Tonix Pharmaceuticals Reports First Quarter 2019 Financial Results and Operational Highlights
May 13 2019 - 8:00AM
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a clinical-stage biopharmaceutical company developing
pharmaceutical products to treat psychiatric and pain conditions,
and biological products to improve biodefense, today announced
financial results for the quarter ended March 31, 2019 and an
overview of recent operational highlights. Tonix’s lead
program is TNX-102 SL, or Tonmya* (cyclobenzaprine HCl sublingual
tablets), for the treatment of posttraumatic stress disorder
(PTSD), which was granted Breakthrough Therapy designation and
which is currently being studied in a Phase 3 efficacy trial.
“We initiated the Phase 3 RECOVERY study of
Tonmya for the treatment of PTSD in March and we are pleased with
the progress of enrollment thus far. We anticipate topline
results in the first half of next year as previously guided,” said
Seth Lederman, M.D., President and Chief Executive Officer.
“RECOVERY is different from our previous trials in PTSD in two
important ways. First, RECOVERY is restricted to patients
with PTSD resulting from trauma within 9 years of screening.
Our prior studies in military-related PTSD have shown that PTSD is
a potentially treatable condition, particularly if treatment is
initiated within 9 years of trauma. Second, RECOVERY is
recruiting civilians with PTSD in addition to those with
military-related PTSD. Affecting approximately 12 million
adults in the U.S., PTSD remains an area of high unmet medical need
in both the civilian and military populations.”
Recent Highlights
- Commenced enrollment in the Phase 3
RECOVERY study of Tonmya for the treatment of PTSD in March 2019.
Topline data is expected in the first half of 2020.
- Received guidance and support from
the U.S. Food and Drug Administration (FDA) to advance TNX-102 SL
into Phase 3 clinical development for the treatment of fibromyalgia
using the 5.6 mg dose taken daily at bedtime. A lower dose of
TNX-102 SL (2.8 mg) was studied previously in fibromyalgia in a
Phase 2b study and a Phase 3 study. Both studies showed
clinical benefits especially in the quality of sleep improvement,
however, primary analyses on pain reduction were not statistically
significant. The FDA also advised that the long-term safety
exposure data from the Company’s PTSD program may be used to
support a New Drug Application (NDA) for the treatment of
fibromyalgia. It is estimated that between 5-10 million
adults in the U.S. are affected by fibromyalgia, of which
approximately 3 million are diagnosed. Among those diagnosed, more
than one-third have used opiates as a means of treatment. TNX-102
SL is a non-opioid, centrally-acting analgesic that would provide a
new therapeutic option for fibromyalgia patients.
- Announced that Breakthrough Therapy
designation (BTD) remains in effect for Tonmya for the treatment of
PTSD and that the Company will meet with the FDA to address its
“Intent to Rescind” Breakthrough Therapy designation notice, and to
present additional data to support continuing Breakthrough Therapy
designation.
*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.
First Quarter 2019 Financial
Results
Research and development expenses for the first
quarter of 2019 totaled $3.9 million, compared to $5.2 million for
the same period in 2018. This decrease is primarily due to a
pharmacokinetic bridging study of TNX-102 SL that was conducted in
the first quarter of 2018.
General and administrative expenses for the
first quarter of 2019 totaled $2.4 million, compared to $1.8
million for the same period in 2018. This increase is primarily due
to investor and public relations activities and an increase in
insurance expenses due to higher premiums in 2019.
Net loss was $6.2 million, or $1.29 per share,
for the first quarter of 2019, compared to net loss of $6.9
million, or $8.80 per share, for the first quarter of 2018. The
weighted average common shares outstanding for the first quarter of
2019 was 4,848,199 shares. The weighted average common shares
outstanding for the first quarter of 2018 was 787,900 shares.
At March 31, 2019, Tonix had $16.4 million of
cash and cash equivalents, compared to $25.0 million as of December
31, 2018. Cash used in operations was $8.6 million for the three
months ended March 31, 2019, compared to $6.8 million for the three
months ended March 31, 2018. The increase in cash used in
operations during the first quarter of 2019 is due primarily to
non-recurring items, including close-out costs for the Phase 3
HONOR study and start-up costs related to the current Phase 3
RECOVERY study. Costs related to the RECOVERY study are
expected to decrease on a quarterly basis going forward.
Additionally, the Company’s annual insurance premiums increased
over the prior year, the payments of which occur in the first
quarter.
About Tonix Pharmaceuticals Holding
Corp.Tonix is a clinical-stage biopharmaceutical company
focused on discovering and developing pharmaceutical products to
treat psychiatric and pain conditions, and biological products to
improve biodefense through potential medical counter-measures.
Tonix’s lead program is the development of Tonmya (TNX-102 SL),
which is in Phase 3 development as a bedtime treatment for PTSD.
Tonmya for PTSD has been designated a Breakthrough Therapy by the
FDA. Tonix is also developing TNX-102 SL as a bedtime
treatment for fibromyalgia and agitation in Alzheimer’s disease
under separate Investigational New Drug applications (IND) to
support potential pivotal efficacy studies. The fibromyalgia
program is in Phase 3 development and the agitation in Alzheimer’s
program is Phase 2 ready. In fibromyalgia, TNX-102 SL acts as
a non-opioid, centrally-acting analgesic that would provide a new
therapeutic option for fibromyalgia patients. The agitation
in Alzheimer’s disease IND has been designated a Fast Track
development program by the FDA. TNX-601 (tianeptine oxalate)
is in the pre-IND application stage, also for the treatment of PTSD
but by a different mechanism from TNX-102 SL and designed for
daytime dosing. TNX-601 is also in development for a potential
indication - neurocognitive dysfunction associated with
corticosteroid use. A Phase 1 clinical formulation selection
pharmacokinetic study of TNX-601 will be conducted outside of the
U.S. in 2019. 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, 2018, as filed with the Securities and Exchange
Commission (the “SEC”) on March 18, 2019, 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 HOLDING
CORP.CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS(In Thousands, Except Share and Per
Share Amounts)(Unaudited)
|
Three Months Ended March 31, |
|
2019 |
|
2018 |
Costs and expenses |
|
|
|
Research and
development |
$ 3,896 |
|
|
$ 5,170 |
|
General and
administrative |
|
2,401 |
|
|
|
1,818 |
|
Total costs and expenses |
|
6,297 |
|
|
|
6,988 |
|
Operating loss |
|
(6,297 |
) |
|
|
(6,988 |
) |
Interest income, net |
|
64 |
|
|
|
53 |
|
Net loss |
$ (6,233 |
) |
|
$ (6,935 |
) |
Net loss per common share, basic and diluted |
$ (1.29 |
) |
|
$ (8.80 |
) |
Weighted average common shares outstanding, basic and
diluted |
|
4,848,199 |
|
|
|
787,900 |
|
TONIX PHARMACEUTICALS HOLDING CORP. CONDENSED
CONSOLIDATED BALANCE SHEETS (In Thousands) (Unaudited)
|
March 31, 2019 |
|
December 31, 2018 (1) |
Assets |
|
|
|
|
Cash and cash
equivalents |
$ 16,448 |
|
$ 25,034 |
Prepaid
expenses and other current assets |
|
2,734 |
|
|
1,022 |
Total current assets |
|
19,182 |
|
|
26,056 |
Other non-current assets |
|
840 |
|
|
263 |
Total assets |
$ 20,022 |
|
$ 26,319 |
|
|
|
|
Liabilities and stockholders'
equity |
|
|
|
Total liabilities |
$
2,211 |
|
$
2,655 |
Stockholders' equity |
|
17,811 |
|
|
23,664 |
Total liabilities and stockholders' equity |
$ 20,022 |
|
$ 26,319 |
|
|
|
|
(1) The condensed consolidated balance
sheet for the year ended December 31, 2018 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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