On November 9, 2018 TG Therapeutics, Inc. (NASDAQ: TGTX) reported its financial results for the third quarter ended September 30, 2018 and recent company developments (Press release, Manhattan Pharmaceuticals, NOV 9, 2018, View Source [SID1234530992]).

Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, stated, "We are pleased by the progress made in the third quarter of 2018, most notably the completion of full enrollment in the current cohorts of the UNITY-NHL trial, as well as in the ULTIMATE Phase 3 program in MS. We now have five Phase 3 or registration directed trials fully enrolled across our three major indications of interest, CLL, NHL and MS, and look forward to significant value creating data releases in 2019 and 2020." Mr. Weiss, continued, "This is just the beginning for TG as we solidify the foundation and look towards the future of building proprietary triple combination therapies with our in-house early stage pipeline."

Recent Developments and Highlights

●ASH Presentations: Announced two triple therapy data abstracts were accepted for presentation at the upcoming 60th American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting.
●ULTIMATE Trials: Completed full enrollment into the ULTIMATE I & II Phase 3 trials, evaluating ublituximab in relapsing form of MS, which are being conducted under Special Protocol Assessment (SPA) agreement with the FDA.
●Ublituximab Data in Multiple Sclerosis: Presented final data from the Phase 2 trial of ublituximab in RMS at the 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Annual Meeting in Berlin, Germany.
●UNITY-NHL: Completed enrollment in the current arms of the UNITY-NHL trial, including the Follicular Lymphoma, Marginal Zone Lymphoma, and Diffuse Large B-Cell Lymphoma cohorts.

Financial Results for the Third Quarter 2018

●Cash Position: Cash, cash equivalents, investment securities, and interest receivable were $97.8 million as of September 30, 2018.

●R&D Expenses: Research and development (R&D) expenses were $33.4 million and $107.1 million for the three and nine months ended September 30, 2018, respectively, compared to $27.1 million and $76.5 million for the three and nine months ended September 30, 2017. The increase in R&D expense is primarily attributable to an increase in clinical trial expenses of $4.4 million and $20.1 million, respectively, during the three and nine months ended September 30, 2018, as compared to prior periods. In addition, included in R&D expenses for the three and nine months ended September 30, 2018 are $5.0 million and $16.4 million, respectively, of manufacturing and CMC expenses for Phase 3 clinical trials and potential commercialization. Also included in R&D expense for the nine months ended September 30, 2018 was $4.0 million of non-cash stock expense recorded in conjunction with the licenses to the BTK and CD47/CD19 programs.

●G&A Expenses: General and administrative (G&A) expenses were $1.0 million and $13.2 million for the three and nine months ended September 30, 2018, respectively, as compared to $4.5 million and $11.3 million for the three and nine months ended September 30, 2017. The decrease in G&A expenses for the three months ended September 30, 2018 relates to a decrease in non-cash compensation expense related to equity incentive expense recognized during the three months ended September 30, 2018 as a result of a decrease in the measurement date fair value of certain consultant restricted stock.

●Net Loss: Net loss was $34.0 million and $119.6 million for the three and nine months ended September 30, 2018, respectively, compared to a net loss of $31.5 million and $87.6 million for the three and nine months ended September 30, 2017, respectively. Excluding non-cash items, the net loss for the three and nine months ended September 30, 2018 was approximately $34.1 million and $104.2 million.

●Financial Guidance: Net cash utilized for operating activities during the nine months ended 2018 was approximately $95.2 million. The Company believes its cash, cash equivalents, investment securities, and interest receivable on hand as of September 30, 2018 will be sufficient to fund the Company’s planned operations through the end of 2019.

Conference Call Information

The Company will host an investor conference call today, November 9, 2018, at 8:30am ET, to discuss the Company’s third quarter 2018 financial results and provide a business outlook for the remainder of 2018.

In order to participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics Third Quarter 2018 Earnings Call. 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 www.tgtherapeutics.com. An audio recording of the conference call will also be available for replay at www.tgtherapeutics.com, for a period of 30 days after the call.

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