On March 10, 2017 TG Therapeutics, Inc. (NASDAQ: TGTX) reported its financial results for the fourth quarter and year ended December 31, 2016 and provided recent company developments along with a business outlook for 2017 (Press release, TG Therapeutics, MAR 10, 2017, View Source [SID1234518067]). Schedule your 30 min Free 1stOncology Demo!
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The Company announced that through the combination of an underwritten public offering, and proceeds raised through the utilization of an ATM program, the Company raised combined gross proceeds of approximately $89M before deducting underwriting discounts and commissions and other estimated offering expenses. The underwritten offering consisted of 5,128,206 shares of its common stock (plus a 30-day option to purchase up to an additional 769,230 shares of common stock, which has been exercised) at a price of $9.75 per share, with expected gross proceeds to TG Therapeutics of $57.5 million, less underwriting discounts and commissions. The offering is expected to close on or about March 14, 2017, subject to the satisfaction of customary closing conditions. Prior to the public offering, the Company also issued approximately 3,000,000 shares through the ATM program for gross proceeds of approximately $31 million at an average price of $10.27, these shares were issued on March 9, 2017.
Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, stated, "2016 was a very productive year for the Company, laying the foundation for pivotal data read-outs in 2017 and 2018. The first of which were reported earlier this week, with the announcement of the positive topline results from our Phase 3 GENUINE clinical trial. For the remainder of 2017, we look forward to the full data presentation from the GENUINE trial in the summer and then in the second half to a meeting with the FDA to discuss a filing for accelerated approval. All along we will continue to remain highly focused on enrolling into our proprietary UNITY programs, which are proceeding nicely and on schedule." Mr. Weiss continued, "This week we also had the opportunity to solidify our cash reserves with the recently conducted offerings, which should provide us with sufficient capital to advance our key programs and get us closer to our goal of bringing our novel treatment options to patients with B-cell malignancies."
2016 Highlights
● Completed enrollment in our Phase 3 GENUINE clinical trial, which resulted in positive topline data
● Launched the UNITY-CLL Phase 3 and UNITY-DLBCL Phase 2b trials for the combination of TG-1101 + TGR-1202
● Announced the positive outcome of our UNITY-CLL Phase 3 DSMB safety review meeting, pursuant to which the study was recommended to continue enrolling both front-line and previously treated patients with no changes recommended to the study
● Launched our first clinical trial in Multiple Sclerosis (MS) for TG-1101
● Announced the issuance of composition of matter patents for both TG-1101 and TGR-1202 providing protection through 2029 and 2033, respectively, both exclusive of available patent term extensions
● Announced two publications in prestigious journals, the first in BLOOD describing a novel mechanism of TGR-1202 with potential in cMYC driven malignancies, and the second in the British Journal of Haematology with data from our Phase 2 clinical trial of TG-1101 plus ibrutinib in patients with Chronic Lymphocytic Leukemia (CLL)
● Presented data at the ASH (Free ASH Whitepaper) annual meeting including 3 oral presentations and 3 poster presentations, with a focus on combination therapy
Key Objectives for 2017
● Present updated clinical data including the full Phase 3 GENUINE data at a major medical meeting in the first half of 2017
● Present clinical data from the Phase 2 Multiple Sclerosis (MS) trial
● Initiate a global Phase 3 trial in MS
● Complete the first interim analysis in the UNITY-CLL Phase 3 trial
● Complete the first interim analysis in the UNITY-DLBCL trial
● Meet with the FDA to review the GENUINE Phase 3 data and discuss suitability for filing for accelerated approval
● Present new and updated data from ongoing trials at various scientific meetings throughout the year, including the ASH (Free ASH Whitepaper) annual meeting in December
Financial Results for the Fourth Quarter and Full Year 2016
● Cash Position: Cash, cash equivalents, investment securities, and interest receivable were $45.0 million as of December 31, 2016. During the first quarter of 2017 the Company raised approximately $84 million of net proceeds from the underwritten public offering of the Company’s common stock and the utilization of the Company’s at-the-market ("ATM") sales.
● R&D Expenses: Research and development (R&D) expenses were $22.3 million and $69.2 million for the three and twelve months ended December 31, 2016, respectively, compared to $15.3 million and $47.7 million for the three and twelve months ended December 31, 2015, respectively. Included in research and development expenses for the three and twelve months ended December 31, 2016, are $9.1 million and $27.0 million, respectively, of manufacturing and CMC expenses for Phase 3 clinical trials and potential commercialization. The increase in R&D expenses for both the three and twelve months ended December 31, 2016, is primarily due to the ongoing clinical development programs and related manufacturing costs for TG-1101 and TGR-1202.
● G&A Expenses: General and administrative (G&A) expenses were $1.8 million and $9.9 million for the three and twelve months ended December 31, 2016, respectively, as compared to $2.4 million and $15.6 million for the three and twelve months ended December 31, 2015, respectively. The period-over-period decrease in G&A expenses from three and twelve months ended December 31, 2015 relates primarily to non-cash compensation expenses related to equity incentive expense recognized during 2015.
● Net Loss: Net loss was $23.7 million and $78.3 million for the three and twelve months ended December 31, 2016, respectively, compared to a net loss of $17.6 million and $62.9 million for the three and twelve months ended December 31, 2015, respectively.
● Financial Guidance: The Company believes its cash, cash equivalents, investment securities, and interest receivable on hand as of December 31, 2016 combined with the additional capital raised in the first quarter of 2017 will be sufficient to fund the Company’s planned operations for approximately the next 24 months.