Analyst Conference Summary

biotechnology

release date: November 5, 2020
for quarter ending: September 30, 2020 (third quarter, Q3)

Forward-looking statements

Overview: Clinical-stage company made pipeline progress.

Basic data (GAAP):

No revenue.

Net income was negative $12.5 milion, down sequentially from negative $16.4 million, and down from negative $9.2 year-earlier.

EPS (earnings per share) were negative $0.58, up sequentially from negative $0.78, and up from negative $5.29 year-earlier, due to 20x increase in share count.

Guidance:

Cash use in 2020 expected between $35 and $40 million. Cash should be adequate into 2023.

Conference Highlights:

Christian S. Schade, CEO of Aprea, said "We made solid progress during the third quarter across our development pipeline as we approach top-line data from the Phase 3 clinical trial evaluating eprenetapopt with azacitidine for the treatment of front-line TP53 mutant myelodysplastic syndromes (MDS) patients by year-end 2020. We continue to execute on our goal of expanding the clinical opportunities for our p53 reactivator programs, including expansion of our front-line AML clinical trials, enrollment of the first patients in our solid tumor trial, initiation of our lymphoma trial, and clearance from the FDA to proceed with the Phase 1 trial of our next-generation p53 reactivator, APR-548."

At the end of the quarter Aprea had cash and equivalents of $101 million, down sequentially from $113 million.

In Q2 2020 completed enrollment of 154 patients in pivotal Phase 3 randomized, controlled trial evaluating eprenetapopt with azacitidine as frontline therapy in HMA-naive TP53 mutant myelodysplastic syndromes (MDS) patients. The primary endpoint is complete remission (CR) rate. Expects top-line data by year-end 2020.

Also completed enrollment, in Q3 2020, in the single-arm, open-label Phase 2 trial evaluating eprenetapopt with azacitidine as post-transplant maintenance therapy in TP53 mutant MDS and acute myeloid leukemia (AML) patients who have received an allogeneic stem cell transplant.

A Phase 1 clinical trial in relapsed/refractory TP53 mutant chronic lymphoid leukemia (CLL) assessing eprenetapopt with venetoclax and rituximab, and eprenetapopt with ibrutinib in order to further assess eprenetapopt in hematological malignancies should begin before year-end 2020. A poster describing the clinical trial has been accepted for presentation at the 62nd American Society of Hematology (ASH) Annual Meeting (abstract # 1311) on December 5, 2020 from 10:00 am to 6:30 pm eastern time.

In August 2020 dosed the first patient in the Phase 1/2 clinical trial in relapsed/refractory gastric, bladder and non-small cell lung cancers assessing eprenetapopt with anti-PD-1 therapy.

The Phase 1 CLL (chrnoic lymphoid leukemia) and mantle cell lymphoma trial start is planned for 2H 2020.

The IND for APR-548, next-generation p53 reactivator received clearance from the FDA in October 2020 to initiate Phase 1 clinical trials. The Company anticipates enrollment in the Phase 1 clinical trial to begin in the first quarter of 2021.

Total operating expenses were $12.2 million, consisting of $8.8 million for R&D and $3.5 million for SG&A.

Q&A summary:

No question and answer session.

OpenIcon Analyst Conference Summaries Main Page

Search

More Analyst Conference Pages: