Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a clinical-stage biopharmaceutical company, today
announced financial results for the third quarter ended September
30, 2022, and provided an overview of recent operational
highlights.
“Tonix continues to make meaningful progress in
the development of multiple programs within its robust pipeline,
having already commenced a confirmatory Phase 3 study for
fibromyalgia in the second quarter of this year and a potentially
pivotal Phase 2 study for Long COVID in the third quarter of this
year,” said Seth Lederman, M.D., Chief Executive Officer of Tonix.
“We look forward to the interim data from both of these TNX-102 SL
studies in the second quarter of 2023. Additionally, we look
forward to advancing our other central nervous system or CNS
product candidates including TNX-102 SL for PTSD, TNX-1900 for
chronic migraine, TNX-1300 for cocaine intoxication, and TNX-601 ER
for depression, all of which we expect to be in the clinic by first
quarter 2023. Finally, we continue to make strides in immunology
with TNX-1500 for preventing organ transplant rejection expected to
enter into a Phase 1 study in the first half of 2023, as well as in
infectious diseases with TNX-801, a vaccine to prevent smallpox and
monkeypox, expected to enter into a Phase 1 study also in the first
half of next year.”
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)
-
Enrollment continues in the RESILIENT study, a double-blind,
randomized, placebo-controlled, potentially pivotal confirmatory
Phase 3 study of TNX-102 SL for the management of fibromyalgia.
Results from a planned interim analysis are expected in the second
quarter of 2023.
TNX-102 SL for the treatment of Long COVID, also
known as Post-Acute Sequelae of COVID-19 (PASC)
- Enrollment
continues in the PREVAIL study, a potentially pivotal Phase 2 study
of TNX-102 SL for Long COVID. Results from a planned interim
analysis are currently anticipated in the second quarter of
2023.
- Tonix presented
data from a previously announced retrospective observational
database study in patients with Long COVID at the International
Association for the Study of Pain (IASP) 2022 World Congress on
Pain. The poster presentation titled, “Retrospective Observational
Database Study of Patients with Long COVID with Multi-site Pain,
Fatigue, and Insomnia: A Real-World Analysis of Symptomatology and
Opioid Use,” included data showing that approximately 40% of
patients had fibromyalgia-like multi-site pain, the rate of opioid
use in Long COVID patients with multi-site pain was 34%, which
increased to approximately 50% when sleep disturbance was also
present. These findings support the feasibility of the currently
enrolling Phase 2 study for patients with Long COVID whose symptoms
overlap with fibromyalgia.
TNX-102 SL for the treatment of Posttraumatic
Stress Disorder (PTSD)
- Tonix
expects to begin enrolling a Phase 2 study of TNX-102 SL in police
in Kenya in the fourth quarter of 2022.
TNX-1300 (recombinant double mutant cocaine
esterase): biologic for life-threatening cocaine intoxication
- Tonix expects to
initiate a new, potentially pivotal, Phase 2 clinical study of
TNX-1300 for the treatment of cocaine intoxication in the first
quarter of 2023, pending agreement with the U.S. Food and Drug
Administration (FDA).
- In August 2022,
Tonix received a Cooperative Agreement grant from the National
Institute on Drug Abuse (NIDA), part of the National Institutes of
Health (NIH), to support development of TNX-1300.
- TNX-1300 has been
granted Breakthrough Therapy designation by the FDA.
TNX-1900 (intranasal potentiated oxytocin):
small peptide for migraine, craniofacial pain, insulin resistance
and related disorders, and obesity associated binge eating
disorder
- The Company
expects to begin enrollment in a Phase 2 study of TNX-1900 for the
prevention of migraine headache in chronic migraineurs in the
fourth quarter of 2022.
- Tonix announced
that U.S. Patent 11,389,473 issued in July 2022. The patent,
entitled "Magnesium-Containing Oxytocin Formulations and Methods of
Use" claims methods and compositions for treating pain, including
migraine headaches, using intranasal magnesium-containing oxytocin
formulations. This patent, excluding possible patent term
extensions, is expected to provide Tonix with U.S. market
exclusivity until January 2036.
TNX-601 ER (tianeptine hemioxalate
extended-release tablets): a once-daily small molecule for the
treatment of major depressive disorder (MDD), PTSD, and
neurocognitive dysfunction associated with corticosteroid use.
- In October 2022,
Tonix announced that the FDA has cleared the Investigational New
Drug (IND) application to support a Phase 2 study of TNX-601 ER for
the treatment of MDD, which the Company expects to initiate in the
first quarter of 2023.
- TNX-601 ER is
being developed as a monotherapy and first-line treatment for MDD.
No tianeptine-containing product has been approved by the FDA.
Rare Disease Pipeline
TNX-2900 (intranasal potentiated oxytocin):
small peptide for the treatment of Prader-Willi syndrome (PWS)
- In July 2022,
Tonix delivered a presentation titled, “TNX-2900 (Intranasal
Oxytocin + Magnesium) in Development for the Treatment of
Hyperphagia in Adolescents and Young Adults with Prader-Willi
Syndrome” at the World Orphan Drug Congress USA.
- TNX-2900 has been
granted Orphan Drug designation from the FDA for the treatment of
PWS.
Immunology Pipeline
TNX-1500 (anti-CD40L monoclonal antibody): third
generation monoclonal antibody for prophylaxis of organ transplant
rejection and treatment of autoimmune disorders.
- Tonix announced
data from three oral presentations at the 29th International
Congress of The Transplantation Society (TTS 2022) by faculty at
the Center for Transplantation Sciences, Massachusetts General
Hospital for TNX-1500 targeting CD40-ligand (CD40L), which is also
known as CD154.
- The presentations
titled, “Long-Term Rejection Free Renal Allograft Survival with
Fc-Modified Anti-CD154 Antibody Monotherapy in Nonhuman Primates,”
and “Monotherapy with TNX-1500, a Fc-Modified Anti-CD154mAb,
Prolongs Cardiac Allograft Survival in Cynomolgus Monkeys,” include
data demonstrating that TNX-1500 treatment showed activity in
preventing organ rejection and was well tolerated in non-human
primates. These presentations suggested that blockade of CD40L with
TNX-1500 monotherapy consistently and safely prevented pathologic
alloimmunity in non-human primate cardiac and kidney allograft
models without clinical thrombosis
- The presentation
titled, “Long-term (>1 year) Rejection-Free Survival of Kidney
Xenografts with Triple Xenoantigen Knockout and Multiple Human
Transgenes in NonHuman Primates,” includes data demonstrating that
TNX-1500 treatment showed activity in preventing xenograft kidney
rejection and was well tolerated in non-human primates. These
presentations suggested that blockade of CD40L with TNX-1500
monotherapy consistently and safely prevented pathologic
xenoimmunity in non-human primate kidney xenograft models without
clinical thrombosis.
- A Phase 1 study of
TNX-1500 is expected to start in the first half of 2023.
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
- As previously
mentioned, Tonix announced a collaboration with the Kenya Medical
Research Institute (KEMRI) to plan, seek regulatory approval for
and conduct a Phase 1 clinical study in Kenya to develop TNX-801 as
a vaccine to protect against monkeypox and smallpox. The study is
expected to start in the first half of 2023.
- Tonix presented
data from a research collaboration with The University of Alberta
in a poster presentation at the 4th Symposium of the Canadian
Society for Virology on June 5, 2022. The poster titled, “Synthetic
Chimeric Horsepox Virus (scHPXV) Vaccination Protects Macaques from
Monkeypox,” describes data from animals vaccinated with TNX-801 to
protect against monkeypox. The poster presentation reports that all
animals (n=8) vaccinated with TNX-801 were fully protected with
sterilizing immunity from a challenge with intra-tracheal
monkeypox. The vaccinations with TNX-801 were well tolerated.
Synthetic horsepox virus is the basis for the Company’s TNX-801
vaccine in development to protect against monkeypox and smallpox
and for the Company’s Recombinant Pox Virus (RPV) platform to
protect against other pathogens, including SARS-CoV-2.
*All of
Tonix’s product candidates are investigational new drugs or
biologics and have not been approved for any indication.
Recent
Highlights--Financial
As of September 30, 2022, Tonix had $140.0 million of cash and
cash equivalents, compared to $178.7 million as of December 31,
2021.
In October 2022, Tonix issued 1,400,000 shares of Series A
convertible redeemable preferred stock and 100,000 shares of Series
B convertible redeemable preferred stock to certain institutional
investors in a private placement for gross proceeds of $15.0
million. The Company expects to use the proceeds to redeem the
preferred stock.
Cash used in operations was approximately $23.5
million for the three months ended September 30, 2022, compared to
$12.9 million for the same period in 2021. The increase in cash
outlays was primarily due to an increase in research and
development activities. Capital expenditures were approximately
$8.8 million for the three months ending September 30, 2022
compared to $7.8 million for the same period in 2021. The increase
was primarily due to the continued buildout of the ADC in North
Dartmouth, Mass.
Third Quarter 2022 Financial Results
Research and development (R&D) expenses for
the three months ended September 30, 2022 were $22.2 million,
compared to $13.1 million for the same period in 2021. The increase
is predominately due to increased clinical, manufacturing,
non-clinical, employee-related and laboratory expenses. The Company
continues to expect R&D expenses to increase throughout the
remainder of 2022 as it moves its clinical development programs
forward and invests in its development pipeline.
General and administrative (G&A) expenses
for the three months ended September 30, 2022 were $7.4 million,
compared to $5.5 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
$29.0 million, or $0.69 per share, basic and diluted, for the three
months ended September 30, 2022, compared to net loss of $18.5
million, or $1.60 per share, basic and diluted, for the same period
in 2021. The basic and diluted weighted average common shares
outstanding for the three months ended September 30, 2022 was
41,944,289 compared to 11,581,367 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 portfolio is composed of central nervous system
(CNS), rare disease, immunology and infectious disease product
candidates. Tonix’s CNS portfolio includes both small molecules and
biologics to treat pain, neurologic, psychiatric and addiction
conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine
HCl sublingual tablet), is in mid-Phase 3 development for the
management of fibromyalgia with a new Phase 3 study launched in the
second quarter of 2022 and interim data expected in the second
quarter of 2023. TNX-102 SL is also being developed to treat Long
COVID, a chronic post-acute-COVID-19 condition. Tonix initiated a
Phase 2 study in Long COVID in the third quarter of 2022 and
expects interim data in the second quarter of 2023. TNX-1300
(cocaine esterase) is a biologic designed to treat cocaine
intoxication and has been granted Breakthrough Therapy designation
by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated
in the first quarter of 2023. TNX-1900 (intranasal potentiated
oxytocin), a small molecule in development for chronic migraine, is
expected to enter the clinic with a Phase 2 study in the fourth
quarter of 2022. TNX-601 ER (tianeptine hemioxalate
extended-release tablets) is a once-daily formulation of tianeptine
being developed as a potential treatment for major depressive
disorder (MDD) with a Phase 2 study expected to be initiated in the
first quarter of 2023. Tonix’s rare disease portfolio includes
TNX-2900 (intranasal potentiated oxytocin) for the treatment of
Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug
designation by the FDA. Tonix’s immunology portfolio includes
biologics to address organ transplant rejection, autoimmunity and
cancer, including TNX-1500, which is a humanized monoclonal
antibody targeting CD40-ligand (CD40L or CD154) being developed for
the prevention of allograft and xenograft rejection and for the
treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is
expected to be initiated in the first half of 2023. Tonix’s
infectious disease pipeline consists of a vaccine in development to
prevent smallpox and monkeypox, next-generation vaccines to prevent
COVID-19, and a platform to make fully human monoclonal antibodies
to treat COVID-19. TNX-801, Tonix’s vaccine in development to
prevent smallpox and monkeypox, also serves as the live virus
vaccine platform or recombinant pox vaccine (RPV) platform for
other infectious diseases. A Phase 1 study of TNX-801 is expected
to be initiated in Kenya in the first half of 2023. Tonix’s lead
vaccine candidate for COVID-19 is TNX-1850, a live virus vaccines
based on Tonix’s recombinant pox live virus vector vaccine
platform.
*All of Tonix’s product candidates are
investigational new drugs or biologics and have not been approved
for any indication.
This press release and further information about
Tonix can be found at www.tonixpharma.com.
Forward Looking Statements
Certain 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 the 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, 2021, as filed with the Securities and
Exchange Commission (the “SEC”) on March 14, 2022, and periodic
reports filed with the SEC on or after the date thereof. All of
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.
TONIX PHARMACEUTICALS HOLDING
CORP. CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS(In Thousands, Except Share and Per
Share Amounts)(unaudited)
|
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Three Months EndedSeptember
30, |
|
|
Nine Months EndedSeptember
30, |
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
COSTS AND EXPENSES: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
22,201 |
|
|
$ |
13,082 |
|
|
$ |
57,202 |
|
|
$ |
46,542 |
|
General and administrative |
|
7,390 |
|
|
|
5,453 |
|
|
|
22,161 |
|
|
|
16,291 |
|
|
|
29,591 |
|
|
|
18,535 |
|
|
|
79,363 |
|
|
|
62,833 |
|
|
|
|
|
|
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|
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|
|
|
|
|
|
Operating loss |
|
(29,591 |
) |
|
|
(18,535 |
) |
|
|
(79,363 |
) |
|
|
(62,833 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income, net |
|
610 |
|
|
|
7 |
|
|
|
825 |
|
|
|
99 |
|
|
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|
|
|
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|
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|
|
|
|
|
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Net loss |
|
(28,981 |
) |
|
|
(18,528 |
) |
|
|
(78,538 |
) |
|
|
(62,734 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock deemed
dividend |
|
— |
|
|
|
— |
|
|
|
4,255 |
|
|
|
— |
|
|
|
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|
Net loss available to common
stockholders |
$ |
(28,981 |
) |
|
$ |
(18,528 |
) |
|
$ |
(82,793 |
) |
|
$ |
(62,734 |
) |
|
|
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|
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|
|
|
|
Net loss per common share, basic
and diluted |
$ |
(0.69 |
) |
|
$ |
(1.60 |
) |
|
$ |
(3.06 |
) |
|
$ |
(6.02 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares
outstanding, basic and diluted |
|
41,944,289 |
|
|
|
11,581,367 |
|
|
|
27,066,489 |
|
|
|
10,429,028 |
|
TONIX PHARMACEUTICALS HOLDING
CORP.CONDENSED CONSOLIDATED BALANCE
SHEETS (In
Thousands)(Unaudited)
|
September 30, 2022 |
|
December 31, 20211 |
Assets |
|
|
Cash and cash equivalents |
$ 139,978 |
|
$ 178,660 |
Prepaid expenses and other |
11,161 |
|
10,389 |
Total current assets |
151,139 |
|
189,049 |
Other non-current assets |
91,507 |
|
51 ,851 |
Total assets |
$ 242,646 |
|
$ 240,900 |
|
|
|
Liabilities and
stockholders' equity |
|
|
Total liabilities |
$ 13,722 |
|
$ 22,183 |
Stockholders' equity |
228,924 |
|
218,717 |
Total liabilities and
stockholders' equity |
$ 242,646 |
|
$ 240,900 |
1The condensed consolidated balance sheet for the year ended
December 31, 2021 has been derived from the audited financial
statements but do not include all of the information and footnotes
required by accounting principles generally accepted in the United
States for complete financial statements.
Contacts
Jessica Morris (corporate)Tonix
Pharmaceuticalsinvestor.relations@tonixpharma.com (862)
904-8182
Olipriya Das, Ph.D. (media)Russo
PartnersOlipriya.Das@russopartnersllc.com (646) 942-5588
Peter Vozzo (investors)ICR
Westwickepeter.vozzo@westwicke.com (443) 213-0505
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