Synta Pharmaceuticals Corp. (SNTA)
Q2 2008 Earnings Call Transcript
August 7, 2008 10:00 am ET
Rob Kloppenburg - VP, IR and Corporate Communications
Safi Bahcall – President and CEO
Keith Ehrlich - VP, Finance and Administration and CFO
Eric Jacobson - SVP, Clinical Research and Regulatory Affairs and Chief Medical Officer
Mike King - Rodman & Renshaw
Jason Kantor - RBC Capital Markets
Joel Sendek - Lazard Capital Markets
Derek Jellinek – SIG
Andrew Vaino - Roth Capital Partners
Robyn Karnauskas, Deutsche Bank
Previous Statements by SNTA
» Synta Pharmaceuticals Corp. Q3 2009 Earnings Call Transcript
» Synta Pharmaceuticals Corp. Q3 2008 Earnings Call Transcript
» Synta Pharmaceuticals Corp. Q1 2008 Earnings Call Transcript
Hello and thank you all for taking the time to join us today. With me are Dr. Safi Bahcall, President and Chief Executive Officer of Synta Pharmaceuticals; Keith Ehrlich, our Vice President and Chief Financial Officer; Dr. Eric Jacobson, Synta's Senior Vice President and Chief Medical Officer; and Dr. Jim Barsoum, the Senior Vice President of Research. This morning we issued a press release that reported results for the second quarter ended June 30, 2008. This release can be found on our Web site at www.syntapharma.com.
Before we go any further, I'd like to remind everyone that we will be making forward-looking statements during this teleconference call. Such statements, including statements relating to the timing and progress of clinical trials and financial guidance for 2008, reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Risks and uncertainties include the risk that the results of completed clinical trials may not necessarily be predictive of results in larger, later-stage clinical trials, and the other risks and uncertainties described under Risk Factors in our Form 10-K for the year ended December 31, 2007, as filed with the Securities and Exchange Commission. Synta undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events, or otherwise, except as required by law.
I will now turn the call over to Dr. Bahcall, after which we will open the floor to questions. Safi?
Thanks Rob and thank you all for joining us this morning. We've had a very busy and productive second quarter. I will highlight some of the most significant developments then turn it over to Keith for a financial update and then open up the call for questions.
First of all, we have been making good progress with our registration program for Elesclomol, our lead cancer drug. Over the past several months, we've seen a substantial increase in enrollment in our Phase 3 SYMMETRY trial to a monthly rate that is among the highest we are aware of for large melanoma trial. We believe this is due to the growing acceptance of the strength of our Phase 2b data, the growing scientific data package behind the mechanism and its potential in melanoma, as well as a decrease in the number of competing trials. If this trend continues, we would expect to complete enrollment of the SYMMETRY trial by the end of the year or first quarter, which would be an impressive achievement for a trial of this size and a reflection of the hard work and abilities of everyone associated with the trial, particularly our clinical and operational teams and the investigators in sites participating in the study.
To date, there have been two independent Data Monitoring Committee safety reviews. On both occasions the recommendation has been to continue the SYMMETRY trial as planned. Coming up in the fourth quarter, we expect the interim, safety, and non-futility analysis of the PFS data to take place by the Data Monitoring Committee. The process for the review will follow the pre-specified charter agreed to with the FDA as part of our SPA. As a reminder, the company is quarantined from this analysis. At no time do we see the results, at no time do we have access to any unblinded data, the DMC will meet, review the data and let us know their recommendation. The charter specifies rules for recommending either to stop the study for futility or to continue the trial. There is no early stopping rule for efficacy. Once we have received the DMC recommendation, we would expect to issue a brief release. Following the DMC review, assuming the recommendation is to continue, we estimate completing our target enrollment of 630 patients by the end of year or first quarter and meeting our goal of conducting the primary PFS endpoint analysis in early 2009. PFS is the primary endpoint of this trial. Therefore, once these final results are available, we would expect to review the results with the DMC and the FDA. Should those results be positive, our intention is to proceed with filing an NDA with the FDA as soon as possible.
Beyond our main registration program for Elesclomol, which is our highest priority, we, together with our partner have been actively developing clinical plans for new indications. While melanoma represents a tremendous unmet medical need and a wide open market opportunity, we are equally excited by the potential for Elesclomol in other high oxidative stress cancers. Our preclinical data very clearly supports usage in additional indications. These indications represent a very substantial growth opportunity, something that both we and our partner clearly recognize. Our plan, as we have previously stated, has been to initiate new trials once the new formulation of Elesclomol was ready. The second-generation sodium salt formulation is water-soluble and does not require combining with a paclitaxel-Cremophor solution. We have made good progress with this new formulation and are on track to initiate a new trial with a sodium salt in a new indication in the fourth quarter. We will have more to say about the choice of indication and trial design details as we get closer to initiation. In 2009, we expect to initiate a broad range of clinical trials with this new formulation and we will have a lot more to say about those choices later.