Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a clinical-stage biopharmaceutical company, today
announced financial results for the quarter ended June 30, 2019,
and an overview of recent operational highlights. Tonix’s lead
program is the development of TNX-102 SL, or Tonmya*
(cyclobenzaprine HCl sublingual tablets), for the treatment of
posttraumatic stress disorder (PTSD), which is currently being
studied in a Phase 3 efficacy trial.
“Enrollment continues in our Phase 3 RECOVERY
study of Tonmya for the treatment of PTSD, and we anticipate
topline results in the first half of 2020, as previously guided,”
said Seth Lederman, M.D., President and Chief Executive Officer.
“Since the end of the first quarter, we have re-started Phase 3
development of TNX-102 SL for fibromyalgia. We are also
expanding TNX-102 SL development to include alcohol use disorder
(AUD), which is in the pre-investigational new drug (IND)
application stage. We also added to our pipeline with the
in-licensing of TNX-1300**, a Phase 2 biologic for the treatment of
cocaine intoxication, and with the internal development of TNX-1500
for the prevention and treatment of organ transplant rejection.
Finally, we successfully raised equity proceeds to reinforce our
balance sheet and further fund our programs. The first half of 2019
has been an exciting time for Tonix and provides great momentum for
the rest of the year.”
Recent Highlights
- In July 2019, raised gross proceeds
of approximately $5.4 million before deducting underwriting
discounts, commissions and other offering expenses payable by the
Company. The Company expects to use the net proceeds to help fund
Phase 3 development of TNX-102 SL, to advance the development of
TNX-1300 and for working capital and other general corporate
purposes.
- Presented results from
pharmacokinetic (PK) analyses of TNX-102 SL in a poster
presentation at the American Society of Clinical
Psychopharmacology. The Company’s poster titled, ‘Steady-State
Pharmacokinetic Properties of a Sublingual Formulation of
Cyclobenzaprine (CBP) HCl (TNX-102 SL): Comparison to Simulations
of Oral Immediate Release CBP’ reports PK results of TNX-102 SL, a
sublingual form of cyclobenzaprine studied in a comparative PK,
open-label, randomized, parallel, two-arm, multiple-dose pivotal
bridging study, with the reference listed drug AMRIX®
(cyclobenzaprine HCI extended release capsules). The study
provided the necessary PK data to support TNX-102 SL as a 505(b)(2)
regulatory approval pathway which can streamline the U.S. Food and
Drug Administration (FDA) approval of TNX-102 SL by relying on the
safety findings and relevant labeling information of AMRIX.
- Added a new program to study
TNX-102 SL as a treatment for alcohol use disorder (AUD). Tonix
plans to meet with the FDA in October 2019 to discuss this new
indication which will be developed under a separate IND. AUD is a
chronic relapsing brain disease characterized by compulsive alcohol
use, loss of control over alcohol intake, and a negative emotional
state when not using. An estimated 16 million people in the United
States have AUD. Sleep disturbance is extremely common in
alcohol recovery; it can significantly impact daytime cognition,
mood, and ability to participate in alcohol treatment, and is
associated with increased risk of relapse. Tonix believes
that by improving sleep quality, the rate of successful recovery
for people with AUD can be substantially improved.
- Expanded pipeline with a Phase 2
biologic, TNX-1300 (T172R/G173Q double-mutant cocaine esterase 200
mg, i.v. solution) for cocaine intoxication. Currently there is no
specific pharmacotherapy indicated for cocaine intoxication, a
state characterized by acute agitation, hyperthermia, tachycardia,
arrhythmias, and hypertension, with the potential life-threatening
sequelae of myocardial infarction, cerebrovascular accident,
rhabdomyolysis, respiratory failure, and seizures. Patients are
currently managed only by supportive care for the adverse effects
of cocaine overdose on the cardiovascular and central nervous
systems.
- Expanded pipeline with TNX-1500,
Tonix’s internally developed, proprietary anti-CD154 monoclonal
antibody (mAb) that targets CD154 for the prevention and treatment
of organ transplant rejection. TNX-1500 is also a potential
treatment for autoimmune conditions. TNX-1500 is in the pre-IND
application stage.
- Expanded intellectual property for
the composition and formulation of TNX-102 SL in China and the
United States, providing intellectual property protection until
2034 and 2035, respectively.
Second Quarter 2019 Financial
Results
At June 30, 2019, Tonix had $12.2 million of
cash and cash equivalents, compared to $25.0 million as of December
31, 2018. Cash used in operations was $4.7 million for the second
quarter of 2019, compared to $5.5 million for the same period last
year and $8.6 million for the first quarter of 2019.
Research and development expenses for the second
quarter of 2019 totaled $3.6 million, compared to $4.1 million for
the same period in 2018. This decrease is primarily due to timing
of development milestones related to the PTSD HONOR study which was
completed in 2018.
General and administrative expenses for the
second quarter of 2019 totaled $2.4 million, compared to $2.1
million for the same period in 2018. The modest increase is
primarily due to an increase in patent prosecution costs and higher
insurance premiums in 2019.
Net loss was $5.8 million, or $0.95 per share,
for the second quarter of 2019, compared to net loss of $6.1
million, or $7.23 per share, for the second quarter of 2018. The
weighted average common shares outstanding for the second quarter
of 2019 was 6,167,012 shares. The weighted average common shares
outstanding for the second quarter of 2018, which gives effect to
the 1-for-10 reverse stock split in November 2018, was 842,041
shares.
About Tonix Pharmaceuticals Holding
Corp.
Tonix is a clinical-stage biopharmaceutical
company focused on discovering and developing small molecules and
biologics to treat psychiatric, pain and addiction conditions, to
improve biodefense through potential medical counter-measures, and
to prevent and treat organ transplant rejection. Tonix’s lead
program is for the development of Tonmya* (TNX-102 SL), which is in
Phase 3 development as a bedtime treatment for PTSD. Tonix is also
developing TNX-102 SL as a bedtime treatment for fibromyalgia,
agitation in Alzheimer’s disease and alcohol use disorder, to be
developed under separate Investigational New Drug applications
(INDs) to support potential pivotal efficacy studies. The
fibromyalgia program is in Phase 3 development, the agitation in
Alzheimer’s program is Phase 2 ready and the alcohol use disorder
program is in the pre-IND application stage. TNX-1300**
(double-mutant cocaine esterase) is being developed under an IND
and is in Phase 2 development for the treatment of cocaine
intoxication. TNX-601 (tianeptine oxalate) is in the pre-IND
application stage, also for the treatment of PTSD but by a
different mechanism from TNX-102 SL and designed for daytime
dosing. TNX-601 is also in development for a potential indication -
neurocognitive dysfunction associated with corticosteroid use. Data
is expected in the second half of 2019 for a Phase 1 clinical
formulation selection pharmacokinetic study of TNX-601 that is
being conducted outside of the U.S. TNX-801 (live virus vaccine for
percutaneous (scarification) administration) is a potential
smallpox-preventing vaccine based on a live synthetic version of
horsepox virus, currently in the pre-IND application stage.
Finally, TNX-1500 is being developed to prevent and treat organ
transplant rejection, as well as to treat autoimmune conditions,
and is in the pre-IND application stage.
*Tonmya has been conditionally accepted by the
U.S. Food and Drug Administration (FDA) as the proposed trade name
for TNX-102 SL for the treatment of PTSD. TNX-102 SL
(cyclobenzaprine HCl sublingual tablets) is an investigational new
drug and has not been approved for any indication.
**TNX-1300 (T172R/G173Q double-mutant cocaine
esterase 200 mg, i.v. solution) is an investigational new biologic
and has 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 failure to obtain FDA clearances or approvals and
noncompliance with FDA regulations; 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, 2018, as filed with the Securities and Exchange
Commission (the “SEC”) on March 18, 2019, and periodic reports on
Form 10-Q filed with the SEC on or after the date thereof. Tonix
does not undertake any obligation to update or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise, except as required by law.
TONIX PHARMACEUTICALS HOLDING CORP. CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share
and per share amounts) (Unaudited)
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
2019 |
|
2018 |
|
2019 |
|
2018 |
Costs and expenses |
|
|
|
|
|
|
|
Research and development |
$
3,554 |
|
$
4,067 |
|
$
7,450 |
|
$ 9,237 |
General and administrative |
2,352 |
|
2,076 |
|
4,753 |
|
3,894 |
Total costs and expenses |
5,906 |
|
6,143 |
|
12,203 |
|
13,131 |
Operating loss |
(5,906) |
|
(6,143) |
|
(12,203) |
|
(13,131) |
Interest income, net |
66 |
|
56 |
|
130 |
|
109 |
Net loss |
$ (5,840) |
|
$ (6,087) |
|
$ (12,073) |
|
$ (13,022) |
Net loss per common share, basic and diluted |
$ (0.95) |
|
$ (7.23) |
|
$ (2.19) |
|
$ (15.98) |
Weighted average common shares outstanding, basic and
diluted |
6,167,012 |
|
842,041 |
|
5,511,249 |
|
815,120 |
TONIX PHARMACEUTICALS HOLDING CORP. CONDENSED
CONSOLIDATED BALANCE SHEETS (in thousands) (Unaudited)
|
June 30, 2019 |
|
December 31, 2018(1) |
Assets |
|
|
|
Cash and cash equivalents |
$ 12,150 |
|
$ 25,034 |
Prepaid expenses and other current assets |
2,009 |
|
1,022 |
Total current assets |
14,159 |
|
26,056 |
Other non-current assets |
849 |
|
263 |
Total assets |
$ 15,008 |
|
$ 26,319 |
|
|
|
|
Liabilities and stockholders' equity |
|
|
Total liabilities |
$ 2,186 |
|
$2,655 |
Stockholders' equity |
12,822 |
|
23,664 |
Total liabilities and stockholders' equity |
$ 15,008 |
|
$ 26,319 |
(1) The condensed consolidated balance
sheet for the year ended December 31, 2018 has been derived from
the audited financial statements but does 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(212) 980-9159
Scott Stachowiak (media)Russo
Partnersscott.stachowiak@russopartnersllc.com (646) 942-5630
Peter Vozzo (investors)Westwicke
Partnerspeter.vozzo@westwicke.com (443) 213-0505
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