Earnings Labs

Madrigal Pharmaceuticals, Inc. (MDGL)

Q2 2015 Earnings Call· Thu, Aug 6, 2015

$519.54

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Transcript

Operator

Operator

Good day. And welcome to the Synta Pharmaceuticals Second Quarter 2015 Earnings Conference Call. Today’s conference call is being recorded and webcast. At this time, for opening remarks, I will turn the call over to Daniel Cole of Synta Pharmaceuticals. Please go ahead, sir.

Daniel Cole

Management

Hello, and thank you all for taking the time to join us today. With me are Chen Schor, Chief Executive Officer; Vojo Vukovic, Chief Medical Officer; and Marc Schneebaum, Chief Financial Officer. This morning, we issued a press release that reported financial results for the second quarter 2015. This release can be found on our website at syntapharma.com. Before we begin, I would like to point out that we will be making forward-looking statements based on our current intents, beliefs and expectations, which are subject to certain risks and uncertainties. Additional details can be found in related SEC filings and are also available through our website. I will now turn the call over to Chen.

Chen Schor

Management

Thanks, Dan. Good morning to everyone. And thank you for joining our call today. The first half of 2015 has been a productive period for us, both for now very broad ganetespib program and our HDC platform. Ganetespib, as you know, is our novel, potent, small molecule inhibitor of heat shock protein 90, or Hsp90. Hsp90 has been recognized as an important target for cancer therapy, yet drugging this target has proven challenging until now. Ganetespib is 10 to 100-fold more potent than first-generation Hsp90 inhibitors. Its chemical structure does not have the moiety associated with liver toxicity observed with first-generation Hsp90 inhibitors. And its rapid clearance from the retina is associated with near-absence of even mild to moderate visual disturbances. The ganetespib program is approaching the first Interim Analysis of our pivotal GALAXY-2 trial in second line non-small cell lung adenocarcinoma which is expected by the end of 2015. The study follows the large randomized Phase 2 GALAXY-1 trial which supported the design and patient selection for GALAXY-2. Assuming GALAXY-2 demonstrates an overall survival benefit and profile similar to that seen in GALAXY-1, we believe ganetespib will be differentiated and become a valuable option in the evolving non-small cell lung cancer landscape. Like others, we believe the recently introduced immunotherapies represent a significant advance in the treatment of patients. What we can say today, based on available data, is that the PD-1 and PD-1 based therapies appear to work best in select non-small cell lung cancer patient, specifically in patients who express significant level of PD-L1. However, a consistent theme from recent reports and trials is that immunotherapy doesn’t cure cancer, improve survival only for a subset of patients and unmet medical need for novel agents such as ganetespib remains. For example significant opportunity exists for ganetespib in patients…

Vojo Vukovic

Management

Thank you, Chen. We are indeed encouraged by the continued progress of our programs, in particular the GALAXY-2 Phase 2 trial, the large randomized ganetespib ISTs and the strides we’re making with 8666. First, let’s touch on ganetespib and GALAXY-2. GALAXY-2 is an ongoing Phase 2 trial, evaluating ganetespib and docetaxel versus docetaxel alone in upto 850 patients for the second-line treatment of patients with non-small cell lung cancer with adenocarcinoma histology. Overall survival is the primary endpoint of the study. As Chen mentioned, the study design in patient population being evaluated is supported by the results from our large randomized exploratory Phase 2 study GALAXY-1, which was published Annals of Oncology in the second quarter of this year. Furthermore, the conduct and execution of GALAXY-2 has been greatly refined, thanks to what we learned from our GALAXY-1 experience. We continue to be pleased by the rate of enrollment in our pivotal Phase 3 study and continue to remain on track regarding the timing of data analysis. Based on our current projections, we expect that the first interim analysis will occur by the end of this year. At a time of the first interim analysis, the independent data monitoring committee can recommend that the study be stopped for efficacy, stopped futility or continue to the second interim analysis. We expect that the second interim analysis and the final data analysis will take place in 2016. Assuming positive interim results from this trial and pending regulatory consultation, we plan to file for regulatory approval of ganetespib for non-small cell lung cancer in 2016. As Chen noticed, the interest in ganetespib extends beyond the GALAXY-2 trial in non-small cell lung cancer. We continue to see important progress in our investigator sponsored studies, particularly the larger unmet studies that are potential registration enabling.…

Marc Schneebaum

Management

Thanks, Vojo, and good morning, everyone. As of June 30, 2015, the company had $98.3 million in cash, cash equivalents and marketable securities, compared to $97.7 million as of December 31, 2014. This includes $41.8 million in net proceeds from an underwritten public offering that closed in April 2015. We expect that our cash resources will be sufficient to fund our operations, at least through the first half of 2016. This estimate assumes no additional funding from new partnership agreements, equity financings or further sales under our ATM facility. The timing and nature of certain activities we’ve planned for through 2016, will be conducted subject to the availability of sufficient financial resources. Now, moving on to our results of operations. We didn’t recognize any revenue in the second quarter of either 2015 or 2014. Research and development expenses were $16.4 million for the second quarter of 2015 compared to $18.8 million in the second quarter of 2014. This net decrease of 2.4 million was primarily the result of lower costs in our ganetespib program, specifically for the Phase II GALAXY-1 study and other earlier stage company-sponsored clinical studies. General and administrative expenses were $3.1 million for the second quarter in 2015 compared to $2.9 million for the same period in 2014. Overall, the company reported a net loss of $19.8 million or $0.15 per basic and diluted share in the second quarter of 2015 compared to a net loss of $22.3 million or $0.24 per basic and diluted share for the same period in 2014. With that, operator, you can open the call for questions.

Operator

Operator

Thank you. [Operator Instructions] Our first question is coming from the line of Christopher James with FBR Capital. Please proceed with your question.

Christopher James

Analyst

Congrats on the progress this quarter. Just going back to something you said earlier, given the evolving landscape with the PD-1 inhibitors, when do you think you will be able to start testing ganetespib with one of the checkpoint inhibitors? And have you done any preclinical work with ganetespib?

Vojo Vukovic

Management

Very good question. We have certainly two collaborations and also internally conducted a number of preclinical studies to evaluate the feasibility of combining with different immunotherapies, including checkpoint inhibitors. These collaborations have produced the encouraging results which have generated a lot of interest and enthusiasm with investigators. And we’re currently in discussions, multiple discussions about potential studies in the clinic, and we’ll provide updates as soon as we can.

Christopher James

Analyst

And when do you think you’ll be able to share some of those data and sort of in what forum will that be; at a medical meeting or do you think some sort of publication?

Vojo Vukovic

Management

Preclinical data has been already presented in multiple meetings earlier this year. As the data evolves, we’ll continue to present. There is also a paper that’s been recently published with the checkpoint inhibition. So, some of the data is in the public domain. We will continue generating new data and continue presenting at scientific meetings. And again, once we are ready to discuss specifics about the clinical studies, will be certainly doing so.

Operator

Operator

Our next question is coming from the line of Mike King with JMP Securities. Please proceed with your question.

Mike King

Analyst

This may sound like the previous question from C.J. If you guys really do have this effect on presentation, it seems like you could do collaborative deals along the line of what inside is done with our IDO inhibitor; is that the way we ought to be thinking about this?

Chen Schor

Management

So just provide maybe, just a little more background and then what I can obviously answer your question directly, I can give you a sense of what we’re thinking. So first I’ll mention that we invested quite a lot of efforts into understanding the biology and preclinical activity of Hsp90 inhibition in general and ganetespib specifically when it comes to the tumor or the tumor environment and learned a couple of things, a couple of angles that are related to the mechanism of action. One is that ganetespib and Hsp90 inhibition eventually leads to down regulation of PD-1 in the tumor; two, we’ve seen localized induction of T-Cell recruitment factors and indeed more T-Cell that can access the tumor. And the third angle is production and presentation of tumor neo-antigens. So, I think this really provides the potential benefit in combination, either with PD-1 or PD-L1s or also with other T-Cell therapies. We have one slide in our corporate presentation that summarizes that, at least some of the data that we have. But we continue to generate a lot more data about the mechanism of action. So that’s at the preclinical setting. When we look at the tolerability of ganetespib and we try to compare it to some of the side effects of other clinical stage immunotherapies, we do see the potential of a combination. And it’s not only us, it’s other investigators that have also approached us with very high level of interest in moving to the clinic with different combinations with immuno-oncology. So, we’re not there yet, but as Vojo mentioned, we continue to progress towards this direction. And at the right point in time, obviously we’ll share and we’ll update and our path forward in the clinic. So, I know I didn’t give you a direct response, but I think I gave you a little more background on where we stand and hopefully it’s helpful.

Mike King

Analyst

Yes, it is, obviously until we see publications and such. I just wonder, you mentioned tumor microenvironment and down regulation of PD-1. I am wondering also if there is anything that you can say about ganetespib ability to effect antigen presentation.

Vojo Vukovic

Management

Mike, in some of our preclinical studies, we have seen that treatment with ganetespib increases the presentation of tumor associated or tumor specific antigens on soft surface and that can potentially play nicely with tumor vaccine based programs or even with T-Cell based mechanisms. And we have also functionally looked that in appropriate models we can clearly see synergy with for example of T-Cell based immunotherapy.

Operator

Operator

Our next question is coming from the line of George Zavoico with Jones Trading. Please proceed with your question.

George Zavoico

Analyst

First one is regard to 8666. I can’t wait to see an IND and going forward on that. But in the same light, when you were working on this program before you made a lot of analogs. And I am wondering if you might be thinking about moving any others forward or partnering or how do you plan to advance all the other assets you’ve developed in that program?

Chen Schor

Management

This is Chen. And I’ll try to give you a little more background. So indeed, when you think about our IP and the different payloads that we have tested with our HDC platform, we have tested more than 40 different payloads. And the first one that we select that is the SN-38 payload and that’s one we’re moving into the clinic. And we do have really phenomenal I believe preclinical data in a couple of indications. We are working on a few other payloads. And pretty consistent with how we addressed sharing more information about 8666 with investors and analysts, we expect to follow the same path. And until we have something that we believe is close to a clinical candidate and is really ready to IND enabling toxicology studies, we think it’s probably a little premature to share it with investors. And not only -- mainly because every point in time we continue to optimize the different efforts that we have in research and we may prioritize one program versus another. And once we progress something we’ll share. Regarding partnerships, we do see some interest in the different programs that we have. And as you know, these type of discussions are -- there is lot of factors that we need to take into account, whether it’s economics; whether it’s shares of vision about the future; development plan and what’s the right thing for shareholders at any point in time. And as discussions mature and once we have something to share with you and with investors, obviously we intend to do that.

George Zavoico

Analyst

Okay, I look forward to hearing more about that in the next year or two then. You mentioned the LI-1 trial in AML going forward. Can you provide any guidance -- I know it’s run by the UK group. But can you provide any guidance on when that might complete enrollment, when you might see some data perhaps by ASH of this year?

Vojo Vukovic

Management

George, I’ll try to answer your question. As you pointed out, this trial is sponsored by European cooperative group. It’s under their control including timelines. We know they are actively recruiting. For a period of time there was halt in this trial as the data monitoring board has evaluated the other drugs that are part of this protocol. And once it was clear that only ganetespib succeeded in meeting the pre-specified efficacy criteria, the trial resumed and the other drugs were eliminated. And I believe that they identified potential new drugs for the Phase 2 of the program. But now the Phase 3 component of the trial is fully recruiting. We need to recruit a total of 200 patients into the ganetespib arm. That effort is ongoing. And based on information that we have indirectly, we would expect this trial start producing some results in the time frame that is specified earlier, 2016-2017.

George Zavoico

Analyst

And you mentioned there were two others, the AML-18 and AML-19.

Vojo Vukovic

Management

Exactly right. So, 18 is now in the randomized phase that completed successfully the Phase 1 pilot which was designed to evaluate the feasibility. And so the combination is feasible. This induction chemotherapy. And now the randomized trial is ongoing. And then finally, the AML-19, we believe that’s waiting for some additional approvals. And we expect the recruitment into this trial to start by the end of this year.

George Zavoico

Analyst

And final question regarding GALAXY-2 and it’s pretty far along. Are pretty much all those sites now recruiting patients? And I’m wondering how that might impact looking forward to next couple of quarters in terms of clinical trial expenses. Unless I’m wrong, I don’t see too much additional expenses with regard to GALAXY-2 because you’re kind of -- if I’m correct, you might try to be at cruise control now, monitoring the recruitment and monitoring the activity in the trial.

Chen Schor

Management

Well, I can certainly speak to some of the operational aspects. You are absolutely right, we are active in all sites. As we previously guided, we have over 200 active sites in this trial. Recruitment is holding up very, very good. We are very pleased with recruitment. And we remain firmly on track for the guidance regarding the output, regarding the first interim analysis and of course the second interim and the final for next year. So, we’re very pleased with that. When it comes to cost, obviously the GALAXY-2 trial is still costing some money because we’re conducting the trial, we’re recruiting new patients. So, I don’t Marc, do you want to comment on anything financial regarding this question?

Marc Schneebaum

Management

George, I think that you hit right on the head. We’re more or less on cruise control with GALAXY-2. And the change, the reduction in our overall R&D expenses had more to do with other earlier stage programs, not GALAXY-2.

Operator

Operator

[Operator Instructions] If there are no further questions, I’ll turn the conference back over to Mr. Schor for any additional concluding comments.

Chen Schor

Management

Thank you all for joining. We look forward to sharing more with you in the coming quarters. And if you would like to know more about our progress, please feel free to reach out to us directly. Thank you and have a great day.