Q4 2021 F-Star Therapeutics Inc Earnings Call
Good day, and thank you for standing by and welcome to the App store Therapeutics fourth quarter 2021 full year earnings conference call.
At this time all participants are in a listen only mode.
Patients will be a question and answer session to ask a question. During the session you will need to press star one on your telephone.
We advised on today's conference is being recorded if you require any further assistance. Please press star Zero I would now like to hand, the conference over to your Speaker today, Lindsay Trickett, Vice President Investor Relations and Communications. Please go ahead.
Hi, Good morning, everyone. Thank you for joining US with me today is Elliott Forrester, our CEO and Darlene Deptula Hicks, our CFO , we announced financial results pre market today for the year ended December 31, 2021, 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 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. 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.
Yeah.
Thank you Lindsey good morning, everyone welcome and thanks for joining <unk> fourth quarter 2021 earnings call. It's great to speak with you today I'm very pleased to review the posture of accomplishments and excited to provide an outlook on all we hope to achieve in 'twenty to 'twenty two.
2021 was our first full year as a NASDAQ listed company. It was a stellar year for it was real progress across every aspect of our business all four of our clinical programs progressed, well successfully navigating COVID-19 .
We were we added two new partners continued to strengthen our patent portfolio and closed a significant financing.
I'm pleased to say that we've carried this momentum into <unk> 2022 despite some of the obvious market headwinds.
Michelle we're positioned to deliver meaningful data across all four of our clinical programs without question. These are the most important value drivers for that store.
Even just one of these and of course, we expect more will be transformational for the company for our shareholders and for patients with cancer.
Additionally, all clinically validated platform technology will continue to add novel molecules toll road portfolio as well as to our partners' portfolios.
We continue to strengthen our senior team and I'm delighted that James Sandy joined the company earlier this month as Chief Development Officer.
Through his leadership of development operations, James is an expert in accelerating concentrate but programs through early and late stage development and this brought eight drugs to market over the course of his career.
His arrival odds yet more momentum to our ability to deliver timely high quality clinical data.
Perjury towards your two is the most important year, so far for X dollars, a clinical stage company.
It's also your which bi specifics are coming of age. This is at least in part demonstrated by collaborations involving by specific technologies, having reached over $18 billion in value over the past two years.
It's also clear that the needs of patients with cancer extend well beyond that which could be delivered by first generation immuno oncology therapies.
The successes many patients do not respond to or progress off the treatment.
Before a proof by specific drugs now being delivered to patients by others demonstrate the benefit of this format and these hard to treat cancers.
In this context that we will be providing data on all four of our programs. During the course of this year.
It's also worth noting about several of our 20 plus partner programs also advanced this year, providing a meaningful source of non dilutive income to App store.
At present, we have more than $2 billion in potential remaining future milestones from our ongoing partnerships.
Along with responsible management Bakhash any partner income will extend that runway.
We believe our tetravalent C is the best approach to bi specifics and the best approach for designing second generation immuno oncology therapeutics that will transform the lives of patients Wisconsin.
<unk> technology and clinical pipeline are at the forefront of this transformation and concentrate but I also would like to say that store by specifics for life.
Our bi specific antibody technology allows us to create two new additional and distinct antigen binding sites in the FC region of a natural human antibody, giving us two plus two or tetravalent binding. These.
These two new binding sites allows simultaneous target against two different pathogens and importantly enable a unique set of pharmacology, we called the three CS crosslinking clustering and conditionality.
Crosslinking provides the bridge between two cells not thoughtful has the architecture took full misfunction with great effectiveness.
Clustering as needed for our chosen receptor targets to elicit that pharmacology by balancing affinity.
The binding to a single antigen with avidity cross linking across multiple antigens, we believe our tetravalent bi specifics are amongst the best in class.
Finally, with respect to conditionality, the third C for a potent bi specifics, we only want pharmacology to hop it in the right place.
Therefore, a conditionally active molecules to live with that affects only web books of the company targets can be engaged simultaneously pointing their activity directly to the tumor.
All of this means a plug and play platform enables rapid prospective design of natural full like human Bispecific antibodies for safe potent immune activation at the site of the tumor.
And with so few changes to this natural human antibody format manufacturing becomes a straightforward process, giving us and people to light yields and stability.
It's.
I want to note that over the last several months, our senior management has met with many existing shareholders as well as potential new investors.
These meetings allows us to explain and ensure that the company and its plants for the arrowhead is properly understood.
That store has multiple significant clinical readouts throughout this year in all four programs.
As I mentioned earlier this means for opportunities for success with it enormous implications for patients the company and in my view for our present valuation even against the backdrop of the current market conditions.
I'll now talk through our programs starting with.
First of all Mike.
As a reminder, our first woman a targets two clinically validated inhibitory checkpoints PDL one in luxury.
First one what is currently being tested in two different patient settings checkpoint inhibitor naive patients with non small cell lung cancer or diffuse large b cell lymphoma, and also in head and neck cancer patients with PD, one acquired resistance, we're anticipating a clinical safety and efficacy readout in the middle of this year for this lots of trial.
Despite some challenges with biopsy sample viability will also report biomarker data for luxury and PD L. One co expression in this patient group.
I'd like to say a few words about the tragic events in Ukraine.
No one could have missed the human tragedy unfolding, Ukraine, and we'd like to express our support and solidarity with the many millions who've been affected by the rule.
According to the F D. A over 250 drugs and devices on clinical trials, and Ukraine, which was selected as one of a number of countries where F. S. Walmart agent checkpoint inhibitor naive patients.
As you'd expect they will now be delays with the study and Ukraine.
Our contingency planning is well underway and will continue to monitor the situation closely.
On a more positive note our recent economic forecasts of Bms's dual antibody program inhibiting lag three and PD. One is expected to add over $4 billion to its immuno oncology revenues by 2029.
Illustrating the tremendous potential value of targeting these two clinically validated checkpoint inhibitors in patients whether a few other treatment options.
We remain very excited about the prospects for F. S woman night and eagerly anticipate clinical data later this year.
<unk> is another important program in the Ash stopped portfolio continues to promise.
And class status as we make more progress in the clinic.
This program has the potential to be truly transformational for patients not getting the full benefit of first generation immuno oncology therapies.
Our first two tutus designed to target a wide range of patients, including those with PD L. One low PD lone expressing tumors and.
Benefits from all of the unique aspects of our platform technology.
It's worth highlighting that in preclinical studies, we observed 100% survival and tumor clearance with F. S. Two to two and that's without having to combine with PD one inhibitors.
As we've previously described our first two to two is designed to have unique balance of avidity and affinity profile against both the co stimulatory C. Do you want three seven and the inhibitory PD L. One targets to provide dose dependent PD L. One driven C. D 137 T cell redirection.
A C D. One through seven contain continues to gain momentum as a promising target immuno oncology in a wide range of settings. We're looking forward to providing a clinical update on F. S. 222 later this year.
This will include safety Tolerability pharmacokinetics, Pharmacodynamic, biomarkers and early signs of efficacy, including objective responses.
So far I'm very excited to see the program translated beautifully from the preclinical setting into the clinical setting more to follow.
In the second half of this year, we're also expecting to provide a clinical update on the phase one trial of F. S. 120. It aims to improve checkpoint inhibitor all chemotherapy treatment outcomes for patients building on the potential of current standards of care, whilst being tumor agnostic.
As a reminder, F. S 120, co stimulator ox 40, and C. D 1372 key targets found on the surface of T cells.
Later this year are ahead of schedule. We will also plan to initiate a study of F. S 120 in combination with Merck's Pepper. This amount we look forward to sharing these data from the ongoing phase one study.
And finally, SB 11, 285 on next generation intravenously administered novel Sting agonist.
Last year, we provided an interim update on the safety Tolerability and pharmacokinetics of SB 11, three five but that time alone and in combination with a taste of this up SB 11, 285 was well tolerated across five monotherapy in three combination dose levels.
Based on these data.
We're continuing to dose escalate it will provide a clinical update on these further dose levels later this year.
Under the terms of the contingent value rights for SB 11, 285, we're exploring partnering options for the program of course, besides the potential further source of non diluted funding for the company.
In addition to the data Readouts on our full programs that I've. Just described we plan to actively participate in scientific conferences, such as a a a C at ESMO and city.
Now turning to our partnerships.
The most recent partner announcements highlight the ongoing potential of our bispecific platform to generate new partnerships and also reaffirms the consistent delivery to our existing partners.
In the fourth quarter of 2021 we were delighted to welcome Johnson a member of the J&J family of companies as a new partner. The deal included a $17.5 million upfront payment and up to $1.35 billion in potential milestones.
So a long term part the Mark Mark K G. A a darmstadt, Germany exercised a fourth licensing option for a bi specific molecule under the ongoing immuno oncology collaboration. We're also pleased to add Astrazeneca has a new partner in the middle of last year.
We're excited to progress with all of our partners in 2022 and we will continue to consider new partnering opportunities in non core areas.
Also in 2021, two composition of matter patents were granted to S door for F. S woman eight in the EU and for SB 11, 285 in the U S. Adding truck growing intellectual property estate, which now includes over 500 granted and pending patents.
Since our founders performed the first experiments on the pathway to Tetra valency, we've been committed to developing novel therapies with potential to transform the lives of patients with cancer.
As I've highlighted we're embarking on a very important yard as a clinical stage company and we look forward to full programs delivering meaningful data in 2022 with the right experience and resource in place we're very much looking forward to sharing these data with you.
As well as the full programs will also bring forward exciting new molecules into the pipeline to find different ways to serve patients' needs and more on this towards the end of the year.
2021 was a year full of achievements we've delivered on our promises and are poised to reap the benefits of those efforts this year.
Our platform is generating novel differentiated pharmacology in the clinic in a way that is potentially huge implications for our understanding of immunology and the tumor microenvironment.
Bi specifics are clearly not monoclonal antibodies or even a combination of monoclonal antibodies, they behave differently and have the potential to deliver different better outcomes for patients.
Bi specifics of come of age.
And with the recent approval of <unk> from my former company, which is the difference a bi specifics can make.
We're committed to continuous outreach to the investment community are grateful for the Investor support that we've received to date, it's been a pleasure to share. These corporate update with you providing insight in how we both kind of transformed the lives of patients with cancer and unlock longer term shareholder value.
With that I'll hand over to our CFO Colleen to give you an update on our financials Dolly.
Thank you Elliot and good morning again, everyone.
As Elliott has highlighted it's been an incredibly busy and exciting 2021 for the company with advanced all four of our clinical programs added two new collaboration partners closed a significant financing and continue to strengthen our patent portfolio in all deliberate while addressing the challenges of COVID-19 and obvious market.
<unk>.
Taking this momentum with us into 2022 we're set up for another strong year with significant upcoming milestones.
I'll now go through the financials for the full year, ending December 31st 2021, which demonstrate excellent progress against our strategy, including executing on our clinical programs securing important new partnerships and robust financial management will be happy to take questions at the end.
Cash and cash equivalents at December 31, 21 was $78.5 million as compared to $18 5 million at December 31 2020.
The $60 million increase in cash was primarily was driven primarily by net proceeds from our $78 million a T. M. An equity financing 10 million dollar debt financing and the $17 5 million upfront payment received from a new partner Janssen us.
Set by the company's operational cash needs during 2021 .
Revenue for the full 'twenty, one 2021 year with $21 2 million as compared with 11.3 million for the prior full year, an increase of $9 $9 million. The 'twenty. One revenue consists of $18.3 million of upfront fees from new licensing agreements, including Janssen and Astrazeneca and too.
9 million, primarily from the marquee G. A a upon exercise of their option to license a third molecule.
Do not currently have any ongoing research and development service arrangements with partners as those programs have either come to the end of the research research days and hence transition to the milestone phases expected or did not include R&D services, all of which is consistent with our collaboration strategy.
It's worth noting that there are currently 20, plus clinical and preclinical programs in development by our partners, which built validates our technology and potentially provides meaningful source of non dilutive income an extended cash runway over the coming months and years.
Turning to research and development total R&D expenses were $28 8 million for the full year 'twenty, one as compared to $14 1 million for the prior full year.
This $14 6 million increase was due primarily to the expansion of our S. S 118 clinical trial into acquired resistance head and neck patients as well as our CPI naive trial in non small cell lung cancer and D. L. D C L.
Our full year spend on the mono and combo S. P. One went to eight five clinical trial, which was acquired in the spring Bank transaction in November of 'twenty and continued progression of our S. 120 in Q2, two clinical programs.
More specifically this increase includes the following.
Pieces of $7.3 million in clinical trial car T point $2 million in manufacturing cost $1.2 million in staff related costs $1 million and share based compensation point $7 million in lab consumables play 2 million of other expenses and a 1 million dollar reduction in the U K R&D tax refund.
Which is recorded as a credit to R&D expense.
R&D expenses also included $1 7 million and point 7 million of noncash stock based compensation expense for 2021 and 2020, respectively.
Total G&A expenses were $23 1 million for the full year 'twenty, one compared to $19 5 million for the prior full year.
This 3.6 million dollar increase is primarily due to two point flat sorry, $2.4 million increase in stock based compensation expense and 1.6 million increase in public company D&O officers insurance for a full year versus approximately two months in the prior year quite.
<unk> 6 million in facilities costs, which primarily felt from the two building leases we assumed in the spring bank transaction quite $4 million in I T related costs, primarily for the implementation of the new quality management software offset by reductions of 8.8 million in legal and professional fees and point $6 million in G&A staff costs.
The offsetting spring Bank Sublease income a point 6 million, which basically netted to zero is recorded in other income.
Of note one of the key spring Bank building leases, we assumed expired in Q2 last year.
G&A expense also includes $5 2 million and 2.8 million of noncash stock based compensation expense for 2021 and 2020, respectively.
Net loss for 'twenty, one was $31 3 million or <unk> 88 per basic and diluted share compared with a net loss of $25 6 million or $9.69 per basic and diluted share for the full year 2020.
In closing 2021 was a year full of achievements, we delivered on our promises that are poised to reap the benefits of those efforts with all four programs expected to deliver meaningful data this year and beyond.
We're grateful for the engagement, we received from the investment and analyst community, particularly given the current market conditions hold.
However, we clearly continue to be undervalued, especially considering that we're trading below cash and therefore, our programs that are progressing well in the clinic.
We're well placed to deliver on our strategy for the current coming months and years, even while facing the same current market headwinds as many other biotech company.
It's an exciting time for bi specifics generally as well as for F star in our investors as we work towards transforming the lives of patients with cancer.
With that operator, we will open the call up 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.
Our first question comes from the line of hard ties thing from Oppenheimer <unk> Company. Your line is now open.
Great. Thank you thanks, Elliot telling everybody for the questions I just got one.
Question I have first 118, and one quick follow up.
You had mentioned that you're still hoping to I guess.
Ill give an update in 2022 or in the head and neck trial can you just give any update on the non small cell lung cancer trials also the CPI naive and Oh I guess, maybe there was a deal Bcl one also with it.
It might have been planned to be initiated this year and then I just got a quick follow up.
Yeah sure. So thanks, Hock Howard nice to speak with you yeah. So the checkpoint naive non small cell lung cancer and diffuse large b cell lymphoma trials.
Our octave right now and we've been guiding towards the first half of next year for our clinical data from those two patient groups and the checkpoint naive study.
Great Great. Thank you and then just the other question on.
I guess, you've seen more data now on the BMS approach with lag three and PD, one and Theres. Some other companies that are trying to two antibody approaches.
Would you be able to see utilizing two antibodies versus one by specific.
<unk> insights that you gained.
That could help you with your clinical trial strategy and also.
Whether it's more something for example, like enriching patients or anything else like that thanks for the question Don.
Yeah, that's great Tatas, yeah. So look at the underlying hypothesis for herself she knows relates to lag three expression and that's true across the three different patient groups head and neck multiple cell lung cancer in diffuse large b cell lymphoma, but really the thing about we.
Drive towards and this will become really important and we look forward to the discussion around a CR is.
Is the removal of luxury from the pills I'm and we believe that all.
Two plus two a bi specific cause the.
Opportunity too.
You drive that removal a in a way, which is more efficient and effective than other approaches so either combinations or even PD one lag three by specifics.
Great. Thank you Elliot Thanks Sterling Thanks for all the questions.
Great. Thanks, I touched I speak here.
Thank you. Our next question comes from the line of Dana Great Bush from SBB Leerink. Your line is now open.
Hi, guys. Thank you for the question a couple clarifying on F. S 118.
I think you said in the prepared remarks that you had some challenges a biopsy, but youll still report biomarker data for lag three and PD L. One.
Our understanding was that positive like three and PD L. One was an inclusion criteria for enrollment in the study is that still the case.
And then as you look forward to the data readout. Later this year can you give us any more guidance on when in the year to expect it and about how many patients given the challenges of biopsy and then a challenge if you stay in Ukraine.
Yeah monarch data nice to speak with you yeah, so two questions, but actually three answers.
So the first is just to clarify we take anyone who's got acquired resistance head and neck cancer into the study and we observe that something like seven or eight out of 10 of those patients in the prior studying through literature and others research Oh like through your PD L. One CRO expressing and the way in which would be appropriate.
But we retrospectively analyze the samples, which which frankly for the first few patients who are tricky and we do that the batch wise mono.
To understand whether they are or are not expressing so assuming our estimates are correct. The stage, one and we're looking between eight and 12 evaluable patients and so we would expect to recruit 50, no or so and that's the that's the sorts of numbers are playing out.
For us to get that data, we continue to guide.
To the middle of this year so for that study with respect to the clinical data that I've mentioned in the prepared remarks.
And I shall repeat back.
Just one clarification.
At the Ukrainian centre was for the checkpoint naive F. S won't monarch study in non small cell lung cancer only.
It's very unfortunate circumstance I guess for US of course, we don't just opened an international study in one.
Country, we opened across several countries and we have several other countries are also participating with just looking right now to see how we may contact so that won't have an impact on the F. S woman I had met study.
And we're obviously, making sure that the checkpoint naive as impacted as little as possible.
I'm glad I asked for the clarification.
And then.
One [laughter].
Got it all right and so then one other question on S. S. One plenty could you remind us why this one.
It makes sense to combine with hambro, where you don't believe you'll need to combine the Pembroke for F. N 118.
Yes.
Yeah sure. So 118, so I'll I'll answer in reverse order. So Walmart agency to contain a checkpoint inhibitor, we put PDL one as you know in in both of those so like through PD L. One for a festival moderated a C. D. One through seven in PD L. One N F. S. T G I F S. One.
Just a reminder is it is a dual agonist. So both ox 40 N C D 137, which at.
At least in a preclinical setting are really synergistic with respect to our immune stimulation.
But and we've described and we'll continue to describe the show that kind of Triple response around C. D. Four C. D. H on the destabilization of T. Regs in some really interesting data emerging that are personal and clinically onto in the clinic.
But of course, I should imagine as you stimulate that immune system, you get cell, killing that you'd get a uptick in <unk>.
Checkpoint pathways are not least of which being the PD one PD L. One and so we found in the preclinical setting that's either combination with checkpoint oren.
More interestingly three different types of chemo and that's something we're really going to start to explore in the not too distant future.
Really give a better survival and this in generic multiples then that just F. S 120 on its own although you know frankly F. S 120th of its own gave an improvement of survival.
As well compared to controls a box that's why we're going with that and we you know with delight to rip. It ahead of the game all about the preclinical data translate really well into the clinic.
S. One twenty's kind of concept type agnostic and we're excited to do the Pembroke combination.
I'll give an update on the phase one when we do that combo a little bit later this year.
Thank you very much.
Great Dane and I speak with you.
Thank you. Our next question comes from the line of Matt Phipps.
William Blair. Your line is now open.
Hi, Thanks for taking my taking my questions I guess a bit of a follow up on dana's, but.
<unk> words from you on F. S 222, with regards to recapitulate, what you've seen pre clinically. So I guess just wanted to confirm at this point you all do not plan to combine with a PD one drug like a lot of your.
Well I guess colleagues at other companies are doing with their.
Automobile and PD Lone PD 137.
Yes.
Yeah.
Very much and nice to speak to you. So look we certainly don't see the need to combine with a PD one in the clinic.
Certain it wasn't required and the preclinical data.
You may recall.
100% survival in total tumor clearance I'll say as a mono therapy of F. S 222.
The other thing is that in immune oncology and we see this more and more and in some of the ACR abstracts are really interesting along these lines as you will have to do combinations right. I mean, it's it's how it's going to go we don't think it needs. We think we've got the PD one PDL one axis completely covered with F. S duty to but there will be other.
Interesting combinations, we looked at as part of development, there's no doubt about that.
But right now and certainly we're very excited about we're seeing are in the clinic as a mono therapy and I'm excited to show those data later this year with everyone.
Okay, Great and it was wondering if you all are looking at or has seen CD 137 shedding.
Similar to what you all have reported with lag three shedding.
With 118.
So just just to repeat that box of CD 137 shedding.
As a kid to the luxury shedding mark was that the question.
Just wondering with two tier two youre seeing any city wants to be seven shedding others have also talked about soluble 137.
Got it got it yeah, Yeah, just just just wanted to make sure. Yeah. So we have a raft of biomarker as we look at a shedding of a PD L. One C. D 137 in the future too.
This is part of that mix, we will publish on that later this year, but but I guess, if I can without giving you the answer let.
Let me just point you to Mechanistically, how well our drugs, which as you know the two plus two tetravalent C are ideally suited for like clustering and shedding them and so we would anticipate.
That's the benefit of removing for example, luxury from pills I would also play out with respect to shedding.
C D 137 of PD L. One with my first two to two <unk>.
And more more roadmap to come this year.
Great. Thank you.
Thanks, Mark nice to talk to you.
Thank you. Our next question comes from the line of Jeff Dan Walsh from B Riley Securities. Your line is now open.
Hi, Thanks for taking the question.
At the start of last month, a competitor announced there's no longer advancing its partners tetravalent, PD, one and lag three and a number of indications due to the clinical data that they saw.
I'm wondering if you can comment on any potential read through to S. 118, and what gives you confidence that your PD L. One lag three asset will do better.
Yeah look thanks, just I mean, one of the one of the central.
Characteristics of a vol two plus two.
Is the ability to cleave like three after him the tills and you know we've showed some of that data in phase one.
We're obviously following that are in phase II, not just in the head and neck setting but of course in a non small cell lung cancer with diffuse large b cell lymphoma, one of the one of the things kind of a foundational hypotheses is around you know the expression and co expression expression of luxury and co expression alongside PD L. One.
And where.
<unk> thought about mechanism will play out in these tumor settings.
With a PD, one bi specific or with even with the combination.
The ability to remove luxury from pills just simply doesn't exist.
And or is or as a minimum has reduced compared to what we see so site.
I think Joel data with.
Carefully.
But I don't think that that will play through mechanistically to what we're seeing with the first woman H.
And I would suggest actually if you forgive are kind of in question adverts now we've got a poster at ACR on the exploration of Tetravalent C. A T.
PD one versus PDL, one on the removal of like three from pills and we're really excited to share those data.
Great looking forward to seeing that one more quick one for me I was wondering if you could provide some color on how F star is managing and prioritizing its busy development efforts and specifically I know that your partners are funding funding those efforts, but wondering how time and effort is allocated in terms of this.
Supporting partner efforts versus advancing your own wholly owned pipeline.
Yeah.
So thanks, Jason that's a great question you asked a key focus is on delivering.
Before our programs and the data from those full full programs, it's actually seven on ongoing trials, but full programs for state of the show.
Our partners are continued to report and I think as Anthony mentioned here, we've got a more than 20 programs.
Without partners now, but the way in which we've structured the deals is that the kind of heavy lifting.
Is undertaken by our partners.
So if you look across them.
Bob Cole or Denali and the <unk>.
Partners are all of the research and clinical development and then ultimately commercialization.
Externally I.
And we obviously maintain the IP, we remain good partners with respect to giving guidance to help if it's if it's needed but we'd also pretty careful about the nature of partners that we would take on.
Just reading through the list I mean, there are outstanding quality partners.
And you know what we learn things from them every day as part of those partnerships as well, but but operational focus is kind of a 19, 9%.
Our in house pipeline, the four programs plus the other things that are coming in to the pipeline from from the platform through the discovery team and we'll talk more about that at the end of the show, which we're really excited about and then the I.
I guess, what you're trying to do the maths right, but the remaining 1%.
With partnerships.
Great looking forward to that thanks for taking the question.
So a pleasure isotope Justin.
Thank you. Our next question comes from the line of Yale Jen.
From Laidlaw and company. Your line is now open.
Good morning, and thanks for taking the questions.
I have two the first one's below 118 in terms of the checkpoint naive to.
The two indications.
Do you sense any sort of typical oh.
Patient recruitment given you know.
Check point has to be a standup care nowadays off those are two indications and then I have a follow up.
Sure Hey, good morning, guys nice to speak with you yeah. So so in part.
This is part of the misfortune with.
Crane in a wall.
It is is we need to go to territories, where.
Use of checkpoints in first or second line is less frequent.
And so we all are doing that are in in in Europe predominantly.
And I think we're reasonably comfortable.
That will we will get that we'll get there I guess the other thing that's worth noting is there aren't any checkpoints approved and.
Diffuse large b cell lymphoma, so that's an easier.
To tackle them.
And you in.
In particular.
If you think about the utility of cough therapies.
In that setting as well then you know there are things, we can do around that and suddenly luxury looks like a very important.
Immune suppression pathway there for non small cell lung cancer, we should not talk publicly about what we're doing with respect to the kind of major subgroup. That's available, but there is certainly significant subgroups in terms of percentage.
Of Ah patients with non small cell lung cancer, who don't typically get.
Checkpoints are in the first instance, and so again, we think there's an opportunity there as well, but we're monitoring that closely.
That's why we do a substantial amount of our work in.
In Europe .
Europe .
Okay, Great. That's very helpful and maybe to just follow up question here is in terms of T. Two.
Given there's oh.
A number of programs both targeting both PD L Y N C P. One check.
<unk> C D 137.
Before we have all that data what do you think the so the potential benefit of a leg up you guys may have or just any comment on a competitor they're a.
Direct competitor at this moment and thanks Yeah.
Yeah, no facts that that's spot on question, So look again I come back.
Two to my response to others.
Is the tetravalent structure, we have the two plus two.
It is really well positioned to give us the cross linking and clustering.
And what we showed in the non clinical setting.
We'll see how this translate later this year into the clinic is a.
Normal dose response, we don't get a hook effect and and in particular, that's because of the way in which we've tuned our the molecule as I said in my talk is a balance between affinity a definitive.
And where.
From a differentiation perspective, we think that's going to be important.
We also think there is there is it looks like there's no need in this just to the question earlier to.
Combined with the PD one and.
And ultimately.
We can go after patients who are low P. D. L. One expressing them who get you know.
Less responses of monotherapy from the first generation and indeed meet often to combine with chemo and one of the things we'd be looking to do is spec chemo and we think the tetravalent underpins all.
All three of those elements. So a no hook effect, a going after PD L. One low and ultimately potentially chemo sparing.
In that patient group.
Okay, Great. That's a very insightful I appreciate it and good luck for the rest of the year.
Thanks, Yeah look forward to speak with them.
Thank you. Our next question comes from the line of Patrick <unk> from H C. Wainwright. Your line is now open.
Good morning team. This is the adjacent Shea on for Patrick and My first question is just around <unk> and CD 137 target.
How does the emphasis is to compare it with other programs in the states, including the new collaboration between <unk> and Sanofi for <unk>.
And what are some of the read through from the other programs for the near term that investors can place more confidence into the flolan or <unk> as a potential target and I have a follow up question after that.
Sure.
To speak with you Jason I mean, I think you know one of our central contentions would be that the simplicity of the way in which you produce the ASCAP. So this is modified FC against PD L. One where.
Why are we sorry, no PD L. One CD, one through seven and where we choose for a visit to rather than for high affinity that gives us a differentiation compared to many of the other C. D. One three serpens Amit. So that's so for us that's different but what were you know frankly pleased to see them.
A more and more C D 137.
Approaches and I think the industry.
You know physicians.
The rest of the community are really beginning to see the potential power of C. D 137.
I come from a previous setting which C. D. Threes are used widely and I think they are important.
It's sometimes difficult to control the immune response of the immune and.
The stimulation from that and C. D 137 looks like in a controlled way.
Going right across the immune stimulation not not just.
The C D falls in H, but also NK cells, and some interesting inverse effect and in the T. Reg population as well. So so so I would say that you know we're different because of the very simple 12 amino acid substitution to produce a C. D 137, a binder and and at the same time, we have.
Have you know an explosion of the interests in CD, one three separate way, we're collectively work well.
Sorry, collectively understand more and more and I guess ultimately the kind of C. D 137 story tripped up I think in its first generation because of safety.
And we've we've all are not just extra all but collectively they understood. It.
In part what that was about something to do with Nonspecific FC Gamma.
Interactions and of course, we've tuned.
Our molecules to be conditional so you only get the effect from both receptors of bond and we think that will be important for us as well so.
All summer Ive summarized wants them with somebody's got so we're really excited about C. Do you want to be something that's really important obviously, we're wedded to it through F. S 222 odd through F. S 120 and.
You know I think the industry is heading in the same direction. The the next the next wave of of C. D. 137 approaches will also be interested in it is clear that the checkpoint pathways, but I think we'll see a great erosion, taking see if he wants to accept them through a T. A a approach to a to the tumor microenvironment, we shouldn't ignore.
Alpha.
Other cell types as well why we are in the.
Okay.
No yes.
And I guess as a follow up what are some of the key data point that we should focus on for the expected data Readouts and the part a study of two trials this year and when can we be expect initiation for the phase <unk> like tumor specific expansion cohort.
Yeah. So we will give a report later this year.
On the progress of <unk> two in the clinic and I think as I said in my presentation will be focusing in in kind of three major areas. So one is obviously safety and tolerability, which is going to be really important and we're expanding.
The level of dosing and the number of doses at each group.
Very well now.
We're also of course really interested to see the kind of PK and PD relationship with P. D relate those Biomarkers and award discussed you know C. D 137 am.
On PD L. One baby shedding is something where we're taking a look at and then finally clearly evidence of efficacy and we measured the same efficacy outcomes as everyone else does we do irregular regulus guidance.
And clearly we'll report on those data that we're seeing there from a from a response perspective.
And I think it's more likely that the.
The full expansion into that kind of pop the policy and we're in all of our programs are built so that there can be modified life as it were rather kind of Bayesian analysis.
We'll be into the early part of next year.
Okay, great and if I could just squeeze in one last one is for universe, how like plug and play platform are there any new programs that we should be expecting in the near term.
Yesterday, where the M. A C S O Neal and his team have been working like Trojans a behind the scenes.
And we're.
We're very excited to.
Be able to talk about at least one new program.
Before the end of this year, that's that's coming through to the clinic and I'm thinking about.
As I've said, new ways of thinking about helping.
Helping patients this route through different sorts of approaches, but based around that platform.
Alright. Thank you that so that's very helpful and good luck with the rest of the year. Thank you.
Thanks, so much Jason nice to speak with you.
Thank you at this time I'm showing no further questions I would like to turn the call back over to Elliott Forster for closing remarks.
Great. Thanks, well look thanks, thanks, everyone for joining this morning, and really appreciate and thanks very much for those insightful questions.
Worth reminding that in 2020 , one we got a first great year as a public company and obviously 'twenty 'twenty. Two is an important one fresh store for patients employees and of course our shareholders.
We delivered on our corporate promises and clinical strategies in 2021 and we'll do the same this year or in 2022.
New partnerships with Johnson and Astrazeneca have highlighted our strategy for capitalizing on noncore assets.
I'm excited about the emerging data from patients in F. S. 222 S won't 20 odd SB 11, 285 trials I also eagerly anticipate the F. S 118 clinical data.
With our current cash runway, we're excited to be on track to deliver these important clinical milestones.
And finally, I'd really like to think we have stopped team our partners and our shareholders for your ongoing support I'd also like to thank the patients participating in our trials and our expert clinical investigators.
As you work through the Covid pandemic and pass into a further period of political uncertainty I know that we are all United behind ambition to develop next generation immunotherapies to transform the lives of patients with cancer and I look forward to sharing our successes with you every step of the way.
And goodbye.
This concludes today's conference call. Thank you for participating you may now disconnect.
Yes.
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