Aeterna Zentaris Announces Closing of Approximately $5.0 Million Registered Direct Offering

On September 24, 2019 Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS), a specialty biopharmaceutical company engaged in commercializing novel pharmaceutical therapies, principally through out-licensing arrangements, reported the closing of its previously announced offering whereby the Company entered into a securities purchase agreement with institutional investors in the United States to purchase approximately $5.0 Million (before placement agent’s fees and expenses) of its common shares in a registered direct offering and warrants to purchase common shares in a concurrent private placement (together, the "Offering") (Press release, AEterna Zentaris, SEP 24, 2019, View Source [SID1234539740]). The combined purchase price for one common share and one warrant was $1.50.

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Under the terms of the securities purchase agreement, Aeterna sold 3,325,000 common shares. In a concurrent private placement, Aeterna issued warrants to purchase up to an aggregate of 3,325,000 common shares. The warrants will be exercisable commencing six months from the date of issuance, will have an exercise price of $1.65 per share and will expire 5 years following the date of issuance.

The gross proceeds from the registered direct offering and concurrent private placement were approximately $5.0 Million before deducting placement agent’s fees and expenses.

Maxim Group LLC acted as sole placement agent in connection with the offering.

In approving the Offering and listing the common shares issued and issuable thereunder, the Company relied on the exemption set forth in Section 602.1 of the TSX Company Manual available to "Eligible Interlisted Issuers", since the Company’s common shares are also listed on the NASDAQ Capital Market and had less than 25% of the overall trading volume of its listed securities occurring on all Canadian marketplaces in the twelve months immediately preceding the date on which application was made to TSX to approve the Offering.

The common shares described above were offered by Aeterna Zentaris pursuant to a "shelf" registration statement on Form F-3 (File No. 333-232935) previously filed and declared effective by the Securities and Exchange Commission (SEC). The warrants issued in the concurrent private placement and shares issuable upon exercise of such warrants were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and have not been registered under the Act or applicable state securities law.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. No Canadian prospectus has been or will be filed in a province or territory of Canada to qualify the common shares in connection with the offering. A prospectus supplement relating to the shares of common shares has been filed by Aeterna with the SEC. When available, copies of the prospectus supplement relating to the registered direct offering, together with the accompanying prospectus, can be obtained at the SEC’s website at www.sec.gov or from Maxim Group LLC, 405 Lexington Avenue, New York, NY 10174, Attention: Syndicate Department, or via email at [email protected] or telephone at (212) 895-3745.

SkylineDx and Mayo Clinic Collaborate on Implementing Skin Cancer Test in Clinical Practice

On September 24, 2019 SkylineDx reported at the 32nd Biennial Dermatology Symposium: The O’Leary Meeting 2019 in Rochester (MN, US) the launch of a pilot study it will conduct with the Mayo Clinic to evaluate and optimize its diagnostic services focused on primary cutaneous melanoma (skin cancer) (Press release, SkylineDx, SEP 24, 2019, View Source [SID1234539756]). SkylineDx’ proprietary diagnostic test combines genetic information from a patient’s tumor cells (taken during a diagnostic biopsy) with tumor – and patient specific characteristics. Put together, the test can accurately predict the risk of regional metastasis at the time of melanoma diagnosis. Currently, based on tumor characteristics alone, too many patients are predicted to have metastasis at diagnosis which results in many unneeded surgical interventions, so-called sentinel lymph node biopsies. The SkylineDx diagnostic test identifies patients who can safely forgo this surgical intervention. This pilot study with Mayo Clinic is an usability evaluation and the final step before starting a national trial in the United States in 2020.

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This announcement follows the joint development agreement that SkylineDx and Mayo Clinic signed in 2018. "In the last 18 months we have been working with the research group of Alexander Meves M.D., a dermatologist of Mayo Clinic, to fully optimize and develop the test", says Dharminder Chahal, CEO SkylineDx. This extensive collaboration has been part of the Falcon Research & Development Program. As the falcon is known as an intelligent creature with unprecedented senses and skills, this R&D program is uniquely equipped to unveil new, detailed insights in the genomic, pathologic and clinical nature of melanoma. "With melanoma being the deadliest form of skin cancer, the launch of this Falcon Research & Development Program will make an important and much needed contribution to improving patient outcomes in this field," continues Dharminder Chahal.

Under the wings of the Falcon R&D Program, a series of specific studies and projects are initiated to demonstrate clinical utility, aimed at developing and introducing an array of diagnostic utilities, ready for the patient. The first focus area is called the Merlin Study Initiative, which covers clinical research and validation studies for the test that predicts if a patient can safely avoid sentinel lymph node surgery. Furthermore, under the Peregrine Study Initiative, SkylineDx is in advanced stages of research to develop a test that predicts a patient’s prognosis and identifies patients that are likely to progress faster and might benefit from early adjuvant therapy.

Dr. Meves and Mayo Clinic have financial interest in the test referenced in this release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education and research.

Hot Company Activity Around European Society of Medical Oncology (ESMO 2019) Congress

The European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) (ESMO 2019) congress takes place in Barcelona, Spain between 27th Sep – 01st Oct 2019.

This conference features more than 2000 abstracts and a global presence of companies ranging from big pharma to smaller innovative global companies with the likes of CStone Pharmaceuticals (China), Rainer Therapeutics (USA), Puma Biotechnology (USA) and Noxxon (Germany) plus many more presenting data.

Read more below on the latest and hottest from companies like AstraZeneca, Merck & Co or any of the selection of companies generating heat about their presence at ESMO (Free ESMO Whitepaper) 2019.

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Halozyme To Participate In 2019 Cantor Global Healthcare Conference

On September 23, 2019 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported that it will participate in the 2019 Cantor Global Healthcare Conference in New York, NY. Dr. Helen Torley, president and chief executive officer, will represent the company in a question and answer session on Thursday, October 3 at 3:35 p.m. ET / 12:35 p.m. PT (Press release, Halozyme, SEP 23, 2019, View Source [SID1234539691]).

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A live webcast of the presentation can be accessed through the "Investors" section of www.halozyme.com, and a recording will be made available for 90 days following each event. To access a live webcast, please visit Halozyme’s website approximately 15 minutes prior to the presentation to register and download any necessary audio software.

4SC AG: Poster presentations at ESMO Congress 2019

On September 23, 2019 4SC AG (4SC, FSE Prime Standard: VSC) reported that two posters on clinical studies combining domatinostat and anti-PD-(L)1 checkpoint inhibitor will be presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress being held on 27 September to 1 October 2019 in Barcelona, Spain (Press release, 4SC, SEP 23, 2019, View Source [SID1234539707]). The posters will be available on 4SC’s website after the presentation.

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Poster presentations at the ESMO (Free ESMO Whitepaper) Congress 2019

Poster EMERGE: Epigenetic Modulation of the Immune Response in Gastrointestinal cancers (Trial in progress)
Session Poster Display session 2 (ID 211)
Time Sunday, 29 September 2019, 12:00 – 13:00 CEST
Location Poster Area (Hall 4)
Poster Phase Ib/II Study (SENSITIZE) assessing safety, pharmacokinetics (PK), pharmacodynamics (PD), and clinical outcome of domatinostat in combination with pembrolizumab in patients with advanced melanoma refractory/non-responding to prior checkpoint inhibitor therapy
Session Poster Display session 3 (ID 212)
Time Monday, 30 September 2019, 12:00 – 13:00 CEST
Location Poster Area (Hall 4)
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11 July 2019, 4SC AG: Positive safety review of Phase Ib/II SENSITIZE study of domatinostat + pembrolizumab in melanoma

8 April 2019, 4SC AG: Domatinostat’s mode of action in Merkel cell carcinoma

6 February 2019, First patient enrolled in Phase II study EMERGE of domatinostat (4SC-202) in gastrointestinal cancer