Q1 2022 F-Star Therapeutics Inc Earnings Call
Greetings and welcome to our first quarter 2022 earnings conference call. At this time participants are in a listen only mode.
A question and answer session will follow the formal presentation. If anyone should require operator assistance. During the conference. Please press star zero on your telephone keypad. As a reminder, this conference is being recorded I would now like to turn the conference over to your host John Francis Managing director of Life Science Advisors. Please proceed sir.
Sure.
Good morning, everyone and thank you for joining US with me today is the Chief Executive Officer of Star Therapeutics, Elliott, Forrester and Chief Financial Officer, Darlene Deptula Hicks, we announced financial results pre market today for the quarter ended March 31, 2022, you can access the press release on the Investor Relations page of our website.
F Star Dot com.
Before we get started let's quickly run through the forward looking statements. Please note that as a part of our discussion today management will be making forward looking statements. These statements are not guarantees of future performance and therefore, you should not place undue reliance on them investors are also cautioned that statements that are not strictly historical constant.
Forward looking statements such forward looking statements are subject to a number of risks and uncertainties that could cause the actual results to differ materially from those anticipated. These.
These risks include risks.
And uncertainties detailed in <unk> filings with the SEC. The company undertakes no obligation to update any forward looking statements in order to reflect events or circumstances that may arise. After the date of this conference call with that I'll hand, the call over to Elliot.
Thank you John .
And thank you and good morning, everyone as ever it's a pleasure to speak with you today and review <unk> first quarter of this year.
It's only been eight weeks since we last met but every new months brings increased confidence in our portfolio. We're pleased with progress across all four programs and in particular that performance in the clinic.
Against the backdrop of a tough ongoing biotech market, we're getting on with the job at hand.
Michigan is a cost to transform the lives of patients and ultimately achieve a future that's free from cancer.
Yeah.
Looking back over the first three months of the I'm pleased to report that we've continued to build them back up across each of our programs.
Oh fall all progressing well in the clinic and the.
Last quarter for each of our street Tetravalent Bispecific assets F. S woman H F. S 222 in FY 'twenty, we've increased the number of clinical research sites and added new countries. So as well as the patients enrolled in the U S. We've also dosed our first SaaS Walmart H F. S 120 patients in Europe .
We're very excited about the full set of important clinical data coming this year.
As you'll recall, our preference is to release data at scientific conferences where possible.
We strengthened our drug development capabilities by welcoming James Sandy truck company as Chief Development officer with more than three decades of clinical development experience.
James brings valuable additional expertise to the team and accelerating concentrate on programs through early stage and late stage development and that will greatly benefit our clinical development strategy.
We are pleased to present a poster on S. S woman, aged novel mechanism of action and at the American Association for Cancer Research annual meeting in April .
Our data reveals the unique tetravalent structure of FX Walmart H plays a crucial role in driving luxury shedding and cell surface reduction on tumor infiltrating lymphocytes, enabling us to overcome compensates the upregulation of block III and do Spike PD L. P D L or PD one blockade.
And with the positive news from the field, including the recent approval of BMS as luxury antibody in combination with PD. One lag three is to become the de facto so to checkpoint inhibitor.
Our partnerships continue to advance well and this past quarter Buck K G. A a darmstadt, Germany exercised a fourth licensing option to develop another bispecific program under our ongoing immuno oncology collaboration I guess just as a reminder, the potential revenue from this collaboration is up to approximately 765 million.
And milestone payments.
This is just one of the more than 20 partnered programs that drive financing. This year based on the discovery capabilities of the <unk> platform.
Also this quarter the U S patent and trademark office granted a patent protecting the composition of matter, whereas this woman eight.
This new patent is expected to provide lifestyle with exclusivity for S. S. Walmart age out to at least August 2038.
We also held a two day meeting of our scientific Advisory board in the last quarter.
It's always time, well spent to discuss our programs and hear the views and getting support from these internationally around experts for our future development plans.
Oh by the way I was particularly struck by one of our advisers reminding us that five in every six patients with head and neck cancer continues to face the most difficult conversations about that futures.
Fight the remarkable progress with immuno oncology treatment over the past decade, we are very mindful of the majority of patients who are running out of options.
We also continued with a busy program of meetings with existing shareholders on potential new investors. We're greatly encouraged by the interest shown in our programs across the portfolio are grateful for the opportunity to share information with those investors.
However, it was a pleasure to present our programs at several investor conferences.
And thanks to our analysts for arranging those.
Okay.
So by specifics have huge potential deliver different and better outcomes for patients, Wisconsin. This is backed up by our own data and by that above us.
Bi specifics really on now coming of age.
They behave differently from monoclonal antibodies and even combinations of monoclonal antibodies. It's this difference up brings hope for improvement treatment options beyond first generation checkpoint inhibitors, particularly for hard to treat cancers in patients with few other options.
The promise of next generation immuno oncology is reflected by the extraordinary amount of capital being invested in by specific drug development.
Specifics now represent nearly 20% of the clinical antibody pipeline and new collaborations account for more than 18 billion in deal value over the past two years.
For example, the Astrazeneca Harbour Biomet deal was 25 million upfront further reinforces the growing importance of bi specifics.
Day full bi specific drugs have already been approved and without question, we expect the pace of investment and future approvals for bi specifics only to accelerate overtime.
We firmly believe architecture by Petrobras and by specifics are amongst the best in class a plug and play platform enables the rapid creation of natural full length human Bispecific antibodies that are designed for safe potent immune activation in the tumor microenvironment.
You can see a model of the natural human IGT want molecule with two natural binding sites at the top of the antibody highlighted in blue we.
We make all bi specifics by introducing two new binding sites of the Boston with antibody structure highlighted in green.
These especially closer together and in a more constrained structure appointing ey, what's enabling binding to both targets.
To achieve these your binding sites were not adding additional loops or domains, but rather making direct changes to those amino acids and a highly conservative and effective manner.
We're not disrupting the antibody structure and functions, but rather an elegant way, making a tetravalent that base two binding sites for one target and two for the other revoking novel Biology, We summarize us cross linking clustering and conditionality.
On top of all of this with so few changes to the natural human antibody format manufacturing is a straightforward process, giving us antibody like yields and stability.
All of this is protected by more than 500 patents granted and pending.
Yeah.
This is our most significant is a clinical stage company with data expected from all four programs before you are right.
These are the most important value drivers for that store.
Success in just one of our four programs and of course, we hope and anticipate for success in more than one will be transformative for patients the company our shareholders.
The field of immunotherapy.
I'll now talk through our program starting with F. S woman eight.
My first one but I targets, two clinically validated inhibitory checkpoints PDL, one and luxury it's currently being tested in two different patient settings checkpoint inhibitor naive patients in non small cell lung cancer and diffuse large b cell lymphoma.
Didn't head and neck cancer patients with PD, one and acquired resistance.
Well this head and neck cancer patient group, which commence additional patient enrollment in Europe to account for a cure available biopsies than initially planned and in anticipation of the expansion of the proof of concept trial.
Off the wall and Ukraine continues our thoughts are with all of those affected including the medical and patient community that.
As we said in our last earnings call. The checkpoint inhibitor naive non small cell component of V. F. S woman I trials was affected by the conflict, but I'm pleased to say that.
It's your problem, we mentioned at the time is now being implemented.
We remain confident about the prospects for F. S. Walmart H and I look forward to updating you on preliminary data from the head and neck study in the coming few months.
My first 222 continues to promise best in class data and we're encouraged by how well it continues to progress in the clinic. The first two to two is designed to target a wide range of patients, including those with PDL one high on PD L. One low expressing tumors it benefits from all of the unique aspects of <unk>.
Our platform technology.
The program has the potential to be truly transformational for those patients who are not getting the full benefit of first generation immuno oncology therapies, it's worth highlighting that in preclinical studies, we observed 100% survival in tumor clearance with F. S. Two to two and that's without having to combine with PD one inhibitors.
As we've previously described F. S 222 is designed for avidity and such balances the affinity profile against both the co stimulatory C. D 137 on the inhibitory PD L. One targets.
This leads to dose dependent PD L. One driven C. D 137 T cell redirection of activation.
We look forward to sharing the data from part a of the phase one trial, including safety and any early signs of efficacy in the coming few months.
First in class S. S. One 'twenty with its triple immune activation aims to improve checkpoint inhibitor all chemotherapy treatment outcomes for patients.
The tumor agnostic of builds on the potential of current standards of care F. S 120, co stimulator Ox 40 and C. Do you want 372 key targets found on the surface of T cells.
Start of a combination trial of S. S. One 'twenty with MX pepper lithium up is on track and we look forward to updating you on progress later this year.
And finally, SB 11, 285 on next generation intravenously administered novel Sting agonist.
Dose escalation is still ongoing successfully in phase one clinical trial, we look forward to sharing more clinical data with you later this year.
Furthermore, we were pleased to read independent commentary from Dr. Michael card from the MD Anderson Cancer Center in Houston, who pointed out that SB 11, two a five may have the best therapeutic window amongst systemic sting agonist currently under clinical evaluation.
Under the terms of the contingent value rights agreement for SB 11 to eight five we continue to explore partnering options for the program as a further source of non diluted funding for the company.
We're also pleased with the high level of interest in next generation stinks therapies at the recent ACR.
Discovery work also continues in a lot of course, and we will share news on this later in the.
We continue to benefit from ongoing and growing partnership income it's.
It's clear the partnerships will continue to be part of our company's future building on those we have today and bringing non dilutive capital and further patient benefit from our extensive antibody discovery technology.
Here's a summary of the milestones we anticipate over the next two years from our programs.
You can see we're entering a data rich period, which we believe will generate multiple value driving catalysts.
Our confidence in our portfolio grows day by day and on this basis, we look forward to sharing clinical data from all four programs in the coming months.
Same time, we'll share with investors our plans to deliver on our future ambitions.
It's been a pleasure to share this corporate update with you and we will continue our outreach to the investment community providing insights into how we both cloud to help more patients with cancer live longer better lives and unlock long term shareholder value.
And with that I'll hand over to our CFO Dolly to give you an update on our financials Dolly.
Thanks, Kelly and good morning, everyone. As you just heard its been a busy first quarter of 2022 for the company as we continue to build on the momentum we carried through from last year.
We're excited to be making great progress in all four clinical programs and just as a reminder success in any one of these four programs would be absolutely transformative for the financial performance of the company and for our shareholders.
I'll now go through the financial results for the first quarter ending March 31st 2022.
Demonstrate strong financial performance as we execute against our strategy will be happy to take questions at the end.
Cash and cash equivalents as of March 31, 'twenty Q4, $68 $8 million as compared to $78 5 million at December 31, 2021, it's part of our partnering strategy Mark P. G. A a also took their fourth licensing option during this first quarter.
We expect our cash and cash equivalents will be sufficient to fund our projected operating plan, including multiple clinical milestones across all four programs through the first quarter of 2023.
Revenue for the first quarter of 2022 was $2 6 million as compared with $2 9 million for the same period in the prior year in both periods Mark exercised their option to acquire IP rights to their third and fourth molecules under our license and collaboration agreement.
Total R&D expenses were $8 million for the three months ended March 31, 22, as compared to $7 1 million for the prior year first quarter. This 900000 dollar increase is primarily due to an increase in clinical CFO call of $1 $4 million, resulting from an increased number of patients on trial.
Yeah on our four clinical trials, an increase of $1.2 million of R&D staff related call primarily to support clinical operations.
It increased the point $4 million of other costs, all of which are offset by decreases in manufacturing cost a point 4 million due to the timing of batch manufacturing activities and $1 $7 million increase in the U K research and development tax credit, which is recorded as a reduction of R&D costs.
The total R&D expenses include <unk> 5 million in point 4 million of noncash stock based compensation expense for both the first quarter of 2022 and 2021 respectively.
Total G&A expenses were $5 7 million for the three months ended March 31, 2022, as compared to $6 4 million for the prior year first quarter.
At this point $7 million decrease is primarily due to a decrease in stock compensation expense a point 8 million a decrease in legal and professional costs of <unk> 4 million, which is due to cost incurred in the prior year quarter for work related to the share exchange agreement with spring Bank Pharmaceuticals.
Decreased costs were offset by increases a point $4 million in facilities in I T related expenses and other general cost a point 1 million.
Total G&A expense also includes 1 million and 1.8 million of non cash stock based compensation expense for Q1, 'twenty, two and 2021 respectively.
Net loss for the first quarter of 2022 was $12 1 million or 57 cents per basic and diluted share compared with a net loss of $9 7 million or $1.07 per basic and diluted share for the first quarter of 2021.
In closing the first quarter of 'twenty, two has brought growing momentum and increased confidence in our portfolio, we're well positioned to deliver on our strategy in the coming months and we're very excited by the important data readouts across all four of our programs expected later this year.
With bi specifics coming of age it's a very important time for SaaS. We can you continue to pioneer bi specifics to help more people with cancer live longer and better lives.
With that operator, we'll open the call for questions now thank you.
At this time, we'll be conducting a question and answer session. If he would like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue.
You May press star two if he would like to remove your question from the queue for participants using speaker equipment. It may be necessary to pick up your handset before pressing the starkey.
One moment, please while we poll for questions.
Our first question is from Dana agrees Bosch.
Phebe Securities. Please proceed with your question.
Yeah. One process question in one science question for me.
Uh huh.
The process side an S. One.
<unk>, specifically you are guiding to preliminary data from phase two where it is in the mid year, but also guiding to medical conferences and I Wonder if you could give us any more details on what potential medical conferences.
It would be submitting to them now about how many Ah patients. We can expect and then on the science side in your recent ACR poster.
Perhaps the most intriguing thing was.
The difference and the lag three Cleveland just dynamics.
For T cells in the tumor versus the blood and I Wonder if you could describe that and what you think is mechanistically are driving the difference in those two compartment.
Hi, good morning Dana.
Thanks for both those question so just to pick off the process one first.
As a company in common with many all preferences.
Typically to go to shareholder sorry, too technical.
Technical or medical conferences in order to present, a new data are clearly that's only if.
The timing of those conferences at work with the timing of the delivery of the data for F. S. 118 were working towards the reporting of the proof of concept study as you buy shares and in head and neck.
We'll make a judgment over the coming few weeks as to where that.
Data will be presented so either at a conference or we'll use a a company.
<unk> press release.
Conference call associated with that and where we're not far away from breaking my judgment right now we've guided in the past that we're.
We're looking for a minimum of 10 evaluable patients. So that's patients who have the right co expression of luxury and PD L. One with the head and neck are acquired resistance profile and again, we'll be working to ensure we hope at least that number available to present.
And then for the second question, which relates to the E.
I E C O M P.
Paper the difference between.
Log expression on the tills buses in the blood.
We're actually in the process of drafting a paper around this I'm going to be reasonably cagey on the mechanism, but I guess I think as you would understand with the cross linking and clustering in particular in the cell to cell environment, you'd expect to see in the tumor a dramatic regulate.
And I think as far as I can go right now in the blood is to say that there is a possibility of compensating mechanisms with respect to our luxury expression. So that's one of the reasons we were potentially seeing.
Some some differences there, but we're as I say, we're working on that manuscript.
But you know I guess fundamentally the key thing we're seeing the drop in luxury.
Entails in patients.
Great. Thank you bye now.
Baxter.
Our next question comes from Matt Phipps with William Blair. Please proceed with your question.
Good morning, everyone. This is Rob on your answer.
I just wanted to return to the comments on this 118 trial as well.
The addition of more trial sites in anticipation of its function, but it seems like a positive set.
Can you just remind us have you specifically disclose the boss rigs funding that study and how are you kind of accounting for the fact that you haven't been able to get biopsy samples.
From all of those patients when you're thinking about the bar that did I catch it right that those patients without biopsies are not going to be considered among the 10 Evaluable patients. She described and then secondly, just a kind of a broader question clearly the FDA is he's kind of focusing on the earlier stage clinical development.
Amortization with project Optimists, So the FDA hosted a two day panel on the subject of dose optimization last week.
Which you know some immunotherapies, we're kind of used as examples.
There's optimization could've been battery in early stage development. So just kind of how youre thinking about that in the whole context of your your own pipeline in terms of how to best satisfy.
SBA sufficient dose optimization has been carried out in these kind of phase one studies across the pipeline. Thanks.
Great. Thanks, so much Robert Thanks for the question good morning.
So with respect to our biopsies at what we've been doing is collecting biopsies and then we have prospectively defined a a retrospective analysis of the PD L. One like three positivity in the in the biopsies and we're looking at.
And robust as it was to see.
How did the patients do who have thought appropriate.
Biomarker profile with the head and neck cancer, we haven't stated.
Stated as you rightly say is what the ball for a successor is however, what we have been doing over the past quarter is adding more patients through our sites in and Europe to this to this and of course the other F. S 118 trials that are ongoing.
And so.
I guess, what we're going to ensure that we have the right level of value ability and and I think it's it's right to be prepared for a success and hence why we're prepping for the second part of.
The study at the same time, so with respect to the project Optimus really I think this is a measure of ensuring the hover kind of lowest effective dose.
For F S woman H, we're pretty comfortable given some.
Some of this is about to be published in a full manuscript we're pretty comfortable that we've now got <unk> got what would be defined as a as a inappropriate selected dose obviously still to be discussed with with the F. D. A I am for the other programs. It also brings so if do you.
Our ways of thinking about the program F. S 32, and F. S 120 <unk>.
Cause we've got drugs that are really well tolerated.
And you know we can continue to escalate the dose.
What you'll see from US is that we've explored.
More than one dose level for each of those programs as we've gone through the early stages of development really with a with a mind to being able to ultimately discussed with the F. D. A to kind of enter phase one or all pre phase two meeting as to whether they want us to carry one or maybe two doses forward and were.
Building a biological on patient rationale.
Around each of those concentrations, it's more pertinent for the for the F. S. Two to two and F. S. One 'twenty than full one one where we're pretty comfortable we've got a package of data that gives us confidence in the dose level. We're at.
Great. Thanks very much.
Thanks, Rob.
Yeah.
Our next question comes from RK Techies thing with Oppenheimer. Please proceed with your question.
Oh, great. Thank you Elliot Darlene and team.
I guess you know when you were at the end of your rope you just tighten on hold on somebody once said in this environment, but really looking forward to these readouts you just a quick question.
On on on head and neck with <unk>.
The Bristol combo has been approved for awhile.
Now or at least few months, but of course in melanoma.
Any insights that you have gotten more so.
From that I know, it's a different tumor as to what gives you a line of sight into F. S 118, the head and neck readout and then what exactly are you looking for or what.
The parameters of what Youre looking for in order to move the project forward and then I've just got a quick follow up.
Yeah, sure, So hey, Hi, Josh Good morning, and we're lucky in the sense that we have full ropes to hang onto them and so so that's great. However, just let's go to that the BMS data. So you know where we are interested as you know from previous conversations in the lag three expression in my response to.
Rob's question about biopsies, you follow that through and that's true.
Not just in the head and neck setting, but also in the two checkpoint naive settings of non small cell lung cancer and diffuse large b cell lymphoma, and that's that's really the central threat, that's run through them. The the work and clinical hypotheses you've put together.
What we draw interestingly, you've got silicon back to the fundamental mechanism of a PD one PD L. One axis, unlike three axis and and what we've demonstrated previously and that's actually being shown by others is if you suppress the.
The PD, one PD L. One axis and the luxury axis with a combination what you. It effective is is cause an upregulation of the expression of both of those receptors and so in effect, even if a patient going into a combination study is.
Initial in inverted commas low express sort of like three during the course of their treatment, even though they'll be getting under control because they go on targets a place that the baseline level of luxury will grow and so you know for us understanding that mechanism and understanding. The fact that we are because of cross docking and classroom cleaning if the law.
<unk>, three and don't see that Upregulation in the tumor.
Micro environment through the tills I'm really gives us.
A point of difference, but also the confidence that like three expression.
Expression on <unk> and then the inhibition of its function in all case through cleavage at become central to that kind of working hypothesis. So that's that's where we are with with luxury and we haven't disclosed on the second question Oh HUD rate is clearly.
This is a patient group, who have a few other options having been through checkpoints, there often third or sometimes fourth line of treatment when they come when they're on our trials and.
There's a relatively low ball, but of course, we want to get much higher the knots am ourselves in order to give us confidence to go forwards one confidence go further forward in this proof of concept study in head and neck, but also planning for.
It kind of basket trial in which we would look at other acquired resistant patients settings of course, Unfortunately head and neck is not the only cancer in which patients who've been treated with PD, one and have a response to them become refractory and we're interested around that luxury hypothesis, but interested in those patient groups as well. So that's where we go next.
<unk>.
You said you had a follow up potash yes.
I noted that that's great. Thank you so much for a detailed answer.
And just a question of Darlene, which is that.
You know again kudos for managing your P&L really well.
These these kind of small, but stepwise increases as your clinical activity increases but joey.
Assuming you have one two or three of these kind of top line readouts important to the company that pretty material readout in the next 612 months how to think about your kind of your your R&D.
Burn rate.
Basically over the next year or two years. Thank you.
Yes, hi, guys.
Well as we said we do expect that we have enough cash to get us well through the first quarter of next year and moving forward with all these programs in all of these readouts now obviously as we take more patients on trial costs will increase over time, so you're sort of seeing them kind of level.
Ending now with a little bit of build over the remainder of the year and into next year. So its a well built some while I expect G&A will sort of stay flat to potentially even come down just a tad.
But again, it's it's really kind of start driven by patients on trial.
Great.
Do you give any update as to your partner revenue I mean, how does that affect.
Your burn you're.
Your revenue run rate through the first quarter of next year.
Yeah. So we have not given guidance on that unless and until it happens, but we do have visibility into some of that and that is acted into our cash flow projections are you can you know there are certain milestones that we that are shorter term and others that are longer term and as they become more.
Closer to solidified we definitely run that through our cash projections, but we have not disclosed that and we've not disclosed what those milestones are based on confidentiality with our partners.
I can say to that one of the unique features in the UK is that they actually had these R&D research and development tax refund not guess credits, but their refunds.
So we're in the process of doing.
I'm doing the calculations and submitting those now but that you know that can be in the millions of dollars and that's.
Our destiny, if you will.
At the time being so that's a nice thing it's not just the tax credit it's actually a tax refund. So we've got that built into the model as well.
Great. Thank you Charlie and thanks Ali Thanks to the team.
Thank you.
Yeah.
Our next question comes from Patrick <unk>.
With H C. Wainwright. Please proceed with your question.
Hi, Good morning team. This is Jason on for Patrick and My first question is just around the SB 11285, and Ah. We were just wondering in terms of kind of benchmarking the potentials of SB one to a five and should we be looking at more of like Merck or GSK is and will it be a potential <unk>.
Passport and I've a follow up question after that.
Great morning, Jason Thanks, very much for your question so.
So you know we sit squarely in the kind of second generation of staying so we can be given intravenously.
Intravenously, and we gave an update at the end of last year that you're a few months ago, saying that you know to date, the as sending a the accelerated the exciting part of the dose.
<unk> had been going well and was safe well tolerated some early signs of staying.
Thank you.
We've tended to benchmark ourselves against other second generation. So we you have the two U you selected we were kind of more point towards the GSK a molecule and suddenly you know we're looking forward to seeing any data from.
That organization is it as it moves one of the challenges if first generation of course was a kind of step wise.
Function in and biological response to Sting agonism, and it was a kind of all or nothing.
We're really interested to see Prof currents are work I'm out of MD Anderson who's been doing analysis of.
The current clinical stage assets as things that are in the clinic and and he had some positive things to say about about epileptoid five with respect to its kind of gradual uptake uptick.
I'll kick my apology uptick in asking agonism. So we're we're excited about what's going on in the clinic, We'll we'll certainly report more in the later part of the show from that study in as a monotherapy and in combination with a taste of this amount.
Okay. Yeah, that's really helpful to know and it just kind of building off the last point. They just said in terms of data being released later this year can you remind us is this for the part a part b or and just again just to kind of clarify, which what is the part a and part b of the phase one study.
Of SB 11, 285, Jason just to be clear, yes, yes, sorry, I feel about it yeah. Yeah. So we it's in two parts of it as a company sorry part a is just a simple mono therapy, a sending dose standard three plus three and pop is in combination with the with a flat dose of occasionalism up thoughts down the dose.
That tells you there's some up and you know I would anticipate will be.
Tens of patients maybe 30 to 40 patients worth of data, we'll be reporting towards the end of this year. So we're we're excited about what we're seeing and I'm looking forward to more data.
Alright, great. Thank you so much.
Great. Thank Jesse I appreciate your call.
Our next question comes from Jimmy <unk> with Ladenburg. Please proceed with your question.
Good morning team. Thanks for taking my question my.
My first question is on the.
118 program, just a follow up on the ACR presentation, knowing the tumor infiltrating lymphocyte aspect do you think you in the mandate do you expect patients with higher kill expression to respond then are we expecting any maybe clinical data on that site.
So hey morning, who nice to speak just just repeat you just broke up slightly in the.
So for the full the til lag three expression.
Just my question that please yeah sure yeah.
No no no they are giving them the knowledge on the pill I'd be expecting to see perhaps better response rate to patients who have hired question and do you plan to show more data on that but I did implementation on the clinical sites.
Yeah sure. So I mean, it just really comes back to a fundamental hypothesis that your luxury I'd PDL one expression in the post checkpoint setting and indeed in the checkpoint naive setting is is really really important and I think you know the.
Our if you look at the phase one data than what we saw was a correlation between them.
Spansion of til activity post treatment with disease control and indeed, you warm unconfirmed a one call phone PR them.
With up with high expression of luxury odd PD L. One and Ah we.
Expect to see that are in our in the phase II proof of concept.
It's a it's a great question to try and get me to kind of spill the beans before the before we announced the data, but we're excited to look at the correlation between luxury expression and.
Clinical benefit in the head and neck proof of concept study.
Yeah.
Thanks, Elliot I have one more question on the foregone Bebe side, you'll have to ask that targeting Paragon BB is that a particular one you are more excited about and you think that you will see Africa preliminary efficacy data on the 222 program I'm curious to hear you.
If there are any other programs in the near term that's.
Perhaps in Mr. Ken place more confidence more one for one lung be yeah, that's where I get maybe doing ethical or any other presentation. She would like to get more information on that type of level.
Well, so so it's where I'm often asked by investors in particular kind of which is my favorite child I always argue that they're they're all lovely, but all different I think for the twofold won't be be molecules F. S to situate F. S. One 'twenty you know they fall into that lovely a different category.
It is true that that first two to two and we'll be reporting our preliminary data.
In the coming few months and we're very excited about what we're seeing with that we've we've been particularly impressed by how the preclinical data translate it into the clinic and I would say for that molecule in particular, we've got some reasonable.
Benchmark from which we'll need to differentiate given some of the competitors who are also developing PD L. One full won't be base you know in the non clinical setting we saw a complete disease control without the need for a combination with a PD one and you know where we're happy to see that a bit.
Getting to translate into the clinic. In addition to that of course, we're going after both high and low PD lone expressing tumors and non clinically we observed no sign of the so-called bell shaped or hook effect that is being presence with some of the competitors. So we know the kind of pillars of differentiation that we're aiming for.
And we're excited to to bring a F. S 62 data forward in the coming few months you may from all of that conclude that that is my favorite child, but but it's it is lovely but different from F. S. One 'twenty and also you know FX one twenty's a first in class dual agonist. Its a really potent molecule, we're very excited to become.
Binding it with pepper leasing them up from Buck.
We'll talk about what.
What we're doing beyond that towards the end of this year, but this is a this is a molecule that is kind of tumor type agnostic and and the way in which it can be used as in this combination. So Penn Bros. Approved in about 17 indications if article of late and so of course, we can go into any of those settings and some of them.
Clinical data with the three different types of chemo showed so some real important synergies. So so I would say in a different sort of way a 120 <unk> is a really important and an exciting molecule for us as well.
And then 62.
Yeah.
Thank you very much for the detailed answer.
No problem at all nice to speak with you all.
As a reminder, if you would like to ask a question. Please press star one on your telephone keypad.
Our next question comes from Yale Jen with Laidlaw <unk> co. Please proceed with your question.
Good good.
Tony and thanks for taking the questions. The first question I have is about two to two <unk>.
My understanding is that that you might have key data reporting in other words Oh another one after your.
Initial one in this year is that correct or.
So that will be my first one.
Yeah. So so two Q2 is going very well and what we've done is managed to bring some of the date.
We were planning to update a much later this year sooner. So we'll do that in the coming few months.
And and we'll then have a look and see what else about just beyond that so so the more data in this first report that than we'd anticipated and clearly we continue to.
Explore the full spectrum of activity for F. S. Two to two and that both and those are PD L. One low and PD L. One a high settings. We also have which we haven't disclosed yet but were also particularly interested in seeing some intriguing data in the colon.
From another biomarker that we've been using in combination with <unk>.
Without PDL, one expression level as well and then all of a sudden it would be talking more about that are in the months to come.
So should I interpret that as that you will have the first day that report with a much more enriched the data and possible. He has a second one or otherwise there will be maybe pushed our second data read out into next year.
Yes, so I, what I would say, yes, I think the the interpret your interpretation of a much enriched updates in the coming few months is a good way of interpreting that will guide our once we're through that as to when the next set of data will be coming.
Okay, and maybe a quick follow up.
So about 118 that Ah I know, Pete and non small cell lung and D. L. P. C L.
Enrollment has some issues there in terms of the Ukrainian situation, what kind of remedial work currently.
To resolve this issue.
Yeah, I I like yeah.
You know I'll repeat what I said.
What we're doing is trivial compared to the suffering of the people of Ukraine, but we also need to keep all programs are moving forward to benefit.
Patients that we can and so what we've done and we did it.
Pretty much immediately is is added additional sites for the countries. We were already open in and then quickly looked for feasibility in new countries, So and and that was part of our contingency planning around this.
The war in Ukraine.
And as I reported a little while ago, we are.
I'm now pleased to say that those contingencies are coming into place I think that the reality is that.
For date or I put the diffuse large b cell lymphoma should still be first quarter of next year. So so that should be fully on track and we think.
Current estimates suggest we may lose about a quarter.
The head and neck and.
Non small cell sorry, non small cell lung cancer study my apologies.
And that will be then to the second quarter of next year, though we will do everything we can to pull that forward of course.
Okay, great. Thanks, a lot and congrats on all the progress and I look forward to it seemed it does read out.
Yeah, great. Thanks, very much I appreciate the question nice to speak with you.
Our next question comes from Justin Walsh with B Riley Securities. Please proceed with your question.
Hi, Thanks for taking the questions.
And I know that you can't provide specific details that havent been announced but I was wondering if you can maybe provide some color on what Merck K G. A has found so consistently attractive about the App started development platform.
Yeah. So.
That's a great question morning, Justice. So look I think one of the things that big pharma in particular are interested in is thinking about you know how to get a molecule to market and and if you look at our Bispecific platform. It's a thing we kind of mentioned in passing often but it actually is really important is that.
We can make these drugs in a really simple way you take the standard cell line put the sequence in them and you know nine months later do you view good to go with high yields good stability low aggregation, just like making you know monocular and those in the kind of 19 nineties, so and so I think that becomes really compelling so.
So in the background the big check box with Big Pharma is and Big biotech is we've got something that's easy to manufacture as a as a platform.
The the second then of course this is a the.
The hunting down without biology that we're looking for in bi specifics you know I saw you mentioned in the in the earnings call about 20% of all clinical activities now heading into is it by specifics it which is which is terrific and in all the bi specifics. Obviously, we believe ours is you know one of the best if not the.
Best format, because we get with the simple changes, we get the tetravalent see and the potency associated with that I'm. Just novel Biology, you know some of which we've reported already for F. S. One eight which is the cleavage of luxury from the surface of pills.
There's much more of that follow from from it on the other programs and I think you know combining manufacture ability simplicity with that.
<unk> unique combination of cross linking clustering and the conditional way.
Seems to be the thing that is consistently attracted muck as a partner and we were really excited by the way to see what we used to call F. S. One to two I don't recall what might call. It now but that day to them on that first program published it at city last year.
Great. Thanks.
One more question for me I was wondering if you could provide some color on any feedback from scientists kols and others working in the space on the the ACR presentation for the S. One money differentiated MLA.
Yeah. So I think you know this is a growing there's a growing body of evidence to to tie them the kind of like III shedding hypothesis today.
Together. So so one is there is a there was a correlation between a lack of effect with a checkpoint inhibitor.
Expression of.
Adam This is the cleavage mechanism for likes ratio at the surface and it's also clear that the.
Like the expression of lag three is a pool prognostic factor from full I'll come to the checkpoint inhibitors and of course, one of the things that.
We have been showing in the clinic and elsewhere is this cleavage mechanism and sudden suddenly people liked Audi of acknowledge who are leaders in the field I'm very excited about this as a mechanism compared to others, where as I said in the very fast response, I think to Dana.
You know we see this a change in in Upregulation of lag three or PD L. One if you're using just mono therapies in combination and indeed interestingly and this was published in a a a C. All paper is that you still see some upregulation if you use a PD L. Sorry.
PD, one and lag three odd difference being PD L. One on luxury giving that cross link and clustering and not shedding. So so you get this kind of hierarchy of expression of luxury which is a you know a really important player in exhaustion pathways and I think that so so.
Landing on my hypothesis is really where a S H b.
Excited.
As well as obviously you.
Talking about specific diseases, where we believe we can bring benefit.
Great. Thanks for taking the question.
Anxious I appreciate it nice to talk to you.
Ladies and gentlemen, we have reached the end of the question and answer session and I would now like to turn the call back over to Elliott Foster for closing remarks.
Great well, thanks, everyone for the questions and appreciate you joining this morning and in the thoughtfulness that goes into that our question and answer session. Clearly 'twenty 'twenty. Two is an important year for us at a store and probably our most significant one is a clinical stage company given the <unk>.
They're coming from all four of our programs.
We believe our success in any one of these has real potential to deliver significant value to shareholders and of course transformed the lives of patients with cancer.
Our partnership strategy also brings new opportunities to patients as well as delivering about important non dilutive cash.
That really has a lot to look forward to back to Paul backed up by the emerging data and I'd like to thank the ethanol team our partners and shareholders for your ongoing support I'd also like to thank the patients participating in our trials and our expert clinical investigators and with that thank you and goodbye.
Yeah.
This concludes today's conference you may disconnect your lines at this time. Thank you for your participation.
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