Insmed Announces Pricing of Concurrent Public Offerings of Common Stock and Convertible Senior Notes due 2028

On May 11, 2021 Insmed Incorporated (Nasdaq: INSM) reported that it priced a registered underwritten public offering of 10,000,000 shares of its common stock (the "Shares") at a price to the public of $25.00 per share before deducting underwriting discounts and commissions, and a registered underwritten public offering of $500 million aggregate principal amount of its 0.75% convertible senior notes due 2028 (the "Notes") (Press release, Insmed, MAY 11, 2021, View Source [SID1234579732]). 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, are expected to be $250 million and $500 million, respectively. In addition, Insmed has granted the underwriters of the offering of Shares (the "Equity Offering") a 30-day option to purchase up to an additional 1,500,000 Shares and to the underwriters of the offering of the Notes (the "Notes Offering") a 30-day option, solely to cover over-allotments, to purchase up to an additional $75 million in aggregate principal amount of the Notes. All of the Shares and Notes to be sold in the offerings are to be sold by Insmed.

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The offerings are expected to close on or about May 13, 2021, subject to satisfaction of customary closing conditions. The closing of each offering is not contingent on the closing of the other offering.

The Notes will be senior unsecured obligations of Insmed and will 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 will 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 will initially be 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 plans to enter into separate and privately negotiated repurchase transactions with certain holders of a portion of the 2025 Notes. In these transactions, Insmed plans to repurchase 2025 Notes with an aggregate principal amount of $225 million for an aggregate repurchase price of approximately $237 million plus accrued interest, 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 are acting as book-running managers for the offerings. Morgan Stanley & Co. LLC is also acting as a book-running manager for the offerings. Credit Suisse Securities (USA) LLC and Stifel, Nicolaus & Company, Incorporated are acting as co-lead managers for the Equity Offering. Cantor Fitzgerald & Co. and H.C. Wainwright & Co., LLC are acting as co-managers for the Equity Offering.

The Equity Offering and the Notes Offering are being made pursuant to Insmed’s shelf registration statement on Form S-3 (File No. 333-238560) including the base prospectus contained therein, a preliminary prospectus supplement related to the Equity Offering (together with such base prospectus, the "Equity Prospectus") and a preliminary prospectus supplement related to the Notes Offering (together with such base prospectus, the "Notes Prospectus"), all of which Insmed filed with the Securities and Exchange Commission ("SEC"). Before investing in the Shares or the Notes, investors should read the Equity Prospectus and the Notes Prospectus, respectively, in each case, including the documents incorporated by reference therein, and any free writing prospectus related to the Equity Offering and the Notes Offering, as the case may be. These documents may be freely obtained by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, copies may be obtained, when available, 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.

Harbour BioMed Announces Dosing of First Patient in Australia for Phase Ib/IIa Clinical Study of its Next-Generation Anti-CTLA-4 Antibody

On May 11, 2021 Harbour BioMed ("HBM", HKEX: 02142) reported the dosing of the first patient in its part 2 of phase I (phase Ib/IIa) clinical study of its next-generation anti-CTLA-4 antibody, where Australian patients with metastatic or advanced melanoma, hepatocellular carcinoma (HCC) and renal cell carcinoma (RCC) and other type of tumors will be enrolled (study no. 4003.1) (Press release, Harbour BioMed, MAY 11, 2021, View Source [SID1234579731]). The objective of this study is to evaluate the safety, tolerability, PK/PD, and anti-tumor activity of HBM4003 as a single agent in multiple solid tumor types. The part 1 of phase I trial study results have been submitted to European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper).

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As Harbour BioMed’s next-generation anti-CTLA-4 antibody, HBM4003 is currently in an open label, multicenter global trial for patients with advanced solid tumors. The part 1 study was focused on dose escalation, and phase Ib/IIa study is to proceed to dose expansion to further explore the anti-tumor activities of HBM4003 in multiple solid tumor types.

"In our previous study, we observed a case of good tumor shrinkage in a man with metastatic liver cancer," said Professor Paul de Souza from St George Private Hospital (Australia). "I look forward to this new stage of the study, which will allow us to recruit more patients with particular cancers that may benefit from this treatment."

"HBM4003 has shown strong anti-tumor activity and great safety in its phase 1 clinical studies," Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed said. "We will continue to accelerate the global development of HBM4003 for multiple tumor types, so that we can help cancer patients around the world to live better and longer lives."

About HBM4003

HBM4003 is the fully human anti-CTLA-4 monoclonal heavy chain only antibody (HCAb) generated from Harbour Mice. HBM4003 shows enhanced antibody-dependent cell cytotoxicity (ADCC) killing activity and is extremely specific to high CTLA-4 Treg cells in tumor tissues. The potent anti-tumor efficacy and differentiated pharmacokinetics with durable pharmacodynamic effect presents a favorable product profile. This novel and differentiated mechanism of action has the potential to improve efficacy while significantly reducing the toxicity of the drug.

Factor Bioscience to Deliver Six Digital Presentations at the American Society of Gene & Cell Therapy (ASGCT) 24th Annual Meeting

On May 11, 2021 Factor Bioscience Inc., a Cambridge-based biotechnology company focused on developing mRNA and cell-engineering technologies, reported its participation in the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 24th Annual Meeting to be held virtually May 11-14, 2021, at which Factor will deliver six digital presentations (Press release, Factor Bioscience, MAY 11, 2021, View Source;cell-therapy-asgct-24th-annual-meeting-301288301.html [SID1234579730]):

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"High-efficiency generation of biallelic gene knockout iPSC lines using mRNA gene editing." -to be presented by Mitchell Kopacz on May 11 from 8-10 am.
"Removing T0 constraint reveals differences in specificity of engineered gene-editing proteins." -to be presented by Mackenzie Parmenter on May 11 from 8-10 am.
"Knock-in iPS cell line generation using end-modified linear DNA donors." -to be presented by Aidan Simpson on May 11 from 8-10 am.
"Splint and ribozyme-free enzymatic synthesis and purification of long circular RNA for in vitro translation in human cells." -to be presented by Aisha Svihla on May 11 from 8-10 am.
"DNA-binding domains containing novel repeat sequences enable temperature-tunable gene editing in primary human cells." -to be presented by Yemi Osayame on May 11 from 8-10 am.
"Lipid-stripped albumin enables high-efficiency mRNA reprogramming of adult human fibroblasts." -to be presented by Jasmine Harris on May 11 from 8-10 am.
Factor reveals advances in mRNA, circleRNA, gene editing, cell reprogramming, and iPS cell-derived NK-cell technologies.

Digital presentations will be made available on the ASGCT (Free ASGCT Whitepaper) website on May 11, 2021. For more information on the upcoming American Society of Genetic & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting, visit View Source

Samus Therapeutics Receives IND Clearance from FDA for PU-AD for the Treatment of Recurrent Malignant Glioma

On May 11, 2021 Samus Therapeutics, Inc. ("Samus Therapeutics" or the "Company"), a privately held, Boston-based biopharmaceutical company developing epichaperome inhibitors to treat CNS diseases and hematologic malignancies, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to develop PU-AD for the treatment of recurrent malignant glioma (Press release, Samus Therapeutics, MAY 11, 2021, View Source [SID1234579728]). Under this IND, Samus will proceed with its Phase 1b study addressing the safety, tolerability and pharmacokinetics of PU-AD (icapamespib) in patients with recurrent malignant glioma. Icapamespib is an orally administered small molecule that is a specific inhibitor of epichaperomes.

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Under the leadership of Dr. John de Groot, at the University of Texas M.D. Anderson Cancer Center and Dr. Howard Colman at the Huntsman Cancer Institute at the University of Utah, the multicenter Phase 1b study will be conducted in two stages at multiple sites across the U.S. The dose escalation will address daily administration of icapamespib in patients with a first, second or third recurrence of isocitrate dehydrogenase (IDH) wild type glioblastoma, or grade 3 or 4 IDH mutant astrocytoma.

"The expansion stage of this trial will not only confirm safety of the Phase 2 dose, but also investigate the biology of recurrent disease through biomarker analysis and evidence of target engagement," said Dick Bagley, President and CEO of Samus Therapeutics.

Malignant glioma is a characterization of Stage 3 and 4 glioblastoma/astrocytoma diagnoses. Standard of care at outset is varied but predominantly includes surgery, chemotherapy, and radiation therapy. According to the American Cancer Society, glioblastoma is the most common and most aggressive form of the primary brain tumors in adults, accounting for half of all primary brain cancers. Despite extensive research, available treatments have not improved the median survival of 14-16 months.

"Through the work of our scientific founder Gabriela Chiosis, PhD and her collaborators, we have established that glioblastomas express high levels of epichaperomes as evidenced in explants, primary and secondary neurospheres, and glial stem cells. Epichaperome driven glioblastoma cells respond well to icapamespib treatment in xenograft mouse models and ex vivo studies even when resistant to Temodar (temozolomide) and Avastin (bevacizumab), giving us a signal that icapamespib could have a clinical impact on this devastating disease," commented Barbara Wallner, PhD, Chief Scientific Officer.

CASI Pharmaceuticals To Report First Quarter 2021 Financial Results And Host Conference Call May 13, 2021

On May 11, 2021 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported the Company will host a conference call reviewing the first quarter highlights at 8:00 a.m. ET on Thursday, May 13th, 2021 (Press release, CASI Pharmaceuticals, MAY 11, 2021, https://www.prnewswire.com/news-releases/casi-pharmaceuticals-to-report-first-quarter-2021-financial-results-and-host-conference-call-may-13-2021-301288283.html [SID1234579727]).

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On the call, CASI’s Chairman & CEO will provide an update on the Company’s business and upcoming milestones. The conference call can be accessed by dialing (833) 420-0382 (U.S.), 8008700181 (China), 58086567 (Hong Kong) to listen to the live conference call. The conference ID number for the live call is 7478587.

This call will be recorded and available for replay by dialing (800) 585-8367 (U.S.) or (404) 537-3406 (international) and enter 7478587 to access the replay.