BERGENBIO ASA: Invitation to first quarter 2020 results webcast presentation

On May 13, 2020 BerGenBio ASA (OSE:BGBIO) reported that it will announce its results for the first quarter 2020 on Tuesday 19 May 2020. A webcast presentation by BerGenBio’s senior management team will take place at 10 am CET (Press release, BerGenBio, MAY 13, 2020, View Source [SID1234557881]).

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The presentation will webcast live and the link will be available at www.bergenbio.com in the section Investors/Financial Reports. A recording will be available shortly after the webcast has finished.

The results report and presentation will be available at www.bergenbio.com in the section: Investors/Financial Reports from 7:00 am CET the same day.

TRILLIUM THERAPEUTICS TO PRESENT DATA ON CD47 BLOCKER TTI-622 IN ADVANCED RELAPSED OR REFRACTORY LYMPHOMA AT THE ASCO20 VIRTUAL SCIENTIFIC PROGRAM

On May 13, 2020 Trillium Therapeutics Inc. ("Trillium" or the "Company") (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported that it will present data on its novel CD47 checkpoint inhibitor, TTI-622, at the Developmental Therapeutics Session of the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program to be held May 29-31, 2020 (Press release, Trillium Therapeutics, MAY 13, 2020, View Source [SID1234557880]). The presentation will highlight a first-in-human study evaluating TTI-622 in patients with advanced relapsed or refractory lymphoma.

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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

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Presentation details are as follows:

Presenter: Krish Patel, MD

Title: Ongoing, First-in-human, Phase 1 Dose Escalation Study of the Investigational CD47-blocker TTI-622 in Patients with Advanced Relapsed or Refractory Lymphoma

Session: Developmental Therapeutics – Immunotherapy

Abstract: 3030

Session Type: Poster Presentation (Poster #94)

The poster will be available on the meeting website beginning Friday, May 29 at 8:00 am ET. A copy of the poster will also be available on the Events and Presentations page of Trillium’s website.

Oncolytics Biotech® to Present at the RBC Global Healthcare Conference

On May 13, 2020 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported that Matt Coffey, President & CEO of Oncolytics Biotech, will present during the RBC Global Healthcare Conference at 1:55 pm Eastern Time on Wednesday, May 20, 2020 (Press release, Oncolytics Biotech, MAY 13, 2020, View Source [SID1234557879]). The conference is being held on May 19 & 20 in a virtual format.

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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

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A live audio link to the webcast session will be available on the Company’s website at View Source It is recommended that listeners log on 10 minutes in advance of the live session to register and download any necessary software. An archived webcast will be accessible approximately two hours following the presentation on the Oncolytics website and will be available for 90 days.

Bristol Myers Squibb and bluebird bio Provide Regulatory Update on Idecabtagene Vicleucel (ide-cel, bb2121) for the Treatment of Patients with Multiple Myeloma

On May 13, 2020 Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE) reported that the companies received a Refusal to File letter from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) for idecabtagene vicleucel (ide-cel; bb2121) for patients with heavily pre-treated relapsed and refractory multiple myeloma, which was submitted in March 2020 (Press release, Bristol-Myers Squibb, MAY 13, 2020, View Source [SID1234557878]).

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Upon preliminary review, the FDA determined that the Chemistry, Manufacturing and Control (CMC) module of the BLA requires further detail to complete the review. No additional clinical or non-clinical data have been requested or are required. Bristol Myers Squibb is planning to resubmit the BLA no later than the end of July 2020.

Bristol Myers Squibb Investor Call and Webcast

Bristol Myers Squibb will hold an investor conference call to discuss this update today at 8:00 a.m. EDT.

Investors are invited to listen to a live webcast of the call at bms.com/investors or by dialing toll free in the U.S. 877-257-8599 or international 1-631-291-4581, confirmation code: 5938714. Please dial in at least 15 minutes in advance to ensure a timely connection to the call.

bluebird bio Investor Call and Webcast
bluebird bio will hold an investor conference call to discuss the update today at 8:45 a.m. EDT.

Investors are invited to listen to a live webcast of the call on the investors page of www.bluebirdbio.com or by dialing toll free in the U.S. (844) 825-4408 or international (315) 625-3227, confirmation code: 2892826. Please dial in at least 15 minutes in advance to ensure a timely connection to the call.

For Holders of Contingent Value Rights (CVR), Ticker BMY-RT

U.S. FDA approval of ide-cel by March 31, 2021 is one of the required remaining milestones of the Contingent Value Rights issued upon the close of the Celgene acquisition in the fourth quarter of 2019. The other is U.S. FDA approval of liso-cel by December 31, 2020. The company is committed to working with FDA to progress both applications and achieve the remaining regulatory milestones required by the CVR.

About Ide-cel

Ide-cel is a B-cell maturation antigen (BCMA)-directed genetically modified autologous chimeric antigen receptor (CAR) T cell immunotherapy. The ide-cel CAR is comprised of a murine extracellular single-chain variable fragment (scFv) specific for recognizing BCMA, attached to a human CD8 α hinge and transmembrane domain fused to the T cell cytoplasmic signaling domains of CD137 4-1BB and CD3-ζ chain, in tandem. Ide-cel recognizes and binds to BCMA on the surface of multiple myeloma cells leading to CAR T cell proliferation, cytokine secretion, and subsequent cytolytic killing of BCMA-expressing cells.

In addition to the pivotal KarMMa trial evaluating ide-cel in patients with relapsed and refractory multiple myeloma, Bristol Myers Squibb and bluebird bio’s broad clinical development program for ide-cel includes clinical studies (KarMMa-2, KarMMa-3, KarMMa-4) in earlier lines of treatment for patients with multiple myeloma, including newly diagnosed multiple myeloma. For more information visit clinicaltrials.gov.

Ide-cel was granted Breakthrough Therapy Designation (BTD) by the FDA and PRIority Medicines (PRIME) designation, as well as Accelerated Assessment status, by the European Medicines Agency for relapsed and refractory multiple myeloma.

Ide-cel is being developed as part of a Co-Development, Co-Promotion and Profit Share Agreement between Bristol Myers Squibb and bluebird bio.

Bristol Myers Squibb: Advancing Cancer Research

At Bristol Myers Squibb, patients are at the center of everything we do. The goal of our cancer research is to increase patients’ quality of life, long-term survival and make cure a possibility. We harness our deep scientific experience, cutting-edge technologies and discovery platforms to discover, develop and deliver novel treatments for patients.

Building upon our transformative work and legacy in hematology and Immuno-Oncology that has changed survival expectations for many cancers, our researchers are advancing a deep and diverse pipeline across multiple modalities. In the field of immune cell therapy, this includes registrational CAR T cell agents for numerous diseases, and a growing early-stage pipeline that expands cell and gene therapy targets, and technologies. We are developing cancer treatments directed at key biological pathways using our protein homeostasis platform, a research capability that has been the basis of our approved therapies for multiple myeloma and several promising compounds in early- to mid-stage development. Our scientists are targeting different immune system pathways to address interactions between tumors, the microenvironment and the immune system to further expand upon the progress we have made and help more patients respond to treatment. Combining these approaches is key to delivering potential new options for the treatment of cancer and addressing the growing issue of resistance to immunotherapy. We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines a reality for patients.

ProMIS Neurosciences Announces First Quarter 2020 Results

On May 13, 2020 ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF) ("ProMIS or the Company"), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, reported its operational and financial results for the three months ended March 31, 2020 (Press release, ProMIS Neurosciences, MAY 13, 2020, View Source [SID1234557877]).

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"Over the course of the first quarter 2020, the value of our unique discovery and development platform was further evidenced as ProMIS made considerable progress in expanding its portfolio of opportunities across multiple neurodegenerative diseases," stated Eugene Williams, ProMIS’ Executive Chairman.

"PMN310, our lead antibody therapeutic candidate for Alzheimer’s disease (AD), showed further significant positive differentiation in both potential efficacy and safety compared to competitive antibody therapeutics currently in development. In addition, antibody candidates selectively targeting toxic forms of alpha-synuclein for Parkinson’s disease, toxic aggregated forms of TDP- 43 for amyotrophic lateral sclerosis (ALS) and toxic aggregates of tau for AD and other dementias were identified and further characterized to support collaborative partnering discussions."

Corporate Highlights

In January and February 2020, we received proceeds from the exercise of warrants in the amount of $958,000.
In January 2020, José Luis Molinuevo, MD, PhD, was appointed to the Company’s Scientific Advisory Board.
In February, we announced initiation of a natural history study of blood-based biomarkers in Alzheimer’s disease in collaboration with Toronto Memory Program, Canada’s largest and most experienced memory clinic and site for drug treatment trials in AD.
In March 2020, we announced that the Toronto Stock exchange approved the amendment of the exercise price of an aggregate of 44,182,530 outstanding common share purchase warrants. The exercise price of the warrants is being repriced to $0.13 effective April 8, 2020 until May 22, 2020.
Financial Results

Results of Operations – Three months ended March 31, 2020 and 2019

Net loss for the three months ended March 31, 2020 was $1,761,919, compared to a net loss of $2,446,577 for the three months ended March 31, 2019. Included in the net loss amount for the three months ended March 31, 2020 were non-cash expenses of $213,739, representing share-based compensation, warrant modification and amortization of an intangible asset, compared to $263,872 for the three months ended March 31, 2019. The decrease in the net loss for the three months ended March 31, 2020 reflects decreased costs associated with external contract research organizations for internal programs, patent costs, decreased consultant salaries and associated costs and share-based compensation offset by warrant modification.

Research and development expenses for the three months ended March 31, 2020 were $973,586, as compared to $1,770,653 in the three months ended March 31, 2019. The decrease in research and development expense for the three months ended March 31, 2020, compared to the same period ended March 31, 2019 is primarily attributed to decreased spending on external contract research organizations for internal programs, reduced patent expense and share-based compensation offset by increased contracted research salaries and associated costs and external consulting expense.

General and administrative expenses for the three months ended March 31, 2020 were $788,346, as compared to $675,924 in the three months ended March 31, 2019. The increase for the three months ended March 31, 2020, compared to the same period in 2019, is primarily attributable to the warrant modification expense.

Outlook

As a prelude to the first PMN310 clinical trial in AD, ProMIS anticipates using a novel biomarker approach that may show evidence of slowing of neuronal death early in the development program. To accomplish this, we initiated the pilot phase of a natural history evaluation of biomarker changes in untreated, mild AD patients in February 2020.

The Company will also continue to further characterize the potential benefits of its programs selectively targeting toxic aggregates of TDP-43 in ALS, toxic forms of alpha-synuclein in PD and toxic aggregates of tau in AD and other dementias to further support on-going pharmaceutical partnering discussions. ProMIS’ unique platform produces antibodies that meet a key success factor for development of therapeutics for neurodegenerative diseases: the ability to selectively target the neurotoxic form of a protein implicated as a root cause of disease, while sparing the normal forms of the protein.

In the infectious disease setting, we will focus our unique technology platform to identify peptide antigens that can be used as an essential component to create accurate and sensitive serological assays to detect the presence of antibodies that arise in response to a specific infection, such as COVID-19.