Item 7.01 Other Events.
Corporate Presentation
The investor presentation about Genprex, Inc. (the "Company") that is furnished
as Exhibit 99.1 to this Current Report on Form 8-K may be presented at meetings
with investors, analysts, and others, in whole or in part and possibly with
modifications, from time to time on or after January 6, 2023. A copy of the
investor presentation slides, substantially in the form expected to be used in
such presentations and meetings, will be available on the Company's website,
www.genprex.com.
The information in this Current Report on Form 8-K under Item 7.01, including
the information contained in Exhibit 99.1, is being furnished to the Securities
and Exchange Commission, and shall not be deemed to be "filed" for the purposes
of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the
liabilities of that section, and shall not be deemed to be incorporated by
reference into any filing under the Securities Act of 1933 or the Securities
Exchange Act of 1934, except as shall be expressly set forth by a specific
reference in such filing."
Item 8.01 Other Events.
Update on Acclaim-2 Clinical Trial
We currently are enrolling and treating patients in the dose escalation portion
of our Phase 1/2 Acclaim-2 clinical trial. The Acclaim-2 trial uses a
combination of REQORSA and Merck & Co.'s Keytruda® in patients with late-stage
non small cell lung cancer ("NSCLC") whose disease has progressed after
treatment with Keytruda. We expect the dose escalation portion of Phase 1 of the
study to be completed by the end of 2023. We will then evaluate 12 more patients
at the maximum tolerated dose ("MTD") or recommended Phase 2 dose ("RP2D") to
expand the safety profile at that dose. The Food and Drug Administration ("FDA")
has granted Fast Track Designation for the Acclaim-2 treatment combination of
REQORSA and Keytruda in NSCLC patients who have progressed after Keytruda.
News on Acclaim-3 Clinical Trial
In Q4 2022 we filed with the FDA our protocol for our Phase 1/2 Acclaim-3
clinical trial using a combination of REQORSA and Genentech, Inc.'s Tecentriq®
as maintenance therapy in patients with extensive stage small cell lung cancer
("ES-SCLC") who did not develop tumor progression after receiving Tecentriq and
chemotherapy. We expect to dose the first patient in Acclaim-3 in Q3 2023. We
anticipate enrolling patients at approximately 10 U.S. clinical sites and
estimate that the Phase 1 escalation portion of the Acclaim-3 trial will enroll
up to 12 patients, and the Phase 2 portion will enroll approximately 50
patients. Patients will be treated with REQORSA and Tecentriq until disease
progression or unacceptable toxicity is experienced. The primary endpoint of the
Phase 1 escalation portion is to determine the maximum tolerated dose or
recommended Phase 2 dose and the Phase 2 is to determine the 18-week
progression-free survival rate from the time of the start of maintenance therapy
with REQORSA and Tecentriq in patients with ES-SCLC. Patients will also be
followed for survival.
Cautionary Language Concerning Forward-Looking Statements
Statements contained in this Report that are not historical facts are
"forward-looking statements" within the meaning of the Private Securities
Litigation Reform Act of 1995. These forward-looking statements are made on the
basis of the current beliefs, expectations and assumptions of management, are
not guarantees of performance and are subject to significant risks and
uncertainty. These forward-looking statements should, therefore, be considered
in light of various important factors, including those set forth in Genprex's
reports that it files from time to time with the Securities and Exchange
Commission and which you should review, including those statements under "Item
1A - Risk Factors" in Genprex's Annual Report on Form 10-K for the year ended
December 31, 2021.
Because forward-looking statements are subject to risks and uncertainties,
actual results may differ materially from those expressed or implied by such
forward-looking statements. Such statements include, but are not limited to,
statements regarding: the timing and success of Genprex's clinical trials and
regulatory approvals, including the extent and impact of the COVID-19 pandemic;
the effect of Genprex's product candidates, alone and in combination with other
therapies, on cancer and diabetes; Genprex's future growth and financial status;
Genprex's commercial and strategic partnerships, including those with its third
party manufacturers and their ability to successfully perform and scale up the
manufacture of its product candidates; and Genprex's intellectual property and
licenses.
These forward-looking statements should not be relied upon as predictions of
future events and Genprex cannot assure you that the events or circumstances
discussed or reflected in these statements will be achieved or will occur. If
such forward-looking statements prove to be inaccurate, the inaccuracy may be
material. You should not regard these statements as a representation or warranty
by Genprex or any other person that Genprex will achieve its objectives and
plans in any specified timeframe, or at all. You are cautioned not to place
undue reliance on these forward-looking statements, which speak only as of the
date of this press release. Genprex disclaims any obligation to publicly update
or release any revisions to these forward-looking statements, whether as a
result of new information, future events or otherwise, after the date of this
press release or to reflect the occurrence of unanticipated events, except as
required by law.
Item 9.01: Financial Statements and Exhibits.
(d) Exhibits.
Exhibit
Number Description
99.1 Investor Presentation
104 Cover Page Interactive Data File (embedded within the Inline XBRL
document).
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