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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 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.
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 Adelene Perkins, Chief Executive Officer and Chair; Larry Bloch, President; and Robert Ilaria, 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 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'd like to turn the call over to Adelene.
Thanks, Jayne, 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 eganelisib in additional solid tumor indications and establishing the best path forward to maximize the value of eganelisib for patients and shareholders.
We are aggressively advancing the development of eganelisib, including the initiation of our first registration trial, MARIO-4 in frontline metastatic triple-negative breast cancer or TNBC by year-end. In parallel, we are also planning to initiate our platform program with MARIO-P 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 eganelisib 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 eganelisib 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.
Thanks, Adelene.
Our team is diligently working to finalize the design and prepare for the initiation of the first registration-enabling study for eganelisib, MARIO-4 and lay the foundation for the next stage of eganelisib development with MARIO-P.
The strength of our data across multiple indications and treatment settings provide solid evidence that eganelisib, 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 eganelisib 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 MARIO-4 in frontline metastatic TNBC patients, building upon the very encouraging MARIO-3 data we presented late last year.
To recap, our MARIO-3 metastatic TNBC data demonstrated a 47% and 30% relative improvement in medium PFS, in PD-L1 positive and PD-L1 negative tumors, respectively, compared with a benchmarking IMpassion130 study. MARIO-4 will be a randomized double-blind registration Phase III study.
On the investigational arm, all patients will receive the MARIO-3 triple of eganelisib, an immune checkpoint inhibitor and chemo, which will 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 TNBC remains an important unmet medical need, particularly for PD-L1 negative patients who still receive chemotherapy alone. Unfortunately, the vast majority of metastatic TNBC 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 MARIO-4 trial design, and we'll provide updates on our progress later this year. One of my highest priorities since joining Infinity is to identify other opportunities to advance eganelisib, 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 eganelisib 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?
Thank you, Rob.
As mentioned in our first full year 2021 earnings call, this past year has been a foundational year for eganelisib and Infinity as we prepare for eganelisib's first registrational study later this year and prioritize initiation of additional clinical studies and indications where eganelisib 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 $8.7 million at December 31, 2021. And research and development expense for the first quarter ended March 31, 2022, was $9 million compared to $8.2 million for that same period in 2021. 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 eganelisib.
General and administrative expense for the first quarter ended 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 $1.6 million or a basic and diluted loss per common share of $0.15 in the 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 said, 2022 is an execution-focused year for Infinity. And as highlighted in our previous guidance and later today, we are aggressively advancing development of a robust eganelisib MARIO-4 first registration study as well as MARIO-P platform program in other solid tumor indications.
We're excited about the continued advancement of our eganelisib program to lay the foundation of initiation of potential future studies and in parallel, we will leverage eganelisib of unique mechanism of action and differentiated clinical data to evaluate and execute on the best path forward to maximize the value of eganelisib for both patients and shareholders.
On basanite, we thank the Infinity team, our investigators, trial sites and especially our patients and their families who have played interval roles in advancing our work to bring better treatments to patients and thank you for 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?
[Operator Instructions] Your first question comes from the line of Anupam Rama with JPMorgan. Your line is open.
Hi guys thanks so much for taking the question. Adelene and Larry, maybe you could expand on how you're thinking about your current cash position. You mentioned 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 potential operational risk, if you don't do that in the middle of the study? Thanks so much.
Sure, thanks Anupam. So we've said for some time that given the breadth of potential of eganelisib that we ultimately think it makes sense for its feed 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's [ph] that many of them. So exactly how we determine the optimal mix of timing of a partnership.
It will 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 MARIO-P and MARIO-4. So we're pursuing all of those in parallel.
And I'd say - it's critical for us to have done the financing we did in the first quarter of last year and to bring in Rob, as our CMO, who's done large studies in immuno-oncology, most recently working with Celgene and BeiGene on PD-1 and then BMS with C34. Regarding the timing of potential strategic collaboration, I just said, last time when we started a global registration study, we actually put in our corporate collaboration on the heels of initiating that Phase III study.
And that was - that was with AbbVie. It was like $275 million upfront and $130 million in first year milestone. So there are pros and cons for getting in advance of the Phase III, there's some streamlining to actually have one person with two hands on the steering wheel as you're going through the FDA process for review of the Phase III 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.
Your next question comes from the line of Robyn Karnauskas with Truist Securities. Your line is open.
Hi, this is [Nishant] on for Robyn. Thank you for taking my question. Just to ask for 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, like, if you can give us any color on the type of combinations you're planning to pursue in your MARIO-P study that would be helpful? Thank you.
Sure, so thanks Nishant. So what we're looking for in a strategic partnership is two things: one, maximizing the development, expanding the development of eganelisib so that it lives up to its potential. So that's a real key value driver and a 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. And related to the expanded development, which we're initiating with MARIO-P, there are a number of different - we've already disclosed the tumor types that we're 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 eganelisib.
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 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 - if the trial design is wrapped up with all the appropriate input, and we're ready to kick it off.
Your next question comes from the line of Nick Abbott with Wells Fargo. Your line is open.
Good afternoon and thank you for taking my questions. First one on MARIO-3 renal cell, can you remind us what you would view as success in that trial?
Sure, Nick. Thanks for the question. I'll start, but then I'll turn it over to Rob. So I'll just remind everybody what the renal cell trial is its combining eganelisib with Tecentriq and Avastin in frontline renal cell [ph]. And Rob can talk a little bit more about our objective to that - from that study, which is really the signal finding of combining eganelisib with the VEGF and chemo.
Yes and of course, we -- 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, what is the role of adding a, TME modulating agents like eganelisib to a VEGF. So I think success could 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.
And just correct, I misspoke, I said a VEGF and a chemo it's a VEGF in a checkpoint inhibitor. And what we said about that regimen, we know -- and everyone knows Tecentriq and Avastin is not an approved regimen in renal cell. So that's why Rob's point is particularly important in terms of looking metinistically 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.
Okay. And then at the end of Phase II 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?
So I missed the front of that, you were asking about whether...?
Whether at the end of Phase II, it's an opportunity to also discuss the urothelial bladder data with the idea being that a degree upon protocol then in addition, the TNBC would presumably add additional value to a potential partner?
Okay. So you're talking about reviewing that with the regulatory authorities so.
Yes, at the end of Phase II meeting, right?
Yes, yes. So we are really focused on reviewing our MARIO-4 trial design. And again getting 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 bladder cancer study. That's not part of our current focus.
Your next question comes from the line of Soumit Roy with Jones Research. Your line is open.
Hi everyone, congratulations on all development. Probably a question for Adelene, or maybe, Rob, I wanted to get a sense of how much usage in the frontline TNBC setting are you seeing of Tecentriq in combination with chemo? Is it -- in light of the IMpassion131? Are you seeing any pullback in the usage of presenting in the frontline or would love to get my idea.
Yes, so in the U.S., because that agent was - atezo [ph] was pulled for that indication, at least in my own experience, clinical - we aren't using atezo now in the U.S. We're using pembrolizumab now as the approved agent in first-line TNBC. So that's what we're using. Now of course, we've been told by Roche and obviously, it's approved in other countries. So obviously, I can't speak to what its usages outside of the United States.
So you're expecting a good frontline of the trial that MARIO, the rate second trial MARIO-4 would focus on likely KEYTRUDA to be used as the IO agent?
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-L1 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 a analyst plus a checkpoint inhibitor plus chemo in both PD-1 positive and mega, and we haven't yet named what checkpoint inhibitor will be.
Right. And the MARIO-3 renal cancer cohort data depth, is that something we should expect in has more time line? Or do you have any final detail on that?
We haven't - we've just said that it will be second half of the year.
[Operator Instructions] Your next question comes from the line of Kalpit Patel from B. Riley.
This is [Andy] on for Kalpit. 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 that impact against eganelisib in any sense or your strategy moving forward in indications beyond TNBC or bladder cancer. Any thoughts on this ruling would be useful.
Yeah. We appreciate it because we've received this question and there's often a conflation of the different PI3 kinase inhibitors. So there are 4 different isoforms, alpha, beta, delta and gamma, and they are all very different in their biologic expression and their function. And the recent ODAC 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 in solid tumors - and we do expect that the path forward, as we described, even in our TNBC registration study will be in controlled studies. So the high-level review of our MARIO-4 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 study. So there really is no read through to eganelisib.
As you may remember, we had a PI3K delta program previously, which is currently approved. And because of the - some of the side effect profiles that we were aware of through our clinical studies, Phase I through Phase III, we decided to pivot to the first-in-class PK gamma program. And so those concerning AEs, including like late onset colitis even like nine months after initiation of the treatment and infections really - we've not seen that through our 350-plus patients that have been treated on the companion of galas study.
So from a first principle perspective, from a design of eganelisib 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 PI gamma, and we don't expect any regulatory intermingling of those issues either.
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.
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 eganelisib registration study and expanding evaluation of eganelisib in additional solid tumor indications. We remain committed to realizing the value of eganelisib 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 internal role 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.
Ladies and gentlemen, this concludes today's conference call. Thank you for your participation, and have a wonderful day. You may all disconnect.