Apollomics Releases H1 2024 Financials and Vebreltinib Update

Apollomics Inc., a biopharmaceutical company focused on developing cancer therapies, reported its financial outcomes for the first half of 2024 and provided updates on its drug development programs. The company, headquartered in Foster City, California, is advancing several oncology drug candidates aimed at treating hard-to-treat and resistant cancers.

Dr. Guo-Liang Yu, CEO of Apollomics, highlighted significant progress in their vebreltinib program. The company has revealed promising preliminary data for using vebreltinib to treat tumors characterized by Met dysregulation. This includes new findings for non-CNS solid tumors with Met fusions, as well as updates on non-small cell lung cancer (NSCLC) with MET Exon 14 skipping mutations and MET amplification.

In August 2024, Apollomics shared data from its SPARTA Phase 2 clinical trial involving 14 patients with non-CNS MET fusion solid tumors. The trial showed a 43% objective response rate (ORR) according to RECIST v1.1 criteria, with six confirmed responses: one complete response in second-line metastatic NSCLC and five partial responses across various cancers, including NSCLC, pancreatic cancer, and intrahepatic bile duct cancer. Vebreltinib also showed activity in glioblastoma with PTPRZ1 MET fusions, demonstrating its potential across various tumor types.

Additionally, the company completed an analysis of 38 patients in the SPARTA MET amplification cohorts. The analysis was complicated by discrepancies in MET amplification determination methods, such as blood sequencing, tumor biopsy sequencing, and fluorescent in-situ hybridization (FISH), along with differences in local versus central laboratory testing. Among patients with the highest MET gene copy number (GCN) determined by central sequencing, the ORR was 30%, compared to 13% in the overall dataset. Consequently, Apollomics will now only enroll NSCLC patients with MET amplification confirmed by central FISH testing. The company suggests that MET GCN ≥10 by sequencing may be similar to GCN ≥6 by central FISH testing, a criterion used in previous MET inhibitor clinical trials.

In March 2024, Apollomics provided an updated efficacy analysis for treating NSCLC patients with MET Exon 14 skipping mutations, showing consistent vebreltinib activity. In patients without overlapping c-Met amplification (GCN<4), a pooled analysis from SPARTA and KUNPENG trials revealed a 67% ORR.

However, the company's uproleselan program faced setbacks. In May 2024, GlycoMimetics, Apollomics' licensor for uproleselan in China, announced negative results from its pivotal Phase 3 study in relapsed or refractory acute myeloid leukemia (AML). Given that positive results were crucial for approval in China, Apollomics decided to terminate its Phase 3 bridging study early. This led to a $10 million impairment loss, writing down the full value of its uproleselan intangible asset.

On the business front, Apollomics is strategically prioritizing the treatment of NSCLC patients with MET Amplification. This focus aims to efficiently utilize resources to generate additional clinical data supporting regulatory submissions. The company also announced leadership changes, with Sanjeev Redkar, Ph.D., and Peony Yu, M.D., transitioning to consulting roles while Dr. Redkar remains on the Board of Directors.

Financially, Apollomics raised $5.8 million in a private placement in May 2024. By the end of June 2024, the company had $25.9 million in cash and cash equivalents, down from $37.8 million at the end of December 2023. This cash position is expected to fund operations into the third quarter of 2025.

For the first half of 2024, Apollomics reported research and development expenses of $16.9 million and general and administrative expenses of $10.2 million. The net loss for this period was $35.2 million, or $0.38 per share, which includes a $10 million impairment loss for uproleselan. This is a significant improvement compared to a net loss of $150.7 million, or $2.55 per share, for the same period in 2023.

Apollomics continues to focus on advancing its oncology pipeline, particularly vebreltinib, to address the unmet needs in cancer treatment.

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