Q1 2020 Earnings Call

[music].

Greetings and welcome to the appears Pharmaceuticals first quarter 2020 earnings call. At this time all participants are in listen only mode. A question and answer session will follow the formal presentation.

When you went you require operator assistance during the conference. Please press star zero on your telephone keypad.

A reminder, this conference is being recorded I would now like to turn the call over to your host Mr., Tom burst Vice President Finance for parents Pharmaceuticals. Thank you you may begin.

Good morning, everyone. Thank you for joining us for first quarter 2020 conference call good corporate update.

On the call today, we have Steve you order <unk>, President and CEO, who will provide a corporate overview outlook on our pipeline he took off and our chief Scientific officer.

Hey, Mark.

SPP.

Well development, and Shane Oh, well, our SVP and head of translational science will be available for acuity.

Yes.

Released released this morning.

Investor Relations page our website.

Www Dot purist dot com.

Before we begin I'd like to cautionary comments made during this conference call may contain forward looking statements.

Holding risks and uncertainties regarding the operations can future results of operations of Paris.

These statements related to the timing and progress our clinical trials in preclinical programs.

Partnerships and our financial position.

Actual results or that may differ materially from those expressed or implied by such forward looking statements.

Factors that might cause such differences are described in our filings with the FCC, including our annual quarterly and current reports.

The information being presented only accurate as of today. It appears undertakes no obligation to update any statements reflect future events or circumstances.

I'll now turn the call Steve.

Well, Thank you Tom and thank you to everyone for joining us today for first quarter 2020 earnings call.

Before I provide an update on a therapeutic pipeline.

I'd like to describe the effects of the Kobin 19 pandemic on our business.

Fortunately despite the numerous challenges of this pandemic execution towards achieving our core corporate objectives for our two lead programs Prs 60.

Prs 343, essentially remains on track and research.

Work in all laboratories has continued with limited disruption.

We of course feel the pressures around the threatened and actual supply chain disruptions alongside other disruptions.

We will continue to rely on a number of third parties crucial for helping to advance our pipeline who have not surprisingly.

Experienced themselves significant disruption.

It's difficult at this juncture to predict what impact this will pose for the rest of the year, but managing coated 19 related risk and adopting new ways of working currently are among our highest corporate priorities.

Meanwhile, within the company across both our U.S. and German sites, we've implemented a number of measures to protect the health and safety of our employees and our communities.

These include requiring all non laboratory employees to work remotely.

And various measures to reduce research labs to stop density at our R&D facility and Hallberg most Germany.

Given the fluidity of this situation, we reassess gryska very frequently make necessary adjustments and we'll continue to update publicly as appropriate.

Moving beyond the covert 19 related impacts I'd now like to provide an update on our therapeutic pipeline and as a brief background. I'm curious you know that we developed a proprietary class of next generation therapeutic proteins called NTK lawns and these any caitlin proteins.

Engineered human liver K ones, which are proteins that are naturally abundant in the body in served to buying the transport various antibodies there's multiples.

As indicated proteins are smaller and typically more stable and engineering then other large molecules such as antibodies. They can offer unique advantages to other treatment options such as inhaled delivery to treat respiratory disorders locally or the ability to create more complex by specific formats to drive a desire biology.

As we are doing in immuno oncology.

Turning first to our respiratory franchise, we have been preparing for the start of the phase two a study for Prs. So 60 isn't he inhaled aisle for receptor alpha antagonist for moderate severe asthma, we are developing in collaboration with Astrazeneca.

Well the continuing impacts of Kogan 19 have the potential to disrupt the timelines for this program. We believe we are currently on track to initiate phase two study by year end.

Because the study will be initiated sponsored and run by Astra Zeneca, we cannot give additional details at this time, but as a reminder, we presented positive interim results from the phase one be study up Trs 60 last year, demonstrating that Prs 60 was safe and well tolerated at all administered doses.

In subjects with controlled mild asphalt and having elevated levels of fractional excel nitric oxide ore Pheno. In addition to significantly reducing pheno relative to placebo at all the liver dosage.

On completion of this forthcoming phase two way study, which will be sponsored and funded and delivered by our partner Astra Zeneca, We will have options to co develop and subsequently co commercialize Prs 60 in the United States.

Our alliance with Astra Zeneca includes four programs beyond Prs. So 60, we're continuing to work on the three programs. We already have initiated and we expect that Astrazeneca will nominate the fourth program later this year.

Although we are fortunate that to date timeline for Prs 60 has not been affected by Kogan 19, there is a chance that the advancement of our earlier stage fully proprietary respiratory programs might become affected.

Last quarter, we announced that we had plans to disclose data and the rationale for advancement into R&D, enabling studies or one of our several proprietary respiratory programs later this year.

Because that dataset is being generated in part in third party laboratories affected by called the 19th there is the possibility we may not be able to disclose the details for that program at a medical meeting later this year as originally planned we are nonetheless hopeful we maybe able to disclose more details by the end of the year and we'll continue to update pub.

Finally as appropriate on this program.

Turning to our immuno oncology assets.

We'd like to focus my time on our plans for continued clinical development of Prs 343, our lead Io asset, but also will provide a brief update on Prs 344.

Prs 343, and 344, our bi specifics would choose a poor one BB targeting and he came when protein.

Well I won't be agonism is believed to play a fundamental role in driving T cell proliferation, cytotoxicity and T cell memory collectively leading to a durable antitumor activity.

Prs 343, which is a four one BB her two by specific was designed to drive for one DB agonism in the tumor microenvironment in her two positive solid tumors and has demonstrated the ability to avoid unwanted peripheral toxicity, while achieving objective clinical responses as.

Observed in both of our clinical studies, which was a monotherapy dose escalation study and a combination dose escalation study with the cause of listen that provided under a drug supply agreement with Roche.

In the fourth quarter of last year, we presented positive interim data from the phase one dose escalation monotherapy study of Prs 343.

Based on the totality of a data we have collected.

Including additional data beyond what we reported last year, we have decided to initiate in the second half of this year a phase two proof of concept study for Prs 343 in combination with the current standard of care in the second line treatment for gastric cancer, just Ramucirumab paclitaxel.

Today, we'd like to share with you some of the additional data we have seen that has informed our thinking as well as the rationale for the clinical development path, we're announcing today.

Turning to the data at the active dose levels for which we presented interim data last year, namely cohorts nine to 11 be with 19 2.5 makes per kilo, given Q3 weekly and cohort 11, B.B. eight megs per kilogram given Q2 weekly.

We observed a partial response.

Three patients and stable disease in 11 patients as best response out of 21, Evaluable patients, which translates to an objective response rate or or or or 14% and a disease control rate or DCR up 67%.

All three objective responses in these cohorts were observed in cohort 11 be in which disease stabilization was also observed in three patients out of seven evaluable patients.

Translating to it or are a 43% and a DCR of 86% in this cohort.

We also observed additional clinical benefit including complete response in the higher dose cohorts, which are still open for enrollment.

Well enrollment is progressing according to plan, we will use the time until the plant started the phase two trial to generate a larger dataset in these cohorts.

We also continue to enroll a b cell depletion cohort to assess the impact of anti CD 20 pre treatment on plasma exposure levels of Prs 343.

Additionally has mentioned we had been conducting a dose escalation study with a total itself that we plan to present detailed data from both the monotherapy study and this I tend to listen I've combination study at a medical meeting in the second half of this year.

Now we're enthusiastic to advance Prs 343 for the second line treatment of Hertwo positive gastric cancer and our rationale for focusing on this path is multi factorial.

Importantly, it prioritizes inefficient path to registration as evidenced by our decision to combine 343 with the current standard of care regimen.

There are also is a key mode of action component at play recognizing myriad data points in the scientific literature, suggesting the potential benefits of combining a four one BD agonist with the bed, Jeff antagonists and a cytotoxic chemotherapy.

More specifically, we believe in the potential synergy between four one BB based T cell activation.

Tumor vasculature normalization and other idle favorable elements that rather serum apps can provide.

And we see an advantage of both tumor debulking and the release of tumor antigens that could drive an enhanced immune response as a result of paclitaxel.

Second line Hertwo positive gastric cancer also represents an attractive commercial opportunity considering the addressable population both in the U.S. and the rest of world.

Planned single arm phase two study of Prs 343 in combination with Ramucirumab and Paclitaxel will include primary endpoints of or our and DCR with a targeted enrollment up between 40, and 60 patients, which we believe will allow us to sufficiently.

Interrogate the efficacy of Prs 343 in both a time and cost effective manner, we're very confident that.

Based on the mode of action synergies just mentioned Prs 343 can achieve our desired clinical endpoints to justify further continued that development.

We plan to initiate this proof of concept study and the second half of this year and will provide further details on matters, including the statistical plan.

Expected trial duration and more detailed commentary on endpoints as we get closer to the formal start of the study.

Turning to you on 343 as mentioned I would also like to give an update on Prs 340, poor, which is a PDL one for lumpy by specific.

Which is the lead program in our immuno oncology collaboration with Sergei and for which peers hold exclusive commercialization rights in the U.S.

We recently learned of a scale up challenge encountered during the manufacture of drug product for Prs 344 that will affect our original timeline for filing and R&D by the end of this quarter as we have been guiding.

Purists inside the a both remain committed to this program and have jointly decided to invest an additional CMC activities given its strategic importance.

As a result, we now anticipate filing to 90 application for Prs 340 for next year the scale up of manufacturing processes for complex biologics modalities can sometimes it poses a challenge, but we're confident that we can overcome this issue by implementing an improved scalable process that will meet high quality.

Standards for robust manufacturing.

Once we have more visibility on the anticipated timing of the R&D filing we will provide an update which we expect will be later this year.

Beyond Prs 344, we are working to complete the non GLP work for Prs 350 to a preclinical stage program addressing undisclosed targets that we're also developing as part of our collaboration with San Diego and we expect to hand it over to serve you also later this year.

In addition to savvy.

We also have an immuno oncology collaboration with Seattle genetics, and we continue to make progress on the development of antibody and he can't win by specifics as part of that alliance.

And lastly, moving beyond our therapeutic pipeline I did want to provide a quick update on our board of directors.

And Dr., John Pierre Bizarre he has transitioned from the board to serve as an advisor on oncology development strategy for the company Dr. bizarre. He has been an invaluable resource for us over the last five years and I'm pleased that we will continue to benefit from as many insights with well more than 30 years of oncology development <unk>.

Periods.

This concludes my prepared remarks that I would now like to hand, the call back to Tom to guide you through our first quarter 2020 financial results.

Thank you, Steve and good morning, everyone.

Cash cash equivalents and investments totaled 86.8 million for the quarter ended March 30, Onest 2020.

Our to our cash cash equivalents and investments balance of 104.2 million for the year ended December 31 2019.

The decrease was due to operating cash expenses annual bonus payments are both capital and onetime expenditures associated with that move.

This audience Albert most.

We believe we have a cash.

In addition to support us through our next inflection points, including the phase two study of Prs 343.

R&D expenses were 12.8 million for the quarter ended March 31st 2020, compared to 14.3 million for the quarter ended March 31st 2019.

The decrease in R&D expenses reflected lower manufacturing spending on Prs 344.

Partially offsetting this decrease was higher personnel expenses due to an overall increase R&D headcount and an increase unallocated facility costs due to the new most site both associated with the advancement of our clinical and preclinical programs.

<unk> expenses were 4.4 million for the quarter ended March 31st 2020, compared to 4.9 billion for the quarter ended March 30, Onest 2019.

The decrease in DNA expenses.

Next lower personnel costs.

And reduction in audit and tax professional fees.

Net loss was 2.8 million or seven cents loss per share for the quarter ended March 30, Onest 2020.

To a net loss of 10.3 million or a 20 cents loss per share for the quarter ended March 31st 2019.

With that I will turn the call back over to Steve.

Thank you Tom.

I'm grateful for our teams perseverance and ability to focus in delivering these trying times.

He said than a few tough months for everyone, but I'm confident we will come out stronger on the other end of this having worked through important prioritization exercises and adapting to more efficient new ways of working and I Hope you who are all listening today are staying safe and healthy.

Thank you for joining us on the call today and now we would like to open the call to your questions. Thank you.

Thank you at this time will be conducting a question and answer session. If you'd like to ask a question. Please press star one on your telephone keypad a confirmation Tom will indicate your line is in the question Q.

You mean, prestart too if you'd like to remove your question from the Q for participants using speaker equipment. It may be necessary to pick up your handset before pressing the star keys.

Our first question comes from the line of Jonathan Miller with Evercore ISI. Please proceed with your question.

Hi, guys. Thanks, so much for taking my question I guess I have a two for you here, let's start with yours or 343, where congrats on the additional responses by the way, but I noticed as you're moving into phase. Two you haven't said much about what the dose level is anticipated to be in phase, two and and what those doses are.

The higher dose cohorts, where you saw that complete response can you give us a little more colour on the on dosing as you forward.

Secondly, I would love to talk about your cash runway would you said goes through that pure that'd be pretty rebates to do you have cash runway through the Oh six. So these two way I do that value inflection point is though.

Thanks, Thanks, John for the questions. Let me start by answering your second question first.

And then I'll turn it over to R&D colleagues to help answer the what goes to recommended phase two dose some more color there after I answered that so with respect to the cash position and the management managing the balance sheet and the runway we've not guide long runway in the past and we won't start to do that today.

I can say that a great deal is thought a great deal of thought has gone into F. DNA as we aligned on a go forward plan for 343.

Resource allocation to other assets within our pipeline and of course be mindful of timelines for phase two a readout for.

Trs was 60 or or I should say an anticipated phase two a readout for.

Prs 60 timelines.

While we might be forced to make additional prioritization decisions in it needs to be corridors to protect 340 threes advancement. According to this plan and also to be mindful that we believe Prs. So 60 is one of the largest value driving opportunities for the company, we see ample opportunity to realize value from the best.

Since we're making both within our existing partnerships as well as from potentially new partnerships and so all of that has gone into our thinking about how to manage our spot.

To your first question around the the the additional dosing beyond a cohort 11 b.

I would actually turn it over to Ingmar to comment on how we're going to be using the interim period between now and the start of the phase two way to better informed the dosage regimen.

For the phase two a study although we're not going to go into specific details. We said we will be providing those details are closer to the formal started that trial, so without I'm going to handed over to a more for a bit more color.

Yeah, I see if and hi, John Yeah, Steve already said I mean, we're not going to disclose details about the ongoing trial beyond the data from the 21, new valuable patients reported today.

As we.

I have reported earlier or described earlier there are additional.

Higher dose levels.

Including on the bi weekly schedule higher doses as well as alternative schedule. So like a weekly dose schedule and the up a b cell depletion toward that you've already mentioned.

I'm not going to comment on where the complete remission and the additional objectively on a general happens a point, but we will guide on this at the next earnings call and as we get closer to the plant startup the phase two trial.

Okay makes sense. Thanks, so much.

I'll hop back in <unk>.

Thank you. Our next question comes from line of Chang with Jefferies. Please proceed with your question.

Hi, This is challenged with their and thank you for taking my other question I had two oh, the length of stay flat discovery and well see for so we'll see what do you sorry, I'm wondering how many additional patients not sure wage patch from now to the medical meeting where you're going to at least a day.

Yep.

Like most Florida monotherapy trial, and the occult dot com most out.

And the second question on safety for its like and manufacture challenging.

Would you mind.

Additional color on what specific challenges facing and.

Well.

So how do you have to mitigate that thank you.

Sure. Thanks, John Thanks, Thanks for the questions.

I would say first the 343 question, we're not guiding on the specific patient numbers today as we are still.

Enrolling in some of the higher cohorts for the monotherapy trial and there is flexibility on the protocol as to how many we can put into these.

Additional cohorts based on the protocol design.

And I think that.

Suffice to say there are additional.

You know patients in across all the cohorts since the disclosure in the since he dataset and indeed.

The cause of combo data, we first disclose at our R&D day.

And I would say stay tuned for the totality of the data out of respect for the investigators, particularly in the combination trial since we have not disclose initially any data in the context of a medical meeting we want to allow an appropriate coming out party for that program by the clinical investigator are put on trial by the investigator at that time.

So if that's not enough color, we can maybe come back to your question on 343 data sets or additional patients.

But for 344.

I would actually ask hit so calphalon to comment on that before I turn it over to hit all I would say that as a reminder.

Both purists.

And sorry, Yeah, I think highly valued the relationship as well as the parties complimentary capabilities in both parties are.

Committed to the relationship now in a pretty focused matter on two programs and we remain very committed to it and see what is now very focused pipeline of these two by specifics would still include as the most advanced assets.

Yes, 344, so with that I'll turn it over to hit toe to provide more color on what we're working through that.

Thank you Steven and good morning, everyone.

As as you typically.

Manufactured biologic drug initially.

Truck stops and then later on the drug product and as you typically initially established you manufacturing processes and smaller scale.

Well you go to what is typically called a technical scale and then the final GP scale.

The problem that occurred a crowded you get the law.

So the drug product stage with the product manufacturing it is not unusual to see this unfortunately, we have now seen that's why the head of wanting to start phase one it is a topic that has occurred.

Has occurred and many other biologics project.

In the global Biopharma manufacturing World, and we're pretty confident that we consult but which most likely will require an adaptation of all scale approaches as we manufacture.

Thank you.

Thank you. Our next question comes from line of My do Kumar with Baird. Please proceed with your question.

Sorry about that so thinking about this.

Phase two trial in combination with the digest drug at Paclitaxel. What do you think is kind of the benchmark response rate that is.

Expected for.

I was here, Matt and Paclitaxel in second line gastric cancer specific when these her two positive population.

Hi matter, that's a great. That's a great question. One you can imagine our team has been Oh.

Vigorously analyzing as we consider not just standard of care about of course on emerging standard of care and with that I would like to hand over to a more to provide a bit more color on our thinking there as we as we look at it today.

Yeah sure. Thanks, the friend high Madu. So yeah, I mean, we plan to evaluate the totality of the clinical data from our single arm second line trial and to fully defined the clinical benefits as well as next steps then in development spokespeople for 343, including.

Registration for its were the primary focus on response rates interoperability that's as much as I can say at this point as we get closer to the form of started that study. We will provide you with additional color on the study design, including the secondary endpoints the studies.

We are confident obviously knowing the.

Therapeutic landscape in the emerging therapeutic landscape.

And standard of care that who can achieve differentiated competitive profile for three for three with respect to both the current any emerging standard of care except for several reasons.

You know the encouraging response rate in some of that has been reported today and durability in particular, we've seen in our phase one.

And then the mechanistic synergy between the who want to be agonism of free for three and Robert sort them up.

And the cytotoxic Debulking factor, the chemotherapy and Steve I'll provide some some more detail there on there on the script and then including also the immunogenic cell death of tumor cells that both could enhance immunogenicity you have to tumor as well as children mature but.

I will say that its important to note that the current standard of care was established from a pull talking that wasn't such that phase three rainbow study involving a very small subgroup of about 20 patients with probably I Trust is about treatment and in light of this limitations and the single arm component of our plan study with peers.

Three for three we have designed statistical plan that would include real world data for 'em Robinson them up on chemotherapy, you have to actually more accurate estimate of the Oh the.

Thank you see there can be expected from that backbone that we can you know more accurately gosh the.

Efficacy of that regimen. In addition, our statistical plan will also retain a robust level of powering.

Above 80% of let's say within the context of what we expect to see in the real world data.

And thereby allowing the outcome of this study to meaningful inform also as I said the future registration studies.

Great and to that and if he also thought like what where are your thoughts about running to kind of later line gastric can't hurt you in gastric cancer trial as well with just straight for three monotherapy.

I would say more you want to do you want to does continue to go go with an answer there.

Yeah, I mean, we've at the moment, where we can really just I think that's close to the next.

Stage of our plans and this includes the second line, which we find attractive cuts doesn't preclude any additional activities that we will inform you about one.

[music].

Okay and last part of your what three you guys. So this has been running through the regulators or is this kind of that conversation that's in progress right now.

That's currently in progress.

So we will give you a more detailed updates at the next earnings call. Once we get a cool sets with us. So we'll use of time a while the team is working hard preparing minutes to generate additional data on the on the ongoing phase one.

Okay, great. Thanks very much.

Well.

Thank you. Our next question comes from the line of Chris Shibutani with Cowen. Please proceed with your question.

Hi, Yes, hi, thanks, very much can you just remind us a little bit in regard to a related within three or four three question what kind of benchmark that we have in terms of durability in that patient setting with Oh.

Existing treatment regiments second line and also can you comment a little bit about what's your thinking is about what you're expecting to see when you talk about changing or dosing between Q2 weeks weekly [laughter]. Thanks.

But the great. Thanks, Thanks, Chris I think that's a two part question I would suggest maybe anymore can can briefly go over the first one which are they getting benchmarks on more durable assets I see I suspect you wanting to talk about PFS and OS Oh second line and.

The second question was with regard to the rationale for the those he bianco word 11, beep and why either adjusting the frequency or the absolute those may or.

May be relevant to a recommended phase two dose and I would suggest the chain maybe could get into the biology on afford won't be because that's principally it.

At play there. So why do we start with Ingmar you want to go over and getting more back to two the rainbow.

Tend to treat and maybe a retrospective her to analysis than any other didn't think is relevant before turning over to change the talk about the problem you He biology, driving our additional escalation strategy.

Yeah sure. So as you know I mean, the the the.

I think regulatory benchmark, if you will a registrational benchmark is still in will remain the Rainbow trial and if you look at.

The.

Yeah I just keep population. There then we see a 28% overall response rate and the durability in terms of median PFS about five months.

You know the post hoc analysis of the Oh the her two positive population as mentioned before showing a higher all our but it's a very small population. It's actually the reason why we think we will utilize rewards data to Oh come from.

That or or having more actually regrets after that the the durability.

In terms of PFS, that's been the same before that's population.

Overall I'm study population we of course also mindful about emerging standard of care and that's probably something youre, referring to while we watch that's.

All I can say in this context, so far it's Scott.

Direct setting off second line, we still you know where you can see.

A more definitive data.

No actually come up with an estimate, but we will provide more color on this as we get closer to the to the startup for trial.

Okay, Thanks, saying Maher and Shane again, if he wants to comment on any of the synergy that would give us a believe well you know our high level of conviction to achieve.

Meaningful endpoint on top of standard of care. You can also take time to do that before going into the the Hum nuances of further a further escalation if you want to.

Yeah sure maybe just to Arthur Wang Merseyside, you know what gives us a lot of conviction about the second line obsessing that opportunity is that we feel there's a real opportunity for synergy between the mechanism of here are three for three or four would be agonism when it comes.

The man tree I'm components of.

I think badger therapy on chemo or chemo component, there and when we look for our clinical car Carla trips, where we can then for the this is worked you know and personal I know, it's not sold on small cell lung cancer. We see these types of agents train Barry.

Well the therapy I'm, you know, resulting in the approval there for for the times, though combo.

As part of the empower one shift to trial and likewise, you know we've seen it in other indications where no more recently <unk> and or see see where I'm again, you've seen a real benefits or complaining.

So.

And your legs for whether or not you guys got therapy on what chemotherapy that can can help in tumor debulking.

In terms of the second the second question no water, we look into and out of the I'm additional cohorts and the different schedules were lucky not and Theres. Certainly you know information that will help or the go forward on Prs 343, but no fundamental.

This is the first program out of our core BB franchise, we want to get as much of an understanding of the what it takes to ultimately activate T cells by four and be in this program and you know when we think about similar.

Relationship there would be won one question that certainly between the C. Hardwoods, you need to activate continuously or would you rather give some sort of the dosing holiday to T cell so that it's not continuously stimulated.

Looking at the behavior over molecule across Q3, Q2 and weekly dosing.

So it's ER Doc sort of information then you know what Weve also disclose that that's it two years. That's part of this trial weve been able to a Monday heard biopsies that's allowed us to already start lucky not card. It serves between our T cell activation.

Well the increase in the tumor microenvironment post therapy and we've also got plans to do additional PD Carla So no what we're looking for out of the trial as the totality of data that.

Confirms our go forward sign up your Threeq or three but also informs do the follow on pipeline.

Great. Thanks to the just some color.

Thank you, ladies and gentlemen, as a reminder, if you'd like to join the question. Please press star one.

Our next question comes from the line of Matt Fips with William Blair. Please proceed with your question.

Hi, Thanks for taking my questions I'm personally I don't suppose you'd be able to disclose what tumor types. The additional responders 54 or three trial.

Oh, no we're not going to comment on the additional tumor types or data beyond that we feel is most appropriately.

No I'm coming out in the context of a conference by the clinical investigator.

As you might expect Matt Thanks for the question.

Okay, then on Olympic though just wanted to all activities on your end been completed and and kinda transfer Astrazeneca yet.

Some lower dosage levels.

That were being looked at earlier this year.

Yes, So I would say we are you know in an active support role.

With who I think is a very committed partner.

Who has defined process. These four program progression like like the progression from phase one phase two way, which is where our program currently is [noise].

At this juncture any of course with all the the standard coded 19 related Kathy odds, we believe all phase two a readiness activities are going to according to plan, including our delivery to Astra Zeneca of phase one de clinical trial data that's needed to inform than official.

Forward decision in accordance with their governance were also playing an active support role in drug product manufacturer regulatory interactions and clinical trial site activation.

With respect to your specific question, Matt, Yes, we do believe we have generated.

All necessary data from the phase lumpy to inform that decision.

Thanks, Dave and then one last quick one with the 344 manufacturing I mean do this.

Yeah, just something specific to the.

I don't know 13 or or cell line up 44, or as the kinda additional manufacturing work something that could be beneficial to future.

Products that one.

Well I was wondering I wouldn't I would I wouldn't I would turn that back over to hit till I would just say that again based on the.

The commitment other parties based on the expertise we have both under his leadership our team in art in our vendors and our advisors were confident we can we can work through this internet expedient manner covert Cobot 19 Committee.

I would I would just finally said this building block any kalen, that's linked to the PD one antibody.

It is the same for while BB and he can't work that is attached to the I've heard to engage in antibody for 343, so well know to buy specifics are the same even if having a building walking common that also gives us some hope.

But I think your question also.

Went to maybe be positive learnings and read through through through the other forthcoming work on ongoing work here, so without maybe I'll turn it over to hit two if he can provide any more color feel free to do so its a.

Thank you Steve Yes at first of all just as a reminder, it was something that happened or that well we observed scaleup differences.

<unk> product part of the off the manufacturing so those are ways like for example, the Sedline hard.

Let me frame it like this in the end these relatively sensitive systems of manufacturing drugs from mailing sales are influenced by the drug but also by as we think will step up the manufacturing processes and even every single component of the actual then actually facility.

Sets up so we can't leave you with its something that is specific to the combination of the three.

I would say they will be a positive living effect.

Mainly for this particular drugs, so probably we will start phase one with having much more knowledge than you would typically happen at that stage because of the issue that we run into will there be learnings beyond that we will have to see I don't think we can say that at the moment.

Yeah. Thanks.

Thank you. Our next question is a follow up from the line of Jonathan Miller with Evercore ISI. Please proceed with your question.

Hi, guys and thanks for letting me I happened to follow up a as a follow up to just last question on the before it's actually challenges what does the sort of you said you your views there both investing in it gives you manufacturing and and fixing the scale up issues. What is the this sort of activity.

Wired by both you and Servier to accomplish those goals is this mostly something that you were doing to provide them with material or is this something that didn't play their facility that is when it gets into a which partner is responsible so it's an activity.

Yes, again, thanks, John I would again, probably hand, it back to hit two for more specifics, but you know I would I would just mentioned, it's a collaborative effort both internally at both parties and with our our and our vendors that are involved in multiple vendors involved in this this overall.

Offsets to get to released drug products and right now I reviewed and I've discussed a what I think is a very thoughtful plan that looks at multiple aspects and confident that the team has come up with jointly with San Diego thoughtful plan, one that is executable on realistic timeline.

And so hit though might be able to going a little more detailed technically if he feels comfortable but I'm I just wanted to mention that at the outset. So it till I don't know if there's anything more you can say or maybe you've said everything already.

[laughter].

Thanks, Steve just maybe a two comments just to confirm what Steve said.

The <unk> seems to be part of this joint development project is very much aligned at every step between the two parties.

And the vendor network that we used to manufacture the drug is of course third component in this.

And just to conclude it is something that has happened another drug manufacturing campaigns for other drugs before and that gives us confidence that with adaptation, we'll be able to so.

Good thanks, guys understand.

Thank you ladies and gentlemen, this concludes our question and answer session I'll turn the floor back to Mr. in order for any final comments.

Hi, Thank you Melissa I, just want to conclude by thanking everyone again for their attention and for your continued support or the company. We look forward to keeping you updated on all of our process progress during that time and.

Thank you for joining the call how great day in and stay well. Thank you very much.

Thank you. This concludes today's conference you may disconnect. Your lines at this time. Thank you for your participation.