APOLLOMICS INC.(APLM)
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 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]
 Apollomics Announces Approval of Vebreltinib in China as a First-in-Class Treatment for Gliomas with MET Fusion Gene
 Newsfilter· 2024-04-25 12:30
Apollomics' partner in China, Avistone, received approval from National Medical Products Administration of China to expand the use of vebreltinib to the treatment of gliomas with PTPRZ1-MET fusion gene Approval based on results from a randomized Phase 2/3 trial  FOSTER CITY, Calif., April 25, 2024 (GLOBE NEWSWIRE) -- Apollomics Inc. (NASDAQ:APLM), a clinical-stage biopharmaceutical company developing multiple oncology drug candidates to address difficult-to-treat and treatment-resistant cancers, today annou ...
 Apollomics Presents Vebreltinib Data at the 2024 American Association for Cancer Research (AACR) Annual Meeting
 Newsfilter· 2024-04-10 11:00
FOSTER CITY, Calif., April 10, 2024 (GLOBE NEWSWIRE) -- Apollomics Inc. ("Apollomics" or the "Company"), a clinical-stage biopharmaceutical company developing medicines to address difficult-to-treat cancers, presented two posters at the 2024 American Association for Cancer Research (AACR) Annual Meeting, held April 5-10, 2024 in San Diego, Calif. Copies of the posters are available on the Apollomics website at ir.apollomicsinc.com/news-events/presentations. "Vebreltinib's selectivity and high in vivo potenc ...
 APOLLOMICS INC.(APLM) - 2023 Q4 - Annual Report
 2024-03-28 20:34
 Oncology Pipeline and Product Candidates - Apollomics has built a pipeline of nine product candidates across 11 programs focusing on oncology, with six candidates currently in the clinical stage[392] - The leading product candidates, vebreltinib (APL-101) and uproleselan (APL-106), are in registration trials and have shown promising initial clinical results[392] - Uproleselan has received breakthrough therapy designation from both the NMPA and FDA for the treatment of relapsed or refractory acute myeloid leukemia (AML), with a global Phase 3 study fully enrolled with 388 patients[401] - Vebreltinib has received conditional approval from the NMPA for the treatment of non-small cell lung cancer (NSCLC) with MET genomic tumor aberrations, and is being investigated in clinical trials for advanced tumors[396] - APL-102 is currently in a Phase 1 dose escalation clinical trial in China, with no dose-limiting toxicity observed as of the latest report[397] - APL-122 is in Phase 1 dose escalation in Australia, targeting ErbB1/2/4 signaling pathways and showing potential to treat brain cancers[398] - Apollomics aims to advance the global development of vebreltinib and other tumor inhibitor candidates to address different c-Met alterations across various tumors[409]   Clinical Trials and Results - Uproleselan has completed Phase 3 enrollment in 388 subjects with r/r AML outside Greater China, with topline results expected in Q2 2024; a bridging Phase 3 study in China has enrolled 140 patients[415] - Vebreltinib has shown a 48% reduction in the risk of death in patients with r/r glioblastoma multiforme compared to the active comparator arm[417] - Among 37 subjects in the Phase 1 trial, the overall objective response rate (ORR) for c-Met overexpression was 35.7%, and the disease control rate (DCR) was 92.9%[433] - In patients with MET amplification and exon 14 skipping, the ORR was 100% and the DCR was also 100%[433] - The ongoing Phase 2 SPARTA study has over 250 subjects enrolled across approximately 90 study sites in more than 10 countries[449] - The primary endpoint of the SPARTA study is objective response rate (ORR) per blinded independent review committee (BIRC) for NSCLC and other solid tumors[450] - Vebreltinib shows an overall response rate (ORR) of 75% in patients with NSCLC harboring Met Exon 14 skipping mutations, with a median duration of response (DOR) of 15.9 months[452]   Safety and Efficacy - The safety profile of vebreltinib showed that 40.5% of patients experienced an increase in ALT, and 35.1% reported peripheral edema[436] - Vebreltinib has been administered to over 500 patients and 170 healthy volunteers, demonstrating an acceptable safety profile[430] - The drug concentration in cerebrospinal fluid (CSF) was about 5% of the steady-state plasma concentration, indicating effective central nervous system penetration[440] - The addition of uproleselan was associated with lower than expected rates of severe Grade 3–4 mucositis, reported at 3% compared to a historical incidence of 20–25%[509]   Market Opportunities and Projections - The incidence of AML in China was 26,900 in 2019, projected to rise to 29,000 by 2024 and 31,400 by 2030[415] - Global incidence of NSCLC is projected to increase from 1.0 million cases in 2019 to 1.3 million by 2030, with the U.S. incidence expected to rise from approximately 178,300 cases in 2019 to 221,200 in 2030[478] - The market size for single-targeted c-Met inhibitors in NSCLC is expected to grow to $1.5 billion by 2025 and $3.1 billion by 2030, representing a CAGR of 14.8% from 2025[479] - Approximately 34% of GBM patients exhibit c-Met dysregulation, indicating a significant market opportunity for targeted therapies[481]   Collaborations and Agreements - The company entered into a collaboration agreement with GlycoMimetics for the development and commercialization of uproleselan and APL-108 in Greater China[559] - GlycoMimetics received an upfront cash payment of $9.0 million and is eligible for up to approximately $180.0 million based on specified development, regulatory, and commercial milestones[563] - The company has exclusive rights to APL-501 outside of China, with Genor holding the rights within China[548] - The company has obtained development and commercialization rights for vebreltinib, APL-501, APL-502, and APL-102 outside of China, Hong Kong, and Macau[540]   Research and Development Focus - The company focuses on developing novel therapies for difficult-to-treat cancers, aiming to improve response rates and reduce treatment resistance and toxicity[392] - The company is committed to leveraging its R&D capabilities to enrich its oncology-focused early-stage pipeline through internal discovery and collaborations[411] - Drug discovery research targets next-generation cancer therapies focusing on the immunosuppressive tumor microenvironment (TME)[586] - The company aims to improve cure rates for various cancers by engaging the immune system in a coordinated, personalized approach[586]
 APOLLOMICS INC.(APLM) - 2023 Q4 - Earnings Call Transcript
 2024-03-28 19:57
Apollomics, Inc. (NASDAQ:APLM) Q4 2023 Earnings Conference Call March 28, 2024 8:00 AM ET Company Participants Guo Liang Yu - Chairman and Chief Executive Officer Sanjeev Redkar - Co-founder, Executive Director and President Matthew Plunkett - Chief Financial Officer Conference Call Participants Tim Moore - EF Hutton Operator Good morning ladies and gentlemen. Welcome to the Apollomics Full Year 2023 Results Conference Call. Before we begin, we want to advise you that over the course of the call and questio ...