Anixa Biosciences Announces Genesis Research to Join Cchek™ Prostate Cancer Study

On November 26, 2019 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on harnessing the body’s immune system in the fight against cancer, reported the addition of Genesis Research, LLC to the ongoing Cchek prostate cancer detection study (Press release, Anixa Biosciences, NOV 26, 2019, View Source [SID1234551680]).

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Genesis Research, LLC the research arm of Genesis Healthcare Partners, based in San Diego, CA, joins a large and growing team of collaborators advancing Anixa’s Cchek artificial intelligence driven liquid biopsy technology toward commercialization. Genesis Research will provide patient samples in support of clinical validation of Anixa’s Cchek Prostate Cancer Confirmation test.

Study enrollment will be led by Genesis Research’s Medical Director, Dr. Paul Dato. Dr. Dato commented, "This is an exciting opportunity for research personnel at Genesis Healthcare Partners to collaborate with Anixa and explore the potential of immune cells to detect the presence of Prostate Cancer."

Dr. Franklin Gaylis, Chief Scientific Officer at Genesis Healthcare Partners, has endorsed the collaboration between the two organizations and commented, "Genesis Healthcare Partners has an active research program focused on the early detection of Prostate Cancer. Our collaboration with Anixa provides a great opportunity to explore the potential for developing a liquid biopsy for detecting Prostate Cancer."

Amit Kumar, Ph.D., Chief Executive Officer of Anixa stated, "We are pleased to have Genesis Research join our expanding group of Cchek collaboration partners. Our team of collaborators have been and continue to be instrumental in the development of our early cancer detection technology. We look forward to Genesis Research’s participation as we prepare for commercial launch of the Cchek Prostate Cancer Confirmation test in the coming weeks."

About Cchek
Cchek is an early cancer detection technology, that measures a patient’s immunological response to a malignancy by analyzing immune system cells in peripheral blood. The goal is to utilize the technology to determine a patient’s cancer status from a simple blood draw, eliminating the need for a biopsy, which can be an expensive, painful and invasive procedure. Further, conventional methods using current cancer screening tests often lack accuracy and reliability. Anixa’s orthogonal approach using flow cytometry coupled with artificial intelligence provides an alternative method that offers improved affordability, efficacy and efficiency. To date, Anixa has successfully used Cchek to detect the presence of 20 different cancers including lung, colon, breast and prostate. The robust cancer detection performance of Cchek makes it a platform from which multiple cancer diagnostic tests may be developed. The first such test, a prostate cancer confirmation test, is slated for commercial launch by the end of 2019.

Genesis Research, LLC
Genesis Research is the wholly owned research subsidiary of Genesis Healthcare Partners, San Diego’s largest premier multi-specialty independent private physician practice, dedicated to the diagnosis and treatment of urologic conditions, digestive health issues and many cancers. With 15 offices located throughout San Diego County, Genesis Healthcare Partners’ team of medical professionals provides access to cutting-edge technology and minimally invasive treatments. Additional information is available at www.mygenesishealth.com.

Axial Biotherapeutics to Present at the 31st Annual Piper Jaffray Healthcare Conference

On November 26, 2019 Axial Biotherapeutics, a biotechnology company dedicated to building a unique class of gut-targeted programs for neurodegenerative diseases and neurodevelopmental disorders, reported that the company will present a company overview at the 31st Annual Piper Jaffray Healthcare Conference on Tuesday, December 3, 2019 at 1:10 PM ET in New York, NY (Press release, Axial Biotherapeutics, NOV 26, 2019, View Source [SID1234551697]).

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BioLineRx to Host Investor and Analyst Breakfast Meeting on December 5, 2019 in New York

On November 26, 2019 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology, reported that it will host an investor breakfast meeting on Thursday, December 5, 2019 at the Convene Conference Center near Grand Central Terminal in New York, N.Y (Press release, BioLineRx, NOV 26, 2019, View Source [SID1234551713]).

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The investor meeting schedule is as follows:

7:45 am EST – Registration and breakfast
8:10-9:30 am EST – Formal presentations

Location:

Convene Conference Center
237 Park Avenue (on 46th St. between Park and Lex)
New York, N.Y.
(888) 730-7307

The event will feature a presentation by Talia Golan, MD, from The Chaim Sheba Medical Center, who will discuss the current treatment landscape as well as the unmet medical need for treating patients with metastatic pancreatic adenocarcinoma (PDAC). Dr. Golan will be available to answer questions at the conclusion of the event.

BioLineRx’s management team will also provide an update on the COMBAT/KEYNOTE-202 triple combination study in metastatic PDAC under its collaboration with Merck. In addition, the management team will provide a comprehensive overview of the Company’s other developments for BL-8040, as well as its second lead asset, AGI-134. BL-8040 is a novel short synthetic peptide that functions as a high-affinity antagonist for CXCR4, which BioLineRx is developing for the treatment of solid tumors, acute myeloid leukemia (AML) and stem-cell mobilization for bone-marrow transplantation. AGI-134, a synthetic αGal novel immunotherapy, is currently in Phase 1/2a development for solid tumors.

Talia Golan, MD is a clinician-scientist currently conducting translational laboratory research while also serving as medical director of the Phase I Unit and the Pancreatic Cancer (PC) Center at Sheba Medical Center in Tel Aviv, one of the leading medical centers in the world. Her clinical interest is in patients with pancreatic cancer. Dr. Golan’s career goals include expertise in clinical medicine, translational laboratory research, and drug development. Dr Golan is PI on multiple early-phase trials on immune modulators. Her clinical and research expertise focuses on the understanding and treatment of hereditary pancreatic cancer patients. Dr. Golan is co-global PI of the first biomarker-selected (BRCA) Phase III clinical trial in PC, the POLO study. Dr. Golan’s translational research lab, established in 2011, is an integral part of the Sheba Pancreatic Cancer Program (SPCC). The research in the lab focuses on improving the standard of care options for pancreatic cancer patients by both finding targeted treatments tailored for each patient based on his own genetic background and developing state of the art early detection methodology. Disease heterogeneity and late detection are still the main challenges of pancreatic cancer treatment.

This event is intended for institutional investors, sell-side analysts, investment bankers, and business development professionals only. Please RSVP in advance if you plan to attend, as space is limited. For those who are unable to attend in person, a live webcast and replay of the event will be accessible here. If you would like to ask a question during the live Q&A portion of the event, please submit your request via email.

Medicure Reports Financial Results for Quarter Ended September 30, 2019

On November 26, 2019 Medicure Inc. ("Medicure" or the "Company") (TSXV:MPH, OTC:MCUJF), a cardiovascular pharmaceutical company, reported its results from operations for the quarter ended September 30, 2019 (Press release, Medicure, NOV 26, 2019, View Source [SID1234551730]).

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Quarter Ended September 30, 2019 Highlights:

Recorded net revenue from the sale of AGGRASTAT (tirofiban hydrochloride) of $5.3 million during the quarter ended September 30, 2019 compared to $7.0 million for the quarter ended September 30, 2018;

$35.7 million in cash as at September 30, 2019;

Adjusted earnings before interest, taxes, depreciation and amortization (EBITDA1) for the quarter ended September 30, 2019 was negative $319,000 compared to adjusted EBITDA of $599,000 for the quarter ended September 30, 2018; and

Net loss for the quarter ended September 30, 2019 was $599,000 compared to net loss of $545,000 for the quarter ended September 30, 2018.
Financial Results

Net revenues for the three months ended September 30, 2019 were $5.5 million compared to $7.4 million for the three months ended September 30, 2018. Net revenues from AGGRASTAT for the three months ended September 30, 2019 were $5.3 million compared to $7.0 million for the three months ended September 30, 2018. Additionally, ReDSTM, contributed $117,000 of net revenue for the three months ended September 30, 2019 and ZYPITAMAGTM contributed $78,000 compared to $326,000 during the three months ended September 30, 2018 following the launch of the product in 2018.

Net revenues for the nine months ended September 30, 2019 were $16.7 million compared to $21.2 million for the nine months ended September 30, 2018. Net revenues from AGGRASTAT for the nine months ended September 30, 2019 were $16.3 million compared to $20.3 million for the nine months ended September 30, 2018. Additionally, ReDSTM contributed $272,000 and ZYPITAMAGTM contributed $87,000 of net revenue for the nine months ended September 30, 2019. The nine months ended September 30, 2018 contained $932,000 of revenue from ZYPITAMAGTM following the launch of the product in 2018.

The Company continued to experience strong patient market share and strong hospital demand for AGGRASTAT during the three and nine months ended September 30, 2019, however this was offset by increased price competition that resulted in lower discounted prices for AGGRASTAT throughout the quarter.

Diversification of revenues remains an important aspect of the Company’s focus with Medicure concentrating on the sales and marketing of AGGRASTAT, growing the sales of ZYPITAMAGTM (pitavastatin) and marketing the ReDSTM system.

Adjusted EBITDA for the three months ended September 30, 2019 was negative $319,000 compared to $599,000 for the three months ended September 30, 2018. The decrease in adjusted EBITDA for the three months ended September 30, 2019 is the result of the lower revenues experienced during the quarter ended September 30, 2019.

Adjusted EBITDA for the nine months ended September 30, 2019 was negative $1.9 million compared to $2.5 million for the nine months ended September 30, 2018. The decrease in adjusted EBITDA for the nine months ended September 30, 2019 is the result of lower revenues experienced during the nine months ended September 30, 2019.

Net loss for the three months ended September 30, 2019 was $599,000 or $0.04 per share. This compares to net loss of $545,000 or $0.03 per share for the three months ended September 30, 2018. Net loss for the three months ended September 30, 2019 is the result of lower revenues experienced during the quarter and a write-down of expiring ZYPITAMAGTM inventory of $578,000 partially offset by a foreign exchange gain relating to an increase in the value of the U.S. dollar experienced during the quarter ended September 30, 2019.

Net loss for the nine months ended September 30, 2019 was $4.3 million or $0.28 per share. This compares to net income of $2.4 million or $0.15 per share for the nine months ended September 30, 2018. Net loss for the nine months ended September 30, 2019 is the result of lower revenues, experienced during the period, a write-down of expiring ZYPITAMAGTM inventory of $578,000 and a foreign exchange loss relating to a decrease in the value of the U.S. dollar experienced during the nine months ended September 30, 2019.

At September 30, 2019, the Company had unrestricted cash totaling $35.7 million compared to $71.9 million of cash and short-term investments as of December 31, 2018. The decrease in cash is primarily due to the investment of U.S. $10 million made in Sensible Medical Innovations Ltd., the acquisition of full ZYPITAMAGTM rights acquired during the third quarter for US$5 million and the purchase of $4.1 million of the Company’s common shares under its normal course issuer bid, a significant reduction in the Company’s accounts payable and accrued liabilities and a decrease in the value of the U.S. dollar as at September 30, 2019 compared to December 31, 2018. Cash flows used in operating activities for the nine months ended September 30, 2019 totaled $10.9 million.

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

Notes

(1) The Company defines EBITDA as "earnings before interest, taxes, depreciation, amortization and other income or expense" and Adjusted EBITDA as "EBITDA adjusted for non-cash and non-recurring items, including the write-down of inventory". The terms "EBITDA" and "Adjusted EBITDA", as it relates to the three and nine months ended September 30, 2019 and 2018 results prepared using International Financial Reporting Standards ("IFRS"), do not have any standardized meaning according to IFRS. It is therefore unlikely to be comparable to similar measures presented by other companies.

Conference Call Info:

Topic: Medicure’s Q3 2019 Results

Call date: Wednesday, November 27, 2019

Time: 7:30 AM Central Time (8:30 AM Eastern Time)

Canada toll-free: 1 (888) 465-5079 Canada toll: 1 (416) 216-4169

United States toll-free: 1 (888) 545-0687

Passcode: 7343307#

Webcast: This conference call will be webcast live over the internet and can be accessed from the Medicure investor relations page at the following link: View Source

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.

Bristol-Myers Squibb to Hold Investor Webcast to Discuss ASH Highlights

On November 26, 2019 Bristol-Myers Squibb Company (NYSE: BMY) reported that it will hold an investor webcast on Sunday, December 8, 2019 at 8:00 p.m. ET to discuss data presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) meeting, in Orlando (Press release, Bristol-Myers Squibb, NOV 26, 2019, View Source [SID1234551681]). Company executives will provide an overview of data presented and address questions from investors and analysts.

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Investors and the general public are invited to listen to a live webcast of the event at investor.bms.com. Materials related to the event will be available at the same website prior to the event. A replay of the event will be available and can be accessed at investor.bms.com.