Analyst Conference Summary

biotechnology

release date: March 15, 2022 press release only.
for quarter ending: December 31, 2021 (fourth quarter, Q4)

Forward-looking statements

Overview: On clinical hold.

Basic data (GAAP):

No revenue.

Net income was negative $7.7 milion, up equentially from negative $9.7 million, and up from negative $13 year-earlier.

EPS (earnings per share) were negative $0.36, up sequentially from negative $0.45, and up from negative $0.73 year-earlier.

Guidance:

Cash should be adequate into 2023. Full year 2022 cash burn expected between $25 and $30 million.

Conference Highlights:

At the end of the quarter Aprea had cash and equivalents of $53 million.

In December 2021 Aprea discussed with FDA the requested data and analyses from the Phase 3 frontline MDS clinical trial and reached agreement on the company's proposals for new clinical trials in myeloid malignancies. In Q1 2022 received clearance from FDA to proceed under its existing myeloid malignancy IND with a new clinical trial in relapsed/refractory MDS and AML. On August 4, 2021, the FDA had placed a partial clinical hold on the clinical trials of eprenetapopt in combination with azacitidine in the Phase 3 MDS clinical trial, the Phase 2 MDS/AML Post-Transplant trial and the Phase 1/2 AML clinical trial.

In August 2021, FDA also placed a clinical hold on a clinical trial evaluating eprenetapopt in patients with non-Hodgkin lymphomas (NHL). In October 2021, the Company discussed with FDA the requested data and analyses from the Phase 3 frontline MDS clinical trial and proposed amendments for clinical trials to proceed in its lymphoid malignancy program. Following interaction with the FDA, the clinical hold was lifted in December 2021. As of Q1 2022 planning for new clinical trials in both myeloid and lymphoid malignancies and is continuing to evaluate other development opportunities.

Aprea has completed enrollment in its Phase 1/2 clinical trial in relapsed/refractory gastric, bladder and non-small cell lung cancers assessing eprenetapopt with an anti-PD-1 therapy. Planning for a future clinical trial to further evaluate orally-administered eprenetapopt with immunotherapy checkpoint inhibitors.

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. The first dosing cohort was completed in Q1 2022, but Aprea does not plan any additional enrollment.

Total operating expenses were $8 million, consisting of $4 million for R&D and $3 million for SG&A.

Q&A summary:

no conference held

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