Enrollment in the dose optimization part of the Phase 1b trial, in which (ALRN-6924 is administered 24 hours
before each dose of topotecan), is complete, and monitoring is ongoing with four of the evaluable patients continuing treatment past the data cut-off date.
The Company continues to enroll patients in a schedule optimization part of the Phase 1b trial intended to determine whether ALRN-6924 given six hours prior
to topotecan could be an alternative dosing schedule that could provide patients and healthcare providers with additional flexibility as to when to administer ALRN-6924 before topotecan. The Company plans to report the final data for the Phase 1b
trial, including data from the 6 hour-schedule part, in the first quarter of 2021.
In the fourth quarter of 2020, the Company plans to initiate a study
of ALRN-6924 in healthy volunteers to characterize the time to onset, and the magnitude and duration of cell cycle arrest in human bone marrow relative to ALRN-6924 administration. Subject to the results of the healthy volunteer study and the final
data from the Phase 1b trial, the Company expects to initiate a clinical program in patients with non-small cell lung cancer beginning with a Phase 1b trial in the fourth quarter of 2021 and a development program in a gastrointestinal cancer
indication at a later point in time. The Company does not currently plan to conduct additional development of ALRN-6924 in patients with SCLC.
Forward-Looking Statements
Statements in this report
[and Exhibit 99.1] about Company’s future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute forward-looking statements within the meaning of The Private Securities
Litigation Reform Act of 1995. These statements include, but are not limited to, statements about the Company’s strategy and clinical development plans. The words “anticipate,” “believe,” “continue,”
“could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would” and
similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a
result of various important factors, including whether the Company’s cash resources will be sufficient to fund its continuing operations for the periods and/or trials anticipated; whether the Company will obtain sufficient cash resources to
conduct its planned clinical trials; whether results obtained in clinical trials will be indicative of results obtained in future clinical trials; whether third party data would be indicative of the data that would be obtained in a randomized,
head-to-head clinical trial; whether the Company’s product candidates will advance through the clinical trial process on a timely basis, or at all; whether the results of such trials will be accepted by and warrant submission for approval from
the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether the Company’s product candidates will receive approval from regulatory agencies on a timely basis or at all; whether, if product candidates obtain
approval, they will be successfully distributed and marketed; what impact the coronavirus pandemic may have on the timing of our clinical development, clinical supply and our operations; and other factors discussed in the “Risk Factors”
section of the Company’s quarterly report on Form 10-Q for the period ended June 30, 2020, and risks described in other filings that the Company may make with the Securities and Exchange
Commission. Any forward-looking statements contained in this report and Exhibit 99.1 speak only as of the date hereof, and the Company specifically disclaims any obligation to update any forward-looking statement, whether because of new information,
future events or otherwise.
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Item 9.01.
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Financial Statements and Exhibits.
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(d) Exhibits:
