On December 6, 2018 Xspray Pharma AB (publ) ("Xspray" or the "Company") reported the company has successfully carried out a directed share issue at a subscription price of SEK 67 per share (Press release, Xspray, DEC 6, 2018, View Source [SID1234650105]). The subscription price corresponds to a discount of approximately 3 percent compared with today’s VWAP, 6 December 2018. The subscription price has been determined through an accelerated book-building procedure.

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A group of Swedish and international institutional investors, among others Unionen, Third Swedish National Pension Fund and Forth Swedish National Pension Fund, have subscribed for shares in the directed share issue. The Company believes that the flexibility of a placing without pre-emption right for existing shareholders is the most appropriate way to diversify the shareholder base among institutional investors prior to the planned list change of the Company’s share to Nasdaq Stockholm’s main list during 2019, and at the same time raise capital in a time efficient manner.

Following the positive data announced on 10 October 2018 for the Company’s lead product, HyNap-Dasa, the Company intends to use the proceeds from the directed share issue to i) continue development of its product portfolio; ii) develop its product candidates through registration; and iii) accelerate the development of product candidate HyNap-Nilo in order to be ready to launch the product earlier than previously planned.

Per Andersson, CEO, Xspray Pharma, comments:

"As a result of the positive results for the product candidate HyNap-Dasa, presented earlier this fall, we are in a strong position to bring our unique HyNap compositions, comprising a number of protein kinase inhibitors (PKIs), to the market. This is an important step towards becoming a powerhouse for PKIs where we address relevant medical needs and more accessible pharmaceuticals to the cancer market."

The directed share issue is expected to raise proceeds for the Company of approximately SEK 92 million before transaction costs. The subscription price has been determined through an accelerated book-building procedure. The directed share issue will result in an increase of the number of shares in Xspray of 1,370,000, from 13,706,460 to 15,076,460, and an increase in the share capital by SEK 1,370,000, from SEK 13,706,460 to SEK 15,076,460, resulting in a dilution of approximately 9.1 percent.

In connection with the directed share issue, the Company has, with customary exceptions, agreed to a lock-up undertaking on future share issuances for a period of 90 days after the directed share issue. In addition, the management and board of directors have undertaken not to sell any shares in Xspray during the same period, subject to customary exceptions.

Advisers

In conjunction with the capital raising, the Company has engaged Carnegie Investment Bank as bookrunner and adviser, Zonda Partners as adviser and Vinge as legal adviser.

On December 6, 2018 Novocure (NASDAQ:NVCR) reported that the results of a retrospective post-hoc sub-group analysis of its EF-14 phase 3 pivotal trial in newly diagnosed glioblastoma (GBM) have been published in the Journal of Neuro-Oncology (Press release, NovoCure, DEC 6, 2018, View Source [SID1234531931]). The analysis demonstrated that more time on Optune predicted increased survival in patients who received Optune plus temozolomide compared to patients who received temozolomide alone. Optune is a noninvasive, portable medical device that delivers Tumor Treating Fields to people with GBM. Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and causing certain cancer cells to die.

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"The total amount of time the device is worn, also known as monthly Optune usage – or treatment compliance – matters greatly for patients with GBM, one of the most aggressive forms of cancer," said Steven A. Toms, MD, Professor of Neurosurgery and Medicine, and Vice Chair of the Department of Neurosurgery at Lifespan Health System, and the Warren Alpert Medical School of Brown University in Providence, Rhode Island, and author of the article. "Optune plus temozolomide has proven to provide long-term quality survival to patients with newly diagnosed GBM. Therefore, the importance of monthly Optune usage should be reinforced with patients by their health care providers."

Data from this sub-group analysis demonstrated that patients using Optune 50 percent or more of the time had a survival benefit compared to those who used temozolomide alone (n=388/450, OS HR 0.67, 95% CI 0.45–0.99). Patients who used Optune more than 90 percent of the time experienced a median overall survival of 24.9 months (n=43; OS HR 0.52, 95 percent CI 0.35–0.79) and a predicted 5-year survival rate of 29.3 percent versus a median overall survival of 16.0 months and a predicted 5-year survival rate of 4.5 percent for patients who used temozolomide alone. Monthly usage was a predictor of survival, independent of other prognostic factors such as Karnofsky Performance Status, age or MGMT methylation status.

Novocure’s phase 3 pivotal EF-14 trial compared Optune in combination with temozolomide to temozolomide alone in a total of 695 patients with newly diagnosed GBM. The trial was designed to test both progression free survival and overall survival. The trial demonstrated unprecedented five-year survival results in newly diagnosed GBM for those patients treated with Optune in combination with temozolomide. Those patients experienced an extension of overall survival without added systemic toxicity compared to patients treated with temozolomide alone. The data also showed that Optune-treated patients were able to maintain their mental, emotional and physical well-being longer than those treated with temozolomide alone, as measured for up to one year.

On December 6, 2018 Aeglea BioTherapeutics, Inc. (NASDAQ: AGLE), a clinical-stage biotechnology company reported that designs and develops innovative human enzyme therapeutics for patients with rare genetic diseases and cancer, will participate in a fireside chat at the BMO Capital Markets 2018 Prescription for Success Healthcare Conference in New York, NY on Wednesday, December 12 (Press release, Aeglea BioTherapeutics, DEC 6, 2018, View Source [SID1234531948]).

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Presentation Details
Date: Wednesday, December 12, 2018
Time: 3:40 p.m. ET
Location: Mandarin Oriental New York Hotel, New York City
Room: North Salon II
Webcast: View Source

To access the live and archived audio webcast of the fireside chat, visit the Presentations & Events section of the Aeglea BioTherapeutics investor relations website. Please connect to the website at least 15 minutes prior to the presentation to allow for any software download that may be necessary. Replays of the webcast will be available for 30 days thereafter.

On December 6, 2018 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported that a clinical development program is underway with Novartis to bring to market a molecular test as a companion diagnostic to guide the use of the investigational compound BYL719 (alpelisib) in combination with fulvestrant for men and postmenopausal women living with PIK3CA mutated hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer (Press release, Qiagen, DEC 6, 2018, View Source [SID1234531932]).

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The Novartis drug candidate is in late-stage development, and QIAGEN expects to provide its companion diagnostic to clinical laboratory partners who will then be ready to offer immediate access to the test upon potential regulatory approvals of BYL719 and QIAGEN’s test.

Novartis has completed a Phase III clinical trial (SOLAR), testing BYL719 in combination with fulvestrant for patients with PIK3CA mutated HR+/HER2- advanced breast cancer.

QIAGEN’s companion diagnostic for PIK3CA mutations will provide a complete Sample to Insight workflow, from DNA extraction to detection of the clinically relevant mutations and final reporting. The test will be clinically validated for analysis of both FFPE tissue and liquid biopsy samples using plasma. The companion diagnostic will run on the Rotor-Gene Q MDx cycler, which is part of the modular QIAsymphony family of automation solutions, established in numerous pathology laboratories worldwide.

On December 6, 2018 Moderna, Inc. (Nasdaq: MRNA), a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, reported the pricing of its initial public offering of 26,275,993 shares of common stock at a public offering price of $23.00 per share, before underwriting discounts and commissions (Press release, Moderna Therapeutics, DEC 6, 2018, View Source [SID1234531949]). Moderna’s common stock is expected to begin trading on The Nasdaq Global Select Market on December 7, 2018 under the ticker symbol "MRNA." All of the common stock is being offered by Moderna. The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Moderna, are expected to be $604.3 million, excluding any exercise of the underwriters’ option to purchase additional shares. The offering is expected to close on December 11, 2018, subject to satisfaction of customary closing conditions. Moderna has granted the underwriters a 30-day option to purchase up to an additional 3,941,398 shares of Moderna’s common stock at the initial public offering price, less underwriting discounts and commissions.

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Morgan Stanley, Goldman Sachs & Co. LLC and J.P. Morgan are acting as joint lead book-running managers for the offering. BofA Merrill Lynch, Barclays Capital Inc. and Piper Jaffray & Co. are acting as book-running managers for the offering. Oddo BHF SCA, Oppenheimer & Co. Inc., Needham & Company, LLC and Chardan are acting as co-managers for the offering.

Registration statements relating to the shares being sold in this offering have been filed with the Securities and Exchange Commission and were declared effective on December 6, 2018. The offering is being made only by means of a prospectus. Copies of the final prospectus may be obtained, when available, from Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014; from Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, telephone: 1-866-471-2526, facsimile: 212-902-9316, or email: [email protected]; or from J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, telephone: 1-866- 803-9204, or email: [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, 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 the registration or qualification under the securities law of any such state or jurisdiction.