Alvotech, a Global Pureplay Biosimilars Company, to Debut on Nasdaq Under the Ticker ALVO on June 16

On June 15, 2022 Alvotech, a global biotech company focused solely on the development and manufacture of biosimilar medicines for patients worldwide reported that its ordinary shares and warrants will begin trading on the Nasdaq Stock Market LLC ("Nasdaq") on Thursday, June 16, under the new ticker symbols "ALVO" and "ALVOW", respectively (Press release, Alvotech, JUN 15, 2022, View Source [SID1234616013]). This follows the successful completion of the company’s business combination with Oaktree Acquisition Corp. II ("OACB"), a special purpose acquisition company sponsored by an affiliate of Oaktree Capital Management, L.P. ("Oaktree"). The merger, which was approved on June 7 by OACB shareholders, creates a publicly traded, pureplay company focused on the growing global biosimilar market.

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The public listing is expected to be the largest debut on a U.S. exchange by an Icelandic company. Ordinary shares of the company are also expected to trade on the Nasdaq First North Growth Market in Iceland commencing on June 23, 2022. Alvotech is expected to be the first dual-listed Icelandic company on both a U.S. and Icelandic stock exchange.

"Becoming a public company is a historic milestone on Alvotech’s growth journey," said Robert Wessman, founder and Executive Chairman of Alvotech. "We expect that becoming a listed company will allow us to continue strengthening our position in the biosimilar space while delivering value to our partners and patients across the globe."

"Oaktree is proud to be associated with Alvotech, a world-class biosimilar platform with a mission-critical focus on providing important drugs at a reduced cost," said Howard Marks, Co-Founder and Co-Chairman of Oaktree. "We look forward to the continuation of our relationship as the company enters its next phase of growth."

Since its inception a decade ago, Alvotech has built a vertically integrated, state-of-the-art platform for developing and manufacturing biosimilars at scale. Biosimilars are therapeutic equivalents to biologics, a rapidly growing category of highly efficacious medicines, that provide lower-cost alternatives to higher-priced originator medicines. Biologics represent over 40% of all pharmaceutical spending in the U.S. and over 30% of spending on medicines in Europe at list prices1. Alvotech’s current portfolio of eight products and product candidates targets multiple therapeutic areas and represents an estimated total addressable market of over $85 billion based on estimated peak sales of the reference products2.

Alvotech’s lead product, AVT02 (adalimumab), a biosimilar to Humira, has launched in Canada and Europe and is expected to launch in the U.S. on July 1, 20233. For the U.S. market, Alvotech is pursuing an interchangeability designation for AVT02 (adalimumab) and has previously announced FDA acceptance of Alvotech’s BLA supporting interchangeability for the company’s high-concentration, citrate-free biosimilar candidate. More recently, the company has announced positive topline results for AVT04 (ustekinumab), Alvotech’s proposed biosimilar to Stelara, for both the confirmatory clinical, safety and efficacy study and a pharmacokinetic (PK) study.

In order to give its products global reach with local expertise, Alvotech has formed strategic commercialization partnerships with leading pharmaceutical companies spanning global markets. These include partnerships with Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) for the US market; STADA Arzneimittel AG for EU and select other territories; and Fuji Pharma Co., Ltd (TSE: 4554) for Japan, among others.

The transaction is supported by a PIPE totaling approximately $175 million, raised entirely as ordinary shares, at $10.00 per share. The PIPE was backed by top-tier investors such as Suvretta Capital, Athos (the Strüngmann Family Office), CVC Capital Partners, Temasek Holdings, YAS Holdings, Farallon Capital Management, and Sculptor Capital Management, among others.

To celebrate the public listing, Mr. Wessman will ring the opening bell at NASDAQ with live ceremonies beginning at 9:15 ET on June 16 at the Nasdaq Market Site in New York City. The event will be livestreamed and can be viewed at View Source

Bristol Myers Squibb Announces Dividend

On June 15, 2022 Bristol Myers Squibb (NYSE: BMY) reported that its Board of Directors has declared a quarterly dividend of fifty-four cents ($0.54) per share on the $.10 par value common stock of the company (Press release, Bristol-Myers Squibb, JUN 15, 2022, View Source [SID1234615998]). The dividend is payable on August 1, 2022 to stockholders of record at the close of business on July 1, 2022.

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In addition, the Board of Directors has declared a quarterly dividend of fifty cents ($0.50) per share on the company’s $2.00 convertible preferred stock, payable September 1, 2022, to stockholders of record at the close of business on August 9, 2022.

AngioDynamics to Report Fiscal 2022 Fourth Quarter and Full-Year Financial Results on July 12, 2022

On June 15, 2022 AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options, and improving quality of life for patients, reported that it will report financial results for the fourth quarter and fiscal year 2022 before the market open on Tuesday, July 12, 2022 (Press release, AngioDynamics, JUN 15, 2022, View Source [SID1234616014]). The Company’s management will host a conference call at 8:00 a.m. ET the same day to discuss the results.

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To participate in the conference call, dial 1-877-407-0784 (domestic) or +1-201-689-8560 (international) and refer to the passcode 13730672.

This conference call will also be webcast and can be accessed from the "Investors" section of the AngioDynamics website at www.angiodynamics.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A recording of the call will also be available from 11:00 a.m. ET on Tuesday, July 12, 2022, until 11:59 p.m. ET on Tuesday, July 19, 2022. To hear this recording, dial 1-844-512-2921 (domestic) or +1-412-317-6671 (international) and enter the passcode 13730672.

Imagia Canexia Health Achieves First CE-IVD Status in the E.U. to Deploy Comprehensive Cancer Testing Platform

On June 15, 2022 Imagia Canexia Health, a genomics-based cancer treatment testing company that accelerates access to precision care by combining AI expertise with advanced molecular biopsy solutions, reported the CE-IVD marking for its Imagia Canexia Health Insights Platform (ICHIP) to operate across Europe (Press release, Canexia Health, JUN 15, 2022, View Source [SID1234616015]). ICHIP provides intricate molecular and computational genome analysis, from targeted next-generation sequencing (NGS) data, for individual cancer patients. The company offers a unique clinical solution for European oncologists to quickly generate reports—including therapeutic and clinical trial recommendations. This new approval furthers Imagia Canexia Health’s mission to combine advanced genomics, oncology, artificial intelligence, and informatics to enable health systems to provide cost-effective testing in-house—thus delivering precision cancer treatments to patients no matter where they live.

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Clinicians receive next-generation sequencing (NGS) data sourced from human tissue or blood samples. These insights are collected, as well as processed, on Illumina’s NextSeq and MiSeq devices. Then, ICHIP uses AI to detect and analyze genomic variants, match interpretations, identify potential clinical trials, as well as generate a cancer-treatment results report. This creates a new ability to integrate clinical and genomic patient data, augmenting treatment decisions by oncologists. With this crucial information, health professionals can rapidly access data about a cancer patient’s genetics, as well as describe the potential associations between detected variants and specific therapeutics, all while making the most informed care-management decisions.

"Achieving the CE-IVD mark, a highly regarded standard around the globe, represents an important milestone that reflects the technological quality and rigor upon which we built the Imagia Canexia Health Insights Platform (ICHIP)," said Imagia Canexia Health CEO Geralyn Ochab. "Our company takes pride in the platform’s ability to quickly provide specialists with vital information to fight cancer, now supporting European oncologists with life-saving information for their patients."

Geron Corporation Announces Appointment of Faye Feller, M.D. to Chief Medical Officer and Transition of Aleksandra Rizo, M.D., Ph.D. to Senior Advisor Role

On June 15, 2022 Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, reported the appointment of Faye Feller, M.D., to Executive Vice President and Chief Medical Officer, effective July 9, 2022 (Press release, Geron, JUN 15, 2022, View Source [SID1234616000]). Dr. Feller will succeed Dr. Aleksandra Rizo, Geronʻs current Chief Medical Officer, who will transition to a consultant role to the Company, as Senior Medical and Regulatory Advisor. Outside of Geron, Dr. Rizo has accepted a leadership position with a privately held discovery and preclinical-stage platform biotechnology company.

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Dr. Feller has been instrumental in the design, execution and management of the imetelstat development program for the past seven years, starting when she served as a medical leader in Janssen’s hematology program. She has continued her work on imetelstat since 2019, as Geronʻs Vice President of Clinical Development reporting to Dr. Rizo.

"Faye has been a cornerstone in the history of imetelstat’s clinical development. Since coming to Geron, she has played a strategic role in designing and driving execution of our Phase 3 clinical trials. In addition, she serves as the primary medical point of contact between Geron and our clinical investigators, leads the preparation of data for assessment by the data monitoring committees, and is preparing for the top-line readout of our IMerge Phase 3 trial in lower risk myelodysplastic syndromes, which is expected in early January 2023," said John A. Scarlett, M.D., Chairman and Chief Executive Officer. "With her background as clinical lead for multiple clinical trials while at Janssen, and as an attending hematologist at Memorial Sloan Kettering Cancer Center, Faye is highly qualified to assume her new role as our Chief Medical Officer."

When Dr. Feller becomes Chief Medical Officer, Dr. Rizo will transition to the consultant role, where she will continue to be involved in key imetelstat development and regulatory activities. These include assessment of data for top-line results from the ongoing IMerge Phase 3 trial in lower risk myelodysplastic syndromes (MDS) and, assuming supportive top-line results, through the planned FDA New Drug Application submission and acceptance process for imetelstat in lower risk MDS.

"Aleksandra has made tremendous contributions to the development of imetelstat," Dr. Scarlett continued. "Her leadership in building and mentoring a deep and experienced development organization is evident with the internal promotion of Faye as Chief Medical Officer. We appreciate the continuity in involvement Aleksandra will provide as Faye assumes her new responsibilities."

"It has been a privilege to work with Chip and the Geron team to advance this innovative first-in-class telomerase inhibitor, imetelstat, into the late stages of clinical development. I remain confident in the potential of imetelstat to be a transformative treatment for patients with hematologic malignancies, and as such, I am fully committed to continuing to contribute to the imetelstat journey through the potential New Drug Application submission and acceptance process. In particular, I am eager to see the Phase 3 top-line results from the lower risk MDS trial expected in early January 2023," Dr. Rizo said. "I am also completely confident that imetelstat will be in excellent hands with Faye and the rest our team at Geron, many of whom I have worked with side-by-side on imetelstat over the past seven years, and for whom I have the greatest respect."

Prior to joining Geron, Dr. Feller was Senior Director at Janssen Research and Development, LLC (Janssen) and both a Compound Lead and Study Responsible Physician for multiple clinical trials of early and late-stage development assets at Janssen, including the IMbark Phase 2 clinical trial of imetelstat. Prior to Janssen, Dr. Feller was an attending physician in the leukemia department of Memorial Sloan Kettering Cancer Center in New York. She received a B.A. from New York University and an M.D. from Mount Sinai School of Medicine. She completed her residency in internal medicine at Mount Sinai Hospital and her fellowship in medical oncology at Memorial Sloan Kettering Cancer Center.