This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
spk00: Ladies and gentlemen, thank you for standing by. Welcome to the Infinity Pharmaceuticals Conference call to discuss the company's operations and first quarter 2022 financial results. My name is Sarah and I'll be your operator for today's call. At this time, all participants are in 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 Goffman. Please go ahead.
spk08: Thank you, Sarah, and good afternoon, everyone. Welcome to today's call to discuss our recent business progress and review of our first quarter 2022 financial results and company highlights. On the call with me today are Adeline Perkins, Chief Executive Officer and Chair, Larry Block, President, and Robert Alaria, Jr., Chief Medical Officer. We'll open up the call for Q&A following our remarks. The press release issued today details our results and is available on our website at infi.com. Please note that during this call, we may make forward-looking statements about our future expectations and plans, including clinical development objectives, the therapeutic potential of our product candidates, our strategic plans and strategies, and financial projections. Our actual results may differ materially from what we project today. due to a number of important factors, including the considerations described in the risk factors section of our annual report on Form 10-K for 2021, and in other filings we make with the FCC. 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'd like to turn the call over to Adeline.
spk09: Thanks, Jane. And thank you to everyone for joining us today to review Infinity's first quarter 2022 progress. As we discussed on our most recent call just five weeks ago, 2022 is an execution year in which we are focused on expanding the clinical evaluation of aganalysib and additional solid tumor indications and establishing the best path forward to maximize the value of aganalysib for patients and shareholders. We are aggressively advancing the development of aganalysib including the initiation of our first registration trial, MERIO4, in frontline metastatic triple negative breast cancer, or TNBC, by year end. In parallel, we are also planning to initiate our platform program with MERIOP on a rolling basis in the third quarter. We also expect updates from the metastatic TNBC, urothelial cancer, renal cell cancer, and squamous cell cancer of the head and neck trials later in the year. In addition, given the promising future of aganalysib as a first in class drug across multiple solid tumor indications, we are currently evaluating different options, including potential strategic partnerships to access additional human and financial resources, as well as combination drug partners to maximize the opportunity for aganalysib in novel combinations and multiple indications. I'll now turn the call over to Rob to review the studies we are initiating this year as well as potential future development paths.
spk07: Thanks, Adeline. Our team is diligently working to finalize the design and prepare for the initiation of the first registration-enabling study for aganalysm, MARIO-4, and lay the foundation for the next stage of aganalysis development with MARIO-P. The strength of our data across multiple indications and treatment settings provides solid evidence that aganalysm a highly specific small molecule inhibitor of the PI3 kinase gamma pathway that reprograms macrophages in the tumor microenvironment to enhance immune activation, has the potential to be a transformative therapy in immuno-oncology. The consistent positive results we have observed with the Ganalysm are very encouraging, particularly in PD-L1 negative patients who are underserved by checkpoint inhibitors today. Towards that end, we plan to initiate our initial registration-enabling study called MARIO4 in frontline metastatic TNBC patients, building upon the very encouraging MARIO3 data we presented late last year. To recap, our MARIO3 metastatic TNBC data demonstrated a 47% and 30% relative improvement in median PFS in PD-L1 positive and PD-L1 negative tumors, respectively, compared with a benchmark in PASSION-130 study. MARIO-4 will be a randomized double-blind registration Phase III study. On the investigation alarm, all patients will receive the MARIO-3 triplet of aganalysib, an immune checkpoint inhibitor, and chemo, which would be compared to standard of care, which is either chemotherapy alone for PD-L1 negative patients or chemotherapy and a checkpoint inhibitor for PD-L1 positive patients. It's important to note that despite recent advances with immune checkpoint inhibitors, metastatic TMBC remains an important unmet medical need, particularly for PD-L1 negative patients who still receive chemotherapy alone. Unfortunately, the vast majority of metastatic TMBC patients will succumb to their disease, underscoring the continued need for novel treatments. Following the end of Phase II meeting with the FDA and meetings with global regulatory authorities, INFINITY will finalize the MARIO4 trial design and will provide updates on our progress later this year. One of my highest priorities since joining INFINITY is to identify other opportunities to advance aganalysib, particularly in cancers where immune checkpoint inhibitors have had limited success. In support of this mission, we will also initiate our MARIO-P program to evaluate the clinical benefit of aganalysib in additional studies to be initiated on a rolling basis starting in the third quarter of this year. We'll provide more color on this program later in the year. And with that, I'll turn the call over to Larry to review the first quarter financials. Larry?
spk01: Thank you, Rob. As mentioned in our first full year 2021 earnings call, this past year has been a foundational year for Gantt Alyssa and Infinity. as we prepare for Gantt-Elizabeth's first registrational study later this year and prioritize initiation of additional clinical studies and indications where Gantt-Elizabeth has the largest potential benefit for patients. At the end of the first quarter of 2022, Infinity had total cash of $67.1 million compared to $80.7 million at December 31st, 2021. And research and development expense for the first quarter ended March 31st, 2022 with $9 million compared to $8.2 million for that same period in 2021. And this increase was primarily related to new hires during the period, partially offset by a decrease in clinical development expenses to support continued development of a GAN illicit. General and administrative expense for the first quarter end of March 31, 2022 was $3.7 million compared to $3.6 million for the same period in 2021. And this increase in G&A expense was primarily due to an increase in stock compensation partially offset by a decrease in professional services. Net loss for the quarter ended March 31, 2022, was $12.4 million, or a basic and diluted loss per common share of $0.14, compared to a net loss of $11.6 million, or a basic and diluted loss per common share of $0.15 that same period in 2021. Infinity's 2022 financial guidance remains unchanged, and so we continue to expect net loss for 2022 to range from between $45 million and $55 million, and to end 2022 with year-end cash ranging from between $25 million and $35 million. And Infinity's financial guidance does not include any additional financing or business development activities. So that being said, 2022 is an execution-focused year for Infinity, and it's highlighted in our previous guidance and later today, we are aggressively advancing development of a robust GANalysib Mario4 first registration study, as well as MarioP, a platform program in other solid tumor indications. We're excited about the continued advancement of our GANalysib clinical program to lay the foundation for the initiation of potential future studies. In parallel, we'll leverage GANalysib's unique mechanism of action and differentiate clinical data to evaluate and execute on the best path forward to maximize the value of GANalysib for both patients and shareholders. On behalf of Infinity, we thank the Infinity team, our investigators, trial sites, and especially our patients and their families who have played integral roles in advancing our work to bring better treatments to patients. And thank you for your continued support. Look forward to updating you on our progress in the coming months. At this time, we can open the call for questions. Operator?
spk00: Thank you, sir. Ladies and gentlemen, if you have a question at this time, please press the star and then the number one key on your touchtone telephone. If your question has been answered, or you wish to move yourself from the queue, please press the pound key. Again, ladies and gentlemen, if you have a question at this time, please press star and then the number one on your touchtone telephone. Your first question comes from the line of Anupam Rama with JP Morgan. Your line is open.
spk02: Hi, guys. Thanks so much for taking the question. Adeline, Larry, maybe you could expand on how you're thinking about your current cash position. You mentioned, you know, thinking about strategic alternatives here. Should we be thinking about, hey, we will be addressing our cash needs ahead of Mario P and or Mario 4, given, you know, potential operational risks if you don't do that in the middle of a study? Thanks so much.
spk09: Sure. Thanks, Hanipam. So, We've said for some time that given the breadth of potential of Eganilisib, that we ultimately think it makes sense for it to be developed in a partnership. And the good news is there is an appetite for first-in-class drugs with unique mechanisms with good Phase II data, and there just aren't that many of them. So exactly how we determine the optimal mix of timing of a partnership, it'll be driven by when it's the right moment and having identified the right partner to help us expand the breadth and create shareholder value and what other tools we use during that process. So it's something that we're actively considering while in parallel. A real value driver for us is putting all the operational pieces in place for both MarioP and Mario4. So we're pursuing all of those in parallel.
spk01: It's critical for us to have, you know, done the financing. We did the first quarter of last year and to bring in Rob as our CMO, you know, who's done, you know, large studies in immuno-oncology, you know, most recently working with, you know, Celgene in Beijing on PD-1 and then BMS with CTLA-4. Regarding the timing of potential collaboration. I just say, you know, the last time we started a global registration study, we actually put in our corporate collaboration on the heels of initiating that phase three study. And that one was with AbbVie. And it was like $235 million up front and $130 million in first-year milestones. So there are pros and cons for getting, you know, in advance of the the phase three, there's some streamlining to actually have, you know, one person with two hands on the steering wheel as you're going through the FTA process for review of the phase three protocol. And I wouldn't prejudge if one is necessarily from first principles better than the other one. But our most recent experience was on the back side.
spk02: Got it. Thanks so much for taking our questions. Okay, thank you.
spk00: Thank you, Anupam. Your next question comes from the line of Robin Karnuskas with Truvis Securities. Your line is open.
spk05: Hi, this is Nishant. I'm on for Robin. Thank you for taking my question. Just to ask more questions on partnership, if you can give us any update on decisions regarding like optimizing what kind of partnerships you're planning to pursue And secondly, if you can give us any color on the type of combination you're planning to pursue in your MarioP study, that would be helpful. Thank you.
spk09: Sure. So what we're looking for in a strategic partnership is two things. One, maximizing the development, expanding the development of GAN-ELISIB so that it lives up to its potential. So that's a real key value driver. And secondly, partnership structure that creates value for infinity shareholders and obviously beyond that there's a lot of different structures that would enable us to achieve that so those are our two overarching goals in related to the expanded development which were initiating with Mario P there are a number of different we've already disclosed the tumor types that were prioritizing with non-small cell lung cancer, prostate, ovarian, soft tissue, sarcoma, and there are a number of different combinations within that that are interesting and it really speaks to the broad mechanism of Eganilisib. There are a lot of combination agents that make sense. What we've done historically is we believe it's most appropriate to outline those trials when we've completed the design. So we've finalized the protocol, we've reviewed with regulatory authorities with KOLs. And so we will be providing more detail on those Mario P trials when the trial design is wrapped up with all the appropriate input and we're ready to kick it off.
spk05: Great. Thank you.
spk09: Thank you.
spk00: Your next question comes from the line of Nick Abbott with Wells Fargo. Your line is open.
spk03: Oh, good afternoon, and thank you for taking our questions. First one, on MARIO3 renal cell, can you remind us what you would view as success in that trial?
spk09: Sure, Nick, thanks for the question. And I'll start it, but then I'll turn it over to Rob. So I'll just remind everybody what the renal cell trial is. It's combining, again, ELISA with Tocentric and Avastin in frontline renal cell. Rob can talk a little bit more about our objective from that study, which is really the signal finding of combining a Gantylisib with a VEGF and a chemo.
spk07: Yes, and of course, one of the goals of the study is to characterize whatever efficacy we see with this regimen and also safety, but we think there's a lot of opportunities with the translational medicine side of this to understand you know, what is the role of adding a TME modulating agent like a GAN ELISIB to a VEGF. So I think, you know, success can come in a lot of different flavors, and we're looking forward to kind of digging into that data and then sharing it with everyone later this year.
spk09: And just, I correct, I misspoke. I said a VEGF and a chemo. It's a VEGF and a checkpoint inhibitor. And what we've said about that regimen, we know, and everyone knows, to centric, and Avastin is not an approved regimen in renal cells. So that's why Rob's point is particularly important in terms of looking mechanistically at that combination and any translational data to determine whether we want to go forward in renal cell. But we might at that time be moving forward with one of the next generation VEGFs that are approved in the renal cell population.
spk03: Okay. And then at the end of phase two meeting, Is this also an opportunity to discuss urothelial bladder data? I'm just asking because wouldn't agreed upon registration protocol add value to a potential partner for the overall program?
spk09: So I missed the front of that. You were asking about whether.
spk03: Whether at the end of phase two it's an opportunity to also discuss the urothelial bladder data. you know, with the idea being that an agreed-upon protocol there, in addition, the TMVC, you know, would presumably add additional value to a potential partner.
spk09: Okay, so you're talking about reviewing that with the regulatory authorities.
spk03: Yeah, in the phase two meeting, right.
spk09: Yeah, yeah. So we are really focused on reviewing our Merriam-Ford file design and getting less and less, of course, When you share your data, you share all of your data, and particularly from a safety perspective, but we're not focused right now on seeking regulatory approval for a bladder cancer study. That's not part of our current focus.
spk03: Okay, thank you.
spk00: Your next question comes from the line that Summit Roy rejoins research. Your line is open.
spk04: Hi, everyone. Congratulations on all the development. Probably a question for Adeline or maybe Rob. I wanted to get a sense of how much usage in the frontline TNBC setting are you seeing of Dyscentric in combination with chemo? In light of the Impression 131, are you seeing any pullback in the usage of Dyscentric in the frontline? I would love to get an idea.
spk07: So, you know, in the U.S., because that agent was, you know, Atezzo was pulled for that indication, at least in my own experience, clinical, you know, we aren't using Atezzo now in the U.S. We're using, you know, Pembrolizumab now as the approved agent in first-line TMBC, so that's what we're using. Now, of course, you know, we've been told by Roche, and, you know, obviously it's approved in other countries. Um, so obviously, you know, I can't speak to what its usage is outside of the United States.
spk04: So you're expecting, um, the frontline of, uh, the trial, the Mario, uh, the registration trial, Mario four would focus on likely key Truda to be used as a, as the IO agent.
spk09: Certainly, we will plan that will be used as the control arm. So the standard of care for PD-1 positive patients only is Keytruda and chemo. So that would be the control arm. And then the PD-1 negative patients where no checkpoint inhibitor has been approved, the control arm would be chemo. What we've said for the treatment arm, the experimental arm, it will be again listed plus a checkpoint inhibitor plus chemo in both PD-1 positive and negative. And we haven't yet named what checkpoint inhibitor will be.
spk04: Right. And the Mario 3 renal cancer cohort data, is that something we should expect in ESMO timeline, or do you have any finer detail on that?
spk09: Schmidt, we haven't. We just said that it will be second half of the year. Thank you so much for taking the call.
spk04: Thank you.
spk09: All right. Thanks, Schmidt.
spk00: Again, ladies and gentlemen, if you have a question at this time, please press star under the number one on your touchtone telephone. Your next question comes from the line of Kalpit Patel from B. Riley. Your line is open.
spk06: Good afternoon. This is Andy on for Kalpit. Thank you for taking my question. How are you viewing the recent ODAC votes on advancing PI3K inhibitors as a drug class with respect to requiring randomized trials? Does the FDA's recent ruling on PI3K inhibitors impact agangelizib in any sense or your strategy moving forward in indications beyond PNPC or bladder cancer? Any thoughts on this ruling would be useful. Thank you.
spk09: Yeah, thank you, Andy, for the question. We appreciate it because We've received this question, and there's often a conflation of the different PI3 kinase inhibitors. So there are four different isoforms, alpha, beta, delta, and gamma, and they are all very different in their biologic expression and their function. And the recent ODAP was focused on the specific PI3 kinase delta inhibitors in hematologic malignancies and the accelerated approval based on single-arm studies. So that doesn't have any parallel to what we're doing. Again, there's a PI3 kinase gamma inhibitor. It's expressed primarily on myeloid cells where delta is expressed on T cells. We're developing it in solid tumors. And we do expect that the the path forward, as we've described even in our TNBC registration study, will be in controlled studies. So the high-level review of our MARIO4 study is that it will be our triple combination relative randomized to current standard of care. So the really, and even follow-on questions that have been asked about the ODAC, there have been confirmatory statements that their findings are limited to PI3 kinase delta limited to heme, limited to accelerated approval on single-arm studies. So there really is no read-through to a ganylysin.
spk01: As you may remember, we had a PI3K delta program previously, which is currently approved. And because of some of the side effect profiles that we were aware of through our clinical studies, phase one through phase three, we decided to pivot to the first-in-class PI3K gamma program. And so those concerning AEs, you know, including, like, late onset colitis, even, like, you know, nine months after initiation of the treatment and infections, you know, really we've not seen that through our, you know, 350-plus, you know, patients that have been treated on the, you know, compendium of aganalysed studies. So from a first principle perspective, from a design of, again, ELISA, you know, from a chemical perspective and from our empirical data clinically and translationally, we've not seen any basis for confabulating the PI3K delta with our PI3K gamma, and we don't expect any regulatory intermingling of those issues either.
spk06: That was helpful. Thank you.
spk09: Thank you for the question.
spk00: 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.
spk09: Thank you, Sarah. In closing, INFINITY's future is very bright. We're fortunate to be developing a promising therapy with the potential to improve the quality and length of life for people with cancer. INFINITY is well-positioned to execute in 2022, initiating the first aganalysib registration study and expanding evaluation of aganalysib in additional solid tumor indications. We remain committed to realizing the value that GAN elicits for the benefit of both patients and shareholders. I'd particularly like to thank the Infinity team as well as our investigators, our trial sites, and our investors, and most importantly, our patients and their families who have all played integral roles in advancing our work to bring better treatments to patients. We look forward to providing updates in the coming months, and thank you for your continued support.
spk00: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation and have a wonderful day. You may all disconnect.
Disclaimer