Q1 2021 F-Star Therapeutics Inc Earnings Call
Ladies and gentlemen, your conference will begin momentarily once again, thank you for your patience and please stand by.
[music].
Good morning, ladies and gentlemen, thank you for standing by welcome to the five Star Therapeutics, Inc. First quarter 2021 earnings call and corporate update at this time all participants are in a listen only mode. Later, we will conduct a question and answer session and instructions will follow at that time as a reminder, this conference will be recorded.
And and available for replay.
I would now like to introduce to you Lindsay forget V. P of Investor Relations for fight for F Star. Please.
Please go ahead.
Good morning, everyone. Thank you for joining us with me today, and Elliott Force, our CEO and Darlene Deptula Hicks our CFO.
We announced financial results pre market today for the quarter ending March 31st 2020.
You can access the press release on the Investor Relations page of our website at <unk> Dot com.
Before we get started I'd like to quickly run through the forward looking statement.
Please note that as part of our discussion today management will be making forward looking statements.
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 constitute 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.
It include risks and uncertainties detailed in <unk> filings with the SEC.
The company undertakes no obligation to update any forward looking statements.
Order to reflect events or circumstances that may arise after the date.
With that let me hand, the call over to Elliot.
Thanks, Lindsey welcome everyone to our first quarter 2021 earnings call. It's a pleasure to provide an update on our achievements during what's been a very busy few months.
So continuing momentum from last year, we susceptible successfully raised $65 million in an underwritten public offering.
This includes a group of top tier investors and means that the company is very well capitalized with a runway into the second half of 'twenty two 'twenty three.
The strength and find out true position ensures delivery of the future milestones you've laid out previously and which I'll detail again here in a moment.
On the clinical side, we've seen a surge of excitement around F. S woman. Nate This is driven by our internal data and external validation of luxury in a pivotal clinical trial and all of your luxury is rightfully, earning its reputation as the Mexican Africans checkpoint inhibitor pathway in immuno oncology.
Protecting our assets and unique platform continues to be a priority and we further expanded our comprehensive patent portfolio during the period.
We're increasingly confident that the first two to two <unk>.
Potential best in class C. D 137, PD L. One by specific.
We outlined that differentiate way that we make these tetravalent bi specifics with the publication of additional data at ACR.
In relation to Austin agonist, SB 11, 285, we highlighted an exciting finding relating to the synergy between radiation on the Sting pathway and an article in nature.
Yeah.
Our partnerships continue to develop positively mark K G. A a exercise the third of four options and our ongoing collaboration.
Following positive preliminary phase one two data Denali therapeutics have been granted fast track designation by the FDA for D. N. L 310 derive from F car X stores F Cop technology.
This is hugely encouraging not least for patients with Hunter syndrome.
And of course, we've continued to progress and exciting portfolio of four clinical stage assets.
Moving to slide five.
Let me remind you of the <unk> platform technology with the only company developing tetravalent bispecific antibodies with a two plus two binding functionality and the ability to simultaneously cross-link immune cells to tumors cluster immune receptors unconditionally activates the immune sign ups on you went both talk.
With Cerner engaged.
As you can see we adopt the natural binding sites of the antibody in blue.
<unk> two <unk> binding sites in dark green with only a small number of changes.
This is a unique way to make bispecific antibodies.
The only company that can do this.
And it's based on protected by our extensive IP portfolio.
Finally, the natural IGD, one antibody format makes up by specifics easy to manufacture with monoclonal like production levels, good stability and low levels of antidrug antibodies in the clinic.
Desktop platform continues to deliver with the expert guidance of our Chief Scientific Officer, Neil Bruce.
And we will have more projects to be taken forwards in the future.
Here on slide six I'd like to take the opportunity to remind you of our four clinical stage programs led by our Chief Medical Officer Louie prior to that we believe each has the potential to be transformative for patients. The most advanced severe salt bispecific antibodies as F. S woman eight toxin PDL, one and <unk>.
<unk> III again luxury has recently been validated as a checkpoint target in immuno oncology and our late stage clinical melanoma trial, showing superior efficacy over PD. One monotherapy, we're very encouraged by these recent data.
We believe luxury will become an incredibly important pathway in patients with advanced cancer, and we look forward to seeing additional data supporting that belief.
Our first woman eight is currently in a phase II proof of concept study focused on patients with advanced head and neck cancer, who are positive for PD L. One and luxury and who've become resistant to previous checkpoint therapy.
The next program in our pipeline as F S. Two to two <unk>.
A C D 137 of PD L. One targeting by specific as I mentioned earlier, we're share data on F. S. Two two two's differentiated approach. This year is a C. All those data demonstrated how specifically tuned affinity and avidity of both targets provides conditional binding avoiding what others have seen as a hook effect we built.
Leif F S. Tucci, two can become best in class Medicine.
The third clinical stage program from a.
Platform is F. S 120, the C D 137, and ox 40 targeting by specific this first in class program causes a coordinated activation of the immune system in the tumor, which we term triple immune activation.
Uniquely it brings together the combined properties of conditional pharmacology with cross linking of clustering of day.
Military talk parts of Ox 40, and C D 137.
The phase one clinical trial for <unk> hundred 20 started in late 2020 on the study is progressing.
With share initial data later this year.
We also have plans to begin a combination study with F. S 120 under an approved PD one inhibitor.
And finally <unk> fourth clinical asset is SB 11, 285 per second generation Sting agonist he.
It could be delivered via an intravenous infusion with the potential for syndicate significant improvements over first generation Sting programs.
We plan to share data on SB 11, two a five later this year.
Before we leave slide six I want to mention really positive ongoing collaborations we hope at Denali Therapeutics and Mark a G. A a.
Denali continues to develop its blood brain barrier transport vehicles in the neuroscience space and as mentioned by K G. A a darmstadt, Germany recently exercised their third or four options and our long standing and valued partnership.
Turning to slide seven.
You can see the multiple value inflection points in clinical data Readouts, we're anticipating in the near term.
As I mentioned over the course of this year, we'll share data on SB 11, 285, and F. S 120, as well as day to from the ongoing phase one study with <unk> two to two <unk>.
We also anticipate sharing data on the F. S. Walmart eight proof of concept trial around this time next year.
And of course, we'll be attending and presenting data at upcoming medical and scientific conferences, where we will share our progress.
So looking ahead to the next quarter and beyond the company's financial outlook is strong and we're incredibly pleased by the success of our first follow on financing. This will power the delivery of our milestones over the next two years.
I'm grateful for the support of our new and existing investors who are on are all with us on this journey to create a paradigm shift for patients with cancer.
I'd also like to thank the team at F Star, who continue to deliver day by day to develop life changing medicines and create value for shareholders.
Now I'll hand over to Darlene to give you an update on our financials Darling.
Great. Thank you Elliot and good morning, everyone. As Elliott has highlighted it's been a very busy quarter. We're extremely pleased with our recent equity financing and the top tiers and best top tier investors, who have joined us.
I'll now go through the financial results for the first quarter ended March 31, 2021, which we believe provides a solid platform for the company strategy that Elliot has just outlined we will be happy to take questions at the end.
<unk> has four programs in the clinic now and continues to work with our two long term collaboration partners are revenue consists of collaboration revenue from Merck K G. A a and our license and collaboration agreement with Denali Therapeutics.
Revenue typically includes amounts that related to upfront payments milestone payments option exercise payments indoor amounts due to us for research and development services.
Revenue for the first quarter ended March 31, 2021 was $3 million as compared to $1 4 million in the prior year first quarter for a quarter over quarter comparative increase of approximately 1.6 million. This quarter increase this quarterly increase in revenue was due primarily to the exercising of.
The third option in our collaboration agreement with Merck K G. A a as Elliot mentioned offset by lower research and development services revenue.
Total research and development expenses were $7 3 million for the first quarter of 2021 compared to $3 4 million for the prior year first quarter. This $3 9 million dollar increase in R&D expenses is primarily due to increased manufacturing costs and clinical trial costs with Q1, 'twenty one being the first full quarter with.
Four programs in the clinic.
Q1, 2021 R&D expense also included <unk> 4 million in noncash stock based compensation expense.
Total G&A expenses were $6 4 million for the quarter ended March 31, 2021, compared to $3 2 million for the comparable first quarter of 'twenty 'twenty.
This 3.2 million dollar increase in G&A expense was primarily due to increased stock based compensation expense per.
Festival season insurance costs associated with being a public company now and rent expense associated with building leases assumed in the share exchange agreement with spring Bank last November.
Q1, 2021 G&A expenses also included 1.8 million in noncash stock based compensation expense.
Net loss for the first quarter 2021 was $9 9 million or $1.08 per basic and diluted share compared to a net loss of $7 2 million or $3.92 per basic and diluted share for the first quarter as 2020.
Now turning to the balance sheet cash and cash equivalents totaled $3 7 million for the quarter ending March 31, 2021 compared to $18 5 million at December 31, 2020.
The $14 8 million decrease in cash was primarily driven by the company's operational needs during the quarter, but also included some spring bank related items during the quarter. We paid 776000 of severance to former spring Bank employees. This severance will continue through November of this year.
The quarter. We also settled the spring bank vendor related dispute totaling approximately $300000. Both of these items were included in the net cash adjustment at the transaction close of the merger last November.
Also with two new programs entering the clinic in Q4, 'twenty 'twenty, we had approximately $5.8 million of disbursements in Q1 for clinical CRM, Pos manufacturing setup costs raw materials and batch fees.
We are very pleased to report that we strengthened our balance sheet considerably and early Q2. This year to the successful closing of our 65 million public offering of common stock in may and the use of our at the market or ATM equity offering program in April netting a combined 70.3 million after fees and expenses.
During this time, we also entered into a 10 million dollar debt facility with Horizon Technology Finance Corp, and have drawn down $5 million on that facility we.
We believe that our current cash and equivalents will be sufficient to fund our projected operating plans as Elliot discussed well into the second half of 2023.
I continue to be encouraged by the positive sentiment we have from our analysts with five analysts now covering us and the investor community interest in our programs and platforms.
At Forum, we look forward to continuing conversations that investor in healthcare conferences. This year and hopefully some of these meetings will be in person.
So in summary, our strength in financial position ensures the cash runway for delivery of our future milestones, we have a new an additional group of top tier investors, joining our mission to deliver for patients with cancer.
I look forward to sharing with this sharing information with you over the course of 2021 and going forward.
With that thank you and operator, we can open the call up for questions.
Thank you if you have a question at this time. Please press Star then one on you touched on telephone. If your question has been answered or you wish to remove yourself from the queue. Please press the pound key to prevent any background noise. We ask that you. Please place your line on mute. Once your question has been stated.
Our first question comes from the line of hard cash think with Oppenheimer <unk> Company. Your line is open. Please go ahead.
Yes, Hi, this is Jackie Yan for hotel art, Congrats on securing the recent financing at all the progress and thanks for taking our questions. So first for Oh from the slower eight if you could comment on the timing of that facility analysis, you will too and then four one 2020 two.
If you could give some color I.
I guess, just a route which those levels are you right now.
Our upcoming milestone timings you just provided here in the last generally speaking have you seen any impact from COVID-19 on our progress. Thank you.
Great. Thanks, very much for the questions. So F S. Wal Mart Eighths, we expect.
The timing of the release of those day during the first half of next year. So the first half of 'twenty to 'twenty two.
And we continue to make good progress with with that ongoing Ah trial.
With respect to our two to two <unk>.
And I think you also asked about F. S 120, <unk> both of those trials again are in phase one a sending dose design, they're going very well, but we haven't disclosed the dose levels. At this time include as we update our we will be able to give more details around those programs and then finally in terms of.
Our COVID-19.
There have been some operational impacts of course, we continue to work hard to minimize those in particular, given we have research and clinical operations based out of the U K. The U K as you May know is only just emerging from our five months of Lockdown and we've worked hard to minimize.
Any impact there and those impacts are reflected.
In the timings we've disclosed.
Got it thanks for that and then second question here, maybe discuss which programs across our pipeline.
Believe are along you'll have full force all possible market.
Given you know the online needs of those particular indications.
Yeah, I mean, we're particularly excited about F S. Walmart H and the possibility that saw first proof of concept program with F. S 118 and.
As I mentioned in the call is with patients who have had.
The refractory response to a prior checkpoint inhibitor are these patients typically have nowhere else to turn palliations or a difficult a course of chemotherapy.
Certainly as we expect and as we showed data emerging in the first half of Nextgen, we'd be excited to look for potential fast track options with a with that program and so that's certainly a possible root forwards. In addition to that F. S 222, which we believe has the potential to be.
Our best in class therapy.
Is designed in a highly adaptive way in its first phase one study and clearly as we begin to see signals.
Of biological activity with that program, then we can rapidly accelerates.
Into development.
And in a way in which you.
Could take us on a fast track to the market.
Got it Super helpful. The last question just on your preclinical efforts using surrogate molecule 40 mice.
I mean as far as I've seen it seems like not all antibody is powerful and cash it through a murine surrogate molecule. If you could just talk more on that aspect in Hollywood platform.
Or does differentiate net.
That would be great. Thank you.
Yeah. So I mean, one of the real advantages, we have with a plug and play technology.
It's not nail and his team can both develop.
The human as well as the surrogate molecules that in parallel.
And of course, it's Oh tier few changes are important changes from that natural human ITG one format.
And I think you know.
What you can see maybe even in the F. S. Two to two data that we published at M. A C. O M is the ability to tune for affinity and avidity.
He is also a measure of us being able to translate those are early.
Signals in the non clinical space into clinically effective molecules and it's and it's a measure of the 10 years, we spent developing the platform that we have.
Such utility within it.
Yeah, well, thanks for all the questions and look forward from more optics.
It's pleasure I strength.
Thank you and our next question comes from the line of Matt Phipps with William Blair. Your line is open. Please go ahead.
Good morning, everyone. This is Rob Andrew here on for from at Phipps, Yes.
Yes.
So nice day true the ACR meeting from the S. G tube program I think as you mentioned in the prepared comments one of the interesting pieces was the day to appearing to show assets to do to kind of avoids the hook effects seen a true American antibodies.
In vitro so challenging from a to do a dose response in vivo, but I'm wondering if you've kind of compare.
The mob square and the Hetro diametric AD formats in vivo and kind of how they use my comparison from a T cell.
Activation perspective.
In vivo and then one of the questions we've been getting.
Is around the kind of relative to a finished piece of PDL, one and form BBVA. The day you all.
It is two to two and for the other molecules that are in develop development and how this could muster from both the safety and efficacy perspective, we've seen some of the other programs.
Of similar affinity for both target some of higher affinity for BD Outworn compatible on B B, perhaps you could just kind of run over a little bit more of the design of a skew T. Two brief in terms of the kind of high PD L. One affinity and how the form BBVA binding relies more on EBIT.
Balan affinity and what you think the implications are.
Those design US watch in terms of clinical development and I think that would be helpful.
Great. Thanks, very much Rob so.
Certainly those comparisons are that you've talked about are we haven't yet published on and clearly we have a body of work that's that we'll continue to publish on during the course of this year.
And well, but it's just not the public domain.
So with respect to the affinity verses avidity. So us as you may recall, Rob. This sits at the very heart of our technology. So this plug and play platform enables us to pre tune AD the molecules really seeking a optimized avidity for the cross linking and COO.
Stirring of the target receptors and certainly with respect to our F. S 222 that it very much plays into that so what we have got in terms of the PD L. One component is is probably our.
Best in class, if not similar a binding PD L. One antagonist and that really in the setting of the tumor microenvironment causes a a constant blockade of a pathway but of course in order to avoid that self competition. So the sort of thing, but well might see in the in the in the clinic.
With other molecules.
<unk> modulators, but C. D 1377 binding and in terms of affinity is actually relatively low compared to the PD L. One. However, when you look at avidity. So those protein protein interactions across that immune synapse and it's got very high avidity. So were enabled with enables us to continue that.
Dose response curve continue a permanent blockade of PD L. One and recruit those C. D. One thirty-seven a full one b b containing our immune cells and freight that.
Sign uptick.
Sorry, that's M immune sign ups in order to create or April doses. So in the clinic the benefits of this it means we can go off to patients who for example have low PDL one expression.
And as you know those are patients who.
Don't have a great opportunity from the first generation of checkpoint inhibitors, and we do believe that will distinguish us from some of the other M C.
F S. Two to two like molecules in the clinic.
Great and then if I could just ask.
Just thinking about the midyear updates for asphalt 20, an 11% to eight five programs.
Just just what's the kind of thinking at the moment on that kind of means of disseminating. Those results you know should we expect.
Congress or are you thinking it's going to be more of a kind of feel disclosure or almost upon that.
Yeah.
We of course always would have a preference to go to scientific conferences. However, the timing.
As you know is such that one off needs.
If not months of lead time I'm not so it's it's more than likely that 11 to eight five in F. S 120, <unk> during the course of the summer will be by the way of of press releases, giving updates on the.
Ongoing phase one studies.
Great. Thanks, very much for taking my questions.
Pleasure I speak.
Thank you and our next question comes from the line of Patrick True Chico with H C. Wainwright. Your line is open. Please go ahead.
Hi, Good morning, and good afternoon, just a follow up on the relativity trial that evaluated the anti lag three antibody in melanoma. The trial met its primary endpoint of progression free survival and at the time of the announcement in March follow up for overall survival. The secondary endpoint was ongoing side a few questions here.
First during the prepared remarks. It was noted that additional data on relativity is expected and assuming this update as possible in the near term I'm wondering what PFS or OS do you believe could provide increased confidence in the lag three mechanism and how we should think about the potential read through from a more granular update.
From relativity to the S 118 program with the understanding of differences in mechanism study design et cetera, and then secondly should we anticipate FX 118 have advantages in efficacy or safety and tolerability or all of the above as compared to combining two antibodies as it's being done in the relativity program and then separately can you discuss the advantages.
As of <unk>, one one over the other bi specific approaches and clinical development that are also targeting lag three.
Yeah, Hey, thanks. Thanks for the question. So we we were delighted I think along with the you know the whole sector, and and and obviously Ah patients, who will who will benefit.
From the B M S you high level data.
From the relatively trial.
We look forward to seeing the data emerge from that I know.
Encouraged by the fact that the primary endpoint.
It has been hit obviously, we only have the same amount of information as everyone else from the public domain I think I think the key as I pointed out in my remarks is is that it's it's becoming clear that like three and really is the next checkpoint pathway that will bring benefits to patients we believe.
And this is certainly demonstrated in our ongoing phase II proof of concept study not having a like three.
Expression in the tumor microenvironment is is really important to get that benefit.
And certainly as a consequence, you would expect that.
And that those patients would benefit more greatly and we're looking to see if if the Ah indication of cars are in those data as well.
With respect to you know to antibodies versus a buy specific and clearly F. S 118 as of two plus twos, a tetravalent bispecific against PD L. One and lag three I mean, what we can achieve a mechanistically and we published some of this at city last year is a shedding of like three F.
From those exhausted our immune cells in the tumor microenvironment and that's brought about by the way in which we crossed Lincoln in particular cluster, the luxury and causing an enzymatic driven shedding of luxury in a obviously in activation of those immune cells. We although we don't think that the.
Combinations at wont to do this we don't think the extent to which they'll be able to achieve it is anything like that which we would achieve a with a with all by specific and with a bispecific and as a consequence, it may well be the case that.
You know the depth and durability of the responses with the combination would not be able to match that with with Bispecific mechanism and its why we we obviously faith about bispecific approach.
Yeah.
Got it that's helpful. And then just a follow up on the study published recently at net showed SB. One went to eight five in combination with radiation is more effective than either as monotherapy in a mouse model.
I'm just wondering if you can discuss the conclusions from the piece a bit more.
More detail on what learnings if any from this preclinical work have or it could be applied to the ongoing phase one a one day trial or could be applied in future studies and development program.
Yeah sure. So so clearly the ongoing 11 toy five study is both as a monotherapy and in combination with a total lithium abso roche's PD L. One AR antagonist.
We will of course look at those data as they emerge over over the summer and the rest of this year I think what was really important about the the nature paper was that the 11th 285, a pathway. So the sting pathway and in ton is needs to be present.
<unk> in the tumor and we see a synergy between 11 to eight five and radiation from in fact were enabled Ah they were able to see a changes in a low radiation setting.
And of course it is the case that that may impact on our future development pathways. What we would what we will continue to do is explore the activation of the Sting pathway by 11, three five and see how we can begin in further development plans begin to bring together.
Aviation checkpoint inhibition and who knows what other modalities may may play I think what thought indicates a sitting alongside them.
The the data around staying is is what a potentially important pathway. The sting pathway is in in that in certain tumor types.
And I guess of course, notably we have much greater flexibility because 11, two a five can be given a five.
By the intravenous route rather than intra tumor Lee is as many of the predecessor were limited to.
Right and.
And just one last one on the corporate announcements, including with Merck TJ and Denali I'm. Just wondering if you can remind us if the three targets that Merck as option value.
And if so what are they and separately what if any milestones would be due to that start on naming are advancing those targets and then secondly regarding to knowledge can you give us some background D&O three 310, and how success in that program could provide a read through if any to at starz programs and as well if there are any milestones star for program success.
When do you now three times.
Yeah. So again, we were really excited and always delighted to have mark take one of the options is now the third of full Ms. Darlene mentioned in her reports that does trigger a small milestone payment at beyond that Unfortunately, the economics are not disclosed and we don't.
Disclose at all the the targets are in those programs.
With respect to Denali.
We're again thrilled with the progress.
Of denial, who are who are excellent partners and have been over many years and we're delighted for them and obviously for Hunter syndrome patients who have few other options the.
The read through really is is back to something I mentioned in an earlier question, which is which is the plug and play technology.
Got real flexibility and adaptability of the modified FC region, just a few amino acid changes to give our in our case.
At bi valent binding for immune oncology and obviously the blood brain barrier transport the for Denali. So I think because we've already good read through from the technology.
And of course, Denali progressing a long way into the clinic now gives us confidence about our the in vivo pharmacology and in the target species being man and of course, some of the safety read through as well.
Terrific. Thank you very much.
Thanks, Brent and I spoke to you.
Thank you and our next question comes from the line of Wang Li with Ladenburg. Your line is open. Please go ahead.
Hi, Thanks for taking my question I, just to one O S S.
Wendy.
The upcoming dates for the accelerated docetaxel creation data could you.
Got it any color if possible on how many single patient.
Extra dose cohort you alero.
Our test it day in the trial and for the upcoming data updates what should we expect it to a single patient.
Dose escalation for safety P could have any information about any potential for activity in it.
Color on the upcoming data would be helpful. And then for the 112, a five similarly I'm glad to have become a data up day, we should do we expect efficacy data must.
Must be safety and PK type of data. Thank you very much.
Yeah, Thanks machines and thanks for the question so nice to talk to you again.
Let me take those in reverse order if you don't mind.
Because that's likely the order of appearance of the data. So 11, two a five mm just as a reminder, we have a two part phase one study ongoing as a mono therapy and a combination in the second part with a taste of this mob and we gave an update at Citi last year on the overall dose designed so Sean book through that right now.
With that we're exploring a number of avenues clearly safety PK and we're also looking to see if there are any biological signals in the dataset and also to indicate to the market at what it is that we anticipate doing next with 11 285, and Ah and we'll report those.
State route over the coming couple of months or so full M. F S at 120, which which will come we.
We will pace will stagger them, where we're not at this time, giving any updates on them on the details of that from a dose level and so on but I can certainly tell you that we're interested in in a couple of things, obviously safety and PK and Tolerability of this really potent dual <unk> agonist and.
And obviously from a biological perspective, and as you know this is a.
A slightly different approach with a phase one study then than we all typically do when we've done for years and years in oncology and that we're not just looking for that safety Tolerability and ultimately no dose limiting toxicity in order to trigger the phase II. What we're looking for are the first signs and a dose in which.
Get that triple activation of the immune response and I thought I mentioned in my remarks, and that will then trigger for us and not move a rapid move to a combination with with PD, one and <unk> and will give us and it will be a trial in progress update.
And give some signals as to where we are with respect to those outputs.
Okay got it thanks, Thanks a lot.
Accenture.
Thank you and our last question comes from the line of Yale Jen with Laidlaw <unk> Company. Your line is open. Please go ahead.
Good morning, and thanks for taking the questions.
First question.
King.
Given that.
<unk> recently reporting about a two day to you how.
Strong binding to.
PD one before you start to create the safety.
Situations and regarding 118 do you also have the ability to.
By strongly to the PD L. One even potentially indeed some of the.
Resistant patient day day expecting the level will be particularly will be low so you'll be able to engage the two molecules.
Commodity carloads tool to produce the therapeutic effect.
Hey, Yeah, nice to nice to speak with you and thanks for the question.
So your full one one H, we again through Chewning, we've got a slightly different a ratio with respect to affinities.
In that both a PDL, one and luxury are actually pretty high affinity and of course in a sense for an antagonist coupling would one would look for that because our key is to drive that cross linking between the PD L. One expressing.
Cancer cells and the like three the exhausted luxury expressing immune cells. So so we've we've driven with a with a kind of high high relatively in terms of affinity the the low PD lone expressing tumors as a good crushing we would certainly have the capability of <unk>.
Picking those off and what we've done in the ongoing proof of concept study in head and neck patients has ensured that all of those patients all both luxury and PDL, one positive and clearly we.
We have a semi quantitative view of that for the purposes of assessment, but of course, we will be able to get more quantitative once we've got that study run out in the end it will be an interesting hypothetical question as to where are the PD L. One cutoff will be where we see benefits.
Okay, Great very helpful. And then maybe two quick one.
First one is on.
<unk> to debt.
That day.
Okay.
Exclusively in Europe I assume.
This is the chorus.
And in Europe, particularly day.
COVID-19 situation has that.
Further impact or you see some alleviation of theater equipment.
Yes. So two two to two currently is in Spain are recruiting them, Spain.
Unfortunately, but I guess Fortunately for our trial had a very early second wave of COVID-19 and is in the oncology centers, there who are world leading him have a continue to operate a functionally and I would say a 222 is going very well in the clinic and we're encouraged by what we see.
And we're in active communication and it's it's likely that in the next phase for <unk>, two will expand globally and bring our recruitment of sorry in further development across not just out of Europe, but also into the U S under 90 day.
And maybe the last question is a housekeeping, one which probably slowdown in the in terms of R&D expenses.
This quarter the first quarter.
EBITDA increased significantly compared to the prior quarters. So should we anticipate the first quarter R&D expenditure will be a basis for the remaining of the year or that just a one quarter or for the uptake.
And thanks.
Yeah.
Thanks sure. So I think you should think about this as being kind of a normalized maybe slightly high but but at more normalized now that this is the first quarter that we have for flow programs in the clinic and we will continue to have that going forward. So I would think of it as as some pretty pre.
Pretty realistic going forward.
Okay, great and thanks, a lot and the congrats book the order the provinces.
Great. Thank you I shall I still true.
Thank you. This concludes our question and answer session and I would like to turn the conference back over to Elliott Foster for any further remarks.
Great. Thanks, well, thanks, very much everyone for joining in and grateful for the questions and I hope you'll agree that momentum is with us and we've had a productive first full quarter as a listed company and in particular, our strength and financial position ensures delivery of all future.
<unk>.
I'd like to thank again on you and existing investors all our colleagues who show unwavering dedication to our mission from the lab to the clinic and of course, the patients and health care professionals, who contribute daily to the progress of our clinical trials.
F Star will continue to work to bring medicines to the market that will truly transform the lives of patients with cancer and we look forward to updating you again in the summer and with that thank you very much.
Yeah.
This concludes today's conference call. Thank you for participating you may now disconnect everyone have a great day.
Yeah.
Okay.
Okay.
[music].
Yes.
[music].