Infinity Pharmaceuticals, Inc. (INFI) CEO Adelene Perkins on Q3 2019 Results - Earnings Call Transcript

Oct. 30, 2019 11:14 PM ETInfinity Pharmaceuticals, Inc. (INFI)
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Infinity Pharmaceuticals, Inc. (NASDAQ:INFI)

Q3 2019 Earnings Conference Call

October 30, 2019 04:30 PM ET

Company Participants

Jayne Kauffman - Senior Executive Coordinator

Adelene Perkins - CEO

Lawrence Bloch - President

Jeff Kutok - Chief Scientific Officer

Conference Call Participants

Matthew Bannon - J.P. Morgan

Kevin DeGeeter - Oppenheimer

Soumit Roy - JonesTrading

Nick Abbott - Wells Fargo Securities LLC

James Molloy - Alliance Global Partners

Operator

Ladies and gentlemen, thank you for standing by. Welcome to the Infinity Pharmaceuticals Conference Call to discuss the Company's Financial Results for the Third Quarter 2019. My name is Bridget and I'll 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 the 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, Bridget, and good afternoon, everyone. Welcome to today's call to discuss our recent business progress and review our third quarter 2019 financial results. With me here today are Adelene Perkins, Chief Executive Officer; Larry Bloch, President; and Dr. Jeff Kutok, our Chief Scientific Officer.

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 third quarter of 2019 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 would like to start off today’s call by highlighting the important clinical progress we’ve made this past quarter. With the initiation of two additional clinical studies with IPI-549. We are very pleased by our advancement of IPI-549 into new indications, combination and earlier lines of therapy as part of a thoughtful clinical development strategy designed to reveal the potentially transformative impact of reprogramming macrophages about the IPI-549.

Successful clinical trial execution has been a key priority for Infinity in 2019 and we are very pleased that progress with MARIO-1 and the initiation of three new trials with IPI-549 over the past few months has enabled our announcement today of important milestones, especially in 2020.

First, we expect to complete enrollment of MARIO-1 by year-end 2019 and to present clinical and translational data in 2020 from the Phase 1, 1b study in collaboration with Bristol-Myers Squibb, evaluating IPI-549 in combination with Opdivo in patients with advanced solid tumors.

Second, in 2020, we expect to complete enrollment and present data from MARIO-3, our Phase 2 study in collaboration with Roche Genentech. MARIO-3 is a Phase 2 study of IPI-549 in combination with Tecentriq and Abraxane as a frontline treatment in patients with triple negative breast cancers and in combination with Tecentriq and Avastin as a frontline treatment for patients with renal cell cancer.

Third, in 2020, we also expect to complete enrollment in MARIO-275, our global randomized Phase 2 study in collaboration with Bristol-Myers Squibb, evaluating IPI-549 in combination with Opdivo in patients with advanced urothelial for bladder cancer.

In addition, we announced earlier this quarter that our partner Arcus Biosciences initiated a Phase 1 collaboration study evaluating IPI-549 in a novel checkpoint inhibitor free regimen that includes there dual adenosine receptor inhibitor AB928 and Doxil in patients with relapse refractory triple negative breast cancer.

These trials are representative of our commitment through data driven approach for the clinical development of IPI-549. Our trials are informed by our clinical and translational data and learning from MARIO-1 as well as clinical and translational data that we've been fortunate to assess from our partners. We believe this rational data-driven approach has enabled the best clinical path forward to match my potential of IPI-549.

It's a particularly exciting and important time for Infinity for two reasons. The first is due to our expected completion of enrollment in MARIO-1, in MARIO-3 and MARIO-275 to presentation of data from MARIO-1 and MARIO-3 by the end of 2020. The second is that in parallel with our generation of data, plus a wide range of indications in combination with best-in-class emerging standards of care. We're witnessing an explosion in the appreciation among the medical and scientific communities for the importance of tumor macrophage directed immuno-oncology therapy.

With meaningful gain expected to IPI-549 study starting in 2020, Infinity has positioned to become a leader in the burgeoning field of macrophage targeted immunotherapy. We are inspired by the ability to leverage our extensive research and groundbreaking discoveries in the tumor macrophage field to bringing IPI-549 forward for patients in need of better therapeutic options. At Infinity, we are deeply committed to advancing our science and clinical programs to serve patients and are very appreciative of the patients and their families for participating in our study designed to demonstrate potential benefit of IPI-549 treatment.

With that, I would like to turn the call over to Jeff to speak to the status of our clinical development plan in more detail.

Jeff Kutok

Thanks, Adelene. It's incredibly exciting to be reviewing our progress in now four trials that are evaluating IPI-549 in a wide range of indications in treatment regimens. To begin, I will provide an update on MARIO-3, our most recently initiated trial. MARIO-3 is particularly exciting to assess as we are moving IPI-549 to a frontline setting.

The Phase 2 study includes three cohorts of frontline patients. 130 patient cohort in frontline triple negative breast cancer patients with high levels of PL-1 tumor expression, evaluating IPI-549 in combination with Tecentriq and Abraxane. Another 30 patient cohort evaluating the same combination therapy in frontline triple negative breast cancer patients with low levels of PDL-1 tumor expression.

And a third cohort of 30 patients in frontline renal cell cancer evaluating IPI-549 in combination with Tecentriq and Avastin. Infinity is conducting the study in collaboration with Roche Genentech. MARIO-3 is an exciting new approach enabled by the safety profile of IPI-549, specifically the safety and tolerability of IPI-549 makes possible, innovative triple combination therapies in both triple negative breast cancer and renal cell cancer patients.

Our goal is to evaluate healthy addition of IPI-549. Can improve upon the benefits of these frontline treatment regimens in patients with real unmet need. Tecentriq and Abraxane were approved in frontline treatment of PDL-1 positive triple negative breast cancer patients based on the impassion 130 study.

Tecentriq and Avastin were evaluated in frontline renal cell cancer patients in the emotion 151 study. The multi-cohort study of 90 patients is being conducted in approximately 25 sites in the U.S. The primary analysis will be the complete response rates in both cohorts of the study which were less than 10% in the impassion and the motion studies.

MARIO-3 will be evaluating the benefit of these combinations independent of MDSC and PDL-1 status. However, we will of course be carefully monitoring how these parameters impact clinical activity as the study progresses. We look forward to presenting our initial clinical and translational findings in 2020.

I'm also pleased to share of that our partner Arcus Biosciences initiated in the third quarter, the evaluation of IPI-549 in novel triple combination therapy with their dual adenosine receptor inhibitor AB928 and Doxil in patients with relapse refractory triple negative breast cancer. This checkpoint inhibitor free Phase 1 study will initially evaluate the safety of IPI-549 with AB928 and Doxil in dose escalation. This utilization of IPI-549 is another triple therapy regimen trial is further testament to its remarkable safety profile allowing for pioneering combinations with diverse agents and wide range in treatment settings.

We're pleased to provide guidance today that we expect to complete enrollment in 2020 of MARIO-275. Our Phase 2 study of IPI-549 in combination with Opdivo in patients with immunotherapy naïve, platinum refractory, advanced urothelial cancer in collaboration with BMS. MARIO-275 is a randomized trial that investigate the effect of adding IPI-549 to Opdivo in bladder cancer patients with high and low levels, [indiscernible] levels of MDSCs.

The trial was developed based on beta from a retrospective analysis of BMS's approval study, CheckMate-275, which showed bladder cancer patients with high baseline levels of MDSCs had a shorter overall survival when treated with Opdivo as a single agent. These data combined with our MARIO-1 data that showed the combination of IPI-549 in Opdivo treatment is associated with a reduction in blood MDSC levels, support our trial design in which IPI-549 can potentially improve outcomes for these bladder cancer patients in combination with Opdivo.

Mario 275 is a global randomized study, with a 160 patients being conducted in approximately 45 sites in both the U.S and Europe. The primary objective of the study is to compare overall response rate in patients with high baseline MDSC levels, following combination treatment with IPI-549 plus Opdivo to that of Opdivo monotherapy.

The study will enroll patients in either the IPI-549 plus Opdivo or Opdivo plus placebo arms in a 2 to 1 fashion regardless of the PDL1 status and will also stratify patients by MDSCs status at a ratio of 2 to 1, high to low in both arms of the study. Finally, we expect to complete enrollment by year-end in MARIO-1, our Phase 1b study evaluating IPI-549 plus Opdivo and expansion cohorts of advanced solid tumor patients with data to be presented in 2020.

MARIO-1 is focused on evaluating IPI-549 plus Opdivo in settings for patients would not be expected to respond to Opdivo monotherapy, including patients with melanoma, non-small cell lung cancer and had neck cancer who could progress on Checkpoint inhibitor as thier immediate prior therapy.

Before I transition the call over to Larry, I would like to take a moment to acknowledge our fantastic collaborators at BMS, Roche Genentech and Arcus, but fortunate to have developed impactful collaborations allowing us to leverage data and strategic insights for the clinical development of IPI-549. We are enthusiastic about our expansion to multiple lines of therapy and novel therapeutic combinations that are grateful to our dedicated partners that help us advance our goal of providing macrophage targeted immunotherapy to improved patient outcomes.

With that, I will turn the call over to Larry.

Lawrence Bloch

Thank you, Jeff. This year it has been a tremendous amount of hard work to initiate multiple Phase 2 studies for IPI-549. And we continue to be very focused on execution to enable complete enrollment of all of our ongoing, okay 549 studies by the end of next year. Importantly, we strategically maintain worldwide rights to IPI-549, the total net sales royalty burden of only 4%.

We are also ensuring sufficient resources push continued development to our clinical collaborations with Bristol-Myers Squibb, Roche Genentech as well as Arcus biosciences. As December 30 2019, we got a total cash, cash equivalents and available for sale securities of $52 million compared to $63 million at June 30, 2019.

R&D expense in the third quarter of 2019 was $7.1 compared to $5.4 million, with the same period in 2018. The increased R&D expense was primarily due to the increase in clinical and development activities for IPI-549.

General and administrative expense was $3.1 million to $3.6 million for the third quarter 2019 compared to $3.4 million for the same period in 2018. Net loss for the third quarter of 2019 was $11.4 million, or a basic and diluted loss per common share of $0.20 compared to net income of $13.4 million or basic and diluted earnings per common share of $0.23 for the same period in 2018. Our financial guidance remains unchanged.

We expect 2019 net loss to range from between $40 million to $50 million and we expect to end 2019 with the cash and investment balance ranging from between $40 million and $50 million.

Based on our current operating plans, which exclude additional funding or business development activities, we anticipate that our existing cash, cash equivalents, and available for sale securities will be adequate to satisfy the company's capital needs for at least the next 12 months. We will appreciate support of our clinical investigators, patients, partners, and the team at Infinity, who have enabled our progress with IPI-549 to date as well as anticipated important milestones in 2020. We are looking forward of providing updates on additional progress in upcoming conferences in our next annual 10-K call.

At this time, we got the call for questions. Operator?

Question-and-Answer Session

Operator

[Operator Instructions] The first question comes from the line of Anupam Rama with J.P. Morgan. Your line is open.

Matthew Bannon

Hey, guys. This is Matt on for Anupam. Thanks so much for taking our questions and congrats on execution in this quarter. Just a couple from us here. So first off, you gave enrollment timeline guidance for the MARIO trials. I may have missed it, but [indiscernible] any timeline for the [indiscernible] trial. So did I miss that, or is that just too early to gauge patient enrollment there. Secondly, on the Marriott 275 trial. Can you just remind us the rational for [indiscernible] that you may be able to take benefit in patients regardless of the MDSC status. And then finally how urgently are you guys are looking for a new CMO. Like is it a top priority right now or have the consultants you brought in been able to get the job done. Thank you so much.

Adelene Perkins

Sure. Matt, so on your first question regarding Arcus, that’s a trial that being conducted by Arcus. So it's an appropriate for us to provide guidance on that. We will look to what Arcus provides as guidance for enrollment. And so that will be driven by them. I will begin on MARIO-275 and then I will turn it over to Jeff. In general, as we presented the date, we’ve seen a reduction in MDSCs in combination of 549 and Opdivo, across all the vast majority of patients that we’ve created with a number of different tumor sites. And that is combined with the really great retrospective analysis that CMS did on MARIO-275. What was very clear that high baseline levels of MDSCs were associated with much poor outcomes. So that’s very high level and Jeff I’m sure you have more to add.

Jeff Kutok

Yes. So the focus of MARIO-275 is on the MDSC high patients and we're ensuring adequate numbers of those patients by stratifying 2 to 1, either low in the study and the primary objective will be to look at response rates in the MDSC high population in the combination compared to the monotherapy Opdivo arm. We are also looking at the MDSC locations because while they’re more relative to the patients with higher levels. They’re still elevated compared to normal healthy individuals. So we don't know a priority that there won't be a significant benefit in patients with lower levels of MDSCs to the combination therapy and we're hoping to evaluate that in the study.

Adelene Perkins

And then I will finish up, Matt on your last question about new CMO. It's not an urgent priority for us right now for several reasons. One is, that our trials are now designed and have been kicked off and so we’ve got a really strong clinical team at Infinity who is now implementing those trials. And of course, we still do have Sam Agresta on our Board and he is actively involved in that process with us. In addition to as you mentioned, a strong network of external CMO collab, partners, consultants that we work with. So we have what we need right now. We don't feel that there is a huge hole, but of course as we go forward, we will be looking to see if there's just a terrific candidate that we could comment as we begin to collect and interpret this data.

Matthew Bannon

Great. Yes that makes a lot of sense. Thanks, guys.

Operator

Thank you. And our next question comes from the line of Kevin DeGeeter with Oppenheimer. Your line is open.

Kevin DeGeeter

Hey, great. I want to add my congratulations and thanks for taking my questions. With regard to the 2020 data update for the MARIO-3 study, should we anticipate getting updates from each of the three arms or at least the triple negative breast, or component just kind of it -- how much visibility do you have on sort of the Phase enrollment and the different cohorts?

Adelene Perkins

Thanks, Kevin. It's a little premature for us to provide specific guidance on which of the three arms we will be presenting on and when. As the trial advances, we will provide more granularity, but we can't provide that granularity at this time.

Kevin DeGeeter

Okay, great. Fair enough. And then with regard to Mario-275, can you just remind us again, you kind of give us a pretty broad sketch in terms of completion enrollment in 2020. But kind of realizing your operating guidance, when you expect to be able to present some data, but sort of a similar line of questionings, should we anticipate that we will see data on specific cohorts, perhaps before the entire data set matures, or is it your kind of current thinking that it is best to be able to present the data when each of the arms is fully enrolled and [indiscernible] follow-up is available.

Adelene Perkins

Sure. So I'll remind you that MARIO-275 is a blinded study and so we will wait until we have un-blinded the study. And its most likely that we will present the data on the various terms [ph] because it's the value of having a controlled study. We will be looking at how patients there on the Opdivo only arm as given that Opdivo is approved as a monotherapy relative to the combination of Opdivo and 549. And I believe that it will be important to look at both arms, control arm and the treatment arm as well as the patients who have -- as we stratified high levels of baseline MDSCs in lower levels. So my expectation is we will be presenting that full dataset at the appropriate time.

Kevin DeGeeter

And one last question for me, more of a high level question. As you sort of alluded to in the top of the call, there has been a pickup in development of multiple different compound strategies targeting and regulation of macrophages to potentially enhance the breadth of response to immunotherapy. On a high level, is your expectation that these various strategies will ultimately be competitive, or is there a rationale here that certain strategies may be complementary, certain macrophage regulate strategy, maybe complementary in terms of expanding your response specifically to PD1s.

Adelene Perkins

Sure. So it's important to highlight that we have the only PI3 kinase gamma specific inhibitor in development. So with respect to our specific mechanism of action there is today no direct competition. There's as you referenced, a number of other programs given the excitement about macrophage modulation. But most are still in early development. We are not aware of any that have randomized Phase 2 data. So it's a little early to know how those will stack up relative to IPI-549 and whether there is an opportunity for potential synergy between them. But we will be watching as the -- as those other programs mature and as they start to get into the front end.

Kevin DeGeeter

Thanks for taking my questions.

Operator

Our next question comes from the line of Soumit Roy with JonesTrading. Your line is open.

Soumit Roy

Hello everyone and thank you for taking the question. Congratulations again on setting up on the clinical trials and it's truly an exciting time. Just want to rehash the catalyst time and I might be repeating Kevin's question a little bit. From MARIO-1, do we -- should we expect, or do we know which cohorts enrolling better and should we expect a larger [indiscernible] melanoma cohort data around? Maybe mid 2020 or is it coming much later? And then for MARIO-275, I remember there was an option that you could show as a interim look, or right now it looks like you would wait for the entire data to mature. In that case, should we expect any data from MARIO-275 in 2020, or it will be more 2021 event?

Adelene Perkins

Sure. So on MARIO-1, we will have completed or we expect to and are guiding that we were completed the enrollment in all of those cohorts by the end of 2019. And so when we look to data that we will present in 2020, our immediate focus will be prioritizing that data that could help inform and build on the momentum of 549 development in additional trials. So we are really focused on that. It's a little premature to focus on what exact data will be presented until we completed the trial and conducted our analysis. But beyond the near-term focus on future developments that comes out of MARIO-1, we're committed to presenting a complete MARIO-1 study findings in a peer-reviewed format when we have all of that data.

Soumit Roy

Would it be reasonable to assume mid 2020 data readout from MARIO-1 or its -- just trying to get a sense.

Adelene Perkins

You know that’s reasonable. Again, until we completed the enrollment it's hard to say, because we have to -- we typically present data at from our clinical studies at major medical meetings. And so we will have to look at when we have that data and when that synced [ph] with abstract submission deadlines. So we will [indiscernible] when we have more insight there. And on MARIO-275, we are guiding that we will complete enrollment in 2020. And so I think your hypothesis, that we will update in 2021 is probably right. We -- if we do have an early look, we may decide to make that pivotal study in which case we wouldn’t be able to present that data, so that we would be able to include all of that in a regulatory submission. So I think our base case plan would be enrollment completion in 2020 and most likely data in 2021. But that will be [indiscernible].

Soumit Roy

Got it. I’ve two quick -- kind of quick question. The one is, do you have any kind of non-compete restrictions with -- on the Roche collaboration? Can you go out and try to investigate 549 [indiscernible] that chemo combination or TKI combination or something like that? And second is, given the amount of robust R&D for activities going on for the next 12 to 18 months, how should we think about the R&D, SG&A expense for the fourth quarter and 2020, in general. If you can give us some guidelines.

Adelene Perkins

Sure. So I will start with the first one. We do not have a non-compete with any of our collaborators. We have arms length collaborations where there is -- there are no restrictions on what we can do outside of those collaborations, and there's no transferral of rights or options on IPI-549 as part of those collaboration. Your second question, was it about the fourth quarter of 2020?

Soumit Roy

No, forward [ph] cost in '19. And then overall 2020, how we should think about the R&D and the SG&A expenses?

Adelene Perkins

Sure. So I will just make a high level comment, and then turn it over to Larry. As we look, we are keenly focused on the importance of managing our expenses such that we are able to generate data and have potential value inflection and 2020 is a really important year to that end. As we guided, we have cash for at least the next 12 months and we will have data by the end of 2020. So we are managing our expenses which I'll turn it over to Larry to address and then we're also -- if and when we decide to accept additional capital, we’ve several levers and Larry you can elaborate on those as well.

Lawrence Bloch

Yes, so we’re kind of wrapping up the enrollment from area one, which is our largest study of 225 approximate patients by the end of this year as we're ramping up the other clinical studies. And so while we haven't finalized our budget and budget approval will occur in December, I think it's a fair estimate to assume that it's going to be very flat from 2019 into 2020 as MARIO-1 sort of winds down and data [ph] trials start ramping up. And then as -- it's that we're saying in terms of accessing additional capital in the future, we always look for the most capital efficient forms of resources. And so, something as we’ve been doing obviously is to excess [indiscernible] mechanisms and comparator drugs from our strategic partners in these clinical studies, which is a big fraction of our overall clinical costs. And then we also have additional options to pursue including -- as you may be aware, we have licensed on a hedgehog program to PellePharm, which is now enrolling their Phase 3 which has [indiscernible] therapy destination from the FDA for growing syndrome, which is very aggressive form of basal cell carcinoma. And so at the appropriate time we can consider monetizing that royalty stream as we did with Copiktra earlier this year. And then there is nonstrategic geographic licenses for 549 that we consider as well. So [indiscernible] we think we are moving very forward with a very capital efficient execution on the clinical studies and don't expect it must be add additional studies beyond the one that we’ve initiated this year and given guidance on for next year. Don’t expect a significant increase in overall R&D.

Soumit Roy

Okay. Thank you so much and congratulations again on the progress.

Operator

[Operator Instructions] And next question comes from the line of Nick Abbott with Wells Fargo Securities. Your line is open.

Nick Abbott

Good afternoon and thanks for taking the questions. So the first one, goes back to Checkmate-275 and I think it was about 18 months ago that retrospective analysis was presented. Are you able to comment on any analysis of the role of MDSCs and other checkpoint inhibitor trials, certainly plenty of them out there. I just like to see if there's actually -- there's a lead really in other tumors based on retrospective analysis with some of these large Checkpoint inhibitor trials?

Jeff Kutok

Sure. I can take that question, Nick. This is Jeff. Yes, there's published data particularly in the melanoma field where in metastatic melanoma, in one study that was published couple of years ago in patients who had failed with ipilimumab and then come on to receive Nivolumab monotherapy where there was an inverse correlation between MDSC levels and response. So the patients who had the lower levels of baseline MDSCs had the better responses in outcomes in that study. So it -- they’re at least in the melanoma area and a similar data that’s been presented at meetings with another indication that show that the full responses are in the patients with high levels of MDSCs to Checkpoint inhibitor therapies and [indiscernible] patients with lower levels have better responses in multiple different indications that the data in the Checkmate 275 study was among the most robust. So that we've seen given the number of patients in the study that had their MDSC levels evaluated and the quality of the data that led to the accelerated approval.

Nick Abbott

Exactly.

Lawrence Bloch

And this is -- the registration study, as Jeff said, that was very helpful as a benchmarking and having access to a partnership with BMS, so their confidential analysis helped us to setup the protocol in an optimal way. But to your -- I think the question -- your question is, are there adjacent indications that have similar dynamics in terms of MDSCs being heavily correlated with a good prognosis and in some of the case, that it is just an [indiscernible]. And so, with positive data from MARIO-275, the next large [indiscernible] first to do would be to consider expeditiously evaluating those other indications including potentially melanoma as Jeff said, with similar types of clinical approaches.

Nick Abbott

Okay. Thank you. And then in terms of MARIO-1, so you said there will be 225 patients in total. We know that for triple negative breast and melanoma that there was cohorts are going to be expanded. It may cause, I believe, with [indiscernible] two stage and both of them did, so they’ve now -- are expanded to 1,429 patients each. Can you tell us what the target enrollment is each? And I know there are seven combo cohorts, what the target enrollment is for those cohorts?

Adelene Perkins

Sure. So we had three cohort that were all in patients who had progressed on a checkpoint inhibitor as their immediate prior therapy. And those three were non-small cell lung cancer where our target was 20 patients. [Indiscernible] cancer at the head and neck where our target was 20 patient. And then melanoma, as you correctly highlighted, the initial target was 20 and based on early responses we increased that to 40. Triple negative breast cancer as you highlighted was also expanded to 29 patients. And then we had cohort of patients in mesothelioma that was 10 patients and in adrenocortical cancer that was 10 patients. And in patients, [indiscernible] MDSC high that was 20 patients.

Nick Abbott

I don’t [indiscernible]. So, the 225 and that would include monotherapy as well as dose escalation?

Adelene Perkins

Correct.

Nick Abbott

Okay. Thank you. And then last question, it's probably a question to Jeff. Jeff, [indiscernible] there is a poster entitled identity [indiscernible] PG an expression profiles, predict response identity in [indiscernible] therapies indicated need for dual blockade of CD-73 and any two [indiscernible] CD-73 inhibitor, [indiscernible] folks on CD-73 and [indiscernible]. But in your discussions with Arcus, do you feel like they can get sufficient suppression of the [indiscernible] pathway just within A2AR inhibitor they need, a combination approach.

Jeff Kutok

Yes. Nick, it's really a question that’s probably best answered by Arcus. I think they feel strongly that they have an excellent inhibitor of the receptor and we haven't really talked about combining multiple nodes in that inhibitors for nodes in that pathway. But it sounds like an interesting presentation.

Nick Abbott

Thank you. Great. Thanks a lot. Look forward to further updates.

Adelene Perkins

Thanks, Nick.

Operator

Thank you. And our next question is from Jim Molloy with Alliance Global Partners. Your line is open.

James Molloy

Hey, guys. Thanks for taking the questions. I was wondering on the MARIO-3 and the MARIO-275. I think that its challenging to figure out when exactly enrollments will complete. But can you speak a little bit to sort of the gating factors that you’re looking for and sort of when you might have an idea of when you might know a better to a [indiscernible] for getting completion on those trials?

Adelene Perkins

So we usually look to have a reasonable portion of the enrollment complete. So we really understand the cadence of enrollment when we provide guidance and cell. It will certainly be some time in the first part of 2020 and its possible that we can provide an update on our next call associated with our 10-K. And so that’s the -- that’s possible window the next time that we are having more call. And what’s the second part of your question?

James Molloy

Just sort of -- sort of the gating factors, I think of it -- I know this is currently thousands of combination trials going on. Is there any challenge that are sort of come up as the number of trials out there multiplied in finding patients to recruit into trials?

Adelene Perkins

You know, we’ve been very fortunate on that front. And we are with MARIO-1 and we believe there's several reasons for it. We -- MARIO-1 enrolled consistent with our projection. And I think there are at least three reasons for that. One is that, we have the only [indiscernible] specific inhibitor in development and there was just a lot of investigator enthusiasm and people are interested working with its mechanism, 5.9 is the drug to work with. The other is that it is a simple once a day oral [indiscernible], so it's very convenient for patients. And the third is that it's been extraordinarily well-tolerated, which of course is a huge advantage in treating both late line and early line cancer patients. So we think we’ve a number of things that were going for us in MARIO-1 and we believe that that will likely very forward in MARIO-3 and MARIO-275.

James Molloy

Okay. And last couple of questions. I know that you guys are very clear on your guidance for ending the year in cash flow and the run rate you have, where you would have instead of $40 million to $50 million, where do you have $100 million to $200 million or sort of --what sort of number -- what would advance more quickly or what additionally would come into play, say in 2020 with additional capital. I guess -- we will stop at that question.

Adelene Perkins

Sure. So the -- what we’ve done in identifying the trials that we have now underway is we've been very disciplined in prioritizing those, that we think are the very best. And we’ve got -- it's leverages are clinical and translational findings to date as well as those of our partners. So we really think we're doing and have deliberately prioritized the best trials. But of course, there are always more that you can do. And part of what we would do next would be informed by the data that will be generating in MARIO-1. So as we complete the enrollment to next trial, by the end of this year and as we analyze that data, we would look to additional findings from that that would help us answer your question about how would we -- we have a list today, but how might that be further refined based on additional data from MARIO-1. So stay tuned as we present data from MARIO-1, it will be with that exact eye, what additional trials would be prioritized based on additional data coming out of MARIO-1.

James Molloy

Great. Thanks for taking the questions.

Operator

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

Adelene Perkins

Thank you, Bridget. We are very excited about the opportunities we have with IPI-549 and we look forward to providing more update on our enrollment completion and data in 2020. So thanks so much for joining us on today’s call.

Operator

Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.

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