Welcome to the Ambit Biosciences’ Second Quarter 2013 Earnings Conference Call. My name is Louresa, 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 conference is being recorded. I would like to turn the call over to Marcy Graham, Executive Director of Investor Relations. Marcy, you may begin.
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.
In the past, the FDA has considered durable CR with acceptable safety but not CRi as a surrogate endpoint for accelerated approval. However, we are encouraged that the FDA noted at the June meeting that the overall clinical benefit of Quizartinib will be a review issue. Further, the FDA asked for additional data to be presented at our upcoming End-of-Phase 2 meeting including further analysis from our Phase 2 and Phase 2B clinical trials and additional historical data to support CRi as a surrogate endpoint that is reasonably likely to predict clinical benefit.
We are working internally and with clinical investigators to summarize the additional historical data and finalize the analysis requested by FDA. As a result, we have adjusted our guidance for the timing of the End-of-Phase 2 meeting from September to November, allowing adequate time to finalize our briefing document and facilitate a comprehensive discussion with the agency. We do not expect the change in timing of our End-of-Phase 2 meeting to impact the start of our Phase 3 trial in relapsed and refractory FLT3 ITD positive AML patients which remains on track for initiation in early 2014.
Finally, we are pleased to report that we have submitted a total of four clinical abstracts for presentation at ASH, which includes the following in addition to the Phase 2B trial abstract; two abstracts in newly diagnosed AML patient giving Quizartinib in combination with chemotherapy. The first is an ongoing Phase 1 study in younger, newly diagnosed patients with AML; the second is an investigator sponsored study, the AML 18 pilot in newly diagnosed elderly patients with AML; the fourth abstract is from the recently completed pediatric trial in patients 21 years of age and younger with relapsed ALL or AML conducted by the capital group.
All four abstracts are pending acceptance by ASH. We cannot discuss the specifics of these abstracts due to the action embargo but we believe the data continue to support the clinical utility of Quizartinib in the treatment of AML, including, for the first time, data using Quizartinib in combination with chemotherapy in newly diagnosed AML patients.
With that, I’ll return the call back over to Mike.
Thanks Athena. We’re very encouraged by the preliminary top line data from the Phase 2B study as well as our recent discussions with FDA. As Athena indicated, we’re preparing to provide the additional analysis that FDA has requested and have reset our guidance for the timing of the End-of-Phase 2 meeting from September to November.
I want to emphasize that we believe this additional time will best position us for this important meeting. Until we know the outcome of the End-of-Phase 2 meeting, we continue to guide to the expectation that a randomized controlled Phase 3 trial will be required for the initial approval of Quizartinib.
Now, I’d like to turn the call over to Alan Fuhrman, our CFO, to review the financials. Alan?
Thank you, Mike. Revenues in the quarter were 11.5 million compared to 5.2 million for the same period a year ago. The increase of 6.4 million was primarily due to an increase in amortization of the upfront license fee related to our collaboration with Astellas. With the termination of the agreement, we are required to recognize all remaining deferred revenue by September 3, 2013, the effective date of the termination. Following the September 3rd termination, we will no longer record any revenue from this collaboration.
Research and development expenses in the second quarter of 2013 were 6.7 million compared to 10.8 million for the same period in 2012. The decrease of 4.1 million was primarily due to reduced Quizartinib research and development expenses, resulting from the wind down of our Phase 2 clinical trial. Going forward, we expect research and development expenses to increase in the second half of 2013 as we prepare for the initiation of the Phase 3 clinical trial of Quizartinib in relapsed and refractory AML in early 2014.
In the second quarter of 2013, general and administrative expenses were 2.2 million compared to 1.6 million in the same period of prior year. The increase of 644,000 was primarily due to an increase in patient and patent prosecution cost and an increase in stock based compensation expense. Total second quarter stock based compensation expense included in operating expenses was $421,000.
Other income was 2.5 million for the three months ended June 30, 2013 compared to other expense of 672,000 for the same period in 2012. The resulting year-over-year increase in income of 3.1 million was primarily due to the change in the fair value of Ambit’s stock warrant liabilities, which resulted from a change in the fair value of the underlying preferred or common securities.
For the quarter ended June 30, 2013, Ambit reported a net profit of 5.2 million compared to a net loss of 7.3 million in the second quarter of 2014. In the second quarter of 2013 we recognized 9.9 million in deferred revenue as compared to 1.6 million in 2012. The increase in deferred revenue is a result of the cancellation of our agreement with Astellas. Without this increase in deferred revenue we would have not shown a profit in Q2 and we would not expect to show a profit for the remainder of 2013.
At June 30, 2013 Ambit had cash and cash equivalents of 85.3 million, compared to 17.5 million in December of 2012. The increase of 67.8 million was primarily due to the completion of our IPO during which we raised net proceeds of 58.1 million and the completion of the concurrent private offering with net proceeds of 25.1 million, these being offset by cash used to fund operations.
At June 30th, the remaining principal balance on our venture debt facility was 1.8 million, which we expect to be paid in full by October of this year. Based on our current guidance that the Phase 3 trial will be a registrational trial, our cash and cash equivalents are expected to be sufficient on operations through top line data at the end of 2015.
At June 30th, we had 17.9 million shares of common stock outstanding. With that I will turn the call back over to Mike.
So on summary everyone the second quarter of 2013 was very productive for Ambit, and we expect the second half of the year to be equally as busy. Specific milestones for the second half of 2013 and early 2014 include participation in the end of Phase 2 meeting with FDA in November to determine the regulatory path of Mike Quizartinib for patients with relapsed or refractory AML.
In December we expect another busy ASH. With multiple presentations, including the new data from the Phase 2B study, the first presentations from studies of Quizartinib in combination with chemotherapy in newly diagnosed patients and the final analysis from the pediatric trial in relapsed AML and ALL conducted by the TACL group.
Of course in each of these abstracts our subject to acceptance for presentation at ASH. In early 2014 we expect to initiate the Phase 3 study of Quizartinib and FLT3-ITD (+) relapse and refractory AML patients. And finally on the second quarter of 2014 we expect to submit an IND for AC708 our CSF1R inhibitor with potential utility in oncology and inflammatory diseases.
That concludes our prepared comments, Louresa please open the line for questions.
Thank you, we'll now begin the question and answer session. (Operator Instructions). Our first question is from Howard Liang from Leerink Swann.
Howard Liang - Leerink Swann
Great, thanks very much. I guess my first question is, you mentioned that FDA said that whether it's CRI or CRC can be a basis approval in the review issue. Does that mean that they are expecting to review this application?
Listen I wouldn't speculate on that in advance of the end of Phase 2 meeting, we’re very encouraged with the progress we have made in our discussions and as indicated encouraged that they have indicated that it will be a review issue. At the same time they have requested additional information including historical analysis supporting the clinical benefit of CRI and specifically that is a reasonable predictor of a clinical benefit. So we're very encouraged by the discussion.
Howard Liang - Leerink Swann
Did agency suggest what type of supportive data you will need to submit, and what type of data do you plan to submit to support CRI as an end point?
Well I don't want to get into the specifics of the details, what we would say again is that we would expect the discussion of the end of Phase 2, we'll focus on our Phase 2 and 2B data, and again when we met with FDA in June they only saw our preliminary analysis in less than half of the 2B patients. But in addition we expect to focus on historical data that supports CRI as a surrogate end point reasonably likely to predict clinical benefit. In addition we would also expect to talk about the Phase 3 trial design.
Howard Liang - Leerink Swann
What dose would you propose for the label, if it’s a lower dose of 30 or 60 milligram? What efficacy data would the label side? Thank you.
Well Howard I am chuckling to myself because as you know from the road show I am eager to ask that question and Athena is cautioning to wait for the full analysis of the data which of course I think clinically and scientifically is the right answer, so we're going to want to have the full analysis of the Phase 2B data and in the context of the discussion with FDA and we'll be in a better position to provide the full guidance on that.
Now having said that, I think we're comfortable in saying that based on the data we have to date including the data around safety and efficacy, and including data related to doses delivered, interrupted, reduced, increased etc. details of course that we're not free to share in advance of ASH but nonetheless I believe at this point taking all of those things into consideration we still believe that the light, 'starting dose', is 60. Now I'd ask Athena for your thoughts on that as well.
Howard, I agree with everything Mike has stated, I would just reiterate again that we’re very encouraged by the continued dialogue with the FDA and at the same time as I stated previously we do believe that we've met the goal of this trial and we have optimized in terms of the benefit risk profile for Quizartinib for a patient population with a very high unmet medical need, which I think puts us in a good position for a productive discussion with the FDA at our end of Phase 2 meeting.
Thank you, the next question comes from Jim Birchenough from BMO Capital Markets.
Good afternoon this is Nick standing in for Jim this afternoon, couple of quick questions, first one could you be a little more specific in terms of the timing of this end of Phase 2 meeting with FDA and whether you intend to report the outcome of that meeting ahead of ASH and secondly as you prepare your data set, you have this very impressive efficacy data for the higher doses, what you're saying is comparable data for the lower doses, are you looking at sensitive biomarkers of example (inaudible) inhibition to either support your thesis that these are indeed equivalent doses from an efficacy perspective, hitting what you want to hit and perhaps not hitting some targets of concern from a safety perspective, thanks.
Hi Nick, I'm going to answer the first question then I'm going to ask you to be more specific please about your second question. On the first question I think we can request a meeting, it's ultimately up to FDA as to when that meeting is scheduled and given our fast track in orphan drug status all we know for sure is that that meeting needs to be scheduled within 60 to 90 days of our request. It is our intent to submit the materials that we need to submit to request and support a meeting by the end of August. Now on your second question, can you be a little more specific about what you're looking for there.
Yes, while the efficacy endpoints are very important some of the safety endpoints are very important, they're fairly blunt instruments, I mean obviously these are two discrete cohorts of patients and I'm thinking from a perspective of bio equivalence, where FDA is stated for by generic drugs, we really want you to be more specific in terms of looking at biomarkers that are relevant safety and efficacy to convince us that the data set you have is representative, so you still have a relatively small number of patients, a lot of those patients have been treated at higher doses at very impressive efficacy and not only you're bridging is transplant but you really want to bridge the higher data saying that these impressive data are truly representative of the dose that we want to take forward to the marketplace which is perhaps I don't know, quarter of the patients have been treated at your 60 milligram dose, I'm just wondering if you can do any work beyond just traditional methods of safety and efficacy to try and convince FDA this is really a homogenous set of data.
Okay, thank you Nick, that clarification is helpful, so let me respond with a couple of comment and then I'll ask Athena to add her thoughts. First and foremost I would say that we do not have a small number of patients here. Including a Phase 1 study we have almost 500 patients in which the drug has been studied and we really believe when you tease apart the data that we can demonstrate that we're on not surprising for a tyrosine kinase inhibitor, we're on a pretty flat plane on the dose response curve from low doses of 30, as high as doses of 200 or higher in terms of efficacy and clearly what we're able to achieve with the lower doses as Athena indicated is a better benefit risk profile primarily as a result of really materially lowering the QT profile of the drug at the lower doses.
Second comment I would make, is, yes, you're absolutely right about using biomarkers to support equivalence of generics, I mean the challenge we have here is this is a first in class molecule. So, our challenge is really proving the clinical benefit of the drug relevant to its risk and we believe that with the CRC data we have with the breadth and depth of PK data that we will submit to support the efficacy and safety profile and finally with the safety profile that we are demonstrating a compelling benefit in a very high end methionine (ph) patient population. So these are kind of my reflex answers. Athena, do you want to add anything to that?
No, I again I agree with Mike’s comment as specifically that we do have a robust data population in over 400 patients irrespective of the starting dose with as I said a very comparable efficacy and safety profile. Having said that, we also have a very robust pharmacokinetic and pharmacodynamic database that’s currently under evaluation. So I can’t speak to specific but you were dead-on in regards to your comments, we are looking at additional markers such as CKIT currently through our PD analysis.
And after you had your end of end of phase 2 med meeting, will you report that outcome?
Yes, Nick without knowing off course what the outcome of that meeting is going to be, I think it’s fair to assume that it will be material. So of course following the receipt of the minutes from the meeting we would anticipate issuing a press release if appropriate.
And I am sorry to belay, but how long does it takes to get the minutes?
Well on a statutory basis, FDA has up to 30 days to issue the minutes from these types of meetings.
The next question is from Laura Chico from Robert W. Baird.
Laura Chico - Robert W. Baird
I guess as we think about your end of Phase 2 meeting that's approaching a potential opportunity here, how should we be thinking about historical CRI data? I guess just to put a little context around it, is there are anything in particular that you would point to in a literature that gives you increased confidence in this endpoint as a surrogate (ph) endpoint?
Again let me give some reflex answers and I’ll ask Athena to add her thoughts. I think unfortunately at this point there is very little in the literature regarding the clinical benefit of CRI. I think we've been clear from the onset here that we are with both the mechanism of action of this drug and the data of that we have demonstrated we're plowing new grounds so to speak with demonstrating clinical benefit associated with CRI. So the historical data that we are summarizing and frankly packaging for presentation in our briefing document is really the first compilation of this data. We are optimistic that it will demonstrate a clinical benefit to CRI and we are hopeful that if you will, the owners of that data will publish it. Until it is published, we have used rights, we don’t have publication rights, so we would have to differ on the publication question. Athena, do you want to add your thoughts?
The only thing I would add Laura is that clearly one of the dilemmas we run into is the lack of published data as Mike referenced but I can’t tell you that we are currently summarizing large data sets from large institutions that have just compiled analysis that have also been put under the ASH embargo. So we have information that’s not in the public domain but will be available once the ASH Embargo is lifted and I do think again its supports the cause that CRI does show benefit especially in the context compared to no response in terms of the patient’s overall survival.
Laura Chico - Robert W. Baird
That’s helpful, I guess one last kind of high level question then you mentioned ASH, you mentioned presentation of some front line data there, I guess what is your current thinking or your plans assuming success in the relapsed and refractory populations, how do you began to advance Quizartinib in to more frontline AML setting?
Well, again, I will give you my top of mind answers for that and ask Athena to add her thoughts as well. Clearly, the candidates for label expansion studies there are fairly straight forward and include front line use in combination with chemo in both elderly patients as well as younger patients and I think the good news there is that the two phase one studies that we have submitted to ASH will really be the first presentation of data in newly diagnosed, elderly and younger patients, so I think that data will begin to give us pretty good view of the clinical utility of the drug in those settings. Again, we need to honor the ASH embargo and one of the studies presented is an investigator sponsored study but we continue to believe that Quizartinib is going to play a role as cornerstone therapy in AML and that includes frontline indications as well as relapsed/refractory indications.
In addition, we think there is a big potential in maintenance therapy and maintenance therapy really comes in two flavors; one flavor would be in maintenance of remission in patients who respond to front-line therapy with chemo presumably in combination with Quizartinib therefore whatever reason do not go onto transplant; and the second flavor of maintenance therapy is in fact as a post-transplant maintenance administration in patients who undergo transplant. So, we view all of those as fertile opportunities for the development of Quizartinib. We have not made a decision nor publicly guided as to what our next or second Phase 3 trial would be if one is undertaken or required. Athena?
Again I agree with Mike’s comments, I think again Mike mentioned earlier that we do anticipate having a big ASH again. And I would reiterate given the fact that we have data from three new studies that will hopefully be presented at ASH this year.
Our next question comes from Chris Raymond from Robert W. Baird.
Chris Raymond - Robert W. Baird
I just wanted to go back to your answer to I guess, I think it was Howard’s question, first question on the call, FDA looking at this as a review issue. Athena I could assure I remember you saying when we were talking about this previously that that was sort of the best outcome. Can you maybe review for us the range of outcome that you expected from that meeting, like what were the alternatives, what else could they have said about this in the June meeting?
Yes Chris, I want to jump in here and make a note that I am sure everybody is aware of that we have multiple audiences for press releases and conference calls. Athena and the team have developed a very constructive relationship with FDA, we believe. And it really would be short sighted of us and I believe of you, but certainly of us to score short-term points on a conference call and jeopardize that relationship.
Now having said that, again the most we are going to say on this call is that we are very encouraged by the response of FDA. There are multiple possible outcomes out of that end of Phase 2 meeting, including that review of Quizartinib will be a review issue. Including that we have not convinced them of the clinical benefit of CRi and of course they are not going to tell us whether to submit an NDA or not, that would be up to us. They can also ask for additional information.
So, we really don’t want to speculate on the outcome except to say we are pleased with the progress, encouraged with the responses to-date. And you can count on us to continue to diligently and assertively move forward based on what we believe is the strength of our data and the historical data that we are in the process of compiling.
Chris Raymond - Robert W. Baird
I wonder then just want to make sure I understand the timing, so am I right in my thinking that you would need to wait until that Phase 3 starts before you’re able to file, if you are given the green light to file?
No, not necessarily again I’ll ask Athena to weigh in on this, but my understanding is that certainly if we were to submit an NDA based on the Phase 2 data, then by the time that is reviewed that it would be very favorable if enrollment in the Phase 3 trial has been initiated. But again Athena what your thoughts on that?
No, I agree with everything that Mike just said, I mean again we are encouraged that we are continuing to have dialog with the FDA. Clearly as I mentioned the change in the guidance around the end of Phase 2 has really started to give us an additional opportunity to do some of the homework they have asked us to do which we will feel pretty good in regards to the data we are collecting now. And at the same time the Phase 3 start is not going to be impacted by the additional change for the end of Phase 2 meeting. And as Mike said, a submission would not be awaiting based on our first patient enrolled into the Phase 3 trial.
We have a follow-up question from Jim Birchenough from BMO Capital Markets.
Jim Birchenough - BMO Capital Markets
Just a couple of questions perhaps about future strategies and first related to nearly diagnosed patients. I think Mark Levis has suggested that resistance to the refractory TKIs maybe mediated by this pulse refractory that’s caused by chemotherapy and that just overwhelms the ability of the agents who shut down the receptors. So, in terms of thinking about newly diagnosed setting, is that something that you’re willing to explore or is that just still very theoretical and then in the relapsed/refractory setting [Audio Gap].
…well I should say for patients over the age of 60 increasingly I am beginning to relate to them and using the word older is objectionable, so for patients over the age of 60 I think that initial response may drop to 50% or 60% but nonetheless and even in FLT3 positive patients, the initial remission rate on chemo is not bad.
I think the problem is the 70% to 80% of those patients then relapse in 12 to 18 months, so based on that understanding I would say that a win for Quizartinib could either be increasing that initial response rate recognizing you can’t go up very far from 70% or 80% or I think more importantly prolonging the remission period or stretching out the event free survival period and I don’t use that phrase likely recognizing that it is a specific clinical and regulatory term or endpoint.
So, I think in frontline patients I think we’ll be able to have a more complete conversation around our strategy in that setting once we’re able to talk about the Phase 1 data from the two studies that are presented at ASH.
In terms of combinations with other drugs with other mechanisms of action, to if you will hit the disease from different angles there is an overwhelming I think interest in studying this drug in different combinations from both clinical investigators as well as from companies sponsors that have other investigational drugs.
As you can imagine, weighing through that demand and prioritizing it as a small company is critical. We are in discussions with the number of investigators around investigator sponsored studies including Quizartinib in combination with other drugs with novel mechanisms of action. It would be premature to discuss those studies and advance of the investigators making announcements that the studies are open for enrollment, but the shorter answer Nick is, yes, we do see potential there and it will take time to develop it.
Athena, I don’t know if you want to add to that or not.
No, I think Nick, the only think that Mike mentioned earlier as the focus has been around the newly diagnosed setting is clearly the aspect of giving Quizartinib as post-transplant maintenance is equally important and we’re extremely encouraged as we begin to look at the data from our ongoing study in the setting with the longevity that patients are staying on Quizartinib and clearly that staying in a response, so there is no rising mutation.
We have no further question. I will now turn the call over from Mark to Marcy for final remarks.
Thank you for joining us today on the call and for your interest in Ambit. If you have further questions or need additional information, please feel free to contact the Investor Relations department at 858-334-2125, thank you.
Thank you ladies and gentleman, this concludes this conference. Thank you for participating. You may now disconnect.
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