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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934
Date of report (date of earliest event reported):
May 13, 2024
TONIX PHARMACEUTICALS HOLDING CORP.
(Exact name of registrant as specified in its charter)
Nevada |
001-36019 |
26-1434750 |
(State or Other Jurisdiction
of Incorporation) |
(Commission
File Number) |
(IRS Employer
Identification No.) |
26 Main Street, Chatham, New Jersey 07928
(Address of principal executive offices) (Zip Code)
Registrant’s telephone number, including area
code: (862) 904-8182
Check the appropriate box below if the Form 8-K filing
is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction
A.2. below):
☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant
to Section 12(b) of the Act:
Title
of each class |
Trading
Symbol(s) |
Name
of each exchange on which registered |
Common Stock |
TNXP |
The NASDAQ Capital Market |
Indicate by check mark whether
the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or
Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company,
indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial
accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 |
Results of Operations and Financial Condition |
On May 13, 2024, Tonix Pharmaceuticals
Holding Corp. (the “Company”) announced its operating results for the quarter ended March 31, 2024. A copy of the press release
that discusses these matters is filed as Exhibit 99.01 to, and incorporated by reference in, this report.
Item 9.01 |
Financial Statements and Exhibits. |
(d) |
|
Exhibit
No. |
|
Description. |
|
|
99.01
104 |
|
Press Release of the Company, May 13, 2024
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURE
Pursuant to the requirement of
the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
|
TONIX PHARMACEUTICALS HOLDING CORP. |
|
|
Date: May 13, 2024 |
By: |
/s/ Bradley Saenger |
|
|
|
Bradley Saenger |
|
|
Chief Financial Officer |
Tonix Pharmaceuticals Holding Corp. - 8-K
Exhibit
99.01
Tonix
Pharmaceuticals Reports First Quarter 2024 Financial Results and Operational Highlights
On
track to submit NDA in the second half of 2024 for Tonmya™ for fibromyalgia;
pre-NDA
meeting with FDA scheduled for second quarter 2024
Commercial
planning continues for U.S. launch of Tonmya, a potential new first-line, centrally-acting, non-opioid analgesic for the management of
fibromyalgia
CHATHAM,
N.J., May 13, 2024 (GLOBE NEWSWIRE) – 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
first quarter ended March 31, 2024, and provided an overview of recent operational highlights.
“Our
near-term priority continues to be the submission of our New Drug Application (NDA) for Tonmya™ (cyclobenzaprine HCl sublingual
tablets) for the management of fibromyalgia, while continuing to build out our commercial strategy for the anticipated product launch
in the event of FDA approval, which we currently estimate to occur in the second half of 2025,” said Seth Lederman, M.D., Chief
Executive Officer of Tonix.
Dr.
Lederman added, “The well-known treatment-limiting side effects of the three currently approved drugs have led to widespread patient
dissatisfaction, creating what we believe is a significant opportunity for a new therapeutic. Tonmya has a differentiated mechanism of
action and is generally free of common side effects associated with the currently approved products, including weight gain, fatigue,
insomnia, increased blood pressure, gastrointestinal issues or sexual dysfunction. As such, we believe Tonmya, if approved, could become
the treatment of choice for the approximately 10 million people in the U.S. suffering the debilitating effects of fibromyalgia.”
The
Company is also advancing other key pipeline programs including those for immunology, obesity, eating disorders, infectious and rare
diseases, many through a capital efficient strategy involving partnerships, grants and in-kind contributions.
Recent
Highlights – Key Product Candidates*
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).
● | In
January 2024, Tonix presented additional safety and tolerability data from the pivotal Phase
3 RESILIENT study that showed Tonmya treatment was not associated with increases in systolic
or diastolic blood pressure or body weight, nor were there any reported sexual side effects.
The Company had previously announced in December 2023 that the Phase 3 RESILIENT study, a
registration-quality, double-blind, placebo-controlled study evaluating Tonyma met its pre-specified
primary endpoint in the second of two positive Phase 3 clinical trials, significantly reducing
daily pain compared to placebo (p-value=0.00005) in participants with fibromyalgia. Statistically
significant and clinically meaningful results were also seen in all pre-specified key secondary
endpoints including those related to improving sleep quality, reducing fatigue, and improving
patient global ratings and overall fibromyalgia symptoms and function. Tonmya was well tolerated
with an adverse event profile comparable to prior studies and no new safety signals observed.
In addition, Tonmya therapy showed activity on improving female sexual function relative
to placebo with a nominal p-value=0.010 by the Changes in Sexual Functioning Questionnaire
short-form, female version. |
| |
● | Tonix
plans to submit an NDA to the FDA in the second half of 2024 for Tonmya for the management
of fibromyalgia. In February 2024, Tonix announced the engagement of Rho, Inc. as our contract
research organization (CRO) to support NDA submission. |
| |
● | In
February 2024, Tonix announced statistically significant 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
March 2024, Tonix announced the selection of two contract manufacturing organizations (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 a nominal 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 University
of North Carolina Institute for Trauma Recovery and supported by a $3 million grant from
the U.S. Department of Defense, 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.
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
anticipates 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. |
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 adolescent obesity, binge
eating disorder, bone health in autism and social anxiety disorder (SAD).
● | TNX-1900
continues to be studied in four ongoing investigator-initiated Phase 2 studies as follows:
Massachusetts General Hospital (MGH): (1) Phase 2 study for binge-eating disorder (BED);
(2) Phase 2 study for adolescent obesity; (3) Phase 2 study for improving bone health in
children with autism spectrum disorder (BOX); and at University of Washington, (4) Phase
2 study for social anxiety disorder (SAD). The BED study and the adolescent obesity study
will investigate whether TNX-1900 has effects on eating behaviors in specialized populations. |
Rare
Disease Pipeline
TNX-2900
(intranasal potentiated oxytocin): small peptide for the treatment of Prader-Willi syndrome (PWS)
● | In
March 2024, Tonix announced that it received Rare Pediatric Disease designation from the
FDA for TNX-2900 for the treatment of PWS. Tonix has an IND to support clinical development
of TNX-2900 to treat PWS in children and adolescents. The planned Phase 2 study 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. PWS is a genetic disorder that affects several body systems, with cognitive
and behavioral symptoms including pathological over-eating beginning in childhood and leading
to severe metabolic sequelae. |
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 proposed 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 with TNX-1500 at the
Massachusetts General Hospital (MGH) on allogeneic transplants in animals.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 greater than 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
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. 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 patient in collaboration with eGenesis, which produced the pig donors and used
an anti-CD40L mAb from another company.5 Some of the pre-clinical work that supported
the living human transplant was performed in collaboration with Tonix and used TNX-1500.6
The patient was able to return home after the transplant, but died after approximately
two months.7 |
Marketed
Products – Recent Highlights
● | 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
● | In
the fourth quarter of 2023, Tonix engaged CBRE, an international real estate brokerage firm,
to potentially find a strategic partner for, or buyer of, its Advanced Development Center
(ADC) to align with the Company’s current business objectives and priorities. At this
time, the Company does not have a commitment in place to sell the building. ADC, located
in the New Bedford business park in Dartmouth, Massachusetts, isan approximately 45,000 square
foot BSL-2 facility intended for clinical scale manufacturing of live-virus vaccines and
biologics. |
*All
of Tonix’s product candidates are investigational new drugs or biologics and none have been approved for any indication.
Tonmya™
is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia.
Tonmya has not 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.2023.03.022
4
Miura S., et al. Am J Transplantation. 2023. https://doi.org/10.1016/j.ajt.2023.03.025
5
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)
6
Anand, R.P., et al Nature. 622, 393–401 (2023). https://doi.org/10.1038/s41586-023-06594-4
7
Stoico, N. Boston Globe. May 11, 2023. “Mass Man who received first kidney transplant from genetically engineered
pig has died, family says”.
Recent
Highlights – Financial
As
of March 31, 2024, Tonix had $7.0 million of cash and cash equivalents, compared to $24.9 million as of December 31, 2023. Net cash used
in operations was approximately $17.6 million for first quarter 2024, compared to net cash used in operations of $32.9 million for the
same period in 2023.
On
April 1, 2024, the Company closed a financing with existing healthcare-focused institutional investors for upfront gross proceeds of
approximately $4.4 million through a registered direct offering.
First
Quarter 2024 Financial Results
Net
product revenue for the first quarter 2024 was approximately $2.5 million. Net product revenue consisted of combined net sales of Zembrace®
SymTouch® and Tosymra®, which were acquired from Upsher-Smith Laboratories, LLC on June 30, 2023. Cost of Sales for the first
quarter 2024 was approximately $1.7 million.
Research
and development expenses for the first quarter 2024 were $12.9 million, compared to $26.5 million for the same period in 2023. This decrease
is predominantly due to decreased clinical, non-clinical and manufacturing expenses.
General
and administrative expenses for the first quarter 2024 were $9.3 million, compared to $7.4 million for the same period in 2023. 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 financial reporting expenses.
Net
loss was $(14.9) million, or $(0.18) per share, basic and diluted, for the first quarter 2024, compared to net loss of $(33.0) million,
or $(3.21) per share, basic and diluted, for the same period in 2023. The basic and diluted weighted average common shares outstanding
for the first quarter 2024 was 80,879,108 compared to 10,268,500 shares for the same period in 2023.
Tonix
Pharmaceuticals Holding Corp.*
Tonix
is a fully-integrated 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 Tonmya1, a product candidate
for which two statistically significant 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.
1Tonmya™
is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia.
Tonmya has 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 on
Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April
1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix's forward-looking statements are expressly
qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
TONIX
PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In Thousands, Except Share and Per Share Amounts)
(unaudited)
| |
Three
months ended
March 31, | |
| |
2024 | | |
2023 | |
REVENUES: | |
| | |
| |
Product
revenue, net | |
$ | 2,482 | | |
$ | — | |
| |
| | | |
| | |
COSTS
AND EXPENSES: | |
| | | |
| | |
Cost
of sales | |
| 1,660 | | |
| — | |
Research
and development | |
| 12,863 | | |
| 26,511 | |
General
and administrative | |
| 9,310 | | |
| 7,391 | |
Total
Operating Expenses | |
| 23,833 | | |
| 33,902 | |
| |
| | | |
| | |
Operating
loss | |
| (21,351 | ) | |
| (33,902 | ) |
| |
| | | |
| | |
Gain
on change in fair value of warrant liabilities | |
| 7,005 | | |
| — | |
Other
(expense) income, net | |
| (593 | ) | |
| 897 | |
| |
| | | |
| | |
Net
loss available to common stockholders | |
$ | (14,939 | ) | |
$ | (33,005 | ) |
| |
| | | |
| | |
Net
loss to common stockholders per common share, basic and diluted | |
$ | (0.18 | ) | |
$ | (3.21 | ) |
| |
| | | |
| | |
Weighted
average common shares outstanding, basic and diluted | |
| 80,879,108 | | |
| 10,268,500 | |
See
the accompanying notes to the condensed consolidated financial statements
TONIX
PHARMACEUTICALS HOLDING CORP.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(In
Thousands)
(Unaudited)
| |
March
31,
2024 | | |
December
31,
20231 | |
Assets | |
| | | |
| | |
Cash
and cash equivalents | |
$ | 7,049 | | |
$ | 24,948 | |
Inventory | |
| 12,351 | | |
| 13,639 | |
Prepaid
expenses and other | |
| 10,698 | | |
| 9,181 | |
Total current
assets | |
| 30,098 | | |
| 47,768 | |
Other
non-current assets | |
| 105,245 | | |
| 106,689 | |
Total
assets | |
$ | 135,343 | | |
$ | 154,457 | |
| |
| | | |
| | |
Liabilities
and stockholders' equity | |
| | | |
| | |
Total liabilities | |
$ | 27,200 | | |
$ | 48,932 | |
Stockholders'
equity | |
| 108,143 | | |
| 105,525 | |
Total
liabilities and stockholders' equity | |
$ | 135,343 | | |
$ | 154,457 | |
| 1 | The
condensed consolidated balance sheet for the year ended December 31, 2023 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
Morris
Tonix
Pharmaceuticals
investor.relations@tonixpharma.com
(862)
904-8182
Peter
Vozzo
ICR
Westwicke
peter.vozzo@westwicke.com
(443)
213-0505
Media
Contact
Katie
Dodge
LaVoieHealthScience
kdodge@lavoiehealthscience.com
(978)
360-3151
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