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VA and GO2 Foundation Partner to Improve Outcomes for Veterans at Risk of Lung Cancer

On June 16, 2020 Bonnie J Addario Lung Cancer Foundation reported that A historic milestone was reached today with the exciting announcement that the Department of Veterans Affairs (VA) and GO2 Foundation for Lung Cancer (GO2 Foundation) have established a formal partnership to advance lifesaving screening and care for our military men and women at greater risk for lung cancer (Press release, Bonnie J Addario Lung Cancer Foundation, JUN 16, 2020, View Source [SID1234561263]). One of GO2 Foundation’s core priorities is educating people at risk for lung cancer and facilitating access to early detection screenings and care that can save lives. Working to better support Veterans who are at elevated risk and incidence for lung cancer than the civilian population has been a key focus of our organization for years.

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This partnership allows GO2 Foundation to offer the VA educational and technical assistance and to collaborate on ways to improve Veterans’ access to high quality screening and care in communities where they live. This partnership will strengthen and accelerate efforts to change the reality of lung cancer for our service members. It will help break down barriers to save lives.

The announcement could not come at a better time as lung cancer advocates are gathering virtually at the 2020 Lung Cancer Voices Summit to call on Congress to increase funding for lung cancer research. As more breakthroughs are achieved, the VA-GO2 Foundation partnership picks up the baton and carries it forward to Veterans who will benefit from these life-saving endeavors.

Pulse Biosciences, Inc. Announces Closing of $30 Million Rights Offering

On June 16, 2020 Pulse Biosciences, Inc. (Nasdaq: PLSE) (the "Company" or "Pulse Biosciences"), a novel bioelectric medicine company, reported the closing of its oversubscribed rights offering and the final results thereof (Press release, Pulse Biosciences, JUN 16, 2020, View Source [SID1234561168]).

The rights offering resulted in the sale of 4,279,600 units consisting of one share of the Company’s common stock, par value $0.001 per share, and 0.15 warrants to purchase shares of common stock (the "Units") at a price of $7.01 per Unit. The common stock and warrants comprising the Units separated upon the closing of the rights offering and were issued individually. 4,279,600 shares of common stock and 641,571 warrants were issued in the offering. The Company received aggregate gross proceeds from the rights offering of $30 million. Total basic subscriptions and over-subscriptions received were almost $56.0 million. Additional proceeds of up to $4.5 million may be received through the exercise of warrants issued in the rights offering, if exercised. Each warrant is exercisable for one share of the Company’s common stock at an exercise price equal to $7.01. Warrants are exercisable immediately and expire on the fifth anniversary of the completion of this rights offering.

Investors who participated in the rights offering should expect to see the shares and warrants issued to them in book-entry, or uncertificated, form. Any excess subscription payments received by Broadridge Corporate Issuer Solutions, Inc. (the "Subscription Agent") will be returned by the Subscription Agent to investors, without interest or penalty, as soon as practicable.

After giving effect to the issuance of 4,279,600 shares of common stock in the rights offering (but excluding up to 641,571 shares of common stock underlying the warrants issued in the rights offering), the Company has 25,149,043 shares of common stock issued and outstanding.

Robert W. Duggan, the Chairman of the Company’s Board of Directors and the beneficial owner of approximately 43% of the Company’s outstanding common stock prior to this rights offering participated in the rights offering and purchased an aggregate of 2,561,873 Units. After giving effect to the rights offering, Mr. Duggan is the beneficial owner of approximately 46% of the Company’s outstanding common stock.

"Once again, I want to thank all participating stockholders, as well as the Board of Directors and the management team. In addition to participation by the Company’s Chairman, Robert Duggan, insider participation totaled approximately $1.1 million. We are grateful for the support and confidence that led us to the successful closing of this offering," said Darrin Uecker, President and Chief Executive Officer of Pulse Biosciences. "The completion of this rights offering provides funding for the continued progress towards commercialization of our proprietary CellFX System and the introduction our platform Nano-Pulse Stimulation technology first to the dermatology market. We are excited about the opportunity ahead and confident we can execute our strategy to create value for stockholders in our next phase of growth."

"I am very pleased with the execution of this Rights Offering. It was our priority to provide stockholders the opportunity to participate in funding the Company in an efficient and minimally dilutive manner," added Robert Duggan, Chairman of the Company’s Board of Directors. "I see tremendous value in the long-term opportunity for Nano-Pulse Stimulation technology and its potential to treat a variety of unmet needs across medical specialties. We are steadfast in our commitment to health innovation as we make this technology accessible to patients in future."

A registration statement, as amended, relating to the Units was previously filed with the Securities and Exchange Commission (the "SEC") and declared effective on May 8, 2020. A prospectus relating to the offering was filed with the SEC on May 14, 2020 and is available on the SEC’s website. Subscription rights that were not exercised by 5:00 p.m. Eastern Time on June 8, 2020 have expired.

Sanofi Invests $679.4 Million in Two French Sites for Vaccine Research and Production

On June 16, 2020 Sanofi reported to increase its vaccines research and production capabilities (Press release, BioSpace, JUN 16, 2020, View Source [SID1234561165]). As part of the plan it will invest $679.4 million (€610 million) to create a new production site and a research center, both in France, both dedicated to vaccines.

"Sanofi’s heart beats in France," said Sanofi’s chief executive officer Paul Hudson in a statement. "We have a long history and exceptional teams working throughout the country, embodying our strong values. By investing in a new industrial site and a R&D center, Sanofi positions France at the core of its strategy, aiming to make France a world-class center of excellence in vaccine research and production."

The company’s Evolutive Vaccine Facility (EVF) will be based in Neuville sur Saone. This industrial site will leverage the latest innovative vaccine production technologies. The company will invest €490 million over a five-year period, with plans to create 200 new jobs.

Sanofi Pasteur is Sanofi’s vaccine company and it will utilize the manufacturing site to handle any new pandemics. Sanofi indicates that EVF "is a new type of factory designed around a central unit housing several fully digital production modules that make it possible to produce three to four vaccines simultaneously, versus only one in current industrial sites. This modularity will make it possible to prioritize the production of a specific vaccine in a more timely manner based on public health issues."

Of the total funding, €120 million will go to form a new R&D center at the Sanofi Pasteur site in Marcy-l’Etoile to develop future vaccines. It too will be a state-of-the-art digital facility with specialized laboratories. Sanofi indicates it plans for the facility to become a world reference for preclinical research and pharmaceutical and clinical development.

Hudson added, "Sanofi is a major healthcare player in France, in Europe, and worldwide. It is our responsibility to focus our resources and expertise against the current pandemic, but also to invest in preparing for future ones. We welcome the ongoing collaboration and commitment of the French authorities who we have been working alongside with the last several months to achieve this."

Sanofi, in collaboration with GlaxoSmithKline, is approaching the development of two different COVID-19 vaccines with two different technological approaches. The first, with GSK, is using recombinant DNA technology, which would allow for manufacturing very large quantities of antigens, the proteins that are injected to stimulate the immune system. The second is messenger RNA technology in collaboration with TranslateBio. This is a new technology also being utilized by U.S.-based Moderna and Germany-based BioNTech, which is collaborating with Pfizer.

Sanofi says it is committed to making its vaccine accessible to "all and around the world."

On April 14, Sanofi and GSK signed a letter of intent to collaborate on the COVID-19 vaccine using technology from both companies. Sanofi is contributing its S-protein COVID-19 antigen, which utilizes recombinant DNA technology. This allows for an exact genetic match to proteins found on the virus surface. The DNA sequence that codes for the antigen has been combined into the DNA of the baculovirus expression program, which Sanofi uses for its recombinant influenza product in the U.S.

GSK is contributing its pandemic adjuvant technology, which can decrease the amount of vaccine protein required per dose, which allows for more manufacturing volume.

At the time, Emma Walmsley, chief executive officer of GSK, said, "This collaboration brings two of the world’s largest vaccines companies together. By combining our science and our technologies, we believe we can help accelerate the global effort to develop a vaccine to protect as many people as possible from COVID-19."

The deal with TranslateBio was signed earlier, on March 27. That deal leverages an existing agreement from 2018 to develop mRNA vaccines for infectious diseases. The primary aspect of that agreement is TranslateBio is producing multiple mRNA constructs using its technology platform to discover, design, and manufacture several SARS-CoV-2 vaccine candidates. Sanofi will provide its vaccine expertise and its external research network to advance vaccine candidates.

HALO Diagnostics Interim Data from Clinical Trial Shows Groundbreaking Results for New Prostate Cancer Treatment

On June 16, 2020 HALO Diagnostics reported interim 10-year results from its Phase II 20-year clinical trial for prostate laser focal therapy in patients with localized prostate cancer (Press release, HALO Diagnostics, JUN 16, 2020, View Source [SID1234561161]). Over 170 men, 45-years or older diagnosed with low-to-intermediate risk or recurrent prostate cancer, volunteered to participate in the study . The results are impressive: less than 1% infection, less than 1% erectile dysfunction and less than 1% incontinence – compared to conventional whole gland prostatectomy which has a risk of up to 50% erectile dysfunction and 25% urinary incontinence. These results, along with a 100% prostate cancer-specific survival rate, are an encouraging development for men looking for a prostate cancer therapy option with a lower risk of side effects.

Prostate cancer is the second leading cause of cancer death in men in the United States. It is estimated that over 191,000 men will be diagnosed with prostate cancer this year and more than 33,000 are expected to die.
Prostate cancer is the second leading cause of cancer death in men in the United States. It is estimated that over 191,000 men will be diagnosed with prostate cancer this year and more than 33,000 are expected to die.
Why is this study important to prostate cancer patients? "Magnetic resonance image (MRI)-guided laser focal therapy enables doctors to contour their approach to the areas of the prostate that needs to be treated, while creating safety boundaries around the areas that need to remain untouched," said Bernadette M. Greenwood, chief research officer of HALO Diagnostics. "This level of precision compared to other approaches, such as radical prostatectomy, radiation therapy and even other focal or targeted approaches like high-intensity focused ultrasound (HIFU), substantially lowers the risk of side effects, including urinary incontinence, impotence and decreased bowel function. Unlike other treatments, laser focal therapy does not limit the option to treat with radiation therapy or surgery if needed later."

The procedure is as follows: the laser focal therapy (also called LITT or FLA) is designed to destroy prostate tissue under MRI guidance using laser energy. The laser device is FDA 510(k) cleared for clinical use for soft tissue necrotization. The planning system is FDA 510(k) cleared for MRI-guided prostate biopsy. HALO Diagnostics is the first company in the world to combine these devices under IRB approved clinical trial NCT 02243033. The procedure is minimally invasive and ambulatory outpatient – no general anesthesia required.

"The purpose of this research, which began on May 24, 2010, is to investigate the safety and effectiveness of using MRI-guided laser focal therapy for prostate cancer and to evaluate oncologic control over 20 years," said Dr. John Feller, chief medical officer of HALO Diagnostics. "The interim Phase II results indicate a paradigm shift in the treatment of men with intermediate risk prostate cancer and those with biochemical recurrence. These results are not only an exciting development in the advancement of laser focal therapy for prostate cancer, but speak to the strength of our clinical team and our commitment to developing life changing patient experiences and outcomes."

Recruitment for the "Phase II Study to Evaluate Outpatient Magnetic Resonance Image-Guided Laser Focal Therapy for Prostate Cancer, a 20-Year Survival Study" will continue through the HALO Diagnostics’ Center of Innovation in Indian Wells and conclude once the study goal of 200 men has been achieved and evaluated for oncological control for a 20 year period. The trial details are listed on clinicaltrial.gov and the 10-year interim results were published in Journal of Urology on May 15, 2020.

Centene To Participate at BMO Capital 2020 Prescriptions For Success Healthcare Conference

On June 16, 2020 Centene Corporation (NYSE: CNC) reported it will participate in the one-day, virtual-only BMO Capital 2020 Prescriptions for Success Healthcare Conference (Press release, Centene , JUN 16, 2020, View Source [SID1234561160]).

Centene will participate in a virtual format on Tuesday, June 23, 2020, at 8:30 a.m. Eastern Daylight Time (EDT). A simultaneous live audio webcast is available at: View Source

A webcast replay will be available afterwards via the Company’s website at www.centene.com under the Investors section.