Item 7.01 Regulation FD Disclosure.
On March 7, 2023, Tonix Pharmaceuticals Holding Corp. (the “Company”) announced
that preclinical results of the Company’s preclinical product candidate,
mTNX-1700 (recombinant murine TFF2-murine serum albumin, or MSA, fusion protein)
were presented in a poster at the Keystone Symposia, “Cancer Immunotherapy:
Mechanisms of Response Versus Resistance” (the “Poster”). A copy of the press
release which discusses this matter is furnished hereto as Exhibit 99.01, and
incorporated herein by reference. The Poster, which may contain nonpublic
information, 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
Exhibit 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 March 7, 2023, the Company announced that preclinical results of mTNX-1700
were presented in a poster entitled TFF2-MSA Suppresses Tumor Growth and
Increases Survival in an anti-PD-1 Treated MC38 Colorectal Cancer Model by
Targeting MDSCs, which includes data from preclinical studies which evaluated
the ability of mTNX-1700 to treat colorectal cancer as monotherapy or in
combination with anti-PD-1 in mouse models. TNX-1700 targets myeloid-derived
suppressor cells (“MDSCs”) which interfere with the immune response to cancer by
suppressing the CD8+ T cell response and creating a toxic tumor
microenvironment. The data show that mTNX-1700 and anti-PD-1 monotherapy each
were able to evoke anti-tumor immunity in the MC38 model of colorectal cancer,
and that mTNX-1700 augmented the anti-tumor efficacy of anti-PD-1 therapy in two
different colorectal cancer models. The Company is developing TNX-1700
(recombinant human TFF2-human serum albumin or HSA) for the treatment of colon
and gastric cancers.
The Company believes that data from these preclinical studies demonstrate that
mTNX-1700 treatment augmented the response of two different models of colorectal
tumors, and that mTNX-1700 inhibits the MDSCs which contribute to the toxic
element of the tumor microenvironment. Together these findings support the idea
that whether a tumor is anti-PD1 non-responsive or responsive may relate to the
tumor microenvironment rather than the tumor itself.
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, 2023
99.02 TFF2-MSA Suppresses Tumor Growth and Increases Survival in an
104 anti-PD-1 Treated MC38 Colorectal Cancer Model by Targeting MDSCs
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