On September 15, 2021 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 and infectious diseases, reported that financial results for the six months ended June 30, 2021 (Press release, Aptorum, SEP 15, 2021, View Source [SID1234587764]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"During the first half of 2021, we remained focused on advancing the development of our therapeutic programs. As announced in early 2021, our ALS-4 program (targeting infections caused by Staphylococcus aureus including MRSA) commenced a Phase 1 clinical study in Canada. We are pleased that 5 total cohorts, which represent the essential part of the single ascending dose ("SAD") portion of the trial, have been completed without any serious adverse events being observed. On the basis of ALS-4’s favourable safety profile, we are commencing the multiple ascending dose ("MAD") portion of the trial in Q3, 2021. Our other lead program SACT-1 (targeting neuroblastoma), has also received clearance from the US FDA to commence clinical trials in the United States. SACT-1 will be our second therapeutic program entering into the clinical phase. Our RPIDD program (liquid biopsy based approach to infectious disease rapid diagnostics) is also progressing well and we are very pleased to continue its clinical validation currently in collaboration with A*Star. Finally, we are excited to continue with our efforts of commercialising our NativusWell DOI product, a novel supplement targeting woman’s health including menopausal symptoms. We are also excited to continue to identify and progress on certain other potential novel therapeutic candidates, including our ongoing assessment of a number of novel immunomodulators developed by Yale University targeting major autoimmune diseases, as we announced earlier in the year," said Mr. Ian Huen, Chief Executive Officer and Executive Director of Aptorum Group Limited.

Clinical Pipeline Update and Upcoming Milestones

In September 2021, Aptorum Group received clearance from the US FDA to open an IND to conduct clinical trials on SACT-1, an orally administered small molecule repurposed drug for the treatment of neuroblastoma. The IND-opening study is a bioavailability/Food Effect study, followed by a Phase 1b/2a trial in neuroblastoma patients which is subject to further FDA approval.

In May 2021, Aptorum Group announced its ongoing Phase I clinical trial for one of its lead programs, ALS-4, an orally administered small molecule drug for the treatment of infections caused by Staphylococcus aureus including MRSA, under which two initial cohorts of the SAD portion of the trial in healthy male and female adult subjects have been completed with no serious adverse events observed. In July 2021, the Company further announced two additional cohorts (Cohort C & D) of the SAD portion have been completed with no serious adverse events observed. In total, up to 6 cohorts for SAD and 3 cohorts for MAD have been planned. The MAD study is commencing in Q3, 2021.

In May 2021, Aptorum Group entered into an agreement with Exeltis regarding Aptorum’s preclinical asset targeting women’s health and gynaecological conditions, including endometriosis, in the European Union and Latin America. Aptorum retained development rights in the rest of the world.

In April 2021, Aptorum Group entered into a material transfer and license option agreement with Yale University to evaluate a group of preclinical stage novel immunomodulators that could represent first-in-class therapeutics in treating autoimmune and oncology diseases, among other indications.

Corporate Highlights

In May 2021, Jurchen Investments Limited, purchased an aggregate of 1,387,925 of the Company’s Class A Ordinary Shares at $2.882 per share, representing 10% premium to the last closing price.

On March 26, 2021, Aptorum Group entered into a Sales Agreement with H.C. Wainwright & Co., LLC, acting as the Company’s sales agent, pursuant to which the Company may offer and sell, from time to time, through the Sales Agent, Class A Ordinary Shares for an aggregate offering price of up to $15,000,000.

Financial Results for the Six Months Ended June 30, 2021

Aptorum Group reported a net loss of $17.1 million for the six months ended June 30, 2021 compared to $7.0 million for the same period in 2020. The increase in net loss in the current period was driven by loss on investments in marketable securities, net of $7.6 million, and there was a gain on non-marketable investment of $1.6 million in the same period in 2020 while there was no such gain in current period.

Research and development expenses were $5.5 million for the six months ended June 30, 2021 compared to $4.3 million for the same period in 2020. The increase in research and development expenses was mainly due to the increase in services provided by contracted research organizations as a result of our projects’ development.

General and administrative fees were $2.6 million for the six months ended June 30, 2021 compared to $2.1 million for the same period in 2020. The increase in general and administration fees was mainly due to a one-off reversal of over-provision in relations to bonus payables to our directors, employees, external consultants and advisors in the last period. It was partly offset by the decrease in travelling expenses due to the outspread of COVID-19 and the decrease in amortization and depreciation due to the disposal of fixed assets in the second half of 2020.

Legal and professional fees were $1.2 million for the six months ended June 30, 2021 compared to $1.5 million for the same period in 2020. The decrease in legal and professional fees was mainly due to the decrease in consultancy services during current period.

As of June 30, 2021, cash and restricted cash totalled approximately $20.1 million and total equity was approximately $26.5 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.

On September 15, 2021 GenesisCare—one of the leading oncology providers in the United States, Australia, Spain, and the United Kingdom—reported that it is collaborating with Lee Health—one of the largest not-for-profit public health systems in Florida—to transform pancreatic patient survival rates (Press release, GenesisCare, SEP 15, 2021, View Source [SID1234587794]). Today the companies announced that their collaborative Florida Center for Pancreas Diseases has been designated a Pancreatic Cancer Center of Excellence (PCCoE) by the National Pancreas Foundation (NPF).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The NPF Center designation is awarded only to institutions offering high-quality, multidisciplinary care that treat the "whole patient," focusing on the best possible outcomes and an improved quality of life.

"Our goal is to provide hope to our patients fighting this dreadful disease using the latest treatment advances available with our world-class multidisciplinary team of over 20 doctors and certified professionals," said Dr. Mark Bloomston, Surgical Oncologist, GenesisCare, and the Founder of the Florida Pancreas Center. "Over the last six years, we have been able to leverage the resources and talent that were already present in the Ft. Myers area and recruit more experts in the field to create an outstanding team. A comprehensive and personalized approach to treating this disease is the only way to truly impact survival rates. We have to be bolder in our approach to treatment if we want to change the trajectory for our patients." Dr. Bloomston was recruited to Southwest Florida in 2015 due to his expertise in gastrointestinal cancers, specifically pancreatic cancer.

"Receiving a cancer diagnosis of any kind is a scary life-altering experience," said Frank Barreiro, a five-year pancreatic cancer survivor treated at the Florida Center for Pancreas Diseases. "Because of the quick efforts of Dr. Bloomston and his team, I’m here today. I’m not just living but thriving. I’m golfing, weightlifting, and fishing again. I’ve seen my daughter graduate high school, college and get married. I was given the gift of five more years with my high school sweetheart, my wife."

In 2021, the American Cancer Society estimates 4,700 Floridians will be diagnosed with pancreatic cancer, a challenging disease to treat because it spreads rapidly and is often found close to other organs.

Physicians at the Florida Pancreas Center treat more cases of pancreatic cancer in a single day than most oncologists see in a lifetime. Patients have access to groundbreaking new treatments before they become standard through the center’s innovative clinical trial program, including oncolytic immunotherapy and irreversible electroporation. The designation as a PCCoE opens the door to new resources. One of them is an MR Linac, a technology that enables the precise targeting of pancreatic cancer cells with real-time MRI imaging to deliver more effective doses of radiation to the tumor while minimizing damage to nearby tissues.

"We now have the opportunity to further improve upon the high-quality care we are providing to hundreds of patients in our community," stated Dr. Bloomston.

"Pancreatic cancer treatment is complex, and patients want to feel confident that they are working with a highly experienced care team with the convenience of receiving that care close to home," said Dan Collins, Founder and CEO, GenesisCare. "Our collaboration with Lee Health brings together Florida’s top pancreatic cancer specialists and the latest treatment advances to meet this need."

"The fastest way to advancing progress against cancer is through collaboration. We will continue to explore partnerships such as this to ensure that no one is left behind when it comes to receiving access to the latest medical breakthroughs and the highest possible quality of care, continued Mr. Collins."

Pancreatic cancer has the highest mortality rate of all major cancers and is the third leading cause of cancer-related deaths in the U.S., surpassed only by lung and colon cancers. Of those diagnosed this year in the U.S., an estimated 80 percent (48,000) will die from the disease.

"After more than five years of planning, we’re launching a collaborative effort, dedicated to ensuring patients facing the bleakest of outcomes may benefit from a team of leading pancreatic cancer specialists," said President & CEO of Lee Health Dr. Larry Antonucci. "Pancreatic cancer is an aggressive and devastating disease that will continue its relentless grasp on our communities if we don’t act. Now is the time for partnerships that seek to overcome obstacles, offer hope, and extend lives."

The Pancreatic Center of Excellence application requires the fulfillment of numerous criteria and dedicated core personnel and specialized physicians who lead multidisciplinary teams. There are only 62 PCCoE facilities in the U.S. This designation allows patients access to evidence-based pathways, multidisciplinary care, participation in clinical trials, ongoing investment in staff training and professional development, and ongoing audits and reviews against a range of quality metrics. The Florida Pancreas Center includes collaboration with Lee Health’s Regional Cancer Center and Lee Physician Group Medical Oncology, and Florida Cancer Specialists. For more information on the Florida Center for Pancreas Diseases. visit View Source

On September 15, 2021 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported that two abstracts highlighting proteomic and genomic data based on their diagnostic tests were presented at the International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer (WCLC) (Press release, Biodesix, SEP 15, 2021, View Source [SID1234587810]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Role of Serum Proteomic Signature in Predicting Survival by PD-L1 Status in Patients with Non-Small Cell Lung Cancer Receiving Immunotherapy
Session P57 – Predictive Tumor Based Assays/ Biomarkers/ Pathology – ICI Biomarkers
An independent study presented by Leeseul Kim, MD of AMITA Health Saint Francis Hospital Evanston, IL, demonstrated that blood-based proteomic testing (Biodesix, Inc.) predicts survival outcomes in patients with non-small cell lung cancer (NSCLC) receiving an immune checkpoint inhibitor (ICI)-based regimen. The authors point out that while immunotherapy is very effective treating many patients with lung cancer, not all patients with lung cancer benefit.

Turnaround Time and Variant Prevalence of a Blood-based KRAS Test in Patients With NSCLC
Session P24 – Liquid Biopsy and Other Non-invasive Diagnostic Modalities – Targeted Therapy
A study presented by Edgardo Santos, MD, Florida Precision Oncology, Aventura, FL, demonstrated that the blood-based GeneStrat test, focusing specifically on the KRAS G12C/V/D+ testing for this analysis, delivered results to ordering clinicians in under 30 hours on average in two large patient cohorts representing a real-world clinical setting, enabling rapid detection of 3 common KRAS mutations across all stages of NSCLC. Expedited time-to-treatment for patients with actionable driver mutations, now including people with NSCLC that have the KRAS G12C mutation (drug Lumakras (sotorasib), Amgen, Inc.) will improve patient access and overall outcomes to the ever-evolving targeted therapies for eligible patients.

"Our mission is to Improve overall patient outcomes and lower healthcare costs by developing diagnostic solutions that reduce ineffective and unnecessary treatments", said Scott Hutton, CEO, Biodesix. "Additionally, it is always our goal to expedite treatment and remain the leader in turn-around times. These abstracts highlight the effectiveness of our approach in utilizing multiple technologies to determine the best treatment plans as rapidly as possible for patients with lung cancer."

On September 15, 2021 ENcell, a contract development and production company specializing in cell therapy, reported on the 15th that it signed a contract manufacturing agreement (CMO) with Ingenium Therapeutics on the 8th for an incurable leukemia treatment (IGNK001) (Press release, Ingenium Therapeutics, SEP 15, 2021, View Source [SID1234643519]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

With this consignment production contract, ENcell will carry out turnkey production of 1/2 phase of samples and investigational drugs (IP) required for clinical trial approval (IND) of an anti-leukemia targeted NK cell therapy based on the Memory-like NK platform.

Jong-wook Jang, CEO of ENCell, said, "We will do our best to ensure that Ingenium Therapeutics’ NK cell therapy product successfully enters clinical trials," and added, "We will implement Ingenium Therapeutics’ latest technology with our GMP technology and know-how." "It will contribute to the development of advanced biopharmaceuticals," he said.

On September 15, 2021 Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported that Johnson Lau, CEO and Board Chairman, and Daniel Lang, Senior Director, Corporate Development will present at the Oppenheimer Fall Healthcare Life Sciences & Med Tech Summit on Wednesday, September 22, 2021 at 10:45 a.m. ET (Press release, Athenex, SEP 15, 2021, View Source [SID1234587731]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live audio webcast of the presentation and replay will be available in the "Events & Presentations" section of the Athenex website at View Source An audio archive of the webcast will also be available on Athenex’s website for the following 90 days.