Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix), a
company in Phase 3 development of Tonmya*, a U.S. Food and Drug
Administration-designated Breakthrough Therapy for the treatment of
posttraumatic stress disorder (PTSD), and in various development
stages for other innovative pharmaceutical and biological products
to address public health challenges, recently announced financial
results for the second quarter ended June 30, 2017.
“The past quarter was a busy and exciting time
for us as we continued enrollment in the Phase 3 HONOR study of
Tonmya for the treatment of military-related PTSD,” said Seth
Lederman, M.D., president and chief executive officer of Tonix.
“HONOR remains on track for an unblinded interim analysis of 50% of
efficacy evaluable participants in the first half of 2018 and to
report topline results from the full study in the second half of
2018. As discussed with the U.S. Food and Drug Administration
(FDA) at the Initial Cross-Disciplinary Breakthrough Therapy
meeting, statistically persuasive topline data from this interim
analysis could support early filing of a New Drug Application
(NDA).”
The sublingual formulation of Tonmya is designed
for transmucosal absorption of the active ingredient,
cyclobenzaprine, which acts on PTSD symptoms by improving sleep
quality. It is administered once daily at bedtime. The FDA
has indicated that no additional drug dependence and addiction
study is needed for the Tonmya NDA.
At June 30, 2017, Tonix had cash and cash
equivalents of $34.4 million. Net cash used in operating activities
for the three months ended June 30, 2017 was $4.4 million.
Recent Program Highlights:
- Continued enrollment of the HONOR study, a 12-week,
multi-center, double-blind, placebo-controlled Phase 3 study of
Tonmya 5.6 mg (2 x 2.8 mg tablets) for the treatment of
military-related PTSD. Interim results of approximately 275
efficacy evaluable participants are due 1H18. Topline results from
the full study (550 participants), if needed, are scheduled for
2H18.
- Received notice that the U.S. Patent and Trademark Office has
issued a patent (U.S. Patent No. 9,636,408) protecting the
composition and manufacture of the unique Tonmya formulation. The
Protectic™ protective eutectic and Angstro-Technology™ formulation
claimed in the patent are important elements of Tonix’s proprietary
Tonmya composition. This patent is expected to provide Tonmya, upon
NDA approval, with U.S. market exclusivity until 2034.
- Participated in the "Pathophysiology of Posttraumatic Stress
Disorder: Rethinking Drug Targets" summit sponsored by the
Department of Defense. The invitation-only meeting assembled
experts from government, industry and academia and was the first of
its kind. Motivated by the need for more effective and safe
pharmacological therapies for PTSD among the military population,
the summit was co-hosted by the U.S. Army Medical Materiel
Development Activity’s Neurotrauma and Psychological Health Project
Management Office and the Joint Program Committee/Military
Operational Medicine Research Program.
- Presented additional retrospective analyses of treatment
response and safety parameters from the Phase 2 AtEase study at the
Annual Scientific Convention of the Society of Biological
Psychiatry, available at http://bit.ly/2uulTLP.
- Presented additional retrospective analyses of treatment
response from the Phase 2 AtEase study the Annual Meeting of the
American Society of Clinical Psychopharmacology, available
at http://bit.ly/2utvAhN.
- Continued development of TNX-801 (synthesized horsepox) to meet
Good Manufacturing Practice quality for a study to be supported by
an Investigational New Drug (IND) application.
- Received FDA conditional acceptance of the proposed trade name
Tonmya (ton-MY-ah) for TNX-102 SL for the treatment of PTSD.
For a video overview of the current Tonix development pipeline,
please see http://ir.tonixpharma.com/video.
*Tonmya® has been conditionally accepted by the
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.
Second
Quarter Financial Results
Tonix reported a net loss of $4.8 million, or
$0.65 per share, for the second quarter of 2017, compared to a net
loss of $9.8 million, or $4.97 per share, for the second quarter of
2016. The net loss for the three months ended June 30, 2017,
excluding non-cash expenditures of $0.5 million, was $4.3 million,
as compared to a net loss, excluding non-cash expenditures of $0.7
million, of $9.1 million for the second 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.
Tonix reported a net loss of $9.8 million, or
$1.74 per share, for the six months ended June 30, 2017, compared
to a net loss of $23.8 million, or $12.31 per share, for the six
months ended June 30, 2016. The net loss for the six months
ended June 30, 2017, excluding non-cash expenditures of $1.1
million, was $8.7 million, as compared to a net loss of $22.1
million, excluding non-cash expenditures of $1.7 million, for the
six months ended June 30, 2016. The lower net loss was primarily
due to decreased research and development expense during the first
six months of 2017 for clinical studies and research, as well as
lower general and administrative expense needed to support these
and other corporate development activities.
Cash used in operations was $4.4 million and
$9.2 for the three and six months ended June 30, 2017,
respectively, as compared to $8.0 million and $23.5 million for the
three and six months ended June 30, 2016, respectively. At June 30,
2017, cash, cash equivalents, and marketable securities totaled
$34.4 million, compared to $26.1 million at December 31, 2016.
Management believes that cash, cash equivalents and marketable
securities as of June 30, 2017 are sufficient to fund operating
expenses and the Phase 3 HONOR study to completion with up to 550
participants.
About Tonmya and the Phase 3 HONOR Study
Tonmya is a patented sublingual transmucosal
formulation of cyclobenzaprine that is in Phase 3 development. 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. In a Phase 2 study,
Tonmya 5.6 mg (2 x 2.8 mg tablets), was found to be effective in
treating military-related PTSD, which formed the basis of the
Breakthrough Therapy designation granted by the FDA. Tonix is
currently conducting a Phase 3 trial of Tonmya in military-related
PTSD in the United States, the HONOR study, which is a 12-week
randomized, double-blind, placebo-controlled trial evaluating the
efficacy of Tonmya 5.6 mg in participants with military-related
PTSD. This two-arm, adaptive-design trial is targeting enrollment
of up to approximately 550 participants across approximately 35
clinical sites. An unblinded interim analysis will be conducted
once the study has accumulated efficacy results from approximately
275 randomized participants. In the Initial Cross-Disciplinary
Breakthrough Therapy meeting, the FDA confirmed that a single-study
NDA approval could be possible if the topline data from the HONOR
study are statistically very persuasive. Additional details of the
HONOR study are available at www.thehonorstudy.com or
https://clinicaltrials.gov/ct2/show/NCT03062540.
About Tonix Pharmaceuticals Holding
Corp.
Tonix is developing innovative pharmaceutical
and biological products to address major public health challenges.
In addition to Tonmya for PTSD, Tonix is developing TNX-601
(tianeptine oxalate), a clinical candidate at pre-IND application
stage, designed as a daytime treatment for PTSD and TNX-801, a live
synthetic version of horsepox virus, at the pre-IND application
stage, to be developed as a potential smallpox-preventing
vaccine.
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 EndedJune
30, |
|
Six Months EndedJune
30, |
|
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
Costs and expenses |
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development |
$2,806 |
|
$7,516 |
|
$5,800 |
|
$18,187 |
|
General and
administrative |
|
2,016 |
|
|
2,320 |
|
|
4,113 |
|
|
5,663 |
|
Total costs and
expenses |
|
4,822 |
|
|
9,836 |
|
|
9,913 |
|
|
23,850 |
|
Operating loss |
|
(4,822) |
|
|
(9,836) |
|
|
(9,913) |
|
|
(23,850) |
|
Interest income,
net |
|
42 |
|
|
30 |
|
|
69 |
|
|
68 |
|
Net loss |
$(4,780) |
|
$(9,806) |
|
$(9,844) |
|
$(23,782) |
|
Net loss per common
share, basic and diluted |
$(0.65) |
|
$(4.97) |
|
$(1.74) |
|
$(12.31) |
|
Weighted average common
shares outstanding, basic and diluted |
|
7,327,890 |
|
|
1,973,643 |
|
|
5,666,457 |
|
|
1,931,193 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TONIX PHARMACEUTICALS HOLDING CORP. |
CONDENSED CONSOLIDATED BALANCE SHEETS |
(in
thousands) |
(Unaudited) |
|
|
June 30, 2017 |
|
December 31, 2016(1) |
Assets |
|
|
|
Cash, cash equivalents
and marketable securities |
$34,355 |
|
$26,121 |
Prepaid expenses and
other current assets |
|
1,130 |
|
1,019 |
Total current
assets |
|
35,485 |
|
27,140 |
Other non-current
assets |
|
338 |
|
370 |
Total assets |
$35,823 |
|
$27,510 |
|
|
|
|
Liabilities and
stockholders' equity |
|
|
|
Total liabilities |
$1,854 |
|
$2,149 |
Stockholders'
equity |
|
33,969 |
|
25,361 |
Total liabilities and
stockholders' equity |
$35,823 |
|
$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.
For more information:
Jessica Smiley
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(212) 980-9155 x18
Media Contact
Rich Allan
Russo Partners
rich.allan@russopartnersllc.com
(646) 942-5588
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