First Participant Enrolled in Phase 3 HONOR Study
of TNX-102 SL in Military-Related PTSD in 1Q2017
Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix), a
company that is developing innovative pharmaceutical products to
address public health challenges, announced financial results for
the fourth quarter and full year ended December 31, 2016.
Seth Lederman, M.D., president and chief
executive officer of Tonix, stated, “Tonix achieved significant
momentum in the last quarter of 2016, which has carried over into
2017. Tonix is focused on pioneering a differentiated
approach for the treatment of posttraumatic stress disorder (PTSD),
through improving sleep quality. TNX-102 SL*, having shown
potential advantages over existing treatments for this disorder,
received Breakthrough Therapy designation from the United States
Food and Drug Administration (FDA) in December 2016.”
“In the first quarter of 2017, the FDA accepted
the protocol design for our Phase 3 HONOR study to support the
registration of TNX-102 SL for PTSD.” Dr. Lederman continued,
“As we planned, the study was initiated in March and is on track to
have an unblinded interim analysis (IA) by an independent data
monitoring committee in the first half of 2018. If the IA results
require continued enrollment, topline results from the full
550-participant trial are expected to be available in the second
half of 2018. With successful capital raising
activities completed in 2017, Tonix is fully funded through the
completion of, and announcement of the topline results, from the
HONOR study.”
At December 31, 2016, Tonix had cash, cash
equivalents, and marketable securities of $26.1 million. Since
January 1, 2017, Tonix has raised approximately $9.1 million in net
proceeds through an at-the-market offering and approximately $8.3
million of net proceeds from the sale of common stock in an
underwritten public offering. Approximately 7.5 million
shares were outstanding as of April 13, 2017.
Recent Events:
- Enrolled the first participant in the 12-week, double-blinded,
placebo-controlled Phase 3 HONOR study of TNX-102 SL 5.6 mg, in
military-related PTSD.
- Held the Initial Cross-Disciplinary Breakthrough meeting with
the FDA. 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.
- Received Notice of Allowance for U.S. Patent Application
14/214,333, titled, “Eutectic Formulations of Cyclobenzaprine
Hydrochloride and Amitriptyline Hydrochloride,” covering the
proprietary sublingual formulation of TNX-102 SL. Patent
expected to be issued in 2Q2017 with protection through 2034.
- Synthesized 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.
- Developed a novel formulation of tianeptine oxalate, TNX-601,
as a potential daytime treatment for PTSD.
- Regained compliance with NASDAQ listing requirements by
completing a 1-for-10 reverse stock split.
2016 Highlights:
- Successfully transitioned Tonix’s core development program of
TNX-102 SL from fibromyalgia to PTSD, leveraging promising Phase 2
AtEase results, regulatory approval clarity, and the urgent public
health issue in military-related PTSD.
- Cash used in operating activities for the fourth quarter of
2016 totaled $5.4 million, representing a 35% decrease as compared
to the third quarter of 2016, and a 54% decrease as compared to the
fourth quarter of 2015.
Programs Update
TNX-102 SL 5.6 mg, for PTSD
- Completed a highly informative End-of-Phase 2 Chemistry,
Manufacturing and Controls (CMC) meeting with the FDA and received
FDA agreement on the proposed CMC data package to support the
TNX-102 SL New Drug Application (NDA) submission.
- Completed a successful Pre-Phase 3/End-of-Phase 2 meeting with
the FDA to thoroughly vet the Phase 3 clinical program to support
the registration of TNX-102 SL for PTSD. Received FDA agreement on
the proposed NDA clinical/nonclinical data package, and
encouragement to submit a Breakthrough Therapy designation
request.
- Awarded Breakthrough Therapy designation by the FDA for TNX-102
SL for the treatment of PTSD, providing eligibility for priority
review of an NDA and increased guidance and organizational
commitment from FDA senior managers.
- Presented encouraging topline data from the Phase 2 AtEase
study.
- Presented clinical results from a retrospective analysis of the
Phase 2 AtEase study demonstrating potential efficacy of TNX-102 SL
5.6 mg, in the reduction of reckless, self-destructive behavior and
suicidal behaviors, with especially strong evidence of clinical
improvement in combat-related PTSD patients.
- Hosted a PTSD Awareness Day with key opinion leaders in PTSD
research, highlighting the challenges in treating this growing
mental health concern, particularly among veterans.
TNX-801 (Live Virus Vaccine) for Smallpox
Prevention
- Successfully synthesized first-ever chimeric horsepox virus
(HPXV), TNX-801, a live form of HPXV that has demonstrated
protective vaccine activity in mice and is being developed as a
smallpox preventing vaccine.
- If licensed by the FDA, TNX-801 is eligible for a
highly-attractive priority review voucher. This voucher is fully
transferrable and may be sold to other companies for priority
review of any NDA or Biologics License Application (BLA).
TNX-601 (tianeptine oxalate) for PTSD
- Developed a novel formulation of tianeptine that may provide
improved stability, consistency, and manufacturability as compared
to known forms of tianeptine. Currently there is no
tianeptine-containing product approved in the U.S., although
tianeptine sodium (amorphous) has been available in Europe, Asia,
and Latin America for the treatment of depression since 1987.
Clinical studies in Europe have shown activity of tianeptine sodium
in treating PTSD.
Fourth Quarter and Full Year Financial
Results
Tonix reported a net loss of $7.5 million, or
$2.08 per share, for the fourth quarter of 2016, compared to a net
loss of $13.4 million, or $7.96 per share, for the fourth quarter
of 2015. The net loss for the three months ended December 31,
2016, excluding non-cash expenditures of $1.1 million, was $6.4
million, as compared to a net loss of $12.3 million, excluding
non-cash expenditures of $1.1 million, for the three months ended
December 31, 2015. The reduced net loss was primarily due to
decreased research and development expenses for clinical studies
and related research, as well as lower general and administrative
expenses needed to support these and other corporate development
activities.
Tonix reported a net loss of $38.8 million, or
$15.41 per share, for the year ended December 31, 2016, compared to
a net loss of $48.1 million, or $28.62 per share, for the year
ended December 31, 2015. The net loss for the year ended
December 31, 2016, excluding non-cash expenditures of $3.6 million,
was $35.2 million, as compared to a net loss of $43.5 million,
excluding non-cash expenditures of $4.6 million, for the year ended
December 31, 2015. The reduced net loss was primarily due to
decreased research and development expenses for clinical studies
and related research, as well as lower general and administrative
expenses needed to support these and other corporate development
activities.
Cash used in operations was $37.3 million for
the year ended December 31, 2016, as compared to $42.5 million for
the year ended December 31, 2015. At December 31, 2016,
Tonix’s cash, cash equivalents and marketable securities totaled
$26.1 million, compared to $43.0 million at December 31, 2015.
Management believes that existing cash and marketable securities
are sufficient to fund Tonix’s operating expenses and planned
clinical trial through at least the next 12 months.
*TNX-102 SL (cyclobenzaprine HCl sublingual
tablets) is an investigational new drug and has not been approved
for any indication.
About Posttraumatic Stress
DisorderPTSD can develop from witnessing or experiencing a
traumatic event in which there was the severe threat of, or actual
occurrence of, grave physical harm or death. PTSD affects
approximately 8.6 million Americans and is a chronic and severely
debilitating condition in which patients re-experience the horrific
traumas that resulted in the condition in the forms of intrusive
memories, flashbacks, and nightmares. PTSD typically is
characterized by disrupted sleep, anxiety, agitation, avoidance,
emotional numbness and estrangement from family and friends, guilt
or negative beliefs about self, and sometimes is associated with
clinical depression and suicidal thinking. Individuals who suffer
from PTSD usually have significant impairment in social
functioning, occupational disability, and an
overall poor quality of life. PTSD
is sometimes associated with substance abuse
and unpredictable violent or suicidal behaviors. It is estimated
that more than 19 percent of the 1.9 million U.S. veterans who were
deployed to the recent conflicts in Iraq and Afghanistan suffer
from PTSD.
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. The Protectic™ protective
eutectic and Angstro-Technology™ formulation are essential elements
of the proprietary TNX-102 SL composition for which a Notice of
Allowance has been issued by the U.S. Patent and Trademark Office.
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
StatementsCertain 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 per share amounts) (1) |
|
|
Three Months ended December 31, |
|
Twelve Months ended December 31, |
|
|
2016 |
|
|
2015 |
|
|
|
2016 |
|
|
2015 |
|
|
(unaudited) |
|
Costs and expenses |
|
Research and
development |
$ |
4,879 |
|
|
9,490 |
|
|
$ |
28,533 |
|
|
35,504 |
|
General and
administrative |
|
2,631 |
|
|
3,912 |
|
|
|
10,436 |
|
|
12,658 |
|
Total costs and
expenses |
|
7,510 |
|
|
13,402 |
|
|
|
38,969 |
|
|
48,162 |
|
Operating loss |
|
(7,510 |
) |
|
(13,402 |
) |
|
|
(38,969 |
) |
|
(48,162 |
) |
|
|
|
|
|
|
|
|
Interest income,
net |
|
28 |
|
|
43 |
|
|
|
127 |
|
|
108 |
|
Net loss |
$ |
(7,482 |
) |
|
(13,359 |
) |
|
$ |
(38,842 |
) |
|
(48,054 |
) |
Net loss per common
share, basic and diluted |
$ |
(2.08 |
) |
|
(7.96 |
) |
|
$ |
(15.41 |
) |
|
(28.62 |
) |
Weighted average common
shares outstanding, basic and diluted |
|
3,596 |
|
|
1,883 |
|
|
|
2,521 |
|
|
1,679 |
|
(1) The condensed consolidated statements of
operations for the years ended December 31, 2016 and 2015 have 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.
|
|
|
|
|
TONIX PHARMACEUTICALS HOLDING CORP. |
|
CONDENSED CONSOLIDATED BALANCE SHEETS |
|
(in
thousands) (1) |
|
|
|
|
December 31, 2016 |
|
|
December 31, 2015 |
|
Assets |
|
|
|
|
|
|
Cash, cash equivalents
and marketable securities |
$ |
26,121 |
|
$ |
43,016 |
|
Prepaid expenses and
other current assets |
|
1,019 |
|
|
3,343 |
|
Total current
assets |
|
27,140 |
|
|
46,359 |
|
Non-current assets |
|
370 |
|
|
659 |
|
Total assets |
$ |
27,510 |
|
$ |
47,018 |
|
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
Total liabilities |
$ |
2,149 |
|
$ |
6,756 |
|
Stockholders’
equity |
|
25,361 |
|
|
40,262 |
|
Total liabilities and
stockholders’ equity |
$ |
27,510 |
|
$ |
47,018 |
|
(1) The condensed consolidated balance sheets
for the years ended December 31, 2016 and 2015 have 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 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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