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Ipsen to present new data at 13th Annual Conference of the International Liver Cancer Association (ILCA 2019)

On September 20, 2019 Ipsen (Euronext: IPN; ADR: IPSEY) reported results from the matching-adjusted indirect comparison (MAIC) of cabozantinib (Cabometyx) versus regorafenib (Stivarga) for the second-line treatment (2L) of patients with advanced hepatocellular carcinoma (aHCC) who received sorafenib as the only prior systemic therapy (Press release, Ipsen, SEP 20, 2019, View Source [SID1234539670]). Using data from the Phase III CELESTIAL and RESORCE trials, the MAIC showed that cabozantinib offers greater efficacy versus regorafenib.

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Using data from the Phase III CELESTIAL and RESORCE trials, the MAIC showed that in the 2L CELESTIAL sub-population who had received sorafenib as the only prior systemic therapy, cabozantinib significantly improved progression-free survival (PFS), with an additional 2.4 months provided vs. regorafenib (5.6 months vs. 3.2 months [95% confidence interval (CI): 4.90-7.26], p<0.05). Median overall survival (OS) was also favorable with cabozantinib (11.4 months vs. 10.8 months), though statistical significance was not met.1

Results from MAIC will be presented by Dr. Katie Kelley, oncologist at the University of California, San Francisco and lead investigator, at the 13th Annual Conference of the International Liver Cancer Association (ILCA 2019) taking place on 20-22 September 2019 in Chicago, USA (poster/abstract #P-021).

In the previously presented randomized, double-blind, Phase III CELESTIAL trial evaluating cabozantinib compared with placebo in previously treated patients with aHCC, in the overall CELESTIAL intent-to-treat population, cabozantinib significantly improved median PFS, with an additional 3.3 months provided vs placebo (5.2 months vs. 1.9 months [95% CI, 4.0 to 5.5], p<0.001) and median OS, with an additional 2.2 months vs placebo (10.2 months vs. 8.0 months [95% confidence interval (CI): 9.1 to 12.0), p=0.005).1

"Hepatocellular carcinoma is a devastating disease with only a few treatment options demonstrating survival benefits and many investigational drugs have failed to meet overall survival endpoints in clinical trials," said Dr. Kelley. "The MAIC analysis brings further insight into the comparative effectiveness of the key second-line treatments for advanced hepatocellular carcinoma, particularly in relation to important endpoints like progression-free survival. These results may support clinicians in making informed treatment decisions in order to deliver optimal care for their patients."

Grade 3/4 adverse events affecting more than 5% of patients were comparable for the two studies, except for diarrhea which was lower with regorafenib.1

MAICs are a way of providing a timely comparison of the effectiveness of different medical interventions in the absence of head-to-head randomized trials.2 While indirect comparisons of treatments across separate studies can be performed, these analyses may be biased by cross-trial differences in patient populations, sensitivity to modeling assumptions, and differences in the definitions of outcome measures. MAICs use individual patient data (IPD), also referred to as individual-level data, from trials of one treatment to match baseline summary statistics reported from trials of another treatment and reduce observed cross-trial differences.2 After matching, treatment outcomes are compared across balanced trial populations. It should be noted that, even after matching, bias may still occur in MAIC due to imbalance in unobserved factors, and it cannot completely replace a head-to-head randomized and controlled trial.1

"At Ipsen, our mission is to prolong and improve patients’ lives and health outcomes, and we acknowledge the importance of providing healthcare professionals with the best available evidence to achieve these goals for patients," said Dr. Yan Moore, Ipsen’s Senior Vice President, Head of Oncology Therapeutic Area. "The recent rapid development of new second-line treatments for patients with advanced HCC has led to the generation of information mainly based on placebo-controlled trials. While alternative methodological approaches such as MAIC are not substitutes to evidence-based prospective clinical trials, it is important to recognize the need for further insights into the comparative effectiveness of current treatment approaches."

1 Abou-Alfa, G.K., et al. Cabozantinib in patients with advanced and progressing hepatocellular carcinoma. NEJM. 2018;379:54-63. Available at: View Source Accessed August 2019.

2 Signorovitch, J.E., et al. Matching-adjusted indirect comparisons: a new tool for timely comparative effectiveness research. Value Health. 2012;15(6):940-7. Available at View Source Accessed August 2019

3 Bruix, J., et al. Regorafenib for patients with hepatocellular carcinoma who progressed on sorafenib treatment (RESORCE): a randomized, double-blind, placebo-controlled, phase 3 trial. Lancet. 2017;389(10064):56-66. Available at: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)32453-9/fulltext. Accessed August 2019

4 Aggarwal, M., et al. Systemic treatment for hepatocellular carcinoma. Chronic Dis Transl Med. 2018;4(3):148–155. Available at: View Source Accessed August 2019.

5 American Institute of Cancer Research. Liver cancer statistics. Available at: View Source Accessed August 2019.

6 European Association for the Study of the Liver. EASL Clinical Practice Guidelines: Management of hepatocellular carcinoma. J. Hepatol. 2018;69(1):182–236. Available at: View Source(18)30215-0/pdf. Accessed August 2019.

Innate Pharma files registration statement for proposed initial public offering in the United States

On September 20, 2019 INNATE PHARMA S.A. (Euronext Paris: IPH – ISIN: FR0010331421) ("Innate" or the "Company"), a French biotechnology company focused on discovering, developing and commercializing first-in-class therapeutic antibodies designed to harness the immune system for the treatment of oncology indications with significant unmet medical need, reported that it has filed a registration statement on Form F-1 with the U.S. Securities and Exchange Commission (the "SEC") relating to a proposed initial public offering of its American Depositary Shares ("ADSs"), representing ordinary shares, in the United States, and a concurrent private placement of its ordinary shares in Europe and other countries outside of the United States (together, the "Global Offering") (Press release, Innate Pharma, SEP 20, 2019, View Source [SID1234539669]). All securities to be sold in the Global Offering will be offered by the Company. The number of ordinary shares to be represented by each ADS, the number of ADSs and ordinary shares to be offered and the price range for the proposed Global Offering have not yet been determined. The Company has applied to list its ADSs on the Nasdaq Global Market under the ticker symbol "IPHA." The Company’s ordinary shares are listed on Euronext Paris under the symbol "IPH".

Citigroup, SVB Leerink and Evercore ISI are acting as joint bookrunners for the U.S. offering and Citigroup is acting as global coordinator for the European private placement.

The securities referred to in this press release will be offered only by means of a prospectus. When available, copies of the preliminary prospectus relating to and describing the terms of the Global Offering may be obtained from Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by telephone at (800) 808-7525, ext. 6132, or by email at [email protected], or from Evercore Group L.L.C., 55 East 52nd Street, 36th Floor, New York, NY 10055, or by telephone at (888) 474-0200, or by email at [email protected].

A registration statement on Form F-1 relating to the securities referred to herein has been filed with the SEC but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release does not constitute an offer to sell or the solicitation of an offer to buy securities in any jurisdiction, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction. The registration statement can be accessed by the public on the website of the SEC.

IGM Biosciences Announces Closing of Initial Public Offering, Including Full Exercise of Underwriters’ Option to Purchase Additional Shares

On September 20, 2019 IGM Biosciences, Inc. (Nasdaq: IGMS) reported the closing of its initial public offering of 12,578,125 shares of its common stock at a price to the public of $16.00 per share, which includes the exercise in full by the underwriters of their option to purchase up to 1,640,625 additional shares (Press release, IGM Biosciences, SEP 20, 2019, View Source [SID1234539668]). The shares began trading on The Nasdaq Global Select Market on September 18, 2019 under the symbol "IGMS." IGM received gross proceeds, before deducting underwriting discounts and commissions and estimated offering expenses, of approximately $201.3 million.

Jefferies, Piper Jaffray, Stifel and Guggenheim Securities acted as joint book-running managers for the offering.

A registration statement relating to the offering was declared effective by the United States Securities and Exchange Commission on September 17, 2019. The offering was made only by means of a prospectus. A copy of the final prospectus relating to this offering may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; Piper Jaffray & Co, Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924 or by email at [email protected]; Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720 or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison, 8th Floor, New York, NY 10017, by telephone at (212) 518-9658 or by email at [email protected].

This press release does not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful before registration or qualification under the securities laws of that state or jurisdiction.

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

On September 20, 2019 Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS), a specialty biopharmaceutical company engaged in commercializing novel pharmaceutical therapies, principally through out-licensing arrangements, reported that it has entered into a securities purchase agreement with institutional investors in the United States to purchase approximately $5.0 million of its common shares in a registered direct offering and warrants to purchase common shares in a concurrent private placement (Press release, AEterna Zentaris, SEP 20, 2019, View Source [SID1234539667]). The combined purchase price for one common share and one warrant will be $1.50.

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

The Company expects gross proceeds from the registered direct offering and concurrent private placement to be approximately $5.0 million before deducting placement agent’s fees and expenses. The registered direct offering and concurrent private placement is expected to close on or about September 24, 2019, subject to the satisfaction of customary closing conditions.

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

The common shares described above are being 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 will be 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.

TG Therapeutics to Present at the Ladenburg Thalmann Healthcare Conference

On September 20, 2019 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, will present at the Ladenburg Thalmann Healthcare Conference, being held at the Sofitel, in New York City (Press release, TG Therapeutics, SEP 20, 2019, View Source [SID1234539666]). The presentation is scheduled to take place on Tuesday, September 24, 2019 at 11:00 AM ET.

A live webcast of this presentation will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source