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Aptorum Group Limited (Nasdaq: APM) is a leading clinical-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapeutic assets targeting diseases with unmet medical needs. Headquartered in London, UK, Aptorum focuses primarily on oncology, particularly orphan indications and infectious diseases.
The company operates through two main segments: Therapeutics and Non-Therapeutics. In the Therapeutics segment, Aptorum is advancing its clinical pipeline with projects such as ALS-4 for Methicillin-Resistant Staphylococcus Aureus (MRSA), SACT-1 for neuroblastoma, and the RPIDD rapid pathogen identification and detection diagnostics technology. These initiatives are backed by a robust drug discovery platform that utilizes systematic screening of existing approved drug molecules and microbiome research for metabolic disease treatments.
Recent milestones include the submission of the Phase 1b/2a clinical trial protocol for SACT-1 to the US FDA for treating neuroblastoma, a solid tumor predominantly affecting pediatric patients. The trial aims to determine the recommended phase 2 dose based on safety and efficacy, representing a significant step forward in addressing this aggressive cancer.
In the Non-Therapeutics segment, Aptorum is also engaged in projects focused on surgical robotics and developing natural supplements for menopausal women. The company's diverse pipeline includes innovations in neurology, gastroenterology, metabolic disorders, and women's health, reflecting its commitment to addressing various complex health challenges.
Financially, Aptorum remains vigilant in controlling costs while continuing to advance its key programs. The company reported a net loss of $6.6 million for the first half of 2023, attributed to stringent budgetary controls and focused development on lead projects. Cash and restricted cash stood at approximately $0.5 million as of June 30, 2023.
On the corporate front, Aptorum recently received approval to transfer the listing of its Class A ordinary shares from the Nasdaq Global Market to the Nasdaq Capital Market, addressing previous listing deficiencies. The company's strategic focus on progressing its clinical programs underscores its potential for delivering significant advancements in biopharmaceutical innovation.
For more information, visit Aptorum Group's official website.
Aptorum Group (NASDAQ: APM) has announced the granting of its first patent for SACT-1, a repurposed drug aimed at treating various cancers, including neuroblastoma. This patent, numbered 11,166,962 B2, provides intellectual property protection for the drug's composition and its method of use in conjunction with other treatments. The company also revealed plans to pursue further patent protection and initiate Phase Ib/2a clinical trials for SACT-1 pending IND clearance. This milestone is crucial for protecting their investment and advancing their oncology pipeline.
Aptorum Group (APM) has completed Phase I clinical trials for two drugs: ALS-4 and SACT-1. ALS-4 targets infections from Staphylococcus aureus, including MRSA, while SACT-1 focuses on neuroblastoma. Both trials reported no serious adverse events and satisfactory safety data. Aptorum plans to submit IND applications to the US FDA for ALS-4's Phase II trial and SACT-1's Phase 1b/2a trial within the year. These milestones highlight Aptorum's commitment to addressing critical health needs, with both drugs aimed at combating serious unmet medical conditions.
Aptorum Group Limited (NASDAQ: APM) has initiated clinical validation of its rapid pathogen diagnostics technology (RPIDD) in Singapore, enrolling 12 patients with febrile neutropenia and sepsis. The RPIDD demonstrated analytical sensitivity of 100% and specificity of 90% in detecting pathogens, including Escherichia coli and Klebsiella pneumoniae. The technology aims to revolutionize infectious disease diagnostics, providing rapid results that could significantly reduce mortality rates. Pre-commercialization efforts are set to begin in 2022.
Aptorum Group Limited (NASDAQ: APM) has launched a new oncology and autoimmune discovery platform. This initiative focuses on developing treatments for significant unmet medical needs, particularly targeting non-small cell lung cancer (NSCLC) and autoimmune diseases like lupus and rheumatoid arthritis. The company aims to optimize first-in-class small molecule and PROTAC drug candidates, addressing mutations in NSCLC with a low five-year survival rate of 25%. Progression through clinical trials is anticipated as Aptorum leverages its drug discovery capabilities.
Aptorum Group Limited (Nasdaq: APM) announced results from its 2021 annual general meeting held on December 2, 2021, in Hong Kong. Shareholders re-elected all current directors and approved the re-appointment of Marcum Bernstein & Pinchuk LLP as independent auditors for 2021. Additionally, an amendment was made to the Articles of Association, allowing the board greater flexibility in setting record dates for shareholder meetings. The company focuses on developing therapies for oncological and infectious diseases, leveraging drug discovery platforms and partnerships for innovation.
Aptorum Group Limited (Nasdaq: APM) has announced its 2021 annual general meeting to be held on December 2, 2021, in Hong Kong. Shareholders of record as of October 6, 2021, are eligible to vote. The company also filed its annual report on Form 20-F with the SEC on April 19, 2021, which is accessible on its website. Aptorum focuses on developing therapeutic assets for unmet medical needs, particularly in oncology and infectious diseases. The meeting aims to engage shareholders in company governance and future strategies.
Aptorum Group Limited (NASDAQ: APM) announced that President Darren Lui's interview will air on The RedChip Money Report on Bloomberg TV on October 16 at 7 p.m. ET. The company is focused on tackling oncological and infectious diseases through innovative therapeutics. Its pipeline includes drug discovery platforms and partnerships for diagnostics technology. The press release emphasizes the forward-looking nature of statements related to business strategies and risks, noting that actual results may vary.
Aptorum Group has received FDA clearance for its IND application to begin clinical trials of SACT-1, a repurposed oral drug aimed at treating neuroblastoma. This milestone underscores the company's focus on oncological diseases and aligns with its strategic goals for 2021. The initial trial, a bioavailability study, will assess SACT-1 in healthy adults before advancing to a planned Phase 1b/2a trial for pediatric patients with high-risk neuroblastoma, pending further FDA approval.
Aptorum Group Limited (NASDAQ: APM) reported a significant net loss of $17.1 million for the first half of 2021, up from $7.0 million in 2020, largely due to losses on investments. However, its clinical programs are advancing; the ALS-4 program has successfully completed the single ascending dose portion of its trial, and the SACT-1 program received FDA clearance for clinical trials. Additionally, the company has $20.1 million in cash and expects to fund operations for at least the next 12 months. R&D expenses increased due to contracted services as clinical projects progress.
Aptorum Group (Nasdaq: APM) has announced further positive results from its ongoing Phase 1 clinical trial for ALS-4, an innovative anti-virulence treatment targeting Staphylococcus aureus, including MRSA. The trial has completed two additional cohorts, C (100mg) and D (200mg), with no serious adverse events reported. All subjects in these cohorts remained in the study, indicating robust safety. The study aims to assess ALS-4’s safety, tolerability, and pharmacokinetics, with plans to advance to the multiple ascending dose stage in Q3 2021.
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