Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a biopharmaceutical company with marketed products and a
pipeline of development candidates, today announced financial
results for the third quarter ended September 30, 2023, and
provided an overview of recent operational highlights.
“Tonix expects topline results from its Phase 3
fibromyalgia study and Phase 2 chronic migraine study before year
end,” said Seth Lederman, M.D., Chief Executive Officer of Tonix.
“The Phase 3 RESILIENT trial in fibromyalgia, if successful, is
expected to be the final efficacy trial required for submitting a
New Drug Application (NDA) for approval by the U.S. Food and Drug
Administration (FDA) for TNX-102 SL (cyclobenzaprine HCl sublingual
tablets). In the Phase 2 proof-of-concept PREVENTION study in
chronic migraine of TNX-1900 (intranasal potentiated oxytocin), all
patients have completed their final visit and topline results are
expected in early December 2023.”
Dr. Lederman continued, “We are continuing to
shift the expense of clinical trials from our operating budget to
U.S. government agencies and other institutions through
partnerships. The U.S. Department of Defense (DoD) is supporting
the upcoming Phase 2 study of TNX-102 SL in acute stress disorder,
being conducted and sponsored by University of North Carolina
(UNC). The U.S. National Institutes of Health (NIH) and National
Institute of Allergy and Infectious Diseases (NIAID), through its
Project NextGen, will conduct the Phase 1 study of our vaccine
candidate TNX-1800 (modified recombinant horsepox virus, live
vaccine). The National Institute of Drug Abuse (NIDA) is supporting
our Phase 2 study of TNX-1300 (recombinant double mutant cocaine
esterase) for cocaine intoxication. Massachusetts General Hospital
(MGH) is conducting Phase 2 studies of TNX-1900 in binge eating
disorder and pediatric obesity, and the University of Washington is
conducting a Phase 2 study of TNX-1900 in social anxiety disorder.
Finally, we continue to collaborate with MGH on several preclinical
non-human primate studies for TNX-1500 (anti-CD40L Fc-modified
humanized monoclonal antibody), currently in a Phase 1 study being
conducted by Tonix. These outside collaborations leverage our
internal resources and allow us to progress our clinical programs
in a capital efficient manner.”
Partnerships with External Funding –
Recent Highlights
- NIH/NIAID selected Tonix’s vaccine
candidate, TNX-1800, as part of Project NextGen; a Phase 1 study is
expected to start in the second half of 2024. NIH/NIAID will cover
the full cost of the clinical trial, while Tonix will supply the
vaccine candidate.
- NIDA is supporting a Phase 2 study
on TNX-1300 for cocaine Intoxication; expected to start enrolling
patients in the fourth quarter of 2023.
- DoD is supporting a Phase 2
investigator-initiated study of TNX-102 SL for acute stress
disorder at UNC for motor vehicle accident victims; expected to
start enrolling patients in 2024.
- MGH/Harvard Medical School is
conducting Phase 2 investigator-initiated studies of TNX-1900 in
binge eating disorder and adolescent obesity.
- The University of Washington is
conducting a Phase 2 investigator-initiated study of TNX-1900 in
social anxiety disorder.
Marketed Products – Recent
Highlights
- In
September 2023, Tonix announced that it is committed to meeting
potential increased demand for Tosymra® (sumatriptan nasal spray)
10 mg after GlaxoSmithKline’s planned discontinuation of Imitrex®
(sumatriptan) nasal spray 5 mg and 20 mg products after January
2024. Tonix is preparing for potential increased demand for Tosymra
to help avoid possible drug shortages for patients who suffer from
migraines. Tosymra nasal spray is approved on the basis of
bioequivalence to Imitrex injection 4 mg.
- Tonix
completed the acquisition of Zembrace® SymTouch® (sumatriptan
injection) 3 mg and Tosymra from Upsher-Smith Laboratories, LLC in
June 2023. Both products are indicated for the treatment of acute
migraine with or without aura in adults.
Key Product Candidates* -- Recent
Highlights
Central Nervous System (CNS) Pipeline
TNX-102 SL (cyclobenzaprine HCl sublingual
tablets): once-daily at bedtime small molecule for the management
of fibromyalgia (FM) – a centrally-acting, non-opioid
analgesic.
- The Company
announced in August 2023 that it completed enrollment of its
potentially confirmatory Phase 3 RESILIENT trial of TNX-102 SL 5.6
mg in FM. 457 participants were randomized in the trial, which, if
successful, is expected to serve as the final, well-controlled
efficacy trial required for submission of NDA for approval by the
FDA. RESILIENT is a registration-quality, double-blind,
placebo-controlled study. Topline results from the RESILIENT trial
are expected in late December of 2023.
TNX-102 SL for the treatment of acute stress
reaction (ARS) and acute stress disorder (ASD), and prophylaxis
against development of posttraumatic stress disorder (PTSD)
- In September 2023,
the Company announced that the UNC Institute for Trauma Recovery
has been awarded a $3 million grant from the DoD to investigate the
potential of Tonix’s TNX-102 SL to reduce the frequency and
severity of adverse effects of acute trauma, which include ASR and
ASD, and development of PTSD. The proposed Phase 2, Optimizing
Acute Stress Reaction Interventions with TNX-102 SL (OASIS) study
will examine the safety and efficacy of TNX-102 SL to reduce
adverse posttraumatic neuropsychiatric sequelae among patients
presenting to the emergency department (ED) after a motor vehicle
collision (MVC). The study will enroll approximately 180 MVC trauma
survivors at ED study sites in the U.S. Participants will be
randomized in the ED to receive a two-week course of either TNX-102
SL or placebo.
- Initiation of
patient enrollment in the proposed investigator-sponsored OASIS
study is anticipated in the beginning of 2024, subject to clearance
by the FDA of an investigator-initiated Investigational New Drug
(IND) application.
TNX-102 SL for the treatment of
Fibromyalgia-Type Long COVID, also known as Post-Acute Sequelae of
COVID-19 (PASC)
- In September 2023,
the Company announced topline results from its Phase 2 PREVAIL
proof-of-concept study of TNX-102 SL for fibromyalgia-type Long
COVID. TNX-102 SL showed a robust Cohen’s d effect size of 0.5 in
improving fatigue relative to placebo; and it showed consistent
activity across secondary measures of sleep quality, cognitive
function, disability and Patient Global Impression of Change, but
did not meet the primary endpoint of multi-site pain reduction at
week 14. TNX-102 SL was generally well tolerated and no new safety
signals were observed.
- The Company
intends to request an End-of-Phase 2 meeting with the FDA to
discuss a potential Phase 3 program based on a proposed primary
outcome measure using the PROMIS Fatigue scale. The meeting is
expected to take place in the first quarter of 2024.
TNX-1900 (intranasal potentiated oxytocin):
small peptide for migraine, craniofacial pain, social anxiety
disorder (SAD), insulin resistance and related disorders, and
adolescent obesity and binge eating disorder
- In October 2023,
the Company announced it completed the clinical phase of the
PREVENTION study, a Phase 2 proof-of-concept study of TNX-1900 for
the prevention of migraine headaches in chronic migraineurs, as the
last of 88 enrolled patients completed their final study visit.
PREVENTION is a registration-quality, double-blind,
placebo-controlled study.
- Topline results
from the PREVENTION Phase 2 trial are expected in early December
2023.
- In September 2023,
the Company announced that David C. Yeomans, Ph.D. presented data
relevant to the proposed mechanism of TNX-1900 in treating chronic
migraine in a poster and an oral presentation at the 2023
International Headache Congress (IHC) in Seoul, South Korea. The
poster and oral presentation titled, “Human trigeminal ganglia
possess oxytocin receptors on CGRP positive neurons: expression
increased by inflammation,” include research sponsored by and
licensed to Tonix. The presentations show that oxytocin receptors
are co-expressed with calcitonin gene-related peptide (CGRP) on
human trigeminal ganglia neurons, which is similar to Professor
Yeomans’ previous findings in animal trigeminal ganglia. The
inflammatory cytokine IL-6 upregulated expression of oxytocin
receptors on human trigeminal neurons, consistent with the
previously observed impact of inflammation on the potency of
oxytocin on its receptor. In animals, oxytocin has been shown to
functionally inhibit the excitability of trigeminal neurons, which
is consistent with oxytocin inhibiting the release of CGRP at
trigeminal nerve terminals.1
- Tonix announced in
July 2023 that the first participant was enrolled in the
investigator-initiated Phase 2 STROBE Study of TNX-1900 for the
treatment of binge-eating disorder at MGH. Tonix is supporting the
STROBE study through a clinical trial agreement with MGH.
- Tonix announced in
July 2023 that the first participant was enrolled in a Phase 2
investigator-initiated, proof-of-concept study of TNX-1900 for
enhancing social safety learning in SADSAD. Tonix entered into an
agreement with the University of Washington to examine the
potential role of TNX-1900 in enhancing vicarious extinction
learning in SAD, compared to healthy controls.
- Tonix announced in
July 2023 that the first participant was enrolled in the Phase 2
POWER study of TNX-1900 for the treatment of pediatric obesity with
MGH. MGH is the sponsor of the NIH-funded trial, being conducted
under an investigator-initiated IND.
TNX-1300 (recombinant double mutant cocaine
esterase): biologic for life-threatening cocaine intoxication
- Tonix expects to
initiate a Phase 2 clinical study of TNX-1300 for the treatment of
cocaine intoxication in the fourth quarter of 2023. In 2022, Tonix
was awarded a Cooperative Agreement grant from NIDA, part of the
NIH, to support development of TNX-1300.
- TNX-1300 has been
granted Breakthrough Therapy designation by the FDA.
Rare Disease Pipeline
TNX-2900 (intranasal potentiated oxytocin):
small peptide for the treatment of Prader-Willi syndrome (PWS)
- In October 2023,
Herbert Harris, M.D., Ph.D., Executive Vice President,
Translational Medicine of Tonix Pharmaceuticals, provided an
overview of Tonix’s TNX-2900 program at the Foundation for
Prader-Willi Research (FPWR) Family Conference in Denver, CO. The
presentation highlights preclinical data showing the enhancing
effects of magnesium (Mg2+) on the activation of oxytocin
receptors. The Mg2+ enhanced formulation of intranasal
oxytocin is the basis for TNX-2900, in development to treat
hyperphagia, or pathological over-eating, in children and
adolescents with PWS. In preclinical studies, Mg2+ increases
the potency of oxytocin, which is a peptide hormone that reduces
appetite and signals fullness, potentially improving receptor
binding and resulting in improved therapeutic action.
Immunology Pipeline
TNX-1500 (anti-CD40L Fc-modified humanized
monoclonal antibody): third generation anti-CD40L monoclonal
antibody for prophylaxis of organ transplant rejection and
treatment of autoimmune disorders.
- In October 2023,
the Company announced data from two oral presentations which were
delivered recently at the American College of Surgeons (ACS)
Clinical Congress 2023, and The International Pancreas and Islet
Transplant Association (IPITA), the International
Xenotransplantation Association (IXA), and the Cell Transplant and
Regenerative Medicine Society (CTRMS) Joint Congress by faculty at
the Center for Transplantation Sciences, MGH. The oral
presentations titled, “Pilot Evaluation of a Clinical Xeno Heart
Transplant Regimen in a Preclinical Model” and “Extended Survival
of 9- and 10-Gene Edited Pig Heart Xenografts with Ischemia
Minimization and CD154 Costimulation Blockade-Based
Immunosuppression” by Dr. Ikechukwu Ileka et al. include data
demonstrating the use of TNX-1500 as maintenance therapy after xeno
heart transplant in non-human primates. In both studies,
genetically engineered (GE) pigs in baboon transplants were treated
with cold-perfused ischemia minimization and a novel
costimulation-based immunosuppressive regimen that includes
TNX-1500.
- In October 2023,
Tonix announced that a study published in the
Journal Nature2 by faculty at the Center for
Transplantation Sciences, MGH in collaboration with biotechnology
company, eGenesis, utilized TNX-1500 as part of the immune
modulating regimen to prevent organ transplant rejection.
The Nature article titled, “Design and testing of a
humanized porcine donor for xenotransplantation” includes data that
provide additional support for TNX-1500’s activity in preventing
pig xenograft organ rejection and for its safety and tolerability
in non-human primates.
- In August 2023,
Tonix announced the initiation of a Phase 1 single ascending dose
study of TNX-1500 in healthy volunteers. The primary objectives of
the study are to assess the safety, tolerability, pharmacokinetics
and pharmacodynamics of intravenous TNX-1500. This first-in-human
study is intended to support dosing in a planned Phase 2 trial in
kidney transplant recipients.
- The first
indication for TNX-1500 will be prophylaxis of organ rejection in
adult patients receiving a kidney transplant, but multiple
additional indications are possible, including autoimmune diseases.
Two peer reviewed publications described the work at the MGH on
allogeneic transplants in animals were published.3,4
Infectious Disease Pipeline
TNX-1800 (modified recombinant horsepox virus,
live vaccine): potential vaccine to protect against COVID-19
designed to express the SARS-CoV-2 spike protein
- In November 2023,
Tonix announced that NIAID, a part of the NIH, will conduct a Phase
1 clinical trial with TNX-1800 as part of Project NextGen. The
Phase 1 trial of TNX-1800 is expected to start in the second half
of 2024. NIAID will cover the full cost of the clinical trial,
including operations and related analyses. Tonix will be
responsible for providing clinical trial materials, and upon
completion will have the right to rely on the findings in
regulatory filings with the FDA to support the approval of its
COVID-19 vaccine and other vaccines based on the RPV platform.
TNX-801 (recombinant horsepox virus, live
vaccine): potential vaccine to protect against mpox disease and
smallpox.
- In August 2023,
Tonix received the official written response from a Type B pre-IND
meeting with the FDA to develop TNX-801 as a potential vaccine
to protect against mpox disease (formerly known as monkeypox) and
smallpox. Tonix believes the FDA feedback provides a path to
agreement on the design of a Phase 1/2 study and the overall
clinical development plan. The Phase 1/2 clinical trial will assess
the safety, tolerability, and immunogenicity of TNX-801, following
the submission and clearance of an IND.
*All of Tonix’s
product candidates are investigational new drugs or biologics and
none have been approved for any indication.
1Tzabazis A, et al. Cephalalgia.
2016. 36(10):943-50.
2Anand R.P., et
al. Nature. 2023. 622, 393–401.
3Lassiter, G., et al. (2023).
TNX-1500, a crystallizable fragment–modified anti-CD154 antibody,
prolongs non-human primate renal allograft survival. American
Journal of Transplantation.
https://doi.org/10.1016/j.ajt.2023.03.022
4Miura, S., et al. (2023). TNX-1500,
a crystallizable fragment–modified anti-CD154 antibody, prolongs
non-human primate cardiac allograft survival. American Journal of
Transplantation. https://doi.org/10.1016/j.ajt.2023.03.025
Recent
Highlights—Financial
As of September 30, 2023, Tonix had
approximately $6.9 million of cash and cash equivalents, compared
to $120.2 million as of December 31, 2022. Additionally, Tonix had
inventory totaling approximately $13.3 million as of September 30,
2023. In August 2023, Tonix received net proceeds of approximately
$6.3 million through a public offering of common stock, after
deducting underwriting discount and other offering expenses. Cash
used in operations was approximately $79.7 million for the nine
months ended September 30, 2023, compared to $75.8 million for the
same period in 2022. Cash used by investing activities for the nine
months ended September 30, 2023 was approximately $28.6
million.
On September 28, 2023, the Company sold
4,050,000 shares of common stock, pre-funded warrants to purchase
up to 4,950,000 shares of common stock, and accompanying common A
warrants to purchase 9,000,000 shares of common stock and common B
warrants to purchase up to 9,000,000 shares of common stock in a
public offering for net proceeds of approximately $4.0 million,
after deducting underwriting discount and other offering expenses.
This public offering closed on October 3, 2023.
Third Quarter 2023 Financial Results
Net product revenue for the third quarter 2023
was approximately $4.0 million. As a reminder, Tonix completed the
acquisition of two currently marketed products from Upsher-Smith
Laboratories, LLC on June 30, 2023.
During the three months ended September 30,
2023, Tonix received $0.4 million from NIDA for the TNX-1300 study
to treat cocaine intoxication.
R&D expenses for the third quarter 2023 were
approximately $21.1 million, compared to $22.2 million for the same
period in 2022. This decrease is predominantly due to decreased
non-clinical and manufacturing expenses, offset by an increase in
clinical, employee-related and professional expenses.
SG&A expenses for the third quarter 2023
were $8.7 million, compared to $7.4 million for the same period in
2022. The increase was primarily due to sales and marketing
associated with the Company’s recently acquired marketed
products.
Net loss available to common stockholders was
$28.0 million, or $1.83 per share, basic and diluted, for the third
quarter 2023, compared to net loss available to common stockholders
of $29.0 million, or $4.24 per share, basic and diluted, for the
same period in 2022. The basic and diluted weighted average common
shares outstanding for the third quarter 2023 was 15,327,558
compared to 6,843,099 shares for the same period in 2022.
Tonix Pharmaceuticals Holding
Corp.*
Tonix is a biopharmaceutical company focused on
commercializing, developing, discovering and licensing therapeutics
to treat and prevent human disease and alleviate suffering. Tonix
Medicines, our commercial subsidiary, markets Zembrace® SymTouch®
(sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray)
10 mg under a transition services agreement with Upsher-Smith
Laboratories, LLC from whom the products were acquired on June 30,
2023. Zembrace SymTouch and Tosymra are each indicated for the
treatment of acute migraine with or without aura in adults. Tonix’s
development portfolio is composed of central nervous system (CNS),
rare disease, immunology and infectious disease product candidates.
Tonix’s CNS development portfolio includes both small molecules and
biologics to treat pain, neurologic, psychiatric and addiction
conditions. Tonix’s lead development CNS candidate, TNX-102 SL
(cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3
development for the management of fibromyalgia, having completed
enrollment of a potentially confirmatory Phase 3 study in the third
quarter of 2023, with topline data expected in late December 2023.
TNX-102 SL is also being developed to treat fibromyalgia-type Long
COVID, a chronic post-acute COVID-19 condition, and topline results
were reported in the third quarter of 2023. TNX-1900 (intranasal
potentiated oxytocin), is in development as a preventive treatment
in chronic migraine, and enrollment has completed in a Phase 2
proof-of-concept study with topline data expected in early December
2023. TNX-1900 is also being studied in binge eating disorder,
pediatric obesity and social anxiety disorder by academic
collaborators under investigator-initiated INDs. TNX-1300 (cocaine
esterase) is a biologic designed to treat cocaine intoxication and
has been granted Breakthrough Therapy designation by the FDA. A
Phase 2 study of TNX-1300 is expected to be initiated in the fourth
quarter of 2023. Tonix’s rare disease development portfolio
includes TNX-2900 (intranasal potentiated oxytocin) for the
treatment of Prader-Willi syndrome. TNX-2900 has been granted
Orphan Drug designation by the FDA. Tonix’s immunology development
portfolio includes biologics to address organ transplant rejection,
autoimmunity and cancer, including TNX-1500, which is a humanized
monoclonal antibody targeting CD40-ligand (CD40L or CD154) being
developed for the prevention of allograft rejection and for the
treatment of autoimmune diseases. A Phase 1 study of TNX-1500 was
initiated in the third quarter of 2023. Tonix’s infectious disease
pipeline includes TNX-801, a vaccine in development to prevent
smallpox and mpox. TNX-801 also serves as the live virus vaccine
platform or recombinant pox vaccine platform for other infectious
diseases, including TNX-1800, in development as a vaccine to
protect against COVID-19. During the fourth quarter of 2023,
TNX-1800 was selected by the U.S. National Institutes of Health
(NIH), National Institute of Allergy and Infectious Diseases
(NIAID) Project NextGen for inclusion in Phase 1 clinical trials.
The infectious disease development portfolio also includes TNX-3900
and TNX-4000, which are classes of broad-spectrum small molecule
oral antivirals.
*Tonix’s product development candidates are
investigational new drugs or biologics and have not been approved
for any indication.
Zembrace SymTouch and Tosymra are registered
trademarks of Tonix Medicines. Intravail is a registered trademark
of Aegis Therapeutics, LLC, a wholly owned subsidiary of Neurelis,
Inc. All other marks are property of their respective owners.
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 the failure to obtain FDA clearances or approvals and
noncompliance with FDA regulations; risks related to the failure to
successfully market any of our products; 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, 2022, as filed
with the Securities and Exchange Commission (the “SEC”) on March
13, 2023, 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 EndedSeptember
30, |
|
|
Nine Months EndedSeptember
30, |
|
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
REVENUE: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenue, net |
|
|
$ |
3,989 |
|
|
$ |
— |
|
|
$ |
3,989 |
|
|
$ |
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COSTS AND EXPENSES: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue |
|
|
$ |
2,374 |
|
|
$ |
— |
|
|
$ |
2,374 |
|
|
$ |
— |
|
Research and development |
|
|
|
21,050 |
|
|
|
22,201 |
|
|
|
69,537 |
|
|
|
57,202 |
|
Selling, general and
administrative |
|
|
|
8,712 |
|
|
|
7,390 |
|
|
|
23,129 |
|
|
|
22,161 |
|
|
|
|
|
32,136 |
|
|
|
29,591 |
|
|
|
95,040 |
|
|
|
79,363 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
|
(28,147 |
) |
|
|
(29,591 |
) |
|
|
(91,051 |
) |
|
|
(79,363 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income, net |
|
|
|
172 |
|
|
|
610 |
|
|
|
1,715 |
|
|
|
825 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
(27,975 |
) |
|
|
(28,981 |
) |
|
|
(89,336 |
) |
|
|
(78,538 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock deemed
dividend |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
4,255 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss available to common
stockholders |
|
|
$ |
(27,975 |
) |
|
$ |
(28,981 |
) |
|
$ |
(89,336 |
) |
|
$ |
(82,793 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share,
basic and diluted |
|
|
$ |
(1.83 |
) |
|
$ |
(4.24 |
) |
|
$ |
(7.40 |
) |
|
$ |
(18.58 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares
outstanding, basic and diluted |
|
|
|
15,327,558 |
|
|
|
6,843,099 |
|
|
|
12,079,583 |
|
|
|
4,455,943 |
|
See the accompanying notes to the condensed
consolidated financial statements
TONIX PHARMACEUTICALS HOLDING CORP. |
CONDENSED CONSOLIDATED BALANCE SHEETS |
(In Thousands) |
(Unaudited) |
|
|
September 30, 2023 |
|
December 31, 20221 |
Assets |
|
|
Cash and cash equivalents |
$ |
6,914 |
|
|
$ |
120,229 |
|
Inventory |
|
13,317 |
|
|
|
- |
|
Receivables, net |
|
1,562 |
|
|
|
- |
|
Prepaid expenses and
other |
|
9,544 |
|
|
|
10,548 |
|
Total current assets |
|
31,337 |
|
|
|
130,777 |
|
Other non-current assets |
|
107,945 |
|
|
|
94,913 |
|
Total assets |
$ |
139,282 |
|
|
$ |
225,690 |
|
|
|
|
Liabilities and
stockholders' equity |
|
|
Total liabilities |
$ |
18,449 |
|
|
$ |
18,508 |
|
Stockholders' equity |
|
120,833 |
|
|
|
207,182 |
|
Total liabilities and
stockholders' equity |
$ |
139,282 |
|
|
$ |
225,690 |
|
1The condensed consolidated balance sheet for the year ended
December 31, 2022 has 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.
Investor Contact
Jessica MorrisTonix
Pharmaceuticalsinvestor.relations@tonixpharma.com (862)
904-8182
Peter VozzoICR Westwickepeter.vozzo@westwicke.com (443)
213-0505
Media Contact
Ben ShannonICR Westwickeben.shannon@westwicke.com(919)
360-3039
Zembrace® SymTouch® (sumatriptan
Injection): IMPORTANT SAFETY
INFORMATION
Zembrace SymTouch (Zembrace) can cause serious side
effects, including heart attack and other heart problems, which may
lead to death. Stop use and get emergency help if you have any
signs of a heart attack:
- discomfort in the
center of your chest that lasts for more than a few minutes or goes
away and comes back
- severe tightness,
pain, pressure, or heaviness in your chest, throat, neck, or
jaw
- pain or discomfort
in your arms, back, neck, jaw or stomach
- shortness of breath
with or without chest discomfort
- breaking out in a
cold sweat
- nausea or
vomiting
- feeling
lightheaded
Zembrace is not for people with risk factors for heart disease
(high blood pressure or cholesterol, smoking, overweight, diabetes,
family history of heart disease) unless a heart exam shows no
problem.
Do not use Zembrace if you have:
- history of heart
problems
- narrowing of blood
vessels to your legs, arms, stomach, or kidney (peripheral vascular
disease)
- uncontrolled high
blood pressure
- hemiplegic or basilar migraines. If you are not sure if you
have these, ask your provider.
- had a stroke, transient ischemic attacks (TIAs), or problems
with blood circulation
- severe liver problems
- taken any of the following medicines in the last 24 hours:
almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan,
ergotamines, dihydroergotamine.
- are taking certain antidepressants, known as monoamine oxidase
(MAO)-A inhibitors or it has been 2 weeks or less since you stopped
taking a MAO-A inhibitor. Ask your provider for a list of these
medicines if you are not sure.
- an allergy to sumatriptan or any of the components of
Zembrace
Tell your provider about all of your medical conditions and
medicines you take, including vitamins and supplements.
Zembrace can cause dizziness, weakness, or drowsiness. If so, do
not drive a car, use machinery, or do anything where you need to be
alert.
Zembrace may cause serious side effects including:
- changes in color or sensation in your fingers and toes
- sudden or severe stomach pain, stomach pain after meals, weight
loss, nausea or vomiting, constipation or diarrhea, bloody
diarrhea, fever
- cramping and pain in your legs or hips; feeling of heaviness or
tightness in your leg muscles; burning or aching pain in your feet
or toes while resting; numbness, tingling, or weakness in your
legs; cold feeling or color changes in one or both legs or
feet
- increased blood pressure including a sudden severe increase
even if you have no history of high blood pressure
- medication overuse headaches from using migraine medicine for
10 or more days each month. If your headaches get worse, call your
provider.
- serotonin syndrome, a rare but serious problem that can happen
in people using Zembrace, especially when used with anti-depressant
medicines called SSRIs or SNRIs. Call your provider right away if
you have: mental changes such as seeing things that are not there
(hallucinations), agitation, or coma; fast heartbeat; changes in
blood pressure; high body temperature; tight muscles; or trouble
walking.
- hives (itchy bumps); swelling of your tongue, mouth, or
throat
- seizures even in people who have never had seizures before
The most common side effects of Zembrace
include: pain and redness at injection site; tingling or
numbness in your fingers or toes; dizziness; warm, hot, burning
feeling to your face (flushing); discomfort or stiffness in your
neck; feeling weak, drowsy, or tired.
Tell your provider if you have any side effect that bothers you
or does not go away. These are not all the possible side effects of
Zembrace. For more information, ask your provider.
This is the most important information to know about Zembrace
but is not comprehensive. For more information, talk to your
provider and read the Patient Information and Instructions for Use.
You can also visit www.upsher-smith.com or call 1-888-650-3789.
You are encouraged to report adverse effects of prescription
drugs to the FDA. Visit www.fda.gov/medwatch, or call
1-800-FDA-1088.
INDICATION AND USAGE
Zembrace is a prescription medicine used to treat acute migraine
headaches with or without aura in adults who have been diagnosed
with migraine.
Zembrace is not used to prevent migraines. It is not known if it
is safe and effective in children under 18 years of age.
Tosymra® (sumatriptan nasal spray):
IMPORTANT SAFETY
INFORMATION
Tosymra can cause serious side effects, including heart
attack and other heart problems, which may lead to death. Stop
Tosymra and get emergency medical help if you have any signs of
heart attack:
- discomfort in the center of your chest that lasts for more than
a few minutes or goes away and comes back
- severe tightness, pain, pressure, or heaviness in your chest,
throat, neck, or jaw
- pain or discomfort in your arms, back, neck, jaw, or
stomach
- shortness of breath with or without chest discomfort
- breaking out in a cold sweat
- nausea or vomiting
- feeling lightheaded
Tosymra is not for people with risk factors for heart disease
(high blood pressure or cholesterol, smoking, overweight, diabetes,
family history of heart disease) unless a heart exam is done and
shows no problem.
Do not use Tosymra if you have:
- history of heart problems
- narrowing of blood vessels to your legs, arms, stomach, or
kidney (peripheral vascular disease)
- uncontrolled high blood pressure
- severe liver problems
- hemiplegic or basilar migraines. If you are not sure if you
have these, ask your healthcare provider.
- had a stroke, transient ischemic attacks (TIAs), or problems
with blood circulation
- taken any of the following medicines in the last 24 hours:
almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan,
ergotamines, or dihydroergotamine. Ask your provider if you are not
sure if your medicine is listed above.
- are taking certain antidepressants, known as monoamine oxidase
(MAO)-A inhibitors or it has been 2 weeks or less since you stopped
taking a MAO-A inhibitor. Ask your provider for a list of these
medicines if you are not sure.
- an allergy to sumatriptan or any ingredient in Tosymra
Tell your provider about all of your medical conditions and
medicines you take, including vitamins and supplements.
Tosymra can cause dizziness, weakness, or drowsiness. If so, do
not drive a car, use machinery, or do anything where you need to be
alert.
Tosymra may cause serious side effects including:
- changes in color or sensation in your fingers and toes
- sudden or severe stomach pain, stomach pain after meals, weight
loss, nausea or vomiting, constipation or diarrhea, bloody
diarrhea, fever
- cramping and pain in your legs or hips, feeling of heaviness or
tightness in your leg muscles, burning or aching pain in your feet
or toes while resting, numbness, tingling, or weakness in your
legs, cold feeling or color changes in one or both legs or
feet
- increased blood pressure including a sudden severe increase
even if you have no history of high blood pressure
- medication overuse headaches from using migraine medicine for
10 or more days each month. If your headaches get worse,
call your provider.
- serotonin syndrome, a rare but serious problem that can happen
in people using Tosymra, especially when used with anti-depressant
medicines called SSRIs or SNRIs. Call your provider right
away if you have: mental changes such as seeing things
that are not there (hallucinations), agitation, or coma; fast
heartbeat; changes in blood pressure; high body temperature; tight
muscles; or trouble walking.
- hives (itchy bumps); swelling of your tongue, mouth, or
throat
- seizures even in people who have never had seizures before
The most common side effects of Tosymra
include: tingling, dizziness, feeling warm or hot, burning
feeling, feeling of heaviness, feeling of pressure, flushing,
feeling of tightness, numbness, application site (nasal) reactions,
abnormal taste, and throat irritation.
Tell your provider if you have any side effect that bothers you
or does not go away. These are not all the possible side effects of
Tosymra. For more information, ask your provider.
This is the most important information to know about Tosymra but
is not comprehensive. For more information, talk to your provider
and read the Patient Information and Instructions for Use. You can
also visit www.upsher-smith.com or call 1-888-650-3789.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call
1-800-FDA-1088.
INDICATION AND USAGETosymra is a prescription
medicine used to treat acute migraine headaches with or without
aura in adults.
Tosymra is not used to treat other types of headaches such as
hemiplegic or basilar migraines or cluster headaches.
Tosymra is not used to prevent migraines. It is not known if
Tosymra is safe and effective in children under 18 years of
age.
Tonix Pharmaceuticals (NASDAQ:TNXP)
Gráfico Histórico do Ativo
De Abr 2024 até Mai 2024
Tonix Pharmaceuticals (NASDAQ:TNXP)
Gráfico Histórico do Ativo
De Mai 2023 até Mai 2024