On April 22, 2020, the Company announced that it plans to report in mid-2020 interim results from the
dose-optimization part of its ongoing Phase 1b/2 clinical trial of ALRN-6924 in patients with small cell lung cancer, or SCLC, being treated with topotecan. The Company is evaluating ALRN-6924 in this trial as an agent to protect cancer patients
against chemotherapy-induced toxicity, a concept known as chemoprotection, and is seeking to identify a dose and dosing schedule of ALRN-6924 administration to reduce severe anemia, neutropenia and thrombocytopenia resulting from topotecan.
In the dose-optimization part of the trial, topotecan is administered daily on days 1 through 5 of every 21-day
treatment cycle, and ALRN-6924 is administered 24 hours before each dose of topotecan (on days 0 through 4 every 21 days). The Company plans to commence the schedule optimization part of the trial in June 2020. In this part of the trial, the Company
plans to evaluate ALRN-6924 at two dose levels in a total of 20 patients. In this part of the trial, ALRN-6924 will be dosed six hours before each dose of topotecan (on days 1 through 5 of every 21-day
treatment cycle).
The Company currently plans to report top-line final data for both 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.
Forward-Looking Statements
Statements in this report
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 uncertainties inherent in the initiation of future clinical studies and in the availability and timing of data from ongoing clinical studies; uncertainties related to the impact of the
COVID-19 pandemic, including the impact on the timing and conduct of our ongoing and planned clinical trials; whether results from preclinical studies or earlier clinical studies will be predictive of the
results of ongoing and future studies; whether interim data from clinical studies such as the data reported in this presentation will be indicative of the final results of the study; whether results from clinical studies will warrant meetings with
regulatory authorities or submissions for regulatory approval; whether submissions for regulatory approval will be made when anticipated or at all; whether the Company will receive will receive regulatory approvals to market products; whether the
company can raise cash resources when needed on attractive terms or at all; whether the Company’s cash resources will be sufficient to fund the Company’s foreseeable and unforeseeable operating expenses and capital expenditure
requirements; other matters that could affect the availability or commercial potential of the Company’s therapeutic candidates; and other factors discussed in the “Risk Factors” section of the Company’s annual report on Form 10-K for the year ended December 31, 2019, 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
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.
