Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a fully-integrated biopharmaceutical company with
marketed products and a pipeline of development candidates, today
announced financial results for the fourth quarter and full year
ended December 31, 2023, and provided an overview of recent
operational highlights.
“Our near-term focus is seeking U.S. marketing
approval for Tonmya (cyclobenzaprine HCl sublingual tablets) for
the treatment of fibromyalgia from the U.S. Food and Drug
Administration (FDA),” said Seth Lederman, M.D., Chief Executive
Officer of Tonix Pharmaceuticals. “Our pre-NDA meeting with the FDA
is scheduled to take place this quarter and we plan to submit our
New Drug Application (NDA) for Tonmya™ in the second half of 2024.
We believe the positive Phase 3 RESILIENT results reported in
December of 2023 together with the positive results from the first
Phase 3 RELIEF study should satisfy the requirements for approval
and, if so, would provide the opportunity for Tonix to launch the
first FDA-approved drug for fibromyalgia in more than a decade. We
believe the activity of Tonmya on improving pain, sleep quality,
fatigue and brain fog in the RESILIENT study are indicative of the
broad-spectrum of activity in fibromyalgia.”
Dr. Lederman added, “While Tonix is focusing its
resources on progressing Tonmya toward NDA submission and potential
FDA approval, we are seeking partnerships and collaborations on our
pipeline programs from government agencies, non-profit
organizations and other biotechnology or pharmaceuticals companies.
Tonix has already shifted portions of our research and development
(R&D) expenses to U.S. government agencies and other
institutions through partnerships involving grants and in-kind
contributions. These outside collaborations leverage our internal
resources, and we believe they provide a capital efficient strategy
for progress.”
Selected Product
Candidates* — Recent Highlights
Central Nervous System (CNS) Pipeline
Tonmya (also known as TNX-102 SL;
cyclobenzaprine HCl sublingual tablets): a centrally-acting,
non-opioid, small molecule analgesic taken once-daily at bedtime
for the management of fibromyalgia (FM).
- The Company announced in December
2023 that the Phase 3 RESILIENT study, a registration-quality,
double-blind, placebo-controlled study evaluating TNX-102 SL met
its pre-specified primary endpoint in the second of two positive
Phase 3 clinical trials, significantly reducing daily pain compared
to placebo (p=0.00005) in participants with fibromyalgia.
Statistically significant and clinically meaningful results were
also seen in all key secondary endpoints related to improving sleep
quality, reducing fatigue, and improving patient global ratings and
overall fibromyalgia symptoms and function. Additionally, as it
relates to improving daily pain, treatment with TNX-102 SL showed a
robust and clinically meaningful analgesic Cohen’s d effect size of
0.38, with rapid onset of action, separating from placebo for every
week of the study. TNX-102 SL was well tolerated with an adverse
event profile comparable to prior studies and no new safety signals
observed. Tonix plans to submit an NDA to the FDA in the second
half of 2024 for TNX-102 SL for the management of
fibromyalgia.
- In January 2024, Tonix presented
additional safety and tolerability data from the Phase 3 RESILIENT
study that showed TNX-102 SL treatment was not associated with
increases in systolic or diastolic blood pressure or body weight,
nor were there any reported sexual side effects.
- In January 2024, Tonix announced
that the FDA has conditionally accepted the trade name, Tonmya, for
the Company’s drug product candidate TNX-102 SL for the management
of fibromyalgia.
- In February 2024, Tonix announced
positive results from its clinical pharmacokinetic (PK) bridging
study of Tonmya in healthy adult male and female ethnic Japanese
and Chinese volunteers. Results indicate that key PK parameters of
cyclobenzaprine are comparable in ethnic Japanese and Chinese
volunteers to Caucasian volunteers from a prior PK study. Tonmya
was generally well tolerated in the ethnic Japanese and Chinese
healthy volunteers. The company expects these data to fulfill the
requirement for a bridging study, and enables Tonix to rely on
Phase 3 studies RESILIENT and RELIEF results to support regulatory
filings for clinical studies in Japan and China where
cyclobenzaprine is a new chemical entity (NCE). Tonix holds issued
patents for market exclusivity rights of Tonmya in Japan, China,
Hong Kong and Taiwan.
- In February 2024, Tonix selected
Rho, Inc., a global contract research organization, to support
Tonix’s preparation and planned submission of its NDA to the FDA
for the approval of Tonmya for the management of fibromyalgia.
- In March 2024, Tonix announced the
selection of two CMOs, including Almac Pharma Services, as dual
supply sources for the potential launch and commercialization of
Tonmya in the U.S.
- In March 2024, Tonix selected
EVERSANA, a leading provider of commercialization services to the
global life sciences industry, to support the launch strategy and
commercial planning of Tonmya in the U.S.
- Tonix presented additional efficacy
data from RESILIENT at the 6th International Congress on
Controversies in Fibromyalgia in Brussels, Belgium, March 7-8,
2024. The data showed that Tonmya treatment resulted in an
improvement in cognitive dysfunction, or ‘brain fog’, measured by
the change in the Fibromyalgia Impact Questionnaire-Revised (FIQ-R)
memory item. The FIQ-R cognitive item showed nominal improvement in
Tonmya-treated patients vs placebo-treated patients with
p-value=0.001 and effect size of 0.31.
TNX-102 SL for the treatment of acute stress
reaction (ASR) and acute stress disorder (ASD), and prophylaxis
against development of posttraumatic stress disorder (PTSD)
- In February 2024, the Company
announced the FDA cleared the Investigational New Drug (IND)
application for the Phase 2 investigator-initiated OASIS trial to
evaluate TNX-102 SL in reducing the severity of ASR and the
frequency of ASD and PTSD. The trial is sponsored by The UNC
Institute for Trauma Recovery and supported by a $3 million grant
from the U.S. Department of Defense (DoD), which was awarded in
September 2023. 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 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 5.6 mg or
placebo.
- Tonix expects the Phase 2 OASIS
trial will initiate in the second quarter of 2024.
TNX-102 SL for the treatment of
Fibromyalgia-Type Long COVID, also known as Post-Acute Sequelae of
COVID-19 (PASC)
- In January 2024, the Company
announced the online publication of a research paper in the Journal
Pain. The article titled, “Chronic Overlapping Pain Conditions
Increase the Risk of Long COVID Features, Regardless of Acute COVID
Status,” by Bergmans, et al. 1, found that patients with
pre-existing chronic overlapping pain conditions (COPCs) had an
increased risk of being diagnosed with symptoms of Long COVID1.
Faculty at the University of Michigan directed the research.
Commentary on the article titled, “A step towards better
understanding chronic overlapping pain conditions” by
Fitzcharles, et al,2 is in the same issue of the journal.
COPCs include fibromyalgia, chronic fatigue syndrome, migraine
headache, irritable bowel syndrome, endometriosis and low back
pain. These results contribute to a growing body of evidence that
common symptoms of Long COVID in many patients are at least partly
driven by central nervous system mechanisms.
- In September 2023, the Company
reported 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 0.50 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.
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 emergency rooms in the second quarter of 2024. In
2022, Tonix was awarded a Cooperative Agreement grant from the
National Institutes of Health (NIH)’s National Institute of Drug
Abuse (NIDA) to support development of TNX-1300.
- TNX-1300 has been granted
Breakthrough Therapy designation by the FDA.
TNX-1900 (intranasal potentiated oxytocin):
small peptide in development through investigator-initiated studies
for bone health in autism, social anxiety disorder (SAD),
adolescent obesity and binge eating disorder
- In November 2023, Tonix announced
that the first participant was enrolled in an
investigator-initiated Phase 2 study of TNX-1900 for improving bone
health in children with autism spectrum disorder, named the BOX
study, at Massachusetts General Hospital (MGH). The aim of this DoD
funded study is to investigate the efficacy and safety of TNX-1900
as a novel therapeutic agent to increase bone density and improve
bone structure and strength in children with autism spectrum
disorder. Tonix is providing active drug and placebo for the BOX
study as part of a drug donation agreement with MGH. MGH is the
sponsor of the trial, which is being conducted under an
investigator-initiated IND application.
- TNX-1900 is also being studied in
three other ongoing investigator-initiated Phase 2 studies as
follows:
- MGH Phase 2 study for binge-eating
disorder (BED)
- University of Washington Phase 2
study for social anxiety disorder (SAD)
- MGH Phase 2 study for adolescent
obesity
Rare Disease Pipeline
TNX-2900 (intranasal potentiated oxytocin):
small peptide for the treatment of Prader-Willi syndrome (PWS)
- In December 2023, Tonix announced
that the FDA has cleared the IND application to support clinical
development of TNX-2900 to treat PWS in children and adolescents.
The Phase 2 study approved under the IND is a dose-finding study
involving approximately 36 PWS patients divided into four groups
with approximately nine per group. One group will receive placebo
and three groups will receive different dosage regimens of
TNX-2900. TNX-2900 for the treatment of PWS was granted Orphan Drug
designation by the FDA in 2022.
- In March 2024, Tonix announced that
it received Rare Pediatric Disease designation from the FDA for
TNX-2900 for the treatment of PWS.
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.
- The first indication for TNX-1500
is 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 Massachusetts General
Hospital (MGH) on allogeneic transplants in animals were
published.3,4
- Preclinical studies have shown that
TNX-1500 maintains the activity of first-generation monoclonal
antibodies (mAbs), yet with reduced risk of thrombotic
complications.3-5 Modeling studies from animal pharmacokinetic
data3 predict a half-life of approximately three weeks for TNX-1500
in humans, which supports a monthly i.v. dosing regimen. This
analysis together with TNX-1500’s activity and tolerability in
animals, suggests that the protein engineering of TNX-1500’s Fc
region has achieved its design goals.
- In October 2023, the Company
announced data from two oral presentations delivered at medical
meetings in 2023. 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 xenogeneic 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 Nature5 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 February 2024, Tonix announced
the completion of the clinical stage of its 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.
Topline results are expected in the third quarter of 2024. This
first-in-human study is intended to support dosing in a planned
Phase 2 trial in kidney transplant recipients.
- In March of 2024, the MGH announced
the first transplant of a genetically modified pig kidney into a
living patent in collaboration with eGenesis, which produced the
pig donors.6 Some of the pre-clinical work that supported this
transplant was performed in collaboration with Tonix and used
TNX-1500.5
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
- Results from a study with our
TNX-1800 vaccine that showed animals were protected from challenge
with SARS-CoV-2 were published as an article in the peer reviewed
journal, Viruses in 2023.7
- In November 2023, Tonix announced
that NIH and National Institute of Allergy and Infectious Diseases
(NIAID) will conduct a Phase 1 clinical trial with TNX-1800 as part
of Project NextGen. 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 recombinant pox
vaccine (RPV) platform.
- We believe the TNX-1800 vaccine
development plan addresses several priority vaccine attributes
advanced by the White House Office of Science and Technology
Policy’s Pandemic Preparedness Plan,8 the National Biodefense
Science Board9 and BARDA.10 Tonix believes its RPV platform can
address a wide variety of disease targets of public health
interest.
TNX-801 (recombinant horsepox virus, live
vaccine): potential vaccine to protect against mpox disease and
smallpox.
- Results from a study with our
TNX-801 vaccine that showed animals were protected from mpox were
reported at a meeting in the first quarter of 2020 and published as
an article in the peer reviewed journal, Viruses in 2023.11
- On December 14, 2023, Dr. Lederman
participated in a panel discussion on Vaccine Research &
Development at the National Academies of Sciences, Engineering, and
Medicine (NAS) Committee on the Current State of Research,
Development, and Stockpiling of Smallpox Medical Countermeasures
public meeting. Discussions explored lessons learned from the
recent COVID-19 pandemic and mpox multi-country outbreak to inform
an evaluation of the current state of research, development, and
stockpiling of smallpox readiness and response measures. The
Consensus Study Report was issued on March 28, 2024.12 Some of the
conclusions included recommendations for single dose vaccines,
safer vaccines, vaccine platforms and attention to supply chain and
manufacturing. Tonix believes TNX-801 has the potential to address
some of the recommendations from the NAS Committee since it
provides single dose protection to animals, and has the potential
for favorable dose, manufacturing and cold chain requirements.
- 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.
- Concerns about current state of new
smallpox and mpox vaccines in development have been raised by the
U.S. Bipartisan Commission on Biodefense13 and by an outbreak of
mpox in the Democratic Republic of the Congo.14
- Results from a study with our
TNX-801 vaccine that showed decreased virulence relative to
traditional live vaccinia vaccine strains were posted on the
website BioRxiv in 2023.15
Broad-spectrum anti-viral programs
Tonix is developing potential broad-spectrum
antiviral drugs in three programs: CD45-targeted therapeutics
(TNX-4200), cathepsin inhibitors (TNX-3900) and viral
glycan-targeted engineered biologics (TNX-4000). In 2020, the DoD
announced that they are seeking broad spectrum antiviral drugs
since it would be hard to predict which or how many viruses may be
deployed on the battlefield.16 Tonix hopes that one or more of our
programs may help the DoD address that goal.
Marketed Products — Recent
Highlights
- Tonix completed the acquisition of
Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra
(sumatriptan nasal spray) 10 mg from Upsher-Smith Laboratories, LLC
on June 30, 2023. Both products are indicated for the treatment of
acute migraine with or without aura in adults.
- Combined net product revenue of
$7.8 million reported for the period July 1, 2023 – December 31,
2023 for Zembrace Symtouch and Tosymra.
- As of April 1, 2024, Tonix
completed the transition to becoming a fully integrated
pharmaceutical company. Tonix Pharmaceuticals has implemented
personnel, systems and contracts required to support a commercial
organization and has assumed responsibility for distribution,
selling and marketing of Zembrace SymTouch and Tosymra, as well as
supply chain, regulatory and quality control of the two
products.
Facilities — Recent
Highlights
- Tonix’s Advanced Development Center
(ADC) located in the New Bedford business park in Dartmouth,
Massachusetts, is an approximately 45,000 square foot BSL-2
facility and is intended to accelerate development and clinical
scale manufacturing of live-virus vaccines and biologics to support
clinical trials. Tonix has engaged CBRE, an international real
estate brokerage firm, to find a strategic partner for, or buyer
of, ADC.
- Tonix’s Research and Development
Center (RDC) in Frederick, Maryland, consisting of one building
totaling approximately 48,000 square feet, conducts research on
central nervous system, immunology, and infectious disease
candidates. The RDC facility is mostly biosafety level 2 (BSL-2),
with some components designated BSL-3.
*All of Tonix’s product candidates are
investigational new drugs or biologics and none have been approved
for any indication.
1 Bergmans RS, et al. PAIN. 2023.
DOI: 10.1097/j.pain.0000000000003110.2 Fitzcharles M-A, et
al. PAIN. 2023.
DOI: 10.1097/j.pain.0000000000003129.3 Lassiter G., et
al. Am J Transplantation.
2023. https://doi.org/10.1016/j.ajt.2023.03.0224 Miura S., et
al. Am J Transplantation.
2023. https://doi.org/10.1016/j.ajt.2023.03.0255 Anand, R.P.,
et al Nature. 622, 393–401
(2023). https://doi.org/10.1038/s41586-023-06594-46
Massachusetts General Hospital press release. March 21, 2024.
“World’s First Genetically Edited Pig Kidney Transplant into Living
Recipient Performed at Massachusetts General Hospital.”
www.massgeneral.org/news/press-release/worlds-first-genetically-edited-pig-kidney-transplant-into-living-recipient
(accessed March 29, 2024)7 Awasthi M, et al. 2023. Vaccines (Basel)
11(11):1682. https://doi:10.3390/vaccines111116828 Office of
Science and Technology Policy (OSTP). American Pandemic
Preparedness: Transforming Our Capabilities. September 20219
National Biodefense Science Board (NBSB). Prioritization of Product
Attribute Categories to Maximize Access for Next Generation
COVID-19 Vaccines and Therapeutics. August 202310 BARDA Strategic
Plan 2022-2026.11 Noyce RS, et al. Viruses. 2023 26;15(2):356. doi:
10.3390/v1502035612 U.S. National Academy of Sciences. March 28,
2024. “Consensus Study Report: Future State of Smallpox Medical
Countermeasures.”
https://nap.nationalacademies.org/catalog/27652/future-state-of-smallpox-medical-countermeasures
13 Bipartisan Commission on Biodefense. (2024). Box the Pox:
Reducing theRisk of Smallpox and Other Orthopoxviruses. Bipartisan
Commission onBiodefense: Washington, DC.
https://biodefensecommission.org/reports/box-the-pox-reducing-the-risk-of-smallpox-and-other-orthopoxviruses/14
Emanuel, G. NPR. March 27, 2024. “Why the mpox outbreak in the
Democratic Republic of Congo is worrying disease docs.” URL:
www.npr.org/sections/goatsandsoda/2024/03/27/1239276957/mpox-outbreak-democratic-republic-of-congo-deadlier-strain15
Trefry, SV et al., BioRxiv 2023.10.25.564033; doi:
https://doi.org/10.1101/2023.10.25.56403316 U.S. Department of
Defense. Chemical and Biological Defense Program. 2022. “Approach
for Research, Development, and Acquisition of Medical
Countermeasure and Test Products.” U.S. Department of Defense.
https://media.defense.gov/2023/Jan/10/2003142624/-1/-1/0/APPROACH-RDA-MCM-TEST-PRODUCTS.PDF
(accessed March 5, 2024)
Recent Highlights —
Financial
As of December 31, 2023, Tonix had approximately
$24.9 million of cash and cash equivalents, compared to $120.2
million as of December 31, 2022. Additionally, Tonix had inventory
totaling approximately $13.6 million as of December 31, 2023. Net
cash used in operations was approximately $102.0 million for the
full year ended December 31, 2023, compared to $98.1 million for
the same period in 2022. Net cash used by investing activities for
the full year ended December 31, 2023 was approximately $29.1
million compared to $48.1 million for the same period in 2022.
In August 2022, the Company announced that it
received a Cooperative Agreement grant from the National Institute
on Drug Abuse (“NIDA”), part of the National Institutes of Health,
to support the development of its TNX-1300 product candidate for
the treatment of cocaine intoxication. During the year ended
December 31, 2023, Tonix received $2.7 million in funding as a
reduction of related research and development expenses. Included in
prepaid expense and other is an additional $0.2 million that was
not received until January 2024.
On December 8, 2023, the Company executed a Loan
and Guaranty Agreement (the “Loan Agreement”) to issue a 36-month
term loan (the “Term Loan”) in the principal amount of $11.0
million with a maturity date of December 8, 2026 (the “Maturity
Date”). The Term Loan was funded with an original issue discount of
9% of the principal amount of the Term Loan, or $1.0 million, which
is being amortized over the term of the debt as an adjustment to
the effective interest rate on the outstanding borrowings.
On December 20, 2023, the Company announced it
had signed securities purchase agreements with existing
healthcare-focused institutional investors for upfront gross
proceeds of approximately $30 million through a registered direct
offering.
On March 28, 2024, the Company announced it had
signed securities purchase agreements with existing
healthcare-focused institutional investors for upfront gross
proceeds of approximately $4.4 million through a registered direct
offering.
As of April 1, 2024, there were 84,490,862
shares of Tonix Pharmaceuticals common stock outstanding.
Fourth Quarter 2023 Financial Results
Net product revenue for the fourth quarter 2023
was approximately $3.8 million. Cost of Sales for the fourth
quarter 2023 was approximately $2.4 million. Tonix completed the
acquisition of two currently marketed products from Upsher-Smith
Laboratories, LLC on June 30, 2023.
R&D expenses for the fourth quarter 2023
were approximately $17.1 million, compared to $24.7 million for the
same period in 2022. This decrease is predominantly due to
decreased non-clinical and manufacturing expenses.
SG&A expenses for the fourth quarter 2023
were $11.6 million, compared to $8.1 million for the same period in
2022. The increase was primarily due to sales and marketing and the
transition services expenses associated with the Company’s recently
acquired marketed products offset by a decrease in
compensation-related expenses.
Net loss available to common stockholders was
$27.3 million, or $0.86 per share, basic and diluted, for the
fourth quarter 2023, compared to net loss available to common
stockholders of $34.1 million, or $3.42 per share, basic and
diluted, for the same period in 2022. The basic and diluted
weighted average common shares outstanding for the fourth quarter
2023 was 31,756,759 compared to 9,952,780 shares for the same
period in 2022.
Full Year 2023 Financial Results
Net product revenue for the full year 2023 was
approximately $7.8 million. Cost of sales for the full year 2023
was approximately $4.7 million.
R&D expenses for the full year 2023 were
approximately $86.7 million, compared to $81.9 million for the same
period in 2022. This increase is predominantly due to decreased
non-clinical and regulatory expenses, offset by an increase in
clinical, manufacturing, employee-related and professional
expenses.
SG&A expenses for the full year 2023 were
$34.8 million, compared to $30.2 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
$116.7 million, or $6.85 per share, basic and diluted, for the full
year 2023, compared to net loss available to common stockholders of
$116.9 million, or $20.01 per share, basic and diluted, for the
same period in 2022. The basic and diluted weighted average common
shares outstanding for the full year 2023 was 17,039,309 compared
to 5,841,447 shares for the same period in 2022.
Tonix Pharmaceuticals Holding
Corp.*
Tonix is a biopharmaceutical company focused on
developing, licensing and commercializing therapeutics to treat and
prevent human disease and alleviate suffering. Tonix’s development
portfolio is focused on central nervous system (CNS) disorders.
Tonix’s priority is to submit a New Drug Application (NDA) to the
FDA in the second half of 2024 for Tonmya, a product candidate for
which two positive Phase 3 studies have been completed for the
management of fibromyalgia. TNX-102 SL is also being developed to
treat acute stress reaction as well as fibromyalgia-type Long
COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase),
a biologic designed to treat cocaine intoxication that has
Breakthrough Therapy designation. Tonix’s immunology development
portfolio consists of 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. Tonix also has
product candidates in development in the areas of rare disease and
infectious disease. Tonix Medicines, our commercial subsidiary,
markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and
Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute
migraine with or without aura in adults.
*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. 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 as filed with the Securities and Exchange Commission (the
“SEC”) 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. |
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
(In Thousands, Except Share and Per Share
Amounts) |
(unaudited) |
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Year EndedDecember 31, |
|
|
Three Months EndedDecember
31, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
REVENUE: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenue, net |
|
$ |
7,768 |
|
|
$ |
— |
|
|
$ |
3,779 |
|
|
$ |
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COSTS AND EXPENSES: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue |
|
$ |
4,741 |
|
|
$ |
— |
|
|
$ |
2,367 |
|
|
$ |
— |
|
Research and development |
|
|
86,655 |
|
|
|
81,876 |
|
|
|
17,120 |
|
|
|
24,674 |
|
Selling, general and
administrative |
|
|
34,752 |
|
|
|
30,215 |
|
|
|
11,621 |
|
|
|
8,054 |
|
|
|
|
126,148 |
|
|
|
112,091 |
|
|
|
31,108 |
|
|
|
32,728 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(118,380 |
) |
|
|
(112,091 |
) |
|
|
(27,329 |
) |
|
|
(32,728 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income, net |
|
|
1,722 |
|
|
|
1,873 |
|
|
|
7 |
|
|
|
1,048 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
(116,658 |
) |
|
|
(110,218 |
) |
|
|
(27,322 |
) |
|
|
(31,680 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock deemed
dividend |
|
|
— |
|
|
|
6,659 |
|
|
|
— |
|
|
|
2,404 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss available to common
stockholders |
|
$ |
(116,658 |
) |
|
$ |
(116,877 |
) |
|
$ |
(27,322 |
) |
|
$ |
(34,084 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share,
basic and diluted |
|
$ |
(6.85 |
) |
|
$ |
(20.01 |
) |
|
$ |
(0.86 |
) |
|
$ |
(3.42 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares
outstanding, basic and diluted |
|
|
17,039,309 |
|
|
|
5,841,447 |
|
|
|
31,756,759 |
|
|
|
9,952,780 |
|
|
See the accompanying notes to the condensed consolidated financial
statements |
TONIX PHARMACEUTICALS HOLDING CORP. |
CONDENSED CONSOLIDATED BALANCE SHEETS |
(In Thousands) |
(Unaudited) |
|
|
|
December 31, 2023 |
|
|
December 31, 20221 |
|
Assets |
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
24,948 |
|
|
$ |
120,229 |
|
Inventory |
|
|
13,639 |
|
|
|
- |
|
Prepaid expenses and
other |
|
|
9,181 |
|
|
|
10,548 |
|
Total current assets |
|
|
47,768 |
|
|
|
130,777 |
|
Other non-current assets |
|
|
106,689 |
|
|
|
94,913 |
|
Total assets |
|
$ |
154,457 |
|
|
$ |
225,690 |
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders' equity |
|
|
|
|
|
|
|
Total liabilities |
|
$ |
48,932 |
|
|
$ |
18,508 |
|
Stockholders' equity |
|
|
105,525 |
|
|
|
207,182 |
|
Total liabilities and
stockholders' equity |
|
$ |
154,457 |
|
|
$ |
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.
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