TG Therapeutics, Inc. (TGTX) Q1 2015 Earnings Report, Transcript and Summary

Greetings and welcome to TG Therapeutics’ First Quarter 2015 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Jenna Bosco, Director of Investor Relations. Thank you. You may begin.

Thank you. Good morning and welcome to our conference call regarding TG Therapeutics’ first quarter 2015 financial results and business update. I’m 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 novel glycoengineered anti-CD20 monoclonal antibody, TG-1101, and our novel once-daily PI3K delta inhibitor, TGR-1202, as well as a review of our preclinical program. 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 website, www.tgtherapeutics.com, where it will be available for the next 30 days. All participants on this call will be on a 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 first quarter of 2015 as well as the company’s overall financial condition.

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 website at www.tgtherapeutics.com. I’d like to begin by providing an update on our cash position. As of March 31, 2015, we had cash, cash equivalents, investment securities and interest receivable of $105.2 million as compared to $78.9 million at December 31, 2014. During the quarter, we were able to take advantage of favorable market conditions to raise approximately $34.2 million of net proceeds from utilization of after-market or ATM sales facility, at an average price of $15.87 per share. Subsequent to the first quarter, we raised an additional $8.0 million of net proceeds from ATM facility at an average price of $16.38 per share. As a result, our pro forma cash balance as of March 31 is approximately $113 million. Turning to the financial results for the quarter, our net loss for the quarter ended March 31, 2015, excluding non-cash items, was approximately $9.2 million which included $4.3 million of manufacturing CMC expenses in preparation for Phase 3 clinical trials and commercialization. The net loss for the first quarter ended March 31, 2015, inclusive of non-cash items, was $14.6 million or $0.39 per diluted share compared to a net loss of $7.5 million during the first quarter of 2014, representing an increase in net loss of $7.1 million. This increase in net loss during the first quarter of 2015 was primarily the result of other research and development expenses for TG-1101 and TGR-1202 increasing approximately $4.1 million and $1.1 million respectively over the first quarter of 2014. The increase in other research and development expenses related to TG-1101 was primarily the result of increased manufacturing and clinical trial expenses in preparation for the launch of Phase 3 registration programs. Also contributing to the increase in net loss during the 2015 period was $1.1 million increase in non-cash compensation expense related to equity incentive grants. I will now turn the call over to Mike Weiss, our Executive Chairman and Interim CEO.

Thank you, Sean, and thanks to all of you for joining us on this call today. Let me mention at the outset that I will be making my prepared remarks very limited today as we just have our year-end conference call, and less than 30 days from today, we’ll be presenting updated data at ASCO. Hopefully, we’ll see many of you at Chicago. And again, as many of you who follow the company closely will agree 2015 is off to a great start and we’re excited about the progress we’ve made thus far, both with our clinical programs as well as enhancing our product portfolio. As a company, we remain committed to developing the best-in-class combination therapies that provide the best possible outcome for patients. To achieve this goal, as mentioned on our last call, one of our top priorities for 2015 is driving enrollment into our GENUINE Phase 3 clinical trial of TG-1101 in combination with ibrutinib in patients with high-risk chronic lymphocytic leukemia or CLL. I’m happy to report that since we launched this study just a few short months ago, we have successfully opened over 80 sites and that number continues to grow with the expectation at over 100 sites across the U.S. will participate in this Phase 3 study. Let me take a moment to remind everyone about the design of the GENUINE Phase 3 study. These are randomized trial where patients will receive either TG-1101 in combination with ibrutinib or ibrutinib alone, while the primary endpoint of the study is progression free survival, the first approximately 200 patients of an expected total enrollment of approximately 330 patients will be assessed for overall response rate or ORR. If the ORR assessment is positive, as per the FDA, the company plans to use the ORR data at the basis for submission for accelerated approval for TG-1101. All patients will then be followed to PFS assessment which is designed to support full approval. Dr. Jeff Sharman, Medical Director of Hematology Research for the U.S. Oncology Network who was the lead investigator on the company’s Phase 2 combination trial of TG-1101 for ibrutinib is the steady chair for the Phase 3 trial. Recall that in ASH, Dr. Sharman presented data on this study showing a 95% overall response rate for the combination in patients with relapsed-refractory, high-risk CLL. We believe this compares very favorably to the single agent overall response rate of 58% for ibrutinib found in [ph] FDA label. Beyond the GENUINE Phase 3 trial, we’re committed to bring our proprietary combination of TG-1101 and TGR-1202 again refers to TG-1303 into Phase 3 trials in both CLL and NHL as soon as possible. To support these Phase 3 trials, we have been actively enrolling into our Phase 1, 2 clinical trials and we’re excited to report that at the upcoming 2015 American Society of Clinical Oncology or ASCO Annual Meeting that’ll be held in Chicago later this month, we’ll have three presentations including two post of presentation, one for TGR-1202 as a single agent, and one for the TG-1303 combination study, and one oral presentation for the triple therapy of TG-1303 of ibrutinib. Beyond the GENUINE Phase 3 trial and our proprietary combination of TG-1303, we continue to push to our future model proprietary combinations. During the quarter, we had the chance to present our first preclinical data from IRAK4 inhibitor program at the American Association for Cancer Research Annual Meeting held in Philadelphia. For those of you who missed the presentation, the poster can be found on our website. /////Mass movie///// And earlier in the year, we announced a global collaboration to develop and commercialize anti-PD-L1 and anti-GITR antibody research programs in the field of hematologic malignancies. These antibodies were developed in the labs of Dr. Wayne Marasco of the Dana-Farber Cancer Institute. We believe acquiring the rights for these compounds is another important step forward to find the optimal combination therapy. In addition to the above achievements, as Sean mentioned earlier, we were able to strengthen our balance sheet through the strategic use of our ATM facility and pro forma as of March 31, 2015, we had approximately $113 million in cash, cash equivalents, investment securities and interest receivable. During and subsequent to the end of the first quarter, we were able to raise approximately $43.6 million at an average price of just under $16 per share. We have ambitious clinical development plans for our combination programs and believe our current cash position throughout this flexibility to aggressively execute our plan and operate our business through significant value creation milestones including the readout of our GENUINE Phase 3 clinical trial, excepted in the second half of 2015. For the remainder of this year, we are projecting a quarterly burn rate of approximately $6 million to $8 million plus CMC CapEx quite expensive as we prepare for commercial launch. With that, let me review our goals and objectives for 2015. Again, we plan to continue to aggressively refer into the GENUINE Phase 3 clinical trial of TG-1101 in combination with ibrutinib. Additionally we look forward to launching combination Phase 3 clinical trials in particular for our proprietary TG-1303 combination of TG-1101 plus TGR-1202, in patients with both CLL and NHL. We plan to launch new triple therapy combination trials in addition to the currently enrolling Phase 1, 2 trials of TG-1303 plus ibrutinib. Our preliminary data will be presented on that combination in an oral presentation at ASCO this year. We’re targeting entering the clinic by year-end for our IRAK4 inhibitor program. We’re also actively building a team to commence clinical development of our drug candidates for the treatment of autoimmune diseases. And finally, we look forward to presenting data on each of our Phase 1 and Phase 2 clinical trials at major hematology and oncology conferences during 2015. Again, reiterate with the next presentations of data at ASCO, Chicago starting later this month. Let me now turn the call back over to the conference operator to begin the Q&A session, following which I will return to make some concluding remarks.

Thank you. [Operator Instructions] Our first question is coming from the line of Jonathan Aschoff with Brean Capital. Please proceed with your question.

Thanks. Good morning, guys. Good morning, guys.

Good morning, but if we don’t say good morning guys, you don’t think we’re here?

I mean we have a sense of patient numbers for these three ASCO presentations, particularly sort of you understand the number of 1202 patients whether they’re single agents during combo, and at that point at which play this might likely have developed? And also the triple regimen given the five at ASH should be willing to know how many more we’ll see on triple?

Sure. So, in terms of TGR-1202 as a single agent, we’ll have somewhere between 60 and 70 patients of data for safety. And we should have approximately anywhere between 45 and 50 patients for efficacy at 800 milligrams of [ph] formulation and higher. And then, I think from a process where basically we have about 40 to 60 patients that have been on 1202 for greater than six months.

Okay, great. And this Phase 3 coming up, have you narrowed down what their control group is going to be, and it sounds kind of most rational to me to have a superiority trial against a one active [ph] approved agent that that not had all aware where it’s going to go?

Jonathan, I like your effort on this front. Unfortunately, we haven’t given out any details of what that study is going to look like. But as soon as we do, we’re going to be one of the first people to know along with everyone else in the public.

Okay, the last one I guess is more for Sean. You haven’t filed your Q, so I was curious, so what is the common share number outstanding at present?

Yeah, Jonathan. So as of today, we have about $48 million primary and $52 million fully diluted.

Okay. That’s very hopeful. Thanks a lot guys.

Thanks, Jonathan.

Thank you. Our next question is coming from the line of Matt Kaplan with Ladenburg Thalmann. Please proceed with your question.

Hey, good morning guys.

Hey, Matt. Good morning.

Congrats on the progress during the quarter.

Thank you.

Looks good. Just a follow-up on Jonathan’s question in terms of, maybe you can give us a little bit more detail in terms of your expecting in terms of the combinations Phase 3 that you plan to launch and kind of why you’re going after, I guess, CLL and NHL and what are your thoughts on DLBCL at this point as well?

Yeah. So I’ll start at the end, and then I’ll work my way through. Again when we say NHL, we obviously refer broadly to Diffuse Large B-cell on Follicular as a group. I’d say, we are very keen on getting studies largely in Diffuse Large B-cell as soon as possible. I think just based on historically where we’ve been and the data we’ve seen to-date is probably will sequence out with CLL first, after that more likely and not all be. Diffused by Large B-cell and Follicular will be third in line in March month because it’s a business more going on the Follicular, obviously [indiscernible] CLL but we see we have a differentiated approach. Follicular I think we can also add to us out there but in the Diffuse Large B-cell, there’s really not much going on in terms of the other delta inhibitors, and again I think it’s a greater field with more unmet medical needs. So I think the overall thinking is, we’re committed to CLL and we think that 1101, 1202 as we kind of refer to the real has a important role in the treatment of CLL, I think it’ll be one of the more important double lifts that are approved in the next, I’d call, two year to four year time horizon. And then that gives us the ability to laying on top of that, not all triple and quad therapies, which we think are really the end game. The doubles are an interim phase [indiscernible] of what we’re looking to achieve and the long-term goal is to get to triples and five. So, again, CLL will likely be first up, and what do I plan [indiscernible] will be second in line [indiscernible] third.

Okay, very good. And then in terms of the presentation that you have coming at ASCO, can you give us a little bit more detail on the triple combination that you have, and there I guess of the oral presentation, the guest number, and stuff like that?

Yes. So for the triple we’re anticipating somewhere between 10 and 15 patients available for both safety and efficacy.

Okay. And then in terms of data that you have coming at other presentations, I guess pretty close to following ASCO at [indiscernible] and I guess with lymphoma conference and [indiscernible], are you going to have any different data to other conferences or what can we expect there?

Yeah. And again given the closest of the trial, will be modest updates between the two conferences or three conferences including [indiscernible]. And I think I guess is down to mid June which is the last conference, which is I think it’s into the June 20 or so. So, it’s about 20 days later and then we’ll get few patients difference of that.

Got it. And then any comments you can make, I guess, in terms of the safety profiles that you’re seeing with [indiscernible] in terms of haven’t had a process and other GI talk as well.

Yeah I don’t – well to be fair, I don’t actually have any update personally, so I guess I can’t say too much more than what we said as we presented at ASH but I’m personally looking forward to the presentations which will be probably 26 days from now …

Right.

…which will be updated and highly confident that will continue to maintain in the datas in terms of safety profile.

Yeah. So, right now, we think, all of our compounds have potential utility in the queue. You starting to talk a little bit about the autoimmune disease application. And can you give us the more color in terms of where and which compounds you’re going to move forward into the autoimmune?

Yeah, so right now we think all of our compounds have potential utility in autoimmune disease. We know that CD20 is, has been quite successful and has a pretty nice utilization in RA. Another areas there is some interesting work going on, you look CD20 in MS right now and in theory you have [indiscernible] activity across all autoimmune as well. So, yeah I mean I think our goal is to bring the same kind of combination approach that we’ve [indiscernible] now in hematology malignancies. Few years ago when we were talking about, there is novel combination approaches, novel, novel is quite far [indiscernible] actually quite a mainstream concept. Autoimmune disease has not had the similar combination strategy approach as it is today and we think we could champion the same concept across autoimmune diseases, so that is our overall strategy and in all of our compounds we think are potentially comfortable, including not just the two [indiscernible] in that but IRAK4 could have some flexibility to that as well.

Great. Thanks for taking my question.

Okay, you’re welcome. Thanks, Matt.

Thank you. Our next question is coming from the line of Arlinda Lee with MLV & Company. Please proceed with your question.

Hi guys, thanks for taking my questions. I also had a question about autoimmune disease. I’m kind of curious about what your, I guess what your thoughts are in terms of prioritization for autoimmune disease and what’s your thoughts on potentially out licensing some of the things as well, so it seems like there is a lot of stuff going on? And then secondly, on the GENUINE trial, you mentioned that you can file on a response rate initially on the first [ph] clinically patient. But for full attributable would just require the 330 patients or would there be other trial that would be necessary? Thanks.

Yeah, so just working backwards, the full approval we would expect based on our experience we would be just from the progression free survival analysis of that study.

Okay, great, thanks.

In terms of your first question in terms of autoimmune disease, we’re actually excited about looking at RA, Lupus and [indiscernible] sort of the big – broader category, there may be obviously subdivisions of these diseases that we’ll target first, but we think all of those are addressable with our compounds and we’re [indiscernible]. In terms of partnerships, both potentially autoimmune diseases, that’s something we would definitely consider overtime. I think once we’re getting to a little bit more and we get a kind of handle on the resource requirements that we’re building now to basically give us a good understanding of what it will take, and we’ll make assessment as we move forward but I wouldn’t move it out as the possibility that’s something we could do but I think it’s just too early for us to know that they’d be best or better strategy for us. So I think stay tune now, we’re not [indiscernible] a prior we have an assessment, again I think on the cancer side our peripheral charges we know confidently we could move forward and we could bring close to market, we can market them. I think with autoimmune diseases we’re still getting up to speed and we’ll learn more so. I think I’m going to have to get back to you with a better answer and we’ll talk again in six months and we’ll give you better answer on what our pro forma strategy as once we get there.

Okay, great. Thanks.

Thank you. Our next question is coming from the line of Joe Pantginis with ROTH Capital Partners. Please proceed with your question.

Hey, guys good morning. Thanks for taking the call. Couple of quick questions, first, Mike, IRAK4 is obviously gaining some momentum as part that you guys put out some very intriguing preclinical data recently. Is there anything you can share with regard to preliminary plans regarding the oncology program that you’ve been looking at the autoimmune landscape for IRAK4? Or what kind of indications you might be looking at to start with?

Sure. So, from a corporate side we’re going to look at oncology first and then we’ll certainly will look at autoimmune diseases. From the oncology side [indiscernible] in terms of sort of the natural place to look at an IRAK4 inhibitor, MYD88 the mutation that is sort of driving through IRAK4 is up regulated in very large proportion 85%, 90% plus of patients with [indiscernible] MYD88 mutation. So, it’s a really good experimental model to see if this job would work, it really works well I think it’s probably the key. We don’t want to rule out that the pathway is important to growth and survival of tumors independent MYD88, so I think outside of [indiscernible] in terms of we’re having broader program looking at all commerce style Phase 1, 2 in NHL and CLL. We do believe that there is about 20% of the CLL patients harder than MYD88 mutation and somewhere on the order of 30% of the ABC sub type Diffuse Large B-cell indication as well. So I think, again we’ll try to get a broader population in NHL and CLL and return whether this works only in MYD88 or in all cases of Diffuse Large B-cell [indiscernible] or it doesn’t work at all, and we’ll obviously figure out a lot moving [indiscernible] we’re not going to say that it’s only for the MYD88 mutation, although the experiment was as long as little bit as a big sense of activity through MYD88 because, like I said most of those patients are MYD88 mutations.

Got it, well that’s helpful, thank you. And again my next question, but it’s not have to nitpicky, it’s more just share curiosity. There were some slight differences between the abstract titles listed in your press release versus the titles that were listed on the ASCO website. I’m just curious about why that is?

Yeah, so basically the abstract titles or the titles of the presentations that we presented were the ones that we filed with ASCO. This year they have some chunked titles when they put out the abstract. It’s unclear to us at this time what the titles we’ll be using when we get to the actual presentation. I assume that our investigators will use the presentations and the titles that they’ve actually submitted. But again I think ASCO has chunked some of the titles when they put out the listing of abstracts. What comes out next I think is, I before abstract we just have the abstract titles, before abstract it will come out, we’ll see when they come out what titles are actually used, the ones we filed or the ones that ASCO [indiscernible]. And likewise, again as we get to the presentation, I assume that the investigators will present in the titles that they filed for abstract, we’ll see where we’re outpacing. It’s a new system for ASCO, they’ve never done this [indiscernible] before, so we’re kind of learning on the go. But the ones that we’ve listed were the titles of the abstracts that were filed for the investigators.

Okay, great. Thanks a lot guys.

Thank you.

Thank you. Our next question is coming from the line of Reni Benjamin with H. C. Wainwright. Please proceed with your question.

Hey, good morning guys, thanks for taking the questions. Just a couple, maybe with the January files, you mentioned that there are about 85 plus and can you give us a little bit of color as to what packaging of the site are all been streaming and what the level of enthusiasm at those sites? And related to that, you mentioned couple of historical numbers in terms of overall response rate, can you just remind us of the content for both overall response rate and PFS for the study?

Sure. So, in terms of the sites, we assume the feedback coming from our CSL is that the sites are enthusiastic, they’re excited about the trial. It fits well into their workflow, as patients come in – most patients are being reviewed for eligibility for [indiscernible] on regular basis now is the probably number of most [indiscernible] patients that relapse after first line treatment or some prior therapy. So from that standpoint it fits nicely into the workflow. We’ve gotten 15 back on the trial and yes, we do met their off-screen, the sites that will open the off-screen for patients for the study. So we are as we fit in today optimistic about the trial and the interest in the community and obviously we continue to look forward still [indiscernible] as many of the sites just got up and running over the last 30 days, so I can show you – and we’ve done trials long time. There is no, it’s not an immediate all of a sudden patients start flying in the door but it takes a little bit of time for the sites to get all the workflows down. But I’d say we’re probably optimistic, we’re hearing back from the field is quite good. And then the second question was related to…

The ORR and PFS.

Yes. So, the overall response assumptions for the trials, and we’re assuming that the control arm we’ll have approximately 60% overall response rate, again as per the ibrutinib label. And in terms of the control arm, we’re assuming approximately 90% response rate give or take and say 5% or so, so I think with the number of patients that we’ll have within that overall response analysis we’ll highly powered, so that differential I gave is more a differential between those arms. In terms of PFS, honestly I have to go back and check with the name and exactly what the power assumption are but in terms of timeframes we are expecting that that PFS analysis will take some time to read out, the ibrutinib PFS is quite robust. It is less robust in the high-risk patients which is why we serve that patient population to basically [indiscernible] a lower PFS for the ibrutinib. And I said, we think that’s very – the PFS will continue for several years beyond approval.

Got it, okay. And just going to a preclinical program, can you just give us a sense as to – you don’t want to touch upon highlights, the immune oncology programs but can you collaborate and can you give us your – obviously an exciting face you’re related costs on how that’s going to move forward and is that really 2015 story or even further up?

I couldn’t hear what team you put into that but I think it’s a 2016 story, I don’t know if actually you said 2015 or 2016 but it’s a 2016 story from the recent year, in terms of our proprietary immune oncology program moving into the clinic. And under what else, like I said there are things where we’re obviously super excited about the area, again I think we’re one of the first to jump in to see the potential of engaging B-cells via PD-L1 – sorry about that. We’re one of the first ones to identify PD-L1 as an instant target, it’s highly expressed on sales with CLL. We noticed there is another competitive side of that that it just recently did a $400 million, $500 million deal for clinical stage PD-L1 to be used in the malignancies. So, again the area is going to heat up, I think we’re ahead of the curve in a lot of ways of thinking about it. I think in terms of executing in this area we’ll hopefully have to do so as soon as possible but we are definitely enthusiastic about the possibility that’s bringing T-cells to help drive the malignancies cells. I think with the principle that T-cells can work in this area would be the CD19 CARTs. We figured obviously using PD-L1 is a much more elegant approach to attack the malignancies cells in using synthetic structure like the CART in CD19. And so I think the true principles of T-cells can’t have the material stuff in this area, we think PD-L1 and cost of PD-1 [indiscernible] could be the most efficient [indiscernible] way of engaging T-cells to do that.

And just as a follow-up to that, can you just give us in terms of, is the program still in – are you still identifying lead candidates or have you identified a lead candidate [indiscernible] getting close behind the enabling study?

I think we’re in the process of finalizing our lead candidates and then we’ll be able to give you lead into [indiscernible] studies.

Perfect. Thank you very much and good luck on the quarter.

Thanks, Reni. I appreciate it.

Thank you. It appears there are no additional questions at this time. I’d like to turn the floor back over to Mr. Weiss for any additional concluding comments.

Okay, thank you. So 2015 is shaping up to be another exciting year for TG Therapeutics. We have aggressive goals including launch of multiple Phase 3 trials, events with the oncology it’s autoimmune disease. [Indiscernible] development our preclinical product candidates into the clinic as well continued exploration of in licensing opportunities which expand our already robust portfolio. All with the similar objective of bringing novel, highly active and non-toxic treatment regimens to patients with B-cell malignancies and B-cell disorders. On behalf of all of us at TG Therapeutics, I’d like to thank our investigators and their patients as well as all our shareholders and investors for their continued support. Thanks again for joining us. And have a great day.

Ladies and gentlemen, this does conclude today’s teleconference. You may disconnect your lines at this time.