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spk07: 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 will be your operator for today's call. At this time, all participants are in a listen-only mode. There will be a question and answer session to follow. Please be advised that this call is being recorded at Infinity's request. Now, I would like to introduce your host for today's call, Jane Kaufman. Ma'am, please go ahead.
spk06: 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 Adeline Perkins, Chief Executive Officer, Larry Block, 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 mv.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 factor section of our annual report on Form 10-K for 2020, and in other filings we make with the SEC. These forward-looking statements may 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'd like to turn the call over to Adeline.
spk08: Thanks, Jane, and thank you to everyone for joining us today. We've reached an exciting inflection point at InfiniDate, having generated compelling data which demonstrate the broad potential of aganalysib 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 27th. Over the last six months, we've generated important clinical readouts from MERIA-1, MERIA-3, R2, and MERIA-275 studies across six different indications, which highlight the broad potential of aganalysib's unique macrophage-targeting immune-modulating mechanism. Our preclinical, translational, and clinical data have consistently shown that aganalysib has the potential to create a T-cell inflamed tumor microenvironment from a non-T-cell inflamed environment, sometimes simplified as turning cold tumors hot, activating an immune response, and increasing PD-L1 expression, thus priming for and increasing the effectiveness of checkpoint inhibitors regardless of baseline PD-L1 level. On today's call, our consulting chief physician, Dr. Brian Schwartz, we'll discuss next steps for our TMDC 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 MARIA-1, our Phase I 1B study in collaboration with Bristol-Myers Squibb, evaluating a GAN elicit in combination with Updivo in patients with advanced solid tumors, namely melanoma and squamous cell cancer of the head and neck, were presented at CITC in November of 2020. These data reinforce the potential of aganalysib to overcome resistance to checkpoint inhibition, including in patients who progressed on a checkpoint inhibitor as their immediate prior therapy. Second, data from the TMDC cohort of MARIO3, our phase two study in collaboration with Roche Genentech, in which we are evaluating the combination of aganalysib with ticentricinabraxane as a frontline treatment in patients with TNBC, were presented at San Antonio Breast in December of 2020. These data show a highly encouraging increase in the overall response rate and disease control rate, irrespective of baseline PD-L1 status, with the addition of a gamma list to the centric and abraxing standard of care doublet, which received accelerated approval for the treatment of PD-L1 high but not PD-L1 low frontline TNBC patients. Third, data from ARCA's collaboration, a phase 1b study evaluating aganalysib and a novel checkpoint inhibitor-free regimen that includes a trumadenant, their dual adenosine receptor antagonist, endoxyl, in patients with relapsed refractory triple negative breast cancer and ovarian cancer were also presented at San Antonio Breast in December and showed an increase in response rate with the addition of aganalysib to the novel doublet therapy in both indications. And most recently, in the first quarter of 2021, we presented data at AXO-GU from MERIA-275, our randomized double-blind placebo-controlled Phase II study in collaboration with BMS, evaluating aganalysib in combination with Afevo in patients with advanced urothelial cancer. These data show improvements in response rates, disease control rates, and progression-free survival, particularly in patients with low levels of PD-L1 expression, who are known to not respond well to checkpoint inhibitor alone, and suggest the addition of aganalysib to standard-of-care Opdivo monotherapy can improve patient outcomes. Our strong execution and steady progress have propelled aganalysib forward with signals of activity across diverse settings, including double and triple combinations in the first, second, and third line, and also across multiple solid tumors, which Brian will review in more detail. These data lead us increasingly confident in the potential of aganalysib to improve responses in patients with some of the greatest unmet needs in oncology. Moving to our high-level thoughts regarding future development opportunities for aganalysib, in frontline TNBC, our path forward in combination with concentric and abraxane will be a function of our maturing data, which we will be presenting on July 27th, and again in the fourth quarter of 2021. We plan to cut the data as close to the end of the first half of 2021 as possible to have the most robust data set possible this summer. Additional data will be presented in the fourth quarter of this year, and completion of enrollment is on track for the second half of the year. Our current plan in bladder cancer is to focus on the PD-L1 low population who represent the majority of second-line bladder cancer patients and are also the patients with the greatest unmet need. Checkpoint inhibitors provide little to no benefit in these patients, with some approvals being limited to the PD-L1 high patient population, as with Keytruda and Tricentris in front-line urethral cancer. While our data suggests GAN elicit could be of benefit to all patients regardless of PD-L1 status, we plan to initially focus on PO and low patients, given the magnitude of the aganalysib benefit seen in these patients over Opdivo monotherapy, such that it should be possible to demonstrate the benefit of adding aganalysib to Opdivo in a relatively smaller number of patients, enabling a smaller registration trial, which can therefore be faster and less expensive to conduct. 2021 is poised to be a year of meaningful data updates and continued execution, and our strong balance sheet from the $92 million public offering in Q1 leaves us well-positioned to continue executing on the development of a GAN ELISIB to demonstrate the potential of our first-in-class and wholly-owned max-rate targeting therapeutic. With that, I'll turn the call over to Brian.
spk00: Thank you, Adeline. As Adeline mentioned, our encouraging initial data from Mario 3 in frontline triple negative breast cancer showed a patient benefit from the addition of Eganilisib to an approved standard of care regimen, in this case, the Roche Genentech regimen of Ticentric and Abraxane in frontline TNBC, which received accelerated approval for use in PD-L1 positive patients. At San Antonio Breast Conference last December, we presented efficacy data from the first 13 evaluable patients as well as safety data on 20 patients, including seven patients who enrolled but had not received their first efficacy scan. We were thrilled to report 100% of the evaluable patients had a reduction in their tumor volume regardless of their PD-L1 status, with 69% had either a partial or complete response, with 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 27th. The accelerated approval of Dicentric and Abraxane in PD-L1 high frontline triple negative breast cancer patients, subject to confirmation in subsequent studies, was a subject of a recent FDA Oncology Drug Advisory Committee, or ODAC, review which highlighted the need for better treatment for these triple negative breast cancer patients. In addition, there's also clearly a need for the PD-L1 low patients for which checkpoint inhibitors have not been approved. Our initial MARIO3 data suggests that the upregulation of PD-L1 with eganilisib treatment could improve the effectiveness of checkpoint inhibitors in triple negative breast cancer regardless of baseline PD-L1 status, such that we see multiple paths forward as our maturing data will be an instrumental in prioritizing the focus of future clinical development. In particular, we will assess whether the addition of Eganilisib provides a greater benefit to PD-L1 low patients, PD-L1 high patients, or all patients. regardless of the PD-L1 status, in designing follow-on registration-focused studies. In Q1, we presented data from MARIA-275, our randomized placebo-controlled Phase II study, evaluating the efficacy and safety of Eganilisib in combination with Optivo in second-line platinum refractory IO-naive patients with urothelial cancer. The results presented at ASCO-GU showed the combination of Eganilisib with Optivo improved the overall response rate, the disease control rate, and the progression-free survival versus second-line standard-of-care Optivo monotherapy in all patients regardless of PD-L1 expression levels. However, the greatest benefit over Optivo monotherapy was observed in the PD-L1 low patients, bringing the ORR and DCR to equal levels or above the response and disease control rates seen in the PD-L1 high patients by BMS in the approval study for Optivo monotherapy. The study was called Checkmate 275. We were also encouraged by the PFS hazard ratio of 0.54, such that patients received combination treatment were 46% less likely to progress relative to patients on the Altivo plus placebo arm, an indication of significant patient benefit. We believe these results demonstrate that again, ELISAB has the potential to raise the level of benefit in PD-L1 low patients to a level equivalent that observed with the standard care IO therapy in PD-L1 high patients, as well as increasing the benefit for PD-L1 high patients. Based on these results, we are in the planning stages of a registration trial, and we look forward to providing details of our progress in bladder cancer based on our interactions with regulatory authorities and in the context of the recent ODAC meeting at which accelerated approvals for Keytruda and Tocentric in frontline bladder cancer were reviewed. Leveraging the strong data from MARIA-275 and initial feedback from the FDA, we expect to provide an update on Eganilisib in PD-L1 low bladder cancer patients on July the 27th. Lastly, moving to our renal cell cohort in MARIA-3, Our guidance remains unchanged and we expect to report data in the first half of 2022 from our ongoing fully enrolled proof of concept novel triple combination of Eganilisib, Ticentric and Avastin in frontline renal cell carcinoma. 2021 is going to be a transformative year for INFINITY. The key data readout, the emerging clarity on our regulatory path forward, and some indication of the potential commercial opportunity in combination treatments. Our results to date have shown consistent and broad activity of Eganilisib across diverse settings, indications, and regimens, which we view as highly encouraging. With our strong execution and growing data foundation, We are now poised to advance Eganilisib in what we believe are opportunities for success in metastatic urethelial cancer, triple negative breast cancer patients. Given Eganilisib's unique mechanism of action and consistent signs of activity across trials, we also see tremendous opportunity to extend beyond those initial indications, potentially in PD-L1 low patients regardless of tumor type, who represent the majority of patients and who are underserved by current therapies. Before I turn the call over to Larry, I would especially like to thank our patients, investigators, collaborators at BMS, Roche, Genentech, and Arcus, as well as the team at Infinity whose continued dedication has enabled our progress. With that, I turn the call over to Larry.
spk02: Thank you, Brian. Following our February 2021 public offering in which we raised $92 million in gross proceeds, at March 31st, 2021, Infinity had total cash, cash equivalents, and available for sale securities of $106.8 million compared to $34.1 million at December 31st, 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 the continued development of the Gantt-Olesen. General administrative expenses for the first quarter of 2021 was $3.6 million, compared to $3.2 million for the same period in 2020, and this increase in G&A expense was primarily due to an increase in stock compensation. During net loss for the first quarter of 2021, this was $11.6 million, or a basic and diluted loss per common share of $0.15, compared to a net loss of $10.9 million, or a 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, it is as follows and remains unchanged. Infinity expects net loss for 2021 to range from between $40 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. We really appreciate your continued support as we move forward with development of the Gantt-Listed and are very much looking forward to sharing with you our progress with the development of the GANalyst at our upcoming July 27th update webcast. At this time, we go up to the call for questions. Operator?
spk07: Thank you. Ladies and gentlemen, if you have a question at this time, please press the star and then the number written key on your touchtone telephone. Again, that will be star, then the number 1 key on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the hash key. Please stand by while we compile the Q&A roster. Your first question comes from the line of Robin Karinoskas from Truist. Your line is now open. You may ask your question.
spk09: 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 about your trial design. So how much for sure will we get around trial design and FDA feedback, and how much will we 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 data and your plan? And how are you thinking about what the best strategic vision would be for your company? Thanks.
spk08: Thanks, Robin. Appreciate the questions. So on July 27th, what 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 Eganilis F. 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 protruding to centric and the front line 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 Keto and Low patients are 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 low patients. 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 of San Antonio in December. And so depending on what that data looks like, as Brian said, the data will determine are we going to concentrate our efforts going forward on the PD-L1 low patients, on the PD-L1 high patients, or on all patients The data we'll have greatest visibility into in July is the TMBC Q1 location.
spk09: And as a follow-up, I mean, what are your strategics 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 thing they're focused on from if you're going to go after the broader opportunity and do a partnership?
spk08: So obviously everyone who's developing cancer drugs is looking for better treatments, and that's certainly true in both bladder cancer and breast cancer. With respect to what any specific strategic, you know, potential partners are looking for in 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.
spk07: Great. Thank you.
spk08: Thank you, Robinson.
spk07: Thank you. Next question comes from the line of Ted Sandhoff from Piper Sandler. Your line is now open. You may ask your question.
spk04: Great. Thank you. Looking forward to the event on July 27th. I wanted to ask, I know you're also evaluating a can of Lissib in renal cell carcinoma. Should we be expecting an update from that cohort as well, and is that something we could also get at the 27th? Thanks, Ted.
spk08: No, our guidance remains unchanged for renal cell that we will be providing an update on that in the first half of 2022. Okay, great.
spk04: Awesome. Great. Thank you. Looking forward. Yeah, go ahead. Sorry.
spk08: Yep. So the July 27th 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.
spk04: Yep, perfect. Understood. Very clear. Thank you.
spk07: Thanks, Ted. Thank you. Next question comes from the line of Anupam Rama from JP Morgan. Your line is now open. You may ask a question.
spk05: Hey, guys. This is Tessa on the call tonight for Anupam. Thanks for taking our question. So for the Mario 3 update and triple negative breast cancer in July, You noted kind of the size of patients we should see there, but can you provide a bit more granular on how you think about what a win 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 your OCD cancer in July as well, will you have the FDA minutes in hand? Thanks so much. Sure.
spk08: 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.
spk00: So, I think, you know, what we do have is we do have, for the PD-L1 positive and the total group, you know, there's very clear benchmarks for what the combination of ticentric and abraxane does. For the PD-L1 low group, There's clarity on the PFS and the OS, but there's not much clarity on the response rate. And it's sort of given a range. So in terms of what I'll be looking at is, you know, about 15% above of what you think the control group performs. 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, it's not really meaningful. So I think you really have to look at the totality of it. And the nice thing in June is we'll have patients on drug for at least a year, we'll be able to get an 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% there, so you're 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 you could make an argument around that, but it's really the totality of the data.
spk08: And then on your second question, Tessa, about our plans in bladder cancer, if we have completed our discussions with the FDA and we finalize the trial design and we know exactly what that's going to look like, we would share that. If we haven't yet finalized the discussions and we don't have the final 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.
spk05: Okay, great. Thanks so much for taking our questions.
spk08: Sure, thank you.
spk07: Thank you. Next question comes from the line of Nick Abbott of Wells Fargo. Your line is now open. You may ask a question.
spk03: Oh, good afternoon. Thanks for taking my questions. First, just going back to the TMBC study, you know, I think on clinicaltrials.gov, the trial originally was going to involve around 90 patients, but I know the expansion cohorts are triggered early by the encouraging data. So first one, are you still expecting to roll around 90 patients in the study?
spk00: You know, the way that it's... Go ahead. So the plan is to have, Nick, at least 30 PD-L1 low patients and 30 PD-L1 high patients. You know, so at a minimum, 60 patients, the total study. But I think it's really gonna depend a little bit on the data and how it rolls. We're rolling currently for every two PD-L1 lows, we're rolling one PD-L1 high. So we might be a little bit shy of one and a little bit more rich in the other.
spk03: Okay. And then just going back, Adeline, you commented 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? Both. I'm sorry, both. Okay. Yep. So the total number is going to be, you know, at least 40 of which at least two-thirds of those will be efficacy eligible. Is that the way to think about it? Correct. Okay, perfect. And then just last one for me. You were supporting an IIT with Ezra Cohen down at 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?
spk08: So, Brian, do you want to talk a little bit about that study?
spk00: I mean, you know, that study we're a little bit, you know, it's a little bit dependent on the investigator. But, you know, 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, you know, 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 Ezra as of yet. But obviously, as soon as we get it available, we'll send it to you. We'll get it out there.
spk03: Okay, terrific. Thank you very much.
spk07: Thank you. Again, if anyone would like to ask a question, you will need to press star, then the number one on your telephone keypad. Again, that will be star one on your telephone keypad. Next question, we have the line from Sumit Roy from Jones Trading. Your line is now open. You may ask a question.
spk01: Hi, everyone. Thanks for taking the question. I don't know if you guys ever touched upon the uncomfortable discrepancy between Impassioned 130 and 131. Curiously, if you would show us some more depth, the details in the data, July 27th, on maybe co-mutational status of these patients, BRCA, or more biopsy data and steroid usage, that kind of details. And the second question is, would you consider redesigning the institution trial in terms of compassion 132, like dysentery as a chemo combo rather than an ambroactive? Thank you.
spk00: 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 Ezra's study, is obviously the translational data sometimes lags behind. So we will have much less translational data to share with you. In terms of other comorbid indications, I think if the sample sizes are big enough, and the groups are big enough, definitely we'll share with you, but it'll really depend on how big the different groups are. And we are aware of some of the potential biases that crept into the data for the different studies with the centrics in breast. 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 drug with just the chemo combination, we've thought 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. As you said, 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. Sorry, thank you so much.
spk07: Thank you. At this time, I'm showing no further questions. I'd like to turn the call back over to Adeline for closing remarks.
spk08: Thank you, Mel. We're very excited to be advancing the tremendous and near-term opportunity for GAN-ELISIB in PD-L1 locations and look forward to meaningful MARIO3 triple negative breast cancer data updates at our corporate update on July 27th, 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.
spk07: Thank you, ladies and gentlemen. This concludes today's conference call. You may now disconnect.
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