Medtronic to Announce Financial Results for its Fourth Quarter and Full Fiscal Year 2021

On May 13, 2021 Medtronic plc (NYSE:MDT) reported that it will report financial results for its fourth quarter and full fiscal year 2021 on Thursday, May 27, 2021. A news release will be issued at approximately 5:45 a.m. Central Daylight Time (CDT) and will be available at View Source The news release will include summary financial information for the company’s fourth quarter and fiscal year 2021, which ended on Friday, April 30, 2021.

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Medtronic will host a video webcast at 7:00 a.m. CDT to discuss financial results for its fourth quarter and full fiscal year 2021. The webcast can be accessed at View Source on May 27, 2021.

Within 24 hours of the broadcast, a replay and transcript of the prepared remarks will be available by clicking on the Investor Events link at View Source.

Looking ahead, Medtronic plans to report its fiscal year 2022 first, second, third, and fourth quarter results on Tuesday, August 24, 2021, Tuesday, November 23, 2021, Tuesday, February 22, 2022, and Thursday, May 26, 2022, respectively. For these events, confirmation and additional details will be provided closer to the specific event.

Insmed Announces Closing of Public Offerings of Common Stock and Convertible Senior Notes and Full Exercise of Underwriters’ Options to Purchase Additional Shares and Notes

On May 13, 2021 Insmed Incorporated (Nasdaq: INSM) reported the closing of the previously announced registered underwritten public offering (the "Equity Offering") of 11,500,000 shares of its common stock (the "Shares"), including 1,500,000 Shares issued pursuant to the exercise in full of the underwriters’ option to purchase additional Shares, at a price to the public of $25.00 per share before deducting underwriting discounts and commissions, and the previously announced registered underwritten public offering (the "Notes Offering") of $575 million aggregate principal amount of its 0.75% convertible senior notes due 2028 (the "Notes"), including $75 million aggregate principal amount of Notes purchased pursuant to the exercise in full of the underwriters’ option to purchase additional Notes, solely to cover over-allotments (Press release, Insmed, MAY 13, 2021, View Source [SID1234580031]). A portion of the net proceeds from the offering of the Notes will be used to repurchase $225 million in aggregate principal amount of Insmed’s existing outstanding 1.75% Convertible Senior Notes due 2025 (the "2025 Notes"). The gross proceeds to Insmed from the offerings, before deducting underwriting discounts and commissions and other offering expenses payable by Insmed, were $287.5 million and $575 million, respectively.

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The Notes are senior unsecured obligations of Insmed and rank senior in right of payment to any of Insmed’s future indebtedness that is expressly subordinated in right of payment to the Notes and rank equally in right of payment with all of Insmed’s existing and future liabilities that are not so subordinated, including the existing 2025 Notes. The Notes will accrue interest payable semiannually in arrears on June 1 and December 1 of each year at the rate of 0.75% per year, beginning on December 1, 2021. The Notes will mature on June 1, 2028, unless earlier repurchased, redeemed or converted in accordance with their terms prior to such date. Prior to June 6, 2025, Insmed will not have the right to redeem the Notes. Subject to certain conditions, on or after June 6, 2025, Insmed may redeem for cash all or a part of the Notes. Prior to March 1, 2028, the Notes will be convertible at the option of holders of the Notes only upon satisfaction of certain conditions and during certain periods, and thereafter, will be convertible at any time until the close of business on the second scheduled trading day immediately preceding the maturity date. Upon conversion, holders of the Notes will receive shares of Insmed common stock, cash or a combination thereof, at Insmed’s election. The conversion rate for the Notes is initially 30.7692 shares of Insmed common stock per $1,000 principal amount of Notes, which is equivalent to an initial conversion price of approximately $32.50 per share, and is subject to adjustment under the terms of the Notes. Insmed may be obligated to increase the conversion rate for any conversion that occurs in connection with certain corporate events or a redemption of the Notes by Insmed. The initial conversion price represents a premium of approximately 30% over the public offering price per share of the Shares in the Equity Offering.

Concurrently with the offerings, Insmed entered into separate and privately negotiated repurchase transactions with certain holders of a portion of the 2025 Notes. In these transactions, Insmed will repurchase 2025 Notes with an aggregate principal amount of $225 million for an aggregate repurchase price of approximately $238.9 million, using a portion of the net proceeds from the Notes Offering. Insmed intends to use the remaining net proceeds from the Notes Offering and the net proceeds from the Equity Offering to fund activities related to the commercialization and development of ARIKAYCE, further research and development of brensocatib, TPIP or any of its product candidates, and for other general corporate purposes, including business expansion activities.

J.P. Morgan Securities LLC and SVB Leerink LLC acted as book-running managers for the offerings. Morgan Stanley & Co. LLC also acted as a book-running manager for the offerings. Credit Suisse Securities (USA) LLC and Stifel, Nicolaus & Company, Incorporated acted as co-lead managers for the Equity Offering. Cantor Fitzgerald & Co. and H.C. Wainwright & Co., LLC acted as co-managers for the Equity Offering.

A shelf registration statement on Form S-3 (File No. 333-238560) relating to the Equity Offering and the Notes Offering as described above has been filed with the Securities and Exchange Commission ("SEC"), and became automatically effective upon filing on May 21, 2020. A final prospectus supplement relating to and describing the terms of each offering was filed with the SEC and is available on the SEC’s website at www.sec.gov. Alternatively, copies may be obtained from: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204 or by email at [email protected]; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6105 or by email at [email protected].

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

Transcenta Announces Updated Clinical Data from Phase I Study of pH-Dependent PD-L1 Antibody MSB2311 to Be Presented at the 2021 ASCO Annual Meeting

On May 13, 2021 Transcenta Holding Limited (Transcenta), a clinical stage global biotherapeutics company with fully-integrated capabilities in discovery, development and manufacturing of antibody-based therapeutics, reported that the updated phase I clinical data on the safety and efficacy of MSB2311, a pH-dependent PD-L1 antibody, in Chinese patients with advanced solid tumors and hematological malignancies will be presented as an abstract online publication at the 57th American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Transcenta, MAY 13, 2021, View Source [SID1234580030]). The 2021 ASCO (Free ASCO Whitepaper) Annual Meeting will be held online from June 4th to June 8th EDT.

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Online Publication

Title: Updated safety and efficacy of MSB2311 (an Anti-Programmed Death-Ligand 1 Antibody) in Chinese patients with advanced solid tumors and hematological malignancies from a phase I study.

Abstract Number: e14547

First Author: Lin Shen, MD (Beijing Cancer Hospital)

About MSB2311

MSB2311 is an investigational humanized PD-L1 antibody with pH dependent binding property. PD-L1 is involved in inhibiting the immune system’s response to fight cancer. MSB2311 blocks the interaction between PD-L1 and PD-1, which reactivates the suppressed or exhausted anti-tumor effector T cell function in the tumor microenvironment. MSB2311 employs engineered IgG1 which lacks FcR binding. In addition, the binding of MSB2311 to PD-L1 results in internalization of MSB2311 and MSB2311 can dissociate from bound PD-L1 in endosome with pH level lower than 5.5. This allows MSB2311 to be recycled to plasma membrane and be reused to bind with PD-L1 on another tumor cell or immune cell. Results from preclinical studies demonstrate that MSB2311 can inhibit tumor growth of PD-L1 expressing tumor cells in syngeneic mouse-model. Two phase 1 studies of MSB2311 have been completed in the US and China. MSB2311 is currently to be tested in phase 2 trial in patients with solid tumors expressing select biomarker in China.

Antengene Announces the IND Approval for Eltanexor in Patients with Advanced Solid Tumors in Mainland China

On May 13, 2021 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that China’s National Medical Products Administration (NMPA) has approved the initiation of a Phase Ib/II open-label, multicenter, dose-escalation study of eltanexor (ATG-016) in patients with advanced solid tumors (the REACH study) (Press release, Antengene, MAY 13, 2021, View Source [SID1234580029]).

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This study aims to assess the safety and efficacy of eltanexor monotherapy in patients with advanced solid tumors. The Phase Ib part of the study will be carried out in patients with advanced solid tumors, including those with KRAS-mutant, p53 wild-type, human papillomavirus (HPV)-associated, Epstein–Barr virus (EBV)-positive and other solid tumors; and the Phase II part of the study will enroll patients with recurrent or metastatic penile squamous cell carcinoma, and patients with recurrent or metastatic nasopharyngeal carcinoma.

Eltanexor is a next-generation selective inhibitor of nuclear export (SINE) compound which exerts antitumor effects by inhibiting the nuclear export protein XPO1 leading to the accumulation and activation of tumor suppressor proteins in the nucleus, while simultaneously blocking the expression and translation of oncogenic proteins. For cancer patients, high XPO1 expression is commonly associated with a poor prognosis and resistance to chemotherapies. Pre-clinical data showed that eltanexor has potent pro-apoptotic activity in a broad spectrum of tumor cells without affecting normal cells. Moreover, eltanexor has also showed potent antitumor activity in animal models with multiple solid tumors including hepatocellular carcinoma, prostate cancer, pancreatic cancer, colon cancer and breast cancer.

"This IND approval marks an important step for Antengene’s clinical development of eltanexor, one that we hope will ultimately allow patients with solid tumors to benefit from eltanexor’s novel mechanism of action," said Dr. Jay Mei, founder, chairman and CEO of Antengene. "Based on the compelling pre-clinical and clinical data, eltanexor monotherapy has the potential of bringing renewed hope and higher quality of life to patients with advanced solid tumors in China."

About Eltanexor (ATG-016)

Eltanexor is a next-generation selective inhibitor of nuclear export (SINE) compound. Compared to the first-generation SINE compound, eltanexor has lower blood-brain barrier penetration and broader therapeutic window which allows more frequent dosing and a longer period of exposure at higher levels with better tolerability. Therefore, eltanexor may be used to target a broader range of indications. Antengene is currently conducting clinical trials of eltanexor in patients with myelodysplastic syndrome (MDS) or advanced solid tumors in China.

TG Therapeutics Announces Data Presentations at Upcoming Medical Meetings

On May 13, 2021 TG Therapeutics, Inc. (NASDAQ: TGTX), reported the schedule of upcoming data presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, to be held virtually June 4 – 8, 2021 and the European Hematology Association (EHA) (Free EHA Whitepaper) annual congress, to be held virtually June 9 – 17, 2021 (Press release, TG Therapeutics, MAY 13, 2021, View Source [SID1234580027]). Details of the data presentations are included below.

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Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer stated, "We are excited to share updated data for TG-1701, our novel BTK inhibitor, as a monotherapy, and as a triple therapy with U2, at the upcoming ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) annual congresses. The EHA (Free EHA Whitepaper) abstract released yesterday included an update from the data most recently presented at the ASH (Free ASH Whitepaper) 2020 congress, and we are pleased to see with additional patients and longer follow-up the data continue to show TG-1701 to be efficacious and generally well tolerated in combination with U2. We look forward to updating the abstract data and presenting at both the upcoming ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) annual congresses."

Data to be presented at the ASCO (Free ASCO Whitepaper) meeting:

Presentation Title: TG-1701, A Selective Bruton Tyrosine Kinase (BTK) Inhibitor, as Monotherapy and in Combination with Ublituximab and Umbralisib (U2) in Chronic Lymphocytic Leukemia (CLL) and Lymphoma

Abstract ID: 7525
Available on Demand: Friday, June 4, 2021 at 9:00 AM ET
Session Title: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Lead Author: Chan Y. Cheah MBBS, DMSc, Linear Clinical Research, and Department of Haematology, Sir Charles Gairdner Hospital, Nedlands Western Australia, Medical School, University of Western Australia, Crawley, Western Australia
The above abstract will be available on May 19, 2021, via the ASCO (Free ASCO Whitepaper) meeting website at www.asco.org.

Data to be presented at the EHA (Free EHA Whitepaper) meeting:

Presentation Title: TG-1701, A Selective Bruton Tyrosine Kinase (BTK) Inhibitor, as Monotherapy and in Combination with Ubituximab and Umbralisib (U2) in Chronic Lymphocytic Leukemia (CLL) and Lymphoma

Abstract Code: EP638
Available on Demand: Friday, June 11, 2021 at 9:00 CEST
Session Title: Chronic lymphocytic leukemia and related disorders – Clinical
Lead Author: Chan Y. Cheah MBBS, DMSc, Linear Clinical Research, and Department of Haematology, Sir Charles Gairdner Hospital, Nedlands Western Australia, Medical School, University of Western Australia, Crawley, Western Australia
The above abstract is now available via the EHA (Free EHA Whitepaper) meeting website at www.ehaweb.org.

At the time of each presentation, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com/publications.cfm