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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

Introduction by Dr. Guo Liang Yu

  • 2023 was a year of significant accomplishment with progress in lead candidates vebreltinib and ophthalescelen.
  • Vibratinib (vebreltinib) advanced in phase two trials, with encouraging efficacy and safety profiles.
  • Everstone received conditional approval in China for vibratinib to treat non small cell lung cancer with MET Exon 14 skipping mutation.
  • Completion of enrollment for APL 106 phase three bridging study in China.
  • Transitioned to public company in March 2023 via business combination and NASDAQ listing.

Sanjeev Redkar's Remarks

  • In February 2024, sought FDA feedback in a type C meeting regarding vebreltinib's development for three conditions.
  • Interim results of vebreltinib in non small cell lung cancer with MET Exon 14 skipping mutation showed promising objective response rates.
  • Plans for milestones in 2024-2025 include disclosing preclinical data at AACR meeting, Avistone's phase three study results for APL 106 in Q2 2024, and APL 106 phase three bridging study data in H1 2025.

Matthew Plunkett's Financials

  • Cash, cash equivalents, etc. as of Dec 31, 2023: $37.8 million vs $58.9 million in 2022.
  • 2023 R&D expenses: $34.2 million (including stock-based comp of $5.9 million).
  • 2023 General and administrative expenses: $20.6 million (including stock-based comp of $6.8 million).
  • Net loss for 2023: $172.6 million.
View in transcript ↓

Segment performance

No traditional product segments with revenue contribution discussed. Focus on lead drug candidates: vebreltinib showed promising clinical results in global trials, including interim data from SPARTA and KUNPENG trials; APL 106 phase three bridging study in China for relapsed or refractory acute myeloid leukemia was fully enrolled in December 2023.

View in transcript ↓

Guidance

Guidance

  • Continue enrolling Sparta cohorts and review data for NDA readiness for vebreltinib.
  • Anticipate disclosing preclinical data on vebreltinib at AACR meeting in 2024.
  • Glycomimetics expects top line results from APL 106 phase three study in relapsed/refractory AML in Q2 2024.
  • Apollomics' phase three bridging study in China for APL 106 expects top line data in H1 2025.
View in transcript ↓

Risks

Risks

  • Forward-looking statements subject to risks and uncertainties described in Apollomics' SEC filings, including those in the annual report on Form 20-F, registration statement on Form F1, and other reports.
View in transcript ↓

Q&A highlights

Q: Clarify timing for 12-month follow up and NDA submission.

A: Need to continue enrolling patients, 12-month follow up is approaching, timeline may be shorter than initially thought.

Q: Feedback from FDA meeting and next steps.

A: Continue enrolling patients to specify results, timeline could be 2025 instead of 2026.

Q: CFO's role and impact.

A: Focus on 20-F filing, experience in finance and strategic collaborations.

Q: R&D expense and cash burn.

A: Cash runway through Q1 2025, lower expenses expected in 2024 due to completion of APL 106 phase three trial, and reduced G&A expenses.

Q: Pipeline focus.

A: Focus on vebreltinib and APL 106, limited cash so staying focused on top candidates.

View in transcript ↓

Key numbers

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Transcript

March 28, 2024

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