Item 7.01 Regulation FD Disclosure.
On January 11, 2022, Tonix Pharmaceuticals Holding Corp. (the “Company”) issued
a press release announcing that the first participant was enrolled in a
dose-finding study for TNX-2100 (SARS-CoV-2 epitope peptide mixtures for
intradermal administration) product candidate, an in vivo skin test to measure
delayed-type hypersensitivity (“DTH”) to SARS-CoV-2. A copy of the press release
which discusses this matter is furnished hereto as Exhibit 99.01, and
incorporated herein by reference.
The information in this Item 7.01 of this Current Report on Form 8-K, including
Exhibit 99.01 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 January 11, 2022, the Company issued a press release announcing that the
first participant was enrolled in a dose-finding study for TNX-2100. The Company
believes that TNX-2100 has the potential to serve as: 1) a biomarker for T cell
protective immunity and durability of vaccine protection; 2) a personalized
approach for vaccine boosters; 3) a method to stratify participants in COVID-19
vaccine trials with a more complete picture of immune status; 4) an endpoint in
COVID-19 vaccine trials for vaccines that elicit T cell immunity, and 5) public
health surveillance. The Company believes that TNX-2100 has the potential to
address the unmet need for a rapid, sensitive, and specific test that may
indicate current or past infection with SARS-CoV-2 and potentially predict
protective immunity, and to inform strategies to protect individuals and
communities from COVID-19.
This dose finding, multi-cohort study is designed to evaluate the safety and
efficacy of intradermally-injectedTNX-2100, synthesized SARS-CoV-2 peptide
antigens, and assess the presence and magnitude of DTH reactions, a measure of
functional T cell immunity.
The study is expected to be conducted in the U.S. in approximately 90 healthy
adult subjects (30 subjects per cohort) who are either uninfected/unexposed
healthy individuals (Cohort 1), who are confirmed to have recovered from
SARS-CoV-2 infection, independent of vaccination status (Cohort 2), or who have
received a complete SARS-CoV-2 vaccine course with no known history of natural
infection (Cohort 3). The study schedule will consist of a baseline/skin test
administration at visit 1 (Day 1) at which time baseline assessments are to be
completed, the skin test is performed, and appropriate test samples are
collected. Follow-up visits to monitor safety and evaluate the presence or
absence of DTH reactions will be conducted at visit 1 (Day 1), visit 2 (Day 2),
visit 3 (Day 3), visit 4 (Day 4), and visit 5 (Day 5). Safety monitoring will
continue through visit 6 (Day 30) and visit 7 (Day 180).
An interim analysis is expected to be conducted after all subjects have
completed their Day 5 visit (or early terminated prior to Day 5). The purpose of
the interim analysis will be to assess the presence of DTH reactions in response
to intradermal injection of TNX-2100, synthesized SARS-CoV-2 peptide antigens,
and to assess safety up to 96 hours post-administration. A full database lock
will occur after all subjects have completed their visit 7 (or early terminated
prior to visit 7).
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 intellectual property rights
and protections related to TNX-1700, 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
Item 9.01 Financial Statements and Exhibits.
(d) Exhibit No. Description. 99.01 Press release of the Company, dated January 11, 2022 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
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