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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): March 7, 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
7.01 |
Regulation FD Disclosure. |
On
March 7, 2024, Tonix Pharmaceuticals Holding Corp. (the “Company”) announced the publication of a research paper entitled,
“A Phase 3, Randomized, Placebo-Controlled, Trial to Evaluate the Efficacy and Safety of Bedtime Sublingual Cyclobenzaprine (TNX-102
SL) in Military-Related Posttraumatic Stress Disorder,” in the journal Psychiatry Research (the “Paper”). A copy of
the press release which discusses this matter is furnished hereto as Exhibit 99.01, and incorporated herein by reference.
The
information in this Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.01 attached hereto, shall not be deemed “filed”
for purposes of Section 18 of the United States Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject
to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the United States Securities
Act of 1933 or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
On
March 7, 2024, the Company announced the publication of the Paper, which found that bedtime treatment of the Company’s TNX-102
SL product candidate is well-tolerated and showed nominal improvement in PTSD severity and sleep quality measures in the first four weeks
in miliary-related posttraumatic stress disorder (“PTSD”). The Company believes these findings suggest a potential role for
short-term bedtime TNX-102 SL treatment in the immediate aftermath of traumatic events, and that bedtime TNX-102 SL has short-term activity
on improving PTSD symptom severity and sleep quality in military-related PTSD.
Forward-
Looking Statements
This
Current Report on Form 8-K contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933
and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating
to the Company’s product development, clinical trials, clinical and regulatory timelines, market opportunity, competitive position,
possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive
in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry
and markets in which we operate and management’s current beliefs and assumptions.
These
statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,”
“intend,” “plan,” “believe,” “estimate,” “potential,” “predict,”
“project,” “should,” “would” and similar expressions and the negatives of those terms. These statements
relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may
cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed
or implied by the forward-looking statements. Such factors include those set forth in the Company’s filings with the SEC. Prospective
investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press
release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information,
future events or otherwise.
| Item
9.01 |
Financial
Statements and Exhibits. |
| (d) |
|
Exhibit
No. |
|
Description. |
| |
|
99.01 |
|
Press
release of the Company, dated March 7, 2024 |
| |
|
104 |
|
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:
March 7, 2024 |
By:
|
/s/
Bradley Saenger |
|
| |
Bradley
Saenger |
| |
Chief
Financial Officer |
TONIX PHARMACEUTICALS HOLDING CORP. 8-K
Exhibit 99.01
Tonix
Pharmaceuticals Announces Publication in Psychiatry Research Showing Activity of Bedtime TNX-102 SL on PTSD Symptoms and Sleep
Quality in Military-Related PTSD at Four Weeks of Therapy
Data
support evaluation of the effects of two weeks of TNX-102 SL therapy on severity of acute stress reaction (ASR) and frequency of acute
stress disorder (ASD) and PTSD after civilian motor vehicle collision in upcoming U.S. DoD-Funded Phase 2 investigator-initiated OASIS
trial
Nominal
improvement in PTSD severity and measures of sleep quality at Week 4 in the HONOR study support development of bedtime TNX-102 SL therapy
in the immediate aftermath of trauma
TNX-102
SL (Tonmya™) is also in late-stage development for the management of fibromyalgia for which NDA preparation is ongoing
CHATHAM,
N.J., March 7, 2024 – Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with
marketed products and a pipeline of development candidates, today announced the publication of a research paper in the Journal Psychiatry
Research. The article titled, “A Phase 3, Randomized, Placebo-Controlled, Trial to Evaluate the Efficacy and Safety of Bedtime
Sublingual Cyclobenzaprine (TNX-102 SL) in Military-Related Posttraumatic Stress Disorder,” by Parmenter, et al. found that bedtime
TNX-102 SL* treatment is well-tolerated and showed nominal improvement in PTSD severity and sleep quality measures in the
first four weeks in miliary-related posttraumatic stress disorder (PTSD).1 The Company believes these findings suggest a potential
role for short-term bedtime TNX-102 SL treatment in the immediate aftermath of traumatic events.
The
data support the U.S. Department of Defense (DoD)-funded Phase 2 investigator-initiated OASIS trial to evaluate bedtime TNX-102 SL2
in reducing the severity of acute stress reaction (ASR) and the frequency of acute stress disorder (ASD) and PTSD. The IND supporting
the OASIS trial was recently cleared,3 and the trial is expected to begin enrolling in the second quarter. The trial is sponsored
by The University of North Carolina Institute for Trauma Recovery and supported by a $3 million grant from DoD. In
the OASIS study, 14 days of bedtime TNX-102 SL 5.6 mg will be tested in the immediate aftermath of motor vehicle collision. The
study will test the potential for TNX-102 SL treatment initiated within 24 hours of index trauma to
target trauma-related sleep disturbance and other ASR symptoms to facilitate recovery from ASR and to prevent PTSD.
“There
is an urgent need for interventions to reduce rates of ASD and PTSD in the immediate aftermath of trauma,”4 said Seth
Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “We believe the results in the published paper suggest that bedtime
TNX-102 SL has short-term activity on improving PTSD symptom severity and sleep quality in military-related PTSD. Poor sleep after trauma
is a risk factor for progressing from ASD to PTSD. Therefore, poor sleep is not only a symptom of ASR, ASD and PTSD, but also a potential
target of therapy.”
Dr.
Gregory Sullivan, Chief Medical Officer of Tonix said, “Sleep disturbances are known to play a critical role in the development
and maintenance of PTSD. The upcoming OASIS trial will test a 14-day short-course of bedtime TNX-102 SL therapy beginning within 24 hours
of index trauma for effects on ASR symptoms and incidence of PTSD development. We are excited to test bedtime TNX-102 SL in the immediate
aftermath of trauma to learn whether drug intervention reorients the trajectory of posttraumatic pathology from acute trauma to early
recovery in the first few weeks.”
About
TNX-102 SL (also known as Tonmya™ for the management of fibromyalgia)
PTSD:
The Phase 3 HONOR study described in the published article was performed in military-related PTSD with the primary endpoint of
improvement from baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score at Week 12 comparing TNX-102 SL 5.6 mg
and placebo. The study did not reach statistical significance on the primary endpoint. While there was nominal improvement by the Week
4 visit on CAPS-5 (p=0.019), the improvement relative to placebo was not sustained at Weeks 8 and 12. The CAPS-5 “sleep disturbance”
item also showed nominal improvement at Week 4 (p=0.002), as well as at Week 8 (p=0.026), but not thereafter. The PROMIS Sleep Disturbance
T-score also showed early nominal improvement with TNX-102 SL 5.6 mg at Week 4 (p=0.015). It is also notable that when the primary endpoint
was analyzed for responder rate, defined as ≥50% improvement on CAPS-5 total score at Week 4, 38.4% of those on TNX-102 SL were responders
versus 24.4% on placebo (p=0.019). TNX-102 SL was well-tolerated and the adverse events reported were similar to those seen in prior
TNX-102 SL studies. There were three participants with serious adverse events (SAEs) reported during the study: two in the placebo group
and one in the active group. None were deemed related to study drug. Administration site reactions were similar in profile to prior studies
with TNX-102 SL, with oral numbness (hypoaesthesia) at the highest rate. These oral sensory adverse events (AE), oral numbness, oral
tingling, and tongue discomfort were temporally-related to dosing and were rated as mild and transient (<60 min) in the majority of
cases. No new safety signals were observed.
In
addition to the Phase 3 HONOR study described in the published article1, Tonix has also studied TNX-102 SL in a Phase 2 (‘AtEase’)
trial in military PTSD5 and in a Phase 3 (‘RECOVERY’) trial in civilian PTSD.6 Both studies were performed
with the primary endpoint of CAPS-5 improvement at Week 12. AtEase compared bedtime TNX-102 SL at two doses (2.8 mg & 5.6 mg) and
placebo. RECOVERY compared TNX-102 SL 5.6 mg and placebo. Neither study reached statistical significance on the primary endpoint.
Fibromyalgia:
TNX-102 SL has shown positive results in two Phase 3 clinical trials for the management of fibromyalgia. Tonix plans to submit a New
Drug Application to the U.S. Food and Drug Administration in the second half of 2024 under the 505(b)(2) regulatory pathway for Tonmya
for the management of fibromyalgia.
Formulation
Technology and Patents: TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which is designed
for daily administration at bedtime with a proposed mechanism of improving sleep quality in fibromyalgia. TNX-102 SL provides rapid transmucosal
absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism.
As a multifunctional agent with potent binding and antagonist activities at the 5-HT2A-serotonergic, α1-adrenergic, H1-histaminergic,
and M1-muscarinic cholinergic receptors, TNX-102 SL is in development as a daily bedtime treatment for fibromyalgia. TNX-102 SL is also
in development for fibromyalgia-type Long COVID (formally known as post-acute sequelae of COVID-19 [PASC]), alcohol use disorder, and
agitation in Alzheimer’s disease. The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408
in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No.
10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are
important elements of Tonix’s proprietary TNX-102 SL composition. These patents are expected to provide Tonmya, upon NDA approval,
with U.S. market exclusivity until 2034/2035. In addition, Tonix has pending but not issued U.S. patent applications directed to the
transmucosal absorption of cyclobenzaprine HCl, with U.S. market exclusivity expected until 2033, for treating depressive symptoms in
fibromyalgia, with U.S. market exclusivity expected until 2032, and for treating pain in fibromyalgia with U.S. market exclusivity expected
until 2041.
*TNX-102
SL has not been approved for any indication; name conditionally
approved by FDA as Tonmya™ for the management of fibromyalgia
| 1. | Parmenter
ME, et al. Psychiatry Research. 2024. 334: 115764. https://doi.org/10.1016/j.psychres.2024.115764. |
| 2. | Tonix
Press Release – September 27, 2023. “Tonix Pharmaceuticals Announces Department
of Defense Grant to Support the University of North Carolina’s Proposed Investigator
Sponsored OASIS Trial of TNX-102 SL for Treatment of Acute Stress Reaction, Acute Stress
Disorder, and Posttraumatic Stress Disorder”. https://bit.ly/3T1LyIl |
| 3. | Tonix
Press Release – Feb 12, 2024. “Tonix Pharmaceuticals Announces FDA IND Clearance
for DoD Funded Trial of TNX-102 SL for the Reduction of Acute Stress Reaction and Prevention
of PTSD” https://bit.ly/3TiQOsj. |
| 4. | Schnurr,
PP et al. Annals of Internal Medicine. 2024: www.acpjournals.org/doi/10.7326/M23-2757. |
| 5. | Sullivan
GM, et al. Psychiatry Res. 2021. 301:113974. https://doi.org/10.1016/j.psychres.2021.113974. |
| 6. | Tonix
Press Release – December 21, 2020, “Tonix Pharmaceuticals Reports Topline Results
from Phase 3 RECOVERY Study of TNX-102 SL in PTSD and Outlines Future Development Plans”
https://bit.ly/3uOgUu8 |
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 with 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 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.
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
Ben
Shannon
ICR
Westwicke
ben.shannon@westwicke.com
(919)
360-3039
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