Tonix Pharmaceuticals Reports Third Quarter 2018 Financial Results and Operational Highlights
November 09 2018 - 7:30AM
New Phase 3 Trial of Tonmya® for the Treatment of
PTSD to Commence First Quarter 2019
Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix or the
Company), a clinical-stage biopharmaceutical company focused on
developing pharmaceutical products to treat serious
neuropsychiatric conditions and biological products to improve
biodefense, today announced financial results for the third quarter
ended September 30, 2018, and an overview of recent operational
highlights.
“We are pleased to be initiating a new Phase 3
study of Tonmya* for the treatment of PTSD in the first quarter of
2019,” said Seth Lederman, M.D., President and Chief Executive
Officer. “This new Phase 3 study has several innovative design
features that are based on retrospective analyses of data from the
Phase 3 HONOR and Phase 2 AtEase studies, in addition to feedback
received from the FDA during a Breakthrough Therapy Clinical
Guidance meeting in October. It has been preliminarily accepted by
the FDA as a potential pivotal efficacy study to support the
registration of Tonmya for the treatment of PTSD.”
Recent Program Highlights
- Received the U.S. Food and Drug Administration’s (FDA)
preliminary agreement on the new PTSD Phase 3 study design in
October. The new Phase 3 study of Tonmya will begin in the
first quarter of 2019 and will have several innovative design
features including: restricting enrollment to individuals with PTSD
who experienced an index trauma within nine years of screening;
enrolling participants who have experienced civilian traumas, in
addition to participants whose traumas are military-related; and a
CAPS-5 primary endpoint assessed at Week 4 instead of at Week 12,
the end of the treatment period. This new 12-week study will
require a baseline CAPS-5 score of ≥ 33 for enrollment, as was the
case with the Phase 3 HONOR study.
- Presented results and retrospective analyses of the Phase 3
HONOR study in a poster presentation at CNS Summit 2018 in
November.
- New composition of matter patent was issued in November which
expands the Company’s intellectual property protection for Tonmya,
or TNX-102 SL, in the U.S. The patent is part of an expanding
portfolio of patents and patent applications and other intellectual
property addressing the formulation, manufacturing, and uses of
Tonmya, or TNX-102 SL, for a variety of indications including
posttraumatic stress disorder, agitation in Alzheimer’s disease and
fibromyalgia.
- Presented results and retrospective analyses of the Phase 3
HONOR study and Phase 2 AtEase Study at the 2018 Military Health
System Research Symposium in August.
- Phase 3 HONOR study stopped early in July based on interim
analysis of Week 12 data in 274 PTSD participants.
- Received Fast Track designation for TNX-102 SL for agitation in
Alzheimer’s disease, from the FDA in July. The Company
received FDA comments on a Phase 2 / potential pivotal efficacy
study protocol for this indication in October.
*Tonmya has been conditionally accepted by the
U.S. Food and Drug Administration (FDA) as the proposed trade name
for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for the
treatment of PTSD. TNX-102 SL is an investigational new drug and
has not been approved for any indication.
Third Quarter 2018 Financial
Results
Research and development expenses for the third
quarter of 2018 totaled $3.3 million, compared to $3.9 million for
the same period in 2017. This decrease is predominately due to the
termination of the Phase 3 HONOR study at the end of July 2018.
General and administrative expenses for the
third quarter of 2018 were $2.3 million, compared to $1.9 million
for the same period in 2017. This increase is primarily due to an
increase in legal fees related to patent prosecution, as well as
investor and public relations.
Net loss was $5.5 million, or $0.57 per share,
for the third quarter of 2018, compared to net loss of $5.8
million, or $0.77 per share, for the third quarter of 2017.
At September 30, 2018, Tonix had $14.7 million
of cash and cash equivalents, compared to $25.5 million as of
December 31, 2017. Cash used in operations was $4.9 million for the
three months ended September 30, 2018, compared to $5.0 million for
the three months ended September 30, 2017.
About Tonix Pharmaceuticals Holding
Corp.
Tonix is a clinical-stage biopharmaceutical company focused on
discovering and developing pharmaceutical products to treat serious
neuropsychiatric conditions and biological products to improve
biodefense through potential medical counter-measures. Tonix is
developing Tonmya, which is in Phase 3 development and has been
granted Breakthrough Therapy designation, as a bedtime treatment
for PTSD. Tonix is also developing TNX-102 SL as a bedtime
treatment for agitation in Alzheimer’s disease under a separate IND
to support a Phase 2, potential pivotal, efficacy study and has
been designated a Fast Track development program by the FDA for
this indication. TNX-601 (tianeptine oxalate) is in the
pre-IND application stage, also for the treatment of PTSD but by a
unique mechanism and designed for daytime dosing. Tonix’s lead
biologic candidate, TNX-801, is a potential smallpox-preventing
vaccine based on a live synthetic version of horsepox virus,
currently in the pre-IND application stage.
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, 2017, as filed with the Securities and Exchange
Commission (the “SEC”) on March 9, 2018, 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 Reports Third Quarter 2018
Financial Results
TONIX PHARMACEUTICALS HOLDING CORP. CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share
and per share amounts) (Unaudited)
|
Three Months Ended September
30, |
|
Nine Months Ended September
30, |
|
2018 |
|
2017 |
|
2018 |
|
2017 |
|
Costs and
expenses |
|
|
|
|
|
|
|
|
Research and
development |
$ |
3,264 |
|
$ |
3,908 |
|
$ |
12,501 |
|
$ |
9,708 |
|
General and
administrative |
2,277 |
|
1,927 |
|
6,171 |
|
6,040 |
|
Total costs
and expenses |
5,541 |
|
5,835 |
|
18,672 |
|
15,748 |
|
Operating
loss |
|
(5,541 |
) |
|
(5,835 |
) |
|
(18,672 |
) |
|
(15,748 |
) |
Interest
income, net |
62 |
|
49 |
|
171 |
|
118 |
|
Net
loss |
$ |
(5,479 |
) |
$ |
(5,786 |
) |
$ |
(18,501 |
) |
$ |
(15,630 |
) |
Net loss
per common share, basic and diluted |
$ |
(0.57 |
) |
$ |
(0.77 |
) |
$ |
(2.15 |
) |
$ |
(2.49 |
) |
Weighted
average common shares outstanding, basic and diluted |
9,587,025 |
|
7,508,036 |
|
8,616,039 |
|
6,287,062 |
|
TONIX PHARMACEUTICALS HOLDING CORP. CONDENSED
CONSOLIDATED BALANCE SHEETS (in thousands) (Unaudited)
|
September 30, 2018 |
December 31, 2017(1) |
Assets |
|
|
Cash and cash
equivalents |
$ |
14,674 |
$ |
25,496 |
Prepaid
expenses and other current assets |
|
1,206 |
|
947 |
Total
current assets |
|
15,880 |
|
26,443 |
Other
non-current assets |
|
175 |
|
311 |
Total
assets |
$ |
16,055 |
$ |
26,754 |
|
|
|
Liabilities and stockholders' equity |
|
|
Total
liabilities |
$ |
2,346 |
$ |
2,138 |
Stockholders' equity |
|
13,709 |
|
24,616 |
Total
liabilities and stockholders' equity |
$ |
16,055 |
$ |
26,754 |
(1) The condensed consolidated balance sheet for the year
ended December 31, 2017 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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