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Apollomics, Inc.

Apollomics, Inc. Q4 FY2023 earnings call

March 28, 2024 · fiscal period ended 2023-12

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Summary

Generated 2024-03-28

Management highlights

  • 2023 was a year of significant accomplishment with progress in lead drug candidates vebreltinib and ophthalescelen.
  • Substantially advanced phase two registrational trial of vebreltinib in non-small cell lung cancer and other solid tumors with Met dysregulation.
  • Received encouraging feedback from FDA in February 2024 on vebreltinib's development plan for three conditions.
  • Everstone received conditional approval in China for vebreltinib to treat non-small cell lung cancer with MET Exon 14 skipping mutation.
  • Completed patient enrollment for phase three bridging study in China for APL-106 in relapsed or refractory AML.
  • Planned to disclose preclinical data on vebreltinib at AACR meeting in 2024.
  • Glycomimetics expects top line results from phase three study of APL-106 in second quarter of 2024.
View in transcript ↓

Segment performance

No detailed segment performance with revenue contribution % provided. Financials noted: Cash, cash equivalents, etc. at 2023 end was $37.8M vs $58.9M in 2022. R&D expenses 2023 were $34.2M including stock-based comp of $5.9M; G&A expenses $20.6M including stock-based comp of $6.8M. Net loss 2023 was $172.6M.

View in transcript ↓

Guidance

  • Continue enrolling Sparta cohorts and review additional patient information with FDA for NDA readiness.
  • Expect to report top line data from phase three bridging study in APL-106 in first half of 2025.
  • Plan to present preclinical data on vebreltinib at AACR meeting in San Diego next week.
View in transcript ↓

Risks

Forward-looking statements are subject to risks and uncertainties including those described in Apollomics' annual reports and SEC filings.

View in transcript ↓

Q&A highlights

Q: Tim Moore asks about the timeline for enrolling Sparta cohorts and submitting NDA to FDA.

A: Guo Liang Yu responds that they need to continue enrolling more patients, with 12-month follow-up time approaching in summer, but additional patient enrollment could extend the timeline to 2025 rather than 2026.

Q: Tim Moore asks about feedback from FDA meeting and next steps.

A: Guo Liang Yu states FDA's key message is to continue enrolling more patients to specify results.

Q: Tim Moore asks about Matt Plunkett's role and expected enhancements.

A: Matt Plunkett mentions near-term focus on 20-F filing and experience in finance and strategic collaborations.

Q: Tim Moore asks about R&D expenses and cash burn.

A: Response mentions cash position sufficient through first quarter 2025, R&D expenses expected to be affected by completion of APL-106 phase three trial and reduced one-time G&A expenses.

Q: Tim Moore asks about other pipeline candidates.

A: Response states focus remains on vebreltinib and APL-106 due to limited cash.

View in transcript ↓

Key numbers

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Transcript

March 28, 2024

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