On October 2, 2020 BrainStorm-Cell Therapeutics Inc. (NASDAQ: BCLI), a leader in developing innovative autologous cellular therapies for highly debilitating neurodegenerative diseases, reported that the Company will hold a conference call to update shareholders on financial results for the third quarter ended September 30, 2020, and provide a corporate update, at 8:00 a.m., Eastern Daylight Time (EDT), on October 15, 2020 (Press release, BrainStorm Cell Therapeutics, OCT 2, 2020, View Source [SID1234568000]).

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BrainStorm’s CEO, Chaim Lebovits, will present a corporate update, after which, participant questions will be answered. Joining Mr. Lebovits to answer investment community questions will be Ralph Kern, MD, MHSc, President and Chief Medical Officer, David Setboun, PharmD, MBA, Executive Vice President and Chief Operating Officer, and Preetam Shah, PhD, MBA, Executive Vice President and Chief Financial Officer.

Participants are encouraged to submit their questions prior to the call by sending them to: [email protected]. Questions should be submitted by 5:00 p.m. EDT, Tuesday, October 13, 2020.

Teleconference Details – BRAINSTORM CELL THERAPEUTICS 3Q 2020

The investment community may participate in the conference call by dialing the following numbers:

Those interested in listening to the conference call live via the internet may do so by visiting the "Investors & Media" page of BrainStorm’s website at www.ir.brainstorm-cell.com and clicking on the conference call link.

Event Link: Webcast URL: https://bit.ly/30pVpNG
Webcast Replay Expiration: Friday, October 15, 2021

Those that wish to listen to the replay of the conference call can do so by dialing the numbers below. The replay will be available for 14 days.

About NurOwn

NurOwn (autologous MSC-NTF) cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm has fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received acceptance from the U.S. Food and Drug Administration (FDA) to initiate a Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS) and initiated enrollment in March 2019.

On October 2, 2020 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported that research conducted at the New York Blood Center investigating the impact of CID-103 on RBC pretransfusion test methods, will be presented at the American Association of Blood Banks (AABB) Virtual Annual Meeting being held October 3-5, 2020 (Press release, CASI Pharmaceuticals, OCT 2, 2020, View Source [SID1234567997]).

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Session: Plenary Oral Abstract Session
Title: CID-103, an Anti-CD38 Monoclonal Antibody Demonstrates Decreased RBC Binding and Decreased Interference with Pretransfusion Test Methods
Poster Number: P-IG-9
Date/Time: Sunday, Oct. 4 from 1:15-2:15pm ET

About CID-103 (Anti-CD38 Mab)

CID-103 is a fully human IgG1 anti-CD38 monoclonal antibody recognizing a unique epitope. Preclinical data demonstrate CID-103 to have enhanced activity against a broad array of malignancies which express CD38, and potentially better preclinical efficacy and safety profile when compared to other CD38 monoclonal antibodies. CASI has exclusive global rights to CID-103 and expects to initiate Phase 1 trials in early 2021.

On October 2, 2020 Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA, reported that its Signatera molecular residual disease (MRD) test will be used in the DARE study, a multi-center clinical trial of palbociclib (IBRANCE), a CDK4/6 inhibitor developed by Pfizer for the treatment of HR-positive, HER2-negative advanced breast cancer when given in combination with an aromatase inhibitor or fulvestrant (Press release, Natera, OCT 2, 2020, View Source [SID1234567995]).

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The DARE study is a randomized, Phase II trial of ctDNA-guided second line adjuvant therapy for stage II-III, HR-positive, HER2-negative breast cancer. DARE will be conducted in the United States through Criterium, Inc. d/b/a the Academic Breast Cancer Consortium (ABRCC) network, which plans to identify about 100 MRD-positive patients for enrollment in the study. These 100 patients will be randomized to continue their current adjuvant endocrine therapy or start treatment with palbociclib plus fulvestrant for two years. Signatera is to be used for patient enrollment eligibility and continued therapy effectiveness monitoring after randomization.

"Detecting relapse before it becomes clinically symptomatic requires a test with high sensitivity and specificity," said Lajos Pusztai, MD, DPhil, Professor of Medicine (Medical Oncology); Co-Leader, Genetics, Genomics and Epigenetics Research Program, Yale Cancer Center, Yale School of Medicine and Principal Investigator of the trial. "Signatera enables us to confidently identify patients with molecular relapse when the disease burden is so low that it is undetectable with imaging. The trial will test if early intervention at this stage could delay or avert a clinical relapse."

Palbociclib was the first CDK4/6 inhibitor to be approved by the FDA as a therapy for patients with HR-positive, HER2-negative advanced breast cancer when taken in combination with endocrine therapy; however, efficacy has not yet been demonstrated in early stage disease. Each year, approximately 69,000 women are diagnosed with Stage II or III HR-positive breast cancer in the United States.1,2

"We are delighted to collaborate with Yale and Criterium/ABRCC to investigate the efficacy of palbociclib in patients with detectable residual disease based on Signatera," said Alexey Aleshin, MD, MBA, Natera’s Senior Medical Director for Oncology. "This is the second clinical trial using Signatera to evaluate the efficacy of a CDK4/6 inhibitor, and it heralds the significant utility of personalized MRD testing for early relapse detection in patients with breast cancer."

About Signatera

Signatera is a custom-built ctDNA test for treatment monitoring and MRD assessment in patients previously diagnosed with cancer. The test is available for clinical and research use, and it was granted Breakthrough Device Designation by the FDA in 2019 and The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. This maximizes accuracy for detecting the presence or absence of residual disease in a blood sample, even at levels down to a single tumor molecule in a tube of blood. Unlike a standard liquid biopsy, Signatera is not intended to match patients with any particular therapy. Rather, it is intended to detect and quantify how much cancer is left in the body, to detect recurrence earlier and to help optimize treatment decisions. Signatera’s test performance has been clinically validated in multiple cancer types including colorectal, non-small cell lung, breast, and bladder cancers. Signatera has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified, and CLIA certified.

On October 2, 2020 Benitec Biopharma Inc. (NASDAQ: BNTC) ("Benitec" or "the Company"), a development-stage, gene therapy-focused, biotechnology company developing novel genetic medicines based on the proprietary DNA-directed RNA interference ("ddRNAi") platform, reported the pricing of an underwritten public offering of 3,225,806 shares of its common stock (or common stock equivalents in lieu thereof) at a price to the public of $3.10 per share (Press release, Benitec Biopharma, OCT 2, 2020, View Source [SID1234567994]). The Company expects to receive aggregate gross proceeds of approximately $10.0 million from the offering. The offering is expected to close on or about October 6, 2020, subject to satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

The Company has also granted the underwriter a 30-day option to purchase up to 483,870 additional shares of its common stock, at the public offering price, less underwriting discounts and commissions, to cover over-allotments, if any.

The Company intends to use the net proceeds from the offering for the continued advancement of development activities for its product pipeline, general corporate purposes, and strategic growth opportunities.

A registration statement on Form S-1 (File No. 333-246314) relating to these securities was declared effective by the U.S. Securities and Exchange Commission (the "SEC") on October 2, 2020. This offering is being made only by means of a prospectus forming part of the effective registration statement. A preliminary prospectus relating to and describing the terms of the offering has been filed with the SEC. Electronic copies of the preliminary prospectus and, when available, copies of the final prospectus relating to the offering may be obtained for free by visiting the SEC’s website at www.sec.gov or by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, New York 10022, by email at [email protected] or by telephone at 646-975-6996.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On October 2, 2020 Medscape reported that The International Association for the Study of Lung Cancer (IASLC) has selected Medscape Oncology as its partner to host and manage these IASLC virtual conferences in 2020 (Press release, Medscape, OCT 2, 2020, View Source [SID1234567992]):

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– IASLC 2020 Hot Topic Meeting: Liquid Biopsy: A worldwide virtual event scheduled for
October 2-3, 2020
– IASLC 2020 North America Conference on Lung Cancer (NACLC): A worldwide virtual event scheduled for October 16-17, 2020

In collaboration with the IASLC, Medscape Oncology and MedscapeLIVE! will offer an immersive and engaging conference learning environment reaching the members of the thoracic oncology community including physicians, nurses, other clinicians, researchers and scientists as well as patients, survivors and advocates in the field of lung cancer.

The two conferences will include interactive educational sessions, late-breaking research, live chats with industry and e-poster presenters, interactive breakout sessions, networking opportunities and Virtual Exhibit Halls with product theaters.

"We are pleased to partner with Medscape in the delivery of the IASLC’s remaining 2020 meetings. The MedscapeLIVE! virtual conference platform and production services allow us to accomplish our mission of using all available means to deliver quality education to eliminate lung cancer and other thoracic malignancies. This partnership allows us to share important information with a global audience through live stream and on-demand content—while allowing us to protect the health of our members and their respective communities," said Dave Mesko, IASLC Chief Executive Officer.

The IASLC’s Mission

To embrace the study of the etiology, epidemiology, prevention, diagnosis, treatment and all other aspects of lung cancer and other thoracic malignancies.
To provide education and information about lung cancer and other thoracic malignancies to IASLC members, to the medical community at large, and to the public.
To use all available means to eliminate lung cancer and other thoracic malignancies as a health threat for the individual patient and throughout the world.
"We are honored to partner with the IASLC to offer comprehensive and immersive virtual meetings. As we are during a time of great change, it is more important than ever that healthcare providers across the world have access to digital education that aids in their ability to stay current with the latest changes in their field. We are excited to be working with the IASLC to deliver this critical information and impact provider practices and patient care," said Rejéan Rochette, Group General Manager, Medscape Education.

To learn more about the IASLC’s upcoming meetings, visit View Source

About the International Association for the Study of Lung Cancer

The International Association for the Study of Lung Cancer (IASLC) is the only global network dedicated to the study and eradication of lung cancer and other thoracic malignancies. Since its founding in 1974, the association’s membership has grown to more than 8,000 lung and thoracic cancer specialists from all disciplines in more than 100 countries.

By hosting global conferences, funding cutting-edge research and educating the health care community and the public about thoracic cancers, the IASLC works to alleviate the burden lung cancer places on patients, families and communities.

Each year, the IASLC hosts the World Conference on Lung Cancer (WCLC), the world’s largest meeting dedicated solely to thoracic cancers. The WCLC attracts more than 7,500 lung cancer specialists from across the world and offers attendees networking opportunities while providing a podium for practice-changing research.

In keeping with their commitment to education, the IASLC publishes the Journal of Thoracic Oncology (JTO), a primary source for thoracic malignancy prevention, detection, diagnosis and treatment information. The JTO serves as an authoritative resource in the field, with its impact factor increased from 12.460 in 2018 to 13.357 in 2019. Additionally, at the beginning of 2020, the IASLC launched a gold open-access publication to accompany the JTO entitled JTO Clinical and Research Reports.