On December 21, 2020, the Company provided a business update and outlined its strategic priorities for 2021, including announcing more details about the
design and conduct of a Phase 1b randomized, double-blind, placebo-controlled clinical trial of ALRN-6924 in patients with advanced non-small cell lung cancer (“NSCLC”) undergoing treatment with first-line carboplatin doublet chemotherapy
(with or without immune checkpoint inhibitors), planned to begin enrolling in the second quarter of 2021.
The Company plans to begin enrolling patients
its planned Phase 1b clinical trial of ALRN-6924 in patients with NSCLC in the second quarter of 2021, subject to obtaining funding for the trial. The Company expects that the randomized, double-blind, placebo-controlled trial will be part of a
registration program designed to ultimately support approval for ALRN-6924 in NSCLC. The Company anticipates enrolling approximately 40 patients with stage IV NSCLC undergoing treatment with first-line carboplatin doublet chemotherapy with or
without an immune checkpoint inhibitor. Patients will be randomized 1:1 to receive either 0.3 mg/kg of ALRN-6924 or placebo. Endpoints will include the effect of ALRN-6924 to limit chemotherapy-induced bone marrow toxicities. The Company anticipates
reporting initial results from the trial late in the fourth quarter of 2021 and full results in mid-2022.
In 2021, the Company plans to report additional
results from its ongoing Phase 1b clinical trial in patients with small cell lung cancer (“SCLC”). In October 2020, the Company presented positive clinical data from the trial demonstrating clinical proof-of-concept that treatment with
ALRN-6924 resulted in a protective effect against severe anemia, thrombocytopenia and neutropenia in patients with p53-mutated SCLC treated with topotecan. The data set from this trial, which the Company plans to announce in the first quarter of
2021, will include results across all dose levels evaluating ALRN-6924 administered 24 hours prior to topotecan administration, including an exploratory 0.2 mg/kg dose level, as well as results from a cohort evaluating 0.3 mg/kg ALRN-6924
administered six hours prior to topotecan administration, which has now completed enrollment, with a total of six patients.
In addition, the Company
initiated a healthy volunteer study in November 2020 to characterize the time to onset, magnitude and duration of cell cycle arrest in human bone marrow relative to ALRN-6924 administration. Due to COVID-19-related delays, the Company is updating
its guidance on the readout of the healthy volunteer study from the second quarter of 2021 to mid-2021.
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 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 September 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 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.