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Cogent Biosciences Announces Proposed Public Offering of Common Stock

On June 13, 2022 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported that it has commenced an underwritten public offering of $125 million of shares of its common stock (Press release, Cogent Biosciences, JUN 13, 2022, View Source [SID1234615928]). In addition, Cogent has granted the underwriters a 30-day option to purchase up to an additional $18.75 million of shares of its common stock. All of the shares in the offering are being offered by Cogent.

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Cogent intends to use the net proceeds from the offering for development, regulatory and commercial preparation activities relating to bezuclastinib and other product candidates, as well as for working capital and general corporate purposes.

Jefferies, Piper Sandler & Co. and Guggenheim Securities, LLC are acting as joint book-running managers for the offering. LifeSci Capital is also acting as lead manager for the offering.

A registration statement relating to these securities has been filed with the Securities and Exchange Commission (SEC) and became effective on May 24, 2022.

A preliminary prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering have been filed with the SEC. The securities described above have not been qualified under any state blue sky laws. This press release shall not constitute an offer to sell or the 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. The offering can be made only by means of a prospectus, copies of which may be obtained at the SEC’s website at www.sec.gov, or by request to Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022; telephone: 877-821-7388; email: [email protected]; or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, or by telephone at (800) 747-3924, or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison, New York, New York 10017, by telephone at 212 518-9544, or by email at [email protected].

Novo Nordisk A/S – Share repurchase programme

On June 13, 2022 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") (Filing, 6-K, Novo Nordisk, JUN 13, 2022, View Source [SID1234615924]). This programme is part of the overall share repurchase programme of up to DKK 24 billion to be executed during a 12-month period beginning 2 February 2022.

Under the programme initiated 3 May 2022, Novo Nordisk will repurchase B shares for an amount up to DKK 4.4 billion in the period from 4 May 2022 to 2 August 2022.

Since the announcement 7 June 2022, the following transactions have been made:

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 14,281,381 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 2,280,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 24 billion during a 12- month period beginning 2 February 2022. As of 10 June 2022, Novo Nordisk has since 2 February 2022 repurchased a total of 12,541,818 B shares at an average share price of DKK 757.65 per B share equal to a transaction value of DKK 9,502,248,235

G1 Therapeutics Announces Completion of Enrollment in Global Multi-Center Phase 3 Clinical Trial of Trilaciclib in Patients with Metastatic Colorectal Cancer

On June 13, 2022 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that the last patient has been randomized in the Phase 3 clinical trial of trilaciclib for patients with metastatic colorectal cancer (mCRC) receiving chemotherapy (PRESERVE 1) (Press release, G1 Therapeutics, JUN 13, 2022, View Source [SID1234615921]). Enrollment is complete at 326 randomized patients; the trial was over-enrolled by approximately 10 percent to compensate for potential loss to follow up at trial sites in Ukraine.

Trilaciclib, an IV-administered transient CDK4/6 inhibitor, is a first-in-class therapy designed to preserve bone marrow and immune system function during chemotherapy to improve patient outcomes. It is approved by the U.S. Food and Drug Administration in another indication.

"FOLFOXIRI is an important chemotherapeutic backbone for people diagnosed with CRC because it is highly efficacious and has shown a survival advantage compared to other chemotherapeutic options; however, it is also the most myelotoxic regimen, so patients may have dose delays and reductions or receive less effective chemotherapeutic regimens – both of which could impact patient outcome and survival," said Raj Malik, M.D., G1’s Chief Medical Officer. "Trilaciclib may be an important addition to this regimen due to its unique ability to preferentially protect the bone marrow from chemotherapy-induced toxicities, and its potential to preserve immune system function and improve survival. Both endpoints are being assessed in PRESERVE 1. We are happy to have completed enrollment, and look forward to presenting initial data, including the primary endpoint of the trial, in the first quarter of 2023. This is a registrational trial; if the data from the primary endpoint are positive, we would work closely with the FDA to expedite our filing for regulatory approval in this indication."

Dr. Malik continued, "I’d like to thank the patients enrolled in the trial, the clinical investigators, our CRO partners, and the G1 and Simcere teams who worked tirelessly and under extraordinarily challenging conditions to advance the trial to this stage."

PRESERVE 1 is a global multi-center, randomized placebo-controlled, line extension pivotal Phase 3 trial of trilaciclib in 326 patients with metastatic CRC receiving first line trilaciclib or placebo administered prior to FOLFOXIRI (a combination of fluorouracil (5-FU), folinic acid, oxaliplatin and irinotecan) and bevacizumab. The regimen is given for two consecutive days of every 14-day cycle. Patients are receiving trilaciclib or placebo administered prior to their chemotherapy for a maximum of 12 cycles of induction followed by maintenance therapy. Treatment is administered until disease progression.

The primary endpoint is myeloprotection as measured by duration of severe neutropenia (DSN) and the occurrence of severe neutropenia (SN) during induction. Key secondary endpoints include the effects of trilaciclib on chemotherapy-induced fatigue compared with placebo and the effect of trilaciclib on progression free survival (PFS) and overall survival (OS) compared with placebo.

About Colorectal Cancer

Colorectal cancer is the third most common cancer in men and women, excluding certain skin cancers. Globally, it is the second leading cause of cancer death, with more than 1.8 million people newly diagnosed with colorectal cancer each year. In the United States, there are approximately 150,000 new cases of colorectal cancer diagnosed each year. Chemotherapy is the standard of care for colorectal cancer, and the majority of patients in the United States, Europe and Japan receive chemotherapy – commonly 5-FU-based regimens – as part of their treatment regimen.

ImCheck Closes Upsized EUR 96 Million (USD 103 Million) Financing to Advance Clinical Program of First-in-human Gamma-delta T Cell Activating Antibody and Accelerate Development of Disruptive Immunotherapeutic Pipeline

On June 13, 2022 ImCheck Therapeutics reported the close of a EUR 96 million (USD 103 million) financing, co-led by Earlybird and Andera Partners (Press release, ImCheck Therapeutics, JUN 13, 2022, View Source [SID1234615917]). The Series C round (EUR 80 Million – USD 86 Million) and the last outstanding tranche of Series B converted in Series C shares (EUR 16 Million – USD 17.2 Million) solidifies ImCheck’s financial position and leadership in the gamma-delta T cell space. Invus and The Leukemia & Lymphoma Society Therapy Acceleration Program also joined the round as new investors. Existing investors including the Growth Opportunity Fund of founding investor Kurma Partners, Eurazeo, Gimv, EQT Life Sciences (previously LSP), Boehringer Ingelheim Venture Fund, Pfizer Ventures, Bpifrance through its Innobio 2 and Large Venture funds, Wellington Partners, Agent Capital, Pureos Bioventures and Alexandria Venture Investments participated.

The proceeds will be used to support the Phase IIa expansion arms of EVICTION in solid tumors and hematologic cancers, and completion of randomized, double-blind, placebo-controlled clinical trials evaluating ImCheck’s lead candidate ICT01 in combination with a PD-1 inhibitor for multiple solid tumors. The Company also will apply the capital to investigate ICT01 in combination with other therapeutic agents, including IL-2, in the forthcoming EVICTION-2 clinical trial. The funding will accelerate the further advance toward the clinic of additional antibody candidates in immuno-oncology, auto-immune and infectious diseases. In addition, it will allow the Company to achieve pivotal study readiness for ICT01 and expand its footprint through extended clinical operations and regulatory affairs in Europe and the US.

"Since its inception, ImCheck has gained the support of a syndicate of outstanding international funds. In a highly challenging funding market, we have secured a significant fundraising through the addition of highly strategic and valuable investors from the U.S. and Europe, putting us in a position to further deliver on the immense promise of our pipeline," stated Pierre d’Epenoux, Chief Executive Officer of ImCheck Therapeutics. "We view our singular proprietary position with butyrophilins, which offer powerful immunomodulation of both the innate and adaptive immune systems, as the key to therapeutic intervention for many disease indications and we value the support we are now gaining from The Leukemia & Lymphoma Society Therapy Acceleration Program as a first investment from a cancer patient nonprofit organization."

In conjunction with the financing round, Florent Gros (Earlybird) and Raphaël Wisniewski (Andera Partners) will join the Company’s Board of Directors.

Florent Gros, Partner at Earlybird, commented,"ImCheck’s approach to immuno-oncology is highly differentiated through the clinical demonstration of gamma-delta T cell activation, an area of immunology that has huge potential and interest from the biopharmaceutical community. At Earlybird, we support companies that dare to think differently and ImCheck’s innovative concept for immunomodulation could be a game-changer for a range of indications."

Raphaël Wisniewski, Partner at Andera Partners, said, "Immune checkpoint inhibitors have heralded a new era in cancer treatments and ImCheck Therapeutics is pioneering the next generation of these immunotherapeutics. In watching their progress to date, we have seen the leadership team execute on a compelling vision for a butyrophilin-based therapeutic approach from the early development stage into a highly valuable clinical development program. We at Andera Partners are confident the company will move its groundbreaking technology forward to meet patients’ needs in a range of cancer indications with wider potential for auto-immune and infectious diseases."

ImCheck Therapeutics’ immunotherapeutic technology is capable of overcoming the tumor’s resistance to adaptive immune responses through a novel superfamily of immune checkpoint targets, butyrophilins (BTNs). BTNs can be modulated to harness a wide range of immune cells including gamma-delta T cells, CD3, CD8, NK cells and macrophages, bridging the innate and adaptive immune responses. The company’s broad pipeline is built upon immunomodulation via BTN-targeting antibodies aimed either at activating the immune system in disease indications such as cancer or infectious diseases, or down-regulating immunity in auto-immune disorders.

Hans Henrik Christensen, Chief Financial Officer of ImCheck Therapeutics, added, "ImCheck has raised a total of EUR 154 million since inception. We truly appreciate the support from existing and new investors, which extends our cash runway until 2026. This enables us to further explore the ‘pipeline in a product’ opportunity we have with our lead clinical candidate, ICT01."

Legal counsel for the Series C transaction provided by Dentons Europe and McDermott Will & Emery. Investor relations support provided by Trophic Communications. French media and communications support provided by ATCG Partners.

Mnemo Therapeutics Launches RHU Project in Collaboration with Leading European Research Partners, Institut Curie and MEARY Cell and Gene Therapy Center, AP-HP

On June 13, 2022 Mnemo Therapeutics, a biotechnology company developing transformational immunotherapies, reported the kick-off of their participation in the prestigious Hospital-University Research in Health (RHU) program (Press release, Mnemo Therapeutics, JUN 13, 2022, View Source [SID1234615911]). Designed by France’s National Research Agency, the RHU funding supports cutting-edge research and cross-institutional collaborations, bringing together academia, businesses, and hospitals to push the boundaries of what is possible in healthcare.

In December of 2021, 17 proposals were selected for the RHU funding. Among them, receiving close to 10 million euros, is the EpCART project. Under the leadership of Sebastian Amigorena, Ph.D., one of Mnemo’s scientific co-founders and head of the Immune Responses and Cancer Team at Institut Curie, the EpCART project aims to clinically validate a novel approach to CAR-T immunotherapy.

"We are honored to be named a laureate for this prestigious initiative and work alongside our long-standing partners at Institut Curie, as well as the MEARY Cell and Gene Therapy Center at Saint-Louis Hospital, AP-HP," said Mnemo CEO, Robert LaCaze.

The EpCART project focuses on epigenetic reprogramming of CAR-T cells. Through the inactivation of SUV39H1, a key enzyme in the differentiation pathway of T cells, the memory phenotype of these cells can be greatly increased. This works to achieve long-lasting tumor control, addressing patient relapse.

"Current immuno-oncology therapies often suffer from immune-cell memory loss, causing therapies to become less active and persistent in their ability to attack cancer cells over time," said Dr. Amigorena. "The EpCART project mines insights into the memory of the immune system to overcome this challenge and produce a new class of CAR-T therapies with enhanced memory and persistence. We believe this will drive more durable responses for cancer patients."

Over the next five years, the EpCART project will seek to clinically validate this technology as an autologous therapy. Mnemo will work in collaboration with the other EpCART partners to conduct a Phase I-II clinical trial, investigating the activity of these innovative CAR-T therapies in a cohort of 35 patients with difficult-to-treat solid tumors.

The EpCART project will accelerate research on Mnemo’s EnfiniT Discovery Engine, an integrated drug discovery tool combining key technologies to create lasting immune memory, identify novel cancer-specific targets, and more.

"Today is an exciting step in our journey to develop transformational immunotherapies with the aim of improving the body’s ability to detect, fight, and overcome cancer," said Mnemo Co-Founder and Chief Operating Officer, Alain Maiore. "We are truly honored to collaborate with such esteemed partners and look forward to the fruits of this initiative."