Q3 2021 Agenus Inc Earnings Call
Good day and thank you for standing by welcome to the third quarter of 2021 financial results Conference call. At this time, all participants are in a listen only mode.
The speaker presentation, there will be a question and answer session to ask a question. During this session you will need to press star one on your telephone if you require any further assistance. Please press star zero I would now like to hand, the conference over to Debbie you Damon. Thank you. Please go ahead.
Thank you Samir and thank you all for joining us today.
Today's call is being webcast and will be available on our website for replay I would like to remind you that this call will include forward looking statements, including statements regarding our clinical development regulatory and commercial plan and timeline as well as timelines for data release and partnership opportunities. These statements are subject to risks.
And uncertainties and we refer you to our SEC filings for more details on these risks.
As another reminder, this call is being recorded for audio broadcast.
Joining me today are Dr. Garo, Armen, Chairman and Chief Executive Officer.
Dr. Jennifer Buell, Chief Executive Officer of maker appeared.
Stephen Though day, Chief Medical Officer, Jonathan and Dr and Christine class skin, Vice President of finance.
Now I will turn the call over to Garo to highlight the progress we have made to date this year Garo.
Thank you very much David and thank you all for your participation and your interest in <unk> as well as make therapeutics.
As we have shared previously our business model is comprised of four pillars now for today's discussion I will redefine what those four pillars are and we will primarily talk about pillar number one two and three.
I'll make some.
Good comments pillar number four.
The first pillar.
Is what we describe as our significant value creators.
We believe these compounds and opportunities.
It would be significant.
And they represent certainly our next generation compounds and one primary example of that which we will talk about in some detail today is our next generation <unk> inhibitor a gen $11 81.
The second pillar is represented by our partnered programs.
And recently launched affiliated businesses, including Meg Peter Jacobs and supports.
The third pillar, we described as supportive programs.
Such as <unk>, and <unk> and I will define what we mean by supported programs in just a bit.
And our fourth pillar, which is a silent.
<unk> of our business, we don't talk very much about it but a very important component because without it we wouldn't be able to accomplish the kind of things innovations and advancements as we had and that is represented by our vertically integrated structure is comprised of key.
Operational capabilities for the company, including our commercial manufacturing.
Including our vision technology, which is our response prediction platform designed to facilitate the development of our pipeline by targeting patients who are likely to respond to therapy.
Now I would like to begin the call by addressing the first of which is driven by our flagship program AGN eliminating one.
Now as you know we have a presentation coming up.
This morning, we announced the publication over an abstract summarizing data.
This dose escalation study.
Over 100 patients treated with our next generation <unk> inhibitor, AJ and 11 81, as both monotherapy and in combination with our PD one inhibitor still it Matt.
More details will be presented this Friday I will provide a topline summary here.
A general eliminated one.
Is the first reported CLA <unk> inhibitor.
<unk> demonstrated clinical activity in.
Nine.
<unk> for treatment resistant tumors.
Mono therapy and in combination with both still a map.
Secondly, a gen eliminating one monotherapy and in combination with all Suezmax has shown compelling clinical activity and durable responses.
And number of cold tumors, such as colorectal.
Endometrial and.
Pancreatic cancer.
And they have been as I said in treatment resistant settings, such as PD one.
Relapsed and refractory melanoma, non small cell lung cancer and cervical cancer.
Yes.
Importantly, we are seeing evidence of more favorable safety profile relative to first generation <unk> four molecule molecules.
Also.
Jen eliminating one is performing as designed we designed this move for us specific performance and so far in the clinic.
Is indicating that it's delivering that performance and that is to expand the benefit of immune therapies, who a broader patient population with deeper more durable responses than what is available to them today.
Yeah.
That does even though they will share additional comments along with our plans to accelerate development totaling 81.
Alone and in combination with volatility map.
As I mentioned earlier full details of this will not be released until the poster is released this Friday.
To accomplish this Friday November 12.
Sure.
Next I would like to address our second pillar of our business, which include our recently launched your affiliates and partnered programs.
As you know amongst our accomplishments with regard to our second pillar is the launch of these businesses to start with on October 15th we announced the successful IPO of <unk> Therapeutics, which has raised over $40 million and evaluation of 400 million we.
Please that Ming has been one of the best performing IPO was recently having depreciated.
58% as of the closing price yesterday.
Dr. Jennifer Buell.
The newly appointed CEO of <unk> Therapeutics will tell you more about mint programs and share a preview over three abstracts.
There, we announced recently, which will be presented at <unk>. This week.
Now separately in September we also announced the launching golf so panics.
<unk> our subsidiary working on building, an integrated vaccine platform based on scalable and secure manufacturing of <unk> based adjuvant.
This premise behind <unk> business model.
Is captured in the following and I will outline this in four different categories. Firstly, the need for a vaccine is offering long lasting efficacy and efficient production has become amplified because of the needs.
As described by the current reality, which is the pandemic.
Secondly.
The durability offered by <unk> 'twenty, one stimuli, which is our flagship adjuvant.
Has been validated by Shin risks, which protection, which offers protection exceeding nine years and this is particularly important in the current climate. When we know the current vaccines are waning in activity after 36 months.
Whereas <unk>.
He was 21, Steve Your line is largely responsible in shale rigs for this long lasting efficacy.
But on the other hand, the supply is limited.
Due to the reliance on a complicated and expensive extraction process from the Chilean soap bark tree.
So to this end we.
Working with two companies <unk> biotech and ginkgo by works co op.
Optimize the plant cell culture process, which we have developed for the purposes of manufacturing <unk> 'twenty one stimulant.
And next generation <unk> based adjuvant is very important because some of our next generation of appointment based Andrew.
<unk> relevant to respiratory viral infections infections.
Among our objective is to also establish a platform for developing next generation adjuvant.
Effective and scalable vaccine formulations with optimized antigen and adjuvant pairing and in the future we'll talk about what we mean by that.
Now in addition to this also a part of our second pillar.
Is the driver of our certainly passed and also importantly future partnerships.
In October we announced the first patient dose with agent one triple seven.
Our FC enhanced <unk> bi specific antibody license to BMS recently.
This achievement triggered a $20 million milestone payment from BMS.
And BMS intends to advanced a gen. One triple seven in high priority indications such as non small cell lung cancer.
We are very excited about the prospects so AGM one triple seven.
Our clinical stage Adrian $23 73 is it differentiated CD 137 molecule CD 137 agonist otherwise in the past it was known as four <unk> as well.
It is designed to selectively enhance tumor immunity, while avoiding toxicity associated with systemic.
137 activation.
We presented clinical data at Ash this year showing that a gen 2373 led to prolong disease stabilization in heavily pre treated cancer patients.
Good Tolerability no evidence of liver toxicity, which has been one of the issues with other CD 130 Sevens.
<unk> of course with this is the fact that this has been done in a monotherapy setting.
And we are of course, starting combination trials with this.
<unk> 2377, seven with our a Gen 11, 81, which is our next generation <unk> four in PD, one relapsed and refractory melanoma this year.
Another program involves our clinical collaboration partner known.
Which is recently dosed the first patient in a combination study of our first generation <unk> four <unk> map.
Map with Neloms Hedgehog inhibitor and chemotherapy in first line pancreatic cancer patients.
Now next is our third pillar, which is our supportive programs and they constitute the third pillar of our business model and our strategy now.
Now what do we mean by this are supported programs include <unk>, our PD, one antibody and sell it for road map, our first generation CTO way for anybody.
These are programs, which on their own do not represent blockbuster opportunities for us. However in combination with other novel agents in our portfolio or in combination with <unk> agents in other company's portfolio they represent important opportunities.
So when people ask us why does the world need now.
Other PD one antibody it isn't that the world needs. Another PD, one antibody, but we need it because we have an extensive portfolio of agents and in the context of developing combinations. Our PD one antibody will make that job a lot easier a lot more efficient and at the end.
Deliver much more prudent economics to the healthcare system and for patients.
Among the important achievements of our supported programs, whereas this year, we reported at ESMO.
Yes.
The nation or Stewart map as other fruit math resulted in near doubling of responses that is 33% responses versus what has been reported for <unk> in PD lone positive share rectal cancer patients.
Now let me touch upon some of the recent announcements that we've made and the.
Potential implications of those developments for our company for our portfolio going forward.
As you May have noted we recently withdraw the BLA for bulk stood them up I don't therapy due to it technicality associated with the accelerated approval window closing for US following of course the.
Technicality associated all the.
<unk> window closing followed the full approval of <unk> in second line cervical cancer, which the FDA granted the approval four months ahead of the FDA Colby.
Now I'll note is the fact that this BLA withdrawal.
<unk> not related to bulk still the maps performance in fact, our agent.
Met and.
And exceeded predefined clinical milestones for this indication for this trial.
Our agent achieved trial endpoints with 20% response rates in PD lone positive patients versus 14% reported in Kimball was a map label.
And of course in single arm trials.
It's very difficult to compare these types of numbers to each other.
We are still heightened very much that we showed 20% responses versus 14% responses.
As opposed to the other way around.
Sure.
Now we also completed successfully three FDA approved inspections for our <unk> date of October 16th 2021.
No 483 sites at which is a.
Very big achievement for our company, our organization and we're very proud of that.
Given the clinical benefit demonstrated by about filling map, we are planning to launch expanded access programs to give patients and doctors access to both fill them up in several countries, perhaps including the U S pending the regulatory process associated.
With expanded access.
As a result of our BLA withdrawal, we also announced discontinuation of our bulk fill them up confirmatory trial Brock.
Which is expected to reduce our R&D expenses by over $100 million over the next couple of years.
Now with these developments, we expect to end the year with approximately $250 million in cash to execute on our combination development programs for Asia, and 11 81 and beyond now.
Now, let me pause here and address to frequently asked questions that have been put to us.
One is.
The fact that we withdrew the BLA for while still amount.
Does that impact our development programs going forward that involve bus dilemma for example, Boston them up plus 11 81 does it impact now before I answer that question. Let me address the fact that we have amassed an enormous.
Mountain <unk> safety information and over 400 patients treated with vascular map and as I mentioned, we have Sean <unk>.
<unk> activity Augusto and map certainly in cervical cancer, where we've treated the substantial number of patients but also in other indications. So we have a highly active PD one antibody.
Now.
With regard to how will this withdrawal of the BLA effect.
Next steps going forward with combinations, we're certainly going to use the data the efficacy data that shows the activity of PDL, one I mean.
One PD one antibody <unk>.
As well as the safety of it we're going to use this going forward in our justification of combinations.
And given the way we have designed our trials, we do not expect at this stage, we do not expect this to be a hurdle for our expeditious development of combinations. So that's number one.
Second question that you asked is because of what has happened with the FDA, having requested us to withdraw their BLA.
A question such as are we blocked.
Black listed by the FDA now that's going to make our lives difficult going forward well, we certainly don't think so and we certainly hope that that's not the case, if we provided that we show high activity with our compounds going forward, which we expect to do which compounds like <unk> 81.
And in combination with Costco would have provided.
Provided that we show profound activity of course anyone stocking too.
Getting the way of an expeditious approval to bring access to patients.
I would have to be questions. So we do not expect that our honorable agency.
Black list us or any other company for that matter for reasons that relate to what we have experienced but.
Having said all of that.
We plan on proceeding.
In a pristine fashion.
<unk> data that will be generated.
Justify the next steps associated with our portfolio of novel agents, reaching patients.
So with that I would now like to turn the call over to our Chief Medical Officer, Dr. Steven O'day to discuss the AGM 11, 81 clinical update share today.
Our sips 60, abstract and just to remind you that on Friday.
There'll be more details associated with the release of our poster that will have more data. So we will hold back on some of the details to date to respect the confidentiality with the CDC rules Stephen.
Thank you Garo and thank you all for joining us this morning.
Got it.
Today, we shared the first presentation of clinical data from a dose escalation study with over 100 patients treated with age of 11 81.
Model therapy or in combination with both still about.
The patient population was heavily pretreated.
Half of these patients received at least three prior lines of therapy.
<unk> anti PD one therapy.
This makes their response to each other a lot of any one even more encouraging.
And he's got a lot of any one as monotherapy and the combination with about still about what applications across a range of tumor types.
<unk> colon poorly immunogenic tumors.
In PD, one refractory setting.
Old model therapy, and combination therapy were well tolerated with no observed cases of high voltage side of it.
Pneumonitis.
Hi, Greg.
Mary go are clinically meaningful toxicities.
First generation <unk> four based therapies.
We have established our recommended phase two dose.
For a gen 11 81.
Monotherapy and in combination with golf still about.
The abstract cut off.
Was July 16 2021.
Observe or confirm responses to single agent <unk> hundred 11 and 81.
These include a complete response.
A patient with microsatellite stable endometrial cancer.
Partial response.
In pancreatic cancer.
A partial response.
In cervical cancer following failure of anti PD one therapy.
To our knowledge. These are the first report.
<unk> CTO for mono therapy in these specific disease settings.
Our fourth response was in a patient with melanoma.
Ill prior anti PD one therapy.
We also observed significant benefit of the combination of 11 81.
Phil about.
Across multiple cold poorly in there today.
Yes.
Among 17, Evaluable <unk> stable colorectal patients treated with at least one milligram per kilo of a general one.
We observed four partial responses.
And seven cases and stable disease.
For a disease control rate of 65%.
Just to put this in perspective.
<unk> trial.
Demonstrate is limited.
No activity of PD, one inhibitors alone or in combination with first generation anti <unk> four.
Mmm stable colorectal cancer.
The efficacy that we have demonstrated in this study to date highlights 811, 81 is a differentiated anti <unk> four and has the potential to address this high unmet.
Among six evaluable ovarian cancer patients receiving at least one milligram of age at 11 91, we observed two partial responses and three cases of meaningful stable disease.
We also observed clinical activity against other <unk> tumors.
With the combination, including partial responses to both of our MF stable endometrial cancer patients who were treated with combination therapy.
Finally, additional combination of responders, including one partial response.
Non small cell lung cancer patients, who have failed prior PD, one therapy and two partial responses and visceral angiosarcoma.
Some type of angiosarcoma, historically resistant to checkpoint inhibition therapy.
The majority of these responses are durable and ongoing.
I want to remind you that additional patient accrual.
And follow up.
We will be included in our poster presentation at <unk>. This week with a cut off on September 17th 2001 or clinical data.
Based on the exciting antitumor activity demonstrated thus far.
Randomize phase two and phase three trial are in active development across colorectal and about stable and <unk> malignancies.
We anticipate the outcomes of these important trials will strengthen the efficacy.
The signal demonstrated today and.
In support of a potential filing.
<unk> accelerated approval.
Based on the magnitude of benefit.
Benefit demonstrated in the studies.
<unk>.
I would now like to turn the call over to Dr. Jennifer Buell Chief Executive Officer.
<unk> therapeutics.
Thank you very much that you are gay and congratulation on those myths out there will be an exciting conference for us at a genus as well and that link, which I'm going to highlight some of the data that's coming out now of course, our abstracts have been released.
But the data updates will be presented on <unk> and the upcoming posters.
So turning to mink.
I wanted to just remind you of our calls and in launching <unk> therapeutics as a separate public entity.
That's the way to create two patient focused companies with independent financing streamlined operations and focus teams to accelerate the development of their collective and independent innovative pipelines.
So as Carl mentioned, we launched the IPO and to date, we actually raised $46 million at point, which includes our initial public offering of $40 million and then the green shoe, which was also executed.
Most recently and with those proceeds will be rapidly advancing our clinical stage portfolio.
Now, we believe that invariant natural killer T cells or <unk> represent a potential best in class allogeneic cell therapy approach.
K T is naturally home to the site of the tumor or infection.
And we believe that this ability to penetrate solid tumors is a critical advantage compared to T cells or NK cells and also the capability of the cells to naturally proliferate enabled us to expand.
Upon that benefit and the functions of these cells.
What we have observed to date is that other cell therapy approaches have shown limited durable efficacy in solid tumors and we've also of course observed some more recent toxicity challenges and what I can tell you that we've publicly informed.
Is that the <unk> T cells can be done to 1 billion cells with no neurotoxicity.
No cytokine release syndrome observed to date very important clinical benefit safety benefit of T cells.
Early data from our clinical trials confirms a rapid translocation of Ian <unk> from the peripheral blood to the site of interest and this is consistent with the cell tumor homing properties are 60 posters will present evidence of iron K T cell persistence beyond the time of our measurement period as well.
As anti tumor activity from our anti tumor and anti and disease mitigating benefit of these cells from our ongoing clinical trials.
We see similar activity in the preclinical settings, we've observed tumor infiltration and anti tumor activity of <unk> in both solid and hematologic in vivo models.
These data will be discussed in great detail and I still see poster presentations, which will be published on November 12.
Well also be presenting data on our car discovery platform, which can further boost the tumor killing potential of ion K T cell and its 50 will present data characterizing the anti tumor activity of our proprietary <unk>, we believe that engineering I N T cells in our own hands as well as has been.
Published by independent researchers that car Ts are engineered imtt's outperform other therapeutic approaches others other T cell approaches.
So together with the ability to advance combinations with the Genesis pipeline agents and.
Including <unk> as well as a general 181.
So excited to develop a powerful suite of IMTT based therapeutic regimens.
With that I'd like to turn the call over to Christine <unk> to discuss our financials for HMS.
Thank you Jim.
We ended the third quarter of 2021, with a cash and short term investment balance of $262 million as compared to $100 million at December 31, 2020.
For the third quarter ended September 2021, our cash provided by operations was $131 million and we reported a net income of $177 million or <unk> 76 per share basic and <unk> 72 per share dilutive.
This compares to cash used in operations for the same period in 2020 of $32 million and a net loss of $52 million or 28 cents per share basic and diluted.
Our cash provided by operations for the nine months ended September 2021 was $33 million with net income of $39 million or <unk> 19 per share basic and <unk> 18 per share diluted.
This compares to cash used in operations of $104 million and a net loss for the same period last year of $145 million or <unk> 87 per share basic and diluted.
Noncash operating expenses for the nine months ended September 2021 were $46 million compared to $35 million for the same period of 2020.
We recognized revenue of $275 million through September 2021, and $57 million for the nine months ended September 2020.
Revenue includes upfront license fee received milestones earned noncash royalties and revenue recognized under our collaboration agreements.
I would now like to turn the call back to Garo.
I'd like to thank my colleagues for their statements. During this call and also thank you all for your interest in a jenison and make therapeutics and joining us this morning.
Looking into the current quarter and beyond into 2022.
We expect to achieve value driving events with our clinical and preclinical pipeline.
And when we talk about pre clinical Bryan we do expect to take a number of our own discoveries into the clinic over the next months.
Firstly.
Accelerating the development of a general of an 81 and Boston the map by launching our phase II III trials in colorectal cancer.
Aerion cancer and endometrial cancers.
Something that we are very much focused on.
And of course, we're very encouraged with the responses that we've seen which we have disclosed some of it this morning.
And Youll see additional details this Friday at city, but even beyond that as Dr. Steven are they mentioned these responses are of a certain cutoff rate.
Date, we do expect responses to develop beyond that kind of space, which will not be released at this meeting this week.
Garo H. Armen: Secondly, initiating a combination study of Agent 1181 with our conditionally active, CD-137 agonist in melanomad. Third, advancing our tuit by specific, phase one studies in collaboration with BMS. And this is a very exciting program, as we have mentioned, first, several patients are condosed already. Fourthly, advancing clinical development of allogenic INKT cell therapies, as you mentioned, in cancer and immune-mediated diseases through Mink therapeutics. We will have a data update at SITC this week, and we will have appropriate updates beyond it.
Secondly, initiating a combination study or a general of an 81 with our conditionally active CD 137 agonist in melanoma this year.
Third.
Advancing our ticket by specific two phase one studies in collaboration with BMS and this is a very exciting program as we have mentioned.
First set of patients who can go still ready.
Fourthly advancing clinical development, our allogeneic NK T cell therapies, as Jen mentioned in cancer and immune mediated diseases through many therapeutics with a data update at <unk>. This week.
And we will have.
Appropriate updates beyond that.
Building, a sustainable supply of Poland based adjuvant proprietary adjuvant that include our Qs 21 stimulus through Super Onyx.
Garo H. Armen: Building a sustainable supply of subpronin-based adjuvants, proprietary adjuvants that include our QS21 stimulant through Seponix, Launching expanded access programs for bolsthylamap and providing an update regarding the strategy for basulimab and Zolumab combination in second-line cervical cancer Now, this is a very important program that we undertake seriously because we've had a number of requests, including from our physicians who have been engaged in our trials, and it is our moral responsibility to make sure that we provide access to products that are active on terms that are going to make patient treatment more efficient.
Launching expanded access programs for a while still a map and providing an update regarding the strategy for <unk>.
So it's really a mass combination in second line cervical cancer.
It is a very important program that we undertake seriously because we've had a number of requests including from our physicians who have been engaged in our trials and it is our moral responsibility to make sure that we provide access to products that are active on <unk>.
<unk> that are going to make the patient treatment streamlined.
Garo H. Armen: Continuing to advance novel programs to I&D, as I just mentioned, with our next I&D filing planned in early 2022, and, of course, integration of our vision, intelligent platform to support discovery of rational drug combinations, selection of new targets, and predictive biomarkers beyond what is commonly practiced today. And lastly, progressing construction of our facility, a fully integrated facility for commercial manufacturing in Emerald, California. And this is a very important undertaking for us because it will make a genus self-reliant in its ability to deliver products without dependence on third parties, which is particularly important in today's environment, where there are significant capacity constraints and supply chain issues. And once again, thank you very much for your attention. We will open it up now to questions.
Continuing to advance novel programs for A&D as I, just mentioned with our next <unk> filing planned in early 2022.
And of course integration of our vision intelligent platform to support discovery of rational drug combinations.
Selection of new targets and predictive biomarkers beyond what is commonly practice to date.
And lastly, progressing construction of our facility fully integrated facility for commercial manufacturing.
In Emeryville, California, and this is a very important undertaking for us because it will make a genus.
Self reliant.
The ability to deliver products without dependence on.
Third parties, which is particularly important in today's environment.
Significant capacity constraints and supply chain issues.
And once again, thank you very much for your attention we will open it up now for questions.
As a reminder to ask a question you will need to press star one on your telephone to withdraw your question press the pound key please standby, while we compile the Q&A roster.
Operator: As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound or hash-key. Please stand by while we compile a Q&A list. Your first question comes from the line of Mayak Natomni with B.R.R.E.R.E.R.E.R.E.R.
Your first question comes from the line of.
Tommy with BR B Riley Securities.
Mayank Mamtani: Good morning team, congratulations on the progress on multiple friends, and thanks for taking our question. So maybe if I could start with the 1181 data abstract at SITC, just a couple of quick questions I have. So on the 24% ORR we are seeing on MSSC here, could you just give an update on where we are in terms of median follow-up with these patients, just trying to understand the durability and depth of response?
Good morning team.
Thats in the progress of multiple trends and thanks for taking my question. So maybe if I can start with the 1181.
Data abstract.
Just a couple of quick questions that have so on the 24%.
As seen on MSS CRC.
But could you just give an update on where we are in terms of median follow up these patients just trying to understand the durability and depth of response that youre seeing and then.
Mayank Mamtani: that you're seeing. And also on the unconfirmed PR we have in PD1 refractory, non-small cell lung cancer, it would be helpful to understand, you know, the baseline patient characteristics and also how many lung cancer patients you have already enrolled. Okay.
Also on the unconfirmed beyond we have in PD, one refractory non small cell lung cancer.
It would be helpful to understand.
The baseline patient characteristics and also how many lung cancer patients who have already in the <unk>.
Cohort enrolled.
Garo H. Armen: Okay, so let me answer the question broadly, and then, of course, we're going to ask Dr. O'Day to provide more color. I would caution against assigning response rates, even though we're very pleased with the responses we're seeing, in such a trial where we've gone through a dosing galation process. In the beginning, certainly, the doses used were not necessarily optimized doses. So to take the denominator and enumerate, and mixing match, this probably is not an accurate depiction of response rates in this trial.
Okay. So let me answer the question broadly and then of course, we're gonna aspect of our data to provide more color I would caution against assigning response rates, even though we're very pleased with the responses. We're seeing in such a trial, where we've gone through a dose escalation process.
In the beginning certainly the doses used were not necessarily optimized doses so to take the denominator and the numerator and mixing and matching this probably is not an accurate depiction.
<unk>.
Response rates in this trial now.
Garo H. Armen: Now, in addition to that, of course, in terms of certain cohorts, because of the high science that we are engaged in here as a general, we really dissect the patient profile based on a whole bunch of predictive and other biomarkers. And so patient selection criteria is going to be much more precise going forward into our phase two and three trials. So with that, Steven, if you could address Mayan's question.
In addition to that of course in terms of certain cohorts.
Because of the high science that we are engaged in here at Janus.
We really dissect the patient profiles based on a whole bunch of predictive and other biomarkers and so patient selection criteria is going to be much more precise going forward into our phase III trials, so with that Steve.
And if you could.
Dress my question.
Question.
Steven J. ODay: Yeah, thank you, Garrow. Thank you for the question.
Thank you Garo. Thank you for the question I think what we can tell you is obviously that.
Steven J. ODay: I think what we can say is, obviously, that the cutoff for this abstract that we're discussing this morning was in July, and the cutoff for the poster, which will be delivered on Friday in September. And we will be updating the follow-up and the unconfirmed to-confirmed responses on the Friday poster. So I think we should wait and share with you the data, but I think you'll see both the development of further follow-up on the patients and, obviously, further follow-up in terms of the confirmation of responses.
The cutoff for the abstract that we are discussing this morning with in July and the cutoff for the poster which will be delivered on Friday in September and we will be updating the follow up and the <unk>.
Confirm.
To confirm responses.
On the Friday poster, so I think.
We should wait and share with you the data, but I think you'll see.
The development.
Further follow up on the patients and obviously further follow up in terms of.
The confirmation of our sponsors.
Mayank Mamtani: I understood. And then my second bucket of questions was around, you know, what sort of work you're doing with Milam and sort of thinking broadly about, you know, two aspects of focus on pancreatic cancer franchise given, you know, the first-gen CDLA-4 has a signal with a hedgehog, but also you're seeing, you know, PR with the next-gen CDLA4 here. But I'm also broadly curious to hear your thoughts, Garrow. So as you look at other agents targeted or IO that, you know, bigger pharma companies have, and you try to, you know, prosecute 1181 in certain indications where, you know, maybe a backbone therapy might not be within a genus portfolio. So how should we think about that?
And then my.
The second bucket of question was around.
What sort of work Youre doing with <unk>.
And sort of thinking broadly about too.
<unk> focus on pancreatic gods and Sanjay is given.
The first Gen <unk> has a signal that the hedge hedgehog, but also youre seeing.
The next Gen Z DLA forehead, but I'm also broadly curious to hear your thoughts gatto.
As you look at other agents targeted Ohio that bigger pharma companies have and you try to process.
Prosecute what 181 in certain indications where.
Maybe a backbone therapy might not be within edginess portfolio. So how should we think about that.
Mayank Mamtani: So if you can repeat the point that you're trying to make with the last point, Lyon, because when you say how should we think about it in the context of large companies' portfolios, what do you mean by that?
So if you can repeat the point that you're trying to make the last point my own.
Because.
When you say or how should we think about it in the context of large companies.
Portfolio, what do you mean by that.
So for instance.
Did you buy any of the big priority for you I'm just making this up.
Mayank Mamtani: Yeah, for instance, you know, if OBGYN is a big priority for you, I'm just making this up, having access to a part or, you know, another targeted therapy could kind of make sense to be combined with CTLA4, for instance. So, you know, you might be thinking of, you know, partnering up with a bigger player here, given that the bigger player will also value the importance of 11181 from an IOS tab. So, with very, very.
They get access to a buyer.
Another targeted therapy.
Good day, no it makes sense to be combining with the CBL and fluids like for instance, so how you might be thinking of.
Partnering up with a bigger player has given the bigger player with lots of value the buttons about lineage one.
<unk> alright, so very good and now now it's clear so in terms of a couple of points here one is.
Garo H. Armen: So, very good. Now it's clear. So in terms of a couple of points here. One is, in comparing what we can do to large companies, we have several advantages here. Number one is that we have a very extensive arsenal of Immine Oncology Age at our disposal. These are our inventions. So mixing and matching and combining them is relatively straightforward for us. That's number one.
In comparing what we can do.
Two large companies we have several advantages here number one.
We have a very expensive armamentarium.
Immuno oncology agents.
At our disposal these are our inventions.
<unk> mixing and matching and combining them is relatively straightforward for us as number one number two.
Garo H. Armen: Number two, we have technology such as vision, which is a very important tool for us in terms of its ability to be predictive of responses and patient selection. Now, what does all that mean? It means that we could be striving as vision advances to identify biomarkers or patient markers that are going to be agnostic to specific indications. Okay, that's not quite there yet, but I think we're heading in that direction.
We have a technology such as vision.
Which is a very important tool for us.
In terms of its ability to be predictive.
Responses in patient selection.
Now what does all that mean it means that we could be striving.
As vision advances to identifying biomarkers or patient monitors that are going to be agnostic to specific indications. Okay. That's not quite there yet now, but I think we're heading in that direction. So we can envision for example.
Garo H. Armen: So we can imagine, for example, selecting patients and therapies matching them, regardless of indications, similar to what they have done at big companies such as Merck, but they have done it in a very crude fashion. We'd like to do that much more specifically. Having said that, to address your last question, "What is our partnering strategy? How do we go about thinking about the future?"
Selecting patients.
<unk> matching them.
Regardless of indication similar to what they have done at big companies, such as Merck, but they have done it in a very crude fashion, we'd like to do that much more specific.
<unk> said that to address your last question.
What is our partnering strategy how do we go about thinking about the future now while we have said in the past is that because of our resource constraints and when I talk about resource constraints, we're not talking about just money, which I'll come back overall capabilities and global reach because of that.
Garo H. Armen: Now, what we have said in the past is that because of our resource constraints, and when I talk about resource constraints, we're not talking about just money. We're talking about overall capabilities with a global reach. Because of that, we opted to license things such as Agent 1-37 globally. Now, going forward, we've made statements about Agent 1181, saying that a logical path forward for us would be the geographic segregation of the rights. So, for example, U.S. rights we will keep, and ex-U.S. rights we will license out.
We opted to license things such as a gen. One triple seven globally.
Going forward, we've made statements about any general of an 81.
Saying that a logical path forward for us would be the geographic segregation of the rights. So for example, U S rights, we will keep.
And ex U S rights, we will license act now in the context of a an appropriate development program.
Garo H. Armen: Now, in the context of an appropriate development program, it's very, very plausible that we may do a global co-developer with a prospective collaborator or a partner with these geographies cuffed out for commercial launch or product. And then, of course, as we put in place substantial resources over the coming years, earned through the performance of our products and commercial launches, I would see us even venturing into taking a bigger share of the global reach for our future collaboration deals. Does that answer your question?
It's very very plausible that we may do a global co development.
Prospective collaborator audit partner with these geographies carved out for commercial launch of product. So and then of course as we put into place substantial resources over the coming years burned with the performance of our <unk>.
<unk> and commercial launches I would see us even venturing into taking a bigger share of the global reach for our future collaboration deals does that answer your question.
Mayank Mamtani: Yes, yes, very helpful, Gary. Thank you. And if I can squeeze in another one before I pass it on to my colleagues, remind us of the pro forma ownership in INKT, and then how should we think of, you know, Seponic QX, given the experience you've had with IMKT, but also, you know, the considerations there are different in terms of, you know, partnerships and scale-up, and capital needs might be very different than what was with INKT. Sure.
Yes, yes very helpful. Thank you and if I can.
We did another one before I pass it on to my colleagues remind us of the pro forma ownership in <unk> and then how should we think of subotnick UX.
Given the experience you've had with <unk>, but also.
The considerations that are different in terms of partnerships and scale up and capital needs might be very different than what it was with <unk>.
Sure I'll let.
That's the real address the <unk> question, and then I'll come back to <unk>.
So land we have.
You now have access to is that the <unk> genus ownership.
Thank <unk>.
Just under 80% 79%.
Garo H. Armen: ask Dr. Beowell to address the INKT question, and then I'll come back to Sheponic. Sure. So, my uncle.
Okay now as far as <unk> is concerned.
So <unk> you can assume.
To follow pretty much the footsteps of our main therapeutics.
Unnamed Speaker: Sure. So, Myank, what you now have access to is that the agenis ownership of the Mink, IMKT, is just under 80%. It's 79%. Thank you.
So.
We formed <unk> recently.
Based on the need that I articulated for a.
And effective vaccine that has long term long lasting protection.
Garo H. Armen: Okay, now as far as Seponix is concerned, Saponics, you can assume to follow pretty much the footsteps of INKT or Mink Therapeutics. So we formed Seponix recently, based on the need that I articulated for an effective vaccine that has long-term, long-lasting protection. And as I said earlier, one of the limitations of current vaccines, even though they're highly efficacious, We don't know, for example, how efficacious they'll be against potential new variants. But we hope that they'll be highly efficacious.
And as I said earlier, one of the limitations of current vaccines, even though they're highly efficacious.
We don't know for example.
Efficacious there'll be two potential new variance, we hope that there'll be highly efficacious, but one thing we know for sure is that the efficacy wanes. After 36 months that is for sure and of course, the prospects of a booster shot every three to six months for forever.
He is not an appropriate.
Strategizing for vaccines, so having longer lasting immunity is critically important and the only limitation of Qs 21 stimulant.
Garo H. Armen: But one thing we know for sure is that their efficacy wanes after three, six months. That is for sure. And, of course, the prospect of a booster shot every three, six months, forever, is not an appropriate way of strategizing for vaccines. So having longer-lasting immunity is critically important. And the only limitation of QS21 Stimilon right now is not that it cannot offer that long-lasting protection. It can, I mean, It can, of course, but we are quantity limited.
Right now is not that it cannot offer that long lasting limitation that can protect.
<unk> it can of course, but we are quantity limit and hence the right thing to do for us.
Morally.
Appropriate thing to do is to collaborate with governance and potential with other companies to sprint towards being able to manufacture Georgetown 21, stimulant and other adjuvant down the pike that have very potent.
Nasal immunity.
Coastal community factory sticks at a high speed. So that we can offer the benefit of Qs 21 beyond the number of limited number of patients that are or I should say healthy individuals that are benefiting in the context of <unk> we.
Garo H. Armen: And hence, the right thing to do for us, the morally appropriate thing to do, is to collaborate with governance and potential partners with other companies to sprint towards being able to manufacture QS.S. Stimiland and other adjuvants down the pipe that have very potent nasal immunity and mucosal immunity characteristics at a high speed so that we can offer the benefit of QS21 beyond the number of, limited number of patients that are, or I should say, healthy individuals that are benefiting in the context of Schingrich, for example. We need to get what we have shown scientifically to be possible with this process. It's an engineering challenge that could have
We need to get what we have shown scientifically to be possible.
With this passes it's an engineering challenge that could take us to billions of doses production of Qs 21 stimulant.
Very helpful. Thanks, again for taking my question.
Thank you.
Your next question comes from the line of Kelly <unk> with Jeffrey.
Hi, Good morning. This is Jason <unk> on for <unk> on for Kelly sheet. Thank you for taking my call and.
Congratulations again on the 11 81 data just one question on the <unk> combo in cervical you mentioned on a previous call you would need to discuss a possible path forward with the FDA can.
Can you provide any do you have any high resolution on the timing of that conversation and maybe when we can expect to learn about the outcome of the meeting and then we'd anticipate that path looking like going forward. Thanks, a lot. Okay. So it's not clear entirely yet.
Mayank Mamtani: Very helpful. Thanks again for taking our question. Thank you.
We will have some additional data points that will inform us.
What the next steps will be whether there will be next steps.
At the end of this year.
Okay, great. Thank you.
Operator: Your next question comes from the line of Kelly Shee with Jeffrey.
Your next question comes from the line of Matt Phipps with William Blair.
Jason Bouvier: Hi, good morning. This is Jason Bouvier on behalf of Kelly Shee.
Good morning, Thanks for taking my questions. Congrats method Dr. <unk> I was wondering if you could I realize but the wait for Friday for a lot of disclosure, but any more comments on any colitis theme with this combination of eliminating one.
Jason Bouvier: Thank you for taking our call, and congratulations again on the 1181 data. Just one question on the Balsall combo and cervical. You mentioned on a previous call you'd need to discuss a possible path forward with the FDA. Can you provide any, do you have any higher resolution on the timing of that conversation and maybe when we can expect to learn about the outcome of the meeting? And then what do you anticipate that path will look like going forward? Thanks a lot. Okay. So it's not entirely clear.
One thing we've kind of been looking at.
Based on the FDA last year.
And then.
As we're thinking about these two.
Two three trials I wondered if I guess, one any thoughts on the endometrial landscape. We've got two approvals this year for anemia therapy regimens one in the.
<unk> setting for monotherapy, and then Keytruda plus bema and the MSS setting. So just kind of curious if you can give us any insight on where youre thinking of going into metrial, assuming that's one of the gynecological cancers, and then you mentioned phase two or phase II <unk> III and any of these potentially accelerated pathway.
Matt. Thank you out of this question, let me just guide you broadly and then of course factor, where they will answer.
Unnamed Speaker: So it's not entirely clear yet, but we will have some additional data points that will inform us what the next steps will be, whether there will be any next steps, by the end of this year.
We have made a strategic decision not to discuss the competitive.
Our next moves with regard to details of our clinical trials design.
Because of competitive reasons because of competitive reasons, I mean, what happened with <unk> monotherapy approval process of course highlights how important competitive.
Operator: Your next question comes from the line of Matt Phipps with William Blair.
Issues are and timelines are and of course, how important FDA consideration is for reviewing one company's product versus other companies products and so that's why we're going to be a little bit guarded in terms of how much detail, we provide but we have discussed this internally and Steven feel free to.
Matthew Phipps: Good morning, thanks for taking my questions. Congratulations on the update.
Matthew Phipps: Dr. O'Day, I was wondering if you could, I realize probably have to wait for Friday for a lot of disclosure, but any more comments on any colitis seen with this combination, 1181, one thing we've kind of been looking at based on the update last year. And then, you know, as we were thinking about these phase two, three trials, I wondered if, I guess, one, any thoughts on the endometrial landscape We've had two approvals this year for any immunotherapy regimens, one in the DMMR setting for monotherapy, and then Qtripo's when VMA and in the MSS setting.
Belgium, any kind of detail that we have determined to be publicly disclosing at this point.
Yes.
Thanks, Matt in terms of the development I think Carol had spoken about it obviously, we're very excited about launching these trials.
<unk> malignancies.
And ovarian.
<unk> will add more to come on that we havent disclose further but needless to say we have kols leadership around these.
These trials that are very excited about the data today.
A rational plan forward in terms of the.
Toxicity I think obviously.
What is really remarkable today, either lack of hypo.
Pneumonitis or clinically relevant.
Matthew Phipps: So I'm just kind of curious if you can give us any insight on where you're thinking of going with endometrial, assuming that's one of the gynecological cancers. And then you mentioned phase two or phase two slash three, any of these potentially accelerated pathways
Hi, Brady hepatitis, which as you know our <unk>.
Densely life threatening <unk> quanta.
The first generation <unk> four so we see this really as a gift.
Correct.
Over 100 patients treated in terms of Florida.
Ill refer you to the abstract right now there will be further.
Garo H. Armen: Matt, thank you for this question. Let me just guide you broadly, and then, of course, Dr. O'Day will answer. So we have made a strategic decision.
Follow up on Friday.
With updated patients in follow up.
Certainly we're confident that the colitis.
He is certainly garik, it's difficult with cross trial comparisons of first generation agents, but we feel very good about the widest in the sense of it.
Steven J. ODay: Thanks, Matt. You know, in terms of the development, I think,
Peers to be comparable or in the same range as first generation that we have the strategies in our phase two programs to mitigate that further which we're very excited about.
Operator: At this time, there are no further questions. I would like to turn the call back over to management for closing remarks.
So more to come with a follow up safety data, but that's what I can say about the Flyers Tonight.
Garo H. Armen: Thank you very much to everybody. I think we've had quite an extensive call and we look forward to your engagement and additional questions. Please feel free to connect with
Alright, thank you.
At this time there are no further question I would like to turn the call back over to management for closing remark.
Sure.
Thank you very much for everybody I think we've had a quite an expensive call and we look forward to your engagement additional questions do please feel free to connect.