Analyst Conference Summary

biotechnology

release date: May 16, 2022 @1:30 PM
for quarter ending: March 31, 2022 (fourth quarter, Q1)

Forward-looking statements

Overview: On clinical hold.

Basic data (GAAP):

No revenue.

Net income was negative $8.0 million, down sequentially from negative $7.7 million, and up from negative $10.1 year-earlier.

EPS (earnings per share) were negative $0.36, flat sequentially from negative $0.36, and up from negative $0.46 year-earlier.

Guidance:

After the close of the acquisition, cash expected near $48 million, providing a runway through 2H 2023.

Conference Highlights:

Christian Schade, CEO of Aprea, said: "Aprea has explored a range of strategic alternatives to maximize shareholder value and we believe the acquisition of Atrin represents an opportunity to create substantial value for Aprea shareholders. The founders of Atrin are pioneers in the development of novel oncology compounds in the DNA damage pathway. We are excited to work with the Atrin team to begin clinical development of Atrin's lead ATR program over the coming months, hasten the development of its differentiated WEE1 program, and support a robust platform to build a pipeline of novel inhibitors of the DDR pathway." Aprea's knowledge of the p53 pathway in oncology is complimentary to Atrin's expertise in developing novel targets in the DNA damage response pathway.

The transaction completed on May 17, 2022. Christian Slade will be stepping down as CEO, to be replaced by Atrin's Oren Gilad.

The conference focussed on the science of the Atrin preclinical therapies.

At the end of the quarter Aprea had cash and equivalents of $47.6 million.

The acquisition of Atrin was structured as a stock-for-stock transaction. All of Atrin's outstanding equity interests were exchanged for a combination of shares of Aprea common stock and shares of Series A non-voting convertible preferred stock. On a pro forma basis and based upon the number of shares of Aprea common stock and preferred stock issued in the acquisition, holders of Aprea equity holders immediately prior to the acquisition will own approximately 41.2% of Aprea on an as-converted basis and former Atrin equity holders will own approximately 58.8% of Aprea on an as-converted basis. The acquisition was approved by the Board of Directors of Aprea and the Board of Directors and the requisite equity holders of Atrin. The closing of the transactions was not subject to the approval of Aprea stockholders. Each holder of Aprea common stock as of immediately before the closing of the transaction will be entitled to a non-transferable contingent value right (CVR). Holders of the CVR will be entitled to receive certain payments from proceeds received by Aprea, if any, related to the disposition, if any, of its legacy p53 reactivator assets during the 2-year period following the closing of the transaction.

The DNA damage repair inhibitor platform has two programs headed to the clinic: ATRN-119 and ATRN-W1051. The hope is that ATR inhibitors and WEE1 inhibitors will work better than PARP inhibitors. Also, they hope to be better targeted and less-toxic than others in their class.

Believes can get to early clinical data quickly.

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. the FDA also placed a clinical hold on a clinical trial evaluating eprenetapopt in patients with non-Hodgkin lymphomas (NHL), but the clinical hold was lifted in December 2021. As of Q1 2022 Aprea had been planning for new clinical trials in both myeloid and lymphoid malignancies and is continuing to evaluate other development opportunities.

If resources become available, could continue development of eprenetapopt. But for now will focus on Atrin therapies.

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

Q&A summary:

First ATR inhibitor was 20 years ago, how does your differ? The early ones were not specific to ATR, so they had toxicities. Atrin developed very selective compounds, which took a while.

ATR plus chemo? First will combine with a PARP inhibitor, we have the preclinical data for that. It is the standard of care, so low-hanging fruit.

Believes PARP + ATR can address additional mutations and biomarkers.

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