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.

Nordic Nanovector: Archer-1 phase 1b Betalutin®/rituximab combination trial advances to next cohort

On May 21, 2019 Nordic Nanovector ASA (OSE: NANO) reported that following a safety review of the first patients in the ongoing Archer-1 (LYMRIT 37-07) trial investigating Betalutin (177Lu-satetraxetan-lilotomab) in combination with rituximab (RTX) in second-line follicular lymphoma (2L FL), the Betalutin dose has been escalated to 15 MBq/kg for the next cohort of patients (Press release, Nordic Nanovector, MAY 21, 2019, https://www.nordicnanovector.com/investors-and-media/press-releases?page=/en/pressreleases/nordic-nanovector%253A-archer-1-phase-1b-betalutin%2528r%2529-rituximab-combination-trial-advances-to-next-cohort-1692267 [SID1234553451]).

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Archer-1 is a Phase 1b open-label, single-arm, multi-centre dose-escalation trial to assess the safety and preliminary activity of combining CD37-targeted Betalutin with CD20-targeted RTX in 20-25 patients with relapsed/refractory FL who have received one or more prior therapies. Starting doses of Betalutin and lilotomab are 10MBq/kg and 40mg, respectively, with the option for dose escalation.

Following Betalutin dosing, patients will receive 375 mg/m2 RTX once per week for four weeks. The primary endpoint is safety, and secondary endpoints include overall response rate, duration of response, progression free survival and overall survival. Data read-out is expected during the second half of 2020.

Lisa Rojkjaer, Chief Medical Officer of Nordic Nanovector, commented: "We are pleased to be moving ahead with the next group of patients in the study, which will enable us to recommend a dose for further evaluation of safety and preliminary efficacy in additional patients."

Rituximab is a CD20-targeting monoclonal antibody that is administered to patients with newly-diagnosed or relapsed FL as a single agent or in combination with chemotherapy. Over time, patients may develop resistance to RTX, thus alternative targets and new treatments are important. The combination of anti-CD37 and anti-CD20 modalities could therefore represent a novel dual immunotherapy approach for the treatment of 2L FL patients, and potentially avoid or delay the use of chemotherapy.

Sorrento Therapeutics to Present at 20th Annual B. Riley FBR Investor Conference in Los Angeles (ca).

On May 21, 2019 Sorrento Therapeutics, Inc. (NASDAQ: SRNE, "Sorrento"), reported that Dr. Henry Ji, Chairman and CEO, will be participating in the upcoming FB Riley Investor Conference and meeting with individual investors (Press release, Sorrento Therapeutics, MAY 21, 2019, View Source [SID1234536512]).

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Date/Time: May 22nd, 2019 at 10:30 AM.

Location: Beverly Hilton, Los Angeles (CA), Room 9.

A copy of the corporate presentation will be made accessible through Sorrento’s Investors Relations website at www.sorrentotherapeutics.com.

Protalix BioTherapeutics Appoints Dror Bashan as its New President and Chief Executive Officer and Director

On May 21, 2019 Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX) reported that Dror Bashan has been appointed to serve as the Company’s new President and Chief Executive Officer, and a director, effective June 30, 2019, replacing Moshe Manor, who is stepping down from those roles for personal reasons (Press release, Protalix, MAY 21, 2019, View Source;p=RssLanding&cat=news&id=2399232 [SID1234536497]). Mr. Manor will assist with the transition and continue to work with the Company on a consultant basis.

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"Dror brings valuable experience and knowledge in the pharmaceutical industry to our Company, and I am happy to welcome him to Protalix," said Shlomo Yanai, Chairman of Protalix’s Board of Directors. "Moshe has made a great contribution to our organization over the last four years, and has played a critical role in our development and success in advancing our pipeline. On behalf of Protalix and the Board of Directors, I would like to thank Moshe for his significant contributions and outstanding leadership and wish him great success in his future endeavors."

"I have the deepest gratitude to Protalix’s employees and its Board of Directors. I have decided that, for personal reasons unrelated to the Company, the time has come to hand over leadership to a new chief executive officer," said Mr. Manor. "I am very honored to have led this great organization and will continue to watch with excitement and anticipation as Protalix progresses in the development and commercialization of its promising pipeline."

"I am very proud to become Protalix’s President and Chief Executive Officer, and am looking forward to working with such a talented management team to continue the progress of Protalix’s future development," said Mr. Bashan. "I believe that my broad experience in the pharmaceutical industry, which covers a range of disciplines in the field, will be a valuable resource for the company. I am very excited about the potential path forward and glad to be part of Protalix’s future."

Mr. Bashan has over 20 years of experience in the pharmaceutical industry with roles ranging from business development, marketing, sales and finance providing him with both cross regional and cross discipline experience and a deep knowledge of the global pharmaceutical and health industries. From 1998 through 2018, he served in a number of senior positions at Teva Pharmaceutical Industries Ltd. Most recently, he served as Teva’s Senior Vice President, Global Business Development, and was involved in strategic alliances, cross-company strategic projects and the acquisition and divestiture of assets. Mr. Bashan holds a BA in Economics and Business Management from the Tel Aviv University in Tel Aviv, Israel, and an MBA from the Tel-Aviv University.

RhoVac publishes research results prior ASCO’s meeting

On May 21, 2019 RhoVac reported that a summary of the collaboration with Lund University has been published prior to the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting (American Society of Clinical Oncology) held in Chicago on May 31-June 4 (Press release, RhoVac, MAY 21, 2019, View Source [SID1234555930]).

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The primary objective of the study was to investigate whether RhoC is expressed to a greater extent in cancer stem cells in prostate cancer induced metastases in radiation exposed mice. The metastasis tissues were harvested, sectioned and analyzed by immunohistochemical methods, comparing the presence of different biomarkers. The biomarkers analyzed were for RhoC, Adenoreceptor (AR), CD 166 (cancer stem cell) and Ki67 (proliferation). The results showed, that RhoC is expressed to a greater extent in the metastatic tissue and, and that there is a subpopulation of RhoC-positive cells in the metastases, which are double-labeled with CD166 to the cancer stem cells.

Anders Ljungqvist, CEO: – It was satisfying to see that these results confirmed that RhoC was expressed to a greater extent in the metastasis tissue than in the tumor, and that a subpopulation of the RhoC-positive cells also has cancer stem cell character.