Interim Analysis for Phase 3 HONOR study of
Tonmya® (Cyclobenzaprine HCl Sublingual Tablets) inMilitary-Related
PTSD Expected in Third Quarter of 2018; Topline Results Expected in
Fourth Quarter of 2018
Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix), a
clinical-stage biopharmaceutical company focused on discovering and
developing pharmaceutical products to treat serious
neuropsychiatric conditions and to improve biodefense through
developing potential medical counter-measures, today announced
financial results for the fourth quarter and full year ended
December 31, 2017.
“We remain on track to report results from the interim analysis
in the third quarter of this year for the Phase 3 HONOR study of
Tonmya*, an FDA-designated Breakthrough Therapy for the treatment
of posttraumatic stress disorder (PTSD),” commented Seth Lederman,
M.D., President and Chief Executive Officer of Tonix. “The interim
readout will be based on approximately 50 percent of the total
number of efficacy evaluable participants in the study and we
anticipate reaching this 50 percent randomization level in the
first quarter of this year. Topline results of all efficacy
evaluable participants, if needed, are anticipated in the fourth
quarter of 2018.”
“In addition,” Dr. Lederman continued, “we are excited about
developing a potential second indication for TNX-102 SL for the
treatment of agitation in Alzheimer’s disease. We are on
schedule to submit an Investigational New Drug (IND) application to
the FDA for a Phase 2 study in this indication before the end of
this month.”
At December 31, 2017, Tonix had cash and cash equivalents of
$25.5 million. Net cash used in operating activities for the full
year was $19.1 million.
Recent Highlights:
- Completed a successful pre-IND meeting with the FDA to discuss
TNX-102 SL as a clinical candidate for the treatment of agitation
in Alzheimer’s disease.
- Appointed General David L. Grange (retired) to the Board of
Directors. General Grange is the current CEO of Pharm-Olam
International, Ltd. and the former CEO of Pharmaceutical Product
Development, Inc., both global clinical research
organizations. General Grange is also a retired U.S. Army
Brigadier General, who brings military experience, expertise in
business and government partnerships, as well as experience in
clinical development services.
- Received a Notice of Allowance from the U.S. Patent and
Trademark Office related to the use of Tonmya’s active ingredient
(cyclobenzaprine HCl) for the treatment of PTSD. Also
received Notice of Allowance from the Japanese Patent Office
related to the eutectic formulation of TNX-102 SL.
- Announced publication of a peer-reviewed article in PLOS ONE,
describing the successful synthesis and characterization of a
potential smallpox-preventing vaccine based on horsepox virus
(TNX-801).
*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 PTSD. TNX-102 SL is an
investigational new drug and has not been approved for any
indication.
Fourth Quarter Financial Results
Tonix reported a net loss of $5.5 million, or $0.71 per share,
for the fourth quarter of 2017, compared to a net loss of $7.5
million, or $2.08 per share, for the fourth quarter of 2016.
The net loss for the three months ended December 31, 2017,
excluding non-cash expenditures of $0.3 million, was $5.2 million,
as compared to a net loss of $6.4 million, excluding non-cash
expenditures of $1.1 million, for the three months ended December
31, 2016. 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 $21.1 million, or $3.17 per share,
for the year ended December 31, 2017, compared to a net loss of
$38.8 million, or $15.41 per share, for the year ended December 31,
2016. The net loss for the year ended December 31, 2017,
excluding non-cash expenditures of $1.8 million, was $19.3 million,
as compared to a net loss of $35.2 million, excluding non-cash
expenditures of $3.6 million, for the year ended December 31, 2016.
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 $19.1 million for the year ended
December 31, 2017, as compared to $37.3 million for the year ended
December 31, 2016. At December 31, 2017, Tonix’s cash, cash
equivalents and marketable securities totaled $25.5 million,
compared to $26.1 million at December 31, 2016.
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 U.S., 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 in approximately 40 U.S. sites. An
unblinded interim analysis will be conducted once the study has
accumulated efficacy results from approximately 275 randomized
participants. In a Cross-Disciplinary Breakthrough Therapy meeting,
the FDA confirmed that (i) a single-study NDA approval could be
possible if the topline data from the HONOR study are statistically
very persuasive, and (ii) an additional abuse assessment study is
not required for the NDA filing. Additional details of the HONOR
study are available at www.thehonorstudy.com or
https://clinicaltrials.gov/ct2/show/NCT03062540.
In 2017, the U.S. Patent and Trademark Office 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 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. Tonix was also awarded European
patent (Patent No. 2,501,234, “Methods and Compositions for
Treating Symptoms Associated with Posttraumatic Stress Disorders
Using Cyclobenzaprine”). This patent is expected to provide Tonmya,
upon European marketing authorization, with European market
exclusivity until November 2030 and the exclusivity may be extended
based on the timing of the European marketing authorization of
Tonmya for PTSD. Also, in December 2017, the Japanese Patent
Office issued Japanese Patent No. 6259452, “Compositions and
Methods for Transmucosal Absorption,” related to the
pharmacokinetic profile of Tonmya, or TNX-102 SL.
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 to improve biodefense through
developing potential medical counter-measures. Tonix’s lead product
candidate, Tonmya, or TNX-102 SL, is in Phase 3 development as a
bedtime treatment for PTSD. Tonix is also developing TNX-102 SL as
a bedtime treatment for agitation in Alzheimer’s disease and has
completed a pre-IND (Investigational New Drug) meeting with the
FDA. TNX-601 (tianeptine oxalate) is in the pre-IND application
stage, also for the treatment of PTSD but 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.
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TONIX
PHARMACEUTICALS HOLDING CORP. |
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CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS |
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(in thousands, except
share and per share amounts) (1) |
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Three Months ended December 31, |
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Twelve Months ended December 31, |
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2017 |
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2016 |
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2017 |
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2016 |
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(unaudited) |
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Costs and expenses |
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Research and
development |
$3,634 |
|
4,879 |
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$13,342 |
|
28,533 |
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General and
administrative |
1,909 |
|
2,631 |
|
7,949 |
|
10,436 |
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Total costs and
expenses |
5,543 |
|
7,510 |
|
21,291 |
|
38,969 |
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Operating loss |
(5,543) |
|
(7,510) |
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(21,291) |
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(38,969) |
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Interest income,
net |
50 |
|
28 |
|
168 |
|
127 |
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Net loss |
$(5,493) |
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(7,482) |
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$(21,123) |
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(38,842) |
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Net loss per common
share, basic and |
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diluted |
$(0.71) |
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(2.08) |
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$(3.17) |
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(15.41) |
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Weighted average common
shares |
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outstanding, basic and
diluted |
7,786,850 |
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3,595,748 |
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6,665,091 |
|
2,521,016 |
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(1) |
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The condensed
consolidated statements of operations for the years ended December
31, 2017 and 2016 have been derived from the audited financial
statements, but do not include all the information and footnotes
required by accounting principles generally accepted in the United
States for complete financial statements. |
TONIX
PHARMACEUTICALS HOLDING CORP. |
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CONDENSED
CONSOLIDATED BALANCE SHEETS |
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(in thousands) (1) |
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December 31, 2017 |
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December 31, 2016 |
Assets |
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Cash, cash equivalents
and marketable securities |
$25,496 |
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$26,121 |
Prepaid expenses and
other current assets |
947 |
|
1,019 |
Total current
assets |
26,443 |
|
27,140 |
Non-current assets |
311 |
|
370 |
Total assets |
$26,754 |
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$27,510 |
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Liabilities and
stockholders’ equity |
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Total liabilities |
$2,138 |
|
$2,149 |
Stockholders’
equity |
24,616 |
|
25,361 |
Total liabilities and
stockholders’ equity |
$26,754 |
|
$27,510 |
(1) |
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The
condensed consolidated balance sheets for the years ended December
31, 2017 and 2016 have been derived from the audited financial
statements, but do not include all the information and footnotes
required by accounting principles generally accepted in the United
States for complete financial statements. |
Contacts
Jessica Morris (investors)Tonix
Pharmaceuticalsinvestor.relations@tonixpharma.com (212)
980-9159
Rich Allan (media)Russo
Partnersrich.allan@russopartnersllc.com (646) 942-5588
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