On November 14, 2019 CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing and providing access to innovative therapies for patients with liver and other chronic diseases with high unmet medical need, reported that management will participate in two investor conferences including the Stifel 2019 Healthcare Conference taking place November 19-20, 2019 in New York City and the Evercore ISI 2nd Annual HEALTHCONx Conference in Boston, MA – December 3-5, 2019 (Press release, CymaBay Therapeutics, NOV 14, 2019, View Source [SID1234551279]).

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Stifel 2019 Healthcare Conference
Date: Tuesday, November 19
Time: 8:00am Eastern Time
Webcast: View Source

Evercore ISI 2nd Annual HEALTHCONx Conference
Date: Tuesday, December 3
Time: 11:45am Eastern Time
Webcast: View Source

On November 14, 2019 Replimune Group, Inc. (Nasdaq: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported the pricing of its public offering of 3,678,031 shares of its common stock at a public offering price of $13.61 per share (Press release, Replimune, NOV 14, 2019, View Source [SID1234551296]). In addition, and in lieu of common stock, Replimune reported the pricing of its public offering of pre-funded warrants to purchase 2,200,000 shares of its common stock at a purchase price of $13.6099 per pre-funded warrant, which equals the public offering price per share of the common stock less the $0.0001 per share exercise price of each pre-funded warrant. The aggregate gross proceeds from the offering are expected to be approximately $80 million, before deducting the underwriting discounts and commissions and estimated offering expenses payable by Replimune. All of the shares of common stock and pre-funded warrants are being offered by Replimune. In addition, Replimune has granted the underwriters a 30-day option to purchase up to an additional 881,704 shares of its common stock from Replimune at the public offering price, less the underwriting discounts. The offering is expected to close on November 18, 2019, subject to the satisfaction of customary closing conditions.

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J.P. Morgan Securities LLC, SVB Leerink LLC, and BMO Capital Markets Corp. are acting as book-running managers for the offering. Wedbush Securities Inc. is acting as co-lead manager and Roth Capital Partners, LLC is acting as co-manager for the offering.

A preliminary prospectus supplement and a free writing prospectus relating to and describing the terms of the offering were filed with the Securities and Exchange Commission (the "SEC") on November 12, 2019 and November 13, 2019, respectively. The final prospectus supplement relating to the offering will be filed with the SEC. Copies of the final prospectus supplement relating to the offering may be obtained, when available, by visiting EDGAR on the SEC website at www.sec.gov or from: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204, or by e-mail at [email protected]; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132, or by e-mail at [email protected]; or BMO Capital Markets Corp., Attention: Equity Syndicate Department, 3 Times Square, 25th Floor, New York, NY 10036, by telephone at (800) 414-3627 or by e-mail at [email protected].

The shares of common stock and the pre-funded warrants described above are being offered by Replimune pursuant to its shelf registration statement on Form S-3, including a base prospectus, that was previously filed by Replimune with the SEC on August 8, 2019 and declared effective by the SEC on August 15, 2019. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On November 14, 2019 Transgene (Paris:TNG) (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapeutics against cancer, reported its business update for the quarter ending September 30, 2019 (Press release, Transgene, NOV 14, 2019, View Source [SID1234551312]).

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Key events of the third quarter 2019

TG4001: Promising Phase 1b data in patients with HPV-positive cancers presented at ESMO (Free ESMO Whitepaper) at the end of September. Combination regimen of Transgene’s therapeutic vaccine TG4001 and avelumab showed durable partial responses in 3 of the 6 difficult-to-treat patients treated with the higher dose of TG4001 (more than 30% reduction in tumor size). These data suggest that this TG4001 based combination could provide a much-improved treatment option for patients who receive second-line treatment for HPV-positive cancers. The median overall survival with currently available treatments remains below 11 months and median progression-free survival is between 2 and 4 months; overall response rates are around 10-15%.
The data presented at ESMO (Free ESMO Whitepaper) also confirmed that TG4001 stimulated the immune system and favorably modified the tumor micro-environment, an element that is key in the success of immunotherapies. The Phase 2 part of the trial is ongoing; interim Phase-2 data are expected during the first half of 2020.
TG4050: Transgene received approvals to start the first clinical trials with myvac from the UK and French health authorities (MHRA and ANSM). The FDA clearance to proceed with a trial of TG4050 was obtained in May 2019. Both Phase 1 clinical trials of TG4050, in the US and Europe, are expected to start before the end of the year.
TG6002: Transgene received approval from the MHRA (UK) to start a Phase 1/2 clinical trial with TG6002 administered via an intrahepatic artery (IHA) infusion in colorectal cancer patients with unresectable liver metastases. The IHA route of administration is expected to deliver TG6002 to the tumor at a higher hepatic concentration to increase efficiency while limiting systemic exposure to patients. This is in addition to the ongoing Phase 1/2 study that is evaluating TG6002 when given via the intravenous (IV) route in patients with CRC. The trial is expected to begin before the end of 2019.
Pexa-Vec: On August 2, 2019, Transgene announced that the Independent Data Monitoring Committee (IDMC) of the PHOCUS Phase 3 trial in HCC recommended that SillaJen stop the study based on the IDMC’s assessment that the trial was unlikely to meet its primary objective at the time of the final analysis. On September 18, 2019, Transgene announced its decision to stop its Phase 1/2 trial evaluating Pexa-Vec in combination with nivolumab in this indication (first-line treatment of advanced liver cancer).
Transgene confirms that the first efficacy readouts from the trial evaluating TG4010 in combination with nivolumab and chemotherapy in the first-line treatment of lung cancer will be communicated during the course of December 2019.

Operating revenue

Revenue from collaborative and licensing agreements, amounted to €3.4 million in the first nine months of 2019, compared with €1.0 million in the same period in 2018. These revenues are mainly derived from the collaboration agreement with AstraZeneca on the Invir.IO program. An initial payment of €8.9 million ($10 million) was received in June 2019 and is recognized as income based on the progress of the activities associated with the collaboration until 2020. As of September 30, 2019, the income recognized was €2.5 million.

As of September 30, 2019, government financing for research expenditures mainly in the form of a research tax credit amounted to €4.5 million versus €4.3 million over the same period in 2018.

In the third quarter of 2018, Transgene saw a significant increase in operating revenues due to the sale of the Chinese rights of TG1050 to Tasly Biopharmaceuticals for €35.6 million ($41 million) in July 2018.

Cash, cash equivalents and other financial assets

Cash, cash equivalents, and other current financial assets stood at €53.9 million as of September 30, 2019, compared to €16.9 million as of December 31, 2018. This increase is due to the completion of a €48.7 million rights issue, that was settled on July 4, 2019. In the first nine months of 2019, Transgene’s cash burn was €10.1 million, excluding the net proceed from the rights issue, compared to €14.8 million for the same period in 2018.

Outlook

Transgene confirms that it expects to have a net cash burn target of approximately €20 million for 2019. Following the rights issue which completed in July 2019, Transgene has extended its financial visibility until 2022.

On November 14, 2019 Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, reported the pricing of a public offering of (i) 10,450,000 Class A Units, each consisting of shares of its common stock and common warrants to purchase its common stock, and (ii) 1,550,000 Class B Units, each consisting of pre-funded warrants and warrants to purchase its common stock, at a price of $0.50 per Class A Unit and $0.4999 per Class B Unit (Press release, Lipocine, NOV 14, 2019, View Source [SID1234551332]). Gross proceeds to the Company are expected to be approximately $6.0 million, before deducting placement agent fees and other estimated offering expenses. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes.

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Roth Capital Partners is acting as sole agent for the public offering.

The offering is being made pursuant to a shelf registration statement on Form S-3 (File No. 333-220942) (including a prospectus) previously filed with and declared effective by the U.S. Securities and Exchange Commission (the "SEC"). A prospectus supplement describing the terms of the offering will be filed with the SEC.

A copy of the final prospectus supplement and the accompanying prospectus relating to these securities may be obtained, when available, by contacting Roth Capital Partners, 888 San Clemente Drive, Suite 400, Newport Beach, CA 92660, (800) 678-9147. Electronic copies of the preliminary prospectus supplement and the accompanying prospectus will also be available free of charge on the website of the SEC at www.sec.gov.

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

On November 13, 2019 Cerus Corporation (Nasdaq:CERS) reported that Kevin D. Green, Cerus’ chief financial officer, will present at the Stifel 2019 Healthcare Conference on Tuesday, November 19, 2019 at 2:25 p.m. ET in New York City (Press release, Cerus, NOV 13, 2019, View Source [SID1234551126]).

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A live webcast of the presentation will be available on the Investor Relations page of the Cerus web site at View Source A replay of the webcast will be available for approximately two weeks following the completion of the event.