Earnings Labs

TG Therapeutics, Inc. (TGTX)

Q2 2014 Earnings Call· Tue, Jul 22, 2014

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Transcript

Operator

Operator

Greetings and welcome to the TG Therapeutics Second Quarter 2014 Earnings Call. At this time all participants are in a listen only mode. A brief question-and-answer session will follow the formal presentation. (Operator Instructions). It is now my pleasure to introduce your host, Jenna Bosco, Director of Investor Relations for TG Therapeutics. Thank you, Ms. Bosco. You may begin.

Jenna Bosco

Management

Thank you. Good morning and welcome to our conference call regarding TG Therapeutics' second quarter 2014 financial results and business update. I am Jenna Bosco, TG's Director of Investor Relations, and I welcome you to our conference call today. Following our Safe Harbor statement, Sean Power, TG's Chief Financial Officer, will provide a brief overview of our financial results, and then turn the call over to Michael Weiss, the Company's Executive Chairman and Interim Chief Executive Officer, who will provide an update on the ongoing development of our product candidates and review the first data presentation if our proprietary combination of TG-1101, our novel glycoengineered anti-CD20 monoclonal antibody and TGR-1202, our novel once-daily PI3K delta inhibitor, reported last night at the 2014 Pan-Pacific Lymphoma Conference in Hawaii. A copy of the posted presentation is available on our Web site. You can find it by following the publications tab contained under the heading Products Pipeline. Before we begin, I would like to remind everyone that various remarks that we make about our future expectations, plans and prospects constitute forward-looking statements for purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. TG cautions that these forward-looking statements are subject to risks and uncertainties that may cause our actual results to differ materially from those indicated. Factors that may affect TG Therapeutics' operations include various risk factors and uncertainties that can be found in our SEC filings. This conference call is being recorded for audio rebroadcast on TG's Web site, www.tgtherapuetics.com, where it will be available for the next 30 days. All participants on this call will be on listen-only mode. Now, I would like to turn the call over to Sean Power, our Chief Financial Officer, to briefly discuss the financial results for the second quarter of 2014 as well as the Company's overall financial condition.

Sean Power

Chief Financial Officer

Thank you Jenna and thanks everyone for joining us. As you may be aware, our financial results were released yesterday evening and can be viewed on the investors and media section of our Web site at www.tgtherapeutics.com. As of June 30, 2014 we had cash, cash equivalents, investment securities and interest receivable of $51.2 million as compared to $45.4 million at December 31, 2013. The consolidated net loss for the second quarter ended June 30, 2014 was $12 million or $0.36 per diluted share, compared to a consolidated net loss of $6.6 million during the second quarter of 2013, representing an increase in consolidated net loss of $5.4 million. The increase in consolidated net loss during the 2014 period was primarily the result of a $6.4 million increase in non-cash compensation expense related to equity incentive grants and $1.2 million of non-cash stock expense recorded in conjunction with the common stock issued to Ligand Pharmaceuticals for the license to the IRAK-4 inhibitors program. These increases were partially offset by a decrease in research and development expenses of $2.3 million during the quarter ended June 30, 2014, principally related to the timing of manufacturing expenses incurred for TG-1101. The consolidated net loss for the six months ended June 30, 2014 was $19.5 million, or $0.62 per diluted share, compared to a consolidated net loss of $10.3 million during the comparable period in 2013, representing an increase in consolidated net loss of $9.3 million. The increase in consolidated net loss during the six months ended June 30, 2014 was primarily the result of an $8.7 million increase in non-cash compensation expense related to equity incentive grants, and $1.2 million in non-cash stock expense recorded in conjunction with the common stock issued to for the license to the IRAK-4 inhibitors program. These increases were partially offset by a decrease in research and development expenses of $1 million during the six months ended June 30, 2014, principally related to the timing of manufacturing expenses incurred for TG-1101. While other research and development expenses in total decreased during both the three and six months, primarily as a result of manufacturing costs incurred during 2013, clinical R&D costs for both of our programs increased over the comparable periods in 2013. I will now turn the call over to Mike Weiss our Executive Chairman and Interim CEO.

Mike Weiss

Management

Thanks Sean and thanks all of you for joining us on this call today. First let me say that we are all very excited about the data presented yesterday at the Pan-Pacific Conference on our proprietary combination and in just a moment I will review the data in some detail. However, before I do, I’d like to say that the last few months have been extremely gratifying for me. The team has worked very hard in advancing our programs with great speed and diligence, resulting in encouraging single-agent data presentation at ASCO for both 1101 and 1202 and very promising data at EHA for the combination of 1101 and Ibrutinib, and now, as reported yesterday, on a proprietary combination. With these encouraging preliminary results, we look forward to a more mature and expanded data before year end we continue be extremely focused on commencing at least one Phase III trial for either TG-1101 or TGR-1202 or possibly both before year end. Now I’d like to review the data released yesterday afternoon at the Pan-Pacific Lymphoma Conference. From our Phase 1/2 study of our proprietary combination of 1101 plus 1202 in patients with relapsed/refractory chronic lymphocytic leukemia, also referred to as CLL and non-Hodgkin’s lymphoma, also referred to as NHL being led by doctors Susan O’Brien and Dr. Nathan Fowler from MD Anderson. The preliminary data from the Phase 1 portion of this study was presented by Dr. Matthew Lunning of the University Of Nebraska Medical Center. The poster presentation includes data from patients with advanced CLL including 17p and 11q [indiscernible] patients and a patient with Richter’s Transformation as well has heavily pre-treated relapsed and/or refractory patients with Diffuse Large B-cell Lymphoma, referred to as DLBCL and Follicular Lymphoma. As of the data cut-off date for the presentation, 21 patients…

Operator

Operator

Thank you. (Operator Instructions) Our first question is from the line of Joe Pantginis with ROTH Capital. Please proceed with your question.

Joe Pantginis - ROTH Capital Partners

Analyst · Joe Pantginis with ROTH Capital. Please proceed with your question

A couple of questions if you don’t mind. First let me ask something about a specific patient from last night’s data, kind of a bit intriguing. It’s the fourth patient that’s listed of the overall efficacy that had FCR Rituxan and then intriguingly [indiscernible] PTK. It didn’t appear that this patient had high risk cytogenetics. So I was just wondering if you had any specific commentary about this patient, about what led to relapse or what you saw with this person?

Mike Weiss

Management

I don’t -- we can check. I don’t know that we have much further information on the prior care, other than what’s listed here. We can probably get some more anecdotal information from the investigator. But clearly the patient was heavily pre-treated, seen a few lines of therapy. They definitely were on a PTK inhibitor. Presumably, they stayed on the inhibitor until they failed, but we will try to figure out more and get more information back to you.

Joe Pantginis - ROTH Capital Partners

Analyst · Joe Pantginis with ROTH Capital. Please proceed with your question

Okay. And then with regard to the responses that you are seeing, are these currently investigator confirmed responses and how often will you be testing for responses again?

Mike Weiss

Management

So I think we test every two months early on and then I think it moves to every three months and these are all investigator confirmed responses.

Joe Pantginis - ROTH Capital Partners

Analyst · Joe Pantginis with ROTH Capital. Please proceed with your question

And then maybe this one last one if you don’t mind. Just wanted to get a sense from the feedback you’ve been getting from investigators and as you talk to others in the field. A, the safety of the combination and B the safety of the monotherapies of these products, especially 1202 with the lack of say the liver enzymes that you have been seeing relative to the competition and also the importance of the ALC data that you've been seeing as well as the patient or as docs evaluate the landscape here?

Mike Weiss

Management

So the feedback we’ve gotten from investigators has been great. I think from -- starting with the activity side, I think they are quite impressed with the combination. They are seeing reactions in patients that they were not expecting to see reactions in. So that’s quite positive. And we’ve had very good feedback from the investigators on the single agent safety profile of both drugs and the combination profile looks quite inline, no unexpected toxicities, patients seem to be tolerating both drugs quite well. Again we’ve now -- you combine single agent and combination 1202, you’ve got almost 60 patients of data without seeing any effects on liver tox that we’ve seen with some of the other PI3K delta inhibitors. I do think that’s a real issue. I do think investigators care. I think that if you had your choice of one drug you have to think about that issue and not, you would go for the drug that you don’t have to think about it and that flows through the combination. So again, I don’t think many PI3K deltas are going to be used as single agents, but you’re going to choose your combination regimen based on the aggregated safety and tolerability profile and I think this one stacks up pretty darn well against the competition and in particular against the other delta combinations that will come through.

Operator

Operator

Our next question comes from the line of Matt Kaplan with Ladenburg Thalmann. Please proceed with your question.

Matt Kaplan - Ladenburg Thalmann

Analyst · Matt Kaplan with Ladenburg Thalmann. Please proceed with your question

So congrats on the initial data you are seeing in the combination studies, 1101 plus 1202. Can you talk about -- a little about the initial responses you're observing I guess in the two combination studies and with specific focus on the different tumor sub-types and what this means with respect to your thinking for potential pivotal studies in Phase III studies that you hope to embark on later this year? And I have a couple of other questions as well.

Mike Weiss

Management

No, only one question Matt. So in terms of the combinations and the different sub-types, we're certainly in an exploratory phase of development. We know we have active -- I’ll say regimens. Clearly Ibrutinib is more straight forward, right? They have two labeled approvals, CLL and mantle cell lymphoma. In both of those sub-types, we are seeing very nice results with the combination. They’ve got approval. They see very nice results with single agent. I think we're seeing again -- it’s early but I think we’re seeing something over and above what one might expect to see with Ibrutinib alone and so I think that both CLL and mantle cell are potential opportunities for us for registration trials and when we look over it, our combination trial, certainly CLL is a focus. Again we know both drugs work quite well in CLL and combination seems to be doing exactly what we would have expected it to do. So that’s all inline and perfectly sets us up for potentially a CLL registration pathway. I think as we look at the data in the other sub-types, follicular again I think it’s a little bit early to say too much about follicular but I think we know that CD20 has very nice activity in follicular, we know that the delta’s have very nice activity. So we’re pretty confident that we will find nice a registration pathway in follicular or more to the matter into lymphomas generally, which would include sub-types like marginal zone, which we know we’ve had an excellent activity whether our CD20 as well. So we think there is always going to be an opportunity for us in follicular. We think the drugs will perform quite well in that area. Again I think at this early snapshot, a little bit hard…

Matt Kaplan - Ladenburg Thalmann

Analyst · Matt Kaplan with Ladenburg Thalmann. Please proceed with your question

And then going back to the safety tolerability you are observing so far, I guess with both molecules but initially focusing on 1202. I guess -- now that you’re using a micronized dose and assuasive state, how does this compare with the mono therapy trial testing? And I guess what’s impressive is you’re still not seeing any liver-tox. So give us a sense in terms of what dose you’re actually at and where you are especially in the combination study and now in the mono therapy study as well, using the micronized dose and how would you compare that to the mono therapy?

Mike Weiss

Management

So we’re now using the 400 milligram once per day micronized dose with food in all of our studies. So in the single agent study, I think we’ve just about completed that dose cohort and we’re probably going to be dose escalating shortly to the 800 milligram dose. But that dose is being used in the single agent as well as now we've just moved that into the combination. So that dose is probably equivalent to approximately 1,200 milligrams, maybe up to 1,600 milligrams of pre-micronized fasted dosing. And so again we had anticipated that’s an active dose. Everything above 800, we’ve seen very nice activity above 800. We went 800 fasted, 1,200 fasted, 800 fed, 1,200 fed, no DLTs, no liver-tox. So the 400 dose we think is probably equivalent to about the 1,200 fasted or also approximately the 800 fed.

Matt Kaplan - Ladenburg Thalmann

Analyst · Matt Kaplan with Ladenburg Thalmann. Please proceed with your question

And when did -- in comparison to some of the other Pi3 kinase delta inhibitors, when did they see the liver-tox start to develop in there in the entire course of their treatment?

Mike Weiss

Management

The liver-tox is a relatively early event, and say it's seen -- if -- it's going to be seen usually in the first two months of treatment.

Matt Kaplan - Ladenburg Thalmann

Analyst · Matt Kaplan with Ladenburg Thalmann. Please proceed with your question

Okay, great. And then in terms of the initial responses and this in little bit of follow up to Joe’s question; initial responses and the criteria using the highlight criteria to define a PR; are you -- you’re doing scans to define the responses in these patients. Is that correct?

Mike Weiss

Management

Yes, all these patients were responders through scans.

Matt Kaplan - Ladenburg Thalmann

Analyst · Matt Kaplan with Ladenburg Thalmann. Please proceed with your question

Okay, great. And I guess the question a Sean and then I’ll jump back in the queue. When you take out the non-cash charges, what you expect I guess the cash burn to be in the second half of this year?

Sean Power

Chief Financial Officer

Matt, we expect the cash burn in the second half to be consistent with what we’ve guided, which has been approximately $4 million to $6 million. If you look at it for the second quarter, it went from roughly 54.5 to 51. So certainly on the low side of that from the cash perspective. So I would say our guidance remains consistent.

Operator

Operator

Our next question comes from the line of [indiscernible] of MLV. Please proceed with your question.

Unidentified Analyst

Analyst

I had a -- I was intrigued by the comments you made about, as you track the patients longer that you’re getting some of the stable diseases converting and looking at your combination data, it looks like there is multiple patients that are kind of right up that cusp and I'm wondering -- obviously this is the first response. But looking at I guess what kind of timeframe do you think some of these will take to convert? And as well, if it’s a dosing issue that you might -- versus a dosing issue I guess?

Mike Weiss

Management

Yes, so very good question. We definitely do not know the answer to that question, which is whether higher doses will make the responses occur faster. But typically with these drugs and we saw with the ibrutinib study too where there's always going to be one or two patients that just don’t get there at the first go around and if you look at ibrutinib alone, it could take six to 12 months to get the patients through to responses. And then clearing up the cytosis takes you longer but we don’t have that issue when we combine with CD20. But when -- so when we look at it, we’re not really sure what the time frame is. I can’t say that I expect by the second everyone should be responder and to be honest we can't expect that everyone is going to respond to both combinations. Even though we’re now at 100% with ibrutinib, I can’t imagine we’re going to maintain a 100% response rate. Obviously that would be amazing, but somewhat unrealistic because there is always going to be a challenging patient out there. And there is always going to be a handful when you go into a larger study. Having said that, I think that we are seeing a very accelerated pattern of responses already and again my expectation is that most of the patients that -- not all but most of the patients that do not respond at the first assessment will ultimately become responders. Again, not all but most and I can’t really -- today we don’t have enough information to predict exactly the time frame.

Unidentified Analyst

Analyst

Okay. And then maybe as a follow up, what kind of data can we expect at ASH this year? Are you going to update all of these trials or maybe hold off on some of them to get longer duration follow up?

Mike Weiss

Management

No, I think we feel comfortable that we’re going to present whatever we have available for all three of these studies, the two combinations and with the continued dosing in our single agent. So we’ll present updated data in both of those, not all three of those studies. In terms of longer term follow up, we’ll continue to follow patients in the single agent study. We continue to follow patients in our proprietary combination study. In the combination was ibrutinib, that study was designed as an early response rate trial, not for long term follow up. So we only actually follow those patients for six months. Part of the reason for that is that we could follow those patients for two years and the expectation is we’re not going to see a lot of progressions based on the ibrutinib data and so I'm not sure what we would learn by following those patients longer in that particular setting. And there is obviously a great cost associated with following those patients for that long, but really very little expectation of change and variables to compare it to. So again for us that study was designed. We wanted the goal of that study and I think we’re already feeling pretty good about it. One very simply -- one safety of the combination is when we’re talking about ibrutinib, I talked about three goals of the combination -- of our proprietary combination. I say the ibrutinib one really has two goals, because it wasn’t really signal finding. We knew that CLL [indiscernible] should be active. So that wasn’t, there was no challenge there. So we only had two objectives there. One was make sure we can safely dose the two drugs together. It looks like that’s what we're seeing. Again we will have a lot more patients for safety evaluable and available for ASH. And two, really our goal was to see if we can get very high response rates relatively early on in the process, within six months basically versus waiting up to two years for Ibrutinib responses and ideally again taking that response rate which is potentially 60% or 70% over two years, not only accelerating it to within the first six months but also driving it closer to 85%, 90%, 95%.

Operator

Operator

Thank you. Our final question today will be from the line of Jonathan Aschoff of Brean Capital. Please proceed with your question.

Jonathan Aschoff - Brean Capital

Analyst · Brean Capital. Please proceed with your question

Congrats on the data and I just had a one, which was for the Diffuse Large-Cell, the GCB subtype. What is the prevalence in incident [ph] to that?

Mike Weiss

Management

Yes, very good question. I don’t have it off the top of my head but it’s a -- it’s a very prevalent form of the disease. I can get you those statistics but it’s almost as common, if not more common than follicular.

Operator

Operator

Thank you. At this time I will turn the floor back over to Mr. Michael Weiss for closing comments.

Mike Weiss

Management

Great, thank you. So as I'm sure everyone can agree, so far 2014 has been a very exciting and productive year for us and we plan to continue to aggressively push forward our clinical development programs and ongoing clinical trials with the goal of commencing one or more registration trials prior to year end. Along the way, we plan to present updated data throughout the rest of the year. On behalf of all of us at TG Therapeutics, I’d like to thank all of our investigators, their patients and all of our shareholders and investors for their continued support. Thanks again for joining us and have a great day.

Operator

Operator

This concludes today’s teleconference. You may disconnect your lines at this time and we thank you for your participation.