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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):
February 27, 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 February 27, 2024, Tonix Pharmaceuticals
Holding Corp. (the “Company”) announced positive results from its clinical pharmacokinetic (“PK”) bridging study
of its Tonmya™ (also known as TNX-102 SL, cyclobenzaprine sublingual tablets) product candidate in healthy adult male and female
ethnic Japanese and Chinese volunteers.
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 February 27, 2024, the Company
announced positive results from its clinical PK bridging study of Tonmya in healthy adult male and female volunteers of documented Japanese
and Chinese ancestry. The study characterized the PK profile and dose proportionality of Tonmya following administration in 10 healthy
volunteers, and compared these findings to an existing PK dataset conducted under similar conditions in Caucasian volunteers. Results
indicate that key PK parameters of cyclobenzaprine for Japanese, Chinese and Caucasian groups were similar, with geometric mean ratios
falling within the 90% confidence interval, and that Tonmya was generally safe and well tolerated at doses up to 5.6 mg as single sublingual
administrations. The Company expects these data to fulfill the requirements for a bridging study, and to support regulatory filings for
clinical studies in Japan and China, where cyclobenzaprine is a new chemical entity. The Company intends to meet with the Pharmaceuticals
and Medical Devices Agency and National Medical Products Administration to further the development of Tonmya in Japan and China, respectively.
The incidence of adverse events
(“AEs”) and investigational product-related AEs was low. No volunteers discontinued due to an AE and no clinically significant
abnormal findings in laboratory parameters, electrocardiograms, or other safety assessments were noted during the study. No severe AEs
and no deaths were reported during the study. The Company believes it can proceed with submitting an Investigational New Drug applications
in Japan and China and begin clinical development of Tonmya to support a registration-enabling Phase 3 study in Asia.
The study was a randomized, single-dose,
open-label, 2-way, crossover study design in ethnic Japanese (N=10) and Chinese (N=10) healthy male and female volunteers. The primary
objective of the study was to characterize the PK profile and dose proportionality of Tonmya following administration of 2.8 mg and 5.6
mg (one and two 2.8 mg tablets) under fasting conditions in the volunteers, and to retrospectively compare these PK data with existing
data from a prior Phase 1 study in Caucasian volunteers dosed under the same conditions. Safety and tolerability were also assessed. A
2.8 mg or 5.6 mg tablet (2 X 2.8 mg) of Tonmya was administered sublingually in the morning under fasted conditions. As the similarity
in PK profile between Japanese and Chinese volunteers was confirmed, the PK data from the two ethnic groups were pooled (n=20) for the
comparison between Asian and Caucasian volunteers. The primary PK endpoints were the total amount of cyclobenzaprine and metabolite norcyclobenzaprine
in the blood (expressed as the area under the curve (AUC0-T)) and maximum concentration (expressed as Cmax).
The Company holds issued patents
for market exclusivity rights of Tonmya expected to provide market exclusivity into 2034 in Japan, China, Hong Kong and Taiwan.
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, dated February 27, 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: February 27, 2024 |
By: |
/s/ Bradley Saenger |
|
| |
Bradley Saenger |
| |
Chief Financial Officer |
Tonix Pharmaceuticals Holding Corp
Exhibit 99.01
Tonix Pharmaceuticals Announces Positive
Results from Clinical Pharmacokinetic Bridging Study of Tonmya™ to Support Development and Partnering in Japan and China
Tonix plans to File a Clinical Trial Notification
(CTN) in Japan and Investigational New Drug (IND) application in China to support a registration-enabling Asian Phase 3 study without
dosage adjustment based on U.S. registrational Phase 3 data
Tonmya’s market exclusivity is supported
by issued patents in Japan, China, Hong Kong and Taiwan; cyclobenzaprine is a new chemical entity in Japan and China
New Drug Application (NDA) submission to the U.S.
FDA for the approval of Tonmya for the management of fibromyalgia planned for second half of 2024
CHATHAM, N.J., February 27, 2024 (GLOBE NEWSWIRE)
– Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products
and a pipeline of development candidates, announced positive results from its clinical pharmacokinetic (PK) bridging study of Tonmya™
(also known as TNX-102 SL, cyclobenzaprine HCl sublingual tablets) in healthy adult male and female ethnic Japanese and Chinese volunteers.
Results indicate that key pharmacokinetic 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 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.
This study characterized the PK profile and
dose proportionality of Tonmya following administration in 20 healthy volunteers of documented Japanese or Chinese ancestry, and compared
these findings to an existing PK dataset conducted under similar conditions in Caucasian volunteers.
“This bridging study is an important
first step as we begin evaluating the potential for approval and marketing Tonmya in Japan and China. The results show a similar pharmacokinetic
profile in ethnic Japanese and Chinese volunteers with a Caucasian comparator group,” said Seth Lederman, M.D., Chief Executive
Officer of Tonix Pharmaceuticals. “As a result, we believe that these data, with supporting results recently reported from the positive
Phase 3 RESILIENT study, are the only clinical data needed to support regulatory filings in Japan and China.”
Dr. Lederman continued, “With patents
issued in Japan, China, Hong Kong and Taiwan expected to provide market exclusivity into 2034, we believe that Tonmya would be a welcome
addition to the therapeutic options for fibromyalgia patients in East Asia and an attractive asset for the right development and commercialization
partners in these markets. Cyclobenzaprine is an NCE in both of these countries. We plan to meet with Japan’s Pharmaceuticals and
Medical Devices Agency (PMDA) and China’s National Medical Products Administration (NMPA) to seek agreement on the development of
Tonmya in Japan and China, respectively.”
About the Asia Bridging Study
The study was a randomized, single-dose, open-label,
2-way, crossover study design in ethnic Japanese (N=10) and Chinese (N=10) healthy male and female volunteers. The primary objective of
the study was to characterize the PK profile and dose proportionality of Tonmya following administration of 2.8 mg and 5.6 mg (one and
two 2.8 mg tablets) under fasting conditions in Japanese and Chinese volunteers, and to retrospectively compare these PK data with existing
PK data of both cyclobenzaprine and norcyclobenzaprine from a prior Phase 1 study in Caucasian volunteers dosed under the same conditions.
Safety and tolerability were also assessed. A 2.8 mg or 5.6 mg dose (2 X 2.8 mg tablet) of Tonmya was administered sublingually in the
morning under fasted conditions. Blood samples were collected pre-dose and up to 15 days post-dose for analyte measurements, with a 28-day
washout between periods. The primary PK endpoints were the total amount of cyclobenzaprine and metabolite norcyclobenzaprine in the blood
(expressed as the area under the curve (AUC0-T)) and maximum concentration (expressed as Cmax).
Study Results
Pharmacokinetics
Ethnic
Japanese and Chinese volunteers were considered comparable on PK parameters for cyclobenzaprine following a 2.8 mg and 5.6 mg dose of
Tonmya, and dose proportionality was demonstrated in both samples. Given that the similarity in PK profile between Japanese and Chinese
volunteers was confirmed, the PK data from the two ethnic groups were pooled for the comparison between Asian (n=20) and Caucasian (n=16)
volunteers. The PK parameters of cyclobenzaprine for Japanese, Chinese, and Caucasian groups were similar, with geometric mean ratios
falling within the 90% confidence interval.
Safety
| § | Tonmya was shown to be safe and well-tolerated at doses up to 5.6 mg as single sublingual administrations
in healthy adult Japanese and Chinese volunteers. |
| § | The incidence of adverse events (AEs) and investigational product-related AEs was low. No volunteer discontinued
due to an AE. |
| § | No clinically significant abnormal findings in laboratory parameters, ECGs, or other safety assessments
were noted during the study. No severe AEs and no deaths were reported during the study. |
Issued Patents in Japan, China, Hong Kong
and Taiwan
| EUTECTIC FORMULATIONS |
Country |
Patent Number |
Expected
Expiry |
| China |
ZL 201480024011.1 |
03/14/2034 |
| China |
ZL201910263541.6 |
03/14/2034 |
| Hong Kong |
HK1218727 |
03/14/2034 |
| Japan |
6310542 |
03/14/2034 |
| Taiwan R.O.C. |
I661825 |
03/14/2034 |
| TRANSMUCOSAL ABSORPTION |
Japan |
6259452 |
06/14/2033 |
| Taiwan R.O.C. |
I590820 |
06/14/2033 |
| Taiwan R.O.C. |
I683660 |
06/14/2033 |
| Taiwan R.O.C. |
I642429 |
06/14/2033 |
| Hong Kong |
1209361 |
06/14/2033 |
About Tonmya* (also known as TNX-102 SL)
Tonmya is a centrally acting, non-opioid, non-addictive,
bedtime medication. The tablet is a patented sublingual formulation of cyclobenzaprine hydrochloride developed for the management of fibromyalgia.
In December 2023, the Company announced highly statistically significant and clinically meaningful topline results in RESILIENT, a second
positive Phase 3 clinical trial of Tonmya for the management of fibromyalgia. In the study, Tonmya met its pre-specified primary endpoint,
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 overall
fibromyalgia symptoms and function. RELIEF, the first positive Phase 3 trial of Tonmya in fibromyalgia, was completed in December 2020.
It met its pre-specified primary endpoint of daily pain reduction compared to placebo (p=0.010) and showed activity in key secondary endpoints.
Tonix plans to submit a New Drug Application (NDA)
to the U.S. Food and Drug Administration (FDA) in the second half of 2024 for Tonmya for the management of fibromyalgia.
*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.
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
443-213-0495
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