Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a clinical-stage biopharmaceutical company, today
announced financial results for the second quarter ended June 30,
2021 and provided an overview of recent operational highlights.
“Our clinical, manufacturing, and regulatory
teams are advancing four programs into clinical trials by the end
of 2021,” said Seth Lederman, M.D., President and Chief Executive
Officer. “We look forward to initiating Phase 2 studies of TNX-1300
for cocaine intoxication and TNX-1900 for chronic migraine in the
third and fourth quarters of 2021, respectively. We also expect to
initiate a Phase 3 study of TNX-102 SL for PTSD outside of the U.S.
and a first-in-human study of TNX-2100, a skin test diagnostic for
COVID-19 T cell immunity, in the fourth quarter of 2021.”
Dr. Lederman continued, “We are expanding our
R&D and manufacturing facilities. In July we announced an
agreement to acquire an infectious disease research facility in
Frederick, MD, and earlier this month we began construction on our
Advanced Development Center (ADC) in New Bedford MA. We expect
these facilities, coupled with our planned commercial scale
manufacturing facility for vaccines in Hamilton, MT, will enable us
to avoid future outsourcing bottlenecks and to work with greater
efficiency in developing our programs for COVID-19, its variants,
and other infectious diseases.”
Dr. Lederman added, “Recent reports of COVID-19
outbreaks in the U.S. and elsewhere, due primarily to the Delta
variant, point to the urgent needs for more robust vaccines and
more potent antiviral therapeutics. We believe the recent steps we
have taken to strengthen our internal capabilities with
company-controlled R&D and manufacturing facilities will
accelerate our full pipeline of COVID-19 product candidates, which
currently includes the TNX-1800 vaccine, TNX-3500 antiviral,
TNX-2100 diagnostic, and TNX-102 SL for treating Long COVID.”
Recent Highlights—Key Product
Candidates*
Central Nervous System (CNS) Pipeline
TNX-102 SL (cyclobenzaprine HCl sublingual
tablets): small molecule for the management of fibromyalgia
- In July
2021, Tonix announced that the RALLY study, the second Phase 3
trial of TNX-102 SL 5.6 mg for fibromyalgia, stopped enrolling new
participants following recommendation from a pre-planned interim
analysis by the Independent Data Monitoring Committee (IDMC). Based
on interim analysis results of the first 50% of targeted
participants (n=337), the IDMC recommended stopping the trial for
futility as TNX-102 SL was unlikely to demonstrate a statistically
significant improvement in the primary endpoint of overall change
from baseline in daily diary pain severity scores between those
treated with TNX-102 SL 5.6 mg (2x 2.8 mg tablets) and those
receiving placebo. Tonix remains blinded to the detailed interim
analysis results and only received the recommendation made by the
IDMC. Preliminary blinded safety data from these participants did
not reveal any new safety signals, and the decision to discontinue
enrolling new participants is not related to safety. The Company
intends to continue studying those participants currently enrolled
until completion and then proceed with a full analysis of the
unblinded data, with the topline results expected to be reported in
the fourth quarter of 2021, to determine the next steps in this
program.
TNX-102 SL for the treatment of Posttraumatic
Stress Disorder (PTSD)
- Tonix
intends to meet with the U.S. Food and Drug Administration (FDA) to
discuss potential new endpoints for the indication of treatment of
PTSD in the third quarter of 2021. The Company also expects to
begin enrolling a Phase 3 study of TNX-102 SL in police in Kenya in
the fourth quarter of 2021.
TNX-102 SL for the treatment of Long COVID
Syndrome or Post-Acute Sequelae of COVID-19 (PASC)
- The
Company met with the FDA in the third quarter of 2021 to seek
agreement on the design of a potential Phase 2 pivotal study and
the overall clinical development plan for TNX-102 SL as an
indicated treatment for Long COVID. Tonix expects to receive
official minutes from this meeting in the third quarter of
2021.
TNX-1300 (recombinant double mutant cocaine
esterase): biologic for life-threatening cocaine intoxication
- Tonix expects to
initiate a Phase 2 open-label safety study in an emergency
department setting to study TNX-1300 in the third quarter of 2021.
Cocaine esterase is the most potent known catalyst for cocaine
degradation. Results of a positive Phase 2 study of volunteer
cocaine users in a controlled laboratory setting were reported
prior to Tonix licensing the technology.
TNX-1900 (intranasal potentiated oxytocin):
small peptide for migraine, craniofacial pain, insulin resistance
and related disorders
- Tonix intends to
submit an Investigational New Drug (IND) application to the FDA in
the third quarter of 2021 and is targeting to start a Phase 2 study
of TNX-1900 for the prophylactic treatment of chronic migraine in
the U.S. in the fourth quarter of 2021. A Phase 2 trial under an
investigator-initiated IND was completed in the U.S. using the
TNX-1900 formulation prior to Tonix’s acquisition of the
program.
TNX-601 CR (tianeptine oxalate and naloxone
controlled-release tablets): small molecule for the treatment of
major depressive disorder, PTSD and neurocognitive dysfunction
associated with corticosteroid use.
- Tonix previously
completed a Phase 1 trial for formulation development outside of
the U.S. Based on official minutes from a pre-IND meeting with the
FDA, the Company expects to initiate a Phase 2 study for the
treatment of depression in the first half of 2022, pending results
of nonclinical toxicology studies and IND clearance.
COVID-19 Pipeline
TNX-1800 (live virus vaccine based on Tonix’s
horsepox virus vector, TNX-801): COVID-19 vaccine designed as a
single-administration vaccine to elicit T cell immunity
- A Phase 1 safety
study using TNX-1800 in humans is anticipated to start in the first
half of 2022, pending IND clearance from the FDA and the production
of cGMP material. In March 2021, positive efficacy results from a
study of TNX-1800 in which non-human primates were vaccinated with
TNX-1800 and challenged with live SARS-CoV-2 were reported.
TNX-1800 was found to induce protection against infection in both
upper and lower airways, which suggests an ability to inhibit
forward transmission. The Company believes these findings also
demonstrate the flexibility of the horsepox vaccine platform, and
its capability to be engineered to construct new vaccines to
protect against other diseases of interest in military and civilian
populations.
TNX-2100 (diagnostic skin test): SARS-CoV-2
epitope peptide mixtures for intradermal administration to measure
the delayed-type hypersensitivity (DTH) reaction to SARS-CoV-2
- Tonix expects to
initiate a first-in-human clinical study in the fourth quarter of
2021. TNX-2100, designed to measure functional in vivo T cell
immunity to SARS-CoV-2, is a test comprising three different
mixtures of synthetic peptides (TNX-2110, -2120 and -2130). Tonix’s
proposed skin test has the potential to serve as: 1) a biomarker
for cellular (T-cell mediated) immunity and protective immunity; 2)
a method to stratify participants in COVID-19 vaccine trials by
immune status; 3) an endpoint in COVID-19 vaccine trials, and 4) a
biomarker of durability of vaccine protection.
TNX-3500 (sangivamycin): antiviral inhibitor of
SARS-CoV-2 for the treatment of COVID-19 and potential other viral
disorders
- In April 2021,
Tonix entered into an exclusive worldwide licensing agreement with
OyaGen, Inc. to develop TNX-3500 (sangivamycin, formerly OYA1) for
the treatment of COVID-19 and potentially other viral disorders. It
has demonstrated broad-spectrum activity in laboratory-based assays
against the coronaviruses SARS-CoV-2 and MERS-CoV. Tonix intends to
conduct further nonclinical animal studies prior to submitting an
IND and initiating a Phase 1 study.
Immunology Pipeline
TNX-1500 (anti-CD154 monoclonal antibody): third
generation monoclonal antibody as first line monotherapy for
preventing or treating organ transplant rejection and treating
autoimmune disorders.
- Tonix expects to
start a Phase 1 study in the second half of 2022. In experiments at
the Massachusetts General Hospital, a teaching hospital of Harvard
Medical School, TNX-1500 product candidate is being studied as
monotherapy or in combination with mycophenolate mofetil in heart
and kidney organ transplants in non-human primates. Preliminary
results from an ongoing experiment in heart transplants indicated
that TNX-1500 appeared to have comparable efficacy to historical
experiments using the chimeric mouse-human anti-CD40L monoclonal
antibody (mAb) hu5c8 and no evidence of thrombosis has been
observed.
- *All of Tonix’s
product candidates are investigational new drugs or biologics and
have not been approved for any indication.
Recent Highlights—Facilities and
Corporate
- In
August 2021, Tonix announced that it has commenced construction on
its Advanced Development Center (ADC) for the development and
manufacturing of Good Manufacturing Practice or GMP live-virus
vaccines to support Phase 1 and 2 clinical trials. The facility is
planned to be BSL-2 and expected to be operational in the first
half of 2022. A groundbreaking ceremony held August 3, 2021 was
attended by local, state, and federal officials, including U.S.
Representative Bill Keating, Massachusetts Housing and Economic
Development Secretary Mike Kennealy and New Bedford Mayor Jon
Mitchell.
- In July
2021, Tonix entered into a contingent non-binding Purchase and
Sales Agreement in connection with an infectious disease R&D
facility in Maryland, which is expected to provide internal
capacity to discover and develop vaccines and antiviral drugs
against COVID-19, its variants, and other infectious diseases. The
BSL-2 facility, currently owned and operated by Tonix partner
Southern Research, has housed research relating to Tonix’s COVID-19
vaccine candidate, TNX-1800, and to Tonix’s smallpox and monkeypox
candidate, TNX-801. Tonix expects the transaction to close in the
fourth quarter of 2021.
- In June
2021, Tonix announced that plans were advancing to construct a
commercial-scale manufacturing facility to develop and manufacture
vaccines in Hamilton, Montana. Construction on the greenfield site
is expected to start in 2022.
- Tonix
announced its addition to both the broad-market Russell
3000® index and the small-cap Russell 2000® Index as part
of the annual reconstitution of the Russell stock indexes, which
was effective after the market opened on June 28, 2021. Russell
indexes are widely used by investment managers and institutional
investors for index funds and as benchmarks for active investment
strategies.
- In July
2021, Tonix announced the appointment to its Board of Directors of
Carolyn E. Taylor, who brings over 35 years of experience in
corporate law, including 15 years as a partner at Covington &
Burling LLP and six years as general counsel of two start-up
companies.
Recent Highlights--Financial
As of June 30, 2021, Tonix had $165.7 million of
cash and cash equivalents, compared to $77.1 million as of December
31, 2020.
Cash used in operations was approximately $19.1
million for the three months ended June 30, 2021, compared to $10.1
million for the three months ended June 30, 2020. The increase in
cash used in operations resulted primarily from an increase in
research and development programs and general and administrative
activities as defined below.
Second Quarter 2021 Financial Results
Research and development expenses for the second
quarter of 2021 were $18.1 million, compared to $10.6 million for
the same period in 2020. This increase is predominately due to
increased non-clinical expenses of $7.1 million, manufacturing
expenses of $2.7 million, employee-related expenses of $1.2 million
and regulatory/legal expenses of $0.4 million offset by a decrease
in clinical expenses of $4.1 million. We expect research and
development expenses to increase during 2021 as we move our
clinical development programs forward and continue to invest in our
development pipeline.
General and administrative expenses for the
second quarter of 2021 were $5.4 million, compared to $3.6 million
for the same period in 2020. The increase is primarily due to an
increase in employee-related expenses of $1.1 million, an increase
in investor relations/public relations expenses of $0.2 million, an
increase in financial reporting expenses of $0.2 million and an
increase in insurance premiums of $0.2 million.
Net loss available to common stockholders was
$23.6 million, or $0.07 per share, basic and diluted, for the
second quarter of 2021, compared to net loss of $14.2 million, or
$0.23 per share, basic and diluted, for the second quarter of 2020.
The basic and diluted weighted average common shares outstanding
for the second quarter of 2021 was 331,281,242, compared to
62,391,006 shares for the second quarter of 2020.
About Tonix Pharmaceuticals Holding
Corp.
Tonix is a clinical-stage biopharmaceutical
company focused on discovering, licensing, acquiring and developing
small molecules and biologics to treat and prevent human disease
and alleviate suffering. Tonix’s portfolio is primarily composed of
central nervous system (CNS) and immunology product candidates. The
Company’s CNS portfolio includes both small molecules and biologics
to treat pain, neurologic, psychiatric and addiction conditions.
Tonix’s lead CNS candidate, TNX-102 SL1, is in mid-Phase 3
development for the management of fibromyalgia. Tonix’s immunology
portfolio includes vaccines to prevent infectious diseases and
biologics to address immunosuppression, cancer, and autoimmune
diseases. Tonix’s lead vaccine candidate, TNX-18002, is a live
replicating vaccine based on the horsepox viral vector platform to
protect against COVID-19, primarily by eliciting a T cell response.
Tonix reported positive efficacy data from animal studies of
TNX-1800 in the first quarter of 2021. TNX-8012, live horsepox
virus vaccine for percutaneous administration, is in development to
protect against smallpox and monkeypox. TNX-35003 (sangivamycin) is
a small molecule antiviral drug in the pre-IND stage of
development.
1TNX-102 SL is an investigational new drug and
has not been approved for any indication.2TNX-1800 and TNX-801 are
investigational new biologics at the pre-IND stage of development
and have not been approved for any indication.3TNX-3500 is an
investigational new drug at the pre-IND stage of development and
has not been approved for any indication.
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, the development of
R&D facilities, risks related to failure to obtain FDA
clearances or approvals and noncompliance with FDA regulations;
delays and uncertainties caused by the global COVID-19 pandemic;
risks related to the timing and progress of clinical development of
our product candidates; 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, 2020, as filed with the Securities and Exchange
Commission (the “SEC”) on March 15, 2021, and periodic reports
filed with the SEC on or after the date thereof. All 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 June
30, |
|
Six Months Ended June 30, |
|
|
2021 |
|
2020 |
|
2021 |
|
2020 |
COSTS AND EXPENSES: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
18,133 |
|
|
$ |
10,571 |
|
|
$ |
33,460 |
|
|
$ |
15,247 |
|
General and
administrative |
|
|
5,429 |
|
|
|
3,621 |
|
|
|
10,838 |
|
|
|
6,242 |
|
|
|
|
23,562 |
|
|
|
14,192 |
|
|
|
44,298 |
|
|
|
21,489 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Loss |
|
|
(23,562 |
) |
|
|
(14,192 |
) |
|
|
(44,298 |
) |
|
|
(21,489 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other income,
net |
|
|
9 |
|
|
|
13 |
|
|
|
92 |
|
|
|
37 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
(23,553 |
) |
|
|
(14,179 |
) |
|
|
(44,206 |
) |
|
|
(21,452 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant deemed dividend |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
451 |
|
Preferred stock deemed
dividend |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,260 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss available to common
stockholders |
|
$ |
(23,553 |
) |
|
$ |
(14,179 |
) |
|
$ |
(44,206 |
) |
|
$ |
(23,163 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share,
basic and diluted |
|
$ |
(0.07 |
) |
|
$ |
(0.23 |
) |
|
$ |
(0.14 |
) |
|
$ |
(0.54 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares
outstanding, basic and diluted |
|
|
331,281,242 |
|
|
|
62,391,006 |
|
|
|
310,807,619 |
|
|
|
43,209,988 |
|
TONIX
PHARMACEUTICALS HOLDING CORP. |
CONDENSED
CONSOLIDATED BALANCE SHEETS |
(in
thousands) |
(Unaudited) |
|
|
June 30, 2021 |
|
December 31, 20201 |
Assets |
|
|
|
|
Cash and cash equivalents |
$165,719 |
|
$77,068 |
Prepaid expenses and other |
|
11,550 |
|
|
10,921 |
Total current assets |
|
177,269 |
|
|
87,989 |
Other non-current assets |
|
11,896 |
|
|
10,194 |
Total assets |
$189,165 |
|
$98,183 |
|
|
|
|
|
Liabilities and
stockholders' equity |
|
|
Total liabilities |
$8,672 |
|
$10,535 |
Stockholders' equity |
|
180,493 |
|
|
87,648 |
Total liabilities and
stockholders' equity |
$189,165 |
|
$98,183 |
1The condensed consolidated balance sheets for the year ended
December 31, 2020 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.
Jessica Morris (corporate)Tonix
Pharmaceuticalsinvestor.relations@tonixpharma.com(862) 904-8182
Olipriya Das, Ph.D.
(media)Russo PartnersOlipriya.Das@russopartnersllc.com
(646) 942-5588
Peter Vozzo
(investors)Westwickepeter.vozzo@westwicke.com (443)
213-0505
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