Aprea Therapeutics, Inc. — Q1 2023 Form 10-Q
Reporting period: Three months ended March 31, 2023. Aprea is a clinical-stage oncology biotechnology company with no product revenue. Its lead candidate, ATRN-119, targets the ATR DNA-damage-response pathway; development is focused on programs acquired from Atrin.
Financial results and liquidity
| Metric | Q1 2023 | Q1 2022 |
|---|---|---|
| Revenue | None | None |
| Research and development expense | $1.26 million | $4.09 million |
| General and administrative expense | $3.37 million | $3.99 million |
| Total operating expenses | $4.62 million | $8.07 million |
| Net loss | $4.38 million | $7.94 million |
| Net loss per share, basic and diluted | $1.34 | $7.25 |
| Net cash used in operating activities | $2.98 million | $5.50 million |
At March 31, 2023, cash and cash equivalents were $31.00 million, current assets were $32.02 million, total assets were $32.02 million, and total liabilities were $4.23 million. Stockholders’ equity was $26.48 million, with $1.31 million of Series A preferred stock presented separately as temporary equity. The balance sheet reports no debt. Accumulated deficit was $298.18 million. Management expects available cash to fund operations into the third quarter of 2024, subject to assumptions; it says additional financing will be needed.
Changes versus the prior-year quarter
- Net loss narrowed by $3.56 million, while operating expenses fell by $3.45 million. Lower R&D reflected the wind-down of legacy eprenetapopt and APR-548 trials, reduced early-stage and Swedish facility/personnel costs, and lower stock-based compensation; these decreases were partly offset by ATRN-119 trial and ATRN-1051 development costs.
- R&D expense included $0.65 million for ATRN-119 and $0.17 million for ATRN-1051; the ATRN-119 Phase 1/2a trial enrolled its first subject in Q1.
- Operating cash use decreased by $2.52 million. Financing provided $5.14 million net, primarily from a February offering and ATM sales. Cash rose from $28.79 million at year-end to $31.00 million.
- Common shares outstanding increased from 2,655,269 at December 31, 2022 to 3,731,571 at March 31, 2023, largely following the February issuance of 1,050,000 shares. Per-share and share-count data reflect the February 2023 one-for-20 reverse split.
Outlook, risks and other notable items
- Management expected ATRN-119 Phase 1 tolerability and pharmacokinetic data in Q1 2024 and anticipated filing an IND for ATRN-1051 by the end of 2023. These are forward-looking expectations, not assurances.
- The company has no approved products or product revenue and expects continuing losses. Clinical failure, enrollment or regulatory delays, dependence on third parties, and the need to raise additional capital could delay, reduce, or end development programs.
- The filing identifies a single third-party manufacturer for product-candidate API and no redundant supply arrangement. It also states that all cash, cash equivalents, restricted cash, and available-for-sale investments were held with Silicon Valley Bank; investors should assess current custody and concentration, noting the filing gives the March 31 cash balance but does not describe any resulting loss.
- The company’s Form S-3 fundraising capacity is limited by its public float under General Instruction I.B.6. Equity financing may dilute shareholders; management also identifies collaborations, debt, grants, or reduced spending as potential responses to funding needs.
- No material legal proceedings or provision for contingent losses were reported. The filing notes approximately $0.1 million of remaining severance liability from the Swedish facility closure. It reports no off-balance-sheet arrangements and no material effect from inflation in the quarter.
Key facts for investors to verify
- Whether ATRN-119 trial enrollment, safety and pharmacokinetic data, and the projected Q1 2024 readout remain on schedule.
- Progress toward the ATRN-1051 IND filing and the costs and development plans for both programs.
- Whether cash runway remains consistent with management’s third-quarter 2024 estimate, and what financing sources are available given the public-float limitation.
- Current cash custody and bank concentration, and any subsequent changes in the company’s banking arrangements.
- Share-count changes and potential dilution from future offerings, ATM sales, preferred-stock conversion, or other securities.