Q3 2021 Infinity Pharmaceuticals Inc Earnings Call

November 2, 2021

Ladies and gentlemen, today's call is scheduled to begin shortly until that time your lines will.

It can be placed on.

Music called [music].

Today's call is scheduled to begin shortly until that time your lines will again be placed on music hold thank you for your patience.

[music].

Ladies and gentlemen, thank you for standing by welcome to the Infinity Pharmaceuticals conference call to discuss the company's operations and third quarter 'twenty 'twenty. One financial results. My name is Tina and I'll be your operator for today's call. At this time all participant lines are in a listen only mode. There will be a question and answer session at the end to follow.

Please be advised that this call is being recorded and at Infinity requests now I would like to introduce your host for today's call Jayne Kauffman. Please go ahead.

Thank you Tina and good afternoon, everyone welcome to today's call to discuss our recent business progress and review of our third quarter 2021 financial results on the call with me today are Abilene Perkins, Chief Executive Officer, Larry Bloch, President, Robert Gloria Chief Medical Officer, and Stephane can lose some.

Chief Scientific officer will open up the call for Q&A following our remarks.

Less release issued this afternoon details our results and is available on our website at <unk> Dot 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 projection.

Yeah.

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 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 Adam.

Thanks, Jayne and thank you to everyone for joining us today.

This is a very important time at infinity as we focus on three significant value drivers for the company.

First our evolving clinical and translational data, which will we will we will review during todays call yes.

I guess, we have a drug with a gander listen and lay the foundation for significant additional value creation.

Second based.

Based on these data we are making the very important transition from seeking proof of concept with the analysts said two advancing our registration focused study.

Third our validation of a gantlet syn <unk> unique mechanism of action in reprogramming macrophages.

Can't cheat again analysts its potential beyond T N B C. In Europe, you have cancer.

The analysts it is distinctively well positioned as the only peer three kinase gamma inhibitor in clinical development to drive differentiated benefits for patients.

In particular, we have shown the ability of the analysts have to approve the outcomes of its combination drug partners, particularly checkpoint inhibitors, which have historically benefited a minority of treated patients and which are increasingly dependent upon complementary combinations to improve result.

I'll now elaborate on each of these three value drivers.

Starting with data.

Last quarter, we presented data in patients with second line metastatic urothelium cancer and in patients with first line metastatic triple negative breast cancer, which provide compelling evidence that again, Melissa improves patient outcomes.

Importantly, we are seeing as evidenced on the most meaningful metric of patient benefit, namely prolonged progression free survival or PFS and extended overall survival or OS.

And we see these benefits for patients regardless of their baseline PD lone status.

We are very pleased to have been invited to present updated T. N D. C data at the 2021, San Antonio breast cancer Symposium. This December.

T M D C data mature, we are especially interested in confirming whether the PFS results from this summer, which exceeded our expectations are maintained over a longer period of time in more patients.

Prolonged PFS is particularly meaningful for PD, one negative metastatic frontline T N B C patients for whom no checkpoint inhibitors have been approved.

Which leads me to our second value driver as we turn our attention to registration enabling studies.

The strength of the PFS and OS data, we have generated in T. N. B C. And you see is particularly relevant is these are likely to be the primary endpoint for potential registration trial.

We are actively engaged with key opinion leaders and regulatory authorities and the design of our registration focused study and you see on the strength of our PFS and OS data gives us confidence in our ability to meet the high bar is necessary for approval.

We look forward to updating you on our plans for Gan illicit and you see on January 5th in conjunction with our 2022 guidance.

Are you see PFS and OS data are further bolstered by translational evidence from biopsy, indicating that there is significantly greater immune attack immune activation and the treatment arm with again, a lift versus the control arm without began Elisa.

So the drug is doing exactly what it was designed to do which brings me to our third value driver, which is the breadth of again a list of potential beyond T N B C and D C.

Over the past 12 months, we have shown very encouraging clinical and translational data on a gamma list of activity relative to reference benchmarks across five different tumor types three different combination regimens and in multiple lines of therapy, all of which demonstrate again a list of power to activate an immune response.

The data from each of these individual studies alone that's notable and becomes even more compelling when viewing the totality of the data where it's consistency across multiple setting underscores the potential of bank analysts said to drive the next generation of immuno oncology therapies.

This is particularly true given the big analysts it is the only <unk> kinase gamma specific inhibitor in clinical development.

The only way to access the unique macrophage reprogramming achieved through inhibition of <unk> kinase gamma is with again listen.

There is no alternative P. S <unk> kinase gamma inhibitor in the clinic, so as our clinical data mature favorably the scarcity value of analysts of increases dramatically.

Does the attractiveness of our strategic options.

Hence our highest priority is to advance the three value drivers outlined above by continuing to generate strong clinical and translational data advanced registration, enabling studies and leverage the fundamental biologic mechanism began illicit and remodeling the tumor microenvironment to improve.

[noise] outcome comes across additional setting.

To achieve this we have further strengthened our clinical and scientific leadership as well as our board of directors.

Last quarter, we announced the appointment of our Chief Scientific Officer, Dr. Stefan Palouse L.

With prior experience at Infinity is uniquely qualified and ideally position to push forward. The important scientific work that is the foundation of our program.

On the clinical front, we have appointed a new chief Medical officer to succeed Dr. Brian Schwartz, who served as our consulting chief position and made impactful contributions and guiding our clinical programs through key data readouts. The paved the way for the ongoing development of analysts said, we could not be more pleased that Brian is continuing to contribute.

To Infinity and again elicit from his new position on our board.

We are thrilled that Dr. Robert Lauria has joined Infinity as our Chief Medical officer to lead the future clinical development of a Gan Elisa.

Rob brings an ideal background to infinity, given his deep expertise in drug development in immuno oncology.

He joins us from BMS and Celgene, where he led BMS as CTO like for program and Celgene PD, one inhibitor program in collaboration with Celgene.

Rob strong track record in drug development from preclinical through approval. During his 10 years at Lilly Celgene and BMS is critical to the top value drivers I just reviewed.

Throughout his pharma career and now with Infinity Doctor or a lawyer has continued to treat patients including for some of the indications for which we are now evaluating analysts said, including T. N D. C. Such that he is acutely aware of the magnitude of the need for those patients.

With that I'll turn the call over to Rob Rob.

Yep.

Thanks, Natalie I'm really thrilled to be part of Infinity at this exciting time my decision to join the company was driven by several key factors. The first is that while approved immuno oncology drugs have led to important advances we still have much work to do to fully harness the immune system to effectively.

Combat cancer.

All of my list and that of others is the ability to reverse the immunosuppressive tumor microenvironment.

That's why I'm, so enthusiastic about the potential for getting a list of highly specific small molecule inhibitor of P. O S refinance gamma to reprogram macrophages in the tumor microenvironment and enhanced immune activation.

The second reason I chose to join US entity is the strength and consistency of a gantlet hoops data across multiple indications and treatment settings, including PD one negative subgroups.

<unk> solid evidence that analysts it has the potential to be transformative therapy and immuno oncology.

And certainly not least because the strength of the infinity team who've worked so passionately to bring again always good to this exciting pointing to mid single.

Among my highest priority since joining affinity is to develop a strategy for registration, enabling studies in Europe, Youll cancer and P. M D C.

Mario 275 overall survival data are truly compelling, particularly given these results we're seeing in both PD lone positive and negative patients.

Based on the strength of these data were considering our next steps extremely thoughtfully with input from Kols and regulatory authorities.

To recap Mario 275 is a randomized double blind placebo controlled study that enrolled 49 second line European real cancer patients randomized two to one to either Gan Alyssa applicable amount, which is marked as up to market. It goes up people or standard of care nibble around plus placebo our streets.

Objective was to increase the effectiveness of second line treatment for patients with advanced here at the old cancer towards that goal. We found that the strong disease control rate and progression free survival data, we presented at <unk> in February has translated into a nearly doubling of overall survival.

Specifically this past July we reported a median overall survival of 15.4 months with the combination of a gantlet southern Nevada now compared to 7.9 months, although they are both of them have control arm.

The importance of overall survival was recently underscored in April Hodac meeting and which PFS findings that provided the basis for accelerated approval did not ultimately translate into a risk benefit.

Against this backdrop, we were delighted to see that our PFS benefit translated into always benefit with Mario 275, including PDL one negative patients.

I would now like to give you a brief update on our Mario three study in advanced metastatic triple negative breast cancer the strategic.

Objective was to characterize the safety and efficacy of the addition of again over to a Tesla lithium now which is marketed as the centric Nab Paclitaxel market is the Brac thing in metastatic T. M D C.

As you may be aware Roche withdrew the U S accelerated approval for Tesla was a man and the <unk>.

First line PD Lone positive metastatic P. M D C patients during Q3 of this year.

Draw was required in accordance with the requirements of the accelerated approval program. After Roche's confirmatory study using a different chemotherapy failed to meet its primary endpoint or not.

Notwithstanding the withdrawal published data from the Impassion 130 studies demonstrated that a person with a map and Nab Paclitaxel is an active treatment regimen and this combination is still approved for first line metastatic T. M. B C patients in over 70 countries outside of the U S.

Roche has been very clear in communicating its commitment to continue studying it says it was the mab in T. M D C and in continuing to supply it as it was about four ongoing Mario three study.

The eligibility criteria for Mario three were designed to mirror. The Impassion 130 studying to facilitate historical benchmarking and patients were enrolled in either a PD lone negative or PDL one positive cohort.

It's important to note the recent approvals of immune checkpoint inhibitors in combination with chemotherapy in first line metastatic T. M. D. C had been limited just to PD lone positive patients. There are no immune checkpoint inhibitor regimens approved for metastatic PD Lone negative T. M. D C patients who represent the majority of T. M D C patients in.

Therefore, a very significant unmet medical need.

The data we presented at San Antonio breast cancer Symposium in 2020, providing exciting initial snapshot of clinical response in our first 13 patients and our Kols event. This past July we reported an update or a larger data set of 38 patients.

87% of Evaluable patients exhibited tumor reductions and we saw early but encouraging PFS data specifically.

<unk> with PDL, one positive tumors, we observed a median PFS of 11 two months compared to the seven five months that have been observed an impression 130 in.

In the patients with PDL, one negative tumors, where you're rewarded we reported a median PFS of seven three months versus $5 six months observed corneum passion was 30.

Together. These results suggest that the addition of the analyst to immune checkpoint inhibitor and chemotherapy has the potential to improve.

For both PD lone positive and PDL, one negative patients.

For T M. B C. The maturing Mario three data will be our north star and outlining our best registration path for gambling.

These data will allow us to make informed decisions about patient subgroups, such as those with PDL one negative tumors.

We've leveraged data from our European when T. M. D C clinical programs to build a very strong foundation of translational data to support a cannibalism fundamental mechanism of action of macrophage reprogramming.

Our July Kols event update we presented the results of a gene expression analysis for Mario 275.

So clearly you can enhanced immune activation and Uganda lists of novel combination compared to the new role map control arm.

Mario three we presented data of paired tumor biopsies from both PD lone positive.

And PD, one negative CNBC patients showing an increase in the M. One two into ratio reflective of macrophage reprogramming and.

An increase in immune activation and an increase in PDL one expression in both PD lone negative and PD, one positive patients compared to baseline.

While our near term focus to determine the optimal path forward in bladder cancer and T. M. D. C. The strong data we generated with analysts have been combinations of both PD one and.

PD, one inhibitors and in checkpoint inhibitor free regimen supports broader investigation of analysts across additional tumor types, including tumors for which immune checkpoint inhibitor based treatments have had limited success.

Again, I'm thrilled to have joined the team at Infinity and look forward to providing updated data in D. C. At the San Antonio breast cancer Symposium and an update on again with a new C with our January 5th guidance for 2022.

And with that I'll turn the call over to Larry to review, the third quarter core quarter financials Larry.

Thank you Rob.

Even for upcoming San Antonio breast cancer Symposium presentation. Later this quarter 2021 has already been a foundational year for the analysts.

<unk>.

As we prepare forgive us its initial potential registration, enabling study as well as prioritizing opportunities with the largest potential benefit for patients to additional clinical studies will begin.

Because that wasn't outlined we've strengthened our executive team with returns to fund to Infinity as Chief Scientific Officer, and addition of Rob as Chief Medical Officer, as well as the transition of Brian disturbing on our board of directors.

He has also strengthened.

Financial position through a public offering in February which we've raised $92 million in gross proceeds to enable our continued execution.

Would your development plans for <unk>.

So at September 32021, and <unk>, two cash cash equivalents and available for sale securities of $90 $1 million compared to $34 1 million at December 31, 2020.

Research and development expense for the third quarter 2021, with $7 1 million compared to $6 1 million for the same period in 2020, and this increase was primarily related to increase in development expenses and compensation related expenses.

General and administrative expense for the third quarter of 2021 was $3 8 million compared to $2 9 million at the same period in 2020.

This increase in <unk> expense was primarily due to the increase in consulting expenses professional fees and stock compensation.

Net loss for the third quarter, 2021 was $10 7 million or basic and diluted loss per common share of <unk> 12.

Compared to a net loss of $9 5 million or basic and diluted loss per common share of <unk> 16.

For the same period in 2020.

At least 2021 financial guidance remains unchanged and we expect net loss for 2021 to range from $40 million to $50 million and to end 2021, with a year end cash cash equivalents and available for sale securities balance ranging from $70 million to $80 million.

So we're very much looking forward to sharing our updated <unk> data in first line metastatic triple negative breast cancer on December 10th in person at the San Antonio breast cancer Symposium.

We're really pleased to have Dr. Hudson Sullivan and medical oncologists specializing in breast cancer for the center for women's oncology at the Moffitt Cancer Center, one of our top enrolling investigators and married with three shifting our data at the San Antonio breast cancer Symposium.

<unk> will also be joining us.

Our investor event, the same day to provide his perspective on our maturing metastatic triple negative breast cancer data in the context of experience treating patients with this again with the regimen.

On behalf and Cindy and thank you for your continued support and we look forward to engage with you again in just about a month.

At this time, we can open the call for questions operator.

Yeah.

To ask an audio question press Star one on your telephone keypad again that is star one to ask a question and we'll pause for a moment to compile the roster.

Okay.

Your first question is from our new Pam <unk> Rama from J P. Morgan.

Hi, guys. Thanks, so much for taking the question.

Just a quick logistical question for me I think the prior guidance was that enrollment will complete Mario three by the end of the year. So where are you on that and then when we get like I think the enrollment dynamics are up to 30 patients with PDL one negative when we get all 30 of those patients at San Antonia. Thanks, So much.

Yeah. Thanks for the question Anna pumps. So we are on track to have enrolled approximately 60 patients in the study by the end of the year.

What we expect to present at San Antonio is.

As you know.

At our event. This summer we had 43 patients who enrolled so we will have all 43 will have been on had the opportunity on the study for another three or four months. So we'll have more mature data on those 43 and four patients who've enrolled since then we will all will be included in the safety data.

And we will include any efficacy scans that we have on those patients who are more recently enrolled.

Okay.

Got it thanks, so much for taking our question.

Sure.

Your next question is from Kevin <unk> with Oppenheimer.

Hey, great. Thanks for taking my questions.

There's been some.

Pretty well publicized.

All of our back saying I'm just curious.

If and to say it.

Getting up the San Antonio patients, who for whatever reason.

They have this vaccine doses, how does that sort of traded from ups Proto.

Protocol and physical perspective.

Sure. Thanks, Kevin I'll, let Rob take this I will just leave by saying that our partner BMS has been extraordinarily helpful. In working with us to ensure that we have access for the patients that were treated and they've made the clinical trial is a priority, but Rob you can take that yeah. There is a nationwide shortage.

As you mentioned about Brexit. However, we are supplying the drug and so far our suppliers. It's been fine we'd been able to provide drug to the current patients and the patients. We are enrolling now so there haven't been any patients who missed any doses because of not having to Brexit.

Anything Kevin the fact that we have.

Uninterrupted supply for Frac sand and providing that for patients is just another benefit for.

Being enrolled on the study.

Great. That's super helpful. And then just in terms of.

Opportunities to you.

Learn more about again.

Outside of CNBC.

Should we think about investigator sponsored studies as one Avenue and it makes for in 2020 are or what really is the right structure to better characterize.

<unk>.

Obviously drove more broadly.

Howard.

Registration.

Strategies for U C M to M D C.

Thanks, Kevin we're all delighted that you asked that question because as we mentioned in our remarks, we really you know based on the mechanism of action data that we've now seen in our existing studies, we really are.

Very.

Cited about leveraging that in other settings, and we have had many discussions with investigators about Isps and other studies, we will if any of those are finalized by the time of our 2022 guidance in January we'll share those.

Not by then we will throughout the rest of the year.

Okay.

Great. Thanks for taking my questions I'll get back in queue.

Okay.

Yeah.

Your next question is from Ted <unk> with Piper Sandler.

Great. Thank you very much primary home was a little choppy, so I didn't get to hear everything, but I wanted to get a sense for.

Plans for triple negative breast.

Data continues to be positive.

Do you envision as next steps and then.

Derek just ask this question so I apologize if it's a repeat.

What about expanding.

John.

<unk> carcinoma.

What are some other ideas and what are some other Charles.

Thanks.

Yeah sure Ted I'll start and then I'll turn it over to Rob who can describe our thinking and 10 B C. I'll I'll just preview. This you know that there are the majority of patients with both Tennessee and bladder cancer are PD lone negative. So that was the first group to enroll and that's the first group that we'll be able to interpret.

The results from because they tend to progress more quickly given the historic benchmark would be a breath pain monotherapy because there is no checkpoint inhibitor at all that's been approved for the frontline metastatic <unk> patients who are PD lone negative so we're likely to be able to map out our thinking.

On the PD lone negative before the positives, but Rob can show you how he thinks about that.

Yeah, I think there's a great point I mean, I think you know.

Since now PDL, one negative and positive patients are treated differently.

What we'd like to see is how our data matures in both groups. That's why we designed that study to have a cohort of negatives in a cohort of positive of course.

That are negatives do not so well so we find out earlier, how they're doing or not doing the positive do a bit better with standard of care and adding again Alyssa, we'll have to see how that matures, but this is something we're being very mindful of and again, we're really looking at.

To see what these maturing data show.

And tears your additional question Ted about what other studies, we are receiving a lot of inbound inquiries could do investigator sponsored studies, we do have one underway now with as we're calling it a window of opportunity study in patients with squamous cell cancer of the head and neck and our team is now prioritizing other ones.

And as soon as those are ready for primetime will very much look forward to sharing them with you because there are many settings, where there's a need for reduction in the immune suppressive microenvironment and a very strong scientific rationale for the use of analysts in other combinations and our chief Scientific officer.

Stefan Pluto is is working with the team to really prioritize one of our.

Scientific rationales that make most sense.

Great that makes so yeah.

Got it.

It just didn't come there's very few validated and partnered macrophage targeting therapeutics and so there really is a sort of a scarcity effect and so were getting both from a corporate side in.

Let's go to sponsored studies that a lot of inbound interest. So we're in the process of prioritizing those but very much look forward to expanding both the depth and the breadth of the again with our clinical footprint.

Yeah.

Great very helpful. Looking forward the data in December and I'm also hearing more about the plans for other indications.

Thanks Ted.

Your next question is from Nick Abbott with Wells Fargo.

Oh, good afternoon, and congratulations on a terrific quarter and.

On some great hires so I guess the first one for me and that is do you expect to have a finalized BBC registration trial designed with regulators final on the January 5th update them.

Are you planning on running this in both North America and in Europe.

Okay.

So thanks Nick.

Let me give you a rough sense of the cadence. So we decided it was very important to look at our overall survival data in bladder cancer to refine our thinking about the registration trial and as you know.

We got the first look at that at the end of July and we've now had the opportunity. We're really pleased with the OS data. We're also really pleased that it had matured and look really nicely in the PD lone positive patients as well.

So we spent the very end of the summer and early fall holding some AD boards, we were delighted to get input from really the world's thought leaders in bladder cancer, who have been really helpful. About the best path forward and so based on this new data, we've revised and enhanced our thinking.

About the most attractive potential registrational trial.

And so now we will go back we've had interactions with the FDA before this new data and the FDA was very helpful very supportive.

Really looking forward to going back as you know the interactions are an iterative process. So we will be requesting feedback on some of our revised and we believe enhanced thinking.

And I would suspect that given the <unk>.

The same lead times for that feed that we're unlikely to have it completely finalized by January 5th, but we'll be able to provide an update on where we are.

Okay, and do you intend to run that trial in North America, and Europe with just North America.

Both.

As you know Mary a 275, we conducted a lot of much of the marriage 275 enrollment was in Europe, and Eastern Europe, and the trial enrolled really well and so we expect to go back and we hope in our sights for terrific. So we hope to use many of the same sites and investigators who are really enthusiastic about the.

<unk> regimen.

And then just in terms of the I guess regulatory strategy here.

I guess, we used to thinking of breakthrough therapy designation request for small trials with.

Aloha and point D along but he has something like overall survival. So how do you balance that let's look for breakthrough therapy designation for <unk>.

Quick approval buses, okay, let's do kind of like you know rolls Royce trial with uncle survival potentially with earlier proof alone on PFS, but designed to support full approval.

Right, so and that can and I'll ask Rob if he wants to add anything.

I can't really get into the specifics because we're still working on the trial design.

The one thing I can say that unfortunately that you know in.

Settings, we're studying the and particularly with bladder cancer you know the overall survivals are or are not terribly wrong such that.

It's not.

Like you know certain settings, where you'd have to wait years and years for an overall survival end point now granted we did have a very nice 15 months overall survival.

But the control arm was in the eight month range, which has been seen historically, so there's not a huge delay and difference between PFS and OS, but that's all going to be part of our deliberations on the trial design and our FDA discussions.

Okay.

Thank you.

Oh, yes, sorry, sorry to interrupt I would just say one other thing I mean, I think from the old Acme.

Earlier this year, it's very clear, we do need to wait on overall survival. So I think we're still focusing on that but that doesn't mean, you can't use an endpoint like PFS for a potential accelerated approval.

Mhm yeah.

And then maybe last one for me and that is so Mario three actually has a renal cell carcinoma cohort and I think you've guided today to one age 21.

Can you just give us an update on that and perhaps what the.

Key hurdle is for that trial.

Yes.

Sure again, I'll start and Rob you can pick up so just.

To remind everyone our renal cell cohort is adding a gantlet centric and avastin.

And our primary purpose there there was a very strong mechanistic rationale to combine again with a bed Jeff inhibitor and so we're really looking for a proof of concept out of that study.

And we.

We should we haven't updated our guidance, which we'll do in early January but it's probably mid year. When we'll have some data from that study and if it looks positive then we will have to map out whats the next step.

As it is.

You look at the current regimens that have had the greatest activity in renal cell. There are other vet, Jeff that are approved and are doing very well. So we may then decide what would be the best checkpoint inhibitor and the <unk> and the best Veg F inhibitor to combine with and taking that regimen.

Mhm.

Thanks, and congratulations again on terrific progress.

Thanks, Nick.

Your next question is from Mike King with H C Wainwright.

Good afternoon, guys. Thanks for taking the question and I'm glad I booked my my Sbcs reservation early just a couple of quick ones.

Also just thinking about sort of the same lines as Ted and Kevin about.

Enhancing the value of the yen.

Hum.

Franchise as far as.

The value too.

The industry in other words physicians patients and of course, your larger brethren and our ISP is sufficient.

To get you, where you need to go as far as generalizing Gan illicit affair.

Or do you think.

More corporate sponsored Formula M D and randomized studies or are more appropriate.

Yeah, Thanks, Mike and Rob who knows more about this than anyone I of course, they they are they sort of slightly different purposes. So you know a company sponsored study is going to be more directed to a registration endpoint in an ice tea is gonna be more exploratory, but Rob why don't you take that well I think as we I mean, you bring up a really good point I mean, I think any clinical development.

<unk> needs to be.

Kind of a mixture of a company sponsored and <unk> and you would like that strategy to be holistic I mean, that's something we're taking a deep look into now because now that we've seen as a positive signal in UC and now in P. M D C.

Question is why wouldn't it work in other tumors you know the team here because I had a very similar so I think this is something we're going to have to think seriously about like how do we do that we want an integrated strategies, where we can leverage both internal resources and external resources.

It will definitely be an add on or strategy would be.

Registration and randomized phase two and I S. T strategy to be kind of all of the above is the answer.

Okay, Yeah, because I mean, the randomize format.

Served you quite well.

The other question is.

Theres a company recently that got.

Oh, how did withdraw and others.

PD, one space, but they had to withdraw it or they.

Chose to withdraw their NDA on their PD, one antibody because of them.

Conversion of a accelerated approval to full approval.

Sure.

For Keytruda.

And I was just wondering I mean, we should we should know these things, but theres. So many different trials going on I just wanted to be certain that there isn't something out there thats lurking that you may know of where and accelerated approval has been granted I know that Roche has withdrawn to century, but there <unk> anything else brewing either.

Triple negative breast cancer or you see that we ought to be mindful of as you know kind of a landmine.

So Mike you know well obviously.

We're looking at what all you know what is happening in the development as we think about future trial designs we.

Yeah that would be an issue if you were.

Using.

A drug in your combination or in your control arm that was receiving that that was that had an accelerated approval that might be withdrawn or if there was something that might be approved that would disrupt the standard of care that you're comparing with the likely strategies. We have we would be comparing again Melissa to.

A drug that has a full approval so that it would not be likely to influence us.

Okay. Thanks for taking the questions.

Thanks, Mike.

Your next question is from <unk> Patel with B Riley.

Yes, hi, good afternoon, and thanks for taking the questions.

First the the.

The update for T. M. D. C should we expect any PFS or OS Kaplan Meier curves in that update or is it too early for this type of analysis.

So thanks.

Well for the 43 patients who were enrolled this summer we will certainly be looking at them all.

All will have had the opportunity to be on study for another three or four months until we will be looking at the updated progression free survival for those patients.

It will be PFS, we will not be having OS data at this with you.

Okay and then.

And the July update you showed paired tumor biopsy data, where a few patients converted from PDL, one negative to PD lone positive status.

Just curious historically are there precedents of observing this effect would suggest chemotherapy alone or even in combination with a checkpoint as a doublet in T. M. D. C. And then can you can you remind us if you've conducted similar biopsies in the bladder cancer study.

So it's a lot well I'll answer the last part of the question and Rob Peanuts in the bladder cancer, we did blood biopsies and we shared a really nice translational analysis of the gene set enrichment and we did the tumor biopsies in the T N B C and so Robinson.

You know I think whenever you know of course in Mario three we had a triplet you know and so we didnt have a double in that exact same study there have been reports that chemotherapy or even a PD one inhibitor may modulate PDL one expression I think what's unusual about our data is five of eight of negatives.

<unk> positive in all three positive that's got higher that's pretty unusual. So we don't think this is just you know a carrier.

Whatever a PD one would do for example, or chemo. We think this is probably much more significant but again, we don't have the control admittedly, but I think seeing movement in that many patients is very impressive.

Okay, great. Thank you.

Your next question is from sounds like ROI with Jones research.

Hi, everyone. Thank you for taking the question and congratulations on the progress.

I'm trying to remember if you guys have ever shown.

Spaghetti plot.

For the Mario for the <unk> trial and curious if you if you are seeing and I got you.

Immuno oncology agent type response.

The time to first response and if.

If it's deepening over time or have you seen any of the PD.

PDL, one negative versus positive patients reacting differently any color would be appreciated.

So Rob can maybe go deeper we have seen patients whose responses have deepened over time, but is there anything.

I think our data is very consistent with a lot of the I O agents. You know originally the responses were thought to be very slow and Io and then as we got more and more experienced they seem to be very similar to chemotherapy, sometimes and so I think if you just look at our or our it's very consistent with a pretty prompt reach us but it is true we have.

Seen some deepening of responses over time.

The patient population of 50 to 60 patients I think it's hard to make definitive statements about how common all of that is but I mean, we've definitely seen some very interesting deepening responses over time.

Got it just curious if we should be thinking with the more mature data if we could see some of that.

Stable disease patient could turn.

Is it responders.

And one last question is can.

Can I just elaborate on that too because as we presented in July.

Where we were really pleased to see that patients with stable disease have had very long intervals of progression free survival and we saw the same thing in our bladder study were stable disease.

The patients with stable disease has very long overall survival and more so on the combination arm and the treatment arm. So it's there.

Effective of the mechanism of action of the analysts have where in remodeling the tumor microenvironment stable disease may be adequate to be driving this long term benefit. So we're a little bit less focused on response rate were much more and it's not as meaningful for patients. So we're much more focused on PFS and OS.

Then on response rate.

Got it and one last question is are you thinking about.

Some kind of Biz Dev or out licensing act.

Activity far maybe Asian market something outside.

North America or Europe.

So we always think about the sort of strategic and tactical opportunities.

We've looked at it so the sleeves off the best things where it would.

You know rates wouldn't necessarily negatively impact anymore.

Any more strategic kind of global beverage can but right now we've really felt that the best value I think you've alluded to this is that we can create so much more value by expanding the breadth and depth of the clinical signal.

You may recall in our last major strategic collaboration we waited until we were.

Into.

Global attrition study before we signed up.

Collaboration with at that time, it was abbvie for like $235 million up from 103 million milestone could do.

Very broad collaboration.

So we think right now, especially with the recent addition of of coupon and Rob It's really time for us to to focus on execution.

Executions, because we've got a lot of singles subtract can follow.

Perfect. Thank you so much for taking the questions and looking forward to them.

San Antonio Dita.

Great Thanks for that.

Okay.

Thank you at this time I'm showing no further questions I'd like to turn the call back over to ethylene for closing remarks.

Thank you and thank you everyone for joining us today, we're incredibly enthusiastic about the data we presented this past quarter, which includes OS data and you see an early PFS data and can be C, which together point to the potential of the analysts have to provide durable clinical benefit for patients independent of PD one status.

Although these data are compelling demonstrating that the addition of the analysts have to standard of care regimen has the potential to improve clinical outcomes and provide meaningful benefit to patients across a broad range of treatment settings and indications even in patients considered least likely to respond to checkpoint inhibitor regimens.

I'd, particularly like to thank the Infinity team, which has grown with our new CFO CMO and Ford appointment as well as all of our investigators trial sites and most importantly, our patients and their families who've. All played an integral role in advancing our work to better treatments to patients.

Courted by a great team here at Infinity, and we look forward to providing updates in the coming months and thank you all for your continued support.

Have a nice night.

Sure.

[music].

Okay.

[music].

Yes.

[music].

Please be advised that this call is being recorded and at Infinity request now I would like to introduce your host for today's call Jayne Kauffman. Please go ahead.

Thank you Tina and good afternoon, everyone welcome to today's call to discuss our recent business progress and review of our third quarter 2021 financial results on the call with me today are Abilene Perkins, Chief Executive Officer, Larry Bloch, President Robert Gloria Chief Medical Officer, that's the bombs looser.

<unk> Chief Scientific Officer will open up the call for Q&A following our remarks.

The press release issued this afternoon details our results and is available on our website at <unk> Dot 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 projection.

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 Abilene.

Thanks, Jayne and thank you to everyone for joining us today.

This is a very important time at infinity as we focus on three significant value drivers for the company.

First our evolving clinical and translational data, which will we will we will review during today's call I guess, we have a drug with a gamma listen and lay the foundation for significant additional value creation.

Second based.

Based on these data we are making the very important transition from seeking proof of concept with the analysts at two advancing our registration focus study.

Third our validation of a gander listen unique mechanism of action in reprogramming macrophages, substantiate again, Melissa to potential beyond T N B C and your theater of cancer.

The analysts it is distinctively well positioned as the only peer three kinase gamma inhibitor in clinical development to drive differentiated benefits for patients.

I'll now elaborate on each of these three value drivers.

Starting with data.

Importantly, we are seeing as evidenced on the most meaningful metrics of patient benefit, namely prolonged progression free survival or PFS and extended overall survival or OS.

And we see these benefits for patients regardless of their baseline PD lone status.

We are very pleased to have been invited to present updated T. N B C data at the 2021, San Antonio breast cancer Symposium. This December.

Our T N B C data mature, we are especially interested in confirming whether the PFS results from this summer, which exceeded our expectations are maintained over a longer period of time in more patients.

Prolonged PFS is particularly meaningful for PD, one negative metastatic frontline T N B C patients for whom no checkpoint inhibitors have been approved.

Which leads me to our second value driver as we turn our attention to registration enabling studies.

The strength of the PFS and OS data, we have generated in T. N. B C. And you see is particularly relevant is these are likely to be the primary endpoint for potential registration trial.

We're actively engaged with key opinion leaders and regulatory authorities and the design of our registration focused study and you see and the strength of our PFS and OS data gives us confidence in our ability to meet the high bar is necessary for approval.

We look forward to updating you on our plans for Gan illicit and you see on January 5th in conjunction with our 'twenty to 'twenty two gotten.

Are you see PFS and OS data are further bolstered by translational evidence from biopsies, indicating that there is significantly greater immune attack immune activation and the treatment arm with the gander lift them versus the control arm without began Elisa.

So the drug is doing exactly what it was designed to do which brings me to our third value driver, which is the breadth of the analysts its potential beyond T. N D C and you see.

Over the past 12 months, we have shown very encouraging clinical and translational data on again, all the sip activity relative to reference benchmarks across five different tumor types three different combination regimens and in multiple lines of therapy, all of which demonstrate again all such power to activate an immune response.

The data from each of these individuals studies alone is notable and becomes even more compelling when viewing the totality of the data where its consistency across multiple settings underscores the potential of the analysts have to drive the next generation of immuno oncology therapies.

This is particularly true given the big analysts it is the only <unk> kinase gamma specific inhibitor in clinical development.

The only way to access the unique macrophage reprogramming achieved through inhibition of <unk> kinase gamma is with again listen.

There is no alternative <unk> kinase gamma inhibitor in the clinic, so as our clinical data mature favorably the scarcity value of analysts of increases dramatically as does the attractiveness of our strategic options.

Hence our highest priority is to advance the three value drivers outlined above by continuing to generate strong clinical and translational data advanced registration, enabling studies and leverage the fundamental biologic mechanism uptake analysts it in remodeling the tumor microenvironment to <unk>.

Prove patient outcomes comes across additional setting.

To achieve this we have further strengthened our clinical and scientific leadership as well as our board of directors.

Last quarter, we announced the appointment of our Chief Scientific Officer, Dr. Stefan Pollute so.

With prior experience at Infinity is uniquely qualified and ideally positioned to push forward. The important scientific work that is the foundation of our program.

On the clinical front, we have appointed a new chief Medical officer to succeed Dr. Brian Schwartz, who served as our consulting chief position and made impactful contributions and guiding our clinical programs through key data readouts that paved the way for the ongoing development of analysts said, we could not be more pleased that Brian is continuing to contribute.

To Infinity and again elicit from his new position on our board.

We are thrilled that Dr. Robert Lauria has joined Infinity as our Chief Medical officer to lead the future clinical development began Elisa.

Rob brings an ideal background to infinity, given his deep expertise in drug development in immuno oncology.

He joins us from BMS and Celgene, where he led Bms's CTO, a four program and Celgene PD, one inhibitor program in collaboration with Beijing.

Rob strong track record in drug development from preclinical through approval. During his 10 years at Lilly Celgene and BMS is critical to the top value drivers I just reviewed.

Throughout his prior career and now with Infinity. Dr. Lauria has continued to treat patients including for some of the indications for which we are now evaluating analysts it including T. N. B C. Such that he is acutely aware of the magnitude of the need for those patients.

With that I'll turn the call over to Rob Rob.

Rob.

Thanks to ethylene I'm really thrilled to be part of Infinity at this exciting time.

Isn't that joined the company was driven by several key factors. The first is that while approved immuno oncology drugs have led to important advances we still have much work to do to fully harness the immune system to effectively combat cancer.

Top of my list and that of others is the ability to reverse the immunosuppressive tumor microenvironment.

That's why I'm, so enthusiastic about the potential of Afghan Alyssa highly specific small molecule inhibitor of <unk> kinase gamma to reprogram macrophages in the tumor microenvironment and enhanced immune activation.

The second reason I chose to join US entity is the strength and consistency of a gallon of data across multiple indications and treatment settings, including PDL one negative subgroups.

<unk> solid evidence that again, Elisa has the potential to be transformative therapy and immuno oncology.

And certainly not least because the strength of the infinity team who've worked so passionately to bring again I listen to this exciting point in its development.

Among my highest priority since joining infinity is to develop the strategy for registration, enabling studies in Europe, Youll cancer and T. M D C.

Mario 275 overall survival data are truly compelling, particularly given these results we're seeing in both PD lone positive and negative patients.

Based on the strength of these data were considering our next steps extremely thoughtfully with input from Kols and regulatory authorities.

To recap Mario 275 is a randomized double blind placebo controlled study that enrolled 49 second line <unk> cancer patients randomized two to one to either <unk> or placebo, a mab, which is marked as update marketed as a tivo or standard of care nimble around plus placebo or.

The objective was to increase the effectiveness of second line treatment for patients with advanced <unk> cancer towards that goal. We found that the strong disease control rate and progression free survival data, we presented at <unk> in February has translated into a nearly doubling of overall survival.

Specifically this past July we reported a median overall survival of $15 four months with the combination of <unk> compared to seven nine months, although there will remap control arm.

The importance of overall survival was recently underscored in April <unk> meeting and which PFS findings that provided the basis for accelerated approval did not ultimately translate into OS benefit.

Against this backdrop, we were delighted to see that our PFS benefit translated into OSB benefit with Mario 275, including PDL one negative patients.

I would now like to give you a brief update on our Mario three study in advanced metastatic triple negative breast cancer the.

The strategic objective was to characterize the safety and efficacy of the addition of <unk> to <unk>, which is marketed as to centric and Nab paclitaxel market as the Brexit in metastatic P. M D C as.

As you may be aware Roche withdrew the U S accelerated approval for telco was a man and.

First line PD Lone positive metastatic P. M D C patients during Q3 of this year.

The withdrawal was required in accordance with the requirements of the accelerated approval program. After erosions confirmatory study using a different chemotherapy failed to meet its primary endpoint.

Notwithstanding the withdrawal published data from the Impassion 130 studies demonstrated that <unk> and Nab Paclitaxel is an active treatment regimen and this combination is still approved for first line metastatic <unk> patients in over 70 countries outside of the U S.

Roche has been very clear in communicating its commitment to continue studying it says it was the mab and CNBC and in continuing to supply it as it was about four ongoing Mario three study.

The eligibility criteria for Mario three were designed to mirror. The Impassion 130 study to facilitate historical benchmarking and patients were enrolled in either a PD lone negative or PDL, one positive cohort.

It's important to note that recent approvals of immune checkpoint inhibitors in combination with chemotherapy in first line metastatic CNBC had been limited just to PD lone positive patients. There are no immune checkpoint inhibitor regimens approved for metastatic PD lone negative PBC patients who represent the majority of CNBC patients in.

Therefore, a very significant unmet medical need.

87% of Evaluable patients exhibited tumor reductions and we saw early but encouraging PFS data specifically in patients with PDL one positive tumors. We observed a median PFS of 11 two months compared to the seven five months that have been observed in the Impassion 100.

Dirty.

In the patients with PD lone negative tumors, where you're rewarded we reported a median PFS of seven three months versus $5 six months observed on Impassion 130.

Together. These results suggest that the addition of an analyst to immune checkpoint inhibitor and chemotherapy has the potential to improve PFS for both PD lone positive and PD lone negative patients.

<unk> the maturing Mario three data will be our north star in outlining our best registration path for catalysts.

These data will allow us to make informed decisions about patient subgroups, such as those with PD lone negative tumors.

We've leveraged data from our European <unk> and <unk> clinical programs to build a very strong foundation of translational data.

Support of journalism fundamental mechanism of action of macrophage reprogramming.

In our July Kols update we presented the results of a gene expression analysis from Mario 275 that showed clearly enhanced immune activation and the <unk> <unk> combination compared to the new role map control arm.

For Mario three we presented data of paired tumor biopsies from both PD lone positive and PD, one negative CNBC patients showing an increase in the <unk> to <unk> ratio reflective of macrophage reprogramming.

An increase in immune activation.

An increase in PDL, one expression in both PD lone negative and PD lone positive patients compared to baseline.

While our near term focus is determined the optimal path forward in bladder cancer and CNBC. The strong data, we generated with analysts who've been combinations of both PD, one and PD, one inhibitors and in checkpoint inhibitor free regimen supports broader investigation of analysts.

Cross additional tumor types, including tumors for which immune checkpoint inhibitor based treatments have had limited success.

Again, I am thrilled to have joined the team at Infinity and look forward to providing updated data and CNBC at San Antonio breast cancer Symposium and an update on again a list of the new C with our January 5th guidance for 2022.

And with that I'll turn the call over to Larry to review, the third quarter quarter quarter financials.

Sorry.

Thank you Rob.

Even for upcoming San Antonio breast cancer Symposium presentation. Later this quarter 2021 has already been a foundational year for the analysts and infinity.

As we prepare forgive us its initial potential registration, enabling study as well as prioritizing opportunities with the largest potential benefit for patients through additional clinical studies will begin a list.

Is that one outlined we've strengthened our executive team with returns to fund to Infinity as Chief Scientific Officer, and addition of Rob as Chief Medical Officer, as well as the transition of Brian disturbing on our board of directors.

He has also strengthened.

Position through a public offering in February which we've raised $92 million in gross proceeds to enable our continued execution on our strategic development plans for <unk>.

So at September 32021, and <unk> cash cash equivalents and available for sale securities of $90 1 million compared to $34 1 million at December 31, 2020.

Research and development expense for the third quarter 2021 was $7 1 million compared to $6 1 million for the same period in 2020, and this increase was primarily related to increase in development expenses and compensation related expenses.

General and administrative expense for the third quarter of 2021 was $2 8 million compared to $2 9 million at the same period in 2020.

This increase in <unk> expense was primarily due to the increase in consulting expenses professional fees and stock compensation.

Okay.

Net loss for the third quarter, 2021 was $10 7 million or basic and diluted loss per common share of <unk> 12.

Compared to a net loss of $9 5 million or <unk>.

Basic and diluted loss per common share of <unk> 16.

For the same period in 2020.

At least 2021 financial guidance remains unchanged and we expect net loss for 2021 to range from $40 million to $50 million and to end 2021 was the year end cash cash equivalents and available for sale securities balance ranging from $70 million to $80 million.

So we're very much looking forward to sharing our updated <unk> data in first line metastatic triple negative breast cancer on December 10th in person at the San Antonio breast cancer Symposium.

We're really pleased to have Dr. Hudson Sullivan and medical oncologists specializing in breast cancer with the center for women's oncology at the Moffitt Cancer Center, one of our top enrolling investigators and married with three shifting our data at the San Antonio breast cancer Symposium.

We are touched all of them will also be joining us at our investor event. The same day to provide his perspective on our maturing metastatic triple negative breast cancer data in the context of experience treating patients with this again Elisa regimen.

On behalf of Infinity, we thank you for your continued support and we look forward to engage with you again in just about a month.

At this time, we can open the call for questions operator.

To ask an audio question press Star one on your telephone keypad again that is star one to ask a question and we'll pause for a moment to compile the roster.

Okay.

Your first question is from our new Pam <unk> Rama from J P. Morgan.

Hi, guys. Thanks, so much for taking the question.

Just a quick with just a quick question for me I think the prior guidance was that enrollment will complete Mario three by the end of the year. So where are you on that and then.

We get like I think the enrollment dynamics are up to 30 patients with PDL one negative when we get all 30 of those patients at San Antonia. Thanks, So much.

Yes, thanks for the question Anna.

We are on track to have enrolled approximately 60 patients in the study by the end of the year.

What we expect to present at San Antonio is as.

As you know at our event. This summer we had 43 patients who enroll so we will have all 43 will have been on had the opportunity to be on the study for another three or four months. So we will have more mature data on those 43 and four patients who have enrolled since then we will all will be.

Included in the safety database and we will include any efficacy scans that we have on those patients who are more recently enrolled.

Okay.

Got it thanks, so much for taking our question.

Sure.

Your next question is from Kevin <unk> with Oppenheimer.

Thank you all right yeah, thanks for taking my questions.

There's been some pretty.

Pretty well publicized shortages of Abaxis and just curious.

Just going to say it.

Get enough data at San Antonio you have patients who for whatever reason may.

And I have this vaccine doses, how does that sort of traded from us Proto.

Protocol and physical perspective.

Sure. Thanks, Kevin I'll, let Rob take this I will just lead by saying that our partner BMS has been extraordinarily helpful. In working with us to ensure that we have access for the patients that were treated and they've made the clinical trial is a priority, but Rob you can take that yeah. There is a nationwide shortage.

As you mentioned of <unk>. However, we are supplying the drug and so far as our suppliers. It's been fine we've been able to provide drug to the current patients and the patients. We are enrolling now so there hasnt been any patients who missed any doses because of not having to Brexit.

Anything Kevin the fact that we have.

Uninterrupted supply of <unk>, San and providing that for patients is just another benefit for.

Being enrolled on the study.

Yes.

Okay, Great. That's Super helpful. And then just in terms of.

The opportunities too.

Learn more about that.

Outside of CNBC.

Should we think about your investigator sponsored studies, one Avenue and it makes for a 2020 are or what really is the right structure to better characterize.

<unk>.

Yes.

As we drove more broadly while you do move forward with.

Registration.

Our strategies for UC and TWC.

Thanks, Kevin we're all delighted that you asked that question because as we mentioned in our remarks, we really based on the mechanism of action data that we've now seen in our existing studies, we really are.

Very excited about leveraging that in other settings, and we have had many discussions with investigators about.

Isps and other studies, we will.

If any of those or are finalized by the time of our 2022 guidance in January we'll share those.

By then we will throughout the rest of the year.

Yes.

Great. Thanks for taking my questions I'll get back in queue.

Okay.

Your next question is from Ted <unk> with Piper Sandler.

Great. Thank you very much primary so it was a little choppy so I didn't get to hear everything, but I wanted to get a sense for.

Plans for triple negative breast.

Data continues to be positive.

What do you envision as next steps and then.

Derek just ask this question so I apologize if it's a repeat.

What about expanding beyond your cereal carcinoma.

Bruce what are some other ideas and what are some of those trials.

Thanks.

Yes, sure Ted I'll start and then I'll turn it over to Rob who can describe our thinking in <unk> I'll just preview as you know that there are the majority of patients with both Tennessee and bladder cancer are PD lone negative. So that was the first group to enroll and Thats. The first group that we'll be able to interpret the results.

<unk> from because they tend to progress more quickly given the historic benchmark would be a <unk> monotherapy because there is no checkpoint inhibitor at all Thats been approved for the frontline metastatic <unk> patients who are PD lone negative so we're likely to be able to map out our thinking on that.

PD lone negative before the positives, but Rob can show you how he thinks about that.

Yes, I think there's a great point I mean I think.

Since now PD lone negative and positive patients are treated differently.

What we'd like to see is how our data matures in both groups. That's why we designed that study to have a cohort of negatives in a cohort of positive of course.

The patients that are negatives do not so well so we find out earlier, how they're doing or not doing the positive do a bit better with standard of care and adding again Alyssa, we'll have to see how that matures, but this is something we're being very mindful of and again, we're really looking excited to see what these maturing data show.

And tears your additional question Ted about what other studies.

We are receiving a lot of inbound inquiries to do investigator sponsored studies, we do have one underway now with as we're calling it a window of opportunity study in patients with squamous cell cancer of the head and neck and our team is now prioritizing other ones and as soon as those are ready for Prime time, we will very much look forward to sharing.

With you because there are many settings, where there is the need for reduction in the immune suppressive microenvironment and a very strong scientific rationale for the use of analysts in other combinations and our chief Scientific officer.

Stephane Pluto is is working with the team to really prioritize what are the.

The scientific rationale is that make most sense.

Well thats great.

Yes.

As Larry just didn't come there's very few validated and partnered macrophage targeting therapeutics and so there really is a sort of a scarcity effect and so were getting both from a corporate side in.

Investigator sponsored studies that a lot of inbound interest. So we're in the process of prioritizing those but very much look forward to expanding both the depth and the breadth of the <unk> clinical footprint.

Great very helpful. Looking forward the data in December and I'm also hearing more about the plans for other indications.

Thanks Ted.

Your next question is from Nick Abbott with Wells Fargo.

Hi, good afternoon, and congratulations on a terrific quarter and.

On some great hires so I guess the first one for me and that is do you expect to have a finalized PVC registration trial designed with regulators final on the January 5th update.

Are you planning on running this in both North America and Europe.

Okay.

So thanks Nick.

We got the first look at that at the end of July and we've now had the opportunity. We're really pleased with the OS data. We're also really pleased that it has matured and look really nicely in the PD lone positive patients as well.

So we said at the very end of the summer and early fall holding some AD boards, we were delighted to get input from really the world's thought leaders in bladder cancer, who have been really helpful. About the best path forward and so based on this new data, we've revised and enhanced our thinking.

About the most attractive potential registrational trial, and so now we will go back we've had interactions with the FDA before this new data and the FDA was very helpful. Very supportive and so we're really looking forward to going back as you know the interactions are an iterative process. So we will be requesting feedback on some of our.

Revised and we believe enhanced thinking.

And I would suspect that given.

Processing lead times for that fee that we're unlikely to have it completely finalized by January 5th, but we'll be able to provide an update on where we are.

Okay, and do you intend to run that trial in North America, Europe, or just North America.

Both.

And Mario 275, we conducted a lot of much of the Mario 275 enrollment was in Europe, and Eastern Europe, and the trial enrolled really well and so we expect to go back and we hope in our sights for terrific. So we hope to use many of the same sites and investigators who are really enthusiastic about the.

<unk> regimen.

And then just in terms of the regulatory strategy here.

I mean, I guess, we used to thinking of.

Breakthrough therapy designation request for small trials with.

Aloha endpoint deal, but he has something like overall survival. So how do you balance that let's look for breakthrough therapy designation for.

Quick approval buses, okay, let's do kind of like.

As always trial with overall survival potentially with earlier approved alone on PFS, but designed to support full approval.

Right.

So Nick and I'll ask Rob if he wants to add anything.

I can't really get into the specifics because we're still working on the trial design.

The one thing I can say that unfortunately that.

In the settings, we're studying the in particular bladder cancer. The overall survivals are not terribly long such that it's.

It's not.

Certain settings, where you'd have to wait years and years for an overall survival end point now granted we did have a very nice 15 months overall survival.

But the control arm was in the eight month range, which has been seen historically, so theres not a huge delay and difference between PFS and OS, but that's all going to be part of our deliberations on the trial design and our FDA discussions.

Okay.

Thank you.

Oh, yes, sorry, sorry to interrupt I was just going to say one other thing I mean, I think from the old Acme.

Earlier this year, it's very clear, we do need to win on overall survival. So I think we're still focusing on that but that doesn't mean, you can't use an endpoint like PFS for a potential accelerated approval.

And then maybe last one for me in that scenario three actually has a renal cell carcinoma cohort and I think you've guided to date to one H 'twenty one.

Can you just give us an update on that and perhaps what the key hurdle is for that trial.

Sure again, I'll start and Rob you can pick up so just.

To remind everyone our renal cell cohort is adding.

Analysts have centric and avastin.

And our primary purpose there there was a very strong mechanistic rationale to combine again, let's put the veg F inhibitor and so we're really looking for a proof of concept out of that study.

And we.

We should we haven't updated our guidance, which we'll do in early January but it's probably mid year. When we will have some data from that study and if it looks positive then we will have to map out whats the next step.

Is it as well.

Alright, Thanks, guys and congratulations again on terrific progress.

Thanks, Nick.

Your next question is from Mike King with H C Wainwright.

Good afternoon, guys. Thanks for taking the question and I'm glad I booked my mic.

Yes.

<unk> early.

Just a couple of quick ones.

Also just thinking about sort of the.

Same lines as Ted and Kevin to get are about.

Enhancing the value of the.

You kind of listed.

Franchise as far as.

The value too.

The industry in other words physicians patients and of course, your larger brethren and our ISP is sufficient.

To get you, where you need to go as far as generalizing like analysts subs.

Effects or do you think.

More corporate sponsored formula.

Formal IMD and randomized studies or are more appropriate.

Yeah, Thanks, Mike and Rob knows more about this than anyone I of course, they are they sort of slightly different purposes. So a company sponsored study is going to be more directed to a registration endpoint in an ice tea is gonna be more exploratory, but Rob why don't you take that well I think you bring up a really good point I mean, I think any clinical develop.

<unk> strategy needs to be kind.

Kind of a mixture of a company sponsored and <unk> and you would like that strategy to be holistic I mean, thats something were taking a deep look into now because now that we've seen as a positive signal in UC and now in TN BC.

Question is why wouldn't it work in other tumors. The team here are very similar so I think this is something we're going to have to think seriously about like how do we do that we want an integrated strategies, where we can leverage both internal resources and external resources.

Sales are going to be an add on or strategy.

Registration and.

My stage, II and IFC strategy to be kind of all of the above is the answer.

Okay, yes, because I mean, the randomized format.

Served you quite well.

The other question is.

Theres a company recently that got.

Oh, how did withdraw and others.

PD, one space, but they had withdrawn or are they choose.

Joseph withdraw their NDA on their PD, one antibody because of them.

Conversion.

Accelerated approval to full approval.

Sure.

For Keytruda.

And I'm just wondering I mean, we should we should know these things, but theres. So many different trials going on I just wanted to be certain that.

There isn't something out there thats lurking that you may know of where.

An accelerated approval has been granted I know that Roche has withdrawn to century, but there <unk> anything else brewing either in triple negative breast cancer or you see that we ought to be mindful of.

Kind of a landmine.

So thanks, Mike.

Obviously, we're looking at what all what is happening in the development as we think about future trial design.

That would be an issue if you work.

Using.

A drug in your combination or in your control arm that was receiving that that was that had an accelerated approval that might be withdrawn or if there was something that might be approved that would disrupt the standard of care that youre comparing with the likely strategies. We have we would be comparing again Melissa.

<unk> a drug that has a full approval so that it would not be likely to influence us.

Okay. Thanks for taking the questions.

Thanks, Mike.

Your next question is from <unk> Patel with B Riley.

Yes, hi, good afternoon, and thanks for taking the questions.

First.

The update for <unk> should we expect any PFS or OS Kaplan Meier curves in that update or is it too early for for this type of analysis.

So thanks.

We will for the 43 patients who were enrolled this summer we will certainly be looking at.

Al will have had the opportunity to be on the study for another three or four months until we will be looking at the updated progression free survival for those patients.

It will be PFS, we will not be having OS data at this with you.

Okay and then.

In the July update you showed paired tumor biopsy data, where a few patients converted from PDL, one negative to PD lone positive status.

Just curious historically are there precedents of observing this effect would suggest chemotherapy alone or even in combination with a checkpoint as a doublet in TN BC and then can you can you remind us if you've conducted similar biopsies in the bladder cancer study.

So well I'll answer the last part of the question and Rob Peanuts in the bladder cancer, we did blood biopsies and we shared a really nice translational analysis of the gene said enrichment and we did the tumor biopsies in the T N V C.

So Robinson.

I think whenever you know of course in Mario three we had a triplet you know and so we didnt have a double it in that exact same study there have been reports that chemotherapy or even a PD one inhibitor may modulate PD lone expression I think it was unusual about our data is five of eight of negatives.

<unk> positive in all three positive that's got higher that's pretty unusual. So we don't think this is just a carrier.

Okay, great. Thank you.

Your next question is from stomach ROI with Jones research.

Hi, everyone. Thank you for taking the question and congratulations on the progress.

I'm trying to remember if you guys have ever shown.

Spaghetti plot.

For the Mario for the <unk> trial and curious if you if you are seeing.

Immuno oncology agent type response.

Time to first response and.

If it's deepening over time or have you seen any of the PDL one negative versus positive patients reacting differently any color would be appreciated.

So Rob can maybe go deeper we have seen patients whose responses have deepened over time, but is there anything.

I think our data is very consistent with a lot of the I O agents. Originally the responses were thought to be very slow and Io and then as we got more and more experienced they seem to be very similar to chemotherapy, sometimes and so I think if you just look at our or our it's very consistent with a pretty prompt recessed but it is true.

We have seen some deepening of responses over time.

Patient population of 50% to 60 patients I think it's hard to make definitive statements about how common all of that is but I mean, we've definitely seen some very interesting deepening responses over time.

Got it and just curious if we should be thinking with the more mature data if we could see some upturn.

Steve will do this patient could turn.

Is it responders.

And one last question is can.

Can I just elaborate on that too because as we presented in July.

Where we were really pleased to see that patients with stable disease have had very long intervals of progression free survival and we saw the same thing in our bladder study were stable disease.

The patients with stable disease has very long overall survival and more so on the combination arm and the treatment arm. So it's very.

Reflective of the mechanism of action of again, a list of where in remodeling the tumor microenvironment stable disease may be adequate to be driving this long term benefits. So we're a little bit less focused on response rate were much more and it's not as meaningful for patients. So we're much more focused on PFS and OS.

Then on response rate.

Got it and one last question is are you thinking about.

Some kind of biz Dev or out licensing active.

Activity for maybe Asian market something outside.

Northern America or Europe.

So we always think about the sort of strategic and tactical opportunities.

We've looked at it through a squeeze out the best things.

And with rates wouldn't necessarily negatively impact.

More strategic kind of global beverage can but right now we've really felt that the the best value I think you've alluded to this is that we can create so much more value by expanding the breadth and depth of the clinical signal.

As you may recall in our last major strategic collaboration we waited until we were.

Into Google.

Global attrition study before we signed up.

Collaboration with Abbvie.

Abbvie for a $235 million of properties $103 million milestone could do.

Very broad collaboration so.

We think right now, especially with the recent addition of of coupon and Rob It's really time for us to to focus on execution.

Execution, because we've got a lot of singles subtract can follow.

Perfect. Thank you so much for taking the questions and looking forward to them.

San Antonio data.

Great Thanks for that.

Okay.

Thank you at this time I'm showing no further questions I'd like to turn the call back over to ethylene for closing remarks.

Okay.

Thank you and thank you everyone for joining us today, we're incredibly enthusiastic about the data we presented this past quarter, which includes OS data in UC and early PFS data in T&D C, which together point to the potential of the analysts have to provide durable clinical benefit for patients independent of PD lone status.

These data are compelling demonstrating that the addition of the analysts to standard of care regimen has the potential to improve clinical outcomes and provide meaningful benefit to patients across a broad range of treatment settings and indications.

Even in patients considered least likely to respond to checkpoint inhibitor regimens.

Particularly like to thank the Infinity team, which has grown with our new CFO, CMO and Florida appointment as well as all of our investigators trial sites and most importantly, our patients and their families who have all played an integral role in advancing our work to better treatments to patients.

Supported by the Great team here at Infinity, and we look forward to providing updates in the coming months and thank you all for your continued support.

Have a nice night.

Q3 2021 Infinity Pharmaceuticals Inc Earnings Call

Request a DemoDemo

INFI

Infinity Pharmaceuticals

Earnings