Tonix Pharmaceuticals Reports First Quarter 2017 Financial Results and Provides Programs Update
May 15 2017 - 7:00AM
Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix), a
company that is developing innovative pharmaceutical products to
address public health challenges, recently announced financial
results for the first quarter ended March 31, 2017.
“Beginning enrollment in the first quarter of
2017 of the Phase 3 HONOR study of TNX-102 SL* for the treatment of
posttraumatic stress disorder (PTSD) was an important milestone for
Tonix,” said Seth Lederman, M.D., president and chief executive
officer of Tonix. “We remain on track with our previously-disclosed
guidance for reporting results next year, and are pleased to note
that this pivotal study is fully funded through completion. If the
topline data from the HONOR study are statistically persuasive, we
can file a new drug application with the U.S. Food and Drug
Administration (FDA) seeking approval for TNX-102 SL for PTSD.
PTSD affects approximately 8.6 million Americans, nearly 1
million of whom are military veterans. Patients with
military-related PTSD experience severe symptoms, and
currently-approved drugs have not shown efficacy in these patients,
creating an urgent need for a new therapeutic approach.”
At March 31, 2017, Tonix had cash, cash
equivalents, and marketable securities of $22.4 million.
Subsequent to quarter end, Tonix raised net proceeds totaling
approximately $16.3 million. Tonix announced an underwritten public
offering of common stock in the first quarter that closed in April
2017 and resulted in net proceeds of approximately $8.3 million.
Additionally, Tonix raised approximately $8.0 million in net
proceeds through an at-the-market offering in April 2017. Net cash
used in operating activities for the first quarter was $4.8
million.
Upcoming Milestones and Recent Program
Highlights
- Interim analysis from approximately 275 randomized participants
in the Phase 3 HONOR study is anticipated in the first half of
2018.
- Topline results from the Phase 3 HONOR study of 550
participants (if needed) are anticipated in the second half of
2018.
- Enrolled the first participant in the 12-week, double-blinded,
placebo-controlled Phase 3 HONOR study of TNX-102 SL 5.6 mg for the
treatment of military-related PTSD in March 2017.
- Held the Initial Cross-Disciplinary Breakthrough meeting with
the FDA in March 2017. Minutes from the meeting indicated that
registration of TNX-102 SL could be solely supported by the Phase 3
HONOR study if topline data are statistically persuasive.
- Eutectic proprietary Protectic™ formulation patent (U.S. Patent
No. 9,636,408), issued in May 2017, provides for TNX-102 SL market
exclusivity until 2034.
- In the first quarter of 2017, announced synthesis of a
potential smallpox-preventing vaccine candidate, TNX-801, a live
form of horsepox virus, which has demonstrated protective vaccine
activity in mice. TNX-801 is the first-ever synthesized chimeric
horsepox virus.
- In the first quarter of 2017, announced addition to pipeline of
tianeptine oxalate, TNX-601, a novel oral formulation for
development as a potential daytime treatment for PTSD.
*TNX-102 SL (cyclobenzaprine HCl sublingual
tablets) is an investigational new drug and has not been approved
for any indication.
First Quarter Financial
Results
Tonix reported a net loss of $5.1 million, or
$1.27 per share, for the first quarter of 2017, compared to a net
loss of $14.0 million, or $7.41 per share, for the first quarter of
2016. The net loss for the three months ended March 31, 2017,
excluding non-cash expenditures of $0.6 million, was $4.5 million,
as compared to a net loss, excluding non-cash expenditures of $1.0
million, of $13.0 million for the first quarter of 2016. The lower
net loss was primarily due to decreased research and development
expense for clinical studies and related research, as well as lower
general and administrative expense related to these and other
corporate development activities.
Cash used in operations was $4.8 million for the
three months ended March 31, 2017, compared to $15.5 million for
the three months ended March 31, 2016. At March 31, 2017, cash,
cash equivalents, and marketable securities totaled $22.4 million,
compared to $26.1 million at December 31, 2016. Management believes
that cash, cash equivalents and marketable securities as of March
31, 2017, in addition to the approximately $16.3 million net
proceeds raised from the recent public offerings, are sufficient to
fund operating expenses and the Phase 3 HONOR study to completion
with up to 550 participants.
About Tonix Pharmaceuticals Holding
Corp.
Tonix is developing innovative pharmaceutical
products to address public health challenges. TNX-102 SL is in
Phase 3 development and has been granted Breakthrough Therapy
designation by the FDA for the treatment of PTSD. PTSD is a
serious condition characterized by chronic disability, inadequate
treatment options especially for military-related PTSD, and an
overall high utilization of healthcare services that contributes to
significant economic burdens. Tonix was issued U.S. patent
9,636,408 “Eutectic Formulations of Cyclobenzaprine Hydrochloride
and Amitriptyline Hydrochloride”, which includes compositions of
cyclobenzaprine HCl and methods of manufacturing the eutectic. The
Protectic™ protective eutectic and Angstro-Technology™ formulation
claimed in the patent are important elements of Tonix’s proprietary
TNX-102 SL composition. The patent provides Tonix with U.S.
market exclusivity until 2034. Other development efforts include
TNX-801, a potential smallpox-preventing vaccine based on a live
synthetic version of horsepox virus, and TNX-601 (tianeptine
oxalate), a clinical candidate at pre-IND (Investigational New
Drug) application stage, designed for daytime use for the treatment
of PTSD.
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,
substantial competition; 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 risks
related to failure to obtain FDA clearances or approvals and
noncompliance with FDA regulations. 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, 2016, as filed with the Securities and Exchange
Commission (the “SEC”) on April 13, 2017, and future periodic
reports filed with the SEC on or after the date hereof. 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 hereof.
TONIX PHARMACEUTICALS HOLDING CORP. |
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
(in
thousands, except share and per share amounts) |
(Unaudited) |
|
|
|
|
|
Three Months EndedMarch
31, |
|
|
2017 |
|
2016 |
Costs and expenses |
|
|
|
|
|
|
|
|
Research and
development |
|
$ 2,994 |
|
|
$ 10,671 |
|
General and
administrative |
|
|
2,097 |
|
|
|
3,343 |
|
Total costs and
expenses |
|
|
5,091 |
|
|
|
14,014 |
|
Operating loss |
|
|
(5,091 |
) |
|
|
(14,014 |
) |
Interest income,
net |
|
|
27 |
|
|
|
38 |
|
Net loss |
|
$(5,064 |
) |
|
$(13,976 |
) |
Net loss per common
share, basic and diluted |
|
$ (1.27 |
) |
|
$ (7.41 |
) |
Weighted average common
shares outstanding, basic and diluted |
|
|
3,985,529 |
|
|
|
1,886,043 |
|
TONIX PHARMACEUTICALS HOLDING CORP. |
CONDENSED CONSOLIDATED BALANCE SHEETS |
(in
thousands) |
(Unaudited) |
|
|
|
|
|
|
|
March 31, 2017 |
|
December 31, 2016 (1) |
Assets |
|
|
|
|
Cash, cash equivalents
and marketable securities |
|
$22,423 |
|
$26,121 |
Prepaid expenses and
other current assets |
|
1,009 |
|
1,019 |
Total current
assets |
|
23,432 |
|
27,140 |
Other non-current
assets |
|
352 |
|
370 |
Total assets |
|
$23,784 |
|
$27,510 |
|
|
|
|
|
Liabilities and
stockholders' equity |
|
|
|
|
Total liabilities |
|
$ 1,809 |
|
$ 2,149 |
Stockholders'
equity |
|
21,975 |
|
25,361 |
Total liabilities and
stockholders' equity |
|
$23,784 |
|
$27,510 |
(1) The condensed consolidated balance
sheet for the year ended December 31, 2016 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 Smiley
Investor Relations
Investor.relations@tonixpharma.com
(212) 980-9155 x185
Edison Advisors (investors)
Tirth Patel
tpatel@edisongroup.com
(646) 653-7035
Russo Partners (media)
Rich Allan
Rich.allan@russopartnersllc.com
(646) 942-5588
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