Current Report Filing (8-k)
November 09 2021 - 9:04AM
Edgar (US Regulatory)
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2021-11-08
2021-11-08
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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): November 8, 2021
_____________________
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 Global 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 November 9, 2021, Tonix Pharmaceuticals
Holding Corp. (the “Company”) issued a press release announcing the poster presentation (the “Poster”) of results
from its Phase 1 clinical study of TNX-601 CR (tianeptine oxalate and naloxone controlled-release tablets) entitled “TNX-601
CR*: a Once-Daily Formulation of Tianeptine in Development for the Treatment of Major Depressive Disorder” at the CNS 2021 Summit.
Copies of the Poster and press release which discusses this matter are furnished hereto as Exhibits 99.01 and 99.02, respectively, and
incorporated herein by reference.
The information in this Item 7.01
of this Current Report on Form 8-K, including Exhibits 99.01 and 99.02 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 November 8, 2021, the Company
presented the Poster of results from its open-label, Phase 1 clinical study of TNX-601 CR (tianeptine oxalate and naloxone controlled-release
tablets) for the treatment for major depressive disorder (“MDD”) and post-traumatic stress disorder and neurocognitive dysfunction
associated with corticosteroid use. The poster provides data related to the Phase 1 pharmacokinetic study in healthy subjects that assessed
several novel modified-release (“MR”) prototype formulations of tianeptine oxalate. The study showed that the selected TNX-601
MR1 demonstrated pharmacokinetics appropriate for once-daily dosing with minimal food effect, which is a potential treatment adherence
advantage over three times per day dosing of immediate release tianeptine sodium. This MR prototype was selected in the development of
the final formulation of TNX-601 CR as a once-daily treatment for MDD. The Company believes that these Phase 1 findings support its upcoming
Phase 2 study of once-daily TNX-601 CR for MDD in the first half of 2022. Based on the Phase 1 results, the Company believes that with
respect to plasma tianeptine and its primary metabolite, TNX-601 CR would meet the bioequivalence standard for daily dosing of these immediate
release products. TNX-601 CR’s proposed mechanism of action is distinct from any antidepressant approved in the U.S for chronic
or long-term use. The Phase 2 study design is expected to be randomized, double-blind, placebo-controlled, parallel group study to evaluate
the efficacy and safety of TNX-601 CR monotherapy versus placebo in MDD. Treatment duration will be 6 weeks, preceded by up to 5 weeks
in screening and followed by a 2-week safety follow-up period (total up to 13 weeks of participation). The Company plans to randomize
approximately 260 individuals with MDD at a 1:1 ratio to two arms of 130 each for drug and placebo at approximately 25-30 US sites. The
primary efficacy endpoint will be the change from Baseline to Week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total
score. Enrollment is estimated to start in the first half of 2022, pending Investigational New Drug Application clearance by the U.S.
Food and Drug Administration.
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 results of the Phase 1 clinical study of TNX-601 CR, 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.
|
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: November
9, 2021
|
By:
|
/s/ Bradley Saenger
|
|
Bradley
Saenger
|
|
Chief
Financial Officer
|
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