Infinity Pharmaceuticals, Inc.
Q1 2021 Earnings Call Transcript

Published: 13 May 2021

[Operator:]

Ladies and gentlemen, thank you for standing by. Welcome to the Infinity Pharmaceuticals Conference Call to Discuss the Company’s Operations and First Quarter 2021 Financial Results. My name is Mel, 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 this call is being recorded at Infinity’s request. Now, I would like to introduce your host for today’s call, Jayne Kauffman. Ma’am, please go ahead.

[Jayne Kauffman:]

Thank you, Mel, and good afternoon, everyone. Welcome to today’s call to discuss our recent business progress and review of our first quarter 2021 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 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. We’ve reached an exciting inflection point at Infinity having generated compelling data, which demonstrate the broad potential of eganelisib to improve – treatment regimens in multiple solid tumors. We’re poised to build on this momentum with a substantial update this summer on the triple negative breast cancer data presented at the San Antonio Breast Cancer Symposium with data on at least twice as many patients in addition to providing an update on our future plans in urothelial cancer at a planned corporate event on Tuesday, July 27. Over the last six months, we’ve generated important clinical readout from MARIO-1, MARIO-3 and MARIO-275 studies across six different indications, which has led the broad potential of eganelisib’s unique macrophage targeting a new modulating mechanism. Our pre-clinical translational and clinical data have consistently shown that eganelisib has the potential to create a T cell inflamed tumor and microenvironment from a non-T cell environment, sometimes simplified is turning cold tumors hot activating an immune response and increasing PD-L1 expression thus planning for and increasing the effectiveness of checkpoint inhibitors regardless of baseline PD-L1 levels. On today’s call, our Consulting Chief Physician, Dr. Brian Schwartz will discuss next steps for TNBC and UC programs. But before that, I’d like to briefly remind you of the data we presented over the last six months in chronological order and program guidance. First, data from MARIO-1 are Phase 1/1b study in collaboration with Bristol-Myers Squibb evaluating eganelisib in combination with Opdivo in patients with advanced solid tumors namely melanoma and squamous cell cancer of the head neck were presented at 60 in November 2020. These data reinforced the potential of eganelisib to overcome resistance to checkpoint inhibition including in patients who progressed on a checkpoint inhibitor as their immediate prior therapy.

[Brian Schwartz:]

Thank you, Adelene. As Adelene mentioned, I encouraging initial data from MARIO-3 in frontline triple negative breast cancer should a patient benefit from the addition of eganelisib to an approved standard of care regimen in this case, the Roche/Genentech regimen of Tecentriq and Abraxane in frontline TNBC, which received approved for use in PD-L1 positive patients. At San Antonio breast conference last September – last December, we presented efficacy data from the first 13 evaluable patients, as well as safety data on 20 patients, including seven patients who were enrolled but had not received their first efficacy scan. We were thrilled to report a 100% of the evaluable patients had their reduction in the tumor volume, regardless of the PD-L1 status with 69% had either a partial or complete response with a 100% in the PD-L1 high patients responding and 50% on the PD-L1 low patients responding. The study has been progressing really well and we look forward to reporting data on approximately twice as many patients, as well as initial look at durability of responses on July 27. The accelerated approval of Tecentriq and Abraxane in PD-L1 high frontline triple-negative breast cancer patients, subject to confirmation in subsequent studies was a subject of the recent FDA oncology drug advisory committee or ODAC review, which highlighted the need for better treatment for these triple-negative breast cancer patients.

[Larry Bloch:]

Thank you, Brian. Following our February 2021 public offering in which we raised $92 million in gross proceeds. At March 31, 2021, Infinity had total cash, cash equivalents and available for sale securities of $106.8 million compared to $34.1 million at December 31, 2020. Research and development expense for the first quarter of 2021 was $8.2 million compared to $7.3 million for the same period in 2020. This increase is primarily related to clinical and development expenses to support continued development of eganelisib. General and administrative expenses for the first quarter of 2021 was $3.6 million compared to $3.4 million for the same period in 2020. And this increase in G&A expense was primarily due to an increase in stock compensation. Turning to net loss, for the first quarter of 2021 was $11.6 million or basic and diluted loss per common share of $0.15 compared to a net loss of $10.9 million or basic and diluted loss per common share of $0.19 for the same period in 2020. If it is 2021 financial guidance following our February 2021 public offering is as follows and remains unchanged. Infinity expects net loss for 2021 to range from between $40 million and $50 million and at the end of 2021, we expect to have year-end cash, cash equivalents and available for sale securities balance ranging from between $70 million and $80 million.

[Operator:]

Thank you. Your first question comes from the line of Robyn Karnauskas from Truist. Your line is now open, you may ask a question.

[Robyn Karnauskas:]

Hi, thanks for taking my question. So two quick ones. So July 27, can you set the standard for how many – what kind of update will we get for sure. Maybe there’s some ambiguity about how much information you’ll actually glean from the FDA or by your trial design. So how much for show will we get around trial design, the FDA feedback and how much will be not? And the second question would be around your data and strategy. Do you think at that time you may be in a position to give us some clarity around strategic view of your dating or plan? And how are you thinking about what the best strategic vision would be for your company? Thanks.

[Adelene Perkins:]

Thanks, Robyn. Appreciate the question. So on July 27, we are confident that we will be sharing, because it’s within our control and we know what patients we have enrolled is an update on the TNBC data. And we’re going to have data on at least twice as many patients as we had at San Antonio breast in December. On bladder cancer, what we’re committing to share is an update on our current outlook for the future development of eganelisib, but that’s going to depend on a couple of different variables that are a little bit outside of our control. One is what decisions the FDA will make on the accelerated approvals for Keytruda and Tecentriq and the frontline based on the recent ODAC, as well as the status of our current interactions with the FDA. So we’ll provide the most recent outlook based on where we’re at, but it’ll depend on those two variables. With respect to what the data will mean for our strategy going forward, it really depends on the quality of the data. So we are really looking forward to having data on twice as many TNBC patients, there will be as we presented at San Antonio, because PD-L1 low patients for about 60% to 70% of the patient population as they were in bladder cancer as well. We will have more data on the PD-L1 location. So we will have both response rates as well as some durability, particularly on the patients who are already the 20 patients who are already enrolled as a San Antonio in December. And so, depending on what that data looks like, as Brian said, the data will determine all we’re going to concentrate our efforts going forward on the PD-L1 locations, on the PD-L1 high patients or on all patients. The data will have greatest visibility into in July is the TNBC PD-L1 location.

[Robyn Karnauskas:]

And as a follow-up, I mean, what are your strategic interested in? I think they’d probably be bigger, more focused on the broader opportunity. I’m sure they’re watching everything. Do you have a sense of their one key finger focus on from – if you’re going to go through the broader opportunity and do a partnership?

[Adelene Perkins:]

So obviously everyone who’s developing cancer drugs is looking for better treatments and that’s certainly true in bladder cancer and breast cancer with respect to what any specific strategic, potential partners are looking for their strategies and intentions. It’s probably better to speak with them directly, because we’re not going to comment on the status of ongoing discussions.

[Robyn Karnauskas:]

Thank you.

[Adelene Perkins:]

Thank you, Robyn.

[Operator:]

Thank you. Next question comes from the line of Ted Tenthoff form Piper Sandler. Your line is now open, you may ask a question.

[Ted Tenthoff:]

Great. Thank you, looking forward to the event on July 27. I wanted to ask, I know you’re also evaluating eganelisib in renal cell carcinoma. Should we be expecting an update from that cohort as well and is that something we could also get up to the 27?

[Adelene Perkins:]

Thanks, Ted. No, our guidance remains unchanged for renal cell that we will be providing an update on that in the first half of 2022.

[Ted Tenthoff:]

2022. Okay, great. Awesome. Great. Thank you. Looking forward, go ahead. Sorry.

[Adelene Perkins:]

Yes. So the July 27 update will be primarily focused on the TNBC with a substantial number of additional patients and the current status of our future development in bladder.

[Ted Tenthoff:]

Yes. Perfect. Understood. Very clear. Thank you.

[Adelene Perkins:]

Thanks, Ted.

[Operator:]

Thank you. Next question comes from the line of Anupam Rama from JPMorgan. Your line is now open, you may ask your question.

[Tessa Romero:]

Hey, guys. This is Tessa on the call today for Anupam. Thanks for taking our question. So for the MARIO-3 in triple-negative breast cancer in July. You noted kind of the size of patients, we should be – we should see there. But can you provide a bit more granular on how you think about what a wind scenario would be for you guys for that update? And then a second question would just be when you give us the update on the pivotal study and urothelial cancer in July as well. Will you have the FDA minutes in hand? Thanks so much. Sure.

[Adelene Perkins:]

So Brian, why don’t you start with our thinking about the outlook for data in TNBC and then I can follow up on the FDA interactions.

[Brian Schwartz:]

So I think, what we do have is we do have for the PD-L1 positive and the total group, there’s very clear benchmarks for what the combination of Tecentriq and Abraxanea does. For the PD-L1 low group, these clarity on the PFS and the OS, but there’s not much clarity on the response rate and the sort of given a range. So in terms of what I’ll be looking at is about 15% above of what you think the controlled group performed and more important, the duration of response and the totality of the data in terms of PFS, durability, all the other pieces. So I think it would be nice to have a specific number, but if you had a response rate of 75% with a duration of four months is not really meaningful. So I think you really have to look at the totality of it. And the nice thing in June is it’s we’ll have patients on drug for at least a year. We’ll be able to get a early feel in terms of those three sort of separate questions, the response rate, the durability of response, and how does the whole group perform and then lastly how the two subsets, the PD-L1 positive and PD-L1 negative perform. But I think the absolute numbers and it’s a range for the PD-L1 high we know. So 59 plus about 15% in the high numbers. For the PD-L1 low, the numbers are a little bit all over the map anywhere from 40% to 50%, so we could – you could make an argument around that, but it’s really the totality of the data.

[Adelene Perkins:]

And then on your second question, Tessa, about our plans in bladder cancer, if we have completed our discussions with the FDA and we finalized the trial design and we know exactly what that’s going to look like, we would share that. If we haven’t yet finalized discussions and we don’t have the finals design, what we’ll do is give you an update on when we think we’ll have that and what the expected timing for that would be.

[Tessa Romero:]

Okay. Great. Thanks so much for taking our questions.

[Adelene Perkins:]

Sure. Thank you.

[Operator:]

Thank you. Next question comes from the line of Nick Abbott from Wells Fargo. Your line is now open. You may ask a question.

[Nick Abbott:]

Good afternoon. Thanks for taking my questions. First, just going back to the TNBC study, I think on clinical trials, the trial originally was going to enroll around 90 patients, but I know the expansion cohorts are triggered early by the encouraging data. So those are new still expecting to all around 90 patients in the study.

[Brian Schwartz:]

The way that…

[Adelene Perkins:]

Go ahead.

[Brian Schwartz:]

So the plan is to have Nick at least 30 PD-L1 low patients and 50 PD-L1 high patients, so at a minimum 60 patients the total study. But I think it’s really going to depend a little bit on the data and how enrolls, we enrolling currently, for every two PD-L1 lows we enrolling one PD-L1 high. So we might be a little bit shy of one a little bit more rich than the other.

[Nick Abbott:]

Okay. And then just going back Adelene you comment on, at least twice the number of patients from San Antonio. Is that in reference to the 13 efficacy eligible patients or the 20 total patients?

[Adelene Perkins:]

Both.

[Nick Abbott:]

I’m sorry. Both, okay.

[Adelene Perkins:]

Yes.

[Nick Abbott:]

So the total number is going to be at least 40 of which at least two-thirds of those will be efficacy eligible. Is that the way to think about it?

[Adelene Perkins:]

Correct.

[Nick Abbott:]

Okay, perfect. And then just last one for me, I know that you were supporting an IIT with Ezra Cohen, UCSD in the neoadjuvant head and neck setting. Do you have any updates on when we might be able to expect some data from that?

[Adelene Perkins:]

So Brian, do you want to talk a little bit about that study?

[Brian Schwartz:]

I mean that study, we are a little bit – it’s a little bit dependent on the investigator, but the more data we can get to you as soon as we get that data available, we’ll get it out to everybody. It has a lot of translational work built in. So it’s not so much getting the patients on. It’s much more getting all the translational work done. But we don’t have a firm timeline from ISRO as of yet, but obviously as soon as we get it available, we’ll send it to you. We’ll get it out.

[Nick Abbott:]

Okay. Terrific. Thank you very much.

[Adelene Perkins:]

Thanks, Nick.

[Operator:]

Thank you. Next question we have the line from Soumit Roy from JonesTrading. Your line is now open. You may ask a question.

[Soumit Roy:]

Hi everyone, thanks for taking the question. I don’t know if you guys ever touched up on the uncomfortable discrepancy between the IMpassion130 and IMpassion131. Curious if you would show us some more depth the details in the data July 27 on maybe co-mutational status of these patients BRCA or more biopsy data and steroid users that kind of details on there. Second question is, would you consider redesigning the efficient trial in terms of IMpassion132 like Tecentriq chemo combo rather than Abraxane. Thank you.

[Brian Schwartz:]

So I think the first question we’d like to share with you as much data as we can, that would be the goal. In terms of the translational data, as I mentioned, the same thing with ISRO study is obviously the translational data sometimes legs behind. So we will have much less translational data to share with you. In terms of other co-morbid indications, I think if the sample sizes are big enough and the groups are big enough, definitely we’ll share with you that will really depend on how big the different groups are. And we are aware of some of the potential biases that are kept into the data for the different studies with Tecentriq and Abraxane. So hopefully we can review that. It will be in an uncontrolled setting, so a little bit more difficult to interpret. In terms of our drag with just the chemo combination, we would talk about it quite a lot. It makes mechanistic sense based on some of the preclinical models. But we really have to evaluate the total program. And I just have the data is really good. We could easily introduce an arm into a study, but right now it’s not forefront of our plans, but a very good and common thought that we have within our group.

[Soumit Roy:]

Got it. Thank you so much.

[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, Mel. We’re very excited to be advancing the tremendous and near-term opportunity for eganelisib in PD-L1 low patients and look forward to meaningful MARIO-3 triple negative breast cancer data update at our corporate update on July 27 for which details will be forthcoming. So thank you very much for your continued support and for joining today’s call. Have a nice evening.

[Operator:]

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