On February 11, 2020 Marker Therapeutics, Inc. (NASDAQ:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on Marker’s planned trial investigating safety and efficacy of its novel MultiTAA T cell therapy in patients with post-transplant acute myeloid leukemia (AML) (Press release, Marker Therapeutics, FEB 11, 2020, View Source [SID1234554150]).

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Marker previously announced on November 12, 2019, that the FDA placed the trial on clinical hold. The FDA requested additional information and technical specifications for two legacy reagents supplied by third parties used in the MultiTAA-specific T cell manufacturing process. The technical specifications and data requested by the FDA could not be produced by the original suppliers. The Company identified alternative suppliers, satisfying the Agency’s request.

Based on data Marker provided, the FDA permitted the Company to initiate its AML trial, beginning with a safety lead-in portion. The FDA placed a partial clinical hold on the trial for the use of the MultiTAA-specific T cell product manufactured using one of the reagents supplied by the alternative supplier, until the final data and certificate of analysis for the reagent are reviewed and accepted by the Agency. The safety lead-in portion of the trial is expected to enroll approximately six patients as part of the amended trial design. Three patients will be dosed with MultiTAA-specific T cells manufactured using the legacy reagent, and three patients will be dosed with T cells manufactured using the reagent from the alternative supplier.

Marker currently estimates that the alternative supplier will deliver the final reagent, along with the final data and certificate of analysis required by the FDA, by the end of the second quarter of 2020. Marker anticipates to complete enrollment of the first three patients and submission of the final technical specifications and comparability data of the new reagents to the FDA during the second half of 2020, thereby satisfying the requirements for lifting the partial hold on the clinical trial. Given this expected timing, Marker does not currently expect the partial clinical hold to significantly impact site and patient enrollment of the AML trial.

The safety lead-in will be followed by the 160-patient randomized portion of the study at approximately 20 transplant centers. Group 1 will comprise 120 adjuvant (disease-free) patients, with the primary endpoint of relapse-free survival of patients receiving MultiTAA-specific T cell therapy versus a control group. Group 2 will comprise 40 active disease patients in a single arm, with primary endpoints of complete remission and duration of complete remission.

"With a clear path identified for getting our study of MultiTAA-specific T cell therapy underway in patients with AML, we’re focused on addressing the remaining requirements from the FDA and enrolling up to 20 clinical centers to conduct our Phase 2 trial," stated Peter L. Hoang, President and CEO of Marker Therapeutics. "We appreciate the productive dialogue with the FDA throughout the process and look forward to advancing MultiTAA-specific T cell therapy for patients with post-transplant AML in a randomized and multicenter clinical trial."

On February 11, 2020 TLC (Nasdaq: TLC, TWO: 4152), a clinical-stage specialty pharmaceutical company developing novel nanomedicines to target areas of unmet medical need in pain management, ophthalmology and oncology, reported financial results for the fiscal year ended December 31, 2019, and provided a business update (Press release, Taiwan Liposome Company, FEB 11, 2020, View Source [SID1234554167]).

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"We saw a monumental year for TLC in 2019, marked not only by tremendous clinical and manufacturing advancements in both our programs in pain management – TLC599 and TLC590, but also by new business development agreements, addition of internationally experienced personnel to the management team, and presentation and publication of impressive data at numerous investor conferences as well as prestigious scientific conventions," said George Yeh, President of TLC. "With this continual momentum, we look forward to achieving more milestones in 2020, including the completion of patient enrollment in the EXCELLENCE trial and data readout from the TLC590 Phase II trial, both of which will bring us closer to the goal of mitigating the proliferation of highly addictive opioids with the availability of our non-opioid alternatives."

Clinical Pipeline Update and Upcoming Milestones

Commencement of patient enrollment in EXCELLENCE trial evaluating single and repeated administrations of TLC599 for knee osteoarthritis pain. The Phase III pivotal study, which enrolled its first patient in November 2019, will dose about 500 patients at a 2:1:1 ratio with TLC599, dexamethasone or placebo across 45 sites in the United States and Australia. At Week 24, patients can receive a second blinded injection of TLC599 or placebo. Primary endpoint is the magnitude of pain relief by WOMAC Pain score versus placebo at Week 16 and Week 40. Patient enrollment is expected to take about one year, and all patients will be followed for 52 weeks.

Commencement of patient dosing in Part 2 of Phase II trial evaluating the analgesic efficacy of TLC590 following bunionectomy. With the first batch of patients dosed in January 2020, a total of about 150 patients will receive TLC590, bupivacaine or normal saline placebo at a ratio of 1:1:1 at the end of their bunion removal surgery. Primary endpoint is area under the curve (AUC) from 0 to 72 hours on the numerical pain rating scale.
Corporate Highlights

Completed US$27.3 million financing. The Company completed a cash capital offering of ordinary (common) shares in Taiwan in October 2019. The offering consisted of 10,200,000 new common shares issued at a price of NT$82 per common share for gross proceeds of NT$836.4 million (~US$27.3 million).

Presented at Berenberg Pain Seminar and JP Morgan Healthcare Conference. At the Berenberg Pain Seminar in November 2019, TLC presented recent data on TLC599 and TLC590 and discussed how they can potentially deter the spread of the opioid crisis with prominent figures in the pain management space. TLC also presented and participated in one-on-one meetings at the 38th annual JP Morgan Healthcare Conference in January 2020, marking the Company’s sixth consecutive attendance at the world’s largest healthcare investment symposium.

Expanded global intellectual property protection to 197 patents, with 126 patents granted and 71 applications worldwide as of December 31, 2019.
Fiscal Year End Financial Results

Operating revenue for the fiscal year 2019 was NT$209.1 million (US$7.0 million), a 235.6% increase compared to NT$62.3 million (US$2.0 million) in the fiscal year 2018. Operating expenses for the fiscal year 2019 was NT$1,026.8 million (US$34.3 million), a 4.7% increase compared to NT$980.3 million (US$32.0 million) in the fiscal year 2018. Net loss for the fiscal year 2019 was NT$807.5 million (US$27.0 million), compared to net loss of NT$901.6 million (US$29.5 million) in the fiscal year 2018, or a net loss of NT$12.32(US$0.41) per share for the fiscal year 2019, compared to a net loss of NT$14.37(US$0.47) per share for the fiscal year 2018.

The Company’s cash and cash equivalents and time deposits with maturity over three months (which are classified as "current financial assets at amortized cost" in the Company’s consolidated financial statements) were NT$1,023.9 million (US$34.2 million) as of December 31, 2019, compared to NT$1,114.6 million (US$36.4 million) as of December 31, 2018.

On February 11, 2020 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that it will report its 2019 fourth quarter and full year financial results on Tuesday, February 25, 2020, after the close of the financial markets (Press release, Jazz Pharmaceuticals, FEB 11, 2020, View Source [SID1234554184]). Company management will host a live audio webcast immediately following the announcement at 4:30 p.m. EST/9:30 p.m. GMT to discuss fourth quarter and full year 2019 financial results and provide a business and financial update and guidance for 2020 financial results.

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Interested parties may access the live audio webcast via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. Please connect to the website prior to the start of the conference call to ensure adequate time for any software downloads that may be necessary to listen to the webcast. A replay of the webcast will be archived on the website for at least one week.

On February 11, 2020 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 an underwritten public offering of 26,315,790 shares of common stock at a public offering price of $19.00 per share, before underwriting discounts and commissions (Press release, Moderna Therapeutics, FEB 11, 2020, View Source [SID1234554223]). In addition, Moderna has granted the underwriters a 30-day option to purchase up to an additional 3,947,368 shares of common stock at the public offering price, less underwriting discounts and commissions. All shares of common stock are being offered by Moderna. Gross proceeds from the offering will be approximately $500 million. The offering is expected to close on or about February 14, 2020, subject to the satisfaction of customary closing conditions.

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Goldman Sachs & Co. LLC and Morgan Stanley & Co. LLC are acting as joint book-running managers for the offering. Piper Sandler & Co. and Barclays Capital Inc. are acting as book-running managers, while Needham & Company, Oddo BHF SCA, Oppenheimer & Co. Inc., Chardan and Roth Capital Partners are acting as co-managers for the offering.

A registration statement on Form S-3 (File No. 333-236348) relating to these securities has been previously filed with the Securities and Exchange Commission (SEC) and has become effective. The offering will be made only by means of a prospectus. A preliminary prospectus supplement describing the terms of the offering has been filed with the SEC and forms a part of the effective registration statement. A copy of the final prospectus supplement relating to the offering will be filed with the SEC and may be obtained, when available, from Goldman Sachs & Co. LLC by mail at Attn: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526, by fax at (212) 902-9316, or by email at [email protected], or from Morgan Stanley & Co. LLC, by mail at Attn: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014.

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 registration or qualification under the securities laws of any such state or jurisdiction.

On February 11, 2020 IntelGenx Technologies Corp. (TSXV: IGX) (OTCQX: IGXT) (the "Company" or "IntelGenx") is reported that it has closed its offering (the "Offering") of 16,317,000 units (the "Units") at a price of C$0.50 per Unit (the "Offering Price") for gross proceeds of C$8,158,500 (Press release, IntelGenx, FEB 11, 2020, View Source [SID1234554151]).

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Each Unit consists of one share of common stock (the "Offered Shares") and one warrant (a "Warrant") entitling the holder to purchase one share of common stock of the Company at an exercise price of C$0.75 per share (a "Warrant Share"). The Warrants are exercisable immediately and will expire on the third anniversary of the date of their issuance.

The Units were distributed under a short form prospectus dated January 27, 2020 filed by the Company in connection with the Offering and available on SEDAR at www.sedar.com and have been registered with the United States Securities and Exchange Commission pursuant to a Form S-1 Registration Statement that was declared effective on January 31, 2020 (the "Registration Statement"). The Offering was conducted, on a best efforts basis, by Echelon Wealth Partners Inc. (the "Agent"). In consideration for the services rendered by the Agent, the Company has paid the Agent an agency fee equal to 7% of the gross proceeds of the Offering and has issued the Agent a number of warrants (the "Agent Warrants") equal to 7% of the number of Units issued under the Offering, each Agent Warrant entitling the holder to purchase one share of common stock of the Company at an exercise price of C$0.75 per share until the third anniversary of the date of their issuance. After the payment of the Agent’s commissions and the reimbursement of certain of the Agent’s Offering expenses and the payment of other Offering expenses, the Company expects the net proceeds from the Offering to be approximately C$7.4 million.

The Company has granted the Agent an over-allotment option exercisable, in whole or in part, at the sole discretion of the Agent, at any time prior to 5:00 p.m. (Montreal time) on the date that is the 30th day after the date hereof, to offer and sell up to an additional number of Units representing 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 TSX Venture Exchange (the "TSXV") has conditionally approved the listing of the Warrants and the common stock that will be issued by the Company in the Offering, including the shares of common stock issuable upon the exercise of the Warrants and the Agent Warrants. Listing on the TSXV will be subject to the Company fulfilling all of the listing requirements of the TSXV within 15 days of the closing of the Offering.

The Warrants will be listed on the TSXV under the symbol "IGX.WT" and will commence trading effective at the opening of the market on Thursday, February 13, 2020.

The Company intends to use the net proceeds from the Offering for its Phase 2A Montelukast Study and general working capital requirements.