Q3 2022 Infinity Pharmaceuticals Inc Earnings Call

November 14, 2022

[music].

The conference will begin shortly to raise your hand during Q&A you can dial star one one.

[music].

Yeah.

The conference will begin shortly to raise your hand during Q&A you can dial star one one.

[music].

Okay.

Ladies and gentlemen, thank you for standing by welcome to the Infinity Pharmaceuticals conference call to discuss the company's third quarter 2022 financial results and business update my name is Michelle and I will be your operator for today's call. At this time all participants are in a listen only mode. There will be a question.

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

Thank you Michelle and good morning, everyone welcome to today's call to discuss our third quarter 2022 financial results and the Mario three data update that we announced in a separate press release earlier this morning.

Both press releases are available on our website at <unk> Dot com.

On the call with me today are Abilene Perkins, Chief Executive Officer, and Chair, Larry Bloch, President and Robert a Warrior Junior Chief Medical Officer, We will open up the call for Q&A. Following our remarks. Please note that during this call. We may make forward looking statements about our future expectations and plans, including clinical.

<unk> objectives, the therapeutic potential of our product candidates, our strategic plans and financial projections are actual results may differ materially from what we project today due to a number of important factors, including the considered <unk>.

Considerations described in the risk factors section of our annual report on Form 10-K for 2021 and in other filings we make with the SEC. These forward looking statements represent our views only as of today and we caution you that we may not update them in the future whether as a result of new information future events.

Or otherwise now I'd like to turn the call over to Abilene.

Thanks, Jay and thank you to everyone for joining us to review <unk> third quarter 2022 business update.

Today, we're pleased to provide encouraging updated data from our single arm Mario three phase II trial evaluating <unk> in combination with the Tesla was a map and Nab paclitaxel.

Patients with frontline metastatic triple negative breast cancer or <unk>.

We are encouraged by the updated results, which continued to show durable long term clinical benefit for patients, which we will review shortly.

As we disclosed on our second quarter earnings call. We have made entering into a strategic partnership to advance the analysts with development and paved the way to eventual approval our top priority.

We plan to initiate additional studies to begin a lithium after putting a partnership in place to ensure that we and our partner are aligned on again, a list of future development.

Let me bring you up to date on our progress.

Our business development discussions are directed towards an initial focused development plan in a randomized controlled setting.

The benefit seen across a broad array of solid tumor and which again a list has been studied to date.

Including breath, Urothelium head and neck.

And melanoma cancers provide multiple potential future development path.

It is our goal to announce the partnership and the focus of the prioritized clinical development plan for <unk>.

In the third quarter of 2023.

Turning to the Mario three data with an additional year of data maturity since our last update at the San Antonio breast cancer Symposium in December 2021, there is encouraging evidence of a long term benefit for patients.

Relative to the Impassion 130 benchmark study.

We are now able to report one year progression free survival rates for patients with both PD lone positive and PDL, one negative tumors, which were promising for all patients regardless of PD lone status.

This long term benefit in patients with CNBC is consistent with the long term benefit seen in other indications in which again a list that has been studied.

Additionally, there were no new safety signals during the extended period of treatment.

We were also pleased to report positive updated results from the randomized controlled Mario 275 Phase II clinical study evaluating <unk> plus in volume versus the volume inpatient.

In patients with second line platinum resistant metastatic <unk> cancer during the third quarter.

As we previously reported the analysts the combination showed approximately a doubling of patient overall survival at the two year landmark analysis.

Here to standard of care <unk> monotherapy.

Again listen it has demonstrated promising clinical results.

Five oncology indications and treatment settings to date.

The continued strength of our data across multiple indications.

Provides solid evidence that again, a listen the potential to be a transformative therapy in immuno oncology for three key reasons.

First we have a first in class therapy with potent and specific on target activity and translational data showing that target inhibition, we began a listen <unk>.

<unk> programs macrophages in the tumor microenvironment.

Reducing immune suppression and activate it.

Anti cancer immune response.

Second the clinical data was again, a listen have demonstrated prolonged progression free survival in multiple indications and extended overall survival over current standards of care in a randomized controlled trials that allows us to see the distinct contribution I'll begin a listen over comp.

<unk> partners.

Third and very importantly, again, a list that has been shown to have an acceptable and manageable safety profile in combination with other drugs.

Excluding in two and three drug combination regimen.

At this time I'd now like to turn the call over to Dr. Laura to review, our recent encouraging again with some data.

Rob.

Thank you Ashley good morning.

The objective of our Mario <unk> Phase II study was to evaluate the safety and efficacy of the addition of <unk> to a Tesla was a map in Nab paclitaxel in frontline metastatic T M D C patients.

Patients were enrolled in either PDL, one positive or PD, one negative tumor cohorts.

The eligibility criteria for Mario three were designed to mirror the Impassion 130 study to facilitate benchmarking.

It's important to note that the approval of Chuck immune checkpoint inhibitors in combination with chemotherapy in frontline metastatic T. M. D. C have been limited to PD, one positive tumors. There are new immune checkpoint inhibitor regimens approved for patients with metastatic PD, one negative tumors, which represent approximately two thirds of D. A.

D C patients.

As of October 8th 2022, 62, TMT C patients were enrolled in Evaluable for safety and 57 patients were evaluable for efficacy in Mario three with a median duration of follow up of 10 months.

And the efficacy dataset 35 patients had PD lone negative tumors 18 patients had PD one positive tumors at eight patients had tumors of undetermined PD lone status.

We're pleased to share that we continue to see very encouraging and durable evidence of a progression free survival benefit in this study.

In patients with PD, one negative tumors, we continued to see an improvement in median PFS with a median PFS of seven three months at Mario three compared to $5 six months Impassion $1 30 at 30% relative improvement.

Even more importantly, we're also seeing evidence of potential long term benefit with a one year PFS rate of 34, 7%.

Although the one year PFS rate was not disclosed for the Impassion 130, PD one negative population the.

It should be noted that the one year PFS rate and Mario three PD lone negative tumors, a subgroup with inferior outcomes with immune checkpoint inhibitor therapy.

Exceeds the $23 seven one year PFS rate.

The Impassion 130, ITT, which of course included patients with <unk> positive and negative tumors.

In patients with PD Lone positive tumors. We also observed evidence of potential long term benefit with a one year PFS rate of 37, 5% compared to 29, 1% and passion 130, a 29% relative improvement.

In addition to the encouraging one year PFS rate.

We observed further evidence of anti tumor activity of the <unk> triplet in patients with PD one positive tumors.

The objective response rate was 67 66, 7%.

<unk> to 58, 9% in Impassion 130.

Largely driven by a higher complete response rate in Mario three patients with PD lone positive tumors.

16, 7% versus 10, 3% of patients the Impassion 130.

Lastly, the median duration of response was 11 seven months compared to eight five months and our passionate 138, 38% relative improvement.

We did not continue to see improvement in the median PFS of the Mario three PD one positive population with a median PFS of six four months compared to seven five months on a passion 130.

With the approval of <unk> plus chemotherapy in patients with PD Lone positive tumors. This proved to be a challenging patient population to enroll which provided us with a less robust sample size to characterize the median PFS compared to our PD lone negative patient cohort.

Nonetheless, the one year PFS rate an indicator of potential long term benefit was very consistent across PD lone tumor status in Mario three.

37, 5% in PD lone positive tumors, and 34, 7% and PD one negative tumors.

These combined for a one year PFS rate of 36% and the Mario three ITT for 52% relative improvement over the one year PFS rate of $23 seven reported in the entire Impassion 130 population.

The updated safety analysis of the Mario three T. MPC triplet regimen remains consistent with expectations for the three component drugs and no new safety signals were observed during the extended time on treatment.

The most common grade three or higher treatment related adverse events were hepatic aes at 24, 2% neutropenia ease at 14, 5% and skin and peripheral neuropathy adverse events each at 11, 3%.

25, 8% of patients discontinue treatment for treatment related Aes, which were a triplet regimen compares favorably to the 19, 1% reported and Impassion 130 for the acetyl is of map and DAP Paclitaxel doublet.

While hepatic aes remain the most common grade three or higher treatment related adverse events. When it can elicit this combined with an immune checkpoint inhibitor. They continue to be reversible within a relatively short amount of time often without corticosteroids.

Bilirubin elevation was infrequent and we saw no evidence of highs law.

In summary, the almost one year greater data maturity and Mario three T. NBC has provided us a new opportunity to gain insight into potential long term benefit of the triplet regimen of analysts have combined with the test it was about a bit at paclitaxel.

With encouraging one year progression free survival rates across tumor PD lone status.

These findings build on the promising two year landmark overall survival data Abilene described from our Mario 275 randomized trial in second line platinum resistant.

Cancer.

Data from our phase II studies are consistent with and build upon findings in our Mario one phase one study, where we demonstrated the potential for an analyst to benefit patients refractory to immune checkpoint inhibitors, such as patients with squamous cell cancer of the head and neck.

The totality of the again lots of data across multiple tumor types supports important next steps and a robust randomized clinical trial setting.

Now I'll turn the call over to Larry to review, our third quarter financial results.

Larry.

Thank you Rob.

The third quarter, we continued to pursue disciplined and prudent approach to capital allocation.

So at the end of the third quarter of 2020 to Infinity had total cash of $47 2 million compared to $80 7 million at December 31, 2021.

Research and development expenses for third quarter, 2022, or $7 $7 million.

$7 1 million at the same period in 2021.

And this increase is primarily related to higher compensation expense due to additional staff to support the future development of the analysts.

General and administrative expense was $3 5 billion for the third quarter of 2022 as compared to $3 8 million the same period in 2021.

The increase was primarily due to a decrease in professional services.

Net loss for the third quarter, 2022 was $10 $7 million or a basic and diluted loss per common share of <unk> 12.

Compared to net loss of $10 7 million or basic and diluted loss per common share at 12.

At the same period in 2021.

This financial guidance for 2022 remains unchanged.

We continue to expect net loss for 2022 to range from between $40 million and $6 million and 23 to year end cash to range from $235 million of $45 million.

The police financial guidance does not include additional financing or visible activities.

Even as our goal was to execute on the <unk> strategic partnership to.

To be announced in the first quarter of 2023.

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

Thank you if you have a question at this time. Please press star one one on your Touchtone telephone.

One moment, while we compile our Q&A roster.

And our first question comes from the line of Edward Tim Hoff with Piper Sandler. Your line is open. Please go ahead.

Great. Thank you very much and thanks for the update on the merger agreement today, we should we be expecting a increase in cement cement terminal breast will you be presenting there or is this sort of the update for this year and I appreciate that.

All the other covenants.

Yes.

Thank you for the question.

This is the data update for <unk> three.

We have presented at San Antonio breast cancer Symposium for the last two years and so we chose this year to present the data on this call. So that we could have the most recent data cut.

You get the data out more quickly as you know there is a longer lead time for the medical meeting.

Yes makes a lot of sense I appreciate it and congrats on the deal looks great.

Thank you.

Okay.

Thank you one moment for our next question.

And our next question comes from the line of Sumit Roy with Jones trading. Your line is open. Please go ahead.

Hi, everyone. Thank you for the update.

I'm just trying to understand.

The new coating patients versus the previous update.

Is there anything particular about these patients that pulled back the median PFS number are.

Did the PDL one expression levels go up more than expected any color would be appreciated.

Thanks Sumit.

The most important.

Okay.

Update in this data is that it's more mature and so that was what we were really focused on.

Pleased to see that the one year PFS rate, which we think is.

Most meaningful reflection of long term benefit, but perhaps Rob you can elaborate a little bit further on the median PFS.

Sure.

Last year, when we provided the data.

We were updating data for almost a year ago and one of the challenges in the median PFS of course is that the middle value of whatever list of number of patients you have and what are the challenging thing that we had is that the PD lone positive patient population.

A bit more challenging to enroll once Pembroke chemo got approved I think a lot of those patients were seen in the community and not in a lot of the research centers. So as a result, we werent able to get as many of the patients in the PD. One positive group is negative and as a result that midpoint can really fluctuate a lot and so last year there were some.

Who hadn't had even their first scan yet so I think the challenges that median PFS can really be variable when you have a smaller sample set.

<unk> for example, our Piedmont negative set was almost twice what deposits were.

Got it thank you so much.

Yes.

Thank you one moment for our next question.

And our last question comes from the line of.

Patel with B Riley. Your line is open. Please go ahead.

Yeah.

Good morning, and thanks for taking our questions and congrats on the drug this is Larry conflict out goods. So maybe.

Focusing on your partnership discussions that are ongoing for UC versus CNBC they have been.

Any interest.

Relatively higher in one indication versus the other end.

Maybe.

Which do you anticipate being the first to advance to the next stage and then add a quick follow up.

Okay. Thank you for the question.

While we're not in a position today to describe the specifics on the future again Elisa development plan until we put the partnership in place.

We can tell you a few things that you might expect to see in the future development.

First is that it will be leveraging some of the encouraging data that we generated with the analysts and to date in one or more indications.

The focus of the development will be in a randomized.

<unk> setting so that we can very clearly show the contribution of analysts have over.

<unk> regimen over standard a standard of care and three it will be in patient setting, where there's a high unmet need.

We've seen the benefit of again, a list of across a broad range of solid tumors. It gives us many potential development paths as you mentioned breast urothelium head and neck ovarian and melanoma and so we're going to we're prioritizing that with a prospective partner and we look forward to announcing the details of the partner.

Chip.

The first next trial and potential subsequent next trials in the first quarter of 2023.

Thank you for that color and just a related follow up in these discussions and your own.

And also coming away from the <unk> conference over the weekend.

Any any thoughts on what this is.

<unk> study could look like in the quarter.

PDL, one status positive or negative.

If there is an opportunity to lump them together also.

We'll always try to guide could you comment on that would be helpful.

Sure.

Turn it over to Rob and just highlight that we have seen benefit with the analysts in patients across multiple different tumor types, regardless of PD lone status of course, a registrational trial.

<unk> what is the approved standard of care in those different patient populations and maybe Rob you can elaborate further.

Sure and also regarding the TBC question specifically.

It's true we are seeing pretty consistent one year PFS rates cross PD, one negative and positive tumors, which certainly is very encouraging.

There are certainly thinking about.

Past four <unk>, one could be going for both patient populations, although now that theres a different standard of care for those two populations. It does make it a complex and probably large trial because of the two different control arms.

The PD Lone negative is certainly a great story building.

Dolby checkpoint inhibitors haven't been successful there. So certainly you could argue that the greatest unmet need is in that PD Lone negative group. So yes. That's certainly also a very attractive path.

And as Italy mentioned, we believe the TBC data kind of adds to totality of the data so I think.

Which way you decide to go which tumor which indication within the tumor I think will be very much influenced by who our partner is and their preferences as well.

No.

And look forward to it.

Yeah.

Thank you and I'm showing no further questions at this time I would like to turn the conference back over to Abilene for any further remarks.

Thank you Michelle and thank you all for joining US today, we are really enthusiastic about the data that we've generated and the progress of advancing to analysts.

Potential treatment of patients with cancers, who are in.

Dire need of improved therapy. So we look forward to updating you on our business development effort and the focus of the next study for analysts within the coming months. Thank you for your continued support.

Thank you. This does conclude today's conference you may all disconnect everyone have a great day.

Okay.

The conference will begin shortly to raise your hand during Q&A you can dial one one.

[music].

Okay.

Yes.

Okay.

[music].

Okay.

[music].

Okay.

Yes.

Sure.

Okay.

Sure.

Yes.

Okay.

[music].

Yes.

Okay.

[music].

Ladies and gentlemen, thank you for standing by welcome to the Infinity Pharmaceuticals conference call to discuss the company's third quarter 2022 of the financial results and business update my name is Michelle and I will be your operator for today's call. At this time all participants are in a listen only mode. There will be a question and answer session to follow.

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

Both press releases are available on our website at <unk> Dot com.

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 financial projections and our actual results may differ materially from what we project today due to a number of import.

Factors, including the consider <unk>.

<unk> described in the risk factors section of our annual report on Form 10-K for 2021, and then 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 Abilene.

Thanks, Jay and thank you to everyone for joining us to review <unk> third quarter 2022 business update.

Today, we're pleased to provide encouraging updated data from our single arm Mario three phase II trial evaluating <unk> in combination with the Tesla was a map and Nab paclitaxel in patients with frontline metastatic triple negative breast cancer or <unk>.

Yeah.

We are encouraged by the updated results, which continued to show durable long term clinical benefit for patients, which we will review shortly.

As we disclosed on our second quarter earnings call.

We have made entering into a strategic partnership to advance the <unk> development and paved the way to eventual approval our top priority.

We plan to initiate additional studies to begin a lithium after putting a partnership in place to ensure that we and our partner are aligned on the gamma listen to future development.

Let me bring you up to date on our progress.

Our business development discussions are directed towards an initial focused development plan in a randomized controlled setting.

The benefit seen across a broad array of solid tumor and which again a list has been studied to date.

<unk> breath.

<unk> head and neck, ovarian and melanoma cancers, providing multiple potential future development path.

It is our goal to announce a partnership and the focus of the prioritized clinical development plan for <unk> in the third quarter of 2023.

Turning to the Mario three data with an additional year of data maturity since our last update at the San Antonio breast cancer Symposium in December 2021.

It was an encouraging evidence of a long term benefit for patients.

Relative to the Impassion 130 benchmark study.

We are now able to report the one year progression free survival rates for patients with both PD lone positive NPV negative tumors, which were promising for all patients regardless of PD lone status.

This long term benefit.

Patients with <unk> is consistent with the long term benefits seen in other indications in which is analysts and has been study.

Additionally, there were no new safety signals during the extended period of treatment.

We were also pleased to report positive updated results from the randomized controlled Mario 275 phase two clinical study evaluating <unk> plus in volume versus the volume yet in.

In patients with second line platinum resistant metastatic <unk> cancer during the third quarter.

As we previously reported the analysts the combination showed approximately a doubling of patient overall survival at the two year landmark analysis.

Here to standard of care the volume that in monotherapy.

Again lifted has demonstrated promising clinical results.

Five oncology indications and treatment settings to date.

The continued strength of our data across multiple indications provides.

Provides solid evidence that again, a listen has the potential to be a transformative therapy in immuno oncology for three key reasons.

First we have a first in class therapy with potent and specific on target activity and translational data showing the target inhibition with analysts then reprograms macrophages in the tumor microenvironment.

Reducing immune suppression and activate and anti cancer immune response.

Second the clinical data with analysts and have demonstrated prolonged progression free survival in multiple indications and extended overall survival over current standards of care in a randomized controlled trial that allows us to see the distinct contribution I'll begin a list them over combo.

Nations partners.

Third and very importantly, <unk> analyst.

Analysts it has been shown to have an acceptable and manageable safety profile in combination with other drugs.

<unk> in two and three drug combination regimen.

At this time I'd now like to turn the call over to Dr. Laura to review, our recent encouraging again with the data.

Rob.

Thank you Ashley good morning.

The objective of our Mario <unk> Phase III study was to evaluate the safety and efficacy of the addition of analysts to a Tesla was a map in Nab paclitaxel in frontline metastatic <unk> patients.

Patients were enrolled in either PD lone positive or PD, one negative tumor cohorts.

The eligibility criteria for Mario three were designed to mirror the Impassion 130 study to facilitate benchmarking.

It is important to note that the approval of check immune checkpoint inhibitors in combination with chemotherapy in frontline metastatic T. M. D. C have been limited to PD Lone positive tumors. There are no immune checkpoint inhibitor regimens approved for patients with metastatic PD, one negative tumors, which represent approximately two thirds of D. M D.

C patients.

As of October 8th 2022, 62, TMT C patients were enrolled in Evaluable for safety and 57 patients were evaluable for efficacy in Mario three with a median duration of follow up of 10 months.

And the efficacy dataset 35 patients had PD lone negative tumors 18 patients had PD one positive tumors at eight patients had tumors of undetermined PDL one status.

We're pleased to share that we continue to see very encouraging and durable evidence of a progression free survival benefit in this study.

In patients with PD, one negative tumors, we continued to see an improvement in median PFS with a median PFS of seven three months at Mario three compared to $5 six months and Impassion $1 30 at 30% relative improvement.

Even more importantly, we're also seeing evidence of potential long term benefit with a one year PFS rate of 34, 7%.

Although the one year PFS rate was not disclosed for the Impassion 130, PD one negative population.

It should be noted that the one year PFS rate and Mario three PD lone negative tumors, a subgroup with inferior outcomes with immune checkpoint inhibitor therapy exceeds the $23 seven one year PFS rate for the Impassion 130, ITT, which of course included patients with PD, one positive and negative tumors.

In patients with PD Lone positive tumors. We also observed evidence of potential long term benefit with a one year PFS rate of 37, 5% compared to 29, 1% at Impassion 130, a 29% relative improvement.

In addition to the encouraging one year PFS rate.

We observed further evidence of antitumor activity of the analysts a triplet in patients with PD one positive tumors.

The objective response rate was 67% 66, 7% compared to 58, 9% in Impassion 130.

Largely driven by a higher complete response rate in Mario three patients with PD lone positive tumors.

16, 7% versus 10, 3% of patients the Impassion 130.

Lastly, the median duration of response was 11 seven months compared to eight five months and our passionate 138, 38% relative improvement.

We did not continue to see improvement in the median PFS of the Mario three PD one positive population with a median PFS of six four months compared to seven five months on a passion 130.

Nonetheless, the one year PFS rate an indicator of potential long term benefit was very consistent across PD lone tumor status in Mario three.

37, 5% in PD lone positive tumors, and 34, 7% in PD lone negative tumors.

These combined for a one year PFS rate of 36% and the Mario three ITT, a 52% relative improvement over the one year PFS rate of $23 seven reported in the entire Impassion 130 population.

The most common grade three or higher treatment related adverse events were hepatic aes at 24, 2% neutropenia ease at 14, 5% and skin and peripheral neuropathy adverse events each at 11, 3%.

25, 8% of patients discontinue treatment for treatment related Aes, which were a triplet regimen compares favorably to the 19, 1% reported and Impassion 130 for the <unk> of map and DAP Paclitaxel doublet.

While hepatic aes remain the most common grade three or higher treatment related adverse events. When again elicit this combined with an immune checkpoint inhibitor. They continue to be reversible within a relatively short amount of time often without corticosteroids.

Bilirubin elevation was infrequent and we saw no evidence of highs law.

In summary, the almost one year greater data maturity and Mario <unk> has provided us a new opportunity to gain insight into potential long term benefit of the triplet regimen of analysts have combined with a typical suburban Nab paclitaxel.

With encouraging one year progression free survival rates across tumor PD lone status.

These findings build on the promising two year landmark overall survival data paddling described from our Mario 275 randomized trial in second line platinum resistant fuel cancer.

Data from our phase III studies are consistent with and build upon findings in our Mario one phase one <unk> study, where we demonstrated the potential for analysts to benefit patients refractory to immune checkpoint inhibitors, such as patients with squamous cell cancer of the head and neck.

The totality of the <unk> of data across multiple tumor types supports important next steps and a robust randomized clinical trial setting.

Now I'll turn the call over to Larry to review, our third quarter financial results.

Larry.

Thank you Rob during the third quarter, we continued to pursue disciplined prudent approach to capital allocation.

So at the end of the third quarter of 2020 to Infinity had total cash.

Of $47 2 million compared to $80 7 million at December 31, 2021.

Research and development expenses for third quarter, 2022, or $7 7 million compared to $7 1 million at the same period in 2021.

And this increase is primarily related to higher compensation expense due to additional staff to support the future development of the catalysts.

General and administrative expense was $3 $5 billion to third quarter of 2022 as compared to $3 8 million the same period in 2021.

This decrease was primarily due to a decrease in professional services.

Net loss for the third quarter, 2022 was $10 7 million or basic and diluted loss per common share of <unk> 12.

Compared to net loss of $10 7 million or basic and diluted loss per common share which falls.

In the same period in 2021.

This financial guidance for 2022 remains unchanged.

We continue to expect net loss for 2022 to range from $240 million and $6 million and 2022 year end cash to range from $235 million to $45 million.

The police financial guidance does not include additional financing or visible activities.

Our goal was to execute on the list of strategic partnerships to be announced in the first quarter of 2023.

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

Thank you if you have a question at this time. Please press star one one on your Touchtone telephone.

One moment, while we compile our Q&A roster.

And our first question comes from the line of Edward <unk> with Piper Sandler. Your line is open. Please go ahead.

Great. Thank you very much and thanks for the update on the merit of agreements there should we be expecting a increase in cement cement terminal breast will you be presenting there or is this sort of the update for this year and.

Appreciate that and then.

All the other covenants.

Thank you Ted for the question.

This is the data update for Mario three.

We have presented at San Antonio breast cancer Symposium for the last two years and so we chose this year to present the data on this call. So that we could have the most recent data cut.

You get the data out more quickly as you know there is a longer lead time for the medical meeting.

Yes makes a lot of sense I appreciate it and congrats on good it looks great.

Thank you.

Okay.

Thank you one moment for our next question.

Our next question comes from the line of Sumit Roy with Jones trading. Your line is open. Please go ahead.

Hi, everyone. Thank you for the update.

Just trying to understand.

As the new coating patients versus the previous update.

Is there anything particular about these patients that pulled back the immediate PFS number are the PDL one expression levels go up.

More than expected any color would be appreciated.

Thanks, Tim.

The most important.

Okay.

Update in this data is that it's more mature and so that was what we were really focused on and are pleased to see that the one year PFS rate, which we think is.

Most meaningful reflection of long term benefit, but perhaps Rob you can elaborate a little bit further on the median PFS.

Sure.

Last year, when we provided the data.

Who hadn't had even their first scan yet so I think the challenges that median PFS can really be variable when you have a smaller sample set.

<unk> for example, our Piedmont pause negative side with almost twice what deposits were.

Got it thank you so much.

Yes.

Thank you one moment for our next question.

And our last question comes from the line of.

<unk> Patel.

<unk> with B Riley. Your line is open. Please go ahead.

Good morning team, thanks for taking our questions and congrats on the drug. This is land concept out goods. So maybe.

Focusing on your partnership discussions that are ongoing for UC versus CNBC.

Ben.

Any interest.

Just relatively higher in one indication.

<unk>.

Which do you anticipate being the first to advance to the next stage and then adequate follow up.

Okay. Thank you for the question well, we're not in a position today to describe the specifics on the future again a list since development plan until we put the partnership in place.

We can tell you a few things that you might expect to see in the future development.

First is that it will be leveraging some of the encouraging data that we generated with analysts and to date in one or more indications.

The focus of the development will be in a randomized.

Controlled setting so that we can very clearly show the contribution of the analysts have over it.

Contribution regimen over standard a standard of care and three it will be in patient setting where there is high unmet need. So we've seen the benefit of again a list of across a broad array of solid tumors that gives us many potential.

Potential development paths as you mentioned breast urothelium had neck ovarian and melanoma and so we're going to we're.

Prioritizing that with a prospective partner and we look forward to announcing the details of the partnership.

First next trial and potential subsequent next trials in the first quarter of 2023.

Thank you for that color.

Just a related follow up and indeed, this guy assumed in your own.

And also coming away from the <unk> conference over the weekend.

And any thoughts on what a registrational study could look like in the context of PDL, one status positive or negative.

If there is an opportunity to lump them together also.

And then kind of a novel trial design could be.

Ill comment on that.

Would be helpful.

Sure.

I'll turn it over to Rob and just highlight that we have seen benefit with analysts in patients across multiple different tumor types, regardless of PD lone status of course, a registrational trial will depend on what is the approved standard of care in those different patient populations and maybe Rob you can elaborate.

There.

Sure and also regarding the TBC question specifically.

It's true we are seeing pretty consistent one year PFS rates cross PD, one negative and positive tumors, which certainly is very encouraging.

There are certainly thinking about.

Pass for <unk>, one could be going for both patient populations, although now that theres a different standard of care for those two populations. It does make it a complex and probably large trial because of the two different control arms.

The PD Lone negative is certainly a great story building.

Dolby checkpoint inhibitors haven't been successful there. So certainly you could argue that the greatest unmet need is in that PD Lone negative group. So that's certainly also a very attractive path.

And as Italy mentioned, we believe the TBC data kind of adds to totality of the data so I think.

Which way you decide to go which tumor which indication within the tumor I think will be very much influenced by who our partner is and their preferences as well.

Thanks for the good questions and look forward to it as well.

Thank you and I'm showing no further questions at this time and I'd like to turn the conference back over to Abilene for any further remarks.

Thank you Michelle and thank you all for joining US today, we are really enthusiastic about the data that we've generated and the progress of advancing with analysts for the potential treatment of <unk>.

Patients with cancers, who are in.

Dire need of improved therapy. So we look forward to updating you on our business development Opex and the focus of the next study towards analysts within the coming months. Thank you for your continued support.

Thank you. This does conclude today's conference you may all disconnect everyone have a great day.

Q3 2022 Infinity Pharmaceuticals Inc Earnings Call

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