KRONOS BIO, INC. Item 8.01 Other Events.
On
The open-label, Phase 1/2 clinical trial for KB-0742 will be conducted over two stages: dose escalation and expansion. The dose-escalation stage will assess the safety, pharmacokinetic (PK) and pharmacodynamic (PD) profile of KB-0742 and establish a pharmacologically active dose and schedule with an acceptable safety profile. This dose and schedule will be further studied in the subsequent expansion stage in patients with MYC-amplified solid tumors and other transcriptionally addicted rare tumors such as sarcomas and chordomas. We expect to report initial PK, PD and safety data from the dose-escalation stage of the study in 2021.
Forward-Looking Statements
Statements in this report that are not statements of historical fact are
forward-looking statements for purposes of the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. This report, in some cases,
uses terms such as "expect," "plan," "will" or other words that convey
uncertainty of future events or outcomes to identify these forward-looking
statements. Forward-looking statements include statements regarding our
intentions, beliefs, projections, outlook, analyses or current expectations
concerning, among other things: our plan to begin a Phase 1/2 clinical trial of
KB-0742 in patients with advanced solid tumors and the expected timing thereof;
the design of such planned Phase 1/2 clinical trial, including to establish a
pharmacologically active dose and schedule with an acceptable safety profile;
our expectation to report data from such planned Phase 1/2 clinical trial and
the expected timing thereof; and other statements that are not historical fact.
Actual results and the timing of events could differ materially from those
anticipated in such forward-looking statements as a result of various risks and
uncertainties, including, without limitation: whether we will be able to
initiate or complete the Phase 1/2 clinical trial of KB-0742 on the timeline
expected, if at all, including due to risks associated with the COVID-19
pandemic and risks inherent in the clinical development of novel therapeutics;
risks related to our lack of experience as a company in conducting clinical
trials; the risk that results of preclinical studies and early clinical trials
are not necessarily predictive of future results; the risk that due to the
relatively small number of patients that we plan to dose in the planned Phase
1/2 clinical trial, the results from the planned Phase 1/2 clinical trial, once
completed, may be less reliable than results achieved in larger clinical trials,
which may hinder our efforts to further develop and obtain regulatory approval
for KB-0742; and risks associated with the sufficiency of our cash resources and
need for additional capital. These and other risks are described in greater
detail in our filings with the
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