On September 30, 2022 Aptorum Group Limited (NASDAQ: APM, Euronext Paris: APM) ("Aptorum Group" or the "Company"), a clinical stage biopharmaceutical company dedicated to meeting unmet medical needs in oncology, autoimmune and infectious diseases, reported that financial results for the six months ended June 30, 2022 (Press release, Aptorum, SEP 30, 2022, View Source [SID1234621593]).

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"During the first half of 2022, we remained focused on advancing the development of our therapeutic programs. As announced in early 2022, both our SACT-1 program (targeting neuroblastoma) and ALS-4 program (targeting MRSA), has announced the completion and positive Phase I clinical trial results. Our RPIDD program (liquid biopsy based approach to infectious disease rapid molecular diagnostics) are also progressing well into its clinical validation studies. We are excited to work towards the commencement of the relevant phase II clinical trials for our ALS-4 and SACT-1 programs and the continuation of the clinical validation of our RPIDD program. Finally, we are also pleased to have announced the commercialization of our NativusWell nutraceutical product, a novel supplement targeting woman’s health including menopausal symptoms, commencing in Hong Kong initially and to be followed into the European and US markets in due course," said Mr. Darren Lui, Chief Executive Officer and Executive Director of Aptorum Group Limited.

Clinical Pipeline Update and Upcoming Milestones

In January 2022, Aptorum Group announced the completion of the Phase I clinical trial for ALS-4,, a small molecule drug targeting methicillin-resistant staphylococcus aureus related infections. The Phase I clinical trial of ALS-4 was a randomized, double-blinded, placebo-controlled, single and multiple ascending dose study designed to evaluate safety, tolerability, and pharmacokinetics or orally administered ALS-4 in healthy male and female adult volunteers. Currently, the Company is preparing the relevant submission to the US FDA to initiate a Phase 2 clinical trials for skin and soft tissue infections and/or bacteraemia. The study treatments were well tolerated and no serious adverse events were observed and no relevant clinical changes in respect of vital signs and clinical laboratory test results.

In May 2022, Aptorum Group announced the finalized data from the Phase I clinical trial of SACT-1, a repurposed small molecule drug targeting Neuroblastoma and potentially other cancer types. The Phase I clinical trial of SACT-1 was an open-label, randomized, 3-period, 3-sequence, single-dose crossover bioavailability and food effect study of SACT-1 (oral suspension) in healthy adult volunteers. The study treatments were well tolerated and no subjects were discontinued from study participation because of adverse events. No serious adverse events were reported during the study. SACT-1 also received Orphan Drug Designation from the US FDA.

In September 2022, Aptorum Group announced further results and updates from its RPIDD’s analytical and clinical validations in patient samples. It was further announced the company has taken steps to initiate the set up of a clinical laboratory in the state of California, which is targeted to require relevant CLIA certification.

In September 2022, Aptorum Group announced the commencement of sale of its NativusWell nutraceutical product targeting woman’s health and the launch of it’s initial sales launch in Hong Kong, to be followed in Europe and United States.

Corporate Highlights

In May 2022, Mr. Darren Lui has been appointed as the Chief Executive Officer. Mr. Lui was previously the Aptorum Group Limited’s President, successfully brought two small molecule drugs (ALS-4 and SACT-1) from discovery to their respective completion of two phase I clinical trials and currently in preparation for their next phase of clinical trials in human patients, as well as conducting ongoing clinical validations of the Company’s RPIDD program, a liquid biopsy based molecular diagnostics for infectious diseases.

In July 2022, Mr. Martin Siu has been appointed as the Head of Finance. Mr. Siu has over 19 years’ experience in the field of audit and regulatory consultancy and has supported a number of listed companies over the years.

Financial Results for the Six Months Ended June 30, 2022

Aptorum Group reported a net loss of $2.7 million for the six months ended June 30, 2022 compared to $17.1 million for the same period in 2021. The decrease in net loss in the current period was driven by an decrease of loss on investments in marketable securities, net of $7.5 million, and there was a gain on non-marketable investment of $5.6 million in 2022 while there was no such gain in the same period in 2021.

Research and development expenses were $4.5 million for the six months ended June 30, 2022 compared to $5.5 million for the same period in 2021. The decrease in research and development expenses was mainly due to the decrease in services provided by contracted research organizations as we are in a planning process for Phase 2 of our lead projects which does not require many services from contracted research organizations.

General and administrative fees were $2.4 million for the six months ended June 30, 2022 compared to $2.6 million for the same period in 2021. The decrease in general and administrative fees was primary due to the decrease in number of employees.

Legal and professional fees were $1.4 million for the six months ended June 30, 2022 compared to $1.2 million for the same period in 2021. The increase in legal and professional fees was mainly due to more share based compensation awards was granted for consultancy services when compared to the same period in 2021.

As of June 30, 2022, cash and restricted cash totalled approximately $7.2 million and total equity was approximately $15.6 million.

Aptorum Group expects that its existing cash and restricted cash together with undrawn line of credit facility from related parties, will enable it to fund its operating and capital expenditure requirements for at least the next 12 months.