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. 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 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 Adelene.

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.

Second, data from the TNBC cohort of MARIO-3, our Phase 2 study in collaboration with Roche/Genentech and which we’re evaluating combination of eganelisib with Tecentriq and Abraxene as a front-line treatment in patients with TNBC were presented at San Antonio Breast in December 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 eganelisib to Tecentriq and Abraxane standard of care doublet, which received accelerated approval for the treatment of PD-L1 high, but not PD-1 low frontline TNBC patients.

Third, data from our Arcus collaboration, a Phase 1b study evaluating eganelisib in a novel checkpoint inhibitor free regimen that includes a etrumadenant their dual identity receptor antagonist and Doxil 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 eganelisib to the novel doublet therapy in both indications. And most recently in the first quarter of 2021, we presented data at ASCO GU for MARIO-275 a randomized double-blind placebo-controlled Phase 2 study in collaboration with BMS evaluating eganelisib in combination with Opdivo in patients with advanced urothelial cancer.

These data showed improvements in response rate, disease control rates and progression-free survival, particularly in patients with low levels of PD-L1 expression who are known to not respond as well to checkpoint inhibitors alone and suggest the addition of eganelisib to standard of care Opdivo monotherapy can improve patient outcomes. Our strong execution and steady progress have propelled eganelisib forward with signals of activity across the 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 eganelisib to improve responses in patients with some of the greatest unmet needs in oncology. Moving to our high level thoughts regarding future development opportunity for eganelisib in frontline TNBC our fast forward in combination with Tecentriq and Abraxane will be a function of our maturing data, which we will be presenting on July 27 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 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 to the second half of the year.

Our current plan in bladder cancer is to focus on the PD-L1 low population who represents 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 Tecentriq in frontline urothelial cancer.

While our data suggests eganelisib could be a benefit to all patients, regardless of PD-L1 status, we plan to initially focus on PD-L1 low patients, given the magnitude of eganelisib benefits seen in these patients over Opdivo monotherapy such that it should be possible to demonstrate the benefit of adding eganelisib 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 your meaningful data updates and continued execution and our strong balance sheet from the $92 million public offering in Q1 leads as well-positioned to continue executing on the development of eganelisib to demonstrate the potential of our first-in-class and wholly-owned [indiscernible] targeting therapeutics.

With that, I’ll turn the call over to Brian.

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.

In addition, there’s also clearly a need for the PD-L1 low patients, for which checkpoint inhibitors have not been approved. Our initial MARIO-3 data suggests that the upregulation of PD-L1 with eganelisib treatment could improve the effectiveness of checkpoint inhibitors in triple-negative breast cancer, regardless of based on PD-L1 status, such that we see multiple paths forward as maturing data will be an instrumental in prioritizing the focus of future clinical development.

In particular, we will assess whether the addition of eganelisib 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 MARIO-275, our randomized placebo-controlled Phase 2 study evaluating the efficacy and safety of eganelisib in combination with Opdivo in second line platinum refractory IO naïve patients with urothelial cancer. The results presented at ASCO GU showed the combination of eganelisib with Opdivo improved the overall response rate, the disease control rate and the progression free survival versus second line standard of care Opdivo monotherapy in all patients, regardless of PD-L1 expression levels.

However, the greatest benefit over Opdivo 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 Opdivo monotherapy, the study was called Checkmate 275. We will also encouraged by the PFS hazard ratio of 0.54 subset patients received combination treatment, where 46% less likely to progress relative to patients on the Opdivo plus placebo arm and indication of significant patient benefit.

We believe these results demonstrated eganelisib as a 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 Tecentriq in frontline bladder cancer were reviewed.

Leveraging the strong data from MARIO-275 and initial feedback from the FDA, we expect to provide an update on eganelisib in PD-L1 low bladder cancer patients on July 27. Lastly, moving to our renal cell cohort in MARIO-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 eganelisib, Tecentriq and Abraxane in front line renal cell carcinoma.

2021 is going to be a transformative year for Infinity. The key data readouts, 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 eganelisib across diverse settings, indications and regimens, which we view as highly encouraging. Without strong execution and growing data foundation, we are now poised to advance eganelisib in what people leave opportunities for six days in metastatic urothelial cancer, triple-negative breast cancer patients.

Given eganelisib unique mechanism of action and consistent signs of activity across trials, we’re 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.

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.

We really appreciate your continued support is move forward with development of eganelisib and are very much looking forward to sharing with you our progress with development of eganelisib at our upcoming July 27 update webcast. At this time, we can up the call for questions.

Operator?

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.

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.

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?

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.

Thank you.

Thank you, Robyn.

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?

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.

2022. Okay, great.

Awesome. Great.

Thank you. Looking forward, go ahead.

Sorry.

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.

Yes. Perfect.

Understood. Very clear.

Thank you.

Thanks, Ted.

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.

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.

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.

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.

Okay. Great.

Thanks so much for taking our questions.

Sure. Thank you.

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.

The way that…

Go ahead.

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.

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?

Both.

I’m sorry. Both, okay.

Yes.

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?

Correct.

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?

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

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.

Okay. Terrific.

Thank you very much.

Thanks, Nick.

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.

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.

Got it. Thank you so much.

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.