APOLLOMICS INC.(APLM)
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 Apollomics 宣布听证会取消后继续在 Nasdaq 股票市场上市
 Globenewswire· 2025-10-16 16:28
 Core Points - Apollomics Inc. has successfully appealed a delisting notice from Nasdaq and will continue to be listed on the Nasdaq Stock Market [1] - The company is focused on developing therapies for resistant and refractory cancers, with its lead candidate being vebreltinib (APL-101), a selective c-Met inhibitor [2]   Group 1 - Apollomics Inc. is a late-stage clinical biopharmaceutical company based in California, dedicated to developing various candidate oncology drugs [1] - The Nasdaq listing qualification department has determined that Apollomics meets the requirements for continued listing, leading to the cancellation of the scheduled appeal hearing [1] - The company's securities will continue to trade on the Nasdaq Stock Market [1]   Group 2 - Apollomics is currently conducting Phase II multi-cohort clinical trials for vebreltinib, targeting non-small cell lung cancer and other advanced tumors with c-Met gene alterations [2] - The company aims to explore and develop cancer therapies that leverage the human immune system and target specific molecular pathways [2]
 Apollomics Announces Continued Listing on The Nasdaq Stock Market Following Hearing Cancellation
 Globenewswire· 2025-10-15 18:36
 Core Points - Apollomics Inc. has successfully appealed a delisting notification from Nasdaq, resulting in the cancellation of the scheduled hearing and the continuation of its listing on the Nasdaq Stock Market [1] - The company is focused on developing oncology therapies, particularly its lead program vebreltinib (APL-101), a selective c-Met inhibitor for non-small cell lung cancer [2]   Company Overview - Apollomics Inc. is a clinical-stage biopharmaceutical company based in California, specializing in oncology drug development aimed at treatment-resistant cancers [2] - The lead drug candidate, vebreltinib, is currently undergoing a Phase 2 multicohort clinical trial in the United States and other countries [2]
 Apollomics, Inc. 公司运营持续状态更新
 Globenewswire· 2025-10-15 16:19
 Core Viewpoint - Apollomics Inc. is a clinical-stage biotechnology company focused on developing innovative cancer therapies, particularly for patients with limited treatment options, and is currently advancing its lead candidate APL-101 (vebreltinib) through global clinical trials [1][3].   Group 1: Company Overview - Apollomics has 9 drug candidates in its pipeline, with 6 in clinical development targeting challenging cancers such as lung cancer and brain cancer [1]. - The company employs a strategy that combines targeted therapies, immuno-oncology, and innovative mechanisms of action to overcome resistance and achieve clinically meaningful efficacy [1].   Group 2: Recent Developments - On August 28, 2025, Apollomics announced plans to terminate all clinical trial activities related to APL-101 due to financial issues and sought shareholder approval for liquidation [2]. - Following a PIPE investment of $4.1 million on September 3, 2025, the company appointed a new board and management team, including Howard Chen as CEO and Alex Chen as COO [2].   Group 3: Clinical Trials and Future Plans - After securing additional funding and a new management team, Apollomics canceled its liquidation plans and will continue its existing operations, including the global development of APL-101 [3]. - The company is committed to completing the SPARTA clinical trials for APL-101, which are crucial for maximizing its therapeutic potential across various tumor types and supporting regulatory submissions in major markets [4]. - Apollomics plans to leverage its partnerships in China to advance regulatory submissions for APL-101 in emerging markets outside of Southeast Asia and the Middle East [4].   Group 4: Workforce and Operations - Apollomics currently has 12 full-time employees, with plans to increase the workforce to 15 by October 31, 2025, while also reducing staff in mainland China and reallocating resources to the U.S. and Taiwan [4].
 Nasdaq Resumes Trading in Apollomics Inc.
 Globenewswire· 2025-10-14 20:05
 Core Points - Trading in Apollomics Inc. Class A ordinary shares and warrants will resume on October 15, 2025, at 9:00 a.m. and 9:05 a.m. Eastern Time respectively [1] - Trading was previously halted on September 17, 2025, at 2:37:17 p.m. Eastern Time [1]   Company Information - Apollomics Inc. is listed on the Nasdaq Stock Market under the symbols APLM for Class A ordinary shares and APLMW for warrants [1] - For further information, stakeholders are encouraged to contact the company directly or check the Nasdaq website [2]
 Apollomics, Inc. Company Operational Continuity Update
 Globenewswire· 2025-10-14 01:22
 Core Insights - Apollomics Inc. is a clinical-stage biotechnology company focused on developing innovative oncology therapies, with a pipeline of nine product candidates across 11 programs, including six in clinical development [2] - The company has reversed its plans to wind up operations after securing $4.1 million in PIPE investments and appointing a new management team [4][5] - Apollomics is committed to advancing the global development of APL-101 (vebreltinib) and continuing its clinical trials, particularly the SPARTA trial [5][6]   Company Overview - Apollomics is dedicated to transforming cancer treatment for patients with limited options, targeting challenging cancers such as lung and brain cancer [2] - The company employs a strategic approach that includes targeted therapies and immuno-oncology to enhance clinical outcomes [2]   Recent Developments - On August 28, 2025, Apollomics announced plans to discontinue clinical trials for APL-101 due to financial concerns, but this decision was reversed following new funding [3][5] - The new management team, led by CEO Howard Chen, has initiated communication with clinical research organizations and licensing partners to ensure continuity in operations and trials [5]   Clinical Trials and Future Plans - Apollomics is actively conducting a global Phase 2 trial of APL-101, which has shown positive results in trials involving over 280 patients [2][5] - The company aims to leverage existing approvals for APL-101 in China to pursue regulatory submissions in other regions, including Southeast Asia and the Middle East [6]   Workforce and Operations - Apollomics currently has 12 full-time employees, with plans to increase headcount to 15 by October 31, 2025, while reallocating resources to the U.S. and Taiwan [7]
 Nasdaq Halts Apollomics Inc., Ltd.

 Globenewswire· 2025-09-17 21:48
 Group 1 - Trading in Apollomics Inc., Ltd. was halted on September 17, 2025, at 14:37:17 Eastern Time for additional information requested by Nasdaq [1] - The last sale price of Apollomics' ordinary shares was $18.4331, while the warrants were priced at $0.0191 [1] - Trading will remain halted until Apollomics has fully satisfied Nasdaq's request for additional information [1]
 APOLLOMICS INC.(APLM) - 2024 Q4 - Annual Report
 2025-04-03 20:51
 Financial Performance - For the year ended December 31, 2024, the company reported net losses of $53.9 million and used $28.7 million in net cash for operating activities[46]. - The company anticipates continued net losses and cash outflows for the foreseeable future, with no guarantee of achieving profitability[44]. - As of December 31, 2024, the company had cash and cash equivalents of $9.8 million, estimating sufficient liquidity to continue operations through at least December 31, 2025[47]. - The company has no approved drugs for sale and generates no revenues from product sales, indicating a high level of risk in its business model[50]. - The company has not generated any revenue from developed product sales and may face unforeseen expenses and difficulties that could adversely affect its financial condition and prospects[54].   Product Development and Regulatory Challenges - The company is heavily reliant on the success of vebreltinib, its most advanced product candidate, which requires additional clinical development and regulatory approval[50]. - Clinical trials for product candidates are complex and expensive, with a high risk of failure, impacting the timeline for regulatory approval and commercialization[65]. - The company may need to conduct additional clinical trials if initial results are inconclusive, which could increase development costs and delay market entry[70]. - Regulatory acceptance of foreign clinical trial data is uncertain, as demonstrated by the FDA's previous concerns regarding data collected exclusively in China[69]. - The process of developing and obtaining regulatory approval for product candidates is lengthy, complex, and costly, with no guarantee of success[97].   Strategic Partnerships and Collaborations - The company has entered into a collaboration agreement with LaunXP for the development and commercialization of vebreltinib in Asia, excluding mainland China[51]. - Collaboration relationships with several biotechnology companies are in place, but the company has yet to demonstrate its capability to launch and commercialize product candidates independently[55]. - A recent collaboration with LaunXP may face challenges if GLP and GCP compliance is not met, potentially delaying the development of vebreltinib[148].   Market and Competitive Landscape - The company faces substantial competition from larger pharmaceutical and biotechnology companies, which may have greater resources and expertise[109]. - The introduction of generic drugs and alternative cancer treatments could adversely affect market acceptance and sales of the company's product candidates[112]. - The potential market for product candidates may be limited to patients who are ineligible for established therapies or have failed prior treatments, impacting profitability[102].   Operational and Management Risks - The company has implemented significant expense reductions and narrowed its development focus to prioritize vebreltinib and uproleselan[47]. - The company has recently reduced its workforce to 13 full-time employees as part of cost-cutting measures, which may impact operational management[119]. - Retaining key executives and qualified personnel is critical for the company's success, and any unanticipated departures could adversely affect operations[114]. - The company may face challenges in managing operations effectively due to limited financial resources and changes in employee numbers[120].   Legal and Compliance Risks - The company is currently defending a legal claim in the Grand Court of the Cayman Islands, which may result in substantial costs and resource diversion[121]. - The company faces inherent risks of product liability exposure during human clinical trials, which could lead to civil and administrative liabilities[122]. - Non-compliance with anti-bribery laws could harm the company's reputation and result in significant penalties[203].   Intellectual Property Risks - The company faces risks related to intellectual property rights, including challenges to patent protection that could impact commercialization efforts[226]. - Competitors may develop similar technologies in a non-infringing manner, limiting the effectiveness of the company's patent portfolio[232]. - Changes in patent laws could diminish the value and scope of the company's patents, particularly under the "first-to-file" system adopted in the US and China[233].   Currency and International Operations - The company incurs expenses in currencies other than the U.S. dollar, exposing it to foreign currency exchange risk, particularly with the Renminbi and Australian dollar[133]. - International markets are crucial for growth, but failure to secure licenses or successful collaborations could adversely affect revenue potential[134]. - The PRC government imposes controls on currency conversion, which may delay cash transfers from PRC subsidiaries to the company[204].   Regulatory Environment in China - The company faces risks related to evolving laws and regulations in China, which could materially affect operations and capital raising efforts[207]. - Compliance with evolving cybersecurity and data protection laws in the PRC is critical, as non-compliance could adversely affect business operations[212]. - The implementation of strict labor laws in China may increase operating expenses and limit employment practices[224].
 Apollomics Reports Full Year 2024 Financial Results and Highlights Clinical Updates and Business Progress
 Globenewswire· 2025-04-03 20:05
 Core Viewpoint - Apollomics Inc. reported financial results for the fiscal year ended December 31, 2024, highlighting its focus on developing oncology drug candidates, particularly vebreltinib, and its strategic collaborations to enhance clinical data and market opportunities [1][9].   Financial Results - As of December 31, 2024, Apollomics had $9.8 million in cash and cash equivalents, a decrease from $37.8 million in 2023 [12]. - The net loss for 2024 was $(53.9) million, or $(52.80) per basic and diluted share, compared to a net loss of $(172.6) million, or $(231.99) per share in 2023 [12][20]. - Research and development expenses for 2024 were $24.6 million, down from $34.2 million in 2023 [12][20]. - Administrative expenses decreased to $17.8 million in 2024 from $20.6 million in 2023 [12][20].   Pipeline and Clinical Updates - Apollomics is focusing on vebreltinib (APL-101), a c-Met inhibitor, which has shown a 43% objective response rate in a Phase 2 clinical trial for non-CNS MET fusion solid tumors [6]. - The company announced a strategic collaboration with LaunXP to develop vebreltinib in combination with an EGFR inhibitor, which includes a $10 million upfront payment and potential milestone payments of up to $50 million [5][12]. - New interim data for vebreltinib includes promising results for treating NSCLC with MET amplification and non-CNS solid tumors with MET fusions [5][6].   Business Highlights - Apollomics raised $5.8 million in a private placement in May 2024 [12]. - The company has terminated collaborations with Glycomimetics and TYG Oncology to focus resources on vebreltinib MET amplification [12]. - The strategic focus on vebreltinib aims to address the unmet medical needs of patients with specific c-Met alterations [12].
 Apollomics and LaunXP Announce Development and Commercialization Agreement for Vebreltinib
 Newsfilter· 2025-03-31 12:00
 Core Viewpoint - Apollomics Inc. has entered into a partnership with LaunXP International Co., Ltd. for the development and commercialization of vebreltinib, a c-Met inhibitor, in combination with an EGFR inhibitor for the treatment of non-small cell lung cancer (NSCLC) in Asia, excluding mainland China, Hong Kong, and Macau [1][2][6]   Company Overview - Apollomics Inc. is a late-stage clinical biopharmaceutical company focused on developing oncology drug candidates for difficult-to-treat and treatment-resistant cancers [1][5] - LaunXP Biomedical Co., Ltd. is dedicated to developing innovative cancer therapies and has successfully licensed several drug technologies [7][8]   Partnership Details - The agreement includes an upfront payment of $10 million to Apollomics, with potential regulatory and pre-commercial milestone payments up to $50 million, along with royalties on net product sales [2][6] - LaunXP will be primarily responsible for the development of vebreltinib in combination with an EGFR inhibitor for NSCLC in the designated territory [2][6]   Product Information - Vebreltinib is a potent, small molecule, orally bioavailable, and highly selective c-MET inhibitor that targets the HGF/c-MET axis, which is crucial for tumor growth and resistance to therapies like osimertinib [3][5] - The drug has shown strong tumor inhibitory effects in various preclinical models, including human gastric, hepatic, pancreatic, and lung cancer xenografts [3]   Clinical Development - Vebreltinib is currently under clinical investigation and is not approved for use in any regions outside of China, where it has received conditional approval for multiple indications [4][5]  - The Phase 1/2 SPARTA global clinical trial is ongoing, assessing vebreltinib as a single-agent therapy and in combination with other novel therapies [4]
 Apollomics 公布在中国对复发或难治性急性髓系白血病患者进行的 Uproleselan III 期桥接试验主要结果
 Globenewswire· 2024-12-20 18:13
 Core Insights - Apollomics Inc. announced the results of a Phase III clinical trial for uproleselan, which is aimed at treating acute myeloid leukemia (AML) [1] - The trial showed that uproleselan improved overall survival (OS) compared to the control group, with a median OS of 9.3 months for the uproleselan group versus 14.3 months for the control group [1] - The company plans to submit a New Drug Application (NDA) for uproleselan in August 2024, with estimated costs for the trial reaching $50 million [1]   Group 1: Clinical Trial Results - Uproleselan demonstrated a median overall survival (OS) of 9.3 months in the treatment group compared to 14.3 months in the control group [1] - The trial involved 69 patients in the uproleselan group and 71 in the control group, with a p-value of 0.48 indicating no significant difference in OS [1] - The treatment showed a 43% rate of severe adverse events compared to 39% in the control group [1]   Group 2: Future Plans and Financials - Apollomics plans to submit an NDA for uproleselan by August 2024 [1] - The estimated cost for the clinical trial is projected to be $50 million [1] - The company is actively preparing for the submission and is optimistic about the trial results [1]