Q1 2020 Earnings Call
[music].
Good afternoon, and welcome to Kodiak signed just first quarter 2020 business highlights conference call and webcast.
My name is Chelsea and I will facilitate the audio portion of today's interactive broadcast.
At any time you need immediate assistance during the conference. Please press star zero to reach an operator.
This time I would like to turn the conference over to Mr., John Boris Johnson CFO of Kodiak, Sir please begin.
Thank you for joining Kodiak Sciences business highlights conference call I'm, John Borgeson, Kodiak, Chief Financial Officer.
Joining me today, our Victor pull Roth, Chairman and CEO, and Jason Ehrlich, Chief Medical Officer in Chief Development Officer.
After our prepared remarks, reviewing updates to our business, we will open the call up for analyst Couponing.
The webcast portion of this call contains a slide presentation that we will refer to during the call.
Those following along on the phone who wish to access the slide portion of this presentation. They do so on the events and presentations section of our website.
An archive of this webcast will be available on our website soon after after the conclusion of this call.
I would like to remind you that remarks made on this call. Today include forward looking statements regarding our business financial guidance. The initiation enrollment conduct in results of clinical trials or regulatory strategies are research and development activities risk related to our business and.
Certain other business matters.
More complete description of these and other material risks can be found in Kodiak spellings with the Securities and Exchange Commission, including form 10-Q for the quarterly period ended March 31, 2020, which was filed with the FCC yesterday.
Cardiac does not undertake any obligation to update publicly any forward looking statements, whether as a result of new information future events or otherwise.
During the call today, we will review the impact to cope with 19 on our ongoing operations provide corporate and clinical updates.
Describe our upgraded K aside three a one pivotal program.
And discuss how we will execute on that program to meet our 2022 vision.
Well this call is intended to focus on reviewing operational highlights and not so much to discuss financials I would like to take a few mountain moments to discuss the strength of our financial position as detailed in our 10-Q published yesterday.
On the heels of our successful funding fundraising efforts in December 2019, we ended the first quarter of 2020 with over 430 million in cash cash equivalents in marketable securities.
During the first quarter, we posted a net loss of 24.4 million, which includes noncash expenses of about 6 million.
Based on our current projections, we estimate that our cash runway will be sufficient to execute on our current operating plans into 2022, including through topline read out of the dazzle study.
So far our cash extends into 2022 is dependent on a number of factors, including how aggressively we choose to invest in pre commercial preparedness.
As we move forward with our 2022 vision of a single B O <unk> BLE application covering the key retinal indications. We also expect to have access to the second tranche of 125 million from our royalty transaction.
I'll now turn it over to Victor who will review business highlights from this past quarter.
Thanks, John.
Good afternoon, everybody. Thanks for joining us for this first quarter 2020 business highlights webcast.
You want it to hold the call to discuss the recent business highlights, including progress with the development of our pipeline and you know to be clear in terms of how we're managing through cobot 19 and impact.
I'm proud of their dedication of our team the Kodiak employees.
And our you know Kodiak community more broadly as we all navigate the challenges of the Cobiz 19, pandemic and you know which team continues to deliver on our mission of helping patients with very serious retinal diseases.
So to date, we're seeing minimal disruption from cobot 19, our labs, our operational and from a manufacturing and the clinical standpoint, we're proceeding and proceeding well.
In dazzle.
As will discuss in more detail patient Miss visit rates are less than 5%.
And clinical trial sites continue to enroll new patients.
This is a testament to the serious diseases that were attempting to treat here at Kodiak and it's a vote of confidence from the patients physicians and the study sites, who are partnering with us to advance KC 301 towards the market.
As John mentioned, removing noncash charges, our monthly burn rate. This past quarter was only $6 million per month, so with over $430 million in cash and equivalents at quarter end, we remain on a very strong financial footing.
Now as of today, we did delay initiation of our next set of Ks Eyeq three a one pivotal studies by one quarter.
We were planning first in human in the June July timeframe, and we've now shifted that.
Planned first in human after the additional Pivotals for KFC three a one to the September October timeframe of this year now we're using this time why easily not just to assess with physicians and our business partners, how best to minimize the impact of cobot 19 on clinical trial conduct but one.
To optimize our pivotal study designs to do engage with regulators on upgrades to the pivotal program in three working with our partner companies in particular on manufacturing and clinical terms of execution and to the structure of our relationships there to put them in the best possible structure.
For this next stage or face of escalation an acceleration of Kodiak growth.
Importantly, our 2022 vision towards a BLA filing in the key retinal disease indications remains intact.
And as I mentioned, we've taken good advantage of the additional quarter. This additional time to upgrade our pivotal study plan for quayside, three or one and Jason will discuss that in more detail.
In summary, though we now intend to conduct a two phase three studies in DMD.
Diabetic macular edema, and one study in wet AMD, our ongoing dazzle study and one study in our view.
And one study and non proliferative diabetic retinopathy there are multiple reasons for this shift into two DMD studies and one our view from our earlier plan, where we had proposed to ARVO studies in one DMC study.
On the operational front with this new plan, we expect a more predictable execution of the studies and of the pipeline and the plan in other words, we expect that Clin ops component of the DMC studies to be faster simpler and more predictable.
And we also believe we'll be able to run studies in fewer countries and fewer research site, which is an important simplification.
Despite this up returns predictability to the program and is particularly important in light of coded 19, especially in the ex US geographies further we prefer to shift resources on the margin into the higher prevalence higher unmet need disease of DMD, rather than our view DMD remains the leading cause of blindness in working.
Page adults in the us and you.
Importantly, the data that's continues to emerge in our phase one be study.
Remains very consistent with observations that we shared in February and we look forward to providing a next R&D update on the phase one data in July of this year that will either be virtually at the American society of retina specialist meeting.
In other words, either in person at the meeting or if that goes virtual either through one of our partnered clinicians right or through a webex similar to this.
Operationally, we've taken steps in line with guidance from CDC in the state of California to protect the health and safety of our employees in the community and that Kodiak as a company you know we've implemented remote workers arrangements for non essential employees since March 17th, notably, though as I mentioned, we continued to be operational in our laboratory.
Yes.
I'd like to plus here and hand, the call over to Jason Jason could you talk about how we're managing ongoing clinical trials through cobot 19, and also introduced the new case III one pivotal study program.
Well, thanks, Victor and good afternoon, everyone. Thanks for joining us.
Yes, so over the last few months the Kodiak team has been focused on ensuring patient safety and data integrity in our ongoing care sector. We are one clinical trials. The phase Oneb study, which is in patients with Dnbi ARVO and letting MD and then dazzle our pivotal study in wedding, Andy that compares cancer three a one standard.
Care Aflibercept.
So we've made numerous enhancements into the ongoing study execution and planning really to help ensure the safety of patients physicians study site staff and Kodiak operations team members as much as possible. So some of the specific actions that we've taken include the use of remote study monitoring which temporarily increased study site.
I should overhead rates to help with additional time, that's required for the studies into the appropriate ERP and so on.
Providing additional transportation service options for patients to make sure that they can.
Safely and comfortably attend the study visits and we've also been focusing new patient enrollment only at the study sites that have appropriate backup resorts plans in place and importantly, where the local coded 19 situation allows.
So work been actively monitoring the ongoing trial participation and we're really being as proactive as we can look with the study sites, our corporate partners, such as our CRM and logistics vendors as well as regulatory authorities to safeguard study integrity and promptly response to potential disruptions.
And in light of the efforts undertaken by our investigators and their teams as well as our team.
And the high risk of permanent vision loss, it's presented by the retinal diseases that we're trying to treat with case like everyone I'm happy to say that existing patients continue to participate with very few mr. visits to date or less than 5% Mr. visits in the overall in March and April and our new patients continue to be enrolled.
In the ongoing dazzle study in the U.S. again, where it makes sense based on the local could situation to do so.
Maybe just some additional color on the efforts that specialists to their staff for making to try to continue in C patients, who need anti VEGF therapy as well as the seriousness of those diseases. The pattern that we see in our studies. It's also reinforced by EMR data collected by best from Health and others. That's been published recently.
So you may seem that overall ophthalmology outpatient visits in the U.S. were down by some 80% in March and April and retina specialty clinics themselves saw declines of over 45% patient visits in March in early April but the proportion of those visits that were for energy Digest administration.
Was up substantially so meaning that the retina specialists, we're prioritizing patients who need anti VEGF therapy and they continue to do so.
So I think that's really highlights the importance of can't say three or one.
You know a law a safe and long acting therapy can help keep patients on therapy in between less frequent office visits.
Potentially improve real world outcomes over time.
Particularly in the study where may become more difficult to readily accessible clinic such as these this pandemic.
I went back to dazzle them as with me Ace 2020, 245 patients have been enrolled into dazzle through most of the first quarter recruitment into the study was very robust the reflection I think on mute the enthusiasm for kids like three one on the part of investigators and patients as well as a underscoring the unmet need for long acting therapy.
So currently we do not intend to pause screening or enrollment into dazzle in the U.S., but we are seeing slower patient enrollment compared to the 50 plus patients per month that we saw in February and March.
As part of the cobot measures that I discussed earlier, we issued guidance encouraging study sites to prioritize participation of currently enrolled patients over enrolling new ones if necessary by for example, due to staffing limitations or off site closures during the pandemic.
And then as if our late April the number of weekly new patient screening and enrollment at dazzle sites in the U.S. is increasing.
And I'd note that we also see that in industrial each our data that was published last week showing that retina clinic volume is starting to turn around in the U.S.
On the European side in the first quarter 2020, we had actually activated.
DASL study sites in Europe, but then due to the pandemic, we deferred the start of patient screening.
But we do now expect to begin patient recruitment activity at certain sites in Europe in the second quarter of 2020 again as guided by the local covert 19 situation.
And then finally with respect to dazzle I'm pleased that the independent data monitoring committee met in early May and recommended that dazzle continue without modification.
As you know the Idmc as the group responsible for safeguarding interests of Dazzled study participants assessing safety during the trial and monitoring overall study conduct.
Sarah.
Grateful for their support and as well as their recommendation.
So then turning to the rest of the pivotal program in the interest of monitoring the progress impacted the Colgate 19, pandemic particular mentioned, we delayed the initiation of the next set of catch real in pivotal studies for DMD and audio into September and October October of this year versus the previously planned June or July timeframe.
We're still evaluating whether we can initiate the MPPR without the study on the same timeframe, we're expecting a potential for a one to two quarter delay additional delay in the MPD our study start.
Due to the pandemic, resulting in deferral of diagnosis and follow up in the end TDR patients as you know those patients have a lower overall disease severity in patients with wedding and B B I mean, our view.
So more on this in a few minutes. Additionally, I'd like to note that our supply chain and manufacturing activities remain intact and we don't currently anticipate disruptions to our supply of case like three or one due to the pandemic <unk>.
Moving away from coded 19, then I'll, let me turn the call back to John to go through some additional recent business highlights John.
Thank you Jason.
As many of you may remember, we announced an agreement for the sale of future royalties of case I three a one for 225 million on December one 2019 during the first quarter of 2020, we closed on the first payment under the agreement receiving $100 million on February 4th of 2020.
I'd also like to say a few words about our board of directors.
In the last several months, we've made two strong additions to our board with the addition of Dr. tie in Yang and most recently Charlie Bancroft.
Tandem currently serves as executive Vice President of pharmaceutical development and manufacturing, a gilead and brings deep experience and leadership with commercial manufacturing and quality operations.
Charlie was formerly the Chief financial Officer of BMS and brings a wealth of pharmaceutical commercial and financial experience.
The cost the combined experience of tightening and Charlie supplement and already deep well rounded board with knowledge that will be instrumental as we accelerate our planning towards the L.A. in commercial launch.
Lastly, I would like to quickly comment on the continued progress with our IP portfolio. Most recently, we received full registration of our trademarks Kodiak and Kodiak Sciences with the U.S. patent and trademark office for our exclusive use further establishing our name records a recognition as a leader in research and development of medicines.
To treat and prevent retinal diseases.
With that let me turn back to Jason to further elaborate on more clinical highlights Jason.
Thanks, John.
So with respect to the phase one beat study, we presented updated safety efficacy and durability data from the ongoing phase when the trial of Kids factory along at the Asia Genesis meeting back in February and we believe that the data continue to support the highly differentiated anti VEGF generation 2.0.
Profile of cancer three in one.
And we plan to continue presenting data updates from the phase Oneb study throughout this year, and if meetings or congresses or canceled due to coded outlet becomes virtual we would anticipate one or more virtual R&D webinars, where new data will be presented so as Victor mentioned, we're pleased with the data that continue to be generate in phase one be and we look forward to providing the.
Next important R&D update in July either at the a Srs meeting depending on whether and how that meeting occurs or else is a virtual R&D webinars in.
In a similar timeframe.
And as we collect additional follow up data on patients in the phase would be out to nine months 12 months and beyond the focus of those presentations will start to turn towards long term outcomes and the durability of the durability of fuel. So we look forward to sharing those upcoming data with you over the course of the year.
Starting with the presentation in July and then Furthermore, on the face when be you know again based on positive feedback from investigators and a desire to continue to generate long term safety and efficacy outcomes data with kids say three or one.
We further amended the phase when the program to include an additional 18 months of treatment and follow up per patient for a total of up to 36 months and I'd note also that in the phase. When these study alone. We're now approaching a 100 patient years of exposure with case I three alone and continue to be very pleased with the safety profile that we're seeing.
So then moving on to talk about the can't say three or when pivotal program. Following our communications with the FDA at the time at the end of Phase two meeting as well subsequently we further upgraded the pivotal study program and as Victor mentioned, we now intend to conduct two phase three studies in diabetic macular edema.
To provide the mutually confirmatory studies required by the FDA for initial demonstration of safety and efficacy and then a one pivotal study in wet AMD D ongoing dazzle study.
One in retinal vein occlusion and one in non proliferative BR without DMV. So by conducting the paired studies in D.N., we were able to generate additional data on the safety efficacy and durability of case that three alone in this area of high unmet need and commercial opportunity. While also narrowing the number of sites in countries that's required for successful enrollment of.
The entire pivotal program. So we expect the majority of research sites to be located in the U.S. with contributions from certain countries in Europe, China and potentially Israel.
Given that we're currently seeing continued new patient enrollment and low missed visit rates in dazzle in the U.S. through the pandemic, we believe that refocusing the case I feel one program and narrowing our.
Focus in terms of number of sites and countries, we're really help us minimize uncertainty with respect to trial conduct during and through the pandemic towards our 2022 vision.
A few additional specific reasons for running the paired DMV pivotals and one orbio as opposed to the other way around.
Include fewer countries insights needed for two DMV studies versus two Orbio studies, which will help with both the cost and logistical burdens of opening and supporting trial sites that might only be needed to participate in the Orbio studies.
Next I think we'll have better overall oversight of operational execution essentially all of the sites that were running our studies and concurrently enroll naive patients and wedding, Andy the or Orbio.
I think we'll have a lower probability of coded related disruptions over time since the scope of countries insights is more focused.
Kill It Victor mentioned, there's a higher unmet need in DMD compared to our view and then it's a marginal if any increase in overall trial execution costs given the similar timeframe through two DM you studies versus two our views.
And then on top of those you know really operational considerations, we remain quite pleased with the DMD clinical data that we're seeing in the phase when B study and why don't you want to align the area of greater clinical data generation DMD given the large number of diabetic patients in the higher unmet need a there as compared to our excuse me as compared to our view.
Now we've been asked if we're going to make a change to the pivotal program plan why make it to de studies as opposed to two wedding. These studies.
And we think two CMU studies makes more sense for a couple of important reasons first as you know from a statistical perspective, the standard deviations or narrower and Dnbi and a non inferiority margin is four and a half letters and dnbi for a comparison to aflibercept, whereas it's for letters little bit narrower and wedding be so when.
Yeah, those things up and additional wedding and do study would require at least the 100 more patients than the Dnbi study.
I will be fairly substantial cost difference.
A cost is not of course really got you know the only driving factor or a driving factor.
When we look at what's happening.
In the community with so many people who are unemployed due to coated and potentially losing access to their health care.
You know working age people the opportunity to participate in their clinical trial.
Where they could have.
Access to high quality care through a retina specialists. So the two year duration of the study you know I think that's also important.
And that should so we believe that the two d. and these studies should recruit relatively quickly.
I am, especially in this environment and also whether you'd be patients given that they are quite elderly or you know really almost at the highest risk of coated related complications.
So to the extent that those people are.
Less willing to go to the physician I began we think focusing the two studies on on DMD makes a lot of sense.
So then finally before I hand, the call back to Victor one other quick note on the acceleration of our bi specific con should get the kids I five a one program.
As you May remember cash like five or one inhibits both aisle six interleukin six as well as that Jeff and I. All six blockade is being explored as a novel therapeutic strategy in patients with severe and critical coded 19 disease.
Now that Jeff is also a potent inducer of vascular permeability ended DEMA, which may play a pathological encoded 19, driven lung assumption.
Oh, Gee 2072, which is the bi specific fusion protein that we use to build our ophthalmology product candidate Kiss I fiber one.
Binds with high affinity to both of its target simultaneously, both iosix ends that Jeff and it shows some quite interesting synergistic inhibition of those mechanisms in vitro.
So we're advancing by six months the GMP manufacturing for the OGC 2072 protein, which may enable an assessment of systemically administered oji 2072 in patients with worsening coded 19 disease.
And ancillary benefits of acceleration include the use of GMP material for the kids I fiber, one toxicology program and a more predictable I and de submission and first in human timeline for the bio conjugate case I fiber one.
In 2021 in patients with retinal vascular disease, featuring an inflammatory component.
So now back to Victor to wrap up our or remarks, and before we get into today.
Thanks, Jason.
Yeah, I think it'd be helpful. If we reviewed our upgraded case I a three a one clinical plan in portfolio quickly as illustrated on slide five and this refined flight kind of brings together the upgraded program and as we work to finalize the study protocols across the program and including the number of.
Subjects with each study of being powered really to 90 plus percent. So the slide five shows our current view of the clinical studies other timelines for first patient and and last patient and.
The overall treatment duration and the refer you into topline data availability and this a program and strategy. Obviously feeds are in parallel 2022 BLE filing plan.
So it's a nice to see.
This refinement of our clinical plan, which the one be ongoing the dazzle study continuing to enroll and our plans to initiate the paired DMV and the audio pivotal.
In September hopefully and then the NPV our study we'd like to bring it on board as much in parallel, but as Jason mentioned will depend a little bit on the clinical communities guidance in terms of weather, where credit credibly going to be able to bring those patients in during the pandemic and door.
What's happening with the pandemic come Q4 into Q1 for next year.
Okay.
So moving into slide six.
What we call sort of the four pillars of retinal vascular disease.
As we continue to finalize the pivotal study designs in the program where of course guided by the phase one be study design and the data.
Which directly educate our phase three pivotal study designs. So in addition to informing the design of the pivotal studies the phase one de data. We're generating is lending we believe a very high degree of confidence.
Nimble to hit the primary endpoint in studies and to clearly differentiate case eyeq three a one on durability.
So these pivotal programs.
Each study alone and even more powerful together.
You can support a very highly differentiated target product profile, what we increasingly call sort of the generation 2.0 profile are real and obvious shifting of that treatment interval within each one of these diseases right part further to the right.
With a clear white space between us and our comparator I Leah.
So we're also thinking through the marketplace that will be entering in 2023.
Given a highly differentiated profile, we're actively assessing also the manufacturing capacity desired to supply. The first years of launch. This assessment you know includes the branded agents.
But also assesses the upside opportunity forecasts I have three or one of capturing monthly have asked in patients and injections as well.
So this slide.
Nick is a bit of an important summary that lets us look at each of these four indications forecasts I take a look at some of the data that's being generated from the Wendy.
That data helps us design and lock in on the protocols in our pivotal program and let us think a little bit about the target product profile that we may end up with.
In terms of Noninferiority, a vision in the core Pivotals as a primary endpoint and then that core differentiation on durability, which is meaningful within each one of these indications and we believe lens of very high overall profitability of success to the medicine in each one of the Pivotals together into a very powerful profile as we think about the complexity.
Of the market that will dropping into.
Moving into five seven.
Really the pieces of our efforts across our pipeline are captured well by this 2022 vision slide the breadth of the indications were evaluating in parallel.
Forecast by three or one really reaches a.
The crux or in apex in 2022 with our plans for a single BLE to be filed for wet AMD D.D. I mean, our video and if we can get the NPV, our studies going with the right level of enthusiasm and momentum potentially D. R 12.
So for cats I fiber, one we hope to benefit from this manufacturing acceleration that Jason mentioned, which also increases our confidence to achieve an eye, Andy and first patient in in 2021.
And we're thinking about a combined sort of phase one a one be type study for case I fiberlan, because that's worked quite well obviously for the case I trio one in terms of.
Evaluation of safety, but also a utility of the molecules and lastly, we're seeing a very interesting progress internally with our new triplet inhibitors. In this case case, isix or one which were bringing together initially for dry MD and we're also looking forward towards submitting an R&D for that program in 2022.
Moving on to slide eight.
We've achieved a quite a lot in 2019, so looking to 2020 will be excited to present additional data as we mentioned from our phase one be that details the durability of the durability of case Eyeq three a one and we expect to present data at the Srs virtually or through as we mentioned to Kodiak hosted virtual event. So we.
Looking forward to July for that new data update we continue we will continue to execute on our dazzle study in wet AMD patients and move that execution also into Europe and ex us.
And will activate the full Kansai three a one pivotal program any additional indications in 2021, we'll continue to report data from our phase one be study and execute on our clinical operations with a potential dazzle pivotal study readout.
Furthermore, will seek to advance case I fiber one into the clinic 2022, obviously is a massive year for the company as we detailed in the prior slide our vision is to report multiple pivotal study topline readout in 2022 and submit that single B away in the big indications in 2023, then we're planning for regulatory.
Hello, and commercialization of case I have three a one in key geographies.
So in summary, we're very pleased with the business highlights for the first quarter.
And first part of the second quarter of 2020.
We believe we are well positioned and we're looking forward to accomplishing our goals for the remainder of the calendar year 2020.
We'll now open the floor to analysts for questions.
Operator, yes.
Tom If you would like to asking question you make you still by pressing star one on your telephone keypad. If you are using speak I found keys make sure. They function is turned off to a lot you're sick not to reach.
Again that is still I want to ask a question.
And our first question will come from an anti Mama with JP Morgan.
Hey, guys. Thanks for taking the question is not on drawn upon so first off well done with being so our job around through one development to be a session and keep timeline to division intact as much as possible.
Good job there I guess one thing we've been trying to think about is little more forward looking and relate to competition from additional bio similars across indication and what these retinal markets might look like when three olin potentially launches. So if you could just comment on how you expect market dynamics at play out.
That would be really helpful. Thanks.
Sure.
Well.
On a problem I think up.
We are focused right now on the acceleration in the clinical execution and making sure that we have the right pivotal study program right that the designed to those pivotal studies. Both are educated from the phase one d. So we can have a very high probability of success and those studies.
Which we think we will and also that the endpoints in the durability that we'll be able to show are really going to be meaningful and I think what I mentioned as we like to think of it as this generation 2.0 profile, which as you know we're gonna be shifting that distribution with non inferior efficacy and safety, but shifting the dosing interval that distribution substantial.
Each of the right in each one of these indications versus say I, Leah and I think what's really special about the data that we're showing and I think predicated on the underlying design of the molecule. It right is.
Really having a lot of white space between us and I Leah.
So we think that's really important to be really differentiated and not coming out as incremental if we can do that.
We we believe will first of all being up you know a very strong position right. What's the complexity of the market like in the 2023 2024 2025 timeframe.
We believe as we've mentioned that bio similars will be important for the branded agents. So lucentis biosimilar circling loose and to share and I Leo Biosimilar is whenever they come out exactly for example in U.S market.
We'll likely Italia share to some degree.
You know, we're getting smarter I would say on some of this I believe you know in in a way the written a marketplace is.
Like us spec pharma no with high concentration.
We believe that.
Hi, K ESI as a branded molecule there are lot of incentives that will drive the the physicians for sure, but maybe even payers to support Catseye SP plus six for example.
We don't see a lot of incentives for say, leading players like regeneron to really compete say with bio similars on price and of course bio similars in retina are gonna have to be more cautious and take things to a higher level of excellence in terms of manufacturing consistency. So.
Those are a lot of words I think the key is that we even believe there's the possibility for us to be able to eat a vast and share if we really bring a molecule like kansai with this important target product profile benefit differentiation, and then vis-a-vis lucentis and I Leah, we think there'll be an incentive to go with an attractively priced.
Okay OSI three to one molecule for retina docs, who can bring a better pino molecule for their patients and perhaps make more money with our branded molecule. So you know we think we're going to get smarter as we continue to build this kind of pre commercial kind of keep ability and knowledge and investment for Kodiak, but we think you know for right now.
We're making all of the right decisions in terms of our pivotal study protocols and designs such that when we come through this program with all of these indications in parallel and fall into the market that we're doing it in a very thoughtful manner that we can compete and access branded share and a key component of all of this as well what percent of the branded market.
Do we think we should plan to capture from a manufacturing standpoint in years, one two and three and I think we hope that's going to be a big number and so we're working from a manufacturing standpoint to be able to service them.
Great. Thank you very much guys. Thanks for taking my question.
Thank you.
Our next question will come from Michael Yee with Jefferies.
Hey, guys. Thanks for the update Ah Thanks Victor.
Two questions. One is you commented on enrollment in the press release and I thought this was pretty important given a it's kind of a gating factor too to getting data can you just comment about what gives you confidence in the timing for completion of enrollment this year and AMTI. What are you seeing and in April and May the shape of the curve and what gives you that coffee.
Then just to talk about these timelines that would be helpful. And then second question is contingent on those timelines that you've laid out I think we're all very excited for the data for AMTI in 2021, potentially but is there any chance given all the things that have a I've gone on our or shifted that there's a chance you look back at that potential interim analysis.
That's built in and say Hey, what are the factors that we could look at this and don't have to wait 10, 2021, maybe just talk about that and and whether that's totally off the table or that's something that's still technically possible. Thanks. So much.
Right, Yeah, Hey, thanks, Thanks, Michael I think you know on the wedding MD timeline.
We were enrolling 50 to 60 patients a month in February and March.
We have close to 50 sites activated in the United States. Our objective is to have another 50 sites by and large activated globally right for a total of say hundred sites across the program.
You know we are even through let's say you know into March and April up you know enrollments were say 25, plus patients a month and we expect that to increase.
Certainly.
Through the end of this year, you know, we're not going to fall on the soared over finalizing enrollment in dazzle. This year I think if you look at what we've put as we kind of put potential.
And the reason you know isn't that we could not we could actually jam the enrollment through I believe with.
Done in a thoughtful and safe manner. It's just we also want to be thoughtful about what percent of patients in our pivotal program do we want ex us because in wedding Emdeon deal I mean, we could rapidly enroll those studies completely in the United States, but we don't want to do that and we have to make a determination is it going to be 15% 20 or 25% of these patients.
In these studies that we want to have from the ex US site and so you know given slightly more complex dynamics in Europe.
We're going to be monitoring that fairly carefully and so in the end. We may hold the study is open in terms of last patient in a little bit longer to bring up the ex us component so that could drive topline data for say dazzle.
Further into.
I guess that would be like you know early 2022, and then that's sort of means that you know this whole pivotal program would sort of be converging in terms of topline data coming out of multiple studies with very quick succession.
We don't see that really really has a negative.
So okay, how does that.
Impact our view of looking at an interim kind of data analysis.
I think you know with the current we were surprised pleasantly I think that physicians continue wanted to continue to enroll patients in our studies you know, let's say in March and April and that we were able to successfully a do so.
So you know and we see things opening up a little bit and with enrollments shifting up in our desire to begin enrolling in recruiting randomizing patients in Europe, starting almost immediately I think.
So you know things look up I mean, if things were to take a very nasty tumble in terms of covert 19 right in enrollment went to even worse than they were in March and April then I think we could revisit the idea of some sort of interim you know because we're close to 250 patients enrolled so at a one to one randomization of like 125 patients per group that begins to.
To be sort of interesting.
But I think you know we don't see that today that things are getting worse, we think overall, it's opening up a bit for us that we should see enrollment rates go north.
Certainly north of where we are today of 25 to 30.
As we activate ex us I don't know exactly what monthly number will get so I think you know as long as things continue to have a reasonably upward trajectory right. The concept of like we're very well capitalized now we don't need the interim as a financing catalyst and rather rather we're really focused on running these studies in parallel and driving towards that topline data and.
We think that will be really powerful on I think we want people to focus on look what do people think is the probability of success of our molecule based on the phase one data right of hitting the endpoints in terms of noninferiority of efficacy of vision right and with a fundamentally differentiated durability, what do people think that Trs as for our mall.
You'll in these studies and had to people think about the receptivity right up clinicians in the marketplace to our molecule and I think the answer hopefully is that we have a very high peak Trs.
Unless we get hit by a bus and if Thats. The case I think you know maybe you want to get an early as a shareholder because theres not a lot of free float available. We are tightly held to a large degree and we're very pleased with the ownership that's fairly concentrated with a lot of long only funds as well as early on.
So you know if you're excited about Kodiak in our profile you you want to be excited early because otherwise you're going to pay up later.
Lucky.
Thanks appreciate the perspective.
Hi, Thank you.
Next question will come from Matthew Harrison with Morgan Stanley.
Hi, Thank you Mr. smack score on purpose Harrison can you comment at all about that.
Regarding the re dosing criteria for the phase three trials will be different than the phase one vitro and in any way could alter the the Pos Thank you very much.
Sure Jason you want to handle that maybe across the portfolio of studies.
Yes sure.
Thanks So.
Call for for Dazzle, we tightened up the criteria a little bit between the phase one D and dazzle and again speaking about what's the different purposes of those studies.
No the phase one be as an exploratory study to help us understand or how the medicine is performing.
In the clinic in these different diseases and.
There's sort of course, you know the pivotal study at the end of the day as a non inferiority study against active comparator right. So.
And it is dazzle, whereas.
Whereas in the phase one be the criteria are for determining when somebody should be treated in dazzle.
And because they'll get to in DMD say.
The criteria are more for regrouping right for in Dazzle is the patient on 12, 16 or 20 weeks dosing.
On a going forward basis, right, not whether or not they get retreated. So the purpose of the criteria is also a little bit different now that being said right as we presented it into a genesis if you overlay the dazzle criteria on top of the.
You know wet AMD patients in the phase one be actually you know it looks quite favorable rate with.
No the time to first a meeting of those dazzle regrouping criteria was.
At that time for <unk> and that cohort like 12.5% of them would have.
Met those criteria at.
But 12 weeks 12 and have personal debt at 16 weeks and everybody else like 75% of the patient SEK five months or 20 weeks.
So that was that's quite a exciting and ensuring so I'd say that's going to the DMD study you know, we Oh, we haven't disclosed the specific criteria, yet, but I think the idea is because the study design fundamentally is similar to dazzle, where I live is on a fixed regimen and the care side regimen.
We'll be able to float.
In this case between two to six months right. So we will tighten keep those criteria a little bit tighter most likely right again for the same reason that you need to have the right balance of durability versus making sure that you meet your Noninferiority comparison.
Envision so and we think that the D. and you did are very supportive of the regrouping criteria that we'll be using.
Then an RV show right in the first six months, which is for the primary endpoint a highly as monthly and the kids. So I can be a one will be every eight week six clinical dosing after the <unk> a couple of loading doses. So there's not really the same criteria in that first six months.
Hi, Thank you.
Our next question will come from John Neale with Goldman Sachs.
Hi, guys I'm actually dialing in on behalf of Graig Suvannavejh I'm, just a quick one from US how sustainable do you think that 6 million monthly burn rate is and how could that may be evolves over the course there.
Yeah, I think you know the rationale for sort of mentioning that I think was more like well if.
Covidien were to get substantially worse and things move more into like a hibernation phase.
What's attractive about Kodiak is with the one be study in dazzle you know in broader efforts on in the labs and stuff like that where we don't have a very high like organic kind of burn rate. So we can hibernate running our existing studies for very long time.
As we but you know the pandemic and its impact we're seeing you know we're going to continue to have the ability to grow and accelerate in increasing momentum right with our plan to 2022 vision as we kind of mentioned so I mean that burn rate will grow substantially right as we initiate the new set of Pivotals Hum.
You know the gearing up the ramping up over the summer and then the initiation of those studies targeting September so it will ramp up substantially and then of course in the background. We have you know our manufacturing related efforts, which as I mentioned.
There are a number of choices there as we think about will what level of how many millions of dosage forms do we think we want to be able to service to provide the market right. In 2023 2024 in 2025 and as we do you know the validation work right that scale for our be outlay. So you know when John talks about well.
How far is our existing say 430 million going to go I think we provide guidance definitively into 2022, you know how far into 20 to 22 really depends on.
The rate of enrollment, which I think as we articulate on that one clinical timelines slide we do expect fairly.
Aggressive you know and appropriate I think enrollment.
And you know that drives a lot of costs and then as I said in the background a lot of the B.L.A. related manufacturing component I think you know at this stage right our pipeline, which is we are definitely.
Focusing on you know as part of the broader remit has written a high science company case I fiber one will begin to have increased costs and then in the background eventually our triplets, but as you know the majority of our burn rate to going to be driven by you know the say 2000 plus patients in our pivotal program for KC 301.
And then in the proper manufacturing scale up and validation activities.
For that manufacturing component of the BLE. So you know it that's sort of more of a backward looking.
Thing and the burn rate will increase.
Substantially but that will be in context of appropriate execution. It's just not like we're sitting on top of a massive burn rate and.
It's all going to be driven by moving towards the objective of the 2022 vision.
Okay. Thank you and if I could maybe get one more.
How do you think about you know I know you talked about him in a lot, but its enrollment rates did sort of surprised even for the to the downside.
Would you think it all about I'm looking to recruiting experienced patients and maybe kind of related to that you know how do you think about how we're going to market potentially only data in treatment naive patients might impact sort of initial uptake.
Right.
I think we feel really comfortable.
With going following the framework or of the anti VEGF biologics of by and large going into treatment naive patients. We like the predictability right of being able to extrapolate from the phase one be situation into our pivotal designs I think.
We feel very comfortable that we can get enough treatment nave wet AMD patients and we feel very comfortable that we can get enough treatment naive DMD patients.
You know were I think a premier anti VEGF biologic, you know as a branded agent.
Such that we find them you know anyway.
The community of retina specialists as excited to participate in our studies, we we believe.
To.
Help bring those treatment naive patients.
Entire studies for RV, Oh, it's not as though you know clinicians are less excited about our agent in our video. It's just that the overall prevalence of ARVO is lower.
And so we were thinking we're gonna have to go to more countries, but I think by shifting the plan or upgrading it you know as we say to one our view of study and perhaps you know the ARVO is higher prevalence than overall CRV Oh. So we think the new design has a number of like predictability inefficiencies. So we think we're going to get there with the treatment.
Patients I think you know do we think it may be useful to run a generate some data right in a in a quote unquote pivotal context.
Using a treatment experienced patients I think the answer is that we have had some discussions along that line I mean, Jason you may want to provide a little bit of commentary I.
I don't think it it would hurt you know from a commercial standpoint, if we did not have that having said that you know it could make sense to the extent that we might want to have a fuller label right because to the extent that say for example in DMD, we're going beyond six months in patients in terms of requiring retreatment and one be having said that we think we take.
And our pivotal study.
And we're actually allowing some patients that they need to dropped to eight weeks, that's not because we think that's fundamentally required from the standpoint of the medicine, but we want to have a broader label. So that positions can get reimbursement and can use case I across all patients and in wet AMD be where we have the Q 12 as the minimum do believe it could make sense.
To have some treatment experience that say Q4 weeks in Q eight weeks and not to wait till after the deal layer after approval to run those studies and doing those credibly in treatment experienced patients could be a way to generate some of that data to get that broader label and you may remember that in year two of dazzle right in the wet AMD pivotal we're actually randomize.
Using the ilea patients one to one so half of those people will go on Q eight week catseye such that we can begin to generate and in a way that is sort of a defined treatment experience population. So we're doing it in a variety of different ways that I think our thoughtful and that will our we're keeping our kind of our our high on what we need from.
A label in a market and a commercial standpoint, Jason do you have any quick comment on not good question.
Ah, Yes, Victor I think you you covered a.
[noise] covered it really nicely I guess, the only thing I would say additionally, as.
Yeah, I think that the you know those data on like well what happens when you switching patients on therapy to another.
We're useful at the time of me I Leo launch.
But then I think people also realize that.
No those data in enough themselves at least the way that a lot of those studies were done could be hard to interpret rights, which is why.
Are we kind of like the the part of our Dazzled study, where we take naive patients treatment for a year with Iberia them switch half of them.
And see what happens when you switch half of them and continue the rest on idea. That's a you know a better experimental design for Phil is getting an answer to a question.
I think for market access.
I don't think it's critical or probably actually even important fundamentally to have data on treatment experienced patients because from a commercial market access perspective, that's not not typically.
Something that's required I think that.
People may switch patients when they start using a new therapy. They may start with switching patients rather than new patients.
Until they get comfortable but you know a lot of our.
Right in the physicians will already have comfort with kids second tier one from participating clinical trials.
But you know to victors point ultimately those data can and will be generated a so it's always a question on from you know, what's the best timing and way to do it in a way that is.
Gives you a credible clinical interest important clinical questions.
Okay. Thank you.
Hi, Thank you.
Next question comes from Robin with Suntrust.
Hi, guys. Thanks for taking my question I guess, you know we're announcing a bias when there's all the time, but I was just thinking given both new and by the way Nike daughters are going to make an apparent on this call.
Guaranteed probably but thinking about like the fear is that people talk about well then that's inside and maybe what concerns.
You asked me about inflammation.
How in Europe, when Youre thinking about developing your clinical trial plan did you think about maybe alleviating those concerns in a clinically <unk> setting versus how many people, saying along kind of nervous in the real world if they see some more of that.
And the dock, how would you factored that in or what kind of trials would you need to help people do that you think it's even need it and then it is <unk>.
Two questions, let me clear that youre by specific drug.
And it sounds like it could be in the when can't really go into patients and are you hitting it hitting its much I absorbent materials six it's like an average IL six drug alone you have a sensor that and third its probably if the question, but just so it sounds like you could actually apply inning or below what you do all three of these.
Indications the RV Eau de any and Andy all at the same time and at the L.A. that possible. Thank you.
Sure.
Robin So I think your your first question is a little bit around well is there a new safety environment.
For new anti VEGF because of what's happened to be a view I.
I think.
An important.
Consideration there is no weather what happened it would be a view.
There's like a surprise.
Right and that only when it went into like a large commercial population right did people begin to see some tail event.
Okay, which I don't think is really accurate I think if you look back right.
Reports of this kind of retinal artery occlusion right or inflammatory blindness really goes back to the beginning of the molecule right. You can look back at some of those ft databases back to 2015 under Alcan right and under the short list of a couple of different severe adverse events, you'll find reports.
Retinal artery occlusion, so I think it was always present.
At a useful yet you know low percentage right, maybe you could argue or quibble right with Novartis is it 0.1%, but more seemingly in the label is closer to 1%.
Hi, good cetera. So I think you know given that and then you begin to say well is it manufacturing.
Right or is that the actual molecule and I think even recently right.
Some of the new Novartis. Our announcement you know suggest that they've looked at manufacturing and they don't think that's.
Cause havent found any correlation with manufacturing I think you know you begin to look more at the molecule itself right and then you begin to look at more some complexities around the biology, you know of that molecule right very high preexisting 80, a very high treatment emergent 80, a lower.
Visual acuity benefits for patients that have.
80, all of these things are unusual for anti VEGF biologics it turns out as the European regulators put right as we've discussed Robyn.
You know in their assessment.
You know that this type of.
Biology, right Hi, pre existing 80, a high treatment emergent has also been team for other sort of quote unquote non natural anti body fragment platforms right like diabetes and.
You know camel. It. So you know maybe there's some whether it's in eight immune or I don't really know right I don't think anybody understands to date, but you know a complex biology that accidentally happens.
To be here with this be of new format. So we don't have that obviously with the KC 301, we're fully anti body.
We haven't had any pre existing 88.
You know in terms of what we've measured to date and appear to have you know very low or what we make whole spurious.
Treatment emergent 88, with our molecule and with the current.
Clinical experience that we have which as you know north of 100 patient years now across the 1 billion dazzle.
I haven't seen any signs of like a similar.
Problem.
That people see would be a view now of course, you know people will worry.
And the question as well when you know when do you feel that enough data has been generated so we have some confidence that theres not a tail safety event and I think you know, there's not really easy answer to that right. I mean, we do monthly or more assessments across all of our Pivotals don't forget will we're running the pivotal program with all of the indications and.
Or low rate rather than running one indication in series rate and then the next and then the next so we're trying to generate as much of this data both from a safety efficacy and durability standpoint, you know you know as quickly as possible and we're trying to be as transparent as we can you know with running this one be study in presenting the data.
So we can so I don't think theres any special secrets, but I think you know fundamentally.
You know, we're not suffering a lot of the same baggage in terms of design and complexity of underlying biology.
You know when we have a good amount of clinical data available and we're not seeing this complex pattern that that they had so that's kind of a comment around be a view in terms of the iosix ved, Jeff we called out our OGC 2072 protein right. It's the protein component of our bio conjugates. So it could be evaluated systemically.
And you know as in a systemic agent, which would be given in an acute manner right say in cobot 19 patients you can give whatever dose level you want I think you know if you looked at the regeneron or you look at the camera the Roche molecule.
They have different dose levels in terms of Migs for keurig.
But from a systemic standpoint, you can get quite large doses. So we think we can get very strong anti IL six in this case as a lot again and also you know very strong anti VEGF whatever dose levels required and also as I think we mentioned you know intriguingly, we've seen some very interesting synergy across both of those biology's and so you know perhaps the molecule.
Could be important.
You know until we want to make the molecule you know available and at the same time, we get those ancillary benefits of some real manufacturing acceleration of the program because the core.
Critical path for the Indian first in human really was GMP manufacturing of the of anti body. So that's you know a cool feature.
You know of the case I fiber one acceleration.
And then in terms of.
Oh, you know, putting all three of the big indications into a single BLE, Jason maybe you could talk a little bit about that regulatory strategy.
Yeah sure Thanks, Victor and the thanks Robin Yeah. So yeah, I think that that's a.
I think quite quite a reasonable approach, particularly or at least in the United States right.
Yes to the more and of course from the agencies perspective, you know the more information that you have the better on your medicine, and you need to submit the safety data.
All of the safety data or that you have right at the time, even if it's across multiple indications are so I think the idea of submitting it in one package, where they can really understand.
The the.
Total safety database as well as the efficacy across the different indications.
I think I think that's a quite nice strategy, Oh, I mean, even I mean, even beyond that I mean, Jason I would say, we haven't writing from at the that there would look forward basically to receiving right I mean, certainly like the wet AMD being the DMC. They expect us to submit those together. So so submitting all three other fronts gather is something that they I think Dave.
<unk>.
I appreciate because it allows them to make higher quality decisions I guess.
Yeah.
Looking at least.
Yes.
Thanks, Thanks Robin.
Hi, Thank you.
Next question comes from the scene away Barclays.
Thank you for taking my questions then <unk> machine.
Awesome follow the S is going to want to Oh, I, just don't talk to me he.
Just wondering no <unk> dot one new trials you trials.
Uh-huh Charles <unk> <unk> he wouldn't you may see.
Oh My second question, we've gotten the Oxyfuels study what your thoughts on page eight down between <unk>.
My first question regarding <unk> less than 5% them <unk> just wondering how you collected data afterwards, and how do you analyze the data and how would that impact.
On the.
Right.
Okay, just to summarize the questions Jason maybe you want to hit them I think the first is well what do we have from at EEI, specifically in terms of our kind of what we call. The upgraded Kinsights real one you know pivotal plan.
Right, So where are we in terms of the FDA on that.
Second being you know the expected breakdown within this single Orbio pivotal for VR Vo NCR video and third when we do have missed visits.
How important is that to the integrity of the study and you know what are we basically doing to prevent them and if they happen you know them.
Is an important or material to the stuff.
Yeah right, yes, so I think with regards to the you know that Sta question Gina Yeah. I think we're you know we're quite comfortable with where we are in terms of I guess what feedback both.
What's in the written feedback as wells subsequent conversations.
The the RV show.
In the context of a single study, we would stratify the randomization between the two different RV show.
Some types of branch rain in the Central Bank, ER and yes, its braintree and it's more common.
You know, we probably have a minimum sort of cap. If you will on the number of CRD O patients to make sure that that.
Category of patients is adequately represented you know I mean in the into community it's probably.
You know like branch and is maybe like 3.5 to four and a half times more content and central names on the depending on where you are Ah. So you know probably like a twentyish percent minimum on the central being patients makes sense to make sure that they are well represented in the study.
In terms of the missed visits and how does that impact of data.
I'd say, a I mean at a high level or provided that it's really one missed the visit say per it for a patient.
Or scatter shot over time as opposed to like a series of missed visits in the low or many just because it's in a row.
Then.
I think those those date or just handled by the statistical methods does that I'd say routinely are right. I mean, there's there's always missing data in every study and what studies also adequately powered for you know assuming a certain rate of Discontinuations from the study and you know our rate of Discontinuations as opposed to missing data is also very low.
So you know I mean, most of the modern statistical methods will basically have different because different methods for imputing missing data in a study oh. So it's really done a question that you know if if a patient where to miss like multiple visits in the low or how you handle those particular data and the protocol specified.
Yes.
You know a considerations for whether a patient should continue with they've missed a certain number of missed as its but you know fundamentally with you know missed visits up the rate that they are I think that this study will absorb those without any meaningful impact in their distributed fundamentally there should be distributed equally across both groups.
But I think yes should really be.
An important starts a bias.
Right I think even when we look in more detail right at the design of the dazzle pivotal and as we think about educating ourselves as we finalize right on the margin the designs for the new Pivotals I think we believe we can withstand a substantially higher missed visit rate I don't know what number we would give you know but is it 20 per se.
Enter more than that or whatever and still.
Have a very good studies that would get us to the you know to the right outcomes.
Okay very helpful. Just wanted to follow up you know the cotton.
Hmm Fine art that isn't study program wins that will move back on that.
Right well that's a good question Jason.
Yeah I'd say.
Yeah may in terms of like the you know how many indications you can file at once yeah. I think there were ultimately have to be some more conversations with them.
You know somebody it depends on sort of national opinions versus where you may scientific advice. So I think that those are those are.
Topics like how many of these indications can you get in the initial license versus the so subsequent variation one we'll need some more discussion with.
Yeah, I may ultimately right I mean, one thing I think thats interesting gene as you know looking out well what's been the response in say the United Kingdom in context of coated 19 for retina, whereas in the United States.
You know, although visits have gone down as Jason mentioned from the best from data right. The proportion of visits where there have been anti VEGF injections has increased and physicians of course are still seeing new treatment naive patients, but in the UK. The guidance has been for treatment naive patients right basically it's not to see the patient it's basically to.
I think Jason wasn't the feedback or the new guide into specifically you know basically come back and four months [laughter].
So you know theres, an important alignment of the target product profile of the differentiation of care side three in one for Europe, and I think one of the things to do is I mean of course, we're gonna be running our pivotal studies in Europe.
But also you know to may be looked for like unique opportunities right, where this new profile for our medicine is a nice fit for example in the UK because it's just not reasonable to leave patients with these diseases for four months without therapy.
[noise] [laughter].
Thank you.
Our next question will come from Matthew Ritchie with BMO capital markets.
Okay.
Good afternoon, and thanks for.
Taking a question. So a couple from me I guess first with regard to the by.
Any idea study timeline.
Beyond sort of the broader coded and by animal are there any other factors that could impact will start of the above those trials from new September October timeframe, much if any color.
And then secondly, just you touched on it I think in the last question, but I just wanted to make an explicit with a single.
Rvs study the plan is to still get a broad RBL label as opposed to something indication specific to either the RV our CRB, though.
And then lastly, I wanted to just come back in manufacturing plants come up a couple of times and if you could just remind us a little bit about where you want us today and versus what you think you need for the revised pivotal program and then ultimately you know where are you hope to be over the next let's say 12 to 18 months. These studies are starting next year.
Read out thank you.
Right I mean I think.
Based on the information that we have today and the decisions that were making.
And I think as you mentioned independent of covert 19, I mean, I think we're feeling very comfortable about you know as September you know slash October 1st in human for the New program. So that's really what we're targeting.
And Ah you know, it's gonna be nice because we're able to follow the dazzle framework that we put in right say for example in the United States into the same site.
And a lot of the pieces of these studies for example, as Jason mentioned the DMC study has a very similar does that design to the dazzle study. So a lot of the pieces of these new paired DMD studies is going to come directly from dazzle into these same site and we're going to drop RV owing to the same sites as well and then we're ahead in terms of site activation right for dazzling Europe, and then we're going to float.
Believed that you know as Jason mentions we'll have both coverage for B.R.V.O.N.C.R.P.O. in the pivotal.
And we believe we're in good shape there.
I think on the manufacturing you know, there's obviously a lot of attention on clinical from the standpoint of these types of discussions right. If you don't have your manufactured material you know when you hit the market you're not going to be in good shape, we don't want to be in a situation of generating really exciting pivotal data and then asking all of you to wait many years before were real.
Be able to service the market. So we're spending you know a good amount of time I think the fact that we've you know had you know such a wonderful safety profile to date.
Is a testament to the quality and attention that we put into manufacturing and have for a number of years.
You know if you remember with Luke sent us when it entered to the market right. It had this you know as much as 15% inflammation and then they were able to clean up that formulation.
From their lyophilized into their liquid and now into their Prefilled syringe.
And really brought that down.
We're we're trying and want to launch in a prefilled syringe and so we're working hard to make that a possibility you know where it you know currently where at 1000 leader Cho scale and we're shifting that into the six to 10000 meet arrange for lunch. So you know, there's some process development and tech transfer work that's been process, but.
Fundamentally you know, it's the same master sell bank in the overall method to what you know will be very similar as we scale. You know you know to where we want to be commercially in the conjugation that we do to make our bio cons you get you know uses industry standard A.D.C. type conjugation methods and so we don't anticipate any technical.
Or technical challenges their rather again, it's more more scale up into of say a larger facilities. So there's a lot of work there. That's a great question I think part of it is you know we can ask you in the community will what percent of the branded market do you think you know in years, one two and three posts launch Kodiak should be investing.
You know that you know what what percent of that branded market in terms of millions of of doses.
For example, I think last year, there were say 25 million Intravitreal injections that were given globally and if half of those were a vast and right. That's 12 and a half million and let's say, it's growing up say, 6% to 10% a year right, so well what percent of that market.
Right in your one two and three <unk> 301, incredibly grab and that helps to drive you know our view of manufacturing scale. So it's it's quite an interesting conversation and we're trying to do it in the context of Prefilled syringe as well so a lot of activities and maybe that will become you know more important over the next couple of years, we have a tremendous.
This amount of drug substance of bio conch, you get that we've manufacturing and we did a very successful resupply.
You know over the last 12 months. So we're moving very good in terms of bio conjured get drug supply to service. The pivotal program. So really our attention you know is towards the scale up and the validation towards the you know B.L.A. activities.
Great. Thank you for the all the color.
Thank you.
Next question will come from check that's <unk> capital.
Yeah.
Hi, hi costs and with that that's the activities.
I've been longer time date accident. They had <unk> Monday study what are you hoping to see some that that outlasts. What are you hoping that in <unk> in that next set of data and got underlined has done that and my kids Yeah pivotal and then just another follow question you just out of curiosity yeah.
How did you come up with the I.D.F.O.G.G., Yeah 72 flux.
<unk> easy and then you know he laughed laid on any of this and it gives then between that <unk> and <unk>.
Yeah could you repeat the first question again.
Yeah, So just like in terms of expertise and.
If these long be studied the longer time data Oh, right well I think our core focus this year is on what we called kind of the durability of the durability right. So the early phase one be we're sort of through the loading phase and then coming out of the loading say is always a bit that time to that first retreatment across the three diseases and now you know well we're sort of.
Looking at you know the durability of that durability and when people who got retreated I'd say four months do they get retreated at four six or two months kind of thing and how that looks across the population of patients. So we think right now that's a really interesting focus and that's where we should be you know exploring.
We're of course extending to study as you 'cause you realized out to say three years and why are we doing that well first of all we think it's really a nice way to follow and see the individual patient detail you know have the patience into medicine over time and also of course it helped.
To extend like kind of the safety database that we want to having a little bit of that safety experience. So that's really the you know the rationale and then to be following them in the background and you know hopefully publishing on that and you know learning more and providing quite a lot of transparency in terms of how this medicine and.
And I bet Biologics work you know in a population that we that we track very carefully and of course, we're trying to encourage as many of the patience to stay in the study through the three year period to maximize it you know does the utility of the data generated.
Yeah.
Yeah, I think that's really helpful. I suppose any changes physicians compared with their mother safety to when it continues to treat these p. can begin longer <unk>.
Yeah, Yeah, and then in terms of like the O.G. 2072, you know the by specific protein.
You know like I mentioned, there's a lot of ancillary benefits to the overall case I five or one program, but I I'd say you know the the context of the Dyssynergy of some of this kind of activity of these two mechanisms is maybe a little bit surprising the antibiotics and the anti bed, Jeff certainly anti I.O. six right and cobin 19 for like to say.
Kind of release syndrome component, but I think you know maybe what what we see.
From some of their you know more recent regeneron data is that you know there are other mechanisms of actions or like pathology, that's kind of happening maybe in parallel right and I think some of these ideas that the vascular permeability, that's either cause directly by the virus into tissues or is related to like to say the kind of release you get this.
Ask EULAR permeability and the tissues and you get that it <unk> well don't forget that anti vent, Jeff you know, it's really maybe not an anti angio genic agent in terms of how it works in the eye right. It's an anti permeability agent and it really functions on vascular permeability. So if that's important you know in this disease, you can kind of get the anti <unk>.
Peace in this anti permeability peace with a molecule that's showing synergy and that's quite potent and so we're you know going to do a drug product run you know of our of our and I body, you know as a release drug substance, which is how we manufacture it anyway and you know look to try and make that available.
When somebody's basket clinical studies, while we you know of course continue on our core mission in retina an apology.
<unk>.
Sure.
Oh, thank you.
Again, that's just I want to ask a question.
Alright speakers going at this time there are no further questions in the queue.
I'd like to turn it back on us the closing remarks.
Well, thanks, everybody for participating and hopefully gives you you know are very up to date veal, what's kodiak in the activities you know for the remainder of of this year. Thanks, So much bye.
Thank you, ladies and gentlemen discount good today's teleconferencing human out disconnect. Thank you for your participation. Please enjoy the rest of your day.
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