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
GEM103 Phase 2a ReGAtta Study Update
Ongoing analysis of the 62 patients enrolled in the ReGAtta study continues to show that more than nine months of GEM103 exposure has been generally well-tolerated, able to durably reduce biomarkers of complement activation, and able to maintain supraphysiological levels of Complement Factor H (CFH). ReGAtta, an open-label, non-controlled study, was designed to evaluate GEM103's safety and pharmacokinetics over multiple intravitreal injections.
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GEM103 Phase 2a as an Add-On to Anti-VEGF Therapy for the Treatment of Wet AMD Study Update
In
GEM103 Study Plans
Having achieved the ReGAtta study's primary goal of assessing GEM103's safety and tolerability, as well as the primary goal of assessing GEM103's safety and tolerability as an add-on to aflibercept for the treatment of wet AMD, the Company will end both of these ongoing Phase 2a studies with patients returning for a final safety visit.
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 the success, cost, timing and status
of our product development activities and clinical trials, the timing of
anticipated announcements of updates with respect to our product candidates and
the timing to commence any potential future clinical trials, the potential
attributes and benefits of our product candidates, including GEM103, the
reliability of the interim or final results of studies relating to safety and
possible adverse effects, including serious adverse events, resulting from the
administration of our product candidates, our ability to obtain and maintain
regulatory approval for our product candidates. 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 Gemini's most recent Annual Report on Form 10-K
filed with the
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits. Exhibit Number Description 99.1 Press Release byGemini Therapeutics, Inc. , datedJanuary 10, 2022 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
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