Insmed Announces Pricing of Public Offering of Common Stock

On May 21, 2019 Insmed Incorporated (Nasdaq: INSM) reported that it priced a registered underwritten public offering of 9,615,385 shares of its common stock, at a price to the public of $26.00 per share before underwriting discounts and commissions (Press release, Insmed, MAY 21, 2019, View Source [SID1234536510]). Gross proceeds from the offering of these shares, before deducting underwriting discounts and commissions, are expected to be approximately $250.0 million. The underwriters have been granted 30-day options to purchase up to an additional 1,042,307 shares of common stock from Insmed and up to 400,000 shares of common stock from William H. Lewis, the Company’s Chairman and Chief Executive Officer.

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Insmed intends to use its net proceeds from this offering to continue to commercialize ARIKAYCE (amikacin liposome inhalation suspension); conduct further trials of ARIKAYCE, including Insmed’s required confirmatory trial to assess and describe the clinical benefit of ARIKAYCE in patients with Mycobacterium avium complex (MAC) lung disease; fund further clinical development of INS1007 and INS1009; invest in increased third-party manufacturing capacity for ARIKAYCE; fund business expansion activities in Europe and Japan; fund working capital, potential debt repayment, capital expenditures, and general research and development; and for other general corporate purposes, which may include the acquisition or in-license of additional compounds, product candidates, technology or businesses.

Morgan Stanley & Co. LLC, SVB Leerink LLC and Goldman Sachs & Co. LLC are acting as joint book-running managers for the offering. Credit Suisse Securities (USA) LLC, Stifel, Nicolaus & Company, Incorporated and H.C. Wainwright & Co. are acting as co-managers for the offering. The offering is expected to close on May 24, 2019, subject to the satisfaction of customary closing conditions.

A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock described above has been filed with the Securities and Exchange Commission (SEC), as amended by Post-Effective Amendment No. 1 thereto, and became automatically effective upon filing. A preliminary prospectus supplement relating to and describing the terms of the offering was filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, from Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, Massachusetts 02110, telephone: 1-800-808-7525, ext. 6132 or email at [email protected]; and Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, facsimile: 1-212-902-9316 or 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.

EXUMA Biotechnology’s Affiliate Shanghai PerHum Therapeutics Announces Preliminary Results of Two First-in-Human Solid Tumor CAR-T Products

On May 21, 2019 EXUMA Biotechnology and affiliate Shanghai PerHum Therapeutics reported interim results of two first-in-human solid tumor CAR-T products in subjects with recurrent or refractory stage IV metastatic renal cell carcinoma (mRCC) (Press release, EXUMA Biotechnology, MAY 21, 2019, View Source [SID1234536509]). The data, presented at the Association for Cancer Immunotherapy (CIMT) (Free CIMT Whitepaper) 2019 Annual Meeting, continues to support the feasibility, comparative safety and pharmacokinetics of dose escalation of two CAR-T products, CCT301-38 (AXL) and CCT301-59 (ROR2), in a single patient population.

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The umbrella clinical trial design being run at SPHCC (Shanghai Public Health Clinical Center) under the direction of lead investigator Tongyu Zhu, M.D., examines the first two CAR-T products in human clinical trial to use AND logic gate control technology. The logic gate design leverages the tumor microenvironment (TME) – turning the growth inhibitory acidic TME into an activating signal – thereby minimizing the potential of on-target, off-tumor activity. One trigger of the logic gate is the TME, and the other is the target antigen (AXL or ROR2, depending on the product). Some of the key highlights presented include:

No dose-limiting toxicities have been observed to date with no indications of on-target, off-tumor toxicity attributed to either product.
CAR-T product blood exposure up to 80,000 copies/ μg observed at the 1 x 106/kg dose level.
Early radiologic evidence of antitumor activity, with stable disease as best response.
In this heavily pre-treated patient population, 6 out of 7 subjects are alive with a median follow-up of 140 days.
These interim results continue to support the potential of the company’s conditionally active biologics (CAB)-CAR-T technology to increase the safety profile of CAR-T therapeutics in mRCC and potentially other target-positive solid tumors.
"The cell processing feasibility, cell exposure and preliminary comparative safety of the two novel products support the potential of CAB-CAR-T technology for solid tumors," said Wendy Li, M.D., Chief Medical Officer of EXUMA Biotechnology. "We look forward to the complete data set from these ongoing clinical studies with collaborators and to bringing these programs forward into multicenter studies in the future."

The full abstract is now available on the annual CIMT (Free CIMT Whitepaper) meeting website (Abstract #123) and the poster will be presented on May 21, 9:00-11:30 am EST.

Arcus Biosciences to Present at the Jefferies 2019 Global Healthcare Conference

On May 21, 2019 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage biopharmaceutical company focused on creating innovative cancer immunotherapies, reported that Terry Rosen, Ph.D., Chief Executive Officer, will present at the Jefferies 2019 Global Healthcare Conference on Tuesday, June 4, 2019 at 4 pm ET at the Grand Hyatt, in New York, NY (Press release, Arcus Biosciences, MAY 21, 2019, View Source [SID1234536508]).

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To access the live audio webcast of the presentation, please visit the "Investors" section of the Arcus website at www.arcusbio.com. A replay of the webcast will be available for 30 days following the live event.

Medpace Holdings, Inc. to Present at Jefferies 2019 Healthcare Conference

On May 21, 2019 Medpace Holdings, Inc. (Nasdaq: MEDP) ("Medpace") reported that it will present at the following investor conference in June (Press release, Medpace, MAY 21, 2019, View Source [SID1234536507]):

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Jefferies 2019 Healthcare Conference
Location: New York, NY
Date: Tuesday, June 4, 2019
Presentation: 8:30 a.m. ET
Speakers: August Troendle, President & Chief Executive Officer, and Jesse Geiger, Chief Financial Officer & Chief Operating Officer, Laboratory Operations

A live webcast of each presentation will be accessible through the "Investors" section of the Company’s website at www.medpace.com and will be available for replay following each event.

Median Technologies to Attend the 2019 ASCO Annual Meeting, May 31 – June 4, 2019, McCormick Place, Chicago, IL, USA

On May 21, 2019 Median Technologies (Paris:ALMDT), The Imaging Phenomics Company, reported that it will be exhibiting at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting, May 31 – June 4 at the McCormick Place, Chicago, IL, USA (exhibition dates: June 1-3) (Press release, MEDIAN Technologies, MAY 21, 2019, View Source [SID1234536506]).

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Median Technologies will share and showcase its offering for imaging solutions and services in clinical trials iSee and present the latest developments of its imaging Phenomics platform iBiopsy, at booth #6102.

The Median’s clinical team will be available at the booth to discuss the abstract results: "Imaging biomarker phenotyping system (iBiopsy) to accelerate hepatocellular carcinoma (HCC) drug development". The abstract is online here.

The ASCO (Free ASCO Whitepaper) Annual Meeting is the world’s premier oncology conference, organized by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), the largest oncology society in the world. Each year, the ASCO (Free ASCO Whitepaper) conference brings together more than 35,000 oncologists from all around the globe, and is attended by all medical, educational and industrial stakeholders involved in the field of oncology worldwide. More about the ASCO (Free ASCO Whitepaper) Annual Meeting: View Source