mid-Phase
3 development for the management of fibromyalgia, and positive data on the RELIEF Phase 3 trial were recently reported. The Company
expects interim data from a second Phase 3 study, RALLY, in the third quarter of 20212 and topline data in the fourth
quarter of 2021. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression,
cancer, and autoimmune diseases. Tonix's lead vaccine candidate, TNX-1800, is a live replicating vaccine based on the horsepox
viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix expects efficacy data from
animal studies of TNX-1800 in the first quarter of 2021. TNX-8013, live horsepox virus vaccine for percutaneous administration,
is in development to protect against smallpox and monkeypox.
SL is an investigational new drug and has not been approved for any indication.
submission and agreement from FDA on statistical analysis plan.
and TNX-801 are investigational new biologics and have not been approved for any indication.
press release and further information about Tonix can be found at www.tonixpharma.com.
statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995.
These statements may be identified by the use of forward-looking words such as "anticipate," "believe,"
"forecast," "estimate," "expect," and "intend," among others. These forward-looking
statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors
that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include,
but are not limited to, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations;
delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development
of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties
of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties;
and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory
approval, and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking
statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31,
2020, as filed with the Securities and Exchange Commission (the "SEC") on March 15, 2021, and periodic reports filed
with the SEC on or after the date thereof. All Tonix's forward-looking statements are expressly qualified by all such risk factors
and other cautionary statements. The information set forth herein speaks only as of the date thereof.
Pharmaceuticals Reports Fourth Quarter 2020 Financial Results
PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts)