On September 15, 2021 Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company that utilizes its human memory B cell platform to discover and develop first-in-class antibody therapeutics, reported that Purnanand Sarma, Ph.D., Immunome’s President and CEO, will present at the Oppenheimer Fall Healthcare Life Sciences and MedTech Summit on Tuesday, September 21, 2021, at 9:55 a.m. ET (Press release, Immunome, SEP 15, 2021, View Source [SID1234587768]).

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!

Interested parties can access the live audio webcast for this conference from the Investor Relations section of the company’s website at www.immunome.com. The webcast replay will be available after the conclusion of the live presentation for approximately 30 days.

On September 15, 2021 AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported that it will report financial results for the first quarter of fiscal year 2022 before the market open on Thursday, September 30, 2021 (Press release, AngioDynamics, SEP 15, 2021, View Source [SID1234587767]). The Company’s management will host a conference call at 8:00 a.m. ET the same day to discuss the results.

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!

To participate in the conference call, dial 1-877-407-0784 (domestic) or +1-201-689-8560 (international) and refer to the passcode 13723182.

This conference call will also be webcast and can be accessed from the "Investors" section of the AngioDynamics website at www.angiodynamics.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A recording of the call will also be available from 11:00 a.m. ET on Thursday, September 30, 2021, until 11:59 p.m. ET on Thursday, October 7, 2021. To hear this recording, dial 1-844-512-2921 (domestic) or +1-412-317-6671 (international) and enter the passcode 13723182.

On September 15, 2021 PsiOxus Therapeutics, Ltd. (PsiOxus), a tumor re-engineering company, reported that they will present key safety and translational data from their first-in-human phase 1 FORTITUDE clinical study at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 this week (Press release, PsiOxus Therapeutics, SEP 15, 2021, View Source [SID1234587766]). Data from the completed monotherapy dose-escalation part of the FORTITUDE study, initiated in 2019 to assess the safety and tolerability of the NG-350A T-SIGn vector, will be presented on Friday 16th September 2021, with the poster available in full at www.psioxus.com shortly afterwards.

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!

NG-350A is a T-SIGn vector designed to re-engineer cancers by selectively expressing a CD40 agonist monoclonal antibody, a potent activator of immuno-inflammatory responses, within the tumour microenvironment. PsiOxus is developing this agent as one of several products within its T-SIGn portfolio of vectors that combine systemic delivery with localized production of powerful transgene payloads to allow the selective re-engineering of both primary and metastatic tumors.

The data to be presented at the ESMO (Free ESMO Whitepaper) Congress show that IV delivery of NG-350A results in sustained elevations of inflammatory cytokines in the phase 1 FORTITUDE trial. In particular, marked and persistent dose-dependent increases in both IL-12 and IFNγ were observed after a single 1-week course of NG-350A, indicative of robust activation of antigen presenting cells via CD40 agonism generated within the tumor. Expansion of new T cell clones, a high proportion of which were new clones, was also observed following a single cycle of NG-350A. Safety data from the 25 patients treated with NG-350A as part of the now completed monotherapy dose-escalation part of FORTITUDE demonstrated that NG‑350A was well-tolerated, with few of the adverse events associated with systemic delivery of anti-CD40 agonists observed.

Together, these data suggest NG-350A contributes to the re-programming of the tumour microenvironment while avoiding the toxicity associated with systemic non-localized dosing of anti-CD40 antibodies.

"The headline data shared at the ESMO (Free ESMO Whitepaper) Congress confirms previous findings that our T-SIGn vector replicates selectively in primary tumor cells and metastases and persists for several months after intravenous delivery. Even more importantly, the biomarker data indicates that ongoing vector replication in tumors effectively translates into sustained production of the transgene payload, in this case a CD40 agonistic antibody. This translational data is a first in class demonstration of a downstream effect of tumor re-engineering, using T-SIGn vectors to turn the patient’s tumor cells into small drug factories," said Tom Lille, M.D., Ph.D., Chief Medical Officer, PsiOxus.

Based on these highly promising data, NG-350A will be assessed in combination with an anti–PD-1 checkpoint inhibitor in Part B of FORTITUDE.

On September 15, 2021 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported its support of legislation recently introduced into the U.S. House of Representatives and the U.S. Senate (Press release, Blue Earth Diagnostics, SEP 15, 2021, View Source [SID1234587765]). The bicameral, bipartisan bill, known as the "Facilitating Innovative Nuclear Diagnostics Act," or the FIND Act of 2021 (H.R. 4479/S. 2609), would reform the current Medicare payment system to improve Medicare beneficiaries’ access to innovative technologies and safeguard appropriate payment to hospitals for innovative diagnostic radiopharmaceuticals.

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 U.S. healthcare system relies on diagnostic imaging radiopharmaceuticals and nuclear medicine to inform patient management and assess disease severity and progression across a wide variety of medical conditions. According to the Society of Nuclear Medicine and Molecular Imaging (SNMMI), more than 20 million Americans benefit each year from nuclear medicine procedures1.

Although diagnostic radiopharmaceuticals are appropriately defined by the U.S. Food and Drug Administration as drugs, the Centers for Medicare and Medicaid Services (CMS) categorizes them as "supplies" by packaging them, after an initial three-year period, alongside nuclear medicine services, into "bundles" for procedures that are conducted in hospital outpatient settings. Bundling payment often reimburses only a fraction of the actual cost of newer diagnostic radiopharmaceuticals and impedes the scientific advancement of new products that can help patients. Procedural bundling results in hospitals not receiving appropriate payment, and patients’ access to advanced diagnostic imaging radiopharmaceuticals may be restricted or denied. The FIND Act, if passed, would help give patients greater access to a wide range of advanced diagnostic radiopharmaceuticals for conditions such as prostate and breast cancers, heart disease, Alzheimer’s and Parkinson’s disease, and neuroendocrine tumors.

"Blue Earth Diagnostics is the recognized leader in diagnostic PET prostate cancer imaging, and in line with our commitment to deliver innovative solutions that inform patient care, we fully support legislative passage of the FIND Act," said Terri Wilson, President, Blue Earth Diagnostics, Inc. "The FIND Act can correct CMS payment policies to provide patients with equity in access and payment, and encourage ongoing development of targeted radiopharmaceuticals that can have transformative effects in patient lives."

Further information about the FIND Act of 2021 is available at www.congress.gov (H.R.4479; S.2609).

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.