Current Report Filing (8-k)
October 03 2022 - 7:06AM
Edgar (US Regulatory)
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2022-10-03
2022-10-03
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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): October 3, 2022
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 October 3, 2022, Tonix Pharmaceuticals
Holding Corp. (the “Company”) announced that the U.S. Food and Drug Administration (the “FDA”) cleared the Investigational
New Drug (“IND”) application to support a Phase 2 clinical trial with the Company’s TNX-601 ER (tianeptine hemioxalate
extended-release tablets) product candidate, a once-daily formulation of tianeptine as a potential treatment for major depressive disorder
(“MDD”). A copy of the press release which discusses this matter is furnished hereto as Exhibit 99.01, and incorporated herein
by reference.
The Company updated its investor
presentation, which is used to conduct meetings with investors, stockholders and analysts and at investor conferences, and which the Company
intends to place on its website, which may contain nonpublic information. A copy of the presentation is filed as Exhibit 99.02 hereto
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 October 3, 2022, the Company
announced that the FDA cleared the IND application to support a Phase 2 clinical trial with the Company’s TNX-601 ER product candidate
as a potential treatment for MDD. The Company expects to initiate the Phase 2 trial in MDD in the first quarter of 2023, with the potential
for additional future indications in posttraumatic stress disorder and neurocognitive dysfunction from corticosteroids. The study is expected
to be a registration-quality, potentially pivotal, Phase 2, 6-week, randomized, double-blind, placebo-controlled, parallel-group study
to evaluate the efficacy, safety, and tolerability of TNX-601 ER monotherapy in male and female subjects aged 18 to 65 years (inclusive),
with current MDD as defined by DSM-5 criteria at screening and a Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥
25 at baseline. A total of 300 participants are planned to be randomized to two treatment arms across approximately 30 clinical trial
sites in the U.S. The study is expected to have a single unblinded interim analysis for sample size re-estimation when the study has results
of the first 50% of efficacy evaluable patients, pending agreement on the comprehensive statistical analysis plan with the FDA.
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 October 3, 2022
|
|
|
99.02 |
|
Corporate Presentation by the Company for October 2022 |
|
|
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: October 3, 2022 |
By: |
/s/ Bradley Saenger |
|
|
Bradley Saenger |
|
Chief Financial Officer |
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