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Ambit Biosciences Corp. (AMBI)

Q4 2013 Earnings Conference Call

March 20, 2014 05:00 PM ET


Marcy Graham - Executive Director, IR

Mike Martino - President and CEO

Athena Countouriotis - CMO

Alan Fuhrman - CFO

Bob Armstrong - VP, Preclinical Biology


Chris Raymond - Robert Baird

Howard Liang - Leerink



Welcome to the Fourth Quarter 2013 Earnings Conference Call. My name is Sherry, and I will be your operator for today’s call. At this time, all participants are in a listen-only mode. Later, we will conduct question-and-answer session. Please note that this call is being recorded.

I would now like to turn your call over to Marcy Graham. Marcy, please go ahead.

Marcy Graham

Thank you Sherry, good afternoon and welcome to the Ambit Biosciences’ Conference Call to discuss financial and operating results for the fourth quarter and full year 2013. Joining me today on the call are Mike Martino, CEO; Alan Fuhrman, CFO; and Athena Countouriotis, our Chief Medical Officer.

Before we 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 involve known and unknown risks, uncertainties, and assumptions that may cause actual results, performance, and achievements to differ materially from those expressed or implied by the statement.

To learn more about these risks and uncertainties, please read the risk factors set forth in our most recent filings with the Securities and Exchange Commission. All forward-looking statements made during this call speak only as of the time they are made. We are under no obligation to update these statements.

I will now turn the call over to Mike Martino, President and CEO of Ambit. Mike?

Mike Martino

Thank you Marcy. Good afternoon everyone thank you for joining us. Today we’ll provide a brief discussion on our operating and financial results for the fourth quarter and our accomplishments in 2013. We’ll also provide a strategic overview of our plans for 2014 including an update on the Quizartinib Phase 3 trial and other ongoing trials. 2013 was a pivotal year for us, most markedly due to the completion of our IPO last May which provided the capital to continue the development of Quizartinib.

Of course the development of Quizartinib continues to be our primary focus in 2013. We had completed enrollment in our Phase 2b trial and presented these results at ASH. ASH was another outstanding conference for us with Quizartinib featured in four oral presentations.

In addition to the data from the Phase 2b study, data was presented for the first time from two studies on the use of Quizartinib in the treatment of newly diagnosed patients in combination with chemotherapy. As we enter 2014 the Phase 3 trial is a central focus for the team and our plan is to initiate the trial in the second quarter. Based on this start we anticipate the interim analysis in the second half of 2015 and top line data as anticipated in the first quarter of 2016. I would remind everyone that both of these are event driven and this is our best forecast given what we know today.

Our Phase 3 trial is a huge undertaking and the details matter. Our team has shown a great deal of commitment throughout the process of preparing to initiate this study and I'm very proud of their efforts. Their dedication and focus have been important factors in getting us to this point and will be key drivers of our success.

In 2013 we also supported a number of additional studies to develop Quizartinib in other clinical settings including post transplant maintenance therapy and in combination with chemotherapy in front line treatment.

These efforts will continue in 2014 with the goal to expand the clinical utility and market potential of Quizartinib beyond the relapsed refractory setting. Athena will elaborate on the Phase 3 trial and ongoing trials in a moment.

I have to say we remain bullish about the potential of our pipelines and are determined to make progress on its development in 2014. AC410 is a potent selective, orally administered small molecule inhibitor of JAK2, which intermediates important cytokines including IL-5 and IL-13. AC410 has potential utility for the treatment of autoimmune and inflammatory diseases or has immunotherapy and oncology. AC708 is a potent and selective small molecule inhibitor of colony stimulating factor 1 receptor or CSF1R which is thought to play a key role in the proliferation of macrophages, which are involved in oncology, autoimmune and inflammatory diseases. We plan to further provide updates on our pipeline in future earnings calls.

We continue to explore strategic partnerships as a means to accelerate development and maximize the potential of Quizartinib and our other pipeline assets. The goal for Quizartinib remains to retain commercial rights in U.S. and enter into collaborative arrangements for development and commercialization in other markets such as Europe and/or Asia.

With that overview, I'll now turn the call over to Athena Countouriotis, our Chief Medical Officer to provide us with additional detail on the Phase 3 study and an overview of other ongoing studies. Athena?

Athena Countouriotis

Thank you, Mike and hello everyone. We are excited to begin the year in preparation to initiate our Phase 3 study and are making progress on our plans to begin this randomized controlled trial in the second quarter. As a reminder, the Phase 3 clinical trial will compare Quizartinib as monotherapy to one of three chemotherapy regimens with a 2 to 1 randomization of Quizartinib to chemotherapy. The trial will be conducted in FLT3-ITD positive patients over the age of 18 who have relapsed from or are refractory to frontline chemotherapy, including those patients relapsing following a stem cell transplant. The trial is expected to enroll approximately 326 patients in the United States, Western Europe, Canada and Australia. The primary endpoint for the Phase 3 clinical trial will be overall survival.

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