Vebreltinib

Apollomics Inc. (NASDAQ:APLM APLMW) FOSTER CITY, CA, UNITED STATES, September 22, 2025 / EINPresswire.com / -- Apollomics Inc. (Nasdaq: APLM) (“Apollomics” or the “Company”), a California based late-stage clinical biopharmaceutical company developing multiple oncology drug candidates to address difficult-to-treat and treatment-resistant cancers, announced that the Company received a letter (the “Letter”) on September 18, 2025 from the Listing Qualifications Staff (the “Staff”) of The Nasdaq Stock Market, LLC (“Nasdaq”). The Letter indicated that unless the Company requests an appeal, Nasdaq will delist the Company’s securities under Nasdaq Listing Rule 5101 based on the Staff’s belief that Apollomics is now only a “public shell”. The Letter stated that the Staff believe the Company no longer has an operating business, citing a lack of personnel and uncertainty around staffing initiatives, and this could lead to the Company’s shares being subject to market abuses and other violative conduct as purchasers of a public shell do not know what the operating business will be in the future. Other than as identified above, the Company believes it is in compliance with the Nasdaq listing requirements set forth in Nasdaq Listing Rule 5550. The Company will appeal. The Company’s management strongly believes that Apollomics is not a public shell and remains an operating clinical-stage pharmaceutical company. Apollomics continues to be focused on the discovery and development of oncology therapies. These therapies have the potential to be combined with other treatment options to harness the immune system and target specific molecular pathways to inhibit cancer. Apollomics historically and continues to use targeted, immuno-oncology, and other innovative approaches to address a range of cancer indications, such as lung cancer, brain cancer, and other solid tumors. The Company’s pipeline includes a variety of cancer treatment programs that utilize tumor inhibitors, immune checkpoint inhibitors, a cancer vaccine, monotherapies, combination therapies or a multi-functional protein with the goals to improve response rates and reduce chemo-resistance and toxicity compared to the current treatment standards. The Company announced on August 28, 2025, that it intended to seek shareholder approval to wind up the Company’s business, and that it expected to discontinue all activities related to the SPARTA clinical trials associated with vebreltinib, our most advanced product candidate. However, on September 3, 2025, the Company received$4.1 million in a private placement and appointed a new board of directors. With additional funding, the Company reversed its wind-up plans. It is continuing previous operations and is actively expanding operations focused on advancing the global development and achieving the full potential of vebreltinib. Among other initiatives, Apollomics seeks to develop vebreltinib across different c-Met alterations across different tumors; developing other tumor inhibitor candidates; expand our drug portfolio through collaboration and partnership; seek development and commercialization partnerships to optimize efficiency; and build a network of centers for clinical trials. Current clinical trials include: trials of vebreltinib as a single agent for the potential treatment of NSCLC and other advanced tumors with c-Met alterations, and also as a combination therapy with epidermal growth factor receptor inhibitors (the “SPARTA studies”). The Company is preparing to file a notice of appeal on or prior to September 25, 2025, and will request a hearing before a Nasdaq Listing Qualifications Panel to review the Staff’s determination. The appeal, when filed, will stay delisting of the Company’s securities pending the Panel’s decision. Unless the Company requests an appeal, trading in the Company's securities will be suspended at the opening of business on September 29, 2025, and a Form 25-NSE will be filed with the Securities and Exchange Commission to remove the Company's securities from listing and registration on The Nasdaq Stock Market. Although the Company believes that it will prevail in its appeal, there is no guarantee that the Company will be able to win its appeal, or will regain or maintain its Nasdaq listing. 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, or the appeal of, response to, or outcome of the NASDAQ Letter, 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, 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. 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. Peter Lin Apollomics Inc. +1 650-209-4055 peter.lin@apollomicsinc.com Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

BEIJING, China I May 31, 2025 I Beijing Avistone Biotechnology Co., Ltd (“Avistone”), an innovative biotechnology company focused on precision oncology therapeutics, today announced that the clinical data for Vebreltinib plus Andamertinib (PLB1004), its innovative combination of potent mesenchymal-epithelial transition factor (MET) inhibitor and epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), has been presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2025. The details of the poster presentation are provided below: Poster title: Vebreltinib plus Andamertinib (PLB1004) in EGFR-mutated NSCLC with MET Amplification or Overexpression after failure on EGFR-TKIs treatment: phase Ib/II KYLIN-1 study Abstract Number For Publication: 8632 Session: Poster Session-Lung Cancer- Non-Small Cell Metastatic Location: Poster Board, 112 Session Date/Time: 5/31/2025 1:30pm-4:30pm CDT MET amplification or overexpression is the most common “off-target” mechanism that drives resistance to EGFR-TKIs in NSCLC patients. The results from Phase Ib/II KYLIN-1 study (NCT06343064) showed that Vebreltinib plus Andamertinib demonstrated notable efficacy and manageable safety in EGFR-mutated NSCLC patients with MET amplification or overexpression after EGFR-TKIs failure. Among the 56 patients enrolled at a dose of Vebreltinib 150mg BID plus Andamertinib 80mg QD (RP2D), the confirmed overall response rate (ORR) was 50.0%, and the median progression-free survival (mPFS) was 9.9 months. In 19 patients with brain metastases, ORR was 42.1% and mPFS was 9.5 months. Grade 3 or higher treatment related adverse events (TRAEs) occurred in 19.6% of the patients. None discontinued treatment or died due to TRAEs. No new safety signal was observed. A multicenter Phase III study, KYLIN-3 study (NCT06970782), is currently ongoing to further evaluate Vebreltinib plus Andamertinib versus platinum-based doublet chemotherapy in patients with EGFR mutations, MET amplification and/or overexpression, locally advanced or metastatic NSCLC following EGFR-TKI failure. To obtain a copy of the poster, please email Avistone. About Vebreltinib Vebreltinib is an orally, potent and selective c-Met inhibitor. Chinese National Medical Products Administration (NMPA) has formally approved the use of Vebreltinib in locally advanced or metastatic NSCLC patients with MET exon 14 skipping mutations, as well as adult patients with isocitrate dehydrogenase mutant astrocytoma with the PTPRZ1-MET fusion gene or glioblastoma with a history of low-grade disease who have the PTPRZ1-MET fusion gene and have failed previous treatments. Currently, Chinese Center for Drug Evaluation (CDE) has formally accepted its New Drug Application (NDA) and granted it priority review, intended for patients with locally advanced or metastatic NSCLC with MET amplification. About Andamertinib (PLB1004) Andamertinib (PLB1004) is an oral, potent, irreversible, and selective EGFR-TKI with potent blood-brain barrier penetration and broad tyrosine kinase activity. Preclinical studies have shown that it can effectively and irreversibly target exon 20 insertion. Additionally, it can also potently target classical EGFR mutations, such as Del19, L858R and T790M with a high degree of selectivity. About Avistone Biotechnology Beijing Avistone Biotechnology Co., Ltd. (“Avistone”) is an innovative biotechnology company dedicated to precision therapies with significant unmet medical needs for patients worldwide. Avistone maintains an extensive pipeline of targeted therapies in Non-Small Cell Lung Cancer (NSCLC) and other solid tumors. SOURCE: Avistone Biotechnology