TG Therapeutics Surges 85% on Results From Study

AbbVie's Imbruvica achieves 80% response rate in combination with TG-1101

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TG Therapeutics Inc. (TGTX, Financial), a U.S. biotechnological company headquartered in New York, Monday announced the successful achievement of the primary endpoint of the Phase 3 clinical trial, GENUINE, assessing TG-1101 (ublituximab) plus AbbVie’s (ABBV, Financial) Imbruvica (ibrutinib) as treatment for patients chronically affected with lymphocytic leukemia (CLL). These high-risk patients are not new to a treatment for CLL.

The company says the study demonstrated "a statistically significant improvement in overall response rate (ORR) compared to ibrutinib alone in both the intent to treat (ITT) population (p=0.001) and treated population (p < 0.001).”

In the treated population of 117 patients, the study achieved an ORR of 80% for TG-1101 plus ibrutinib compared to 47% for ibrutinib alone.

The population of 117 CLL patients comprised 59 patients who were treated with the combined therapy based on TG-1101 and Abbvie’s Imbruvica (Ibrutinib) and 58 patients who were treated only with Imbruvica.

The company will present all the results of the study, phase 3 Genuine, at the forthcoming medical conference that will take place in the first half of 2017.

Following the medical conference, TG Therapeutics will discuss with the FDA “an application for accelerated approval,” the company says.

TG-1101 is an anti-CD20 monoclonal, glycoengineered antibody that targets and binds to the CD20 protein that is present on tumor B cells. The compound has been specifically designed to enhance the destruction of cancer cells, or inducing other immune cells to attack cancer cells or by directly inducing cell death.

At the moment, TG Therapeutics is surging. Its shares of the company that is engaged in the advancement of treatments for autoimmune diseases and cancers that affect B cells were trading at $10.05 per share, up $4.70 or 87.85% from the previous trading day.

The company closed the third quarter of 2016 with a loss of 50 cents and missed analysts’ expectations on third-quarter 2016 earnings by 19 cents, generating a negative surprise of 61.30%.

For the last quarter of 2016, analysts forecast a loss of 35 cents on average, ranging between a low estimate of 39 cents and a high estimate of 31 cents. Analysts’ estimate on fourth-quarter 2016 bottom line is 5.4% higher than the same figure of one year ago.

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Source: Yahoo Finance

For the fourth quarter of 2016, analysts forecast that revenue will come in at $30,000.

As of the third quarter, the company had approximately $60.6 million and the total debt amounted to $117,130.

TG Therapeutics has a market capitalization of $519.67 million and an enterprise value of $246.01 million.

The stock is trading at 9.04 times its book value, while the EV/EBITDA is negative, -3.39 times.

The company has 54.73 million shares outstanding, of which 57.5% is traded on the Nasdaq. The percentage of the company’s shares held by insiders is 49.75% and by institutions is 35.10%.

Among the top institutional holders, The Bridger Management LLC stands out with 4,921,059 shares, approximately 8.99% of the company’s total shares, valued at $22,882,924 as of Dec. 31, 2016.

AbbVie was trading at $63.77 per share, up 43 cents or 0.68% from the previous trading day.

Disclosure: I have no position in any stock mentioned in this article.

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