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

Item 7.01    Regulation FD Disclosure.



On September 15, 2022, Tonix Pharmaceuticals Holding Corp. (the “Company”)
announced data from three oral presentations by faculty at the Center for
Transplantation Sciences, Massachusetts General Hospital Center at the 29th
International Congress of The Transplantation Society (TTS 2022) held September
10-14, 2022 (collectively, the “Presentations”). The data involve studies of the
Company’s TNX-1500 (Fc modified anti-CD40L monoclonal antibody) product
candidate in development for the prevention of organ transplant rejection. A
copy of the press release which discusses this matter is furnished hereto as
Exhibit 99.01, and incorporated herein by reference. The Presentations, which
may contain nonpublic information, are filed as Exhibits 99.02, 99.03 and 99.04
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, 99.02, 99.03 and 99.04 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 September 15, 2022, the Company announced data from the Presentations
involving studies of the Company’s TNX-1500 (Fc modified anti-CD40L monoclonal
antibody) product candidate. The molecular target of TNX-1500 is CD40-ligand
(CD40L, which is also known as CD154). The Presentations include data
demonstrating that TNX-1500 treatment showed activity in preventing organ
rejection and was well tolerated in non-human primates. Blockade of CD40L with
TNX-1500 monotherapy consistently and safely prevented pathologic alloimmunity
in non-human primate cardiac and kidney allograft models without clinical
thrombosis.

The Presentations include data demonstrating that TNX-1500 treatment showed
activity in preventing xenograft kidney rejection and was well tolerated in
non-human primates. Xenografts are transplanted organs from donors of a
different species from the recipient, and in this study, the xenografts
originated from genetically engineered pigs. Blockade of CD40L with TNX-1500
monotherapy consistently and safely prevented pathologic xenoimmunity in
non-human primate kidney xenograft models without clinical thrombosis. TNX-1500
is a third generation anti-CD40L mAb that has been designed by protein
engineering to decrease Fc?RII binding and to reduce the potential for
thrombosis. Animal studies found that TNX-1500 retains activity to prevent
rejection and preserve graft function. The Company believes that TNX-1500 has
the potential for treating and preventing organ transplant rejection in both
allograft and xenograft transplants. The Company expects to initiate a Phase 1
trial of TNX-1500 in the first half of 2023. Based on results of anti-CD40L in
numerous animal models, the Company believes that TNX-1500 has the potential for
treating a number of autoimmune conditions.



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 September 15, 2022
        99.02     Monotherapy with TNX-1500, an Fc-modified anti-CD154 mAb, prolongs
                  cardiac allograft survival in cynomolgus monkeys
        99.03     Long-term (>1 year) rejection-free survival of kidney xenografts
                  with triple xenoantigen knockout and multiple human transgenes in
                  nonhuman primates
        99.04     Long-term rejection-free renal allograft survival with Fc-modified
                  anti-CD154 antibody monotherapy in nonhuman primates
         104      Cover Page Interactive Data File (embedded within the Inline XBRL
                  document)

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