Madrigal Pharmaceuticals Inc (MDGL) 2010 Q1 法說會逐字稿

Good day and welcome to the Synta Pharmaceuticals First Quarter 2010 Financial Results Conference Call. Today's conference is being recorded and webcast. At this time for opening remarks I would like to turn the call over to Rob Kloppenburg, Vice President of Investor Relations and Corporation Communications at Synta Pharmaceuticals. Please go ahead, sir.

Good morning and thank you all for taking the time to join us today. With me are Dr. Safi Bahcall, our Chief Executive Officer, Keith Ehrlich, our Chief Financial Officer and Dr. Vojo Vukovic, Synta's Chief Medical Officer.

This morning we issued a press release that reported results for the first quarter of 2010. This release can be found on our website at www.syntapharma.com.

Before we begin I would like to point out that we will be making forward-looking statements based on our current intent, belief and expectations. They are subject to certain risks and uncertainties and I encourage everyone to look at the SEC filings for additional detail. I will now turn the call over to Dr. Bahcall, after which we will open the floor questions. Safi?

Thanks, Rob, and thank you for joining us this morning. Today I will give a brief update on our programs and Keith Ehrlich will summarize our first quarter financials.

I would like to start by saying this is an exciting at Synta because we are in a period with many new trials being initiated and results from earlier trials maturing. As a result, we expect to have considerable data flow for the rest of this year and into next year.

STA-9090, our Hsp90 inhibitor, is now in five Phase II trials including the new colon and gastric cancer trials announced today. Three previously initiated Phase II trials in lung cancer, GIST and AML are enrolling well.

We are pleased that the tolerability of the drug continues to be positive and appears to show certain distinct advantages over other Hsp90 inhibitors. Results to date from our two solid tumor Phase I trials will be presented at ASCO which will describe the safety and tolerability in greater detail.

Preliminary results from the first stage of each of our Phase II lung, GIST and AML trials will be available in the second half of the year. We will be discussing with the lead investigators on these trials at the most appropriate meetings to present these results and we will let you know when we have a meeting presentation scheduled.

We are excited about the opportunity for 9090 and the new Phase II indications announced today, colon cancer and gastric cancer. There is a good scientific rationale in these tumor types based on the underlying pathways targeted by 9090. In addition, in our Phase I trial we did see a response which qualified as a confirmed partial response by rhesus criteria in a colorectal cancer patient who had progressed in numerous prior therapies. The Phase I activity profile, as well as safety profile will be discussed in greater detail at ASCO next month.

We are very pleased to be working with leading investigators at such high profile institutions as Memorial Sloan Kettering in New York and Mass General Hospital in Boston. This reflects our approach in building a strong support network in the scientific and medical communities for 9090 driven by the data from the drug and the broad therapeutic potential.

To this end we are confirming our prior guidance and very much look forward to announcing an additional four to eight new trials for 9090, for a total of six to 10 new trials this year. The breadth and quality of this program positions 9090 to be the leading Hsp90 inhibitor in the industry. That is our goal and we are fully committed to leading this field.

I would like to give a brief update on Elesclomol today as well. At AACR last month we presented results showing that anticancer activity of Elesclomol correlates with the level of HIF-1 alpha and LDH. Essentially, Elesclomol needs oxygen to work. Low levels of oxygen in cells reduce Elesclomol activity.

These results are consistent with the results from both our Phase IIb and Phase III melanoma trials in which only the normal LDH population showed benefit from Elesclomol. As a reminder, that is not a small subpopulation, but rather the majority across both trials.

Based on the positive results seen for Elesclomol in an x cebo analysis in patients with acute myeloid leukemia which were presented at ASHE in December, as well as our prior supporting data for Elesclomol in hematologic cancers, we are in discussions to initiate a trial for Elesclomol in AML. We expect this trial to start before the end of this year.

Finally, with regard to partnerships, our guidance has not changed from our last call. We continue to be in active discussions for each of our unpartnered programs and are targeting conducting -- concluding at least one partnership this year. I will now turn the call over to Keith Ehrlich.

Thank you, Safi, and good morning everyone. Together with a $26.7 million of net proceeds raised in our follow-on offering of common stock in January, 2010, we entered 2010 with approximately $71 million of cash resources. As of March 31, 2010 our cash balance was approximately $58 million.

Total collaboration revenues in the first quarter of 2010 were $4 million as compared to $4.5 million in the same period of 2009. In the first quarter of 2010, our research and development expenses were $10.2 million, as compared to $22.6 million for the same period of 2009 during which we were conducting the Phase III symmetry for Elesclomol.

In the first quarter of 2010, our general and administrative expenses were $3.1 million, as compared to $4.1 million for the comparable period in 2009. In the first quarter of 2010 our net loss was $9.3 million or $0.24 per basic and diluted share, as compared to $23.5 million or $0.69 per basic and diluted share.

Based on our current operating levels, we continue to estimate that our cash resources, together with the expected research and development reimbursements and milestone payments anticipated under the Roche agreement, will be sufficient to fund the Company's operations into 2012. I will now turn the call back to Safi.

Thanks, Keith. We will open the call now to questions. Operator?

Thank you, Dr. Bahcall. We will now begin conducting a question-and-answer session. (Operator Instructions). Our first question comes from the line Jason Kantor of RBC Capital Markets. Please proceed with your question.

Hey guys. I was able to find the colorectal cancer study on clinicaltrials.gov, but not the gastric, so maybe you could give us a little bit more detail on what that trial is going to look like, how many lines of therapy of those patients failed, what is the dose, et cetera.

Sure. Vojo, you want to take that one?

Sure. Hi, Jason. The gastric trial is conducted in advanced gastric cancer patients, so these patients who have failed standard care, which is frontline treatments, and all the second line and beyond. It is a single agent study like our other Phase II programs.

And it is a weekly 200 mgs/m2?

Yes. We are using the same dose schedule that we are taking also forward in our other Phase II trials.

Okay. And then in terms of, Safi, in terms of partnering, can you give us an idea of what are some of the flavors of deals that you are considering?

Yes. We are looking at across each of our programs and we are in discussions with a number of partners on both global types of deals, as well as regional types of deals. And right now it is kind of too early to say exactly which one we will converge on.

And then in terms of your Phase I hematologic study, is that going to be at ASHE or at EHA? When are we going to see more data there?

ASHE is a reasonable place to present hem data from a study like that, but we haven't made any final decisions. We will talk with the investigators over the next few months.

Thank you.

Our next question comes from the line of Brian Martin of Barclays Capital. Please proceed with your question.

Hi. Thanks for taking the questions. I believe on the GIST trial, do you save the randomized trial? I was asking because I was looking for the ASCO titles online, and it looks like Novartis has a data presentation for the Hsp90 in a bit of which I believe is a randomized study.

Yes. There was a Novartis Phase III study for a different agent which was largely randomized, but the Hsp90 studies have been like ours have been, nonrandomized.

Okay, thanks. And in terms of your studies of STA-9090, can you maybe provide more color on the biomarker studies that you have been doing?

Sure. The -- we were looking at the variety of biomarkers and the specifics that clearly depended on the tumor type that you are investigating. Some of the common ones that may be shared across several studies include placebo AtT. They may include HER2/neu, may include EGFR, but there is also lots of disease specific biomarkers. As well for our studies we will be doing tumor sample analysis so we will be able to learn a lot about biomarkers in our Phase II studies.

Okay, thanks, and finally, maybe Safi you mentioned having one partnership probably by the end of this year. Does this still include the Hsp90 and bit of as a potential partnership?

Yes. That is in discussions and that is one of the types of partnerships that we are looking at.

Okay. Thanks for taking the questions.

(Operator Instructions). Our next question comes from Andrew Vaino of Roth Capital Partners. Please proceed with your question.

Just a quick question on how best to think about the revenue from the collaborative royalties and reimbursement going forward, do you reckon same levels as in Q1?

From our -- are you referring to our partnership with Roche?

Yes. I think if you look at the prior quarters it has been a fairly consistent revenue which is related to essentially reimbursing R&D costs. And that is a fairly reasonable assumption to continue to project that.

Okay, and any inkling as to when we might see some Phase II data from the 9090?

Yes, second half of this year we will have preliminary data from our Phase II trial.

Okay, thank you.

This concludes this question-and-answer session. I will now turn the conference back over to Dr. Bahcall for closing remarks.

Thank you, everyone, for your time and this ends the call.

Ladies and gentlemen, this concludes today's call.