On November 22, 2021 Medicure Inc. ("Medicure" or the "Company") (TSXV: MPH) (OTC: MCUJF), a company focused on the development and commercialization of pharmaceuticals and healthcare products for patients and prescribers in the United States market, reported its results from operations for the quarter ended September 30, 2021 (Press release, Medicure, NOV 22, 2021, View Source [SID1234595933]).

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!

Quarter Ended September 30, 2021 Highlights:

Recorded total net revenue from the sale of products of $4.9 million during the quarter ended September 30, 2021 compared to $3.5 million for the quarter ended September 30, 2020;
Recorded total net revenue from the sale of AGGRASTAT of $2.9 million during the quarter ended September 30, 2021 compared to $3.4 million for the quarter ended September 30, 2020;
Adjusted earnings before interest, taxes, depreciation and amortization (EBITDA1) for the quarter ended September 30, 2021 was $282,000 compared to adjusted EBITDA of $4,000 for the quarter ended September 30, 2020;
Net loss for the quarter ended September 30, 2021 was $946,000 compared to a net loss of $1.05 Million for the quarter ended September 30, 2020
Financial Results

Net revenues for the three months ended September 30, 2021 were $4.9 million compared to $3.5 million for the three months ended September 30, 2020. Net revenues from AGGRASTAT for the three months ended September 30, 2021 were $2.9 million compared to $3.4 million for the three months ended September 30, 2020. ZYPITAMAG contributed $388,000 for the three months ended September 30, 2021, compared to $105,000 for the three months ended September 30, 2020. Marley Drug, which was acquired in December 2020, contributed $1.64 million for the three months ended September 30, 2021.

Net revenues for the nine months ended September 30, 2021 were $14.9 million compared to $9.2 million for the nine months ended September 30, 2020. Net revenues from AGGRASTAT for the nine months ended September 30, 2021 were $8.3 million compared to $8.7 million for the nine months ended September 30, 2020. ZYPITAMAG contributed $941,000 for the nine months ended September 30, 2021 compared to $371,000 for the nine months ended September 30, 2020. Marley Drug contributed $5.62 million for the nine months ended September 30, 2021. Additionally, SNP contributed $66,000, during the nine months ended September 30, 2021, compared to $53,000 for the nine months ended September 30, 2020.

The volume of AGGRASTAT sold in Q3, 2021 was consistent with demand in Q3, 2020. The Company continues to show strong patient market share with AGGRASTAT, and demand from hospitals, driven by the Company’s sales and marketing team. There was an increase in demand for ZYPITAMAG, which was facilitated by sale through Marley Drug and the Company expects growth in ZYPITAMAG revenues going forward. Marley Drug sales remain consistent, and the Company expects growth in sales as marketing is expanded.

Adjusted EBITDA for Q3, 2021 was $282,000 compared to $4,000 for Q3, 2020. The increase in adjusted EBITDA for Q3, 2021 is the result of changes in research and development spending and the recovery of a liability associated with PREXXARTAN.

Adjusted EBITDA for the nine months ended September 30, 2021 was $471,000 compared to negative $1.02 million for the nine months ended September 30, 2020. The improvement in adjusted EBITDA for the nine months ended September 30, 2020 is the result of lower selling and research and development expenses and increasing revenues with Marley Drug and ZYPITAMAG sales and the recovery of a liability associated with PREXXARTAN.

Net loss for the three months ended September 30, 2021 was $946,000 or $0.09 per share compared to net loss of $1.05 Million or $0.10 per share for the three months ended September 30, 2020.

Net loss for the nine months ended September 30, 2021 was $2.6 million or $0.26 per share compared to $2.5 million or $0.23 per share for the nine months ended September 30, 2020. The loss per share increased due to a reduced share count due to the NCIB that took place during 2020.

At September 30, 2021, the Company had unrestricted cash totaling $3.3 million up from the $2.7 million of unrestricted cash held as of December 31, 2020. Cash flows from operating activities for the nine months ended September 30, 2021 totaled $1.82 million compared to cash flows used in operating activities of $1.05 million for the nine months ended September 30, 2020.

All amounts referenced herein are in Canadian dollars unless otherwise noted.

You may request international country-specific access information by e-mailing the Company in advance. Management will accept and answer questions related to the financial results and operations during the question-and-answer period at the end of the conference call. A recording of the call will be available following the event at the Company’s website.

On November 22, 2021 Quirónsalud, the largest private hospital group in Spain and part of Fresenius Helios, reported that it has signed agreements to acquire Centro Oncológico de Antioquia (COA) and Clínica Clofán, further expanding the company’s presence in Colombia (Press release, Fresenius, NOV 22, 2021, View Source [SID1234595954]). The clinics, located in Colombia’s second largest city Medellín, will become part of Quirónsalud’s existing healthcare network in the country, which already comprises six hospitals and ten diagnostic centers.

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!

COA is specialized in the diagnosis and treatment of cancer. It has 75 beds, four operating rooms, and specialized centers for nuclear medicine, radiotherapy and bone marrow transplants. Clínica Clofán is the second largest ophthalmic center in the city, with ten operating rooms and further dedicated facilities for treating even severe ophthalmic diseases and performing complex procedures.

Both clinics offer state-of-the-art medical standards and technology to their patients and are regarded as leading medical facilities with highly renowned physicians. Together they generate sales of around €30 million.

The acquisition is another important step in strengthening Fresenius Helios’ presence in the growing and consolidating healthcare services markets in Latin America.

The transaction is expected to close in the first quarter of 2022, pending anti-trust clearance of the Colombian authorities. Fresenius Helios expects the acquisition to be accretive to Fresenius’ Group net income already in fiscal year 2022.

On November 22, 2021 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported the successful completion of the acquisition of Acceleron Pharma Inc. (Nasdaq: XLRN) Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported the successful completion of the acquisition of Acceleron Pharma Inc. (Nasdaq: XLRN) (Press release, Merck & Co, NOV 22, 2021, View Source [SID1234595881]).

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!

"This is an important and strategic opportunity for our company to continue growing our cardiovascular portfolio and pipeline, that builds on our long and proud legacy in cardiovascular disease and further bolsters our business development strategy," said Rob Davis, chief executive officer and president, Merck. "Fueled by Acceleron’s groundbreaking research, we are excited to explore the opportunities and possibilities ahead to reach even more patients by addressing this critical health need."

Acceleron is focused on harnessing the power of the transforming growth factor (TGF)-beta superfamily of proteins that is known to play a central role in the regulation of cell growth, differentiation and repair. Acceleron’s lead therapeutic candidate, sotatercept, has a novel mechanism of action with the potential to improve short-term and/or long-term clinical outcomes in patients with pulmonary arterial hypertension (PAH), a progressive and life-threatening blood vessel disorder. Sotatercept is in Phase 3 trials as add-on to current standard of care for the treatment of PAH.

On November 22, 2021 Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) reported financial results for its fiscal year ended September 30, 2021 (Press release, Arrowhead Research Corporation, NOV 22, 2021, View Source [SID1234595900]). The company is hosting a conference call today, November 22, 2021, at 4:30 p.m. ET 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!

Conference Call and Webcast Details

Investors may access a live audio webcast on the Company’s website at View Source For analysts that wish to participate in the conference call, please dial 855-215-6159 or 315-625-6887 and provide Conference ID 8074256.

A replay of the webcast will be available on the company’s website approximately two hours after the conclusion of the call and will remain available for 90 days. An audio replay will also be available approximately two hours after the conclusion of the call and will be available for 3 days. To access the audio replay, dial 855-859-2056 or 404-537-3406 and provide Conference ID 8074256.

Selected Recent Events

Entered into an exclusive license agreement with GlaxoSmithKline (GSK) under which GSK will develop and commercialize ARO-HSD, Arrowhead’s investigational RNA interference (RNAi) therapeutic in a Phase 1/2 trial that is currently being developed as a treatment for patients with nonalcoholic steatohepatitis (NASH)
Presented new clinical data at The Liver Meeting, the Annual Meeting of the American Association for the Study of Liver Disease (AASLD), for the following investigational candidates:
JNJ-73763989 (JNJ-3989), formerly called ARO-HBV, being developed by collaborator Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen)
ARO-HSD, the investigational RNAi therapeutic being developed as a treatment for patients with NASH and recently licensed to GSK
ARO-AAT, also known as TAK-999, the investigational RNAi therapeutic being co-developed with Takeda Pharmaceutical Company Limited as a treatment for the rare genetic liver disease associated with alpha-1 antitrypsin deficiency
Presented additional Phase 1/2 clinical data on ARO-APOC3, the investigational RNA RNAi therapeutic targeting apolipoprotein C-III (APOC3) being developed as a treatment for patients with hypertriglyceridemia, severe hypertriglyceridemia, and familial chylomicronemia syndrome, at the American Heart Association (AHA) Scientific Sessions 2021
Initiated and began dosing patients in AROAPOC3-2002, now called MUIR, a Phase 2b clinical study of ARO-APOC3
Initiated and began dosing patients in AROANG3-2001, now called ARCHES-2, a Phase 2b clinical study of ARO-ANG3, the company’s investigational RNAi therapeutic being developed as a treatment for patients with mixed dyslipidemia
Received Breakthrough Therapy designation from the U.S. Food and Drug Administration for ARO-AAT
Announced that Janssen disclosed its collaboration with Arrowhead on investigational compound JNJ-75220795, which in a Phase 1 clinical study and is designed to reduce expression in the liver of patatin like phospholipase domain containing 3 (PNPLA3) as a potential treatment for patients with NASH
Earned a $10 million milestone from Janssen after Janssen dosed the fifth patient in a Phase 1 clinical study
Filed a CTA to begin clinical studies of previously undisclosed candidate ARO-C3, an investigational therapeutic designed to reduce production of complement component 3 as a potential therapy for various complement mediated diseases, and hosted a key opinion leader webinar to discuss the complement pathway and the diseases Arrowhead will initially focus on

On November 22, 2021 NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX) (Paris:ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported that new data from the ongoing Phase 1/2 GLORIA trial with NOX-A12 and radiotherapy in brain cancer (glioblastoma multiforme, GBM) were presented at the Society for Neuro-Oncology (SNO) Annual Meeting (Press release, NOXXON, NOV 22, 2021, View Source [SID1234595917]). The presentation was held by Frank A. Giordano, M.D., Director and Chair of the Department of Radiation Oncology, University Hospital Bonn, Germany, and lead investigator of the ongoing GLORIA study.

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 oral presentation, entitled "CXCL12 inhibition in MGMT unmethylated glioblastoma – results of an early proof-of-concept assessment in the multicentric phase I/II GLORIA trial", included results from 9 chemotherapy refractory (MGMT promoter unmethylated) patients participating in the proof-of-concept study on CXCL12 inhibition during and after radiotherapy of glioblastoma. Eight of 9 patients (89%) receiving NOX-A12 showed reductions in tumor size (2 patients with objective responses [>50% reduction] and 6 patients with stable disease [<50% reduction], while one patient progressed. These results compare favorably with historic patient outcomes from a matched cohort that received standard of care, where only 1 out of 13 patients (8%) showed a reduction in tumor size with an objective response and 12 patients’ tumors progressed.

Also, data from tissue analysis of a patient on NOX-A12 therapy shows [1] a significant reduction of the NOX-A12 target, CXCL12, on tumor blood vessels, [2] a significant decrease in tumor cell proliferation and [3] an increase in tumor infiltration of activated killer immune cells. Interestingly and very importantly, such benefits were observed across all available tumor tissue and not only in small subsections.

These benefits are strongly supportive of the dual mechanism of action of NOX-A12:
– inhibiting repair of blood vessels damaged by radiotherapy
– promoting of immune-response
This dual mechanism of action could prove transformational since this is not consistently observed in historical samples including patients treated with immune checkpoint inhibitors.

"The data presented by Dr. Giordano at the SNO meeting are a significant step forward in bringing NOX-A12 to glioblastoma patients. While a diagnosis of chemotherapy-resistant glioblastoma leads almost inevitably to systematic rapid progression of the disease, NOX-A12 combined with radiotherapy managed to achieve stable disease or an objective response in 8 out of the 9 patients. We very much look forward to presenting and explaining the transformational nature of these new data at our upcoming KOL event on Tuesday, November 23, when Dr. Giordano will also be available to answer questions," commented Aram Mangasarian, CEO of NOXXON.

Details of the Key Opinion Leader webinar are as follows:
Title: NOX-A12 and Radiotherapy combination: A Differentiated and Promising New Approach to Treating Brain Cancer
Presenter: Dr. Frank A. Giordano, Director and Chair of the Department of Radiation Oncology, University Hospital Bonn, Germany
Webinar time and date: November 23, 2021 at 02:00 p.m. CET (08:00 a.m. EST)
Registration: To register for the event, please click here

NOX-A12 acts via a unique mechanism of action, which was confirmed by the presented results: by removing the CXCL12 chemokine from the tumor blood vessels the revascularization of the irradiated tumor area is blocked and a significant increase in activated killer immune cell infiltration to the tumor can be seen.

More information about the GLORIA study can be found at ClinicalTrials.gov number NCT04121455.

Dr. Frank A. Giordano, is Director and Chair of the Department of Radiation Oncology at the University Hospital Bonn, Germany. He is an expert in precision radiation therapy and intraoperative irradiation of malignant tumors and has received international recognition for his brain tumor research, including an award from the American Society of Radiation Oncology (ASTRO) and an honorary membership of the Spanish Society of Radiation Oncology (SEOR). Dr. Giordano received his medical degree from the University of Heidelberg, Germany, and did his post-doctoral training as a Peter Engelhorn fellow at the German Cancer Research Center (DKFZ). He received clinical training at the National Center for Tumor Diseases (NCT) Heidelberg and the University Medical Center Mannheim, where he served as acting chairman and director of the Department of Radiation Oncology before moving to Bonn. For many years, his research has focused on optimized radiation therapy of brain cancers to offer cancer patients personalized and even more effective treatment. As one of the few Else-Kröner-Fresenius Excellence Fellows, Dr. Giordano developed innovative therapy options that even found their way in clinical practice. He sees great potential in the combination of radiotherapy and immunomodulatory therapy.