Infinity Pharmaceuticals, Inc.
Q1 2020 Earnings Call Transcript

Published: 12 May 2020

[Operator:]

Ladies and gentlemen, thank you for standing by. And welcome to the Infinity Pharmaceuticals Conference Call to discuss Company's Operations and Financial Results for the First Quarter 2020. My name is Elaine and I will be your operator for today's call.At this time, all participants are in a listen-only mode. There will be a question-and-answer session to follow. Please be advised that this call is being recorded at Infinity's request.Now, I would like to introduce your host for today's call, Jayne Kauffman. Please go ahead.

[Jayne Kauffman:]

Thank you, Elaine, and good afternoon, everyone. Welcome to today's call to discuss our recent business progress and review our first quarter 2020 financial results. On the call with me today are Adelene Perkins, Chief Executive Officer; and Larry Bloch, President. We will open up the call for Q&A following our remarks.The press release issued this morning details our results and is available on our website at infi.com. Please note that during this call, we may make forward-looking statements about our future expectations and plans, including clinical development objectives, the therapeutic potential of our product candidates, our strategic plans and strategies, and financial projections.Our actual results may differ materially from what we project today due to a number of important factors, including the considerations described in the Risk Factors section of our annual report on Form 10-Q for the first quarter of 2020 and in other filings we make with the SEC. These forward-looking statements represent our views only as of today, and we caution you that we may not update them in the future, whether as a result of new information, future events or otherwise.Now, I would like to turn the call over to Adelene.

[Adelene Perkins:]

Thanks, Jayne, and thank you to everyone for joining us today. I'd like to start off today's call by recognizing the unprecedented circumstances we are facing at Infinity and throughout the entire life sciences community with the ongoing COVID-19 pandemic. While COVID-19 has created new challenges that we are facing together as a community, it has also highlighted the dedication, commitment and innovation that is allowing a continued advancement of desperately needed treatment for patients. We remain committed to our clinical approach which was designed to demonstrate potential benefit of IPI-549 treatment for the patients in our trials, who have some of the most challenging cancers with poor prognosis. It is imperative that they have continued access to treatment and that the development of promising new therapies continues. I'm particularly proud of our team at Infinity along with collaborators and investigators are continuing to prioritize the safety of our patients and teams, while still enabling our progress in the clinics to continue.As a reminder, our clinical program for IPI-549 has multiple ongoing trials including MARIO-275, a randomized controlled Phase 2 study in collaboration with BMS, evaluating IPS-549 in combination with Opdivo in patients with advanced urothelial or bladder cancer; MARIO-3, our Phase 2 study in collaboration with Roche/Genentech to evaluate the combination of IPI-549 with Tecentriq and Abraxane as a frontline treatment in patients with triple negative breast cancer or TNBC; and in combination with Tecentriq and Avastin as a frontline treatment for patients with renal cell cancer or RCC. We also have MARIO-1, our Phase 1/1b study in collaboration with Bristol-Myers Squibb, evaluating IPI-549 in combination with Opdivo in patients with advanced solid tumors.In addition to these Infinity sponsor trials, our collaborator Arcus Biosciences is running a Phase 1 study evaluating IPI-549 in a novel checkpoint inhibitor free regimen that includes their dual adenosine receptor inhibitor, AB-928, and Doxil in patients with relapsed/refractory triple negative breast cancer.I would now like to review the current status and updates of our studies. For MARIO-275 we were pleased to announce the U.S. FDA granted Fast Track designation for IPI-549 in combination with the checkpoint inhibitor Opdivo for the treatment of patients with advanced urothelial cancer. Fast Track designation is an important acknowledgment about the unmet need for these patients and the potential of this regimen to improve patient outcome.As you may recall, MARIO-275 is our controlled randomized Phase 2 study evaluating IPI-549 in combination with Opdivo in platinum-refractory immuno-oncology naïve patients with advanced urothelial cancer in collaboration with BMS. The objective of this controlled study is to evaluate the potential benefit of adding IPI-549 to Opdivo monotherapy building on the exploratory biomarker data from the BMS CheckMate-275 study, demonstrating an association between high levels of myeloid -- high baseline levels of myeloid-derived suppressor cells or MDSCs and lower median overall survival as well as Infinity’s MARIO-1 showing that treatment with IPI-549 reduced MDSC levels in the majority of patients treated. These data suggest that IPI-549 has the potential to further improve outcomes beyond what was seen with Opdivo monotherapy for this patient population.In today's press release, we shared that we recently held the first scheduled MARIO-275 Independent Data Monitoring Committee or IDMC meeting to review the safety data on the initial 42 patients treated in the study. In these 42 patients, liver enzyme elevations of Grade 3 and higher were seen in 7 patients, 5 with Grade 3 and two with Grade 4, one of which was newly observed and has not yet been reviewed by the IDMC. The liver enzyme elevations from the six patients that were reviewed by the IDMC were reversible and have resolved without sequel. Of the 17 patients that were evaluable for efficacy, objective responses have been observed both in patients with Grade 3 and above liver enzyme elevation as well as in patients without these elevations.Today, we've received a written communication from the IDMC, which was consistent with a safety management plan we had communicated to our sites earlier in the day, which included the continued treatment of patients now on study with additional patient monitoring, and a suspension of new patient enrollment.Pending review of additional data, our objective is to identify changes to or redesign of the protocol to support resumption of new patient enrollment in the future. In addition to the IDMC recommendations, we instituted a reduction in the dose of IPI-549 from 40 milligrams to 30 milligrams once daily, with no change to the Opdivo dose. We are comfortable with the pharmacokinetics and pharmacodynamics of the 30 milligram dose because as previously presented, there is near complete and sustained inhibition of PI3 kinase gamma with IPI-549 monotherapy at a dose of 20 milligrams once daily and above. The issue we are addressing regarding AST and ALP liver enzyme elevations is in the context of the package insert and prescribing information for Opdivo, which recommends the discontinuation of Opdivo following Grade 3 liver enzyme elevations. This is the result of the 1% to 5% occurrence of acute autoimmune hepatitis in with Opdivo as a monotherapy and in combination with ipilimumab. It is difficult to distinguish between liver enzyme elevations due to Opdivo and IPI-549. So, we are taking a prudent approach in pausing enrollment of new patients while we analyze the data.Our goal is to develop a protocol amendment that ensures patient safety, while enabling us to evaluate the potential benefit of IPI-549 plus Opdivo in advanced bladder cancer patients.Now, transitioning to a brief update on MARIO-3. As a reminder, there are two cohorts in this ongoing Phase 2 study. One, evaluating IPI-549 in combination with Tecentriq and Abraxane as a frontline therapy in patients with triple negative breast cancer; and another evaluating IPI-549 in combination with Tecentriq and Avastin, as a frontline therapy for patients with renal cell carcinoma. The MARIO-3 multi-cohort study of 30 RCC patients and 60 TNBC patients is being conducted in approximately 25 sites in the U.S.While some site initiation activities have been conducted remotely, MARIO-3 site initiation has been negatively impacted by COVID-19 and we are working to initiate additional sites over the coming months. Independent of the impact of COVID-19, the TNBC cohort is also experiencing initial enrollment and site initiation delays, which we're working closely with our CRO and investigators to address. By working with sites and investigators to leverage early site initiation and enrollment experience, insights can be generated to inform new site initiation and patient recruitment initiative. Though COVID-19 has limited our access to sites over the past few months and made this work more challenging, we have identified and are implementing initiatives designed to accelerate site initiation in TNBC enrollments.Despite these challenges, a number of sites have continued to enroll patients, which is taking place on a patient-by-patient basis with investigators after carefully evaluating the ability of patients to stay on treatment and follow steady protocol visits and procedures. In early April, we provided an update regarding the potential impact of COVID-19 on our clinical programs. While the situation continues to evolve, we can confirm that the pandemic is negatively impacting new patient enrollment and site initiation across our clinical programs. Patients enrolled in MARIO-275, MARIO-3 and MARIO-1 have continued treatment and study visits with limited disruption to-date. Infinity is working closely with trial sites to protect the health and safety of patients and trial site personnel to enable to continued treatment of patients while maintaining compliance with protocols to ensure study integrity. We have not experienced and do not anticipate any COVID-19 related disruptions to drug supply for ongoing trials.The patients in our trials have extremely challenging to treat cancers, often with poor prognosis and we are committed to trying to ensure that they can safely continue to access treatment and that we can continue the development of drugs with the potential to provide meaningful patient benefit. We anticipate being able to provide an update on our clinical programs and financial guidance by our second quarter webcast.Moving next to corporate updates, we were pleased to add Dr. Richard Gaynor to our Board of Directors. Richard has a well-established track record of success including senior roles at Neon Therapeutics and Lilly Oncology. We are thrilled to have him on Board and are already benefiting from his insights. We are also proud to have established a world-class Clinical Advisory Board that we believe will provide unmatched guidance and expertise as we advance our IPI-549 clinical program.Before I transition the call over to Larry, I'd like to acknowledge that it is challenging for us and you as valued stakeholders that we're not able to provide concrete guidance on when we expect to complete enrollment or have data from our trials. While I wish I could be more specific, given the evolving circumstances we're unable to make more definitive statements on timelines at this time, but look forward to updating you as we have additional clarity.Finally, I'd like to take a moment to acknowledge the incredible work and commitment we have seen from our team at Infinity, our investigators and our fantastic collaborators at BMS, Roche/Genentech and Arcus, particularly during these unprecedented and challenging times. By working together, we're ensuring that our progress continues and hope these efforts lead to meaningful improvements for patients in need.And with that, I'll turn the call over to Larry.

[Larry Bloch:]

Thanks, Adelene. As we discussed on our last call in January, we completed a $20 million asset-backed financing with BVF Partners with sole recourse in potential royalty payments due on future sales of patidegib, a hedgehog pathway inhibitor discovered by Infinity which we licensed to PellePharm back in 2013.And this financing enabled us to provide guidance last quarter that I just think financial resources were sufficient to fund all of our ongoing clinical programs through key data readouts. But due to the delays related to COVID-19 pandemic as well as delays that Adelene discussed specific to MARIO-3 as well as the MARIO-275 suspension of enrollment, we no longer believe our current resources will be sufficient to fund this milestone. While we continue to project cash runway in the second half of 2021, we do recognize that we'll need to find additional cost savings and/or seek additional capital resources to fund IPI-549 studies through these key data readouts.Now turning to our first quarter financial results. At March 31, 2020 we had total cash, cash equivalents and available-for-sale securities of $50.3 million, compared to $42.4 million at the end of last year, December 31, 2019. And during the first quarter of 2020, as Adelene discussed, Infinity did recognize a $20 million gross proceeds from BVF, this is net of transaction costs, as a liability that will be amortized that using the effective interest method over the full life of the arrangement in accordance with the accounting guidance.While recognized this as a liability for the purpose of accounting, the company is not obligated to repay the $20 million to BVF.Turning to R&D. Our research and development expenses for the first quarter of 2020, it was $7.3 million compared to $5.8 million for the same period in 2019 and the increase in R&D expense in 2020 compared to 2019 was primarily due to an increase in clinical and development activities for IPI-549. G&A expense was $3.3 million for the first quarter of 2020 compared to $3.4 million for the same period in 2019 and net loss for the first quarter 2020 was $10.9 million or a basic and diluted loss per common share of $0.19 compared to net loss of $13.7 million or a basic and diluted loss per common share of $0.24 in the same period in 2019.Our financial guidance remains unchanged. So we expect [2019] net loss to range from $40 million to $50 million and we expect to end 2020 with a cash and investment balance ranging from between $15 million and $25 million. So, based on our current operating plans, which exclude additional funding or business development activities, we do anticipate our existing cash, cash equivalents and available-for-sale securities will be adequate to satisfy our needs into the second half of 2021.But this financial guidance does not include potential funding or business development activities, including potential $5 million milestone payment from BVF based upon PellePharm’s ongoing Phase 3 clinical trial of patidegib topical gel in Gorlin Syndrome, or any milestones from, or the sale of the company's equity interest in PellePharm itself.So, in closing, I would say we really appreciate your patience and continue to work understand the ultimate impacts on timelines for enrollments and data readouts and we look forward to be able to provide an update on our clinical programs and potential guidance by our future webcasts.At this time, we’ll turn the call for questions. Operator?

[Operator:]

[Operator Instructions]. Anupam Rama. Your line is open

[Anupam Rama:]

[Audio Gap]And then elevations were reversible. So I was just wondering if you can comment on the typical time to resolution for these events. And if you have the data off the top of your head, maybe how this compares to what you might expect from Opdivo -- sorry Opdivo alone? And then on MARIO-3, on the enrollment and site initiation delays, I guess do you have any theories here on the non-COVID impact and then can you give us a sense of how many of the 25 sites are experiencing these non-COVID delays? Thanks so much.

[Adelene Perkins:]

Sure. So, Anupam you broke up a little bit at the beginning. So -- but was your first question, how long it takes for the liver enzyme elevations to resolve?

[Anupam Rama:]

Yes, that's correct, yes.

[Adelene Perkins:]

Yes. So, for the six patients that were reviewed, they resolved very quickly. So, the patients were put on a dose hold and the resolution was very rapid, and as we said, without any sequela. So we're comfortable with the speed and the reversibility as I mentioned. We're really focused on the challenge of differentiating from the more acute autoimmune hepatitis in Opdivo label. And so that's why we're doing the pause to figure out how to make sure we can safely enroll the patients going forward.On your second question on MARIO-3, are still experiencing challenges with site initiation for the TNBC cohort. We're working with them to address, collecting the data from the sites to understand, whether it's strictly operational and administrative in terms of receiving the necessary approvals to initiate the sites or whether there's any other factor at play that we need to address. So, we're collecting that data now.

[Anupam Rama:]

Okay. And then if I may just sneak one more in. In the press release you mentioned that there's one newly observed Grade 4 EE. Just wondering when that -- when the next meeting is, when that will be reviewed, the Data Monitoring Committee?

[Adelene Perkins:]

We don't have the next meeting scheduled yet with the IDMC. And so, we are looking to have discussions with the IDMC about the additional data and analysis that we'll be collecting. And so, we will probably review it at that time. In general, we have planned IDMC meetings at scheduled intervals. And so, this one may be reviewed when we are reviewing some of the data that we'll be collecting.

[Operator:]

And your next question comes from the line Kevin DeGeeter from Oppenheimer.

[Kevin DeGeeter:]

Perhaps with regard to the liver enzyme observations, could you put those in context to the Phase 1b experience? I think I guess even going back to SITC maybe about two years ago, it was an interesting, that were you looking at about 82 patients. The rates there were somewhat elevated from some of the data we've seen from nivol alone across different histologies. But my question here is, what sort of -- the order of magnitude of the increase here is notable from 1b but it's not a dramatic step up. So, I just want to make sure I'm appreciating, is this just sort of an ALT/ASP issue or is there sort of other aspects of the clinical presentation of some of these seven patients that informed the decision to pause enrollment?

[Adelene Perkins:]

So, Kevin, as you mentioned, we have seen Grade 3 liver enzyme elevations in our Phase 1. What we're focused on with the MARIO-275 is the frequency of these events. So, we're seeing them at a higher rate than we saw them in MARIO-1. And the reason that we're pausing enrollment is again, because of this relatively rare but important acute autoimmune hepatitis that came with Opdivo as a monotherapy and the path that we can't distinguish between the two. So, we've really got to get in and dig into the PK and the PD from the patients that we dosed to-date to better understand that, so that we can assure our goal is to reduce the frequency of the Grade 3 liver enzyme elevations. And so, that's our goal. And that's the combination. What we're doing with the patients that are on study right now? We've reduced the dose. We're doing more frequent monitoring. And so, our objective is to reduce the frequency, which is we're seeing those Grade 3 elevations.

[Kevin DeGeeter:]

Then maybe just one more from me, and that is, we appreciate the update on MARIO-3 for the TNBC cohort. Can you just remind us with regard to the RC cohort, where you are there in terms of a number of open sites and what was the prior guidance with regard to an update on that cohort?

[Adelene Perkins:]

Sure. So, our prior guidance on renal cell was that we would complete that with 30 patient cohort, that we would complete enrollment by the end of this year and have preliminary data. And we are still -- the only effect to that timeline that was unchanged but for COVID-19. And so we haven't had any delays that are not related to COVID-19 and we're really working with our sites now to try to understand how quickly they're going to be able to resume site initiation and enrollment coming out of COVID-19, so that we can quantify what we have up -- provide an updated guidance that we no longer accept to complete enrollment by the end of 2020 and that the completion of enrollment and the availability of data will be pushed into 2021 but we want to be able to provide more granular timelines, but we need to do more work with our sites to understand when may hope to come out of the COVID-19 slowdown.

[Kevin DeGeeter:]

And then maybe just building on that last observation and so my final question and that is, when we think about burn rate for the year, directionally it would seem to the puts and takes would be towards a lower burn rate from kind of the prior baseline expectations at a more aggressive enrollment trajectory. Larry, are there any items that might not be transparent as we think about, that sort of are increasing the expense side of the spectrum perhaps related to COVID-19 directly, that we should be mindful as we think about the flexibility you may have in balance sheet management?

[Larry Bloch:]

Sure, Kevin. Thanks for the question. So, yes I think in terms of the cash management and cash burn, the first quarter tends to be one of our higher quarters, because you have sort of annual bonuses prepays and as well as some drug purchases for the ongoing clinical trials. So, it's likely that the first quarter will be where our highest burns. But in terms of things that might be happening on a going forward basis, you can possibly think about mitigation efforts. As Adelene we said, we're trying to work with trial sites to understand what the enrollment dynamics are, then evaluation dynamics, and if there's ways that we can potentially accelerate those and of course those could be -- require additional funding from us in order to try to move the enrollment and initiation at a more solid pace.

[Operator:]

And your next question comes from the line of Jim Birchenough from Wells Fargo.

[Nick Abbott:]

It’s Nick on for Jim this afternoon. First question, just going back to the announcement from 275 on the liver enzyme elevations. So, this is a 2 to 1 randomization so approximately 28 patients that would have been in the combination arm. Can you break down for us in terms of this territory for events between combination versus Opdivo monotherapy?

[Adelene Perkins:]

Yes, thanks, Nick. As you know this is a blinded study and so we're not able to do a breakdown of either the AEs or of the responses, because it's really critically important that we not break the blind, so that we can maintain the integrity of the study. So, I'm sorry that we're not able to break that blind data.

[Nick Abbott:]

Is that the IDMC has?

[Adelene Perkins:]

Yes, yes.

[Nick Abbott:]

Okay. And you quoted, right, autoimmune hepatitis for Opdivo as a monotherapy, but obviously it's high with durability. So suggesting there's potentiation of this toxicity since one of the hopeful mechanisms of 549 is to improve the mean status. Is there a concern that you might be potentiating any signal that's from Opdivo versus something that's to do with 549 alone?

[Adelene Perkins:]

Nick, it's really a great question. But again, because we can't identify the adverse events and whether they're on the treatment arm or the control arm, we can't break down whether we think they're mechanistically tied to IPI-549. So, I'm sorry again that we just require...

[Larry Bloch:]

Nick to your point, this is Larry. It’s a insightful question. And when we talk about evaluating the risk benefit for patients, that's exactly what we're trying to understand in the context of the blinded study with IDMC.

[Nick Abbott:]

Okay. And then I'm interested to know if this has any impact on MARIO-3? Are you considering reducing the dose of 549 MARIO-3, since it’s also in combination with PD-1 checkpoint inhibitor?

[Adelene Perkins:]

Right. So, MARIO-3 as you know is a different combination in the different patient populations. So, we're really evaluating it independently, but looking very closely at both the safety and the signals of efficacy in that patient population. So, we will be paying very close attention to liver enzyme elevations, but we'll be looking at the actual data in the triple negative and renal cell patients.

[Nick Abbott:]

And then just one from me and that is, would you consider terminating MARIO-3 to carry you through to the finish of 275 with the runway or even perhaps the more troublesome TNBC cohort?

[Adelene Perkins:]

We haven't had any discussions around how we might change our portfolio. So, right now we're really just focused on how do we continue with the trials and how do we move them forward. We haven't had any other discussions at this point yet.

[Operator:]

Your next question comes from the line of Soumit Roy from JonesTrading.

[Soumit Roy:]

Hi everyone. Thanks for taking the question. Could you give us a little sense of when we will get an update on the status of MARIO 275 enrollment? Is it a matter of weeks or this we have to wait till the second quarter earnings or is there possibility we will get interim look at the data or you would wait until the entire trial results during 2021?

[Adelene Perkins:]

Yes, Sumit. So thanks for the question. We expect to provide the next update on the second quarter call, which will be very end of July or beginning of August. And so in that time, we will have analyzed the data and worked on protocol amendments that would allow us to proceed and we would -- it will provide an update on where we are in that process by the second quarter call. I don't expect that we'll be sharing any of the data from these first 42 patients that we reviewed with the IDMC. Again because it's a blinded study, I do expect that we won't have the data from the study until it's completed.

[Soumit Roy:]

Do you have the distribution of LFTs, they're coming from one center or is there a possibility these patients have been infected by SARS-CoV-2 and causing any information, or just well distributed around from different sites? And the last question is, do we know which cohort from MARIO-1 end of this year we're going to see data from?

[Adelene Perkins:]

So, first on understanding whether there's a concentration of any liver enzyme elevations at sites. That's precisely the data that we're digging -- we're going to be digging and looking at each of the sites where these happen, is there anything that will explain the elevations that we've seen. And so that's really the focus sort of looking at the sites, looking at the individual patients, looking at any con-meds, any previous history. So we're really going to be digging in and that's really why we put the new enrollment on pause until we can go in and do that digging. So those are the key questions and answers that we'll try to get going forward.And with respect to MARIO-1 is as we've said, we're conscious of it, we will absolutely be presenting the full data set at some future point. Any update that we do before the study is fully completed will be tied to any additional studies that might be suggested by the data so that if there's data that's coming out of MARIO-1 that will inform our interest in pursuing additional trials, that's the data that we'll be prioritizing for presentations until we have the whole study completed and present the comprehensive clinical and translational data set at some future point.

[Operator:]

And your last question comes from the line of Andrew D'silva from B. Riley FBR.

[Unidentified Analyst:]

This is [Wayne Wu] on for Andy. So, just a few questions from us to start. Could you give us additional color on what we should expect in terms of amendments for the MARIO-275 and are you still going to be able to utilize the data from the patients that were enrolled before?

[Adelene Perkins:]

I can't provide any insight on what may be in the protocol amendment because that's really going to be informed by the analysis that we'll be doing. So, we have to -- some of the key questions are around the pharmacokinetics and pharmacodynamics. And one of the reasons that we paused new enrollment is that that's data that we need to go get and analyze so that will inform our suggested protocol changes. So, that will really be data driven. And the second part of your question is, yes, because -- and that’s -- will the 42 patients be included in the analysis? Yes, they will be, which is why we're being so rigorous of ensuring the study blind, and not providing any data that's unblinded either from safety or from efficacy with respect to where those events have occurred on either the treatment arm or the control arm. So, we're taking great lengths to ensure that should keep the blind so that those patients will be counted towards the ultimate analysis from the study.

[Unidentified Analyst:]

Okay. Thanks. And as it relates to the enzyme elevations we're seeing, could you please refresh our memory and let us know when you would have expected for patients on Opdivo alone, what was initially seen in MARIO-1 and also does the cause in the study change your thoughts on MARIO 275's ability to be a registrational study?

[Adelene Perkins:]

So, what we've seen in MARIO-275 is a higher frequency of the Grade 3 liver enzyme elevations than we saw in our Grade -- in our Phase 1 study. So we've seen an increase and that's what we're really doing the detailed detective work now to understand exactly why we're seeing greater frequency. When we finish that analysis and our goal is to identify protocol amendments that will enable us to continue to safely dose patients, so that we can evaluate what we still hope will be a benefit for these advanced bladder cancer patients of the combination of Opdivo and 549 in finding a path to go forward and then completing the study, which is our goal. If the data suggests that there's a significant benefit, we will have discussions with the regulatory authorities, about what is the best path to approval. But ultimately our goal is to seek approval with this regimen in this patient population, and that will all be a function of the data that we're able to generate.

[Larry Bloch:]

Yes, I think -- this is Larry. And I think one thing worth emphasizing is that for the LFT increases that were reviewed by the IDMC, those were reserved and resolved without sequel. But the critical issue is in the context of the Opdivo, not just liver enzyme elevations but 1% to 5% occurrence of acute autoimmune hepatitis. And so, that's really the context with which we're trying to analyze this data and ensure patient safety. It's not sort of ALT/ASP elevations in the abstract, but how they may or may not result in with Grade 3 liver enzyme elevations or higher in acute autoimmune hepatitis.

[Unidentified Analyst:]

Okay. Thanks for the color. A couple more quick ones if I may. Could you please give us an update on the competitive landscape specifically as it relates to PI3 K-gamma? Has there been any updates in -- on the Arcus Biosciences’ on their like preclinical candidate as well?

[Adelene Perkins:]

No. we -- what I can tell you is that we watch carefully if there are any other PI3 kinase gamma specific inhibitors in clinical development, and we're not aware of any others that are in clinical development. We know that there are some that are in preclinical development, but we don't know what the status is of the move of those drug candidates into the clinic.

[Larry Bloch:]

The two that we are aware are AstraZeneca and as you said Arcus Biosciences.

[Unidentified Analyst:]

So, finally as it relates to Arcus. Does their work with the PI3 K-gamma change turns your thoughts on collaborating with them going forward?

[Adelene Perkins:]

No, we are very aware that they have an interest in this mechanism and that they have a preclinical program and they've been very forthcoming. I think we both share an interest in seeing what's the clinical benefit of the combination that we're testing together with their dual adenosine antagonist and Doxil. So we both have an interest in generating that data.

[Operator:]

And we have a follow up question from Jim Birchenough with Wells Fargo.

[Nick Abbott:]

And a couple of follow ups if I may. If any of the patients with increased LFTs get steroid treatment for presumptive autoimmune hepatitis?

[Adelene Perkins:]

Yes, they have.

[Nick Abbott:]

And then going forward, they will get 30 milligram dose or is it only for patients who come -- who will come on to the trial won’t stop at 30?

[Adelene Perkins:]

No, that -- it's the patients who are currently on study that we’ve sent a letter to the site asking that those patients who had been at 40 are all reduced to 30. We have not yet prescribed what would be in a protocol amendment for new patients. So, that's really going to be a function of us completing the analysis and determining what if any dose reduction is appropriate for an ongoing protocol amendment that's going to be really driven by the data that we'll collect. So, it's premature for us to talk about what's going to be in a future protocol amendment at this time.

[Nick Abbott:]

And then finally, so should we expect a partial clinical halt will be placed on this trial?

[Larry Bloch:]

I think it’s important to differentiate regulatory determination, it’s a sponsor IDMC recommendation, the sponsor Infinity either accepts or in this case we actually augmented their recommendation with the dose reduction and today there has been no regulatory action on 549?

[Operator:]

Thank you. At this time, I'm showing no further questions. I'd like to turn the call back over to Adelene for closing remarks.

[Adelene Perkins:]

Thank you for participating on the call this afternoon. We appreciate your interest in Infinity and IPI-549 and we're very committed to continuing our progress on the development of IPI-549 to -- with the goal of helping patients who really need better therapies. And so we look forward to updating you in the coming months. And hope you have a nice evening.

[Operator:]

Thank you for joining today's conference call. You may now disconnect your line.