IntelGenx Announces Pricing of $12 Million Equity Offering

On October 18, 2018 IntelGenx Technologies Corp. (TSX-V:IGX) (OTCQX:IGXT) (the "Company" or "IntelGenx") reported the pricing of an agency offering (the "Offering") of 17,144,314 units (the "Units") for gross proceeds of approximately US$12,000,000 million at a price of US$0.70 per Unit (the "Offering Price") (Press release, IntelGenx, OCT 18, 2018, View Source [SID1234530113]). Each Unit will consist of one share of common stock of the Company (an "Offered Share") and one half of one warrant (a "Warrant") each whole Warrant to purchase one share of common stock of the Company at an exercise price of US$1.00 per share (a "Warrant Share"). The Warrants will be exercisable immediately and will expire on the third anniversary of the date of their issuance.

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The Offering is made on a best efforts basis in the United States and the Canadian provinces of British Columbia, Alberta, Manitoba, Ontario and Québec. H.C. Wainwright & Co. ("Wainwright") is acting as the exclusive agent for the Units offered in the United States. Echelon Wealth Partners Inc. ("Echelon") is acting as the exclusive placement agent for the Units offered in Canada.

The closing of the Offering is expected to occur on or about October 22, 2018.

The Company has granted Echelon an over-allotment option exercisable, in whole or in part, at the sole discretion of Echelon, at any time prior to 5:00 p.m. (Montreal time) on the date that is the 30th day after the closing of the Offering, to purchase shares of common stock of the Company and/or Warrants in an amount representing up to an additional 15% of the number of Units sold pursuant to the Offering, at the Offering Price to cover over-allocations, if any, and for market stabilization purposes.

The Company intends to use the net proceeds of the Offering for its 2a Montelukast study, Tadalafil 505(b)(2) submission to U.S. Food and Drug Administration, and working capital.

The Company has applied to the TSX Venture Exchange ("TSXV") for approval of the listing of the Offered Shares and the Warrant Shares. The approval is subject to fulfillment by the Company of customary conditions of TSXV. There is no established trading market for the Warrants and IntelGenx does not expect a market to develop. IntelGenx does not intend to list the Warrants on any national securities exchange or any other nationally recognized trading system

The Company intends to file a final prospectus supplement (the "U.S. Supplement") to the U.S. registration statement on Form S-3 (File No. 333-227498) which was declared effective on October 15, 2018 (the "Registration Statement") and a final Canadian MJDS prospectus supplement (the "Canadian Supplement") to the Canadian MJDS short-form base shelf prospectus dated October 15, 2018 (the "MJDS Prospectus") with respect to the Offering today.

Before investing, you should read the Canadian Supplement, the U.S. Supplement, the MJDS Prospectus and the Registration Statement as well as other documents the Company has filed or will file later today with the United States Securities and Exchange Commission (the "SEC") and the Canadian securities regulators for more complete information about the Company and this offering. Copies of the Canadian Supplement and the MJDS Prospectus are available under the Corporation’s profile at www.sedar.com and copies of the U.S. Supplement and the Registration Statement can be obtained from the SEC’s website at www.sec.gov.

Copies of the U.S. Supplement, when filed, and the Registration Statement may also be obtained from H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by calling (646) 975-6996 or by emailing [email protected], and copies of the Canadian Supplement and the MJDS Prospectus may also be obtained from Echelon Wealth Partners Inc., 1 Adelaide Street East, Suite 2100, Toronto, ON M5C 2V9, by calling (416) 479-7370 or emailing [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, Units, Warrants or shares of common stock of the Company in any state or province in which such offer, solicitation or sale would be unlawful, prior to registration or qualification under the securities laws of any such state, province, or other jurisdiction.

Spectrum Pharmaceuticals Announces Dr. Francois Lebel as Chief Medical Officer

On October 18, 2018 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, reported the appointment of Francois Lebel, M.D., F.R.C.P.C. as Chief Medical Officer, effective November 5, 2018 (Press release, Spectrum Pharmaceuticals, OCT 18, 2018, View Source [SID1234530082]).

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"Dr. Lebel is an accomplished leader and has deep expertise in biopharmaceuticals with an emphasis in oncology drug development," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "Given his qualifications, we believe Dr. Lebel will add significant value to Spectrum and our clinical programs. We have several near-term milestones and priorities including expanding the development of poziotinib in broader patient populations, gaining regulatory clarity for breakthrough designation on poziotinib, and filing the ROLONTIS BLA in the fourth quarter."

Dr. Lebel will be responsible for leading the Spectrum clinical program which includes directing the clinical research staff, overseeing the company’s ongoing clinical trials, and regulatory submissions. He will also direct clinical development strategies, life-cycle management, relationships with regulatory bodies and provide strategic counsel on all business development activities.

"It is a great time to have the opportunity to lead the medical and scientific organization at Spectrum ahead of multiple FDA submissions," said Francois Lebel, M.D., F.R.C.P.C, Chief Medical Officer of Spectrum Pharmaceuticals. "In evaluating Spectrum’s pipeline drugs, I have been very impressed with the robust clinical data, especially the recently released poziotinib data in heavily pretreated lung cancer patients who have very few options. I plan to aggressively expand the utility of this targeted therapy in areas of high unmet medical need. I look forward to leading Spectrum into a new era in medical and clinical development with the goal of significantly advancing patient care in oncology."

Dr. Lebel brings nearly 30 years of clinical leadership experience within the biopharmaceutical industry. He has designed and managed global medical organizations to deliver results, enhance productivity and practice sound risk management. Most recently, he served as the Executive Vice President of Research & Development, Chief Medical Officer at ZIOPHARM Oncology. He also held various leadership roles including Vice President of Research & Development at Baxter International and Global Head of Medical and Scientific Affairs at MedImmune. In the last 25 years, he provided strategic leadership on eight NDA/BLAs in various therapeutic areas and on a number of mergers and acquisitions. Dr. Lebel has broad and deep experience in oncology drug development, medical affairs, regulatory and pharmacovigilance acquired through various roles of increasing responsibilities at Chiron (Novartis), Warner-Lambert (Pfizer) and Burroughs Wellcome (GSK). He received his medical degree from the University of Ottawa, Canada, and he completed his post graduate training at McGill University and Harvard Medical School. He is Board Certified in Internal Medicine and a fellow of the Royal College of Physicians of Canada.

Shire to announce third quarter 2018 results

On October 18, 2018 Shire plc (LSE: SHP, NASDAQ: SHPG), reported that it will announce third quarter 2018 earnings on Thursday November 1, 2018 (Press release, Shire, OCT 18, 2018, View Source [SID1234530027]).

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Results press release will be issued at:

12:00 GMT / 08:00 EDT

Investor conference call time:

14:00 GMT / 10:00 EDT

Live conference call for investors:
Flemming Ornskov, MD, M.P.H., Chief Executive Officer and Thomas Dittrich, Chief Financial Officer will host the investor and analyst conference call at 10:00 am EDT / 14:00 GMT.

The details of the conference call are as follows:

UK dial in:

0800 358 9473 or +44 333 300 0804

US dial in:

1 855 857 0686 or 1 631 913 1422

International Access Numbers:

Click here

Password/Conf ID:

28705371 #

Live Webcast:

Click here

Replay:
A replay of the presentation will be made available, subject to approval by the UK Takeover Panel, for two weeks by phone and for three months by webcast. Replay information made available will be contained on the Investor Relations section of Shire’s website at View Source

For further information please contact:
Investor Relations

Christoph Brackmann [email protected] +41 41 288 4129
Sun Kim [email protected] +1 617 588 8175
Scott Burrows [email protected] +41 41 288 4195
Media
Katie Joyce [email protected] +1 781 482 2779

Delcath Announces Enrollment of First Patient in ALIGN Trial

On October 18, 2018 Delcath Systems, Inc. (OTCQB: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported that patient treatments have begun in the Company’s second global US registration trial investigating Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) in the treatment of patients with intrahepatic cholangiocarcinoma (ICC) (Press release, Delcath Systems, OCT 18, 2018, View Source;p=RssLanding&cat=news&id=2372259 [SID1234530000]).

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The University of Tennessee Health Science Center (UTHSC) in collaboration with Methodist University Hospital (MUH) and West Cancer Center (WCC) in Memphis, Tennessee have enrolled the trial’s first patient and treatments have begun by a team led by Dr. Evan S. Glazer. Dr. Glazer, a board certified surgical oncologist, is the principal investigator for the trial at the UTHSC/MUH/WCC location.

The trial, entitled A Randomized, Controlled Study to Compare the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment Given Sequentially Following Cisplatin/Gemcitabine versus Cisplatin/Gemcitabine (Standard of Care) in Patients with Intrahepatic Cholangiocarcinoma, (the ALIGN Trial) will seek to enroll approximately 295 ICC patients at approximately 40 clinical sites in the U.S. and Europe.

"ICC is a deadly form of liver cancer, and the current treatment options have only shown very limited benefit," said Dr. Evan Glazer, "Our team is encouraged by the initial data available for Melphalan/HDS and are pleased to participate in this trial to explore this therapy’s potential as a new treatment option for these patients. We are most excited by the multi-disciplinary approach that this trial takes to help our patients."

"We are delighted to be working with Dr. Glazer and the team in Memphis to initiate The ALIGN Trial," said Jennifer K. Simpson, PhD, MSN, CRNP, President and Chief Executive Officer of Delcath Systems. "In this orphan population where there exists a large unmet need, this trial provides us with a potential second pathway to commercial drug approval in the United States, and if successful we believe will be an important value driver for Delcath."

TESARO to Announce Third-Quarter 2018 Financial Results on November 1, 2018

On October 18, 2018 TESARO, Inc. (NASDAQ: TSRO) reported that it will announce third-quarter 2018 financial results on Thursday, November 1, 2018, after the close of the U.S. financial markets (Press release, TESARO, OCT 18, 2018, View Source [SID1234529997]). TESARO’s senior management team will host a conference call and live audio webcast at 4:15 p.m. ET on November 1, 2018 to discuss the Company’s operating results for the quarter in greater detail, as well as the status of its development programs.

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This quarterly earnings call will be available via phone and webcast. The conference call dial-in information is listed below. To access the webcast, please log on to the TESARO website at www.tesarobio.com at least 15 minutes prior to the start of the call to ensure adequate time for any software downloads that may be required.