Sanofi intends to sell its equity investment in Regeneron; confirms no change to ongoing collaboration

On May 25, 2020 Sanofi reported its intent to sell its equity investment in Regeneron (NASDAQ: REGN) through a registered public offering and related share repurchase by Regeneron (Press release, Sanofi, MAY 25, 2020, View Source [SID1234558465]). The registered offering and share repurchase will have no impact on the ongoing collaboration between Sanofi and Regeneron.

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A preliminary prospectus supplement relating to the offering of Regeneron’s shares will be filed with the U.S. Securities and Exchange Commission. Sanofi currently holds approximately 23.2 million shares of Regeneron’s common stock, representing approximately 20.6% ownership.

Regeneron has agreed to repurchase $5 billion of its stock from Sanofi conditional on completion of the proposed public offering. If the offering and repurchase are completed and the underwriters fully exercise their option to purchase additional shares1, Sanofi will continue to own approximately 400,000 shares of Regeneron’s common stock, which Sanofi is retaining in support of the ongoing collaboration with Regeneron.

"Sanofi and Regeneron’s collaboration has been one of the most productive in the industry, creating significant value for both companies but more importantly, resulting in five important medicines for patients. Sanofi remains committed to continuing our collaboration with Regeneron which remains an integral part of our overall strategy, and this decision was fully aligned with Regeneron, said Paul Hudson, Chief Executive Officer, Sanofi. "The decision to divest our holdings is consistent with our efforts to enhance value creation for our shareholders. We believe the proceeds from this transaction will help further our ability to execute on our strategy to drive innovation and growth."

Following completion of the proposed public offering and share repurchase, Sanofi will discontinue accounting for its ownership in Regeneron’s common shares under the equity method. After restatement of Sanofi previously reported non-GAAP indicator (Business Net Income) and change of its definition to exclude the effect of equity method accounting for Regeneron investment, Sanofi business EPS is expected to grow by approximately +5% in 2020 at constant exchange rate compared to 2019 restated business EPS of €5.64, which is in line with Sanofi’s 2020 business EPS growth guidance.

In connection with the offering, the underwriters will have an option to purchase up to an additional 10% of Regeneron’s shares offered, exercisable within 30 days following the pricing of the offering.

The Companies have had a successful and long-standing clinical and commercial collaboration dating back to 2003 that has resulted in five approved treatments to date with additional candidates currently in clinical development. Sanofi originally purchased a shareholding in Regeneron in 2004. Sanofi’s decision to sell its Regeneron common shares was made in consultation with Regeneron and the contemplated structure will allow both companies to achieve their mutual objectives.

The transaction has been approved by Sanofi and Regeneron’s Boards of Directors.

The public offering will occur simultaneously in the United States and internationally through underwriters led by BofA Securities and Goldman Sachs as joint book-running managers.

The shares offered to the public are being offered pursuant to an existing effective shelf registration statement (including a base prospectus) that has been filed by Regeneron with the U.S. Securities and Exchange Commission (the "SEC"). A preliminary prospectus supplement relating to and describing the terms of the offering will be filed by Regeneron with the SEC and will be available on the SEC website at www.sec.gov. Alternatively, any underwriter or any dealer participating in the offering will arrange to send you the prospectus and the prospectus supplement, when available, if you request them by contacting: (1) BofA Securities, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department or by email at [email protected], or (2) Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, via telephone: 1-866-471-2526, or via email: [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities described herein, nor shall there be any offer or 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.

Regeneron Announces Secondary Offering of its Common Stock Held by Sanofi and $5 Billion Stock Repurchase

On May, 25, 2020 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported the commencement of an underwritten public secondary offering of its common stock through which Sanofi (NASDAQ: SNY) intends to exit its investment in Regeneron shares (Press release, Regeneron, MAY 25, 2020, View Source [SID1234558434]). The shares being offered by Sanofi will be sold in an underwritten public offering. Sanofi currently owns approximately 23.2 million Regeneron shares and intends to sell approximately 12.8 million shares in the public offering.1 Sanofi also expects to grant the underwriters a 30-day option to purchase an additional 10% of the shares offered in the base offering. The registered offering and share repurchase will have no impact on the ongoing collaboration between Regeneron and Sanofi.

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Regeneron also announced today that subject to and immediately following the close of the secondary offering, Regeneron agreed to repurchase approximately $5 billion of common stock directly from Sanofi. The purchase price to be paid by Regeneron will be equal to the net offering price per share after deducting any underwriters’ discount and commission. Regeneron will fund the purchase with a combination of $3.5 billion of cash on hand and $1.5 billion of fully-committed bridge financing from Goldman Sachs Bank USA.

Following the offering and Regeneron’s $5 billion share repurchase, and assuming that the underwriters exercise their option to purchase additional shares in full, Sanofi will have disposed of all of its shares, other than 400,000 shares it intends to retain. Regeneron will not receive any of the proceeds from the sale of shares in this offering. The offering will occur simultaneously in the United States and internationally through underwriters led by BofA Securities and Goldman Sachs as joint book-running managers.

Regeneron has filed a registration statement (including a prospectus) with the SEC for the offering. Before you invest, you should read the prospectus in that registration statement and other documents Regeneron has filed and will file with the SEC, including the preliminary prospectus supplement to be filed by Regeneron with the SEC, for more complete information about Regeneron and this offering. You may get these documents for free by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, any underwriter or any dealer participating in the offering will arrange to send you the prospectus and the preliminary prospectus supplement, when available, if you request them by contacting BofA Securities, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department or by email at [email protected]; or Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, via telephone: 1-866-471-2526, or via email: [email protected].

This announcement shall not constitute an offer to sell or the solicitation of any 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.

Innovent Announces First Patient Dosed in A Phase 1 Clinical Trial of Anti-TIGIT Monoclonal Antibody in China

On May 25, 2020 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic and other major diseases, reported that the first patient has been successfully dosed in a Phase 1 clinical trial (CIBI939A101) of anti-T-cell immunoreceptor with Ig and ITIM domains (TIGIT) recombinant fully human monoclonal antibody drug candidate (IBI939) in China (Press release, Innovent Biologics, MAY 25, 2020, View Source [SID1234558433]).

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CIBI939A101 is a Phase 1 clinical study conducted in China to evaluate IBI939 in the treatment of patients with advanced malignancies. The primary objectives of the study are to evaluate the safety, tolerability, and initial anti-tumor efficacy of IBI939, either as monotherapy or in combination with TYVYT (sintilimab injection), an anti-programmed cell death protein 1 (PD-1) antibody drug.

IBI939 can directly bind to TIGIT, disturb the interaction between CD155 and TIGIT, relieve the inhibition and depletion of T cells and NK cells, enhance the anti-tumor immune response of T cells and NK cells. We anticipate IBI939 to be a brand new clinical option to cancer patients. Furthermore, the combination of anti-TIGIT and anti-PD-1/PD-L1 may provide synergistic enhancement and improve the anti-tumor efficacy.

Professor Lin Shen, Vice President of Peking University Cancer Hospital, stated: "Although immune checkpoint inhibitors have made encouraging progress in the treatment of a variety of tumors, there are still some problems to be solved, such as potential drug resistance and initial treatment efficacy to be further improved. Therefore, it is of great significance to develop the next generation of tumor immune drugs. TIGIT is expected to be one of the most promising targets for a new generation of tumor immune drugs, and we are looking forward to the clinical results of IBI939."

Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent, stated: "TIGIT is an important immuno-inhibitory receptor, and currently there is a series of relevant clinical trials of anti-TIGIT antibodies ongoing abroad, but none of them received approval. The preliminary clinical results have shown certain safety and anti-tumor effectiveness of anti-TIGIT antibody in combination with anti-PD-1/PD-L1 antibody. Now, CIBI939A101 is the first clinical study of TIGIT-targeted drug in China. We hope to advance the evaluation of the potential clinical value of IBI939 and its combination therapy as soon as possible to benefit more patients in need."

About IBI939

IBI939 is an innovative recombinant fully human anti-TIGIT monoclonal antibody developed by Innovent. As class 1 innovative drug, IBI939 can directly bind to TIGIT, relieve the inhibition and depletion of T cells and NK cells, thus activate and enhance the anti-tumor immune response of T cells and NK cells. IBI939 may synergize with anti-PD-1/PD-L1 antibody to improve the anti-tumor efficacy, delay the drug resistance, which may provide more effective treatments for cancer patients.

About CIBI939A101

CIBI939A101 is a Phase 1 clinical study conducted in China to evaluate IBI939 in the treatment of patients with advanced malignancies. The primary objectives of the study are to evaluate the safety, tolerability, and initial anti-tumor efficacy of IBI939, either as monotherapy or in combination with TYVYT (sintilimab injection), an anti-programmed cell death protein 1 (PD-1) antibody drug.

About TYVYT (Sintilimab Injection)

TYVYT (sintilimab injection), an innovative drug developed with global quality standards jointly developed by Innovent and Lilly in China, has been granted marketing approval by the NMPA for relapsed or refractory classic Hodgkin’s lymphoma after second-line or later systemic chemotherapy, and included in the 2019 Guidelines of Chinese Society of Clinical Oncology for Lymphoid Malignancies. TYVYT is the only PD-1 inhibitor that has been included in the new Catalogue of the National Reimbursement Drug List (NRDL), in November 2019. In April 2020, the NMPA accepted the supplemental new drug application for TYVYT in combination with ALIMTA (pemetrexed) and platinum as first-line therapy in non-squamous non-small cell lung cancer (NSCLC). In May 2020, TYVYT combined with Gemzar (gemcitabine for injection) and platinum chemotherapy met the predefined primary endpoint in the Phase 3 ORIENT-12 study as first-line therapy in patients with locally advanced or metastatic squamous NSCLC, TYVYT monotherapy met the primary endpoint in the ORIENT-2 study as second-line therapy in patients with advanced or metastatic esophageal squamous cell carcinoma as well.

TYVYT is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/ PD-Ligand 1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies with TYVYT to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registration or pivotal clinical trials.

PORTAGE ANNOUNCES NON-BROKERED PRIVATE PLACEMENT

On May 25, 2020 Portage Biotech Inc. (CSE: PBT.U, OTC Markets: PTGEF) ("Portage" or the "Company") reported that, in addition to completing its previously approved plan to consolidate (reverse stock split) its common shares, it will be conducting a non-brokered private placement of post-consolidation common shares for gross proceeds of up to US$10,000,000 (the "Offering") at a price of US$10.00 per post-consolidated common share (the "Offering Price") (Press release, Portage Biotech, MAY 25, 2020, View Source [SID1234558432]). The Offering Price is based on a 20 day weighted moving average of the common shares on the CSE less a 10% discount. The Offering may close in one or more tranches at the discretion of the Company. The Company also has the discretion to increase the maximum offering amount by up to 10% to cover over-subscriptions.

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Two of the Company’s directors, Dr. Gregory Bailey and Mr. James Mellon, have agreed to provide standby commitments in respect of the Offering by subscribing for that portion of the Offering not otherwise subscribed for by outside investors, up to an aggregate of US$2,000,000. This commitment would be reduced if the Offering is oversubscribed.

Ian B. Walters, MD, CEO of Portage, said "this financing expands our investor base while existing investors continue to support the mission. As released recently, several portfolio companies have achieved development milestones and we are advancing products into human testing requiring more funding. Our discussions with institutional investors and banks have necessitated the consolidation in an effort to prepare for movement to a senior exchange. We are excited by the prospects that this financing will bring for the future growth of Portage and its shareholders."

This Offering is only open to residents of the United States and Canada who are "Accredited Investors" as defined under applicable securities legislation in the United States and Canada and for accredited investors in other international jurisdictions pursuant to applicable exemptions from prospectus and registration requirements. The minimum subscription amount is US$25,000 per investor. Accredited investors who are interested in participating may obtain offering materials from Ian Walters, CEO, at [email protected].

The net proceeds of the Offering will be used for a number of different purposes including: (i) further development of the Company’s immune-oncology portfolio towards clinical testing; (ii) the formation of one to two new companies; and (iii) enable the Company to pursue an additional listing of its common shares on a senior stock exchange.-2-Prior to and as a condition of closing, the Company will be completing, subject to CSE approval, a consolidation (the "Consolidation") (also known as a reverse stock split) of its issued and outstanding common shares on the basis of 100 pre-consolidation common shares for each post-consolidation common share. The Consolidation was approved by shareholders at an annual meeting held on January 8, 2019 with the consolidation ratio being approved by the directors of the Company on May 19, 2020. More details regarding the effective date of the Consolidation and other relevant information including a new CUSIP number for the postconsolidated common shares will be disclosed in a separate news release.

Closing of a first tranche of the Offering is expected to occur on or about June 8, 2020 (the "Closing") subject to completion of the Consolidation and any regulatory approval including that of the CSE. The Company may pay a finder’s fee on the non-insider portion of the Offering within the amount permitted by the policies of the CSE. The potential issuance of any securities to Messrs. Bailey and Mellon at the closing of the Offering will be considered related party transactions within the meaning of Multilateral Instrument 61-101 Protection of Minority Security Holders in Special Transactions ("MI 61-101"). The Company intends to rely on appropriate exemptions from the formal valuation and minority shareholder approval requirements of MI 61-101 in respect of any insider participation.

All securities issued in connection with the Offering will be subject to a statutory hold period of four months plus a day from the date of issuance in accordance with applicable securities legislation.

Imago BioSciences To Present Update on Phase 2 results of Bomedemstat (IMG-7289), a Lysine Specific Demethylase-1 (LSD1) Inhibitor for the Treatment of Myelofibrosis (MF)

On May 25, 2020 Imago BioSciences, Inc. ("Imago"), a clinical stage biopharmaceutical company developing innovative treatments for myeloid diseases, reported that positive Phase 2 data from its lead pipeline program bomedemstat (IMG-7289), will be presented at the Virtual Edition of the 25th EHA (Free EHA Whitepaper) Annual Congress beginning June 12, 2020 (Press release, Imago BioSciences, MAY 25, 2020, View Source [SID1234558429]).

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Title: A PHASE 2 STUDY OF BOMEDEMSTAT (IMG-7289), A LYSINE-SPECIFIC DEMETHYLASE-1 (LSD1) INHIBITOR, FOR THE TREATMENT OF LATER-STAGE MYELOFIBROSIS (MF)

Session Topic: 16. Myeloproliferative Neoplasms

Final Abstract Code: EP1080

The data demonstrates the potential of bomedemstat as a monotherapy in intermediate-2 and high-risk patients with myelofibrosis who have become intolerant of, or resistant to, or are ineligible for a Janus Kinase (JAK) inhibitor.

Imago is currently conducting a Phase 2 study of bomedemstat in five countries. Clinical endpoints include spleen volume reduction, reduction in total symptom scores, and improvement in circulating inflammatory cytokines, anemia, bone marrow fibrosis and blast count. For additional information, visit cliniciatrials.gov (NCT03136185).

About Bomedemstat (IMG-7289)

Bomedemstat is being evaluated in an open-label Phase 2 clinical trial for the treatment of advanced myelofibrosis (MF), a bone marrow cancer that interferes with the production of blood cells. The endpoints include spleen volume reduction and symptom improvement at 12 and 24 weeks of treatment. Bomedemstat is used as monotherapy in patients who are resistant to, intolerant of, or ineligible for a Janus Kinase (JAK) inhibitor.

Bomedemstat is a small molecule developed by Imago BioSciences that inhibits lysine-specific demethylase 1 (LSD1 or KDM1A), an enzyme shown to be vital in cancer stem/progenitor cells, particularly neoplastic bone marrow cells. In non-clinical studies, IMG-7289 demonstrated robust in vivo anti-tumor efficacy across a range of myeloid malignancies as a single agent and in combination with other chemotherapeutic agents. Bomedemstat (IMG-7289) is an investigational agent currently being evaluated in ongoing clinical trials (ClinicalTrials.gov Identifier: NCT03136185 and NCT02842827). Bomedemstat has FDA Orphan Drug and Fast Track Designation for the treatment of myelofibrosis and essential thrombocythemia, and Orphan Drug Designation for treatment of acute myeloid leukemia.