APOLLOMICS INC.(APLM)

Search documents
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]
Apollomics Announces Top-line Results for Phase 3 Bridging Trial of Uproleselan in China in Patients with Relapsed or Refractory Acute Myeloid Leukemia
GlobeNewswire· 2024-12-20 13:00
Core Insights - The Phase 3 trial of uproleselan in patients with relapsed or refractory acute myeloid leukemia did not demonstrate a favorable clinical benefit compared to chemotherapy alone, with median overall survival of 9.3 months versus 14.3 months [1][7] - Apollomics announced a write-down of the intangible asset related to the uproleselan program and expects future expenses for this program to be less than $500,000 [2] Company Overview - Apollomics Inc. is a late-stage clinical biopharmaceutical company focused on developing oncology drug candidates for difficult-to-treat cancers [7][9] - The company's lead program is vebreltinib (APL-101), a selective c-Met inhibitor currently in a Phase 2 clinical trial across multiple countries [9]
Apollomics to Present at the H.C. Wainwright 26th Annual Global Investment Conference
GlobeNewswire News Room· 2024-09-04 20:05
Group 1 - Apollomics Inc. is a late-stage clinical biopharmaceutical company focused on developing oncology drug candidates for difficult-to-treat and treatment-resistant cancers [1][2] - The company will present at the H.C. Wainwright 26th Annual Global Investment Conference from September 9-11, 2024, with a presentation available on demand starting September 9, 2024, at 7:00 am ET [1] - Key presenters include Guo-Liang Yu, PhD, Chairman and CEO, and Matthew Plunkett, PhD, CFO, with opportunities for virtual one-on-one meetings for interested investors [1] Group 2 - Apollomics' lead product candidate is vebreltinib, a selective c-Met inhibitor for non-small cell lung cancer, currently in a Phase 2 multicohort global clinical trial [2] - The company is also developing uproleselan, an E-Selectin antagonist, which is in a Phase 3 clinical trial in China for treating acute myeloid leukemia and other hematologic cancers [2]
APOLLOMICS INC.(APLM) - 2024 Q2 - Quarterly Report
2024-08-14 21:05
Financial Performance - Loss before taxation for the six months ended June 30, 2024, was $35,206,000, compared to a loss of $150,684,000 for the same period in 2023, indicating a significant improvement[6] - Basic and diluted loss per common share improved from $(2.55) in 2023 to $(0.38) in 2024[6] - For the six months ended June 30, 2024, Apollomics reported a loss of $35,206,000, compared to a loss of $150,694,000 for the same period in 2023[31] - Other income for the six months ended June 30, 2024, was $1,737,000, compared to $401,000 in the same period of 2023[27] - The company generated no revenue during the six months ended June 30, 2023, and 2024[26] Assets and Liabilities - Total assets decreased from $55,387,000 as of December 31, 2023, to $34,573,000 as of June 30, 2024, representing a decline of approximately 37.5%[4] - Current assets decreased from $39,925,000 to $28,412,000, a reduction of about 29.0%[4] - Total equity decreased from $41,234,000 to $20,807,000, reflecting a decline of approximately 49.6%[4] - Non-current liabilities increased from $597,000 to $1,117,000, an increase of approximately 87.5%[4] - Total non-current assets decreased from $15,462,000 to $6,161,000, a reduction of approximately 60.1%[4] - Cash and cash equivalents decreased from $32,056,000 to $25,929,000, a decline of about 19.1%[4] - Cash and cash equivalents at the end of the period were $25,929 thousand, compared to $25,296 thousand at the end of June 2023[9] - As of June 30, 2024, the company's total intangible assets had a net book value of $4.7 million, down from $14.8 million as of December 31, 2023[34] Cash Flow and Operating Activities - Operating cash flows before movements in working capital improved to $(16,932) thousand from $(22,499) thousand year-over-year[9] - Net cash used in operating activities decreased to $(15,988) thousand compared to $(24,397) thousand in the previous year[9] - The company recognized an impairment loss on intangible assets amounting to $10,000 thousand during the six months ended June 30, 2024[9] Shareholder Information - The total number of shares issued to PIPE investors, net of transaction costs, was 19,166,666 shares[9] - Apollomics has a total of 57,994,911 post-closing ordinary shares outstanding as a result of the Business Combination and PIPE Financing[23] - The company issued 19,166,666 Class A Ordinary Shares to PIPE investors as of January 1, 2024[43] - As of June 30, 2024, the company had 109,970,348 issued and fully paid ordinary shares[43] Expenses and Compensation - Research and development expenses were $16,926,000 for the six months ended June 30, 2024, compared to $16,518,000 in 2023, showing a slight increase[6] - The company reported a share-based payment expense of $8,224 thousand for the six months ended June 30, 2024, up from $5,282 thousand in the same period last year[9] - The total staff costs for the six months ended June 30, 2024, amounted to $13,190,000, an increase from $10,748,000 in the prior year[29] - Key management personnel remuneration increased to $5.8 million for the six months ended June 30, 2024, from $4.3 million for the same period in 2023, reflecting higher share-based payments[64] Strategic Developments - Apollomics has a pipeline of nine drug candidates across 11 programs, with six candidates currently in the clinical stage[1] - The company announced a strategic focus on the clinical development of vebreltinib for NSCLC patients with MET amplification as of July 3, 2024[66] - The company will require additional capital from equity, debt, or strategic partnerships to continue as a going concern in the future[14] Business Combination and Financing - The company completed a business combination with Maxpro Capital Acquisition Corp. on March 29, 2023, resulting in the issuance of 28,800,926 Class B Ordinary Shares[20] - The net proceeds from the PIPE Financing and Business Combination totaled $20.2 million[22] - Maxpro's stockholders redeemed 10,270,060 out of 10,350,000 public shares available, representing 99.2% of Maxpro's public float, leading to nominal cash received by Apollomics[22] Share-Based Payments - The total expense recognized for restricted share awards was $1.9 million for the six months ended June 30, 2024, compared to $39 thousand for the same period in 2023, indicating a significant increase[51] - The total expense recognized for share options granted was $8.2 million for the six months ended June 30, 2024, compared to $5.3 million for the same period in 2023, showing an increase of approximately 55%[57] - The number of share options outstanding as of June 30, 2024 was 24,166,868, with a weighted-average exercise price of $2.575, compared to 12,708,781 options with a weighted-average exercise price of $4.704 as of June 30, 2023[54] Other Financial Information - The company had no financial assets at fair value through profit or loss (FVTPL) as of June 30, 2024[36] - Other payables and accruals totaled $8,877,000 as of June 30, 2024, a slight decrease from $9,162,000 as of December 31, 2023[39] - The company did not grant any share appreciation rights or restricted share unit awards during the six months ended June 30, 2023, and 2024[50]
Apollomics Reports First Half 2024 Financial Results and Highlights Vebreltinib Clinical Progress
GlobeNewswire News Room· 2024-08-14 10:00
Core Insights - Apollomics Inc. reported continued clinical progress for its vebreltinib program, focusing on treatment for non-CNS MET fusion tumors and non-small cell lung cancer (NSCLC) with MET amplification [1][2] - The company has $25.9 million in cash and cash equivalents as of June 30, 2024, providing a cash runway into the third quarter of 2025 [1][8] Pipeline Update - Vebreltinib (APL-101) achieved a 43% objective response rate (ORR) in a Phase 2 trial involving 14 patients with non-CNS MET fusion solid tumors, including six confirmed responses [3] - In the SPARTA MET amplification cohorts, an ORR of 30% was observed among patients with the highest MET gene copy number, while the overall dataset showed a 13% ORR [3] - A pooled analysis of NSCLC patients with Met Exon 14 skipping mutations indicated an ORR of 67% [3] Business Highlights - Apollomics has strategically prioritized the treatment of NSCLC patients with MET amplification to address unmet medical needs [6] - Leadership changes occurred with the departure of co-founder Sanjeev Redkar and former Chief Medical Officer Peony Yu, transitioning to consulting roles [6] - The company raised $5.8 million in a private placement in May 2024 [7] Financial Results - As of June 30, 2024, cash and cash equivalents decreased from $37.8 million at the end of 2023 to $25.9 million [8] - Research and development expenses for the first half of 2024 were $16.9 million, compared to $16.5 million in the same period of 2023 [8] - The net loss for the first half of 2024 was $(35.2) million, significantly reduced from $(150.7) million in the first half of 2023 [9][18]
Apollomics Granted 180-Day Extension to Regain Compliance with Nasdaq Minimum Bid Price Requirement
Newsfilter· 2024-07-16 20:47
Core Points - Apollomics Inc. has received a 180-day extension from Nasdaq to regain compliance with the minimum bid price requirement of $1.00 per share, with a new deadline set for January 13, 2025 [1][2] - The company had previously been notified on January 16, 2024, that it was not in compliance due to its Ordinary Shares closing bid price being below $1.00 for 30 consecutive business days [1][2] - If the closing bid price reaches at least $1.00 for ten consecutive business days before the deadline, Nasdaq will confirm compliance [2] - The company is actively monitoring its share prices and evaluating options to regain compliance, but there is no assurance of success [3] Company Overview - Apollomics Inc. is a late-stage clinical biopharmaceutical company focused on developing oncology therapies for difficult-to-treat and treatment-resistant cancers [1][4] - The company's lead product, vebreltinib (APL-101), is a selective c-Met inhibitor currently in a Phase 2 clinical trial for non-small cell lung cancer and other advanced tumors [4] - Another key product, uproleselan (APL-106), is an E-Selectin antagonist in Phase 1 and Phase 3 trials for acute myeloid leukemia and other hematologic cancers [4]
Apollomics Granted 180-Day Extension to Regain Compliance with Nasdaq Minimum Bid Price Requirement
GlobeNewswire News Room· 2024-07-16 20:47
Core Points - Apollomics Inc. has received a 180-day extension from Nasdaq to regain compliance with the minimum bid price requirement for its Class A ordinary shares, which must be at least $1.00 per share [1][2] - The extension allows the company until January 13, 2025, to meet the compliance requirement, with the possibility of delisting if it fails to do so [2][3] - The company is actively monitoring its share prices and evaluating options to regain compliance, although there is no guarantee of success [3] Company Overview - Apollomics Inc. is a late-stage clinical biopharmaceutical company focused on developing oncology therapies for difficult-to-treat and treatment-resistant cancers [1][4] - The company's lead product, vebreltinib (APL-101), is a selective c-Met inhibitor currently in Phase 2 trials for non-small cell lung cancer and other advanced tumors [4] - Another key product, uproleselan (APL-106), is an E-Selectin antagonist in Phase 1 and Phase 3 trials for acute myeloid leukemia and other hematologic cancers [4]