Analyst Conference Summary

biotechnology

release date: August 11, 2020
for quarter ending: June 30, 2020 (second quarter, Q2)

Forward-looking statements

Overview: Clinical-stage company made pipeline progress.

Basic data (GAAP):

No revenue.

Net income was negative 16.4 milion, down from negative $5.3 million year-earlier.

EPS (earnings per share) were negative $0.78, up from negative $4.45 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 "The full enrollment in June of our Phase 3 clinical trial evaluating eprenetapopt (APR-246) with azacitidine for the treatment of front-line TP53 mutant myelodysplastic syndromes (MDS) was a major milestone for Aprea and we look forward to top-line data by year-end 2020. In addition, we continue to advance the clinical development of eprenetapopt in different clinical settings and have recently enrolled the first patient in our solid tumor clinical trial program."

At the end of the quarter Aprea had cash and equivalents of $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 continuing enrollment 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.

The Phase 1 trial evaluating the safety, tolerability, and preliminary efficacy of eprenetapopt therapy in TP53 mutant AML patients continued enrollment. The lead-in portion of the trial evaluated the tolerability of eprenetapopt with venetoclax, with or without azacitidine. No dose-limiting toxicities were observed in patients receiving either regimen. Aprea has expanded the trial to treat approximately 30 additional frontline TP53 mutant AML patients with the combination of eprenetapopt, venetoclax and azacitidine. Plans to activate a separate cohort in the trial to evaluate the combination of eprenetapopt with azacitidine in approximately 30 frontline TP53 mutant AML patients.

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 has been delayed to answer additional questions from the FDA.

Total operating expenses were $14.5 million, consisting of $10.7 million for R&D and $3.8 million for Sg&A. Foreign currency loss $1.9 million.

Q&A summary:

No question and answer session.

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