Apollomics phase 3 trial in China shows no benefit

Published 12/20/2024, 09:06 PM
APLM
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FOSTER CITY, Calif. - Apollomics Inc. (NASDAQ:APLM), a biopharmaceutical company focused on developing oncology drug candidates, has announced the results of its Phase 3 bridging trial of uproleselan in China. The trial, which involved patients with relapsed or refractory acute myeloid leukemia (AML), did not meet its primary endpoint of demonstrating a favorable benefit. The company, which currently maintains a market capitalization of approximately $10.3 million, has seen its stock experience significant volatility, with InvestingPro data showing a 90% decline year-to-date.

The randomized, double-blinded study aimed to assess the safety and efficacy of uproleselan in combination with chemotherapy, compared to chemotherapy alone. A total of 140 subjects were enrolled, with the median overall survival (OS) being 9.3 months for the uproleselan group versus 14.3 months for the chemotherapy-only group. The difference was not statistically significant, with a p-value of 0.48. According to InvestingPro analysis, the company's financial health score is rated as "WEAK," with rapidly depleting cash reserves being a key concern for investors.

Despite the drug being generally well-tolerated and having a safety profile similar to the control arm, Apollomics' CEO, Guo-Liang Yu, Ph.D., expressed disappointment in the trial's outcome. He noted that the results aligned with those of a global Phase 3 trial by their partner, Glycomimetics, which also did not meet its primary endpoint earlier this year.

Given the reliance on positive global Phase 3 trial results for their regulatory and commercial strategy in China, Apollomics is now concluding the uproleselan program. The company has expressed gratitude to patients, families, investigators, and clinical teams involved in the trial. Despite the setback, InvestingPro data indicates the company maintains a healthy current ratio of 2.25, suggesting adequate liquidity to meet its near-term obligations. Subscribers to InvestingPro can access 10 additional key insights about APLM's financial position and market performance.

In August 2024, Apollomics recognized a write-down of the intangible asset related to the upfront payment for the uproleselan program. The company anticipates future expenses for the program to be under $500,000 and plans to present the full trial results at a future medical conference.

Apollomics' lead program is now vebreltinib (APL-101), a c-Met inhibitor currently in a Phase 2 multicohort clinical trial for non-small cell lung cancer and other advanced tumors with c-Met alterations. Based on current market conditions and the company's financial metrics, InvestingPro's Fair Value analysis suggests the stock may be undervalued at current levels, though investors should note the company's significant cash burn rate and absence of profitability in recent quarters.

This news is based on a press release statement from Apollomics Inc.

In other recent news, Apollomics Inc., a clinical-stage biopharmaceutical company, has executed a 1-for-100 reverse share split of its class A ordinary shares. This move was approved by shareholders at an Extraordinary General Meeting and took effect recently on the Nasdaq Stock Market. As a result of the reverse split, every 100 existing class A ordinary shares were consolidated into one new share, increasing the company's authorized share capital from 6,500,000 shares to 130,000,000 shares.

The company also adjusted its warrants in response to the reverse split, with the exercise price for each public warrant now standing at $1,150.00, up from the pre-split price of $11.50. These developments are part of Apollomics' strategic actions to adjust the number of shares outstanding, a common practice among public companies.

In terms of product development, Apollomics' lead program, vebreltinib (APL-101), a c-Met inhibitor, is currently undergoing a Phase 2 multicohort clinical trial for non-small cell lung cancer and other advanced tumors with c-Met alterations. It's important to note that the reverse split does not change the company's market capitalization but may affect stock liquidity and investor perception. These are the latest developments for Apollomics Inc.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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