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Ambit Biosciences Corp (AMBI)
Q2 2013 Earnings Call
August 13, 2013 05:00 PM ET
Marcy Graham - Executive Director of IR
Mike Martino - CEO
Athena Countouriotis - CMO
Howard Liang - Leerink Swann
Jim Birchenough - BMO Capital Markets
Laura Chico - Robert W. Baird
Chris Raymond - Robert W. Baird
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Thank you. Good afternoon and welcome to the Ambit Biosciences’ Conference Call to discuss financial and operational results for the second quarter of 2013. My name is Marcy Graham, and I am pleased to join Ambit as Executive Director of Investor Relations and Corporate Communications. I look forward to meeting with many of you in the coming weeks and months. Joining me on the call are Michael Martino, CEO; Alan Fuhrman, CFO; and Athena Countouriotis, the Chief Medical Officer.
Before I proceed, I would like to remind everyone that statements made during this call regarding matters that are not historical facts, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Forward-looking statements are not guarantees of performance. They involved known and unknown risks, uncertainties, and assumptions that may cause actual results, performance, and achievement to different materially from those expressed or insight by the statement.
To learn more about these risks and uncertainties, please read the risk factors that forth in our most recent filings with Securities and Exchange Commission. All forward-looking statements made during this call speak only as of the time they are made. We undertake no obligation to update the statements. I will now turn the call over to Mike Maritino, President and CEO of the Ambit, Mike?
Thank you, Marcy, and welcome to Ambit. WE are delighted to have you on the team. Good afternoon everyone. Welcome to our second quarter call. We are pleased to provide you with an update on our operating and financial results for the second quarter and update our look for the second half of the year. The highlights are as follows.
First, we raised net proceeds of approximately $83 million from our IPO and concurrent private placement in May. We expect this financial to provide the capital needed to take us through top line data from the Phase 3 trial that we planned to initiate in early 2014. Alan will update financial results later in the call.
Second, we presented our data from the Phase 2 study of Quizartinib in patients with relapsed or refractory AML at both ASCO and EHA. We believe the presented data continue to support our view that Quizartinib is a highly selective and potent oral FLT3 inhibitor that can be administered daily and is a potential game changer in the treatment of AML.
Third, we completed a preliminarily top line analysis of all 76 patients treated in our Phase 2B clinical trial.
Fourth, we had a very encouraging Type C meeting with FDA in June.
And finally, we have submitted four clinical abstracts from ongoing studies of Quizartinib to ASH for presentation at the annual meeting in December.
I would now like to turn the call over to, Athena Countouriotis, our Chief Medical Officer to provide an update on three things a top line data from the Phase 2B clinical trial, our recent discussions with FDA, and the abstracts we just submitted to ASH. Athena?
Thank you, Mike. We have completed our preliminarily top line analysis of data from all 76 patients enrolled in the Phase 2B clinical trial. As a reminder, this trial studies 30 mg and 60 mg doses administered daily to FLT3 ITD positive patients 18 years and older who were relapsed or refractory to second line treatment or a hematopoietic stem cell transplant. This population of patients is comfortable to cohort 2 of the previously reported Phase 2 trial.
Efficacy data from the top line analysis of the Phase 2B trial at both 30 mg and 60 mg doses are consistent with data from cohort 2 in the Phase 2 study. You may recall that in the Phase 2 study in cohort 2, there was a 46% composite complete response rate or CRC rate with 35% of patients bridged to transplant.
In terms of safety, the top line analysis from both the 30 mg and 60 mg doses suggest that the Grade 3 QT prolongation rate has been reduced compared to the previously reported Phase 2 results and remains in line with the preliminary analysis from the first 39 patients in the Phase 2B trail in which we reported a Grade 3 QT prolongation rate of less than 5%.
Other safety findings are consistent with the previously reported Phase 2 results. We have submitted an abstract to ASH of the complete data from the Phase 2B trial for the 2013 annual meeting in Orland in December. At this time we believe we have met our goal for this study. By the reducing the dose of Quizartinib it appears we have improved QT safety profile and maintain the efficacy demonstrated at the higher doses studied in our Phase 2 trial.
In regards to our recent discussions with FDA, in June we participated in a Type C meeting to discuss the potential acceptability of CRC and specifically complete remission with incomplete hematologic recovery of Cri, as a surrogate endpoint that could support an accelerated approval based on the two Phase 2 clinical trials.