On April 29, 2022 Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) ("Aptorum Group" or "We"), a clinical stage biopharmaceutical company dedicated to meeting unmet medical needs in oncology, autoimmune diseases and infectious diseases, reported financial results for the fiscal year ended December 31, 2021, and provided an update on clinical and corporate developments (Press release, Aptorum, APR 29, 2022, View Source [SID1234613239]).
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Mr. Ian Huen, Chief Executive Officer and Executive Director of Aptorum Group, commented "Aptorum’s operational plans remain on track. In particular, our lead projects, ALS-4 (targeting infections caused by Staphylococcus aureus including Methicillin-resistant Staphylococcus aureus (MRSA)) and SACT-1 (targeting neuroblastoma), have respectively completed their phase 1 clinical trials and we are working towards the commencement of the next stage of human clinical trials for further proof of concept of these 2 lead projects in the United States. We are also pleased with the progress of our other lead project, RPIDD, a liquid biopsy program targeting infectious disease diagnostics which is currently undergoing human clinical validations in Singapore. We are also excited about previously announced expanded oncology and autoimmune drug discovery programs targeting unmet mutations and novel biomarkers utilizing first-in-class drug molecules. Last but not least, we are excited about the near-future commercialization of our woman’s health supplement product NativusWell in Asia and Europe, which we hope to be followed by launch in the United States, subject to the successful completion of our registration process. Our team is currently focused on delivering the above milestones for our stakeholders and we believe 2022 will be an exciting year for the company."
Clinical Pipeline Update and Upcoming Milestones
In 2022, we announced a number of updates for our lead and other projects:
Our ALS-4 (a first in-class anti-virulence based small molecule drug targeting infections caused by Staphylococcus aureus, including, but not limited to Methicillin Resistant Staphylococcus Aureus ("MRSA")) Phase 1 clinical trial is completed. Dosing and clinical evaluations of the Single Ascending Dose studies ("SAD") and Multiple Ascending Dose studies ("MAD") have been completed for a total of 72 healthy subjects, no subjects were dropped from the studies and no serious adverse events observed. With the encouraging safety data, we are on track to submit an IND application to the United States Food and Drug Administration ("US FDA") this year seeking to initiate a Phase 2 clinical study to assess the safety and efficacy of ALS-4 in patients.
Our SACT-1 (a repurposed small molecule drug targeting Neuroblastoma and potentially other cancer types) Phase 1 clinical trial for assessing relative bioavailability and food effect has been completed with no serious adverse events observed. Our first patent on SACT-1 has been granted by the US Patent and Trademark Office and the US FDA has also granted an Orphan Drug Designation for SACT-1 for the treatment of neuroblastoma. We plan to hold an end of Phase 1 meeting and submit a clinical protocol to the US FDA this year to initiate a Phase 1b/2a clinical study to assess the safety and efficacy of SACT-1 in patients.
Our first patent on the molecular based rapid pathogen diagnostics liquid biopsy technology ("RPIDD") has been granted by the US Patent and Trademark Office. We started the clinical validation of our RPIDD for the diagnosis of pathogens including viruses, bacteria, fungi and parasites. We have been enrolling patients with febrile neutropenia and sepsis for our clinical validation.. Various bacteria and viruses have been detected in these patient samples, including Escherichia coli, Klebsiella pneumoniae and Herpesviridae. The data have been cross-validated by standard of care diagnostics results such as blood culture technology. RPIDD achieved high analytical sensitivity and specificity of the clinical samples respectively at both low depth (60,000 reads) and high depth (1 million reads) sequencing and further clinical validation is ongoing.
We launched our oncology and autoimmune discovery and development platform. The platform will initially focus on non-small cell lung cancer ("NSCLC") and autoimmune diseases such as lupus, rheumatoid arthritis, inflammatory bowel diseases, etc. We are currently conducting optimization for selected candidates as part of its small molecule library for major targets including, but not limited to EGFR, ALK, KRAS, p53 mutations.
Fiscal Year End Financial Results
Aptorum Group reported a net loss of $27.1 million in 2021, as compared to net income of $4.9 million in 2020. The net income in 2020 was mainly driven by the gain on investments in marketable securities, net of $25.2 million, while there was a loss on investments in marketable securities, net of $8.0 million in 2021.
Research and development expenses were $10.9 million in 2021 as compared to $11.6 million in 2020. The decrease in research and development expenses in 2021 was primarily due to less sponsored research to universities in 2021, partly offset by the increase in contracted research organizations services and consultation due to the development progress of our lead projects.
General and administrative fees were $5.4 million in 2021 as compared to $4.9 million in 2020. The increase in general and administration fees was mainly due to increase in bonus expenses to our directors, employees, external consultants and advisors. The increase is partly offset by a significant decrease in travelling expenses due to the outbreak of COVID-19.
Legal and professional fees were $2.6 million in 2021 as compared to $2.9 million in 2020. The decrease in legal and professional fees was mainly due to less one-off professional services engaged during 2021.
Aptorum Group reported $8.3 million of cash and restricted cash as of December 31, 2021 compared to $3.6 million as of December 31, 2020. The increase in cash and restricted cash was mainly the result of the proceeds from sales of investment securities of $20.1 million and proceeds from issuance of Class A Ordinary Shares of $4.0 million in 2021, partly offset by the cash used in operating activities of $14.7 million, net repayment of loan from related parties of $2.0 million, and loan to a related party of $3.4 million in 2021.