Biohaven Announces Pricing Of $200 Million Public Offering Of Common Shares

On March 15, 2021 Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a commercial–stage biopharmaceutical company with a marketed drug for the acute treatment of migraine and a portfolio of innovative, late–stage product candidates targeting neurological diseases, including rare disorders, reported the pricing of its underwritten public offering of 2,686,409 of its common shares at a price to the public of $76.00 per share (Press release, Biohaven Pharmaceutical, MAR 15, 2021, View Source [SID1234576671]). In addition, Biohaven has granted the underwriter a 30-day option to purchase up to an additional 402,961 common shares at the public offering price, less underwriting discounts and commissions. The gross proceeds from the offering are expected to be approximately $200 million before deducting underwriting discounts and commissions and estimated offering expenses payable by Biohaven. The offering is expected to close on March 17, 2021, subject to satisfaction of customary closing conditions.

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Goldman Sachs & Co. LLC is acting as the book-running manager of the offering.

The offering is being made only by means of a prospectus supplement and the accompanying prospectus, copies of which, when available, may be obtained from the offices of Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1–866-471-2526, facsimile: 212-902-9316 or by emailing [email protected].

The shares will be issued pursuant to an effective shelf registration statement on Form S-3. Copies of the registration statement can be accessed through the SEC’s website at www.sec.gov. This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the applicable securities laws of such state or jurisdiction.

Novo Nordisk A/S – Share repurchase programme

On March 15, 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, MAR 15, 2021, View Source [SID1234577317]). This programme is part of the overall share repurchase programme of up to DKK 17 billion to be executed during a 12-month period beginning 3 February 2021.

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Under the programme initiated 3 February 2021, Novo Nordisk will repurchase B shares for an amount up to DKK 3.0 billion in the period from 3 February 2021 to 3 May 2021.

The details for each transaction made under the share repurchase programme are published on novonordisk.com.

With the transactions stated above, Novo Nordisk owns a total of 42,011,629 B shares of DKK 0.20 as treasury shares, corresponding to 1.8% of the share capital. The total amount of A and B shares in the company is 2,350,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 17 billion during a 12- month period beginning 3 February 2021. As of 12 March 2021, Novo Nordisk has since 3 February 2021 repurchased a total of 3,109,017 B shares at an average share price of DKK 446.14 per B share equal to a transaction value of DKK 1,387,052,209.

Cue Biopharma to Present Corporate Overview and Clinical Progress at the Upcoming Oppenheimer 31st Annual Healthcare Conference

On March 15, 2021 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics designed to selectively engage and modulate targeted T cells directly within the patient’s body, reported that it will present at the virtual Oppenheimer 31st Annual Healthcare Conference being held March 16-18, 2021 (Press release, Cue Biopharma, MAR 15, 2021, https://cuebiopharma.gcs-web.com/news-releases/news-release-details/cue-biopharma-present-corporate-overview-and-clinical-progress [SID1234608283]).

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Cue Biopharma will provide a corporate update highlighting clinical progress with CUE-101, the lead Immuno-STAT (Selective Targeting and Alteration of T cells) platform-based therapeutic, in clinical trials for the treatment of patients with HPV+ recurrent/metastatic head and neck cancer. The presentation will also focus on the Company’s platform developments and pipeline progress including the CUE-400 series, a novel class of therapeutic molecules for broad applications in multiple autoimmune diseases.

Presentation Details

Oppenheimer 31st Annual Healthcare Conference
Date and Time: Thursday, March 18, 2021 at 9:20 a.m. EDT
Webcast link: View Source
A live and archived webcast of the presentation will be available in the Investors and Media section of the Company’s website at www.cuebiopharma.com. The webcast will be archived for 30 days.

ElevateBio Scales Disruptive Cell and Gene Therapy Business Model with $525 Million Series C Financing

On March 15, 2021 ElevateBio, a cell and gene therapy technology company focused on powering transformative cell and gene therapies, reported it has raised $525 million in a Series C financing (Press release, ElevateBio, MAR 15, 2021, View Source [SID1234576632]). ElevateBio has created a new disruptive business model addressing the most pressing challenges in the field of cell and gene therapy. With an unprecedented suite of next generation-enabling technologies; including gene editing, induced pluripotent stem cells, and protein, viral, and cellular engineering; the company is changing the way the field advances cell and gene therapies. ElevateBio is positioned to power the industry’s most promising therapies with an "Elevate Inside" approach by democratizing access to its technologies, and using ElevateBio BaseCamp (a technology-enabled process development and CGMP manufacturing capability) to advance transformative therapies across the entire industry. With this financing, ElevateBio will continue to develop and expand its technology platforms, build upon its network of process development and GMP manufacturing capacity, and advance an increasing number of industry partnerships, while also continuing to develop its own highly innovative cell and gene therapies.

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Matrix Capital Management led the Series C financing alongside additional new investors SoftBank Vision Fund 2* and Fidelity Management & Research Company who joined ElevateBio’s existing investors: MPM Capital, F2 Ventures, Redmile Group, EcoR1 Capital, Samsara BioCapital, The Invus Group, Emerson Collective, Surveyor Capital (A Citadel company), EDBI, and Vertex Ventures, iTochu, and a large insurance company.

"ElevateBio has created the first fully-integrated technology company exclusively focused on cell and gene therapy, disrupting the current paradigm by providing end-to-end capabilities that enable partners a strategic advantage in the market and, ultimately, meet the urgent need of patients and families suffering with life-threatening and devastating diseases," said David Hallal, Chairman and Chief Executive Officer of ElevateBio. "While we see remarkable breakthroughs in the earliest days of the cell and gene therapy revolution, accelerating innovation requires next-generation technology, analytics, and production capabilities to deliver therapies better, faster, and cheaper. We are poised to power the field today and for many decades to come and are thrilled to welcome Matrix Capital Management, SoftBank, and Fidelity to our stellar group of existing investors."

Mitchell Finer, Ph.D., Chief Scientific Officer of ElevateBio, President of ElevateBio BaseCamp, and Chief Executive Officer of LifeEDIT Therapeutics continued by saying, "In my nearly 35 years of driving cell and gene therapy innovation across a range of technologies and therapeutics, I have seen much progress toward our ambition to serve patients with intractable diseases – yet innovation is often delayed by technology limitations and the lack of manufacturing robustness. At ElevateBio, we can realize the full potential of cell and gene therapies, by re-envisioning the way these products are made, breaking down silos, leveraging powerful enabling technologies, and changing the mindset from simple manufacturing scale-up to conducting large scale biology. This approach will drive transformative cell, gene, and regenerative therapies today and tomorrow that have the potential to enable access for patients around the globe."

As part of the financing, two new members, Karan Takhar, Senior Managing Director at Matrix Capital Management and Deep Nishar, Senior Managing Partner, SoftBank Investment Advisers, will join ElevateBio’s Board of Directors.

Mr. Takhar leads and oversees key portfolio investments at Matrix Capital. He is a member of the Board of Directors at Encoded Therapeutics, Palleon Pharmaceuticals, and Zentalis Pharmaceuticals. Before joining Matrix, Mr. Takhar spent time working for High Vista Strategies, Goldman Sachs Investment Strategies, and Moody’s Investor Service.
Mr. Nishar leads life sciences, frontier tech, and enterprise software investments at SoftBank Investment Advisers. He has more than 20 years of experience in helping build and grow businesses, and sits on the board of directors of Encoded Therapeutics, Relay Therapeutics, Seer and Vir Bio, amongst other companies. Prior to joining SoftBank, Mr. Nishar served as Senior Vice President of Products and User Experience at LinkedIn.
"ElevateBio’s business model maximizes the potential to capitalize on the convergence of technology and healthcare, creating an entirely new category in cell and gene therapy," said Karan Takhar. "The company is redefining the way cell and gene therapies are discovered, developed, and manufactured, bringing together cutting-edge scientific and digital technologies to enable a seismic shift in the field."

Deep Nishar added, "We are proud to support ElevateBio’s world-class team to expand and advance its technology and manufacturing platforms to accelerate the production and development of tomorrow’s life-saving cell and gene therapies."

Addressing the need in cell and gene therapy:

There are nearly a thousand cell and gene therapies in development targeting a broad range of diseases, yet as of February 2020, only nine cell or gene therapies were approved in the U.S. Despite the small number of approved therapies, the global cell and gene therapy market is expected to reach nearly $50 billion by 2027. The U.S. Food and Drug Administration (FDA) predicts that by 2025, they will be approving 10 to 20 cell and gene therapy products a year based on an assessment of the current pipeline and the clinical success rates of these products. Scaling production from a few million cells in the lab to manufacturing the billions of cells needed to treat patients is uniquely complex. While innovation has greatly advanced in the discovery and development of cell and gene therapies, the approach to manufacturing these novel medicines has largely relied on traditional modes of development or a patchwork of technologies and providers, hampering and slowing their impact on human health.

ElevateBio was built to bring the insights, skills, and technological know-how needed to navigate these complex challenges in a repeated fashion to advance transformative cell and gene therapies to patients whether they are ElevateBio’s own therapeutics or the innovative therapies of its partners.

Scopus BioPharma Finalizes Arrangements for Submission of IND Package

On March 15, 2021 Scopus BioPharma Inc. (Nasdaq: "SCPS") reported the finalization of arrangements for the completion of the investigational new drug ("IND") package for the company’s lead drug candidate and its submission to the United States Food and Drug Administration ("FDA") (Press release, Scopus BioPharma, MAR 15, 2021, View Source,the%20treatment%20of%20multiple%20cancers. [SID1234576652]). The IND submission is expected in Q2 2021.

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Scopus is a biopharmaceutical company developing transformational therapeutics based on groundbreaking scientific and medical discoveries. The company’s lead drug candidate is a novel, targeted immuno-oncology gene therapy for the treatment of multiple cancers.

Joshua R. Lamstein, Chairman of Scopus BioPharma, stated, "We are extremely excited about the forthcoming submission of the IND for the Phase 1 clinical trial for our lead drug candidate. We believe investors will recognize this milestone as an important near-term driver of shareholder value."

The company’s lead drug candidate is highly distinctive, encompassing both gene therapy and immunotherapy by synthetically linking siRNA to an oligonucleotide TLR9 agonist, creating the potential for targeted gene silencing with simultaneous TLR stimulation and immune activation in the tumor microenvironment.