Analyst Conference Summary

biotechnology

release date: November 8, 2021 press release only.
for quarter ending: September 30, 2021 (third quarter, Q3)

Forward-looking statements

Overview: On clinical hold.

Basic data (GAAP):

No revenue.

Net income was negative $9.7 milion, sequentially from negative $na million, and up from negative $12.5 year-earlier.

EPS (earnings per share) were negative $0.45, sequentially from negative $na, and up from negative $0.58 year-earlier.

Guidance:

Cash should be adequate into 2023.

Conference Highlights:

Christian S. Schade, is CEO of Aprea. ""

At the end of the quarter Aprea had cash and equivalents of $61 million.

More data from programs will be presented at ASH.

On August 4, 2021, the FDA placed a partial clinical hold on the clinical trials of eprenetapopt in combination with azacitidine in our Phase 3 MDS clinical trial, our Phase 2 MDS/AML Post-Transplant trial and our Phase 1/2 AML clinical trial. Concerns referred to the safety and efficacy data from the Phase 3 frontline MDS clinical trial. They requested more information related to a potential risk-reward imbalance between the combination of eprenetapopt and azacitidine versus azacitidine alone. No additional patients will be enrolled until the partial clinical hold is resolved. Aprea intends to work with the FDA to analyze the data and resolve the partial clinical hold.

In Q1 2021 announced the pivotal Phase 3 randomized, controlled trial evaluating eprenetapopt with azacitidine as frontline therapy in HMA-naive TP53 mutant myelodysplastic syndromes (MDS) patients failed to meet its prespecified complete response rate. Active arm CR was 53% higher than control arm, but that did not reach statistical significance. More detailed data will be released in Q2 2021.

A Phase 1/2 clinical trial of eprenetapopt therapy in TP53 mutant AML patients is currently enrolling. The lead-in portion of the trial evaluated the tolerability of eprenetapopt with venetoclax, with or without azacitidine, and no dose-limiting toxicities were observed in 12 patients receiving either regimen. So expanded the trial to treat 33 additional frontline TP53 mutant AML patients with the combination of eprenetapopt, venetoclax and azacitidine. In the 19 frontline AML patients who are evaluable for efficacy with the triplet regimen, achieved 63% CR + CRi composite response rate and a 31% CR rate. In Q2 should complete enrollment and report data from the expansion cohort.

Data from the Phase 1/2 clinical trial in relapsed/refractory gastric, bladder and non-small cell lung cancers assessing eprenetapopt with anti-PD-1 therapy was presented at ESMO 2021. In the bladder/urothelial cohort, one patient with localized TP53 mutant high-grade transitional cell bladder cancer had achieved complete remission (CR) by RECIST criteria at the first response assessment at 9 weeks. In the NSCLC cohort, two patients with TP53 mutant squamous NSCLC had reductions in target lesions of 26.7% and 8.2%, respectively, from baseline by RECIST criteria at the first response assessment at 9 weeks.

The Phase 1 CLL (chronic lymphoid leukemia) and mantle cell lymphoma trial is also on hold.

APR-548 is a next-generation p53 reactivator that is being developed in an oral dosage form. A Phase 1 dose-escalation clinical trial evaluating the safety, tolerability, and preliminary efficacy of APR-548 with azacitidine in frontline and relapsed/refractory MDS patients began enrollment in Q3 2021.

Total operating expenses were $9.4 million, consisting of $6.0 million for R&D and $3.4 million for SG&A.

Q&A summary:

no conference held

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