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Earnings documents stored for APLM.
Investor releaseQuarter not tagged2026-04-27Apollomics Reports Full Year 2025 Financial Results and Provides Clinical Updates and Business Progress
GlobeNewswire
Apollomics Reports Full Year 2025 Financial Results and Provides Clinical Updates and Business Progress
Phase 2 studies ongoing to advance global development of vebreltinib, a highly potent, de-risked and differentiated c-MET Inhibitor with best-in-class and first-in-class potential. To date, more than 600 patients and 170 healthy volunteers have been dosed with vebreltinib in clinical trials. Phase 2/3 IND submission for development of vebreltinib in combination with an EGFR inhibitor in the U.S. and select Asian countries for the treatment of NSCLC. FOSTER CITY, Calif., April 27, 2026 (GLOBE NEWSWIRE) -- Apollomics Inc. (Nasdaq: APLM), a clinical-stage biopharmaceutical company advancing innovative oncology therapies to transform the treatment landscape for patients with few or no options, today announced financial results for the full year ended December 31, 2025. “Our primary focus is to advance the global development of vebreltinib for the treatment of patients with c-MET alterations across different tumors,” said Hung-wen (Howard) Chen, Chief Executive Officer of Apollomics. “Based on guidance from the U.S. Food and Drug Administration (FDA), we anticipate submitting an Investigational New Drug Application for accelerated approval of vebreltinib for second-line treatment for non-small cell lung cancer (NSCLC) patients with c-MET amplification in the first half of 2027.” Pipeline Update Vebreltinib (APL-101) – a highly specific, CNS-penetrant c-MET inhibitor for treating NSCLC, brain tumors, and other solid tumors with MET dysregulation. It also shows significant potential in combination regimens, particularly with EGFR inhibitors. The China rights of APL-101 were out-licensed to Apollomics’ partner, Beijing Avistone Biotechnology Co., Ltd., while Apollomics retains the global (ex-China) rights. Vebreltinib has been approved by China’s National Medical Products Administration (NMPA) for three distinct indications: METex14 skipping NSCLC, MET-amplified NSCLC, and PTPRZ1-MET fusion high-grade gliomas. Notably, it is the first c-MET inhibitor approved for the latter two conditions. The Company is advancing global development of vebreltinib, prioritizing NSCLC with c-MET amplification while expanding its application across diverse MET alterations and tumor types. Simultaneously, the Company is investigating strategic combinations with other tumor inhibitors to fully maximize vebreltinib’s therapeutic potential. The Phase 2 component of the SPARTA clinical stu…Read full documentShow less
Phase 2 studies ongoing to advance global development of vebreltinib, a highly potent, de-risked and differentiated c-MET Inhibitor with best-in-class and first-in-class potential. To date, more than 600 patients and 170 healthy volunteers have been dosed with vebreltinib in clinical trials. Phase 2/3 IND submission for development of vebreltinib in combination with an EGFR inhibitor in the U.S. and select Asian countries for the treatment of NSCLC. FOSTER CITY, Calif., April 27, 2026 (GLOBE NEWSWIRE) -- Apollomics Inc. (Nasdaq: APLM), a clinical-stage biopharmaceutical company advancing innovative oncology therapies to transform the treatment landscape for patients with few or no options, today announced financial results for the full year ended December 31, 2025. “Our primary focus is to advance the global development of vebreltinib for the treatment of patients with c-MET alterations across different tumors,” said Hung-wen (Howard) Chen, Chief Executive Officer of Apollomics. “Based on guidance from the U.S. Food and Drug Administration (FDA), we anticipate submitting an Investigational New Drug Application for accelerated approval of vebreltinib for second-line treatment for non-small cell lung cancer (NSCLC) patients with c-MET amplification in the first half of 2027.” Pipeline Update Vebreltinib (APL-101) – a highly specific, CNS-penetrant c-MET inhibitor for treating NSCLC, brain tumors, and other solid tumors with MET dysregulation. It also shows significant potential in combination regimens, particularly with EGFR inhibitors. The China rights of APL-101 were out-licensed to Apollomics’ partner, Beijing Avistone Biotechnology Co., Ltd., while Apollomics retains the global (ex-China) rights. Vebreltinib has been approved by China’s National Medical Products Administration (NMPA) for three distinct indications: METex14 skipping NSCLC, MET-amplified NSCLC, and PTPRZ1-MET fusion high-grade gliomas. Notably, it is the first c-MET inhibitor approved for the latter two conditions. The Company is advancing global development of vebreltinib, prioritizing NSCLC with c-MET amplification while expanding its application across diverse MET alterations and tumor types. Simultaneously, the Company is investigating strategic combinations with other tumor inhibitors to fully maximize vebreltinib’s therapeutic potential. The Phase 2 component of the SPARTA clinical study, APL-101-01, is an ongoing open-label multi-cohort study for evaluation of efficacy and safety of vebreltinib for the treatment of a number of solid tumors, including NSCLC with MET Exon 14 skipping, NSCLC with c-MET amplification, brain tumors with MET fusion or MET amplification and other solid tumors with MET amplification or MET fusion. Apollomics is currently conducting the ongoing Phase 2 portion of the global SPARTA study at approximately 25 study sites in over 10 countries in North America, Europe and Asia-Pacific. As of April 2026, over 282 subjects have enrolled in the SPARTA study. Interim efficacy and safety data from the global multi-cohort Phase 2 SPARTA trial and from the multi-cohort Phase 2 KUNPENG trial demonstrated that vebreltinib appeared efficacious in NSCLC patients with MET Exon14 skipping mutation with or without co-occurring MET amplification. In March 2025, the Company announced a development and commercialization agreement for vebreltinib with LaunXP International Co., Ltd., an affiliate of LaunXP Biomedical Co., Ltd (Collectively, “LaunXP”). LaunXP will receive exclusive development and commercialization rights for vebreltinib in combination with an EGFR inhibitor in Asia (excluding mainland China, Hong Kong and Macau) for the treatment of NSCLC. Apollomics is committed to expanding its clinical pipeline through ongoing collaborations with global partners. These efforts will focus on investigating new combination therapies that maximize vebreltinib’s efficacy, ensuring the asset’s potential is fully realized across diverse patient populations. Immuno-Oncology Product Candidates APL-501 (Anti-PD-1 antibody): APL-501 is an investigational, humanized, IgG4 monoclonal antibody that selectively binds to PD-1 on T lymphocytes and other immune cells. The China rights of APL-501 were out-licensed to Apollomics’ partner, Edding Genor Group Holdings Ltd., while Apollomics retains the global (ex-China) rights. Data from a Phase 1 study in advanced or relapsed/refractory solid tumors in Australia are currently being analyzed. APL-502 (benmelstobart, anti-PD-L1 antibody): APL-502 is a novel IgG1 humanized monoclonal antibody against PD-L1. The China rights of APL-502 were out-licensed to Apollomics’ partner, Chia Tai-Tianqing Pharmaceutical Holdings Co., Ltd. (CTTQ), while Apollomics retains the global (ex-China) rights. APL-502 (also known as TQB-2450 in China) has been approved by China’s NMPA for three distinct indications: extensive-stage small cell lung cancer, recurrent/metastatic endometrial cancer, and late-stage unresectable or metastatic renal cell carcinoma. Ongoing clinical trials include the following tumor types: NSCLC, esophageal cancer, ovarian cancer, hepatocellular carcinoma, cholangiocarcinoma, primary mediastinal large B cell lymphoma, and alveolar soft part sarcoma. Business Highlights New senior management team: In September 2025, Apollomics appointed a new management team, led by Hung-wen (Howard) Chen, Chief Executive Officer, and Yi-kuei (Alex) Chen, Chief Operating Officer, and Peter Lin, Chief Financial Officer. Positive Turnaround Developments: With the appointment of a new board of directors and management team, the Company has made meaningful progress executing its strategic turnaround plan. In 2025, the Company successfully implemented significant cost reduction initiatives to streamline operations and enhance financial discipline. In parallel, Apollomics has strengthened its financial and legal position through the resolution of legacy matters, including the settlement of the Cayman litigation in November 2025, and the clearance of substantial outstanding legal and clinical program-related obligations. Furthermore, Apollomics has a renewed commitment to advancing its pipeline, including the relaunch of a previously paused clinical program for vebreltinib. Full Year 2025 Financial Results Cash, cash equivalents, bank deposits and money market funds as of December 31, 2025, were approximately $3.3 million, compared with $9.8 million as of December 31, 2024. In September 2025, the Company raised $4.1 million in a private investment in public equity (PIPE) financing, before transaction expenses. Revenue for the full year 2025 was $8.5 million compared to $0 for full year 2024. Revenue in 2025 is a result of the upfront payment related to the LaunXP licensing agreement for the development and commercialization in Asia (excluding mainland China, Hong Kong and Macau) of vebreltinib. Research and development expenses were approximately $5.5 million for full year 2025, compared to approximately $24.6 million for full year 2024. General and administrative expenses were approximately $12.4 million for full year 2025, compared to approximately $17.8 million for full year 2024. Net loss for the full year 2025 was $(10.9) million, or $(7.57) per diluted share, compared with a net loss of $(53.9) million, or $(52.80) per diluted share, for the full year 2024. As part of its strategic turnaround plan, Apollomics significantly reduced costs and expenses in 2025 compared to the previous year. For the full year 2025, operating expenses were $19.8 million compared to $55.7 million for the prior year, representing a 64% decrease year-over-year. About Apollomics Inc. Apollomics Inc. is an innovative clinical-stage biopharmaceutical company focused on the discovery and development of oncology therapies with the potential to be combined with other treatment options to harness the immune system and target specific molecular pathways to inhibit cancer. Apollomics’ lead program is vebreltinib (APL-101), a potent, selective c-MET inhibitor for the treatment of non-small cell lung cancer and other advanced tumors with c-MET alterations, which is currently in a Phase 2 multicohort clinical trial in the United States and other countries. For more information, please visit http://www.apollomicsinc.com. Cautionary Statement Regarding Forward-Looking Statements This press release includes statements that constitute “forward-looking statements” within the meaning of the federal securities laws, including Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements, other than statements of present or historical fact included in this press release, regarding Apollomics’ strategy, prospects, plans, objectives and anticipated outcomes from the development and commercialization of vebreltinib are forward-looking statements. When used in this press release, the words “could,” “should,” “will,” “may,” “believe,” “anticipate,” “intend,” “estimate,” “expect,” “seek,” “project,” the negative of such terms and other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain such identifying words. These forward-looking statements are based on management’s current expectations and assumptions about future events and are based on currently available information as to the outcome and timing of future events. In addition, Apollomics cautions you that the forward-looking statements contained in this press release are subject to unknown risks, uncertainties and other factors, including those risks and uncertainties discussed in the Annual Report on Form 20-F for the year ended December 31, 2025, filed by Apollomics Inc. with the U.S. Securities and Exchange Commission (“SEC”) under the heading “Risk Factors” and the other documents filed, or to be filed, by Apollomics with the SEC. Additional information concerning these and other factors that may impact the operations and projections discussed herein can be found in the reports that Apollomics has filed and will file from time to time with the SEC. Forward-looking statements speak only as of the date made by Apollomics. Apollomics undertakes no obligation to update publicly any of its forward-looking statements to reflect actual results, new information or future events, changes in assumptions or changes in other factors affecting forward-looking statements, except to the extent required by applicable law. Investor Contacts Peter Lin, Chief Financial Officer Apollomics, Inc. 1-650-209-4055 [email protected] Peter Vozzo ICR Healthcare [email protected] 1-443-213-0505
Investor releaseQuarter not tagged2025-12-23Apollomics Reports First Half 2025 Financial Results
GlobeNewswire
Apollomics Reports First Half 2025 Financial Results
FOSTER CITY, Calif., Dec. 22, 2025 (GLOBE NEWSWIRE) -- Apollomics Inc. (Nasdaq: APLM) (“Apollomics” or the “Company”), a late-stage clinical biopharmaceutical company developing multiple oncology drug candidates to address difficult-to-treat and treatment-resistant cancers, today announced financial results for the first half of 2025 ended June 30, 2025. First Half 2025 Financial Results Ended June 20, 2025 Cash, cash equivalents, bank deposits and money market funds as of June 30, 2025, were $2.1 million, compared to $9.8 million as of December 31, 2024. Based on current projections, the Company believes its cash position is sufficient to fund planned operations into the third quarter of 2026. Research and development (R&D) expenses were $4.6 million, including share-based compensation of $0.8 million, for the first half of 2025, compared to $16.9 million, including share-based compensation of $3.7 million, for the first half of 2024. General and administrative (G&A) expenses were $14.5 million, including share-based compensation of $2.5 million, for the first half of 2025, compared to $10.2 million, including share-based compensation of $4.5 million, for the first half of 2024. Net loss for the first half of 2025 was $(12.5) million, or $(11.37) per basic and diluted share, compared to a net loss of $(35.2) million, or $(37.53) per basic and diluted share, for the first half of 2024. About Apollomics Inc. Apollomics Inc. is an innovative clinical-stage biopharmaceutical company focused on the discovery and development of oncology therapies with the potential to be combined with other treatment options to harness the immune system and target specific molecular pathways to inhibit cancer. Apollomics’ lead program is vebreltinib (APL-101), a potent, selective c-Met inhibitor for the treatment of non-small cell lung cancer and other advanced tumors with c-Met alterations, which is currently in a Phase 2 multicohort clinical trial in the United States and other countries. For more information, please visit www.apollomicsinc.com. Cautionary Statement Regarding Forward-Looking Statements This press release includes statements that constitute “forward-looking statements” within the meaning of the federal securities laws, including Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, a…Read full documentShow less
FOSTER CITY, Calif., Dec. 22, 2025 (GLOBE NEWSWIRE) -- Apollomics Inc. (Nasdaq: APLM) (“Apollomics” or the “Company”), a late-stage clinical biopharmaceutical company developing multiple oncology drug candidates to address difficult-to-treat and treatment-resistant cancers, today announced financial results for the first half of 2025 ended June 30, 2025. First Half 2025 Financial Results Ended June 20, 2025 Cash, cash equivalents, bank deposits and money market funds as of June 30, 2025, were $2.1 million, compared to $9.8 million as of December 31, 2024. Based on current projections, the Company believes its cash position is sufficient to fund planned operations into the third quarter of 2026. Research and development (R&D) expenses were $4.6 million, including share-based compensation of $0.8 million, for the first half of 2025, compared to $16.9 million, including share-based compensation of $3.7 million, for the first half of 2024. General and administrative (G&A) expenses were $14.5 million, including share-based compensation of $2.5 million, for the first half of 2025, compared to $10.2 million, including share-based compensation of $4.5 million, for the first half of 2024. Net loss for the first half of 2025 was $(12.5) million, or $(11.37) per basic and diluted share, compared to a net loss of $(35.2) million, or $(37.53) per basic and diluted share, for the first half of 2024. About Apollomics Inc. Apollomics Inc. is an innovative clinical-stage biopharmaceutical company focused on the discovery and development of oncology therapies with the potential to be combined with other treatment options to harness the immune system and target specific molecular pathways to inhibit cancer. Apollomics’ lead program is vebreltinib (APL-101), a potent, selective c-Met inhibitor for the treatment of non-small cell lung cancer and other advanced tumors with c-Met alterations, which is currently in a Phase 2 multicohort clinical trial in the United States and other countries. For more information, please visit www.apollomicsinc.com. Cautionary Statement Regarding Forward-Looking Statements This press release includes statements that constitute “forward-looking statements” within the meaning of the federal securities laws, including Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements, other than statements of present or historical fact included in this press release, regarding Apollomics’ strategy, prospects, plans, objectives and anticipated outcomes from the development and commercialization of vebreltinib are forward-looking statements. When used in this press release, the words “could,” “should,” “will,” “may,” “believe,” “anticipate,” “intend,” “estimate,” “expect,” “seek,” “project,” the negative of such terms and other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain such identifying words. These forward-looking statements are based on management’s current expectations and assumptions about future events and are based on currently available information as to the outcome and timing of future events. In addition, Apollomics cautions you that the forward-looking statements contained in this press release are subject to unknown risks, uncertainties and other factors, including those risks and uncertainties discussed in the Annual Report on Form 20-F for the year ended December 31, 2025, filed by Apollomics Inc. with the U.S. Securities and Exchange Commission (“SEC”) under the heading “Risk Factors” and the other documents filed, or to be filed, by Apollomics with the SEC. Additional information concerning these and other factors that may impact the operations and projections discussed herein can be found in the reports that Apollomics has filed and will file from time to time with the SEC. Forward-looking statements speak only as of the date made by Apollomics. Apollomics undertakes no obligation to update publicly any of its forward-looking statements to reflect actual results, new information or future events, changes in assumptions or changes in other factors affecting forward-looking statements, except to the extent required by applicable law. Investor Contacts Peter Lin, Chief Financial Officer Apollomics, Inc. 1-650-209-4055 [email protected] Peter Vozzo ICR Healthcare 1-443-213-0505 [email protected]
Investor releaseQuarter not tagged2025-04-04Apollomics Reports Full Year 2024 Financial Results and Highlights Clinical Updates and Business Progress
GlobeNewswire
Apollomics Reports Full Year 2024 Financial Results and Highlights Clinical Updates and Business Progress
Strategic collaboration with LaunXP for the development of vebreltinib in combination with an EGFR inhibitor (“EGFRi”) to bring in $10 million upfront payment and expand dataset to combination therapy New interim data for the vebreltinib development program, including in non-CNS MET fusion tumors and non-small cell lung cancer (NSCLC) with MET amplification $9.8 million in cash and cash equivalents as of December 31, 2024, in conjunction with LaunXP upfront payment, pipeline focus and expense reductions expected to provide cash runway into the first quarter of 2026 FOSTER CITY, Calif., April 03, 2025 (GLOBE NEWSWIRE) -- Apollomics Inc. (Nasdaq: APLM) (“Apollomics”), a late-stage clinical biopharmaceutical company developing multiple oncology drug candidates to address difficult-to-treat and treatment-resistant cancers, today announced financial results for the fiscal year ended December 31, 2024, and highlighted clinical updates and business progress. “Our new partnership with LaunXP provides an opportunity to expand the clinical dataset for vebreltinib to include combination therapy with an EGFRi. This class is currently the frontline treatment for many patients with NSCLC, and combination therapy with vebreltinib may delay the emergence of resistance to this foundational therapeutic class,” said Dr. Guo-Liang Yu, CEO of Apollomics. “We will continue to seek collaborative opportunities to maximize the global opportunity for vebreltinib, both as a single agent and in combination approaches for the treatment of cancers.” “In addition, preliminary results we announced in 2024 for various SPARTA cohorts highlight the opportunity for vebreltinib in the treatment of various tumors with c-Met dysregulation. This includes new interim data for the treatment of NSCLC with MET Amplification, new interim data for the treatment of non-CNS solid tumors with MET fusions, and an incremental update for NSCLC with Met Exon 14 skipping,” continued Dr. Yu. Pipeline Update Vebreltinib (APL-101) – a highly specific c-Met inhibitor for the treatment of NSCLC and other solid tumors with MET dysregulation In August 2024, Apollomics announced interim data from its SPARTA Phase 2 clinical trial for 14 patients with non-CNS MET fusion solid tumors, where a 43% objective response rate (ORR) was achieved by RECIST v1.1 criteria. This includes six confirmed responses out of 14 eva…Read full documentShow less
Strategic collaboration with LaunXP for the development of vebreltinib in combination with an EGFR inhibitor (“EGFRi”) to bring in $10 million upfront payment and expand dataset to combination therapy New interim data for the vebreltinib development program, including in non-CNS MET fusion tumors and non-small cell lung cancer (NSCLC) with MET amplification $9.8 million in cash and cash equivalents as of December 31, 2024, in conjunction with LaunXP upfront payment, pipeline focus and expense reductions expected to provide cash runway into the first quarter of 2026 FOSTER CITY, Calif., April 03, 2025 (GLOBE NEWSWIRE) -- Apollomics Inc. (Nasdaq: APLM) (“Apollomics”), a late-stage clinical biopharmaceutical company developing multiple oncology drug candidates to address difficult-to-treat and treatment-resistant cancers, today announced financial results for the fiscal year ended December 31, 2024, and highlighted clinical updates and business progress. “Our new partnership with LaunXP provides an opportunity to expand the clinical dataset for vebreltinib to include combination therapy with an EGFRi. This class is currently the frontline treatment for many patients with NSCLC, and combination therapy with vebreltinib may delay the emergence of resistance to this foundational therapeutic class,” said Dr. Guo-Liang Yu, CEO of Apollomics. “We will continue to seek collaborative opportunities to maximize the global opportunity for vebreltinib, both as a single agent and in combination approaches for the treatment of cancers.” “In addition, preliminary results we announced in 2024 for various SPARTA cohorts highlight the opportunity for vebreltinib in the treatment of various tumors with c-Met dysregulation. This includes new interim data for the treatment of NSCLC with MET Amplification, new interim data for the treatment of non-CNS solid tumors with MET fusions, and an incremental update for NSCLC with Met Exon 14 skipping,” continued Dr. Yu. Pipeline Update Vebreltinib (APL-101) – a highly specific c-Met inhibitor for the treatment of NSCLC and other solid tumors with MET dysregulation In August 2024, Apollomics announced interim data from its SPARTA Phase 2 clinical trial for 14 patients with non-CNS MET fusion solid tumors, where a 43% objective response rate (ORR) was achieved by RECIST v1.1 criteria. This includes six confirmed responses out of 14 evaluable patients: one complete response in second-line metastatic NSCLC and five partial responses (three patients with NSCLC, one patient with pancreatic cancer, and one patient with intrahepatic bile duct cancer). Alongside the Avistone data for vebreltinib in the treatment of glioblastoma with PTPRZ1 MET fusions, vebreltinib has now demonstrated activity in a variety of tumors with MET fusions. Also in August 2024, Apollomics announced an interim analysis of 38 patients in the SPARTA MET amplification cohorts. Testing method discordance (determination of MET amplification by status sequencing of blood, sequencing of tumor biopsies, and/or fluorescent in-situ hybridization (FISH), as well as the use of local versus central laboratory testing), has complicated the analysis. Of the patients with the highest MET gene copy number (GCN) as determined by central sequencing, an ORR of 30% (3/10) was achieved, as compared to 13% (5/38) in the overall dataset. Going forward, Apollomics will only enroll NSCLC patients with MET amplification confirmed by central FISH testing. Apollomics believes that MET GCN ≥10 by sequencing may be comparable to GCN ≥6 by central FISH testing, which is the criteria to define MET amplification used in previous clinical trials of other MET inhibitors. However, challenges associated with this diagnostic test limit the enrollment rate as well as the commercial opportunity for this patient population, and Apollomics is evaluating alternatives for development of vebreltinib in this indication. In March 2024, Apollomics announced an updated efficacy analysis by GCN subgroup in the treatment of NSCLC patients with Met Exon 14 skipping mutations. The data show vebreltinib activity similar to previously announced. In the absence of overlapping c-Met amplification (GCN<4), in a pooled analysis of patients from SPARTA and KUNPENG an ORR of 67% was achieved (n=86). Other pipeline programs APL-122: Apollomics licensed rights to this ErbB1/2/4 inhibitor from Edison Oncology Holding Corporation (“Edison”) in 2021. Edison has completed six dose escalation cohorts in the Phase 1 trial, including two within the expected therapeutic window, and expects to provide a data update in 2025. APL-102: APL-102 is an oral, small molecule MTKi targeting the VEGFR and MAPK pathways via B-RAF and C-RAF, and colony stimulating factor 1 receptor. The Phase 1 clinical trial in China has been closed and Apollomics expects to provide topline results in 2025. Business Highlights Collaboration with LaunXP: In March 2025, Apollomics and LaunXP announced a collaboration agreement for the exclusive development and commercialization rights for vebreltinib in combination with an EGFRi in Asia (excluding mainland China, Hong Kong and Macau) for the treatment of NSCLC. Under the terms of the agreement, Apollomics is to receive upfront payments totaling $10 million within 60 days of the date of the agreement. Apollomics is also eligible for regulatory and other pre-commercial milestone payments of up to $50 million, and royalties on net product sales. Focus on vebreltinib MET Amplification: In July 2024, Apollomics announced a strategic prioritization for the treatment of NSCLC patients with MET Amplification. By focusing on the patient population with the greatest unmet medical need that can be addressed by c-Met inhibition with vebreltinib, Apollomics intends to apply its resources in the most efficient manner to generate additional clinical data for support of regulatory submissions. Raised $5.8 million: In May 2024, Apollomics raised $5.8 million in a private placement in public equity (PIPE) financing, before transaction expenses. Expense reductions: In line with the strategic focus on vebreltinib MET Amplification, Apollomics has terminated collaborations with Glycomimetics and TYG Oncology. Along with the vebreltinib focus and previously announced headcount reductions, Apollomics expects current cash and equivalents, and the LaunXP upfront payment, will be sufficient to fund planned operations into the first quarter of 2026. Full Year 2024 Financial Results Cash, cash equivalents, bank deposits and money market funds as of December 31, 2024 were $9.8 million, compared to $37.8 million as of December 31, 2023. Research and development expenses were $24.6 million, including share-based compensation of $4.3 million, for 2024, compared to $34.2 million, including share-based compensation of $5.9 million, for 2023. Administrative expenses were $17.8 million, including share-based compensation of $6.7 million, for 2024, compared to $20.6 million, including share-based compensation of $6.8 million, for 2023. Net loss for 2024 was $(53.9) million, or $(52.80) per basic and diluted share, compared with a net loss of $(172.6) million, or $(231.99) per basic and diluted share, for 2023. Net loss for 2024 includes impairment losses of intangible assets of $13.0 million. Net loss for 2023 includes a non-cash expense for change in fair value of convertible preferred shares of $76.4 million and expenses related to capital markets activities of $45.5 million. About Apollomics Inc. Apollomics Inc. is an innovative clinical-stage biopharmaceutical company focused on the discovery and development of oncology therapies with the potential to be combined with other treatment options to harness the immune system and target specific molecular pathways to inhibit cancer. Apollomics’ lead program is vebreltinib (APL-101), a potent, selective c-Met inhibitor for the treatment of non-small cell lung cancer and other advanced tumors with c-Met alterations, which is currently in a Phase 2 multicohort clinical trial in the United States and over 10 other countries. For more information, please visit www.apollomicsinc.com. Cautionary Statement Regarding Forward-Looking Statements This press release includes statements that constitute “forward-looking statements” within the meaning of the federal securities laws, including Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements, other than statements of present or historical fact included in this press release, regarding Apollomics’ strategy, prospects, plans, objectives including with respect to the expected payments under its agreement with LaunXP, anticipated outcomes from the development and commercialization of vebreltinib with an EGFR inhibitor and with respect to updates for other programs in the pipeline, are forward-looking statements. When used in this press release, the words “could,” “should,” “will,” “may,” “believe,” “anticipate,” “intend,” “estimate,” “expect,” “seek,” “project,” the negative of such terms and other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain such identifying words. These forward-looking statements are based on management’s current expectations and assumptions about future events and are based on currently available information as to the outcome and timing of future events. Apollomics cautions you that these forward-looking statements are subject to numerous risks and uncertainties, most of which are difficult to predict and many of which are beyond the control of Apollomics. In addition, Apollomics cautions you that the forward-looking statements contained in this press release are subject to unknown risks, uncertainties and other factors, including: (i) the impact of any current or new government regulations in the United States and China affecting Apollomics’ operations and the continued listing of Apollomics’ securities; (ii) the inability to achieve successful clinical results or to obtain licensing of third-party intellectual property rights for future discovery and development of Apollomics’ oncology projects; (iii) the failure to commercialize product candidates and achieve market acceptance of such product candidates; (iv) the failure to protect Apollomics’ intellectual property; (v) breaches in data security; (vi) the risk that Apollomics may not be able to develop and maintain effective internal controls; (vii) unfavorable changes to the regulatory environment; and (viii) those risks and uncertainties discussed in the Annual Report on Form 20-F for the year ended December 31, 2024, filed by Apollomics Inc. with the U.S. Securities and Exchange Commission (“SEC”) under the heading “Risk Factors” and the other documents filed, or to be filed, by Apollomics with the SEC. Additional information concerning these and other factors that may impact the operations and projections discussed herein can be found in the reports that Apollomics has filed and will file from time to time with the SEC. These SEC filings are available publicly on the SEC’s website at www.sec.gov. Forward-looking statements speak only as of the date made by Apollomics. Apollomics undertakes no obligation to update publicly any of its forward-looking statements to reflect actual results, new information or future events, changes in assumptions or changes in other factors affecting forward-looking statements, except to the extent required by applicable law. Investor Contact: Eric Ribner LifeSci Advisors, LLC (646) 751-4363 [email protected]
TranscriptFY2023 Q42024-03-28FY2023 Q4 earnings call transcript
Earnings source - 21 paragraphs
FY2023 Q4 earnings call transcript
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 question and answer session, forward- looking statements will be made regarding events, trends, business prospects and financial performance which may affect Apollomics future operating results and financial position. All such statements are subject to risks and uncertainties, including the risks and uncertainties described under the Risk Factors section, including an Apollomics annual report on form 20-F, registration statement on Form F1, and other reports filed with the securities and Exchange Commission. Apollomics advises you to review these risk factors in considering such statements. Apollomics assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the dates they are made. It is now my pleasure to turn the floor over to Dr. Guo Liang Yu, Apollomics Chairman and Chief Executive Officer. Sir, you may begin.
Thank you Shannon. Good morning, everyone and thank you for taking the time to join us today as we provide an overview of recent business highlights and discuss our full year 2023 financial results. Joining me for the call today is Dr. Sanjeev Redkar, our President, Dr. Peony Yu, our Chief Medical Officer and Dr. Matthew Plunkett, our recently appointed Chief Financial Officer who joined us earlier this month. Matt brings to Apollomics an outstanding track record of executive leadership in financial strategy and business development. We look forward to his contributions as we continue to execute on our vision of bringing Vebreltinib or APL-101 APL 101 and our other pipeline candidates towards regulatory approvals to better serve patients with a number of and the under serve indications. I'll begin the call with some introductory remarks which will be followed by a review of our recent corporate and development progress by Sanjeev. Matt will also cover our full year 2023 financials and then we'll open the call for Q&A. We recently reviewed interim data from our global SPARTA Trial and KUNPENG a trials with FDA in February 2024 and received informative and encouraging feedback on our lead product candidate vebreltinib. But first, before we go into that, I want to remind everyone our strategic focus and what were accomplished in 2023. 2023 was a year of significant accomplishment as we made substantial progress in our two lead drug candidates, vebreltinib and ophthalescelen [ph] Both have shown promising clinical results. First, we substantially advanced our phase two registrational trial of our lead product candidate vibratinib in non small cell lung cancer and other solid tumors with Met dysregulation. Vibratinib is a novel oroactive brain penetrate highly specific CMAD inhibitor being evaluated in global clinical trials including the US, Europe and China. Dysregulation in CMAT signaling can play an essential role in the development, progression and the survival of cancer. Vibratinib has the potential to treat cancers with MeT or HGF dysregulations beyond MET Exon 14 skipping. Our multicohort global SPARTA Trial, which includes over 90 clinical sites in North America, Europe and Asia. Together with our partner Evanstone Pharmaceutical technology company known as Everstone, more than 500 patients have been treated to date and have observed encouraging efficacy from vibratim in clinical trials. The safety profile is generally similar to other met tyrosine kinase inhibitors on the market at this time given our encouraging clinical data on vibratinib monotherapy to date, we are focused on three initial indications. We expect the first to be non small cell lung cancer with Mad exon 14 skipping mutation, for which vibratinib has the potential to be best in class to further improve patient treatment beyond available therapies. The other two indications are expected to be first in class targeted treatments including non small cell lung cancer with CMAD amplification and glioblastoma metaphor with PTPRZ-MET Fusion. Sanjeev will provide further update on where we are in clinical and regulatory development with each of the indication in a moment. In December 2023, we reported the overall response rate of vibratinib by gene, carbon number or GCN subgroup analysis in 83 non small cell lung cancer patients from the ongoing multicohort phase two KUNPENG trial in China and the ongoing global multicohort phase two SPARTA Trial. The interim data, demonstrated by broadening efficacy in non small cell lung cancer patients with MET Exon 14 skipping a patient, provide a robust overall response rate and an acceptable safety profile in patient with and without co occurring mat amplification. In November 2023, Evanstone received conditional approval from the National Medical Products Administration of China for the commercialization of vibratin to treat patients with Mad Exon 14 skipping non small cell lung cancer cancer. Note under our partnership agreement, Everstone holds the exclusive rights to vibratinib in Greater China, while Apollomics retain the exclusive rights in the US, Europe and the rest of the world, and partners have access to each other's data. In addition, in January 2024, we announced the completion of patient enrollment for our phase three bridging study in China for Apollomics or APL 106 in patients with relapsed or refractory acute myeloid leukemia or AML. Apollomics licensed apolecylin from glycomimetics including the right to clinical development, production and commercial cells in greater China market. Apollomics is a first in class e selectin inhibitor being used in combination with standard of care chemotherapy in patients with AML. It has the potential to improve efficacy and tolerability of chemotherapy. Epilepsy has been granted breakthrough therapy designation by both the FDA and the NMPA. Glycomatics US and the global phase three epolicide study in the reflexed and the refractory AMR patient was fully enrolled as of November 2021. Glycomimetics expects top line results from this trial in the second quarter of 2024. Finally, in March 2023, we successfully transitioned to a public company by completing our business combination and listing on NASDAQ. With that, I will turn the call over to Sanjeev.
Thank you, Guo Liang. In February 2024 we sought feedback from the FDA in a type c meeting with the objectives to review our development plan as well as our registration pathway of federal vebreltinib for the treatment of three conditions. The first was non small cell lung cancer with medoxone 14 skipping mutation, the second non small cell lung cancer with CMAT amplification and the third glioblastoma or GBM with PTPRZ-MET fusions. Now the interim results in the first indication, Medoxon 14 skipping mutation included 107 non small cell lung cancer patients with centrally confirmed Medexon 14 skipping mutations. Now of the 107 patients, 71 were treatment naive and 36 previously treated patients with no prior met inhibitor and no immune checkpoint inhibitor treatment immediately prior to webrathen. Now in the 71 treatment, naive small cell lung cancer patients, about half are from Sparta and half are from the KUNPENG trial. The objective response rate was 66.2%, supported by median duration of response of 16.5 months. In the 36 previously treated patients, of which 19 are from Sparta and 17 from KUNPENG, the ORR was 61.1% with a median duration of response of 16.7 months. An updated efficacy analysis by Gene Copy Number or GCN subgroup continues to show similar webraltinib activity in the treatment of non small cell lung cancer patient with medexon protein skipping mutation regardless of overlapping met amplification, that is, in the absence of overlapping C Net amplification with GCN gene copy number less than four the ORR was 67% in a pooled analysis of 86 patients from the Sparta and KUNPENG trials. Now in the treatment, naive patients with GCN less than four. The ORR was 64.3% in 28 Sparta patients and the ORR was 71.4 in 28 KUNPENG patients. Based on the feedback from the FDA from this type C meeting, we will continue to enroll in these Sparta cohorts and review additional information on patients from the Sparta and KUNPENG trials with the FDA on the NDA readiness for this indication. We will analyze data after all patients have achieved a 12v month follow up to support a traditional approval. Now, based on the discussions with the FDA, we believe that pre treated non small cell lung cancer patients with CMAT amplification may remain an unmet medical need and that the preliminary data presented could represent an improvement over available therapy. We'll continue to enroll non small cell lung cancer patients with CMR amplification in this Sparta study to increase the precision around the point estimate for the ORR and provide geographic diversity in the NDA package for supporting an accelerated approval. The primary efficacy analysis could potentially be based on the single on trial results from KUNPENG and Sparta. We expect enrollment of these incremental patients in Sparta will continue into 2025 and if these results are positive, we could potentially submit an NDA in 2026 to seek accelerated approval of fibrelative as a second line treatment for non small cell lung cancer patients with CMET amplification. Now for patients with GBN with PDPR Z one Med fusions the agency acknowledged that PDPR Z one med fusion positive high grade glioma is a serious illness with an unmet medical need. We do need additional study data and additional to determine if the randomized phase two three study completed by Avistone, which showed a 48% reduction in risk of death supported by data from the Sparta study, could support a marketing authorization for this indication in the US, For the remainder of 2024 and into 2025, we look forward to the following milestones and updates. We look forward to disclosing exciting new preclinical data on webraltinib at the AACR meeting in San Diego next week. We are planning to present results from multiple preclinical studies in two posters. Now on APL 106 at upper Lasland. Apollomics, partner in the US, Glycomimetics expects to report top line results from its pivotal phase three study of April Esalan in the relapsed refractory AML in the second quarter of 2024. Our phase three bridging study in relapse refractory AML in China was fully enrolled at the end of 2023 while waiting for data to mature in this event driven study we expect to report top line data in the first half of 2025. \ I'll now turn the call over to Matt who will review the financials.
Thank you, Sanjeev. Please refer to our press release issued earlier this morning, March 28, 2024, for a summary of our financial results for the year ended December 31, 2023. As of December 31, 2023, cash, cash equivalents, bank deposits and money market funds were $37.8 million, as compared to $58.9 million as of December 31, 2022. In March 2023, the company raised $23.7 million before transaction expenses in a pipe financing in conjunction with the business combination and listing on Nasdaq. Based on current projections, we believe our cash position is sufficient to fund planned operations through the first quarter of 2025. For the year ended December 31, 2023, research and development expenses were $34.2 million, including stock based compensation, of $5.9 million. This compares to $35.4 million, including stock based compensation, of $2.4 million for the full year 2022. General and administrative expenses were $20.6 million, including stock based compensation of $6.8 million for the full 2023 year. This compares to $9.9 million, including stock based compensation of $0.6 million for the full year 2022. The increase was primarily from administrative expenses related to our business combination in 2023, directors and officers insurance as a result of being a publicly listed company, and an increase in employee stock based compensation. Net loss for full 2023 was $172.6 million, or $2.32 per diluted share, as compared to a net loss of 240.8 million, or $8.44 per diluted share, for the full year 2022. The net loss includes a non cash expense for change in fair value of convertible preferred shares of $76.4 million in 2023 and $189.6 million in 2022 and also includes expenses related to capital markets activities of $46.0 million in 2023 and $6.6 million in 2022. For the year ended December 31, 2023, net cash used in operating activities was approximately $43.2 million, as compared to $42.8 million in the prior year. At this point, I'll now turn it back over to the operator for our Q&A session.
Thank you [Operator Instructions] Our first question comes from the line of Tim Moore with EF Hutton. Your line is now open.
Thanks for your press release and your prepared comments on the call. It's great that you want to move forward with enrolling the Sparta cohorts. So I just want to maybe clarify the timing you need to reach the 12 month follow up period. It sounds like you will expect the enrollment to be finished by maybe early 2025. So does that mean you'd have more data that you're pretty confident on submitting to the FDA sometime? I guess it would be early 2026. Does that timeline make sense?
Maybe. Puny. Would you be able to answer Tim's question here?
Peony, your line may be on mute.
I can do another question if you want. Come back to that one. Sure. Yep.
Great. So that's good that you might seek the NDA application route. And that was good news. And is there anything else you can maybe share feedback from the FDA meeting there? Anything that they want you to do or follow up on or any kind of request that they had?
Yeah, so I think the key message is that FDA basically we need continue to enroll more patients to kind of specify result that we already have. So we will just continue what we're doing. I think Peony is on. Could you answer the previous question Tim has asked? Puny, are you on? If he's not. Okay. Yeah, so actually maybe I'll give you a high level answer. I think the timeline might be a little shorter than what you think. With the current patient that we have presented to FDA, the 12 months follow up time will coming up in the summer, but if we need additional patient to be enrolled, that will basically extend another 12 months. So we are thinking of in the year of 2025 rather than 2026. That answer your question? That's why I was curious because these extra patients might push out that timeline a bit. Right. For the 12 month. I'm just wondering if the FDA is going to redefine the twelve month follow up. If it's not this summer and it gets moved out to early 2026. Yeah. So for the non small cell lung cancer with Exxon 14 [ph] skipping because we're going after the traditional approval. Therefore 12 months follow up is required.
Okay. Okay, I got it then. One other question I had was you added the CFO role last week. Doctor Plunkett spoke a bit. I just love to hear from him. What is he expected to enhance and improve at the company? Is he bringing over some best practices of commercialization, regulatory approval learned at Imago and Carta Therapeutics?
Great question. Matt, would you able to share your thoughts? Yes, I certainly can, Tim, thanks for, thanks for the question. Near term focus here is really to help the existing team with our 20 f filing, which you'll see come out later today. As you've seen, I do have some extensive experience in a variety of finance and business roles in various small biopharma companies, ranging from capital formation to strategic collaborations. And those are some of the things that I'll be looking to work on in the coming months. So stay tuned there.
Great, great. Not to put Matt on the spot, but whoever wants to answer financial expense questions, I'm just trying to update my model for this year, and I got to imagine that your R&D expense climbs I think it was 34 million for 2023. Is it reasonable for me to expect because you got enrollments and other expenses and clinical trials going on, is 50 million this year maybe too much and just kind of curious about the R&D number?
Yeah. Happy to answer that for you. What I would really do is look at our guidance for cash Runway and kind of back into it from there. So 37.8 million in cash, bank deposits and mutual fund balances at the beginning of 2024. And we said we've got cash through the first quarter of 2025. So five quarters there. So basically you can just do the math there and kind of get a total expense number. I would point out that with the completion of enrollment in the Aprilisin phase three trial, obviously those expenses one would expect are not going to be as great in 2024 as 2023. So hopefully that gives you a little bit of help there. And then obviously, with some significant one time expenses related to the de SPAC transaction in 2023, 1st time ever, public reporting, etcetera, we're going to expect some of those G&A things not to be as large in 24 as 23, but really the best thing to do is just look at the overall cash burn guidance and Runway guidance. So I think that should get you where you need to go.
Yeah, that's what I was thinking originally. It's just I was kind of curious. You know, it was really helpful to say through the first quarter next year. Makes you feel comfortable on the cash burn, but I didn't know how much that does. That factor in the additional patients enrollment, if that's the route you're going to go, you know, the extra patience.
It sure. It sure does, Tim. Okay, good, good, good. Anything else to add on the rest of the pipeline? I know you touched on, you know, a couple other indications. Anything else going on with some of the other drug candidates? Not really. We try to stay focused with vibratinib and plessant at this time, especially with limited cash that we have. So we really kind of try to stay focused and get our first drug approved.
Good. No, I like the focus. I think that's very good. Too many biotechs try to fund five or six things at once, and you're focusing on your two top ones. So I appreciate it. And that's it for my questions. Thanks.
Thank you. [Operator Instructions] Thank you, Tim. Thank you. As a reminder to ask a question at this time, I'd like to hand the call over to Dr. Guo Liang Yu for closing remarks.
Okay, thank you, everyone, for joining today. We appreciate your interest in the company and thank you for the questions. I look forward to updating you on our business in the near future.
This concludes today's conference call. Thank you for your participation. You may now disconnect.+

