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underwriting agreement

April 12, 2022, Affimed N.V. ("Affimed" or the "Company") reported that entered into an underwriting agreement (the "Underwriting Agreement") with Jefferies LLC, SVB Securities LLC, Truist Securities, Inc. and Wells Fargo Securities, LLC, as representatives of the several underwriters named therein (collectively, the "Underwriters"), relating to the issuance and sale (the "Offering") of 22,500,000 of the Company’s common shares (the "Underwritten Shares"), as well as an additional 3,375,000 common shares to be sold pursuant to the full exercise of the option to purchase over-allotment shares granted to the Underwriters (the "Over-Allotment Shares") (Filing, 6-K, Affimed, APR 12, 2022, View Source [SID1234612395]). The price to the public in the Offering is $4.00 per share, and the Underwriters have agreed to purchase the common shares from the Company pursuant to the Underwriting Agreement at a price of $3.76 per share. The net proceeds to the Company from the Offering of the Underwritten Shares and the Over-Allotment Shares are expected to be approximately $97.0 million, after deducting underwriting discounts and other estimated offering expenses payable by the Company. All of the common shares in the Offering are being sold by the Company.

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The Offering is being made pursuant to the Company’s effective registration statement on Form F-3 (Registration Statement No. 333-260946) previously filed with the Securities and Exchange Commission and a prospectus supplement thereunder.

The Underwriting Agreement contains customary representations, warranties and covenants by the Company, customary conditions to closing, indemnification obligations of the Company and the Underwriters, including for liabilities under the Securities Act of 1933, as amended, other obligations of the parties and termination provisions. The representations, warranties and covenants contained in the Underwriting Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to such agreement, and may be subject to limitations agreed upon by the contracting parties.

The Underwriting Agreement is filed as Exhibit 1.1 to this report, and the description of the terms of the Underwriting Agreement is qualified in its entirety by reference to such exhibit. Copies of the opinions of De Brauw Blackstone Westbroek N.V. relating to the validity of the Underwritten Shares and the Over-Allotment Shares issued and sold in the Offering are attached as Exhibit 5.1 hereto and Exhibit 5.2 hereto, respectively.

Ankyra Therapeutics Announces Cooperative Research and Development Agreement with the National Cancer Institute

On April 18, 2022 Ankyra Therapeutics reported that it has established a formal Cooperative Research and Development Agreement with the National Cancer Institute (NCI) to pursue basic, translational and clinical research using Ankyra Therapeutics’ emerging anchored immunotherapy pipeline in collaboration with NCI’s Center for Cancer Research (CCR) (Press release, Ankyra Therapeutics, APR 18, 2022, View Source [SID1234612394]). CCR is located within the National Institutes of Health (NIH) in Bethesda, Maryland, and it has made many contributions to cancer therapy. CCR includes intramural investigators focused on understanding cancer biology and developing new therapeutic strategies for the treatment of cancer. The primary NCI investigators include Dr. Jeffrey Schlom, Chief of the Laboratory of Tumor Immunology and Biology in CCR, NCI, and Dr. James Gulley, Chief of the Genitourinary Malignancies Branch, Director of the Medical Oncology Service, and Deputy Director of the CCR, NCI.

"Ankyra is excited to partner with both the basic scientists and clinical investigators at NCI to more rapidly understand how our drugs promote anti-tumor immunity and to quickly get our drugs into clinical trials for patients with cancer," stated Dr. Howard L. Kaufman, Chief Executive Officer of Ankyra Therapeutics. Dr. Michael Schmidt, Chief Scientific Officer of Ankyra, added "We are especially excited to collaborate with NCI researchers to expand the pre-clinical and clinical development of our lead cytokine therapeutic ANK-101 and look forward to combining our expertise to demonstrate the ability of our anchored immunotherapy platform to enhance the safety and efficacy of powerful immune agonist drugs."

Shionogi and NEC Enter into Strategic Research Collaboration for Novel Hepatitis B Therapeutic Vaccine

On April 18, 2022 Shionogi & Co., Ltd. (Head Office: Osaka, Japan; President & CEO: Isao Teshirogi, Ph.D.; hereafter "Shionogi") and NEC Corporation (Head Office: Tokyo, Japan; President & CEO: Takayuki Morita; hereafter "NEC"), reported the execution of a strategic research collaboration agreement for the development of a novel hepatitis B therapeutic vaccine (Press release, NEC, APR 18, 2022, View Source [SID1234612393]). NEC OncoImmunity (Head Office: Oslo, Norway, CEO: Richard Stratford Ph.D.), an NEC subsidiary that specializes in artificial intelligence-driven biotechnology, is also participating in this research collaboration.

Hepatitis B is a potentially life-threatening liver disease caused by the hepatitis B virus (HBV). Chronic infection with HBV results in a high risk of death from cirrhosis and liver cancer. About 300 million people are living with chronic hepatitis B infection worldwide, and hepatitis B resulted in an estimated 820,000 deaths in 20191. Although the widespread use of hepatitis B vaccines in infants has considerably reduced the incidence of new chronic HBV infections under the age of 5, the number of new infections by other routes continues to increase2.

Interferon (IFN) and nucleotide analog therapy are currently used in the treatment of hepatitis B. However, treatment with IFN has a high frequency of side effects, and nucleotide analog therapy has a high recurrence rate if treatment is interrupted, so it is necessary to take drugs for a lifetime3. Therefore, the unmet medical need for safe and highly effective drugs that can finally achieve a complete cure for hepatitis B is high.

The Kuraray Foundation Announces its New Website

On April 18, 2022 The Kuraray Group reported that the Kuraray Foundation, a general incorporated foundation established to promote the Group’s social contribution activities, launched a website on April 18 to introduce said activities (Press release, Kuraray, APR 18, 2022, View Source [SID1234612378]).

The Kuraray Foundation was established in April 2016 in order to realize the Kuraray Group’s desire to increase the scope and scale of its social contributions in line with global expansion in its business and presence.

Brooklyn ImmunoTherapeutics Announces Fourth Quarter and Full Year 2021 Financial Results

On April 15, 2022 Brooklyn ImmunoTherapeutics, Inc. (Nasdaq:BTX) ("Brooklyn"), a biopharmaceutical company focused on exploring the role that cytokine, gene editing, and cell therapy can have in treating patients with cancer, blood disorders, and monogenic diseases, reported financial results for the fourth quarter and year ended December 31, 2021 (Press release, Brooklyn ImmunoTherapeutics, APR 15, 2022, View Source [SID1234612348]).

Financial and corporate highlights for the quarter and year months ended December 31, 2021 and subsequently include the following:

Fourth quarter ended December 31, 2021:

Appointed Susan McClatchey as Vice President and Head of Quality
Named to both the Nasdaq Biotechnology Index and the ICE Biotechnology Index
Transitioned from the NYSE American to the Nasdaq Global Market to better align with industry peers
The period January 2021 – September 2021:

Appointed Howard J. Federoff, M.D., Ph.D., as Chief Executive Officer and President; Kevin D’Amour, Ph.D. as Chief Scientific Officer; Jay Sial as Chief Administrative Officer and Roger Sidhu, M.D. as Chief Medical Officer
Completed the acquisition of Novellus, Inc. ("Novellus") in July 2021, which developed next-generation engineered mesenchymal stem cell ("MSC") therapies using patented mRNA-based cell reprogramming and gene editing technologies licensed from Factor Bioscience ("Factor")
Raised over $52 million in net proceeds through equity line sales of common stock for general corporate purposes, including working capital to be used to enhance the development of the mRNA gene editing and cell therapies technology licensed from Factor
Published results of IRX-2 (a human-derived mixed cytokine product) monotherapy in early-stage breast cancer in Breast Cancer Research
Acquired an exclusive license for mRNA gene editing and cell therapies technology of Factor Bioscience Limited and Novellus Therapeutics
Became a public company pursuant to our merger transaction with NTN Buzztime, Inc. ("NTN")
Howard Federoff, M.D., Ph.D., Brooklyn’s President and Chief Executive Officer, commented, "2021 was a transformational year for Brooklyn ImmunoTherapeutics. I am proud to be working with our new team of experts and seasoned professionals, Roger Sidhu, M.D., Jay Sial and Kevin D’Amour, Ph.D. Together with our board of directors and scientific advisors, we are committed to our mission to discover, develop and deliver innovative products to patients who need them. We believe that we have created a leading platform company in cell, gene-editing and cytokine therapies, with a broad and deep pipeline. Our accomplishments in 2021 reflect our continued progress towards our vision of transforming patients’ lives through science.

Dr. Federoff continued: "We began 2022 with the launch of our new research and development facilities in San Diego, California. Another sign of our growth is the transfer of our common stock listing from the NYSE American to the Nasdaq Global Market in late 2021, being named to represent the biotech sector as part of the Nasdaq Biotechnology Index (Nasdaq:NBI) and being added to the ICE Biotechnology Index (NYSE:ICEBIO). We believe that our Nasdaq listing better aligns Brooklyn with industry peers, is more in line with the innovation we are pursuing and acknowledges and further validates our approach and technology."

"We believe that we are well positioned for growth. As we await the readout of our Phase 2b trial for neoadjuvant head and neck cancer with our original asset, IRX-2, during the second quarter of 2022, we continue investigator-driven trials in a number of additional cancer types and look forward to sharing these outcomes as appropriate. I want to thank the team for all of their hard work and commitment and our shareholders, partners and investors for their continued support," concluded Dr. Federoff.

Financial Results
Operating expenses for the three and twelve months ended December 31, 2021 were $9.1 million and $113.6 million, respectively, compared to $21.4 million and $26.5 million of operating expenses for the same periods in 2020.

Research and development expenses were $4.2 million and $93.2 million for the three and twelve months ended December 31, 2021, respectively, compared to $1.7 million and $4.0 million for the same periods in 2020, respectively. Research and development expenses increased during the fourth quarter primarily due to increased license fees and non-cash stock-based compensation resulting from the issuance of equity awards. Research and development expenses increased for the full year of 2021 due to license fees, non-cash stock-based compensation and $80.5 million of acquired in-process research and development expense related to the Novellus acquisition in July 2021.

General and administrative expenses were $4.4 million and $14.7 million for the three and twelve months ended December 31, 2021, respectively, compared to $0.6 million and $3.3 million during the same periods in 2020. The quarter-over-quarter and year-over-year increases in general and administrative expense were primarily related to increased legal, accounting and consulting fees, costs associated with being a publicly traded company, increased headcount, increased insurance expense and increased non-cash stock-based compensation.

The change in the fair value of contingent consideration was $0.6 million of expense for the three months ended December 31, 2021 and a credit of $0.2 million for the twelve months ended December 31, 2021 compared to expense of $19.2 million for both the three and twelve months ended December 31, 2020.

The Company recognized transaction costs of $5.8 million during the twelve months ended December 31, 2021 related to the value of shares issued to its banker for the merger transaction with NTN in March 2021, as well as a loss on the subsequent sale of the NTN assets of $9.6 million.

Net loss for the three and twelve months ended December 31, 2021 was $8.5 million and $122.3 million, respectively, compared to a net loss of $21.5 million and $26.5 million for the same period in 2020.

As of December 31, 2021, Brooklyn had approximately $17.0 million in cash, compared to $1.6 million as of December 31, 2020.