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Edited Transcript of INFI earnings conference call or presentation 30-Jul-19 12:00pm GMT

Q2 2019 Infinity Pharmaceuticals Inc Earnings Call

Cambridge Aug 3, 2019 (Thomson StreetEvents) -- Edited Transcript of Infinity Pharmaceuticals Inc earnings conference call or presentation Tuesday, July 30, 2019 at 12:00:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Adelene Q. Perkins

Infinity Pharmaceuticals, Inc. - Chairman & CEO

* Jayne Kauffman

Infinity Pharmaceuticals, Inc. - Senior Executive Coordinator

* Lawrence E. Bloch

Infinity Pharmaceuticals, Inc. - President

* Samuel Agresta

Infinity Pharmaceuticals, Inc. - Chief Medical Officer

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Conference Call Participants

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* George B. Zavoico

B. Riley FBR, Inc., Research Division - Analyst

* James Francis Molloy

Alliance Global Partners, Research Division - MD of Equity Research and Biotechnology & Specialty Pharmaceuticals Equity Research Analyst

* Kevin Michael DeGeeter

Oppenheimer & Co. Inc., Research Division - MD & Senior Analyst

* Matthew Alexander Bannon

JP Morgan Chase & Co, Research Division - Analyst

* Soumit Roy

JonesTrading Institutional Services, LLC, Research Division - VP & Healthcare Analyst

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Presentation

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Operator [1]

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Ladies and gentlemen, thank you for standing by. Welcome to the Infinity Pharmaceuticals conference call to discuss the company's financial results for the second quarter 2019. My name is Amanda, and I will be your operator for today's call. (Operator Instructions) 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.

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Jayne Kauffman, Infinity Pharmaceuticals, Inc. - Senior Executive Coordinator [2]

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Thank you, Amanda, and good morning, everyone. Welcome to today's call to discuss our recent business progress and review our second quarter 2019 financial results.

With me here today are Adelene Perkins, Chief Executive Officer; Larry Bloch, President; Dr. Sam Agresta, our Chief Medical Officer; 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 projection. 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 second 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.

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Adelene Q. Perkins, Infinity Pharmaceuticals, Inc. - Chairman & CEO [3]

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Thanks Jayne, and thank you, everyone, for joining us today. At the beginning of this year, we highlighted that 2019 is a year of execution as we expanded the development of IPI-549 into earlier lines of therapy, new indications and novel, potentially transformative immuno-oncology combinations.

Today, I'm pleased to report that we have made important progress in initiating new trials over the last quarter, keeping this fully on track to achieve these objectives. In the past few months, we have worked diligently to ensure the successful and timely execution of our 2 Phase II combination trials of IPI-549. Yesterday, we announced that we have initiated MARIO-275 with our partner, Bristol-Myers Squibb. MARIO-275 is a Phase II trial of IPI-549 in combination with Opdivo in immuno-oncology naïve platinum-refractory advanced urothelial cancer patients.

In addition, we are initiating MARIO-3 with our partner Roche/Genentech this quarter. MARIO-3 is a Phase II study of IPI-549 in combination with Tecentriq and Abraxane as a front-line treatment in patients with triple-negative breast cancer and in combination with Tecentriq and Avastin as a front-line treatment in renal cell cancer. These are significant milestones for us, positioning us to generate compelling clinical data in a range of settings in combination with several best-in-class emerging standards of care, and with the validation and support from industry leaders in immuno-oncology drug development and commercialization.

Our Phase II clinical development strategy and our specific trial design were informed by our existing IPI-549 clinical and translational data from MARIO-1 as well as from clinical data and exploratory analyses of our partners' data. With these data, we identified and prioritized the best clinical development path for IPI-549, which are represented by the new Phase II trial we are now initiating and in areas where there is both a critical unmet need and data that suggests IPI-549 has the potential to offer a meaningful benefit for patients. We expect to complete enrollment in MARIO-1 this year, and we'll provide any further interim updates on the trial as they give rise to additional development paths before presenting the final data as soon as the clinical and translational analyses are complete.

In addition to the trials we're conducting at Infinity, our partner, Arcus Biosciences, plans to initiate development of IPI-549 in novel triple combination therapy with their adenosine inhibitor, AB928 and Doxil in patients with relapsed/refractory triple-negative breast cancer in the third quarter of this year. We're encouraged that we've been able to expand our development of IPI-549 into new indications and earlier lines of treatment and are pleased by the excitement we're seeing building in scientific and medical communities about the potential of the immunosuppressive macrophage approach to IIO treatment, particularly in light of recent clinical progress in the field including our own. We're committed to following the science and developing IPI-549 in indications where it can improve upon the current standard of care, and where we believe it can provide the most profound benefit to patients.

We're building on the trial initiation momentum we established in the first half of the year, as we now turn our focus to trial execution in the second half of this year. We are keenly aware that patients are waiting and we're driven by the magnitude of the unmet needs for better treatment option. The more clinical experience we gain with IPI-549, the more confident we are that it can play an important role in improving patient outcome.

With that, I'll turn the call over to Sam to speak to the status of our clinical development plan in more detail.

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Samuel Agresta, Infinity Pharmaceuticals, Inc. - Chief Medical Officer [4]

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Thanks, Adelene. Bristol-Myers Squibb and Roche/Genentech have been fantastic collaborators in expanding the development of IPI-549, particularly with regards to sharing data and strategic insights.

Armed with these insights, we moved with a great sense of urgency in initiating MARIO-275 and MARIO-3. MARIO-275 is now open. This is our Phase II study of IPI-549, in combination with Opdivo, in patients with immuno-oncology naïve platinum refractory advanced urothelial cancer in collaboration with Bristol-Myers Squibb. The goal of MARIO-275 is to address the unmet medical need for bladder cancer patients with high baseline levels of MDSCs. Bladder cancer patients with high baseline levels of MDSCs had a shorter overall survival when treated with Opdivo as a single agent, based on a retrospective analysis with BMS' approval study CheckMate-275.

Data from MARIO-1 demonstrated that the combination of IPI-549 and an Opdivo treatment is associated with a reduction in blood MDSC levels, and, therefore, our hypothesis is that adding 549 to Opdivo can potentially improve outcomes for these bladder cancer patients.

MARIO-275 is a global randomized study of 150 patients being conducted in approximately 45 sites in both the U.S. and Europe, the primary end point is the object of response rate in the MDSC high cohort of the study, comparing IPI-549 plus Opdivo to Opdivo plus placebo. The study will enroll all patients regardless of PD-L1 status and will stratify the patients by MDSC's status at the ratio 2:1, high to low in both arms of the study. Importantly, we are also evaluating the benefit of the combination in bladder cancer patients in the study, independent of both MDSC and PD-L1 status.

MARIO-3 remains on track and will open this quarter. This is our Phase II study, which includes 2 cohorts of frontline patients, 160 patient cohort in front-line triple negative breast cancer evaluating IPI-549, in combination with Tecentriq and Abraxane, and a second cohort of 30 patients in frontline renal cell cancer evaluating IPI-549, in combination with Tecentriq and Avastin. This study is being conducted in collaboration with Roche/Genentech.

The goal of MARIO-3 is to address the unmet medical needs for both patients with triple-negative breast and renal cell cancer. Tecentriq and Abraxane was approved for front-line treatment of PD-L1 positive triple-negative breast cancer patients based on the IMpassion 130 study. Tecentriq and Avastin was evaluated in front line renal cell cancer patients in the IMmotion151 study. The safety profile of IPI-549 enables the evaluation of triple therapies, so we are evaluating how the addition of 549 to these doublet regimens can improve on the benefit for front-line patients.

We are initially evaluating the benefit of the combination, independent of MDSC and PD-L1 status, however, we will carefully -- we will be carefully evaluating these parameters and how they relate to clinical activities throughout the course of the study. MARIO-3 is a multicohort study of 90 patients being conducted in approximately 25 sites in the U.S. The primary analysis will be the complete response rate in both cohorts of the study, which were less than 10% in the IMpassion and IMmotion studies. As I mentioned, the study will enroll all patients, agnostic of PD-L1 status and MDSC level.

MARIO-1 is our Phase Ib study evaluating IPI-549 plus Opdivo in combination expansion cohorts of advanced solid tumor patients. These cohorts include patients with checkpoint inhibitor refractory melanoma, non-small cell lung and head and neck cancer. This study is on track to complete enrollment by the end of this year.

In addition, Arcus Biosciences is on track to initiate the evaluation of IPI-549 in novel triple combination therapy with their adenosine receptor inhibitor, AB928 and Doxil, in patients with relapsed and/or refractory triple-negative breast cancer this quarter. This is a checkpoint-inhibitor free Phase I study, which will evaluate the safety of the triplet in approximately 15 patients. I'm very excited with the progress we've made over the course of the last year. The team at Infinity has done a tremendous job in keeping MARIO-1 on track, executing on MARIO-275 and 3, and working with BMS, Roche/Genentech and Arcus. Because of their hard work, IPI-549 is well positioned to be evaluated in treatment through multiple lines of therapy, which includes front-line standard of care and novel-novel combinations, and in indications which include bladder cancer, triple-negative breast cancer and renal cell cancer.

We expect to provide guidance on the anticipated completion of enrollment of these studies in early 2020, at which point we'll have a better sense of the timing around potential data readouts for both trials.

With that, I'll turn the call over to Larry.

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Lawrence E. Bloch, Infinity Pharmaceuticals, Inc. - President [5]

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Thank you, Sam. As you can tell, we are working hard to prepare for the initiation of our Phase II study for IPI-549, building on the foundation of the clinical and translational results for MARIO-1 Phase 1/Ib study. We maintain worldwide rights to IPI-549, while also ensuring that we have the resources in place for the expanded next stage of its development, including through our clinical collaborations with Bristol-Myers Squibb, Roche/Genentech as well as Arcus.

As of June 30, 2019, we had total cash, cash equivalents, and available-for-sale securities of $63 million compared to $70.5 million at March 31, 2019. R&D expenses second quarter of 2019 was $6.1 million compared to $3.7 million for the same period in 2018. The increase in R&D expense was largely related to an increase in clinical and development activities for IPI-549. General and administrative expense was $3.8 million for the second quarter 2019 compared to $3.4 million for the same period in 2018.

In the first quarter of 2019, Infinity recognized $30 million in gross cash proceeds received from the Copiktra royalty monetization and recorded it as a liability on the balance sheet in accordance with accounting guidance for royalty monetization. The company is amortizing the liability to noncash interest expense on a quarterly basis. And for the second quarter of 2019, this noncash interest expense was $1.1 million. Net loss for second quarter 2019 was $10.5 million or a basic and diluted loss per common share of $0.18 compared to net loss of $7 million or a basic and diluted loss per common share of $0.12 for the same period in 2018.

Our financial guidance remains unchanged. We expect 2019 net loss to range from $40 million to $50 million, and we expect to end 2019 with a cash and investment balance ranging from $40 million to $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 provide a cash runway well into the second half of 2020. 2019 continues to be a very strong year, focused on execution on all IPI-549 clinical studies, and we look forward to updating you on our continued progress in the balance of the year.

At this time, we'll open up the call for questions. Operator?

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Questions and Answers

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Operator [1]

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(Operator Instructions) Our first question is from the line of Anupam Rama from JPMorgan.

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Matthew Alexander Bannon, JP Morgan Chase & Co, Research Division - Analyst [2]

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This is Matt on for Anupam. And congrats on all the execution this quarter. Just 2 quick ones from us. On the Phase I trial with Arcus, when do you think we might see some potential data from this noncheckpoint triplet? And will these announcements come jointly from both you and Arcus? And then on a MARIO-275, I think you mentioned there's going to be 40 global sites. Can you just remind us of how many these are currently up and running?

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Adelene Q. Perkins, Infinity Pharmaceuticals, Inc. - Chairman & CEO [3]

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Sure. With Arcus, like all of our Phase II studies, we will wait until they've been up and running for a little while, so that we have really good information on the enrollment cadence, so that we can provide more accurate guidance on both completion of enrollment and data presentations. And so we would expect with our 2020 goals that we announce at New York conference at the beginning of the year, we'll probably provide -- we expect to be providing guidance on both the completion of enrollment and potentially for data readout time in all of our Phase II studies as well as the Phase I with Arcus.

And on MARIO-275, we don't usually go into the detail of exactly how many sites are opened. We -- what we have announced today is that the study has been opened, and we will be continuing to add to the sites that are open until we [get going].

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Operator [4]

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Our next question comes from the line of Kevin DeGeeter with Oppenheimer.

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Kevin Michael DeGeeter, Oppenheimer & Co. Inc., Research Division - MD & Senior Analyst [5]

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And congrats on the progress, as well. Just maybe 2 from me. We did see some interesting data earlier this week from the keynote 522 study. You're looking at pembro and you had your incent occur for triple-negative breast cancer. Can you just talk more generally, if we -- do you see a positive readout in MARIO-3 kind of where the potential opportunities to expand 549 triplets in triple-negative breast cancer could go next, whether that's with Roche or with other partners?

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Adelene Q. Perkins, Infinity Pharmaceuticals, Inc. - Chairman & CEO [6]

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Sure, I'll start it and then turn it over to Sam. So our MARIO-3 study, combining Tecentriq and Abraxane with IPI-549, is in front-line triple-negative breast cancer patients, so it's really designed to build upon the IMpassion130 data, where they got approval in front-line, and as Sam mentioned in his remarks, had a complete response rate of less than 10%. So we're -- our primary end point is complete response rate to see if we can increase the number of complete responders. And if so the natural place to go would be in the front-line, building on the exact data set. And Sam, you can elaborate further.

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Samuel Agresta, Infinity Pharmaceuticals, Inc. - Chief Medical Officer [7]

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Sure. This is Sam. I think the MARIO-3 also includes both PD-L1 positive and negative patients. So the goal -- where can we go with that data is we can -- the intent would to expand the label to include PD-L1 negative patients.

That's different from most indications. Well, from this indication, with Tecentriq and Abraxane, I think how that can translate into other indications is can we look at more broader indications with regard to the PD-L1 status as we look at triplet therapies in front-line. If there is -- I am not concerned about adjuvant use of checkpoint inhibitors and front-line use of checkpoint inhibitors, given typically -- when you give adjuvant therapy, you have to wait quite some time for patients to progress and then retreat in front-line. Therefore, they will still be -- checkpoint-inhibitor regimens will be useful in front-line breast cancer -- in front-line triple-negative breast cancer even with KEYNOTE data, if that makes sense?

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Kevin Michael DeGeeter, Oppenheimer & Co. Inc., Research Division - MD & Senior Analyst [8]

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That does. Extremely helpful. Then maybe just 1 more from me and maybe more directed to Larry. Your company has been very effective at monetizing your various asset royalties across the board. Can you just kind of maybe walk through for us what opportunities may still be out there to bring additional capital into the company, short of geographic licenses for 549?

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Lawrence E. Bloch, Infinity Pharmaceuticals, Inc. - President [9]

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Sure. So as you pointed out, we have -- quantitatively we've raised less than $10 million in equity since the end of 2012 by leveraging partnerships' access to the debt facilities and monetizing assets, such as the recent monetization of the delisted royalty stream. And as you point out, there is potential for nonstrategic geographical licenses, and we additionally have licensed in 2013 a hedgehog program for Gorlin Syndrome to a company called PellePharm, who's recently started their Phase III study in a genetically-defined patient population, and so that's another opportunity for nondilutive financing as you pointed out. And in the meantime, we've been able to expand as a Sam just reviewed, our IPI-549 expense to include 4 clinical studies encompassing now approximately 500 total patients to be enrolled. So we really feel like we're making a really extremely robust investment in 549, while also being very physically prudent.

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Operator [10]

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

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Soumit Roy, JonesTrading Institutional Services, LLC, Research Division - VP & Healthcare Analyst [11]

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Congrats, again, on the execution. I just have -- I'm not sure if I missed it. Are we still on track to see some of the MARIO-1 second half of this year, maybe later this year? And if we are -- can you provide any more clarity on what we are going to see there in terms of -- I assume these are all very late line patients, so rather than the response rate -- focusing on the response rate, are we going to be able to see PFS -- 6-month PFS or more detailed translation data by marker data and things like that?

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Adelene Q. Perkins, Infinity Pharmaceuticals, Inc. - Chairman & CEO [12]

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Sure. Soumit, so as you correctly pointed out, our MARIO-1 study was designed to treat patients with the combination of 549 and Opdivo in patients that would not be expected to respond to Opdivo monotherapy. So the goal really was looking for responses, which would be a good reflection of activity of IPI-549, and that data to date has informed the study that we are now initiating.

What we've said regarding the additional analyses, if we do any additional interim update, it will be associated with a new trial that we're starting to share the rationale for any additional trials that we add to the current portfolio of trials underway. If -- in the absence of that, we will present the final analysis of the study once we have all of the clinical and translational data complete.

We are expecting to complete the enrollment of MARIO-1 this year. So we will certainly be presenting the final analysis, once we have it, but it's possible we'll do some interim updates if we decide to start new trials out of that study data.

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Soumit Roy, JonesTrading Institutional Services, LLC, Research Division - VP & Healthcare Analyst [13]

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Just to be clear, so when should we expect any update like -- when will we know if there will be any interim update later this year or not? In the 3Q earnings or...

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Adelene Q. Perkins, Infinity Pharmaceuticals, Inc. - Chairman & CEO [14]

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That's possible. Yes, Q3 may be a time. If we're going to be presenting data by the end of the year, we'd know in that time frame.

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Operator [15]

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Your next question comes from the line of George Zavoico of B. Riley FBR.

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George B. Zavoico, B. Riley FBR, Inc., Research Division - Analyst [16]

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Nice to see the trial is taking off. And I just had a couple of questions. Could you just reveal a bit how the costs for the combination trials with Roche and BMY are going to be shared? Are they just providing drug or they're providing also resources and other resources and logistics?

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Lawrence E. Bloch, Infinity Pharmaceuticals, Inc. - President [17]

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This is Larry. So all of our trials to date have been designed with really 2 intents. One, is to follow the preclinical signals that Jeff laid out in the 2 Nature articles and that the Sam has been delineating through MARIO-1 and the business intent has been to retain 100% of worldwide rights to 549. So consistent with that, we have set in place these arm's length collaboration, so with Roche/Genentech and BMS, it's really they're providing 2 critical assets: one is access to their lead programs and then secondly, the confidential information from the development of those programs has really enabled us to -- and Sam's team to design these studies in the most -- with most insight and the most efficient execution.

And then with Arcus collaboration, we're co-funding those -- the trial with the triple combination. So that's enabled us, again, in a very cost-efficient way, enabled 500 patients of forced -- across 4 studies while retaining all worldwide rights to 549.

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George B. Zavoico, B. Riley FBR, Inc., Research Division - Analyst [18]

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Can you elaborate the previous experience with Tecentriq and Opdivo by using some of the same clinical sites that ran those previous trials that informed these current ones?

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Samuel Agresta, Infinity Pharmaceuticals, Inc. - Chief Medical Officer [19]

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Yes. George. This is Sam. Yes, we can.

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Adelene Q. Perkins, Infinity Pharmaceuticals, Inc. - Chairman & CEO [20]

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BMS has been very helpful in lots of details about both the design of the study, which helped Sam and team on the stats, and the powering of the study as well as the execution and site selection.

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Samuel Agresta, Infinity Pharmaceuticals, Inc. - Chief Medical Officer [21]

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As well as Genentech.

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George B. Zavoico, B. Riley FBR, Inc., Research Division - Analyst [22]

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Wonderful. And then as a follow-up to that, with the Tecentriq -- do you have the same sort of, I guess, data this post-hoc data that was provided with CheckPoint-275 (sic) [CheckMate-275] in the new internal journal paper that showed a big difference in response rates and survival, whether they were MDSC high or MDSC low, is that -- does that kind of data also available for Tecentriq trials?

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Samuel Agresta, Infinity Pharmaceuticals, Inc. - Chief Medical Officer [23]

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George, this is Sam. I'm not going to comment on the specifics of why Genentech or BMS has provided with us, with the caveats that they have been strategically very helpful in the designs, based on the data they both have presented and what is confidential to them.

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Lawrence E. Bloch, Infinity Pharmaceuticals, Inc. - President [24]

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Yes, throughout we've been able to refer directly to the CheckMate-275 retrospective data is because that was published by -- with Pam Sharma at ACR last year. We absolutely need to respect the confidentiality of the information that we have been privy to regarding their programs that have not yet been made public.

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George B. Zavoico, B. Riley FBR, Inc., Research Division - Analyst [25]

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Okay. I didn't see that. So I figured that was probably what the case was and I respect obviously your intent to keep that confidential until those -- those other companies decide to publish it, if they do. And finally with regard to your finances, you ended -- you're saying you're going to end the year with $40 million to $50 million and your net loss is $40 million to $50 million, but you ended the year with $63 million. So there is a little bit of difference there that is unaccounted for. Do you have some other revenue streams that you're anticipating in that period before the end of the year?

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Samuel Agresta, Infinity Pharmaceuticals, Inc. - Chief Medical Officer [26]

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Our guidance is that we -- at the end of Q2, we have $53 million, we'll end the year with $40 million to $50 million, and our guidance does not presume any additional financing or business development activity.

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Adelene Q. Perkins, Infinity Pharmaceuticals, Inc. - Chairman & CEO [27]

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But George, in the first quarter, as you know, we did receive $30 million from the monetization of our Copiktra royalty stream, so that's how we can have a loss of $40 million to $50 million and still finish the year with $40 million to $50 million.

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Operator [28]

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And our next question comes from the line of James Molloy of Alliance Global Partners.

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James Francis Molloy, Alliance Global Partners, Research Division - MD of Equity Research and Biotechnology & Specialty Pharmaceuticals Equity Research Analyst [29]

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I have a question. We were discussing at last time we chatted about expectations for FDA's white paper here on sort of immuno-oncology clinical trials coming out here sometime in the second half of this year. Can you just speak a little bit to what you guys anticipate the scene in that white paper and how it may impact -- how you designed your trials or maybe some of the trial designs across the competitors in general?

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Samuel Agresta, Infinity Pharmaceuticals, Inc. - Chief Medical Officer [30]

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Sure. This is Sam. I believe the white paper you're speaking to is the effort with the FDA and a melanoma group of PIs defining what it means to be checkpoint-inhibitors refractory, with the intent of setting some guidelines for drug developers, not only ourselves in defining regulatory standard for an unmet medical need in patients who are checkpoint-inhibitor refractory, given all of the studies that have been going on in this space. So what I don't want to do is comment on the details of the white paper because I haven't seen it. I know that -- but I would expect to see by the end of the year is guidelines around that, and I think that will augment -- that will help not only us but others in defining more clearly from a regulatory perspective what it means to be checkpoint-inhibitor refractory.

My feelings, and these are my feelings around MARIO-1, is our bar is likely higher, given we required patients to be refractory, with documented scans as their last line of therapy prior to coming on MARIO-1 with a checkpoint inhibitor.

That part of me I can't expect -- I don't expect the white paper to define a higher bar. But I do think they'll be very specific with regards to that, how much checkpoint-inhibitor therapy the patients will have to have received and other inclusion criteria, so drug developers like ourselves can look at our studies and future studies and align it with that FDA expectations.

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Lawrence E. Bloch, Infinity Pharmaceuticals, Inc. - President [31]

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Jim, to your point, we think that having this regulatory clarity that we anticipate, but don't have any direct knowledge of exactly how it's being formulated, will be really helpful in informing our thinking, for example, of how we might leverage on a going-forward basis, the melanoma data that Sam's team has been generating in MARIO-1, because as he said, we think that has been generated under arguably the highest possible standard for refractoriness and future studies, it would be very helpful for us to be able to align those with the regulatory standard.

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James Francis Molloy, Alliance Global Partners, Research Division - MD of Equity Research and Biotechnology & Specialty Pharmaceuticals Equity Research Analyst [32]

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You guys are very clear that you're the -- you're coming out with IPI-549 on immediate prior checkpoint inhibitor failure and obviously there's any number of studies out there, that some are doing that, some are not. Do you think that will become the standard -- the gold standard for an actual checkpoint failure?

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Samuel Agresta, Infinity Pharmaceuticals, Inc. - Chief Medical Officer [33]

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What -- I'm sorry, the guidance that the white paper will provide?

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James Francis Molloy, Alliance Global Partners, Research Division - MD of Equity Research and Biotechnology & Specialty Pharmaceuticals Equity Research Analyst [34]

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Yes. What you think guidance will be -- has to be and immediate, yes...

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Samuel Agresta, Infinity Pharmaceuticals, Inc. - Chief Medical Officer [35]

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Yes. I think that will provide insight into what it means to be a checkpoint-inhibitor refractory from a regulatory standard to run studies in late-line cancers, thinking about where checkpoint inhibitors are ending up, i.e., front-line and most likely very late-line. So it will provide a lot of insight for us, not only in melanoma, but non-small cell lung, [in nac] where we're also looking at checkpoint-inhibitor refractory patients.

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James Francis Molloy, Alliance Global Partners, Research Division - MD of Equity Research and Biotechnology & Specialty Pharmaceuticals Equity Research Analyst [36]

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Great. Any thoughts on the timing on that?

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Samuel Agresta, Infinity Pharmaceuticals, Inc. - Chief Medical Officer [37]

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I really don't want to comment. I mean hopefully by the end of the year would dovetail nicely with us and data and complete an enrollment for MARIO-1, but I don't want to comment on FDA and...

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Lawrence E. Bloch, Infinity Pharmaceuticals, Inc. - President [38]

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And I said the FDA, we do it for our convenience, but they're looking from a industry-wide perspective, but we will be certainly very interested observers as it becomes available.

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Operator [39]

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And at this time, I'm showing no further questions. I'd like to turn the call back over to Adelene for any closing remarks.

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Adelene Q. Perkins, Infinity Pharmaceuticals, Inc. - Chairman & CEO [40]

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Thank you, Amanda. We're very excited about the opportunity we have with IPI-549, and we'll look forward to providing additional updates as our trials progress. So thank you for joining us today and hope everyone enjoys the rest of your summer.

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Operator [41]

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Ladies and gentlemen, thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Everyone, have a great day.