Jaren Madden - ‎Director, IR and Corporate Communications Adelene Perkins - President and CEO Larry Bloch - EVP, CFO, and Chief Business Officer

John Chung - RBC Capital Markets Mike King - JMP Securities. Jason Kantor - Credit Suisse Eric Stein - JPMorgan Brian Klein - Stifel Katherine Xu - William Blair Eun Yang - Jefferies

Thank you, Candice. And good afternoon, everyone.

Welcome to today's call to discuss our recent business progress and review our full year 2014 financial results. With me here today are Adelene Perkins, President and Chief Executive Officer; and Larry Bloch, Executive Vice President and Chief Financial Officer and Chief Business Officer.

Julian Adams, our President of R&D, is traveling and unable to join us today. Following our remarks, we will open the call for Q&A.

The press release issued earlier today details our results and is available on our website at www.infi.com. Please note that during this call, we may make forward-looking statements about our future expectations and plans, including clinical development milestones, the therapeutic potential of our product candidates and financial projections.

It is possible that our actual results may differ materially from what we project today due to the considerations described in the Risk Factors section of the Form 10-Q of 2014. While these forward-looking statements represent our views as of today, they should not be relied upon in the future as representing our then current views.

We may update the statements in the future, but are not taking on an obligation to do so. Now, I'd like to turn the call over to Adelene.

Thanks, Jaren. Good afternoon, everyone, and thank you for joining us.

At Infinity, we are working to realize our vision of developing better treatments for patients with blood cancer. Our lead molecule duvelisib has demonstrated a high level of clinical activity across a broad range of hematologic malignancies.

Entering 2015, we have four important pillars in place to help further advance our goal of bringing duvelisib to patients. These include: first, a product candidate with the potential to become a first-in-class PI3 kinase delta gamma therapy; second, a global partnership with AbbVie for duvelisib in oncology that enables us to accelerate and expand the development of duvelisib and ultimately the potential to expand our commercial reach.

Third, the anticipated completion this year of patient enrollment in DYNAMO and DUO, our two registration focused trials in indolent non-Hodgkin lymphoma in chronic lymphocytic leukemia respectively. And fourth, our strategy to develop duvelisib in combination with other novel targeted agents including AbbVie's BCl-2 inhibitor venetoclax also knows as ABT-199.

And we have a dedicated team of citizen owners who are working every day towards this vision. In Julian's absence, I'll briefly review our development program for duvelisib.

We are continuing to enroll patients in DYNAMO, our Phase 2 monotherapy study designed to enable registrations which is expected to enroll approximately 120 patients with refractory iNHL. The primary end point of the study is overall response rate.

We hope that positive data from DYNAMO will support establishing duvelisib as the best oral therapy for the treatment for iNHL and could provide a compelling rationale to seek accelerated approval. We expect to report top line results from this study in the second half of the year.

Patients enrollment is also going well for DYNAMO+R, a Phase 3 randomized, double-blind, placebo-controlled study comparing duvelisib in combination with Rituxan to placebo plus Rituxan in patients with relapsed follicular lymphoma. This trial is expected to enroll approximately 400 patients and can serve as the confirmatory study for DYNAMO.

Our enthusiasm for duvelisib and iNHL is based on maturing Phase 1 data in patients with relapsed refractory iNHL, most recently reported at the ASH meeting last December. In the study, duvelisib demonstrated an overall response rate of 72%, including a 33% complete response rate among 18 patients who received duvelisib dosed at 25 mg twice daily, which is the dose being used in our registration study.

This is the highest response rate that's been reported to date with any monotherapy in iNHL. We are also encouraged by the early durability data.

The median progression free survival and median overall survival had not yet been reached with 69% progression-free survival and 89% overall survival for patients at 24 months. In terms of the safety profile, the majority of adverse events were Grade 1 or 2, reversible and/or clinically manageable.

Given the strength of our data in relapsed refractory patients, we are also evaluating duvelisib in the frontline setting. We have recently initiated a Phase 1b/2 study in patients with previously untreated follicular lymphoma, designed to compare the safety and activity of duvelisib plus Gazyva to duvelisib plus Rituxan.

We are also planning to initiate new studies in patients with iNHL this year, and we look forward to providing more details as we move closer to beginning these studies. Turning to our second indication CLL, we are continuing to enroll patients in the DUO study.

This trial is designed as a registration supporting Phase 3 randomized, open label study in approximately 300 relapsed refractory patients and will evaluate the safety and efficacy of duvelisib compared to ofatumumab. We expect to complete enrollment in the second half of 2015.

DUO is supported by encouraging Phase 1 data, which showed an 83% novel response rate and a 57% overall response rate. We also saw one complete response, which is uncommon for monotherapy treatment.

The majority of adverse events seen in these patients were grade 1, 2 reversible and clinically manageable. As with iNHL, we are also seeing early evidence of durability in CLL with 59% progression free survival and 63% overall survival for patients at 24 months.

While we are encouraged by our monotherapy data, we are anticipating the evolution of the treatment landscape for CLL. As patients who relapsed on ibrutinib therapy tend to have an aggressive form of disease, we believe there will be a tremendous medical need for new effective treatment options for these patients.

At ASH, we reported early evidence of activity in patients previously treated with ibrutinib. Based on this data, we've recently initiated a Phase 1b clinical study of duvelisib in combination with Gazyva in patients with CLL whose disease has progressed following treatment with a BTK inhibitor.

We believe that targeted combination may have the potential to provide patients with effective, durable treatment options and liberate patients from chemotherapy. In addition to the two studies of duvelisib in combination with Gazyva now underway, we expect AbbVie to initiate the first clinical study of duvelisib in combination with venetoclax this year.

This first study of duvelisib plus venetoclax is supported by preclinical data conducted in collaboration with Dr. Varsha Gandhi at the MD Anderson Cancer Center in Houston, and will be presented in a poster on April 20 during the annual AACR meeting.

This work highlights our efforts to identify synergistic combinations of targeted therapy so that we can better leverage the unique profile of duvelisib with a hope of providing deeper and more durable responses for patient. This and the other new trials I described today are all part of the expansion of our DUETTS global development program to evaluate the therapeutic potential of duvelisib in patients with blood cancer across multiple indications and lines of therapy.

We expect 2015 to be an important year as we look to complete enrollment in both of our registration focused studies, while extending our development program in iNHL and CLL. With these efforts, we remain on track towards advancing our mission of building a sustainable, fully integrated biotechnology company.

We look forward to this next stage of growth for Infinity and for duvelisib as we work to develop better treatment options for patients with blood cancer. I will now turn the call over to Larry to discuss our financials for the quarter.

Thanks, Adelene. We continue to be in a strong financial position to execute on our strategic development plan and to explore the broad potential of duvelisib.

As part of our global collaboration with AbbVie to develop and commercialize duvelisib in oncology, we received an upfront payment of $275 million and are eligible to receive up to $530 million in additional payments for the achievement of development, regulatory, and commercial milestones. Of this $530 million in milestone payments, $405 million are related to milestones through the first commercial sale of duvelisib, including a $130 million milestone payment associated with the completion of patient enrollment in either DYNAMO or DUO.

The remaining $275 million of the $405 million in potential regulatory filing and approval milestones to the first commercial sale are designed to fund Infinity's continuing investment in duvelisib development program up to commercialization. Now I'd like to provide an overview of our financial results for the fourth quarter and year-end 2014.

December 31, 2014, Infinity had total cash investments of $333.2 million compared to $214.5 million at December 31, 2013, and $379.5 million at September 30, 2014. Revenue during 2014 was $165 million, which was composed of a one-time license fee of $159.1 million associated with the strategic collaboration with AbbVie and $5.9 million in R&D services.

Infinity did not record any revenue in 2013. R&D expense for full-year 2014 was $143.6 million, compared to $99.8 million for 2013.

The increase in R&D expenses in 2014 compared to 2013 was primarily due to higher clinical development expenses related to duvelisib. General and administrative expense was $29.3 million for the full-year 2014 and $27.9 million for the full-year 2013.

Net loss for full-year 2014 was $17.4 million, or a basic and diluted loss per common share of $0.36, compared to $126.8 million, or a basic and diluted loss per common share of $2.64 for 2013. In January, we provided financial guidance for 2015 which remain unchanged.

We set revenue for 2015 to range from $105 million to $125 million based upon the anticipation of the $130 million milestone payment for AbbVie associated with the completion of enrollment for the first occur of either DYNAMO or DUO. We set net loss for 2015 to range from $190 million to $210 million.

And we expect to end 2015 with a yearend cash and investment balance ranging from $145 million to $165 million. This yearend cash investment forecast is based on the company's current upgrading plan and exclusive of any business development activities.

Our financial strength is important and we are pleased to have a global strategic partnership designed to help fund development of duvelisib while also providing opportunity to accelerate and expand the development program. Registration enabling phase moving towards enrollment completion this year a validated path to regulatory approval and strong IP protection in 2030, we are well positioned to advance our vision of becoming a fully integrated biotech company that can deliver best in class medicine and making meaningful difference in patients' lives.

With that we will open the call up for Q&A.

Hi, thanks. This is John on behalf of Michael Yee.

Just wondering if you could just provide a little more color on the pending combination study with venetoclax? Have you indicated the specifics, and also any details on whether it is in a sequence one after the other or used in combination together?

And who makes the primary decision how these drugs are combined? Thanks.

So thanks, John. Important part about studying of combining duvelisib and venetoclax is that we've got strong preclinical data that we presented at AACR; the details of the exact clinical trial will disclose at the time of that trial is being started.

And we are working collaboratively with AbbVie in designing the right trial; of course the first trial will be focused on safety. So that's our primary objective is demonstrating that the two drugs can be safely combined, and we are still working with them on exactly what that patient population will be and we will describe that as the trial gets started.

And also just on maybe the potential combination approaches, whether sequence or combined on top of each other?

Again, that's a detail that we will disclose at the time that trial is actually initiated.

Thanks for taking the question guys and congrats on all the progress. Just a couple of quick detailed questions on some of the trials, I am just wondering in follicular and the combination with Gazyva since my recollection is Gazyva is only approved in conjunction with chlorambucil, how do we envision enrolling patients with newly diagnosed disease?

So I am not sure Mike I understand your question. The trials that we have is, as you said, a newly diagnosed disease, it is duvelisib patients will be enrolled either on duvelisib plus Gazyva or duvelisib plus Rituxan, and it will allow us to see which of these anti-CD 20s are better in this patient population, and then from that we will go forward and design the control trial.

Right now, we are just assessing both of these two agents.

No. I understand, but Gazyva is only indicated for relapsed refractory setting.

Isn't it with in combination with chlorambucil?

Yes. We don't need -- it doesn't need to have a label for the patient population that we are studying it now, no we are enrolling this trial now.

Okay, all right.

We thought what was important about the study was there is interesting data about Gazyva and obviously a lot of data out there on Rituxan, but we really thought it to be rigorously data driven to basically have a head-to-head study to determine which is best in this patient population.

Right, okay. All right, thanks for the clarification on that.

And then with regard to both the studies you have got, one study specifically for patients with CLL that relapsed after treatment with Imbruvica and then you also have -- the registration strategy in the relapsed refractory setting, I am just wondering if someone would -- how you differentiate the randomization to DUO versus -- I don't know if it has an acronym for the BTK failures, but how are you going to stratify those patients into one trial versus another?

So, the DUO trial, which is now enrolling is for relapsed refractory patients, who have not previously been treated with the BTK inhibitor, so there is a very clear delineation, those are non overlapping trials. And then the trial that we most recently announced is for patients who have already progressed on any BTK inhibitor, it doesn't have to be just ibrutinib, and they will be put on the duvelisib plus Gazyva.

Okay, and in that population, will you be undertaking genomic analyses to see what mutations they may have?

Absolutely, yes. We have very extensive translational medicine effort that we’re looking to understanding exactly which of those patients respond.

As we have even in our Phase 1 data where we treated patients who have progressed on ibrutinib, we have extensively profiled those patients.

Great. Can you hear me?

So I just was curious on the DYNAMO study, you made the statements that you are hopeful that it is going to establish as kind of best in class. What do you think you need to show both in terms of safety and efficacy in order to feel like you hit that bogey?

Sure. So we have a benchmark now with the data that has most recently been presented on idelalesib, and we are encouraged by the Phase 1 data that we’ve generated which had higher overall response rate and higher complete response rate than has been reported, and so we think that gives us a cushion anywhere between what the response rate that we thought in our Phase 1 study and the response rate that were the basis for the approval of idelalesib, we think anything in that range on the efficacy and then anything that might show a better tolerated treatment profile.

Right. I mean I guess given -- it is hard to compare trial to trial, different patients and all that, but do you think with these number of patients you have potentially power to say the lower end of your confidence interval could be above what's been seen for idelalesib to be able to more strongly make the case, but there could be superiority there given it is not a comparative study?

Yes, no. Jason, you are absolutely right.

I mean we have to be very careful with trials that are not head to head. That we don't over extrapolate the data.

I think it provides you general reference point of what we are looking for and with the design DYNAMO as a monotherapy single arm trial is reflective of the fact that there are no drug that have been -- have a full approval in this patient population. So it's still being that there are no fully proof treatment options for these patients and we need to show that there is a benefit over what would be the typical course of progression in those patients.

But we are careful not to go too far on direct comparison across trials. What I can tell you is of course we power the study such that we are comfortable with the 120 patients we have, if we see the kind of response rate and complete response rate that we are hoping to see, it would be and we have the discussion with regulatory agencies that with the responses we hope to see it could be the basis for an accelerated approval.

And then finally I think you guys mentioned that you are now planning to take the inflam [ph] program forward without a partner, could you speak to what sort of interest there might be out there for these assets of those indications? Thanks.

This is Larry, Jason. So we are -- we have initiated some discussions at the conference beginning of the year and there is certainly interest that we have had inbound calls about in the same information and we think in this case probably the optimal way to for a partner that we want to have to perceive would be probably through the inhaled formulation routes to deliver it directly to lung [ph]

Hey, guys, this is Eric in for Anupam. Can you hear me?

Great, just wondering if there any updated thoughts on the potential development pack T -cell informant with duvelisib. I know you guys have mentioned attending a small T-cell forum last month, and just wondering if there is new -- anything new in your -- that could help shift off some potential path forward.

And I have a follow up.

Yes. So thanks, Eric.

You are right. We had contingent of the Infinity counsel team at the T- cell meeting in San Francisco recently and lots of interesting conversations with lots of investigators and lot of ideas, we are just not in a position yet to describe what that path forward will be.

Yes. It will be bringing that feedback from the T-cell forum conference back to our joint development committee and in the context of our collaboration with AbbVie that would be the decision making for all additional trials.

Okay, great. And maybe kind of following on Mike's question about the BTK failure trial, just looking at the trial on clintrials.gov and some of the dosing information that's listed there is a little bit confusing with both 25 mg and 5 mg dose being listed.

I am just wondering if it means that there is potential for patients to be possibly dose escalated above 25 mg BID. I am wondering if you can try and clarify that.

Thanks.

The current plan is not to go with the 25 mg twice a day dose for duvelisib and the approved dose for Gazyva, so that's -- we don't currently have any plans to go above that.

Hi, guys, thank you. Adelene you highlighted the Phase 1 data in NHL.

And just wondering if you think will have mature PFS and survival data available at this year's ASCO?

So we presented the Phase 1 data at ASH and that's for maturity of that dataset. When the study is completely finished we will have probably wrap up publication but we do not anticipate continuing to report on that data.

We have gotten everything out of that we need to dictate the strategy going forward. And the next data that we plan to present in indolent non-Hodgkin lymphoma will be from the DYNAMO trial and we expect to have that data from DYNAMO at the end of this year.

Okay, great. And then just to follow up who is responsible for submitting the NDA and any sort of interactions with the FDA?

Is it a joint process between you and AbbVie or just one or other company lead that effort? Thanks.

So Infinity is responsible for filing the NDA. Yes, at the same time we are working very collaboratively, we have great working group meetings and governance groups with AbbVie but Infinity is responsible for filing the NDA.

AbbVie is responsible for filing the MAA outside the US. And our regulatory and other teams are working collaboratively on that effort.

Great and good afternoon. I am just wondering after the failure of duvelisib in asthma, RA and what sort of trigger the decision to discontinue IPI443 as well?

And is it scientific or resource related type of decision? And another question for Larry, what are you going to do with the Deerfield financing at this moment?

Sure. So first question I think Kath is regulated to the 443, that was up surely scientific data driven analysis, the data from asthma study and our RA study were getting input to our determination of the best path forward IPI443 and information and because we think that the best way to move forward is to inhale group now to get the type of response we saw the 25 mg dose in asthma but not with systematic route since we don't have inflammatory expertise nor we do intend to develop it.

We think the best approach forward going now is to have a partner who already has these capabilities to take the 443 forward information. Your second question regarding Deerfield is that the Deerfield option is going to lapse because we think that there are alternative financing resources that we can tap in the future if and when we need them.

Do you still believe that 443 is potentially advantageous over duvelisib?

No. 443 and duvelisib have very similar profiles of being inhibiting both the delta and gamma isoforms of PI3 kinase .We don't see the need to take two molecules with similar profiles forward in hemalignancies or oncology because we are really very pleased with what we are seeing with duvelisib.

So we don't see a role for 443 in oncology. We really referring that forward in the events that we wanted to develop that in information I think our conclusion is that it is going to be require some more work and information because we believe that it will most likely require inhale delivery for asthma and that's not something that is in Infinity's core area of strength and so we believe it is better for our partner to develop it there.

But we really like what we are seeing with duvelisib and oncology and we see no reasons for a second delta gamma in oncology.

I understand that. I was referring to the auto- immune area whether that increased activity in 443 against gamma what really make a difference scientifically in the auto-immune disease?

I understand.

Okay, I would say yes. We don't know.

I mean that's something for our partner will have to determine and it is a combination of both is 443 better than duvelisib information and or would a different delivery route, in short that it would be more application in asthma, so that something our partner will determine.

Hi, thank you. Question on the regulatory side.

So is it fair to assume that at least in the US, you do file for iNHL first for on accelerated basis and still that is one of the normal usual regulatory filing?

Yes. Our current plan is with -- to seek accelerated approval for the DYNAMO trial.

We haven't yet guided on whether the relative timing of filing in iNHL for DYNAMO and CLL and DUO are but we will be moving both of those in filing on both of those as quickly as possible. But DYNAMO would be accelerated approval; DUO would be seeking full approval because it is randomized trial against obinutuzumab.

Okay. How long in the EU, the iNHL, the filing would be potentially you have to file for DYNAMO study or do you need have DYNAMO+R data in order to file?

So the driver of the filing in Europe will be the DUO study. And the way the approvals work in Europe, duvelisib and could be approved for both CLL and indolent on the basis of the DUO study.

I see, okay. And then last question is DYNAMO+R study they risk into the December last year, how long do they take to enroll all 400 patients?

Eun, we haven't yet provided guidance on the completion of enrollment in the DYNAMO+R study. What we typically do is the year in which we expect to complete enrollment we provide that in our guidance so that you can infer that we don't expect completion of the DYNAMO+R in 2015 and then in the year in which we think it will complete, it will be part of our guidance.

Thanks for taking the follow up. Can you hear me?

Just a quick follow up question about -- sorry -- now it is gone out of my head, you know what if we can may talk offline because I have back in the queue and I forgo what --

We will give you call back after.

Hi, thanks. This is John here again.

Just one follow up. I am just thinking there is good chance you partner AbbVie -- reach the market first before duvelisib based on their data from the GP population, so just curious given they maybe out in the market with a price tag, how much would you ask for price of duvelisib and who make that decision?

Is it a joint decision with AbbVie? Thanks.

Thanks, John. You tucked a little bit but I think I got the jest of the question.

The way we structure our relationship with AbbVie is we hope that through our joint commercialization committees and joint committees that we will make decision collaboratively. We also did divide if there were dispute certain decisions that either party would have the equivalent of trump vote and so Infinity has the final decision making with respect to the pricing strategy for duvelisib.

AbbVie has to leverage their contracting organization, they will be having a final say on any final contracting so we have gone through a number of important decisions and each of us has that final say where necessary. And on pricing strategy that belongs to Infinity.

It is a miracle, it came back to me.

I didn't doubt you for a minute, Mike.

Yes, it is getting old stuff for the birds. Just wanted to ask you if we could get a sense of what the longest term on therapy now if you have got anybody on duvelisib?

Sort of picks up on an earlier question about comparisons to idelalisib in terms of the GI talks they have seen and I am just wondering if you have enough of treatment experience with duvelisib to figure out if the side effect profile, the GI side effect profile is going to be any different?

Right. So with respect to the first question about what's the longest that someone has been on study, that would be the data that we had presented at ASH and so it is iNHL -- let's see where that data is, we had a patient that was out 32 months which was the longest patient on our Kaplan Meier curve and you can see obviously there are fewer patients that are out that long.

We had 12 patients that were out to 20 months and to your question absolutely, we will learn more and the longest patients are on study in terms of the side effect profile were --as we've seen so far the AE sort of been reported our grade 1 grade 2 they are manageable so we are not seeing a safety signal but alarming at this point but of course that's a number one priority and we will continue to monitor that as we have more patients who have been on study for longer and particularly in the DYNAMO study where we just have larger group of patients.

Well, thank you everyone for joining us today. And we look forward to talking with you throughout the rest of the year.

Bye.