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Apollomics Inc.
Apollomics Highlights Clinical Progress and Reports Full Year 2023 Financial Results
Business
Mar 28 2024
3 min read

Apollomics Highlights Clinical Progress and Reports Full Year 2023 Financial Results

  • Continued clinical and regulatory progress for the vebreltinib (APL-101) registration-enabling program
  • Completed patient enrollment for the uproleselan (APL-106) Phase 3 bridging study in China – topline data expected in the first half of 2025
  • $37.8 million in cash, cash equivalents and money market funds as of December 31, 2023, with a cash runway through first quarter 2025
  • Management to host conference call today, Thursday, March 28, 2024 at 8:30 a.m. ET

FOSTER CITY, Calif., March 28, 2024 (GLOBE NEWSWIRE) --  Apollomics Inc. (Nasdaq: APLM) (“Apollomics” or the “Company”), a late- stage clinical biopharmaceutical company developing multiple oncology drug candidates to address difficult-to-treat and treatment-resistant cancers, today announced financial results for the full year ended December 31, 2023, and highlighted progress of its pipeline.

“2023 was a year of significant accomplishment as we advanced the vebreltinib registrational program for the treatment of specific patient populations with non-small cell lung cancer (NSCLC) and other solid tumors with MET dysregulation. In addition, we finished patient enrollment for our Phase 3 bridging study in China for uproleselan and made progress in the development of other product candidates,” said Guo-Liang Yu, Ph.D., Chairman and Chief Executive Officer of Apollomics. “We remain on track to generate key clinical data across our pipeline and, given the data to date, are optimistic about the outcomes.”

Pipeline Update

  • Vebreltinib (APL-101) a highly specific cMet inhibitor for the treatment of non-small cell lung cancer (NSCLC) and other solid tumors with cMet dysregulation
    • In February 2024, the Company had a productive meeting with the U.S. Food and Drug Administration (FDA) on clinical data requirements for a potential New Drug Application (NDA) for vebreltinib for the treatment of patients with NSCLC with Met Exon 14 skipping mutation, during which interim results from the SPARTA and KUNPENG studies were included. These results are comprised of 107 NSCLC patients with centrally confirmed Met Exon 14 skipping mutation, including 71 treatment-naïve and 36 previously treated patients with no prior MET inhibitor and no immune checkpoint inhibitor treatment immediately prior to vebreltinib. In the 71 treatment-naïve NSCLC patients with Met Exon 14 skipping mutation (36 from SPARTA and 35 from KUNPENG), the objective response rate (ORR) was 66.2% (95% confidence interval (CI) 54.0, 77.0), supported by median duration of response (mDOR) of 16.5 months (95% CI 9.2, 23.0). In the 36 previously treated patients (19 from SPARTA and 17 from KUNPENG), ORR was 61.1% (95% CI 43.5, 76.9) with mDOR of 16.7 months.
    • An updated efficacy analysis by gene copy number (GCN) subgroup continues to show similar vebreltinib activity in the treatment of NSCLC patients with Met Exon 14 skipping mutation regardless of overlapping Met amplification: in the absence of overlapping c-Met amplification (GCN