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 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that it will report third quarter 2020 results on Thursday, October 22, 2020, before the market opens (Press release, Quest Diagnostics, OCT 1, 2020, View Source [SID1234567890]). It will hold its quarterly conference call to discuss the results beginning at 8:30 a.m. Eastern Time on that day.

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The conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, using the passcode: "7895081." The earnings release and live webcast will be posted on www.QuestDiagnostics.com/investor. The company suggests participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or by phone at 800-337-6568 for domestic callers or 402-220-9660 for international callers; no passcode is required. Telephone replays will be available from approximately 10:30 a.m. Eastern Time on October 22, 2020 until midnight Eastern Time on November 5, 2020.

Anyone listening to the call is encouraged to read the company’s periodic reports on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

On October 1, 2020 The Scripps Research Institute reported that The U.S. Food and Drug Administration has granted Fast Track designation to a novel "switchable" CAR-T cell therapy in a move to accelerate the drug development and review process (Press release, The Scripps Research Institute, OCT 1, 2020, View Source [SID1234567889]). The therapy is currently being evaluated as a treatment for B-cell malignancies, a class of blood cancers that includes non-Hodgkin’s lymphoma and chronic lymphocytic leukemia.

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FDA’s Fast Track designation, which enables enhanced access to the agency during development, is designed to bring important new drugs to patients that address unmet medical needs in serious or life-threatening conditions.

The CAR-T cell therapy known as "CLBR001 + SWI019," has begun enrolling subjects in a Phase 1 trial assessing the safety and tolerability of the cell therapy. The study is being conducted at multiple sites in the United States.

"This important designation will enable Calibr to interact with the agency on study-related items, such as appropriate data collection and study design to support the approval of this innovative therapy," says Pamela Garzone, PhD, chief medical officer of Calibr, who is leading the clinical study of the therapy and was the primary author of the Fast Track application.

Calibr’s investigational CAR-T cell therapy leverages patients’ own immune cells to treat cancer, putting the cells under control of a novel molecular "switch" that seeks to mitigate potentially life-threatening side effects that have hampered the use of cell therapies to date.

"The versatility and potential for greater safety enabled by this switchable platform can yield significant benefits for patients and we look forward to the opportunity to accelerate its development," says Travis Young, PhD, Calibr’s vice president of biologics and leader of its CAR-T program.

CAR-T, short for chimeric antigen receptor T-cell, is a relatively new form of cancer therapy that has achieved remarkable responses in patients with blood- or bone marrow-based diseases such as leukemias and lymphomas. It works by genetically engineering a patient’s T cells—a cell type which plays a key role in anti-tumor immunity—to seek and destroy cancer within the body. However, some patients who receive T-cell therapies experience an adverse effect called cytokine release syndrome, which occurs when the immune system reacts too strongly.

Calibr’s switchable CAR-T cell platform incorporates an antibody known as "SWI019" that acts as a switch, activating the engineered cells (CLBR001) and directing them to engage the cancer target. This may allow doctors to have more control over the therapy which could provide a significant safety advantage. In preclinical studies, the approach proved highly effective at eliminating tumors while controlling the level of cytokines produced in response to treatment. Further, by switching the CLBR001 cells "on" and "off" the approach allows the engineered cells to "rest", which in preclinical models afforded greater efficacy.

The current clinical trial is enrolling patients with blood-based cancers that have returned after remission or didn’t respond to initial treatments. However, Calibr’s switchable CAR-T cell platform employs a universal design that can be applied to solid-tumor cancers and other types of blood cancers in the future—providing potential advantages in an area that CAR-T cell therapies have not been as successful in the past.

The switchable CAR-T cell platform was invented at Scripps Research and progressed to the clinical testing stage with support from the Wellcome Trust. Calibr has partnered its platform with biopharmaceutical company AbbVie, which holds certain rights to commercialization. The clinical trial is the third to be run independently by the institute and the fifth originating from Calibr’s research.

Patients interested in enrolling in the clinical trial (NCT04450069) can learn more on the National Institutes of Health (NIH) clinical trials portal.

On October 1, 2020 SOPHiA GENETICS, global leader in Data-Driven Medicine, reported the closing of a $110 million financing round to enter into the next stage of its expansion, with a focus on supporting the growing clinical and biopharma demand for Data-Driven Medicine worldwide (Press release, Sophia Genetics, OCT 1, 2020, View Source [SID1234567888]).

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This Series F round was led by aMoon, a leading health-tech & life sciences venture fund based in Israel, and Hitachi Ventures, a venture arm of Japanese Hitachi Group. The company also received the trust of prime financial institutions Credit Suisse and the Pictet group. Existing investors Swisscom Ventures, Endeavour Vision, Generation Investment Management, Alychlo, and Eurazeo Growth participated in the round, as well as newcomers ACE & Company and Famille C Invest.

Having established the world’s largest Data-Driven Medicine community network through its universal and collaborative AI platform, SOPHiA GENETICS supports healthcare professionals by translating multiple sources of complex medical data into valuable clinical insights. The SOPHiA Platform is used by over 1’000 healthcare institutions and has analyzed 600’000 genomic profiles; up to 17’000 new profiles a month. Through continual learning and network effects, experts worldwide are empowered to act with confidence for better patient management.

The new funding round will boost the company’s penetration in both the US and Asian markets. Proceeds will also be dedicated to increasing the platform multimodal capabilities and its adoption by healthcare institutions worldwide. Leveraging this momentum, SOPHiA GENETICS will be best positioned to power biopharma’s effort to optimize and accelerate the development of new targeted therapies.

As SOPHiA enters this new phase of rapid expansion, Didier Hirsch, former CFO at Agilent, joins the company’s Board of Directors. He will also chair the company’s Audit Committee, ushering SOPHiA GENETICS toward its next important milestones.

"The overall demand for Data-Driven Medicine is rapidly growing, and the next step is to successfully combine multiple sources of data to better address clinicians’ needs," said Dr. Tomer Berkovitz, Partner & CFO of aMoon. "With this shift, more complex data will be generated, and we believe that SOPHIA’s decentralized model will play a pivotal role in empowering health organizations to offer better patient care".

Keiji Kojima, Executive Vice President and General Manager of Hitachi’s Smart Life Business Division, added: "Over the years, SOPHiA GENETICS has emerged as a leader in Data-Driven Medicine and we look forward to supporting the company expand its footprint in the Japanese market and beyond."

"SOPHiA has established an impressive track record of disrupting healthcare and enabling a decentralized approach. This new funding round will further strengthen SOPHiA’s already unique offering, performance, and life-changing impact on patients and targeted therapies," said Troy Cox, Chairman of the Board of Directors of SOPHiA GENETICS.

"Since inception, we knew that leveraging a wide range of data modalities powered by cutting-edge technologies was key to sustainably deliver better outcomes to the global healthcare community", concluded Jurgi Camblong, CEO and Founder at SOPHiA GENETICS. "Now, with this new funding round, we can embark on the next stage of our development and take our collaborative approach further, delivering intelligent medicine, together."

On October 1, 2020 Covis Group S.à r.l. ("Covis") and AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) reported that they have entered into a definitive agreement under which Covis will acquire AMAG for $13.75 per share in cash, or approximately $498 million on a fully diluted basis and approximately $647 million on an enterprise basis, including debt obligations expected to be assumed or repaid net of cash (Press release, AMAG Pharmaceuticals, OCT 1, 2020, View Source [SID1234567886]). The offer represents a premium of approximately 46% to the closing price of AMAG’s common stock on September 30, the last full trading day prior to the announcement.

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Commenting on the transaction, Covis CEO Michael Porter said, "AMAG’s category leading treatments are strong strategic complements to our existing therapeutic portfolio. Through this combination, we believe we will be able to unlock value for all of our stakeholders, employees and patients through the effective and efficient management of these products, coupled with our two companies’ longstanding commitment to expanding patient access to therapy and putting patient interests first. At Covis, we never lose sight that our patients are our paramount concern. We look forward to engaging with the talented team at AMAG as we work together to plan the integration of our two organizations."

AMAG CEO Scott Myers added, "In the beginning of 2020, AMAG announced that the company had undertaken a strategic review of our product portfolio and strategy, the guiding principles of which included driving near- and long-term profitability and enhancing shareholder value. This strategic review resulted in the company pursuing and accomplishing the divestiture of its women’s health assets, and other efforts to streamline and strengthen the core business to position AMAG for the future. Following this initial transformation, our Board of Directors and management team, together with independent legal and financial advisors, thoroughly evaluated the transaction with Covis as well as other strategic options and concluded that it represents the most compelling opportunity for shareholders, providing them certain and immediate cash value. We believe Covis is the right partner for AMAG, especially in light of Covis’ shared commitment to ensuring that our therapies will reach patients in need. We are confident the work we’ve done will continue to thrive under Covis’ leadership."

The completion of the tender offer is subject to customary closing conditions, including the tender of at least a majority of the outstanding shares of AMAG’s common stock, the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, and other customary conditions. Following the successful completion of the tender offer, an indirect, wholly owned subsidiary of Covis will merge with AMAG (the "merger") and the outstanding AMAG shares not tendered in the tender offer will be converted into the right to receive the same $13.75 per share in cash paid in the tender offer. The tender offer is expected to commence in October 2020. Covis plans to finance the transaction with cash on hand, and a combination of committed debt and equity financing. There is no financing condition to the obligations of Covis to consummate the transaction.

As part of the transaction, Covis intends to enter into an amended and restated credit facility with its current lenders (the "Lenders"), pursuant to which the Lenders will provide up to a $460 million senior secured incremental term loan and a $55 million secured revolver (the "Covis Debt Financing"). The proceeds from the Covis Debt Financing, plus equity commitments from Covis’ equity sponsor, will be used to pay the cash purchase price for the transaction and repay any of the existing AMAG debt that is not assumed. The Covis Debt Financing amount will be added to Covis’ current $450 million term loan facility with the Lenders. As the merger will result in a change of control under the terms of AMAG’s Indenture governing its 3.25% Convertible Senior Unsecured Notes Due 2022 (the "Convertible Notes"), the holders of the Convertible Notes will have the right to put at par the Convertible Notes held by them for a period of twenty business days following the closing of the merger.

All Board members and executive officers of AMAG have agreed to tender their shares in favor of the transaction. The transaction, which has been unanimously approved by the Board of Directors of each company, is expected to close in November 2020, pending Hart-Scott-Rodino (HSR) approval and the conditions to the tender offer being satisfied.

Goldman Sachs & Co. LLC is acting as exclusive financial advisor, and Goodwin Procter LLP is acting as legal advisor to AMAG. Paul, Weiss, Rifkind, Wharton and Garrison LLP is acting as legal advisor to Covis.