On February 4, 2020 Boundless Bio, a company interrogating and targeting extrachromosomal DNA (ecDNA) in aggressive cancers, reported presentations at the following upcoming conferences this month (Press release, Boundless Bio, FEB 4, 2020, View Source [SID1234553847]):

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5th Annual Biomarker and Companion Diagnostics Conference: Jason Christiansen, Ph.D., Chief Technology Officer of Boundless Bio, will give a presentation titled: "Targeting extrachromosomal DNA (ecDNA), a new approach to treating cancers with high copy number gene amplification." The presentation will take place at 3:25 p.m. PST on Friday, February 7, 2020 in San Diego, California.

BIO CEO & Investor Conference: Zachary Hornby, President and Chief Executive Officer of Boundless Bio, will provide an overview of the company’s efforts to pioneer novel cancer therapeutics directed to ecDNA. The presentation will take place at 1:30 p.m. EST on Monday, February 10, 2020 in New York, New York.
About ecDNA

Extrachromosomal DNA, or ecDNA, are large circles of DNA containing genes that are outside the cells’ chromosomes and can make many copies of themselves. ecDNA can be rapidly replicated within the cell, causing high numbers of oncogene copies, a trait that can be passed to daughter cells in asymmetric ways during cell division. Cells have the ability to upregulate or downregulate ecDNA and resulting oncogenes to ensure survival under selective pressures, including chemotherapy, targeted therapy, immunotherapy, or radiation, making ecDNA one of cancer cells’ primary mechanisms of recurrence and treatment evasion. ecDNA are rarely seen in healthy cells but are found in many solid tumor cancers. They are a key driver of the most aggressive and difficult-to-treat cancers, specifically those characterized by high copy number amplification of oncogenes.

On February 4, 2020 SIRION Biotech GmbH ("SIRION"), a world leader in viral vector-based gene delivery technologies for gene and cell therapy, and InProTher Aps ("InProTher"), a Danish start up supported by Novo Nordisk Foundation’s BioInnovation Institute (BII), reported a broad licensing agreement which includes coverage of SIRION’s adenovirus technologies to cancer vaccines encoding Endogenous Retrovirus (ERV)-derived antigens for active immunotherapy (Press release, Sirion Therapeutics, FEB 4, 2020, View Source [SID1234553846]). In addition, the companies have agreed to the assignment of ownership rights in a patent application for an adenoviral vector capable of encoding a virus-like particle (VLP), which displays an inactive immune-suppressive domain (ISD). This vaccine shows an improved immune response from either or both of the response pathways initiated by CD4 T cells or CD8 T cells. SIRION and InProTher have been collaborating for over five years in the fields of HPV vaccine development and ERVs.

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InProTher is an immunotherapy company that is applying adenovirus technologies both for cloning large nucleic acids and increasing the yield of replication-incompetent adenoviruses. The goal is to develop the world’s first adaptive immune therapy capable of targeting immunosuppressive genes of ancient retroviruses that normally are dormant in the human genome. The retroviral genes are reactivated in cancer and essential for tumor development. InProTher’s proprietary combination of novel technologies is designed to break tolerance to this unique antigen family, thus providing broad anti-cancer efficacy.

As part of this agreement, SIRION Biotech will receive shares of InProTher Aps, as well as representation on their Board of Directors. The parties have also agreed on milestones and royalties should InProTher’s developments pass clinical development hurdles.

"This innovative cancer vaccine approach holds great promise, and our adenovirus was initially developed for such a vaccination. We congratulate InProTher as they prepare to enter clinical development with the support of the BII," said Dr. Christian Thirion, Chief Executive Officer of SIRION.

Peter J. Holst, Ph.D., Interim CEO and CSO of InProTher, is a former Associate Professor at the University of Copenhagen with long-standing experience in immunology, having made pivotal discoveries in the field. "InProTher’s proprietary combination of novel technologies is designed to break tolerance to this unique antigen family, thus providing broad anti-cancer efficacy. SIRION has been a creative, loyal and responsive partner over the years, and their adenovirus technology is ideally suited to our needs."

On February 4, 2020 McKesson Corporation (NYSE:MCK) reported results for the third quarter ended December 31, 2019 (Press release, McKesson, FEB 4, 2020, View Source [SID1234553845]).

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Fiscal 2020 Third-Quarter and Year-to-Date Result Summary

1Reflects continuing operations attributable to McKesson, net of tax

2Represents a non-GAAP financial measure; refer to the reconciliations of non-GAAP financial measures included in accompanying schedules

"We delivered solid operating performance and we are pleased to report third-quarter adjusted earnings results ahead of our expectations," said Brian Tyler, chief executive officer. "McKesson’s unwavering focus on strategic and operational execution is demonstrated in the adjusted operating profit growth we reported in the third quarter across our core operating segments. Additionally, we have deployed meaningful capital toward share repurchases year-to-date, delivering further value to our shareholders. Our outlook for fiscal 2020 Adjusted EPS remains unchanged from the prior guidance we provided on January 13th, 2020."

Third-quarter revenues were $59.2 billion, up 5% from a year ago. On an FX-adjusted basis, revenues grew 6%, primarily driven by growth in the U.S. Pharmaceutical and Specialty Solutions segment, largely due to branded pharmaceutical price increases and higher volumes from retail national account customers.

Third-quarter earnings per diluted share of $1.06 included a pre- and post-tax charge of $282 million within our European Pharmaceutical Solutions segment for the remeasurement to fair value of assets and liabilities held for sale related to the expected formation of a new German wholesale joint venture with Walgreens Boots Alliance.

Third-quarter Adjusted Earnings per diluted share was $3.81 compared to $3.40 a year ago, an increase of 12%, primarily driven by growth in the U.S. Pharmaceutical and Specialty Solutions, Medical Surgical and European segments and a lower share count, partially offset by the previously anticipated increase in corporate expenses and a higher tax rate. Prior year third-quarter results included a pre-tax charge of $60 million related to a customer bankruptcy, partially offset by a $17 million pre-tax reversal of an accrued estimated liability related to the New York State Opioid Stewardship Act. Excluding the impact of these prior year items from Adjusted Earnings, third-quarter adjusted results per diluted share increased approximately 7% year-over-year.

For the first nine months of the fiscal year, McKesson returned $2.2 billion of cash to shareholders via $1.9 billion of common stock repurchases and $222 million of dividend payments. During the first nine months of the fiscal year, McKesson used cash from operations of $280 million, and invested $338 million internally, resulting in negative free cash flow of $618 million.

U.S. Pharmaceutical and Specialty Solutions Segment

Third-quarter revenues were $46.9 billion, up 6%, driven primarily by branded pharmaceutical price increases and higher volumes from retail national account customers, partially offset by branded to generic conversions.
Third-quarter operating profit was $687 million and operating margin was 1.46%. Adjusted operating profit was $658 million, up 11% from a year ago. Prior year third-quarter results included a $60 million pre-tax charge related to a customer bankruptcy, partially offset by a $17 million pre-tax reversal of an accrued estimated liability related to the New York State Opioid Stewardship Act. Excluding the net $43 million impact of these prior year items, adjusted operating profit increased approximately 3%, driven by continued growth in the specialty businesses. Adjusted operating margin was 1.40%, up 6 basis points.
European Pharmaceutical Solutions Segment

Third-quarter revenues were $6.9 billion, flat on a reported basis and up 3% on an FX-adjusted basis, driven primarily by growth in the pharmaceutical distribution business.
Third-quarter operating loss was ($303 million) and operating margin was (4.37)%, primarily driven by a pre- and post-tax charge of $282 million for the remeasurement to fair value of assets and liabilities held for sale related to the expected formation of a new German wholesale joint venture with Walgreens Boots Alliance. Adjusted operating profit was $80 million, up 16%, and adjusted operating margin was 1.15%. On an FX-adjusted basis, adjusted operating profit was $82 million, up 19%, and adjusted operating margin was 1.16%, up 16 basis points, driven in part by expense rationalization.
Medical-Surgical Solutions Segment

Third-quarter revenues were $2.1 billion, up 6%, driven primarily by growth in the Primary Care business, largely due to higher pharmaceutical volumes and an early start to influenza season.
Third-quarter operating profit was $124 million and operating margin was 5.79%. Adjusted operating profit was $184 million, up 8%, and adjusted operating margin was 8.59%, up 14 basis points. The year-over-year increase primarily reflects organic growth in the Primary Care business.
Other remaining businesses

Third-quarter revenues were $3.2 billion, up 6% on a reported basis and up 5% on an FX-adjusted basis, primarily driven by growth in the Canadian business.
Third-quarter operating profit was $61 million. Adjusted operating profit was $214 million, down 4% on both a reported and FX-adjusted basis, as increased investment spend within the MRxTS business was partially offset by growth in the Canadian business.
Company Updates

On February 4, 2020, McKesson’s wholly-owned subsidiary, PF2 SpinCo, Inc., filed a registration statement with the Securities and Exchange Commission (SEC) relating to a potential exit of the company from its investment in the Change Healthcare joint venture.
McKesson was selected by the Department of Veterans Affairs to continue to serve as the prime pharmaceutical provider when the current contract expires in August 2020.
On December 12, 2019, McKesson and Walgreens Boots Alliance announced an agreement to create a joint venture that is expected to combine their respective pharmaceutical wholesale businesses in Germany.
For the seventh year in a row, McKesson was honored as one of the "Best Places to Work for LGBTQ Equality" by the Human Rights Campaign (HRC) Foundation, achieving 100 percent on the HRC’s 2020 Corporate Equality Index (CEI).
McKesson appointed Nancy Flores as Executive Vice President, Chief Information and Technology Officer effective January 13, 2020, following Kathy McElligott’s announced retirement.
Fiscal 2020 Outlook

McKesson reaffirmed fiscal 2020 Adjusted Earnings per diluted share guidance range of $14.60 to $14.80, which was previously narrowed and raised from $14.00 to $14.60 on January 13, 2020.
Conference Call Details

The company has scheduled a conference call for today, Tuesday, February 4th at 8:00 AM ET to discuss the company’s financial results. A live audio webcast of the conference call will be available on McKesson’s Investor Relations website at View Source The conference call can also be accessed by dialing 786-815-8297. The password is ‘McKesson’. A telephonic replay of this conference call will be available for 14 calendar days. For individuals wishing to listen to the replay, the dial-in number is 404-537-3406 and the pass code is 6206708. An archive of the conference call will also be available on the company’s Investor Relations website at View Source

Non-GAAP Financial Measures

GAAP refers to the U.S. generally accepted accounting principles. This press release includes GAAP financial measures as well as Non-GAAP financial measures, including Adjusted Earnings, FX-Adjusted results and Free Cash Flow which are financial measures not calculated in accordance with GAAP. Refer to the "Supplemental Non-GAAP Financial Information" section of the accompanying financial statement tables for the definitions and usefulness of the Company’s Non-GAAP financial measures and the attached schedules for reconciliations of the differences between the Non-GAAP financial measures and their most directly comparable GAAP financial measures.

The company does not provide forward-looking guidance on a GAAP basis as McKesson is unable to provide a quantitative reconciliation of this forward-looking non-GAAP measure to the most directly comparable forward-looking GAAP measure, without unreasonable effort, because McKesson cannot reliably forecast LIFO inventory-related adjustments, gains from antitrust legal settlements, restructuring, impairment and related charges, and other adjustments, which are difficult to predict and estimate. These items are inherently uncertain and depend on various factors, many of which are beyond the company’s control, and as such, any associated estimate and its impact on GAAP performance could vary materially.

On February 4, 2020 Life Image reported that the WISDOM study, a groundbreaking effort to determine the optimal guidelines for breast cancer screening, is seeking qualifying women across the country that wish to participate in improving breast cancer screening and prevention (Press release, Life Image, FEB 4, 2020, View Source [SID1234553844]).

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The recent nation-wide expansion of WISDOM offers all women regardless of where they live, where they receive health care, or health insurance type the opportunity to participate in groundbreaking research and receive screening recommendations. The study seeks to enroll 100,000 women of all backgrounds to participate in an online study, and compares two different approaches to breast cancer screening: annual mammography versus a personalized approach based on risk. The results of the study aim to optimize breast cancer screening and improve treatment for millions of women and future generations of women.

Participation in the WISDOM study demonstrates personal commitment and support of World Cancer Day’s "I Am and I Will" campaign, an empowering movement uniting the world to fight against cancer through awareness and education.

The study will follow volunteers over time to determine whether a personalized risk-based approach to breast cancer screening can improve prevention and clinical outcomes for women when compared to the current, one-size-fits-all approach using standard annual mammograms.

Participation in the WISDOM study is free, and open to all women ages 40-74 who HAVE NOT been diagnosed with breast cancer. Participants may opt to be assigned at random to one of the study groups, or choose to be assigned to one of two study groups with different screening protocols:

Annual mammogram screenings – the current gold standard of care.
Personalized screening schedule based on factors including family history, genetics, lifestyle, and breast density.
Patients who are identified as being at high risk will be offered educational support from a genetic counselor, breast health specialist, and guidance for cancer risk reduction and prevention.

Over the course of the study, doctors will compare the two groups and determine if a personalized screening protocol can improve breast health outcomes for all women.

"We are proud to honor World Cancer Day and partner with the WISDOM study to help gather scientific evidence to make breast cancer screening safer and more effective, while empowering women with digital ownership of their own health records," said Matthew A. Michela, CEO of Life Image. "We encourage women in northern New Jersey and beyond to participate. It costs nothing and participation is simple, women are given the tools they need to support this research online throughout the duration of the study."

Participants in New Jersey can have their screenings done at Summit Medical Group, the first health care provider in New Jersey to participate in the study. By supporting the development of better screening guidelines, Summit Medical Group will assist in the creation of better tools to help women avoid unnecessary tests and procedures and lower the total cost of care. More information can be found at View Source

Life Image is the world’s largest medical exchange network specializing in diagnostic images. It is supporting the WISDOM study by offering participants Mammosphere, an electronic personal health app that enables women to securely request, store, and share their breast health history (including mammogram images) with the study or their healthcare providers.

Enrollment is simple and participation is fully online. To learn more about the WISDOM study or sign up, please visit www.wisdomstudy.org.

About The WISDOM Study
WISDOM is a five-year longitudinal study that compares two different approaches to breast cancer screening – annual mammography vs. a personalized, risk-based approach. The goal of the study is to determine whether personalized screening is more effective than annual screening. The personalized screening approach will take multiple risk factors into consideration, including genetic markers, to determine the most effective screening frequency and modality for an individual. Over time, we can learn which risk factors are most important and continue to improve our screening recommendations accordingly

On February 4, 2020 The French specialty pharmaceutical company, Juvisé Pharmaceuticals is reported its successful syndication of its EUR 213 million debt package supporting the acquisition of Arimidex and Casodex from AstraZeneca, with the collaboration of Société Générale and HSBC, acting as Physical Bookrunners and Mandated Lead Arrangers, BNP Paribas, acting as Mandated Lead Arranger and Lazard acting as financial advisor to Juvisé Pharmaceuticals (Press release, Juvise Pharmaceuticals, FEB 4, 2020, View Source [SID1234553843]).

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On the back of a strong support from both relationship lenders and institutional investors, syndication was wrapped following a successful and oversubscribed early-bird phase. The covenanted financing is comprised of a EUR 128 million TLB alongside a EUR 85 million TLA. This syndication was made possible through the collaboration with Juvisé Pharmaceuticals financial partners, with whom the company relies on long-term partnership characterized by openness and trust.

This successful syndication is another important step in Juvisé Pharmaceuticals development. It reasserts the company ability to leverage all debt capital instruments to fulfil its growth ambition, while keeping the flexibility and independence in decision making allowed by its privately held structure.

Frédéric Mascha, Founder and President of Juvisé Pharmaceuticals, declared, "We are very pleased that our acquisition debt package was successfully syndicated in this oversubscribed early-bird phase and we would like to thank our financial partners for the trust they have shown in our project. We are proud to see that our commitment towards physicians, patients, and our Pharma partners convinced renowned financial institutions to support our ambitious development plan."

About Arimidex and Casodex
Arimidex (anastrozole) and Casodex (bicalutamide) are hormone treatments for breast and prostate cancer. The two products are recognized as pillar in those cancer treatments and essential for both patients and physicians.

On 19th December 2019, Juvisé Pharmaceuticals acquired the rights of Arimidex and Casodex in 45 countries in Europe and a number of Middle Eastern and African markets.