NexImmune Announces Closing of Upsized Initial Public Offering and Full Exercise of Underwriters’ Option to Purchase Additional Shares

On February 17, 2021 NexImmune, Inc. (Nasdaq: NEXI), a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to employ the body’s own T cells to generate a specific, potent and durable immune response, reported the closing of its previously announced upsized initial public offering of 7,441,650 shares of its common stock at a price to the public of $17.00 per share, which includes the exercise in full by the underwriters of their option to purchase 970,650 additional shares (Press release, NexImmune, FEB 17, 2021, View Source [SID1234576168]). Including the option exercise, the gross proceeds to NexImmune from the offering, before deducting the underwriting discounts and commissions and estimated offering expenses, were approximately $126.5 million.

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Barclays Capital Inc., Cantor Fitzgerald & Co., Raymond James & Associates, Inc. and Allen & Company LLC acted as the joint book-running managers for the offering.

Registration statements relating to these securities have been filed with the Securities and Exchange Commission and became effective on February 11, 2021. The offering was made only by means of a prospectus. Copies of the final prospectus related to the offering may be obtained from: Barclays Capital Inc., Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, telephone: (888) 603-5847, or email: [email protected]; Cantor Fitzgerald & Co., Attention: Capital Markets Department, 499 Park Avenue, New York, NY 10022, or email: [email protected]; Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, FL 33716, telephone: (800) 248-8863, or email: [email protected]; or Allen & Company LLC., Attention: Prospectus Department, 711 Fifth Avenue, New York, NY 10022, telephone: (212) 339-2220, or email: [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or 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 jurisdiction.

INOVO : the Oncofactory’s new project with the Carnot Calym Institute and Astrazeneca

On February 17, 2021 Astrazeneca, The Carnot Calym Institute and Inserm Transfert for Inserm sign a framework agreement for research collaboration in lymphomas (Press release, OncoFactory, FEB 17, 2021, View Source [SID1234575981]).

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In order to accelerate the search for therapeutic solutions for lymphoma patients, the three partners have decided to pool their expertise by signing a tripartite agreement. This partnership sets up the conditions for the collaboration between the pharmaceutical group AstraZeneca, research teams from the Carnot CALYM Institute network and Inserm Transfert, Inserm’s private subsidiary, representing the research teams. This 3-year collaboration will allow the funding of up to two projects per year.

This agreement defines the terms of the collaboration with respect to governance, funding, intellectual property, exploitation of results and eligibility of research projects. It provides a platform facilitating the alliance between AstraZeneca’s R&D, bringing new drug candidates from its technology platforms of excellence, and the world-renowned expertise of the academic teams of the CALYM’s network, dedicated to the pathophysiology of lymphomas.

According to Bertrand Nadel, Director of CALYM, "Successful therapeutic innovation today requires interfacing academic expertise with R&D practices and the drug development value chain and intensifying the dialogue between public and private players. AstraZeneca’s commitment to connecting the Discovery/Innovation/Transfer segments makes it a partner of choice for our Carnot CALYM Institute to meet this challenge".

PRESS RELEASE: Generating recommendations for the design, analysis and interpretation of patient- reported outcome (PRO) data for cancer clinical trials: the launch of SISAQOL-IMI

On February 17, 2021 An international multidisciplinary consortium, co-led by the European Organisation for Research and Treatment of Cancer (EORTC) and Boehringer Ingelheim (BI), reported that has been convened to generate recommendations to standardize the use, analysis, and interpretation of patient reported outcome (PRO) data in cancer clinical trials (Press release, EORTC, FEB 17, 2021, View Source [SID1234575348]).

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SISAQOL-IMI (Setting International Standards of Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials – IMI) will establish guidance on how to use patient-reported outcomes in cancer clinical trials so that they can be used in a methodologically sound way, analysed in a statistically adequate manner, and intelligibly presented to ensure a high study quality and a better comparability of results across clinical trials.

SISAQOL-IMI is a public-private collaborative research project under the Innovative Medicines Initiative (IMI). Forty-one stakeholder groups are involved in the partnership, including researchers from the pharmaceutical industry, academia, non-profit associations, cancer institutes, regulators, and patient advocacy organisations. The project aims to improve the interpretability of cancer clinical trials and thereby (in the long run) also provide a more solid and reliable basis for shared decision making between patients and physicians to improve outcomes, treatment satisfaction, and care treatment decisions in clinical practice.

Andrew Bottomley, Assistant Director and Head of the Quality of Life Department at the EORTC and SISAQOL-IMI project coordinator said,

"Outcomes from this project will help us understand more about the impact of treatment on the lives of patients. We are looking forward to working with our project partners to generate recommendations that will be useful to so many different stakeholders "

Kathy Oliver, Chair and Co-Director of the International Brain Tumour Alliance also commented,

"The SISAQOL-IMI initiative is a ground-breaking project which will set much-needed international standards for PRO data analysis in cancer clinical trials. We look forward to WECAN’s involvement with this exciting initiative"

Dr Ingolf Griebsch Head of Corporate Market Access Oncology at Boehringer Ingelheim and SISAQOL-IMI project leader said,

"SISAQOL-IMI is a great example of how researchers from academia and industry can truly partner with regulators and patient organisations to develop useful recommendations for interpreting PRO data in the future"

SISAQOL-IMI kicked off at the beginning of January and will run for four years.

Cannabics Pharmaceuticals’ in-vivo Tumor Inhibitory Effect Study Concludes with a Statistical Significance of p ? 0.016

On February 17, 2021 Cannabics Pharmaceuticals Inc. (OTCQB: CNBX), a global leader in the development of cancer related cannabinoid-based medicine, reported that further clarifies with regards to the final study results released on February 16, 2021, that said study results showing "a significant and robust inhibitory effect on tumor growth, as evidenced by a 33% reduction in tumor volume in mice exposed to RCC-33 in comparison with sham control mice," are said to have statistical significance with p ≤ 0.016 (Press release, Cannabics Pharmaceuticals, FEB 17, 2021, View Source [SID1234575344]).

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CHARLES RIVER LABORATORIES TO ACQUIRE COGNATE BIOSERVICES TO CREATE A PREMIER SCIENTIFIC PARTNER
FOR CELL AND GENE THERAPY DEVELOPMENT

On February 17, 2021 Charles River Laboratories International, Inc. (NYSE: CRL) reported that it has signed a definitive agreement to acquire Cognate BioServices, Inc., a premier, cell and gene therapy contract development and manufacturing organization (CDMO), for approximately $875 million in cash, subject to customary closing adjustments (Press release, Charles River Laboratories, FEB 17, 2021, View Source [SID1234575317]). The transaction is expected to close by the end of the first quarter of 2021, subject to regulatory requirements and customary closing conditions.

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James C. Foster, Chairman, President and Chief Executive Officer of Charles River Laboratories, commented, "Cognate BioServices presents a unique opportunity to expand into a high-growth, value-added sector of the CDMO market and enhance our ability to meet our clients’ needs in emerging areas of scientific innovation. This acquisition will be an exceptional strategic fit, adding to our comprehensive suite of early-stage research and manufacturing support solutions and enabling us to achieve our goal of establishing a single scientific partner to provide biopharmaceutical clients with an integrated solution to help accelerate their cell and gene therapy programs from discovery and non-clinical development through commercialization."

"Because of the synergistic fit with Charles River, the market growth potential, and the emerging role of advanced drug modalities as treatments for oncology and rare disease, we believe Cognate will meaningfully enhance our long-term revenue and earnings growth potential. We look forward to welcoming Cognate’s dedicated employees to the Charles River family," Mr. Foster concluded.

Cognate is a premier, cell and gene therapy CDMO offering comprehensive manufacturing solutions for cell therapies, as well as for production of plasmid DNA and other inputs in the CDMO value chain. The planned acquisition will establish Charles River as a premier scientific partner for cell and gene therapy development, testing, and manufacturing, providing clients with an integrated solution from basic research and discovery through CGMP production. Cognate has extensive experience producing various cell types and technologies used in cellular immunotherapy and immuno-oncology, regenerative medicine, and advanced cell therapy. Headquartered in Memphis, Tennessee, Cognate has operations in North America and Europe with over 500 employees.

Strategic Rationale

The acquisition of Cognate will expand Charles River’s scientific capabilities into the emerging, high-growth cell and gene therapy CDMO sector, establishing a comprehensive solution from discovery and non-clinical development through CGMP manufacturing in advanced drug modalities.

Expands Scientific Expertise into Major CDMO Platforms for Cell and Gene Therapies – Cognate offers its clients a broad portfolio of cell and gene therapy solutions across the major CDMO platforms, enhancing its ability to meet its clients’ evolving scientific needs. Its primary area of expertise is in CGMP cell therapy manufacturing, which processes a variety of cellular products and other starting materials to develop and produce allogeneic (donor-derived) and autologous (patient-derived) cell therapies. Cognate also produces plasmid DNA, which is a foundational tool used in the development of gene-modified cell therapies and gene therapies, as well as other CDMO inputs.
Complements Charles River’s existing portfolio and establishes a premier scientific partner for the development, testing, and manufacturing of advanced drug modalities – Biopharmaceutical clients are seeking to drive greater efficiency and leverage scientific benefits by working with fewer, trusted partners who have broad, integrated capabilities. The addition of Cognate will be complementary to Charles River’s existing, non-clinical capabilities, establishing a premier scientific partner for cell and gene therapy development, testing, and manufacturing, and providing clients with an integrated solution from basic research through CGMP production.

Cognate will be particularly synergistic with the Company’s Biologics Testing Solutions business. It will enable clients to seamlessly conduct analytical testing, process development, and manufacturing for advanced modalities with the same scientific partner, enabling them to achieve their goal of driving greater efficiency. Clients will also have access to the Company’s cellular products as the starting point for their cell therapy programs and will be able to work with Charles River through every step of the research and early-stage development process before moving into CGMP production with Cognate, accelerating clients’ speed to market for advanced drug modalities.
Enhances Charles River’s growth potential with increased exposure to a high-growth market sector – Cognate will immediately enhance Charles River’s growth potential by expanding its comprehensive platform of high-growth cell and gene therapy solutions. The addressable market for Cognate’s CDMO services – principally cell therapy and plasmid production – is currently estimated at approximately $1.5 billion and expected to grow at least 25% annually over the next five years. With a significant portion of cell and gene therapy programs in the preclinical phase, demand for Cognate’s services is expected to intensify as more of these programs progress into late-stage development and commercialization.
Expected to drive profitable growth and shareholder value – The acquisition is expected to generate attractive financial returns that are consistent with Charles River’s disciplined investment criteria. It is also expected to be meaningfully accretive to Charles River’s long-term revenue and earnings per share growth. Cognate is expected to generate annual revenue of approximately $140 million in 2021, and is expected to grow at least 25% annually over the next five years.
Additional Financial and Transaction Details

Based on the anticipated completion of the acquisition by the end of the first quarter, Cognate is expected to add approximately $110 million to Charles River’s 2021 consolidated revenue for the partial year. The transaction is expected to be neutral to non-GAAP earnings per share in 2021, and accretive thereafter. Items excluded from non-GAAP earnings per share are expected to include all acquisition-related costs, which primarily include amortization of intangible assets, advisory fees, certain costs associated with efficiency initiatives, and certain third-party integration costs.

The acquisition and associated fees are expected to be financed through Charles River’s existing credit facility and cash. The Company is evaluating further optimizing its debt structure which could be used to finance the acquisition and for general corporate purposes.

Cognate is expected to be reported as part of Charles River’s Manufacturing Support segment.

Advisors and Cognate Ownership

Gordon Dyal & Co., LLC is acting as the exclusive financial advisor to Charles River. Davis Polk & Wardwell LLP is acting as Charles River’s transactional legal counsel, and Weil, Gotshal & Manges LLP is acting as antitrust counsel. Dark Horse Consulting Group, Inc. is acting as Charles River’s strategic advisor.

Cognate is supported by its majority shareholder, EW Healthcare Partners, as well as minority shareholders, Medivate Partners, BlackRock, and a sovereign wealth fund. Morgan Stanley & Co. LLC is acting as the exclusive financial advisor and Kirkland & Ellis LLP is acting as legal counsel to Cognate and its shareholders.