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$TGTX TG Therapeutics Targets Combination Blood Cancer Treatments

publication date: Dec 16, 2013
 | 
author/source: Mike Havrilla

Written by Mike Havrilla--TG Therapeutics (TGTX) is a cancer biotech formed as a spin-out from a privately held, French company (LFB Biotechnologies) in JAN12 that is developing a pair of experimental blood cancer drugs outlined below.

 

CLINICAL TRIAL CATALYSTS:

 

1.) Ublituximab (TG-1101) (CD20 targeted anti-cancer monoclonal antibody)--Phase 1 / 2 Clinical Trials

 

- ClinicalTrials.gov ID NCT01647971 for P1/2 single-agent trial for a variety of lymphomas and NCT01744912 for P1/2 trial in combo w/ REVLIMID for relapsed or refractory B-cell cancers w/ final results expected during 1H14 from both trials

 

- In NOV13 began P1 trial in combo w/ TGR-1202 for CLL & NHL, in DEC13 began P2 trial in combo w/ IMBRUVICA (recently approved blood cancer drug from $PCYC/$JNJ) w/ initial combo data expected at ASCO 2014 (May 30-June 3) to support potential start of pivotal combo trial(s) mid-2014

 

2.) TGR-1202 (oral PI3K delta inhibitor anti-cancer agent)--Phase 1 Clinical Trial

 

- ClinicalTrials.gov ID NCT01767766 for ongoing P1 dose-escalation study in patients with relapsed or refractory blood-based cancers w/ final results expected during 2Q14

 

- In NOV13 began combo trial w/ Ublituximab w/ initial results expected at ASCO 2014 (May 30-June 3), in NOV13 began first expansion cohort in P1 dose-escalation trial to enroll additional patients at 800mg once-daily dose level w/ maximum tolerated dose not reached yet

 

FINANCIAL STATS:

 

- As of 9/30/13, reported cash and equivalents of $50.2 million (M) with total debt of $3M (notes payable)

 

- As of 11/1/13, reported 33.5M shares of common stock outstanding

 

- Used ($5.9M) in cash to fund operations during the first nine months of 2013

 

- In late July, $TGTX closed a public offering for the sale of approx. 6.6M shares of common stock @$6.15 for net cash proceeds of $38M

 

- In late May, $TGTX began trading on the NASDAQ stock market from previous trading on the OTC Market

 

 

- CEO Michael Weiss is a large shareholder who owns 7.8M shares of common stock (23% ownership stake) and recently (12/11) purchased 10,000 shares on the open market @$3.43

 

 

TRADE SUMMARY & OUTLOOK:

 

As seen on the chart below, shares of $TGTX have been highly volatile with a downside bias recently—breaking key support at $4 and forming what may be a double bottom and bounce off new support at $3. The stock has quickly moved from the mid-$3s to the mid-$4s back to the mid-$3s several times over the past few months--resulting in highly volatile trading with no easily discernable pattern aside from buying the stock when it is down big for a bounce while having the discipline to cut losses around 10% since the stock tends to move in large percentages to the upside or downside so it doesn't really pay to fight the trend and average down if the stock continues to decline. Also, the recent 10,000 share purchase by the CEO on the open market @$3.43 may provide a new support level in the mid-$3s for the stock to form a solid base ahead of key catalysts expected in the spring at ASCO.

 

With a strong balance sheet, low cash burn rate and key combination blood cancer trial updates expected at ASCO in spring 2014; shares of $TGTX are poised for a bounce/run ($4-5 target) with the goal of starting pivotal combination blood cancer trial(s) as soon as mid-2014, which could provide additional upside back toward the $5-6 range depending on the strength of the data presented at ASCO, which is hard to gauge given the combination trials have only recently started so it is unknown how the trials will progress and there is not a lot of clinical trial data for either of the Company’s pipeline compounds to date aside from early-stage PK/safety data and initial evidence of anti-cancer activity.

 

Disclosure: No positions

 

FYI, I will be in Las Vegas from December 28 through January 1 and would like to organize an informal subscriber meet-up. I have received a few emails so far from interested subscribers so please email me (mike@biorunup.com) if you are interested. If there is any interest, I am planning the meet-up for Sunday 12/29 @5pm at the Hard Rock Café (http://bit.ly/18ohg9) (3771 S. Las Vegas Blvd.) located on the Vegas Strip where we can meet for a few (or more) drinks and share our biotech stock trading experiences so if you don’t have any plans for New Year’s or have never been to Vegas this is a great time of the year to go there.