On June 22, 2021 Blackstone (NYSE: BX) reported that funds managed by Blackstone Life Sciences have committed $250 million towards the launch of a new autologous and allogeneic universal chimeric antigen receptor (CAR) T-cell therapy company, along with Intellia Therapeutics, Inc. (NASDAQ: NTLA) and Cellex Cell Professionals GmbH ("Cellex"), the parent company of GEMoaB GmbH ("GEMoaB"), a clinical-stage cell therapy company (Press release, Intellia Therapeutics, JUN 22, 2021, View Source [SID1234584227]). The new company will combine GEMoaB’s world-leading clinical-stage universal CAR-T platforms with Intellia’s differentiated allogeneic cell platform and CRISPR cell engineering.

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Intellia Therapeutics is a clinical stage, leading genome editing company focused on developing curative therapeutics using CRISPR/Cas9 technology. Cellex Cell Professionals GmbH holds the clinical-stage biopharmaceutical company GEMoaB, which is focused on the development of next-generation immunotherapies and cell therapies for hard-to-treat cancers.

The new company will be headquartered in Cambridge, Massachusetts and will acquire Cellex’s subsidiary GEMoaB GmbH with established offices and labs in Dresden, Germany. GEMoaB is developing a switchable universal platform to improve the therapeutic window of CAR T-cell therapies. This approach enables increased efficacy and safety across a range of cancers, including solid tumors, that are currently a challenge for existing cell therapies. In addition, the new company and Intellia will gain access to Cellex’s established cell therapy manufacturing capabilities to accelerate their respective ex vivo programs.

Andrew Schiermeier, Ph.D., current Executive Vice President and Chief Operating Officer of Intellia, will lead the launch as President and Chief Executive Officer.

"This launch represents the first of many steps to addressing the various limitations that currently exist in the cell therapy space, and I am both humbled and excited to be leading the creation of this company with a team of extremely talented individuals," said Schiermeier. "Bringing together GEMoaB’s universal CAR-T platform with Intellia’s differentiated allogeneic T cell platform and CRISPR-based cell engineering provides a unique opportunity to move cell therapy technology to new heights. Our focus is on providing significantly safer and more efficacious treatments to patients who are suffering from hard-to-treat cancers and autoimmune diseases."

"We can now build on our established and ongoing collaboration with Intellia," said Dr. Armin Ehninger, GEMoaB’s Chief Scientific Officer. "With Blackstone’s contribution of funds and expertise, we will be able to combine our switchable CAR-T platform which has broad potential applicability and has already shown early signs of efficacy and a favorable side effect profile in an ongoing Phase Ia trial, with Intellia’s leading genome editing technology," added Gerhard Ehninger, M.D., founder of Cellex and GEMoaB. "This will allow us to potentially replace the living drug, currently manufactured from the patient’s own immune cells, by cells from healthy donors. Our goal is for these cells to be immediately available to patients. This is a good day for patients."

"Collaborations like this one are a key instrument for Intellia to strengthen investment in areas of strategic importance to us, enabling us to more quickly realize the full scope and potential of our genome-editing technology for patients in need of more effective therapies. With today’s announcement, we can drive the expansion of our pipeline into new areas, accelerating clinical validation of what we believe to be a platform for universal, allogeneic CAR-T cell therapies. Further, we can fortify our allogeneic cell engineering capabilities for wholly owned programs through a preferred relationship with Cellex," said Intellia President and Chief Executive Officer, John Leonard, M.D.

"We believe that this exciting effort has the potential to leapfrog current CAR-T technologies and improve the standard of care for a broad range of patients," said Dr. Nicholas Galakatos, Global Head of Blackstone Life Sciences. "As the sole founding investor, Blackstone will be actively involved in building this platform, leveraging our deep expertise in oncology and our scale capital. Our partnership with Intellia and Cellex is customized to address the new company’s needs and set it up for success from day one, and while it is an earlier-stage, growth investment for us, it demonstrates the versatility of our investment platform and commitment to advance potentially transformational technologies to benefit patients."

Business transformation and responsibilities

Key components of the new company upon formation include the following highlights:

The new company will have an exclusive license to combine Intellia’s CRISPR/Cas9 allogeneic platform with GEMoaB’s switchable, universal CAR T-cell platforms (UniCAR and RevCAR).
GEMoaB will become a subsidiary of the newly established company and will continue to advance its clinical stage CAR T-cell programs.
The new company and Intellia will also simultaneously enter into a co-development and co-funding (Co-Co) agreement to develop an allogeneic universal CAR T-cell product for an immuno-oncology indication. Intellia will have one additional option to enter into a second Co-Co agreement from selected allogeneic universal CAR T-cell therapy products that the parties will develop under the collaboration.
Blackstone Life Sciences, Intellia and Cellex (and certain related entities) will each have equal ownership of the new company.
Experienced management to drive growth and scientific advancement

Dr. Schiermeier has spent more than two decades as an executive in the biotech and pharmaceutical industries, with experience ranging from managing the growth and operations for startups to directing the strategic and operational expansion of global brands for large pharma companies. At Intellia, he was responsible for working with the board of directors and executive committee in establishing and overseeing the implementation of Intellia’s strategic direction in both in vivo and ex vivo (engineered cell therapy) areas. He also oversaw the company’s portfolio management, drug development, manufacturing, and business development efforts. Prior to Intellia, he served as SVP and Global Head of Merck KGaA’s Oncology Business, a global operation with revenues in excess of $1 billion across 66 countries.

The new company includes a seasoned management team, including Chief Medical Officer Professor Gerhard Ehninger, a founding shareholder of GEMoaB who served as its Chief Medical Officer. Prof. Ehninger is also a founding shareholder and Chief Executive Officer of GEMoaB’s parent company Cellex. Prof. Ehninger was the Head of Hematology and Oncology at University Hospital Carl Gustav Carus of the Technical University Dresden, Germany, as well as the former President of the German Society of Hematology and Oncology (DGHO). As one of the world’s leading researchers in the areas of acute leukemias and solid tumors, Prof. Ehninger has published more than 700 scientific articles in peer-reviewed journals and was principal investigator for multiple pivotal studies in hematology and oncology. The new company has also appointed Dr. Armin Ehninger as its Chief Scientific Officer. Dr. Ehninger has served as Chief Scientific Officer of GEMoaB since 2014. He has more than 15 years of research and drug discovery experience in oncology and hematology, stem cell biology as well as cancer immunotherapy. Dr. Ehninger’s expertise and leadership were decisive in establishing GEMoaB’s Research & Development and pre-clinical capabilities. At GEMoaB, he was responsible for pre-clinical Research and Development, the translational programs for clinical studies as well as for Quality Systems and Quality Management.

The new company’s Board of Directors will be chaired by Dr. Olivier Brandicourt, a Senior Advisor to Blackstone Life Sciences and the former CEO of Sanofi S.A.

The transaction is expected to close in the third quarter of 2021 and is subject to customary closing conditions, including regulatory clearances.

Goldman Sachs & Co. LLC served as exclusive financial advisor to Intellia and Goodwin Procter and Hogan Lovells (Germany) acted as Intellia’s legal advisors. Ropes & Gray and Freshfields (Germany) acted as legal advisors to Blackstone Life Sciences. Noerr and Morgan Lewis acted as legal advisors to Cellex and GEMoaB.

Intellia Therapeutics Webcast Information

Intellia management will host a live webcast today, June 22, 2021 at 8:00 a.m. E.T. to discuss the corporate development. To join the webcast, please visit this link, or the Events and Presentations page of the Investors & Media section of the company’s website at www.intelliatx.com. A replay of the webcast will be available on Intellia’s website for at least 30 days following the call.

On June 2, 2021 Cyteir Therapeutics, Inc. ("Cyteir") (Nasdaq: CYT), a company focused on the discovery and development of next-generation synthetically lethal therapies for cancer, reported the closing of its initial public offering of 7,400,000 shares of its common stock at an initial public offering price of $18.00 per share (Press release, Cyteir Therapeutics, JUN 22, 2021, View Source [SID1234584246]). All of the shares are being offered by Cyteir. In addition, Cyteir has granted the underwriters a 30-day option to purchase up to an additional 1,110,000 shares of common stock at the initial public offering price, less the underwriting discounts and commissions. Cyteir’s common stock is listed on The Nasdaq Global Select Market under the ticker symbol "CYT."

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The gross proceeds to Cyteir from the offering were $133.2 million, before deducting underwriting discounts and commissions and other estimated offering expenses.

J.P. Morgan, Morgan Stanley and BofA Securities acted as joint book-running managers for the offering and Wedbush PacGrow acted as co-manager.

A registration statement relating to the shares sold in this offering was declared effective by the Securities and Exchange Commission on June 17, 2021. The offering was made only by means of a prospectus. Copies of the final prospectus relating to the offering may be obtained for free by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, copies of the final prospectus may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, or by telephone: 1-866-718-1649; or BofA Securities, Inc., NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department or by email at: [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On June 22, 2021 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, ("Transgene" or the "Company") reported the successful completion of its capital increase through the issuance of ordinary shares through a private placement with waiver of preferential subscription rights, via an accelerated bookbuilding pursuant to Articles L. 225-136 of the French Commercial Code and L. 411-2 1° of the French Monetary and Financial Code for an amount of approximately 34,1 million euros (the "Capital Increase") (Press release, Transgene, JUN 22, 2021, View Source [SID1234621817]).

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Hedi Ben Brahim, Chairman and CEO of Transgene, said: "We are very pleased to have concluded this successful fund raising, which has been supported by both historical shareholders and specialized healthcare investors, such as Invus. We are now well placed to execute on our ambitious corporate strategy of progressing our world leading myvac and Invir.IO technology platforms through first clinical validations of our personalized cancer vaccine TG4050 and our novel oncolytic virus BT-001 while advancing our randomized Phase II of TG4001. Transgene’s future has never looked brighter, and I am looking forward to the multiple key value-driving corporate milestones, we expect to announce over the next 18 months."

The capital increase results in the issuance of 13,930,000 new ordinary shares at a subscription price of 2.45 euros (including issue premium), representing 16,6 % of the current share capital of the Company for a total amount of approximately 34,1 million euros. The subscription price represents a discount of 6.5% compared to the closing price of Transgene on June 21, 2021 (€2.62).

Institut Mérieux, which currently holds 99.5% through its subsidiary TSGH, 60% of the company’s share capital, and SITAM Belgium, which holds 4.9% of the company’s share capital, subscribed for new ordinary shares in the capital increase for a total amount of 25 million euros and 1,67 million euros, respectively. Several specialized healthcare investors, including Invus, also participated in the Offering.

As a result of the Capital Increase, the company’s share capital will be made up of 97,771,334 shares, each having a nominal value of €0.50, for a total share capital of 48,885,667 euros.

The funds raised in the Capital Increase will be used to strengthen the Company’s financial structure until the fourth quarter of 2023, in order to be able to conduct its clinical development plan, in particular on its new innovative product platforms myvac and Invir.IO, with the finalization of clinical studies, and to be able to serenely negotiate partnership and codevelopment agreements based on the results obtained from the end of 2021.

Funds will be directly used by descending order of strategic priority:
• circa €25m for the finalization of clinical studies and the obtention of data with TG4001, TG4050, BT-001 and TG6002;
• circa €4m to launch the clinical development of new oncolytic viruses based on the Invir.IO platform and currently undergoing preclinical evaluation;
• for the remainder, to finance, together with operational products of the Company, R&D and operational costs, as well as current cash consumption.

The transaction will be carried out under the 22nd resolution of the Combined General Shareholders’ Meeting of May 27, 2020. The Capital increase was the subject of a placement agreement entered into by the Company and the Global Coordinators on June 21, 2021. The placement agreement may be terminated by the Global Coordinators at any time up to (and including) the settlement date of the Capital Increase which is expected to take place on June 24, 2021, subject to certain customary conditions. Not for release, publication or distribution, directly or indirectly, in or into the United States of America, Canada, Australia or Japan

To the Company’s knowledge, the breakdown of its share capital after the Capital Increase is as follows

(1): (1) On a non-diluted basis: before the potential exercise of the 41,352 stock-options outstanding as of the date of this press release and representing 0,0004% of both share capital and voting rights of Transgene.

SHAREHOLDERS’ SUBSCRIPTION AND LOCK-UP AGREEMENTS TGSH and SITAM Belgique have agreed with the Global Coordinators for the contemplated transaction that they will not sell or transfer its shares of Transgene for a period ending 90 days after the settlement and delivery of the Capital Increase, subject to the customary exceptions. In connection with the Capital Increase, the Company will enter into a lock-up agreement with the Global Coordinators for a period ending 90 days after the settlement and delivery of the Capital Increase, subject to the customary exceptions.

RISKS FACTORS Transgene draws the attention of the public to:
• The risk factors presented in the Universal Registration Document; the materialization of any or all of these risks is likely to have a detrimental effect on the activity, financial situation, or the results of Transgene or on its ability to achieve its objectives.
• The main risks associated with the Capital Increase are the following: o the market price of the Company shares may fluctuate and fall below the subscription price of the new shares; o due to stock market fluctuations, the volatility and liquidity of the Company shares may vary significantly; o the sale of Company shares may occur on the secondary market, after the capital increase, and have a negative impact on the Company share price; o regarding the use of the expected proceeds of the issuance within the context of the Capital Increase, the Company has room for maneuver as to the use of the funds raised and could use them in a way that the shareholders may not adhere to or that would not increase the value of their investment in the short term; and o a new market-based call by the Company, after the Capital Increase, could result in further dilution for the investors.

On June 22, 2021 Anavex Life Sciences Corp. ("Anavex" or the "Company") (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) disorders, reported that it has entered into a definitive purchase agreement with Deep Track Capital for the issuance and sale of an aggregate of 2,380,953 shares of its common stock at a purchase price of $21.00 per share of common stock a registered direct offering (Press release, Anavex Life Sciences, JUN 22, 2021, View Source [SID1234584212]). The registered direct offering is expected to close on or about June 24, 2021, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds from the offering are expected to be approximately $50 million before deducting placement agent fees and other offering expenses. Anavex currently intends to use the net proceeds from the offering for advancing its pipeline and for working capital and general corporate purposes.

The shares of common stock described above are being offered pursuant to Anavex’s shelf registration statement on Form S-3 (File No. 333-232550) filed with the Securities and Exchange Commission (the "SEC") on July 3, 2019 and declared effective on July 15, 2019. Such shares of common stock may be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and the accompanying prospectus relating to the shares of common stock being offered in the registered direct offering will be filed with the SEC. Electronic copies of the final prospectus supplement and the accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by e-mail: [email protected] or by telephone: (212) 856-5711.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of any of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

On June 22, 2021 Novo Nordisk reported that initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, JUN 22, 2021, View Source [SID1234584228]). This programme is part of the overall share repurchase programme of up to DKK 18 billion to be executed during a 12-month period beginning 3 February 2021.

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Under the programme initiated 7 May 2021, Novo Nordisk will repurchase B shares for an amount up to DKK 3.3 billion in the period from 10 May 2021 to 3 August 2021.

Since the announcement as of 14 June 2021, the following transactions have been made:

With the transactions stated above, Novo Nordisk owns a total of 14,210,192 B shares of DKK 0.20 as treasury shares, corresponding to 0.6% of the share capital. The total amount of A and B shares in the company is 2,310,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 18 billion during a 12- month period beginning 3 February 2021. As of 18 June 2021, Novo Nordisk has since 3 February 2021 repurchased a total of 15,371,694 B shares at an average share price of DKK 459.84 per B share equal to a transaction value of DKK 7,068,566,393.