Blog: TONIX PHARMACEUTICALS HOLDING CORP. : Regulation FD Disclosure, Other Events, Financial Statements and Exhibits (form 8-K) –

Item 7.01    Regulation FD Disclosure.

On June 21, 2022, Tonix Pharmaceuticals Holding Corp. (the “Company”) announced
the publication of a paper entitled “Impact of Magnesium on Oxytocin Receptor
Function,” in the journal Pharmaceutics (the “Paper”), that includes data
showing the enhancing effects of magnesium (“Mg2+”) on the activity of
intranasal oxytocin in an animal model of craniofacial pain. A copy of the press
release which discusses this matter and the Paper, which may contain material,
nonpublic information, 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.

 Item 8.01. Other Events.

On June 21, 2022, the Company announced the publication of the Paper that
described results from a research team led by Professor David Yeomans. The paper
includes data showing the enhancing effects of Mg2+ on the activity of
intranasal oxytocin in an animal model of craniofacial pain. The Mg2+ enhanced
formulation of intranasal oxytocin is the basis for the Company’s TNX-19002 drug
candidate in development to prevent migraine headaches in chronic migraineurs,
and TNX-2900, which is in development to treat hyperphagia in adolescent and
young adult patients with Prader-Willi syndrome. Professor Yeomans was the
scientific founder of Trigemina, Inc. from which Tonix acquired rights to the
Mg2+enhanced oxytocin technology. Professor Yeomans is a consultant to Tonix and
the research described in the paper was funded in part by Tonix. The data
evidences the role Mg2+ plays in the effect of oxytocin on pain reduction both
in vitro and in vivo in an animal model of head pain, and that adding Mg2+ to
intranasal oxytocin reduces or eliminates high dose inhibition such that
analgesia increases with higher doses of oxytocin. The Company expects that the
Mg2+ enhanced formulation of intranasal oxytocin in TNX-1900 and TNX-2900 may
provide consistent effects to the extent that the Mg2+ component of the
formulation reduces or eliminates high dose inhibition and may also allow for
using higher oxytocin doses. Intranasal oxytocin with Mg2+ demonstrated
augmented craniofacial analgesia in animal models, and, under test conditions,
oxytocin has the potential to allow for the use of higher oxytocin doses. The
clinical significance of these observations is that the formulation of oxytocin
plus Mg2+ in the Company’s TNX-1900 and TNX-2900 product candidates has the
potential to enhance oxytocin efficacy for pain and other uses.

The Company believes that TNX-1900 has the potential to be a non-addicting,
non-constipating and easy to administer alternative to opioids to treat migraine
and craniofacial pain, and that targeted delivery of oxytocin could translate
into selective blockade of the neurotransmitter calcitonin gene-related peptide
(“CGRP”) in release in the trigeminal ganglion and not throughout the body,
which could be a potential safety advantage over systemic CGRP inhibition.

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 development of TNX-102 SL, 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 June 21, 2022
        99.02       Impact of Magnesium on Oxytocin Receptor Function
         104      Cover Page Interactive Data File (embedded within the Inline XBRL

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