On October 1, 2020 Boston Scientific Corporation (NYSE: BSX) reported that it will webcast an investor update at the virtual 2020 Transcatheter Cardiovascular Therapeutics (TCT) on Thursday, October 15 from 1:00 – 2:00 p.m. EDT (Press release, Boston Scientific, OCT 1, 2020, View Source [SID1234567861]). Joe Fitzgerald, executive vice president and president, Interventional Cardiology; Michael Jaff, D.O., vice president and chief medical officer, clinical affairs, technology and innovation, Peripheral Interventions; Dr. Ian Meredith, AM, executive vice president and global chief medical officer; and Jeff Mirviss, executive vice president and president, Peripheral Interventions will provide a business update and answer questions from investors about the Boston Scientific cardiovascular portfolio.

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On Wednesday, October 28, 2020 Boston Scientific will webcast its conference call discussing financial results and business highlights for the third quarter ended September 30, 2020. The call will begin at 8:00 a.m. EDT, hosted by Mike Mahoney, chairman and chief executive officer, and Dan Brennan, executive vice president and chief financial officer. The company will issue a news release announcing financial results for the third quarter on October 28 prior to the conference call.

A live webcast and replay of the webcast for each event will be accessible at investors.bostonscientific.com. The replay will be available beginning approximately one hour following the completion of each event.

On October 1, 2020 Delcath Systems, Inc. (NASDAQ: DCTH) reported that the Board of Directors appointed Gerard Michel as Chief Executive Officer, effective October 1, 2020 (Press release, Delcath Systems, OCT 1, 2020, View Source [SID1234567891]). Mr. Michel will also serve as a member of the Delcath Systems Board of Directors. In his most recent role, Mr. Michel was the Chief Financial Officer and Vice President of Corporate Development at Vericel Corporation. Mr. Michel was a key member of the executive team that successfully restructured Vericel enabling it to become a commercial leader in the fields of advanced Cell Therapy and specialty Biologics.

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In addition to Mr. Michel’s appointment as CEO, John Purpura, was appointed as Chief Operating Officer. Mr. Purpura’s leadership and operational excellence in areas of regulatory affairs, manufacturing and distribution have been a critical component of preparing Delcath for its planned New Drug Application (NDA) resubmission to the FDA in mid-2021.

"Following an intensive process, the Board determined that Gerard is the right leader for Delcath at this critical juncture," said Dr. Roger Stoll, Chairman, Delcath Systems. "He is uniquely qualified to take on this role given his track record of success and experience across therapeutics classes. Gerard’s extensive experience in strategy, operations, commercialization, business development and capital markets will be a tremendous asset." Dr. Stoll added, "We thank John for successfully guiding Delcath as interim CEO over recent months. On behalf of the Board, I congratulate him on his appointment to COO."

Mr. Michel commented, "I am excited to join the talented Delcath team ahead of a transformational year as we prepare to report phase 3 FOCUS trial data in metastatic ocular melanoma (mOM) in early 2021. I am committed to leading the organization towards its goal of making Melphalan/HDS the first product specifically labeled for metastatic ocular melanoma patients, a population which currently has limited therapeutic options."

Mr. Michel added, "Interventional oncology is a rapidly growing segment of comprehensive oncology care. Within that segment Melphalan/HDS is a clinically differentiated, high-value platform with the potential to address multiple cancer indications of high-unmet medical need. I look forward to building value both through the successful commercialization of Melphalan/HDS in mOM and initiating additional targeted clinical programs to expand the market opportunity of this platform technology."

Mr. Michel joins Delcath Systems with over 30 years of experience in the pharmaceutical and medical technology industries across multiple functional areas. Prior to Delcath, he was Chief Financial Officer of Vericel since June 2014 where he was a key member of the management team which integrated a transformative acquisition and revised the company’s business model from a research focused company to a fully integrated, profitable commercial business. Mr. Michel also served as Chief Financial Officer and Vice President, Corporate Development of Biodel from November 2007 to May 2014, and Chief Financial Officer and Vice President of Corporate Development of NPS Pharmaceuticals Inc. from August 2002 to November 2007. Prior to that, Mr. Michel was a Principal at Booz Allen and held a variety of commercial roles at both Lederle Labs and Wyeth Labs. Mr. Michel holds a M.S in Microbiology from the University of Rochester School of Medicine, an M.B.A. from the Simon School of Business, and a B.S. in both Biology and Geology from the University of Rochester.

Inducement Grant Under NASDAQ Listing Rule 5635(c)(4)

The Company also announced the grant of an option award to Mr. Michel, which was approved by the Board on August 31, 2020 as an inducement material to his entering employment with the Company in accordance with NASDAQ Listing Rule 5635(c)(4). The inducement award was approved subject to his commencement of employment with the Company on October 1, 2020 and consists of an option to purchase up to 498,000 shares of the Company’s common stock. The option will be exercisable at a price of $11.67 per share (the closing price on October 1, 2020) as to the first 396,000 shares to vest, (ii) 1.5 times the closing trading price per share of the Company’s common stock on October 1, 2020 as to the next 51,000 shares to vest and (iii) 2.0 times the closing trading price per share of the Company’s common stock on October 1, 2020 as to the remaining 51,000 shares to vest and will vest ratably over thirty-six months, provided that he remains employed by Delcath on each vesting date.

On October 1, 2020 Hologic, Inc. (Nasdaq: HOLX), an innovative medical technology company primarily focused on improving women’s health, reported a multi-year commitment to decreasing breast cancer screening disparities for Black women (Press release, Hologic, OCT 1, 2020, View Source [SID1234567923]).

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The program is in partnership with the Black Women’s Health Imperative (BWHI), the only nonprofit organization created by Black women to help protect and advance the health and wellness of Black women and girls through awareness and education, and RAD-AID, a nonprofit dedicated to ensuring equal access to radiology health services for medically underserved communities.

Research has shown that Black women are almost 40 percent more likely to die from breast cancer than non-Hispanic white women.1 Hologic’s initiative, which launched today in conjunction with the start of Breast Cancer Awareness Month, is designed to encourage all Black women to get annual mammograms beginning at age 40, and to provide women in underserved communities with access to superior breast cancer screening technology. The situation has become even more urgent due to the COVID-19 pandemic, as the National Cancer Institute recently predicted that 10,000 more people in the United States will die in the next decade from breast or colorectal cancer because of delayed screening and treatment.2

The multi-pronged initiative includes BWHI’s P.O.W.E.R. of Sure campaign, which will examine common barriers to early screening and encourage Black women to schedule and attend their annual mammograms. The campaign features Grammy award winning, Oscar and Golden Globe nominated artist Mary J. Blige and a multimedia digital hub with resources including common facts and myths about mammography, frequently asked questions regarding breast cancer and screening guidelines, a list of locations offering breast cancer screening, and information about what to expect when getting a mammogram during the COVID-19 pandemic.

"As a nonprofit laser-focused on the health and wellness of Black women and girls, we have a deep understanding of the barriers Black women face when it comes to annual breast cancer screening," said Linda Goler Blount, MPH, President and CEO, Black Women’s Health Imperative. "The P.O.W.E.R. of Sure campaign will address those barriers head-on, with the help of our spokeswoman, Mary J. Blige, whose voice resonates like no other when it comes to speaking directly to Black women in an authentic and inspiring way."

Additionally, in partnership with RAD-AID, Hologic will fund screening and diagnostic services, and ensure there is a pathway for medically disenfranchised women to receive treatment. "Our approach is evidence-based to target regions of the United States having urgent need for breast cancer screening and diagnostics, particularly where breast cancer disproportionately impacts women of color due to healthcare inequalities," said Dr. Daniel J. Mollura, MD, Founder and CEO of RAD-AID. "Our interdisciplinary solution will help patients by mobilizing RAD-AID’s 12,000+ volunteer radiologists, technologists, nurses, radiation oncologists/therapists, IT professionals, health navigators, and public health specialists for new service models that overcome racial barriers."

Hologic’s grant to RAD-AID for this initiative will support innovative care, radiology, public education, and nurse navigation at multiregional sites selected by RAD-AID as clinical partners to provide critical screening, diagnostic breast imaging, and treatment for women who may otherwise go without. Sites and facilities under development for this program are located in regions including the Bronx/Washington Heights areas of New York, the South Side of Chicago, Washington D.C., North Carolina, Georgia, Mississippi, Alabama, Arizona, Seattle/Pacific Northwest, and Colorado.

Facilities supported through this collaborative program will be equipped with Hologic’s 3D Mammography system, which features the Genius 3D Mammography exam. The Genius exam is the only mammogram FDA approved as superior to 2D mammography for all women, including those with dense breasts, which is common among Black women.3,4,5,6

"As a company committed to improving women’s health and well-being, we have always played an active role in increasing awareness and access among all women, including those who are traditionally underserved, because it’s core to our mission and our culture," said Jennifer Meade, Hologic’s Division President, Breast and Skeletal Health Solutions. "We believe this initiative will make a significant impact, as it unites our passion for women’s health with that of our nonprofit partners, BWHI and RAD-AID, who share our commitment to increasing awareness of the importance of breast cancer screening and improving access to 3D mammography, the standard of care for annual screenings."

The Genius 3D Mammography exam (also known as the Genius exam) is only available on a Hologic 3D Mammography system. It consists of a 2D and 3D image set, where the 2D image can be either an acquired 2D image or a 2D image generated from the 3D image set. There are more than 7,000 Hologic 3D Mammography systems in use in the United States alone, so women have convenient access to the Genius exam. To learn more, visit View Source

On October 1, 2020, Protalix BioTherapeutics, Inc., a Delaware corporation (the "Company"), reported that it entered into an ATM Equity OfferingSM Sales Agreement (the "Sales Agreement") with BofA Securities, Inc., as the Company’s sales agent (the "Agent") (Filing, 8-K, Protalix, OCT 1, 2020, View Source [SID1234567892]). Pursuant to the terms of the Sales Agreement, the Company may sell from time to time through the Agent shares of the Company’s common stock having an aggregate offering price of up to $30 million (the "Shares"). The Shares will be issued pursuant to the Company’s shelf registration statement on Form S-3 (Registration No. 333-230604). The Company intends to use the net proceeds from the offering, after deducting the Agent’s commissions and the Company’s offering expenses, for general corporate purposes.

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In accordance with the terms of the Sales Agreement, the Company may offer and sell the Shares at any time and from time to time through the Agent. Sales of the Shares, if any, will be made by means of transactions that are deemed to be "at the market" offerings as defined in Rule 415 under the Securities Act of 1933, as amended, including block trades and sales made in ordinary brokers’ transactions on the NYSE American or otherwise at market prices prevailing at the time of the sale, at prices related to prevailing market prices or at negotiated prices. Under the terms of the Sales Agreement, the Company may also sell Shares to the Agent as principal for its own account at a price to be agreed upon at the time of sale. Any sale of Shares to the Agent as principal would be pursuant to the terms of a separate terms agreement between the Company and the Agent.

The foregoing description of the Sales Agreement in this report does not purport to be complete and is qualified by reference to the full text of the Sales Agreement, which is filed as Exhibit 1.1 hereto. The legal opinion and consent relating to the Shares are included as Exhibits 5.1 and 23.1, respectively, hereto.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy any Shares, nor shall there be any sale of Shares in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

On October 1, 2020 Qualigen Therapeutics, Inc. (NASDAQ: QLGN) reported it has entered into an amended Sponsored Research Agreement with the University of Louisville (UofL) to advance development of Qualigen’s anticancer drug candidate AS1411-GNP, also known as ALAN (Aptamer-Linked Anti-Nucleolin) (Press release, Qualigen, OCT 1, 2020, View Source [SID1234567931]).

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The work being performed under the original Sponsored Research Agreement comprises animal studies to assess antitumor efficacy and safety of different ALAN compositions designed to treat pediatric and adult acute myeloid leukemia (AML). Under the amended Sponsored Research Agreement UofL will perform preclinical studies on AML and on additional indications including glioblastoma, a malignant brain cancer that is difficult to treat because most drugs cannot pass the blood-brain membrane, and non-small cell lung cancer, which comprises approximately 85% of the 1.6 million global lung cancer cases each year.

Additionally, Qualigen and UofL will study how ALAN may inhibit metastasis of cancer cells as a potential adjuvant therapy. The recurrence of cancer after initial treatment is the cause of approximately 90% of cancer deaths and represents a pressing unmet clinical need.

"Our expanded agreement with UofL should provide Qualigen with additional data to help us achieve our goal of advancing our ALAN cancer drug candidate into clinical trials against AML next year. We are especially interested in several new applications of this drug candidate, namely the treatment of pediatric cancers such as leukemia, the treatment of glioblastoma, the deadliest form of brain cancer and as an adjuvant therapy to stop the recurrence of cancer after initial treatment. We believe these paths will become a larger part of our clinical efforts and will accelerate the expansion of our product pipeline over the coming year, as they represent high unmet needs for critically important areas of cancer treatment," stated Michael Poirier, President, Chief Executive Officer and Chairman of Qualigen.

ALAN is a combination of AS1411 plus a DNA-coated gold nanoparticle, which dramatically increases its potency. This cancer drug candidate has the potential to target and destroy tumor cells in a wide variety of cancer types with minimal side effects. The Company is aiming to commence Phase 1 human trials in 2021 for AML, its lead indication. Qualigen has an exclusive worldwide license agreement from the UofL for ALAN.

"We are pleased to continue our relationship with Qualigen Therapeutics to expand the development program for ALAN," added Paula Bates, PhD, Professor of Medicine at UofL, who will be leading the project at UofL in collaboration with Martin O’Toole, PhD, and Levi Beverly, PhD. "We look forward to conducting these studies, which have the potential to demonstrate ALAN’s broad applicability as an effective therapy for these difficult-to-treat cancers."