Infinity Pharmaceuticals, Inc.
Q4 2020 Earnings Call Transcript

Published: 16 Mar 2021

[Operator:]

Ladies and gentlemen, thank you for standing by, and welcome to the Infinity Pharmaceuticals Conference Call to Discuss the Company's Operations and Full-Year 2020 Financial Results. My name is Victor, and I'll be your operator for today's call. At this time, all participant lines 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, Victor, and good afternoon, everyone. Welcome to today's call to discuss our recent business progress and review of our full 2020 financial results. On the call with me today are Adelene Perkins, Chief Executive Officer; Larry Bloch, President; and Brian Schwartz, Consulting Chief Physician. We'll open up the call for Q&A following our remarks. The press release issued this afternoon details our results and is available on our website at infi.com.

[Adelene Perkins:]

Thanks, Jayne, and thank you to everyone for joining us today. The past four months have been transformative for eganelisib and Infinity with two presentations of MARIO-1 data at the Society for Immunotherapy of Cancer Meeting in November, two presentations at the San Antonio Breast Cancer Symposium in December, of front-line triple-negative breast cancer data from our MARIO-3 study and second-line and above TNBC and ovarian cancer data from the ARC-2 study conducted by our collaborator Arcus Biosciences and our most recent presentation last month of MARIO-275 data in second-line urothelial cancer at ASCO GU, which together, demonstrates the broad potential of eganelisib to improve upon diverse standard repair treatment regimens. We're thrilled that our foundational work in discovering and developing eganelisib, a first-in-class macrophage REIT programming therapeutic candidate in solid tumors, has now translated through to clinical benefit across our programs, driven by eganelisib's unique and fundamental immune modulating mechanism. On today's call, our Consultanting Chief Physician, Dr. Brian Schwartz, will review the clinical and translational data from our recent again listed presentation and discuss next set to our programs. But before that, I'd like to briefly summarize this encouraging data. First, data from MARIO-1, our Phase 1/1b study in collaboration with Bristol-Myers Squibb evaluating eganelisib in combination with Opdivo and in patients with advanced solid tumors was presented at this week. The data from this study reinforced the potential of eganelisib to overcome resistance to checkpoint inhibition in patients with melanoma and squamous cell cancer of the head neck who had progressed on a checkpoint inhibitor as their immediate prior therapy.

[Dr. Brian Schwartz:]

Thank you, Adelene. I'd like to start with MARIO-275, our randomized placebo-controlled Phase 2 study evaluating the efficacy and safety of eganelisib in combination with nivolumab or Opdivo in second-line platinum refractory IO naive patients with advanced urothelial cancer. The study was designed to evaluate the benefit of adding eganelisib to standard of care, nivolumab, by leveraging eganelisib mechanism of action, the insights of CheckMate-275 and the accelerated approval study for nivolumab in second-line IO naive urothelial cancer patients. Our results presented at ASCO GU were highly encouraging. With the combination of the eganelisib with nivolumab demonstrating improved overall response rate, disease control rate and progression-free survival versus second line standard of care in nivolumab monotherapy. And as Adelene described, it was really in the PD-L1 low patients where we saw the greatest benefit. Our MARIO-275 ORR of 26% in the PD-L1 low patients is exactly the same as the overall response rate that BMS achieved in the PD-L1 high patients with nivolumab monotherapy in CheckMate 275. When looking at disease control rates, we reported 57% in the PD-L1 low, which is just above the DCR rate of 52%, which BMS achieved in the PD-L1 high patients with nivolumab monotherapy in that study. Together, these results strongly suggest that the eganelisib has the potential to raise the level of benefit for which the PD-L1 patients received to the same level of benefit from IO therapy as the PD-L1 high patients currently receive from standard of care.

[Larry Bloch:]

Thank you, Brian. Before I turn to our financial results, I'd like to emphasize what Brian just said with regard to our appreciation for our patients and their clinicians who have been our inspiration and our collaborators who've been our true thought partners. Regards to ladder, the true intellectual foundation for our MARIO studies, which stands for macrophage reprogramming in immuno-oncology was laid out in collaboration with our preclinical collaborators, including Professor Jedd Wolchok from Memorial Sloan Kettering Cancer Center and Professor Judy Varner from UCSD. We have lead offers on our two back to back major articles, which were published member 2016 and which delineated the fundamental methods of action of elective pharmacological inhibition of PSP gamma. And then into 2017 American Association for Cancer Research Annual Meeting, Dr. Jeff Kutok, the Chairman of Infiniti Sands Advisory Board, gave a similar presentation entitled reprogramming tumor-associated microphages by targeting kids k gamma through a small molecule approach. And now we're truly gratified by the progress, which we made in the course of the last four years since Dr. Kutok's ACR presentation as well as the increasing appreciation for the potential from macrophage targeting therapies more broadly. And we're therefore very pleased that Dr. Judy Varner has been invited to give a talk at the upcoming AACR annual meeting next month. It will be a major symposium presentation entitled improving therapy through normalization of the two microenvironments. The presentation release date is Friday, April 9, and there will also be a moderated 30-minute panel session for question and answers on Thursday, April 15, at 1

[Operator:]

Our first question will come from the line of Nick Abbott from Wells Fargo. You may begin.

[Nick Abbott:]

Good afternoon and thanks for taking my question. Congratulations on quite impressive set of data readouts there over the last few months. Just in terms of guidance, had the cash is going to be sufficient for the next phase of eganelisib? What does that entail? Is that a single registration trial or a registration trial plus some other exploratory trials?

[Larry Bloch:]

This is Larry. I'll take that question. So the guidance we have currently is based on our current operating plans, which includes the initiation of the potential registration-enabling study. But obviously, that will be informed by, as Brian said, our upcoming interactions with the FDA. So there's some confidence interval around what the scale and scope of that trial might look like. It does not include additional initiations of studies that we might initiate based upon, for example, the ongoing MARIO-3 TNBC data, providing updates for later -- first half this year as well as in the second half of this year. And we look forward to providing some updates on additional clinical investigations that we might initiate in the balance of this year or thereafter.

[Operator:]

Our next question will come from the line of Anupam Rama from JPMorgan.

[Matt Bannon:]

Good evening guys. Thanks for taking our question. This is Matt on for Anupam. So we know that the details on the design of the trial for eganelisib in urothelial cancer are forthcoming, but we were wondering more on the financial and logistical side. If the clinical collaboration with Bristol from earlier studies, including MARIO-275, will carry over into the registration focused trial? And actually, if you could remind us of the terms of the existing agreement, that would be super helpful. Thanks so much.

[Adelene Perkins:]

Sure, Matt. Thanks for the question. So the existing relationship with BMS on the MARIO-275 is what we refer to as an arm's length relationship. And so, BMS has been extraordinarily supportive in providing Opdivo free of charge, which has been important because Opdivo is included on both arms of the study, given that we're adding -- again, was a two Opdivo on the combination arm and comparing it to the treatment arm as well as sharing a lot of insight from their CheckMate-275 study and being actively involved in the design of our MARIO-275 study. So, it's been a terrific collaboration. We have not yet made decisions about partnerships with who and when will make partnerships for the registration study. So, that's to be determined at this point.

[Operator:]

Our next question will come from the line of Ted Tenthoff from Piper Sandler. You may begin.

[Ted Tenthoff:]

Great. Congrats on the update on all the progress. Just trying to get a sense, appreciate that you provide more detail following additional conversations with the FDA. But how large do you think Phase 3 study might be in urothelial cancer phase?

[Adelene Perkins:]

So I'll start that. And Brian, you might elaborate. It really does depend on some of the conversations that we'll have. But the reason that we've we're pursuing right now a focus on the PD-L1 low patients is because of that strong hazard ratio of 0.54, which, as a result, when we look at ranges of -- for the registration trial, we believe we can achieve an approvable hazard ratio with a relatively small number. Again, a little premature prior to having those conversations, you might target in the -- and it depends on exactly what endpoints we use something in that 200-patient range, plus or minus 50 patients. So, it really does depend on conversations, but that's the ballpark of what we're thinking about right now.

[Operator:]

Thank you. And I'm actually not showing any further questions. I'd like to turn the call over to Adelene for any closing remarks.

[Adelene Perkins:]

Thank you, Victor. We're really excited to be advancing this tremendous opportunity for eganelisib in the PD-L1 locations in urothelial cancer, and we look forward to sharing additional data from MARIO-3 in frontline TNBC as well as our plans -- more specific plans for the registration trial in the coming months. So thank you all for your continued support and for joining us on today's call and have a nice evening.

[Operator:]

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