The full interim data announced by the Company are set forth on the slides filed as Exhibit 99.1 to the
report, which are incorporated herein by reference.
The Phase 1b portion of the trial is designed to identify a dose and a schedule of ALRN-6924
administration to reduce chemotherapy toxicities such as severe anemia and thrombocytopenia, and other toxicities resulting from topotecan. In the ongoing dose optimization part of the study, ALRN-6924 is administered 24 hours before each dose of
topotecan, which is administered daily on days 1 through 5 of every 21-day treatment cycle.
The Company is
enrolling patients into the expansion cohort of its 0.3 mg/kg dose level and plans to initiate enrollment in the schedule optimization part of the Phase 1b/2 trial in June 2020.
As previously reported, the Company plans to report the top-line final data for the dose optimization and schedule
optimization parts of the trial in the fourth quarter of 2020. The Company expects that these results will determine a recommended ALRN-6924 dose and schedule for subsequent trials.
The Company also plans to initiate a trial of ALRN-6924 in healthy human volunteers to develop a universal dosing regimen for ALRN-6924 for use as a cell
cycle arresting agent across a range of additional chemotherapies and tumor indications. Subject to the results of this study and data from the dose- and schedule-optimization trials, and obtaining sufficient funding, the Company expects to initiate
a Phase 2 randomized, placebo-controlled clinical trial in second-line SCLC in the first quarter of 2021 and a Phase 1b clinical trial in non-small cell lung cancer and in an additional cancer indication in
the second quarter of 2021.
The Company is carefully monitoring the effect of the coronavirus pandemic on its clinical trial sites and the healthcare
system, which may impact the future timing of the trial and the Companys planned data announcements.
Forward-Looking Statements
Statements in this report and Exhibit 99.1 about Companys 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 Companys 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 Companys cash resources will be sufficient to fund its continuing operations
for the periods and/or trials anticipated; whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical
trial such as the interim results presented will be indicative of the final results of the trial; whether Companys product candidates will advance through the clinical trial process on a timely basis, or at all; whether the results of such
trials will warrant submission for approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether Companys 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; whether the coronavirus pandemic will have an impact on the timing of our clinical development, clinical supply and our operations; and other
factors discussed in the Risk Factors section of the Companys quarterly report on Form 10-Q for the period ended March 31, 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.