Item 7.01 Regulation FD Disclosure
On
The information in this Item 7.01, including Exhibit 99.1 to this Current Report on Form 8-K, shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such a filing.
Item 8.01 Other Events
On
GreenLight's mRNA vaccine candidate, GLB-COV2-043, contains mRNA, encoding the
SARS-CoV-2 full-length spike protein from the
The Phase I/II study is designed to assess safety and immunogenicity as measured by humoral and cellular immune-response endpoints. Enrollment will be open to eligible adults who have received a 2-dose priming course of the mRNA BNT162b2/Comirnaty vaccine or a 2-dose priming and a third injection (i.e. as a booster) of the same mRNA vaccine. Participants will be evaluated in four cohorts, with the GreenLight vaccine candidate being administered in 15 microgram, 30 microgram, 60 microgram and 90 microgram doses, respectively. Each cohort will include 10 participants receiving the GreenLight vaccine candidate.
Forward-Looking Statements
Certain statements in this Current Report on Form 8-K may constitute
"forward-looking statements" for purposes of the federal securities laws. Our
forward-looking statements include, but are not limited to, statements regarding
our or our management team's expectations, hopes, beliefs, intentions or
strategies regarding the future, including those relating to the success, timing
of and costs associated with our clinical trials, including estimates regarding
when patients will be enrolled, when data will be report for ongoing clinical
trials, and timing to commence future clinical trials, the success, cost and
timing of our research and development activities in our plant and human health
programs, the acceptance of RNA-based technologies by regulators and the public,
our ability to raise and productively deploy capital and the rate at which we
can successfully bring products to market, our projected cash runway and our
ability to obtain funding for our operations when needed. Forward-looking
statements include statements relating to our management team's expectations,
hopes, beliefs, intentions or strategies regarding the future. In addition, any
statements that refer to projections, forecasts or other characterizations of
future events or circumstances, including any underlying assumptions, are
forward-looking statements. The words "anticipate," "believe," "contemplate,"
"continue," "could," "estimate," "expect," "intends," "may," "might," "plan,"
"possible," "potential," "predict," "project," "should," "will," "would" and
similar expressions may identify forward-looking statements, but the absence of
these words does not mean that a statement is not forward-looking. These
forward-looking statements are based on current expectations and beliefs
concerning future developments and their potential effects. There can be no
assurance that future developments affecting us will be those that we have
anticipated. These forward-looking statements involve a number of risks,
uncertainties (some of which are beyond our control) or other assumptions that
may cause actual results or performance to be materially different from those
expressed or implied by these forward-looking statements. These risks and
uncertainties include, but are not limited to, those factors described under the
heading "Risk Factors" in the Company's most recent Annual Report on Form 10-K
filed with the
--------------------------------------------------------------------------------
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
Exhibit No. Description
99.1 Press Release issued by
104 Cover Page Interactive Date File (embedded within the Inline XBRL document)
--------------------------------------------------------------------------------
© Edgar Online, source