Kodiak Sciences Inc.

Kodiak Sciences Inc.

KOD·NASDAQ

$33.87

-8.2%
HealthcareBiotechnology

Kodiak Sciences Inc., a clinical stage biopharmaceutical company, researches, develops, and commercializes therapeutics to treat retinal diseases. Its lead product candidate is KSI-301, an anti-vascular endothelial growth factor antibody biopolymer that is in Phase IIb/III clinical study to treat wet age-related macular degeneration (AMD), as well as for the treatment of diabetic macular edema, naïve macular edema due to retinal vein occlusion, and non-proliferative diabetic retinopathy. The company's preclinical stage product candidate includes KSI-501, a bispecific conjugate to treat retinal diseases with an inflammatory component; and KSI-601, a triplet inhibitor for the treatment of dry AMD. The company was formerly known as Oligasis, LLC and changed its name to Kodiak Sciences Inc. in September 2015. Kodiak Sciences Inc. was incorporated in 2009 and is based in Palo Alto, California.

At a Glance

Live Snapshot
Market Cap$1.79B
EPS-4.3200
P/E Ratio-7.84
Earnings Date08/12/2026

Earnings Call Transcript

KOD • 2020 • Q1

Operator
Good afternoon and welcome to Kodiak Sciences 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. [Operator Instructions] At this time, I would like to turn the conference over to Mr. John Borgeson, CFO of Kodiak. Sir, please begin.
John Borgeson
Thank you for joining Kodiak Sciences’ business highlights conference call. I’m John Borgeson, Kodiak’s Chief Financial Officer. Joining me today are Victor Perlroth, Chairman and CEO, and Jason Ehrlich, Chief Medical Officer and Chief Development Officer. After our prepared remarks, reviewing updates to our business, we will open the call up for analyst Q&A. The webcast portion of this call contains a slide presentation that we will refer to during the call. Those following along in the phone, who wish to access the slide portion of this presentation, may do so on the Events and Presentations section of our website. An archive of this webcast will be available on our website soon 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 and results of clinical trials, our regulatory strategies, our research and development activities, risks related to our business and certain other business matters. A more complete description of these and other material risks can be found in Kodiak’s filings with the Securities and Exchange Commission, including Form 10-Q for the quarterly period ended March 31 2020, which was filed with the SEC yesterday. Kodiak 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 of COVID-19 on our ongoing operations, provide corporate and clinical updates, describe our upgraded KSI-301 pivotal program, and discuss how we will execute on that program to meet our 2022 Vision. While this call is intended to focus on reviewing operational highlights, and not so much to discuss financials, I would like to take a few moments to discuss the strength of our financial position, as was detailed in our 10-Q published yesterday. On the heels of our successful fundraising efforts in December 2019, we ended the first quarter of 2020 with over $430 million in cash, cash equivalents and marketable securities. During the first quarter, we posted a net loss of $24.4 million, which includes non-cash 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 top-line readout of the DA
Victor Perlroth
Thanks, John. Good afternoon, everybody. Thanks for joining us for this first quarter 2020 business highlights webcast. We wanted to hold the call to discuss the recent business highlights including progress with the development of our pipeline, and to be clear in terms of how we’re managing through COVID-19 and its impact. I’m proud of the dedication of our team, the Kodiak employees, and our Kodiak community more broadly, as we all navigate the challenges of the COVID-19 pandemic, and 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 COVID-19. Our labs are operational. And from a manufacturing and a clinical standpoint, we’re proceeding and proceeding well. In DA
Jason Ehrlich
Well, thanks, Victor, and good afternoon to everyone. Thanks for joining us. Yeah, so over the last few months, the Kodiak team has been focused on ensuring both patient safety and data integrity in our ongoing KSI-301 clinical trials. The Phase 1b study, which is in patients with DME, RVO and wet AMD; and then DA
John Borgeson
Thank you, Jason. As many of you may remember, we announced an agreement for the sale of future royalties of KSI-301 for $225 million on December 1, 2019. During the first quarter of 2020, we closed on the first payment under the agreement, receiving $100 million on February 4, 2020. I’d also like to say a few words about our Board of Directors. In the last several months, we’ve made 2 strong additions to our board with the addition of Dr. Taiyin Yang, and most recently, Charlie Bancroft. Taiyin currently serves as Executive Vice President of Pharmaceutical Development and Manufacturing at Gilead and brings deep experience and leadership with commercial manufacturing and quality operations. Charlie was formerly in Chief Financial Officer at BMS and brings a wealth of pharmaceutical, commercial and financial experience. The combined experience of Taiyin and Charlie supplement an already deep in a well rounded board with knowledge that will be instrumental as we accelerate our planning towards BLA and 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 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?
Jason Ehrlich
Thanks, John. So with respect to the Phase 1b study, we presented updated safety, efficacy and durability data from ongoing Phase 1b trial of KSI-301 at the Angiogenesis meeting back in February. And we believe that the data continue to support the highly differentiated anti-VEGF Generation 2.0 profile of KSI-301. Now we plan to continue presenting data updates from the Phase 1b study throughout this year, and if meetings or congresses are canceled due to COVID, or become 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 generated in Phase 1b. And we look forward to providing the next important R&D update in July, either at the ASRS meeting, depending on whether and how that meeting occurs, or else is a virtual R&D webinar in a similar timeframe, and as we collect additional follow-up data on patients in the Phase 1b up to 9 months, 12 months and beyond. The focus of those presentations will start to turn towards long-term outcomes and the durability of the durability if you will. 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 Phase 1b, again based on positive feedback from investigators, and a desire to continue to generate long-term safety and efficacy outcomes data with KSI-301, we further amended the Phase 1b program to include an additional 18 months of treatment and follow-up per patient for a total of up to 36 months. And I note also that in the Phase 1b study alone, we’re now approaching 100 patient years of exposure with KSI-301 and continue to be very pleased with the safety profile that we’re seeing. So then moving on to talk about the KSI-301 pivotal program, following our communications with FDA at the time of the end of Phase 2 meeting as well as subsequently, we further upgraded the pivotal study program. And as Victor mentioned, we now intend to conduct 2 Phase 3 studies in diabetic macular edema to provide the mutually-confirmatory studies required by FDA for initial demonstration of safety and efficacy, and then 1 pivotal study in wet AMD with ongoing DA
Victor Perlroth
Thanks, Jason. Yeah, I think it would be helpful if we reviewed our upgraded KSI-301 clinical plan in portfolio quickly, as illustrated on Slide 5. And this refined slide 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. So the Slide 5 shows our current view of the clinical studies, their timelines for first patient in and last patient in, the overall treatment duration, and a rough view into top-line data availability. And this program and strategy, obviously, feeds – are in parallel 2022 BLA filing plan. So it’s nice to see this refinement of our clinical plan, which the 1b ongoing, the DA
Operator
Yes, sir. [Operator Instructions] And our first question will come from Anupam Rama with J.P. Morgan.
Matthew Bannon
Hey, guys. Thanks for taking the questions. This is Matt on for Anupam. So first off, well done with being so agile around 301 development to be efficient and keep timelines for Vision intact as much as possible, so good job there. I guess, one thing we’ve been trying to think about is little more forward-looking and relates to competition from additional biosimilars across indication, and what these retinal markets might look like when 301 potentially launches. So if you could just comment on how you expect market dynamics to play out, that would be really helpful. Thanks.
Victor Perlroth
Sure. Well, Anupam, I think, 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 designs of those pivotal studies, both are educated from the Phase 1b, so we can have a very high probability of success in those studies, which we think we will. And also, that the endpoints and the durability that we’ll be able to show are really going to be meaningful. And I think what I mentioned is we like to think of it as this generation 2.0 profile, which is we’re going to be shifting that distribution with non-inferior efficacy and safety; but shifting the dosing interval, that distribution substantially to the right, in each one of these indications versus, say, EYLEA. 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, right, is really having a lot of whitespace between us and EYLEA. So we think that’s really important to be really differentiated and not coming out as incremental. If we can do that, we believe we’ll, first of all, be in 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 biosimilars will be important for the branded agents. So Lucentis biosimilars will be Lucentis’ share. And EYLEA biosimilars, whenever they come out exactly, for example, in the U.S. market, will likely eat EYLEA share to some degree. We’re getting smarter, I would say, on some of this I believe, in a way the retina marketplace is like a spec pharma, with high concentration. We believe that KSI as a branded molecule, there are a lot of incentives that will drive the physicians for sure, but maybe even payers to support KSI, ASP plus 6%, for example. And we don’t see a lot of incentives for, say, leading players like Regeneron to really compete, say, with biosimilars on price. And, of course, biosimilars in retina are going to 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 Avastin’s share, if we really bring a molecule like KSI with this important target product profile benefit and differentiation. And then, vis-à-vis Lucentis and EYLEA, we think there will be an incentive to go with an attractively priced KSI-301 molecule for retina docs, who can bring a better molecule for their patients and perhaps make more money with our branded molecule. So we think we’re going to get smarter, as we continue to build this kind of pre-commercial kind of capability and knowledge and investment for Kodiak. But we think 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 is well, what percent of the branded market do we think we should plan to capture from a manufacturing standpoint, in years 1, 2, and 3. And I think we hope that’s going to be a big number. And so, we’re working from the manufacturing standpoint, to be able to service that.
Matthew Bannon
Great. Thank you very much, guys. Thanks for taking the question.
Operator
Thank you. Our next question will come from Michael Yee with Jefferies.
Michael Yee
Hey, guys. Thanks for the update. Thanks, Victor. Two questions. One is you commented on enrollment in the press release. And I thought this was pretty important given it’s kind of a gating factor to getting data. Can you just comment about what gives you confidence in the timing for completion of enrollment this year in AMD? What are you seeing in April and May, the shape of the curve? And what gives you that confidence 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 AMD in 2021, potentially. But is there any chance given all the things that have gone on or shifted that there is a chance you look back at that potential interim analysis that’s built into it and say, hey, what are the factors that we could look at this and don’t have to wait till the end of 2021? Maybe just talk about that and whether that’s totally off the table? Is that something that’s still technically possible? Thanks so much.
Victor Perlroth
Right. Yeah. Hey, thanks. Thanks, Michael. I think on the wet AMD 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, 100 sites across the program. We even through, let’s say, end of March and April, enrollments were, say, 25-plus patients a month. And we expect that to increase certainly through the end of this year. We’re not going to fall on the sword over finalizing enrollment in DA
Michael Yee
Thanks. I appreciate the perspective.
Operator
All right, thank you. Our next question will come from Matthew Harrison with Morgan Stanley.
Maxwell Skor
Hi, thank you. This is Max Skor on for Matthew Harrison. Could you comment all about the –regarding the re-dosing criteria for the Phase 3 trials? Will it be different in the Phase 1b trial? And in any way could it alter the POS? Thank you very much.
Victor Perlroth
Sure. Jason, you want to handle that maybe across the portfolio of studies?
Jason Ehrlich
Yeah, sure. Thanks. So call it for DA
Operator
Right. Thank you. Our next question will come from John McNeil with Goldman Sachs.
John McNeil
Hi, guys, I’m actually dialing in on behalf of Graig Suvannavejh. Just a quick one from us. How sustainable do you think that $6 million monthly burn rate is? And how could that maybe evolve over the course of the year?
Victor Perlroth
Yeah, I think the rationale for sort of mentioning that I think was more like, well, if COVID were to get substantially worse and things moved more into like a hibernation phase, what’s attractive about Kodiak is with the 1b study in DA
John McNeil
Okay. Thank you. And if I could maybe get one more. How do you think about – I know, you talked enrollment a lot, but if enrollment rates did sort of surprise even further to the downside? Would you think at all about looking to recruit treatment experienced patients, and maybe kind of related to that, how do you think about how going to market potentially only data and treatment naïve patients might impact sort of initial uptake?
Victor Perlroth
Right. I think, we feel really comfortable with going – following the framework of the anti-VEGF biologics of by and large going into treatment naïve patients. We like the predictability, right, of being able to extrapolate from the Phase 1b situation into our pivotal designs. I think, we feel very comfortable that we can get enough treatment naïve wet AMD patients and we feel very comfortable that we can get enough treatment naïve DME patients. We’re – I think a premier anti-VEGF biologic, as a branded agent, such that, we find them anyway the community of retina specialists is excited to participate in our studies, we believe, and to help bring those treatment naïve patients into our studies. For RVO, it’s not as, though, clinicians are less excited about our agent in RVO, it’s just that the overall prevalence of RVO is lower. And so we were thinking, we were going to have to go to more countries. But I think by shifting the plan or upgrading it, as we say to 1 RVO study, and perhaps, BRVO, is higher prevalence than overall CRVO? So we think the new design has a number of like predictability and efficiency. So we think we’re going to get there with the treatment naïve patients. I think, do we think it may be useful to run, generate some data, right, 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 don’t think it would hurt, from a commercial standpoint, if we did not have that. Having said that, 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 DME were going beyond 6 months in patients in terms of requiring retreatment in the 1b. Having said that, we’ve taken our pivotal study and we’re actually allowing some patients that they need to drop to 8 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 physicians can get reimbursement and can use KSI across all patients. And in wet AMD, where we have the q12 as the minimum, we do believe it could make sense to have some treatment experience, let’s say, q4 weeks and q8 weeks, and not to wait till after the BLA or 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 your 2 of DA
Jason Ehrlich
Yeah, Victor, I think you covered it really nicely. I guess, the only thing I would say, additionally is – yeah, I think that there’s data on like what happens when you switch a patient from one therapy to another. We’re useful at the time of the EYLEA launch, but then I think people also realize that those data in and of themselves, at least the way that a lot of those studies were done to be hard to interpret, right, which is why we kind of like the part of our DA
John McNeil
Okay. Thank you.
Operator
Thank you. Our next question comes from Robyn with SunTrust.
Robyn Karnauskas
Hi, guys. Thanks for taking my question. I guess, everyone is asking about biosimilars all the time. But I was just thinking given Beovu, and by the way, my 2 daughters are going to make an appearance on this call, a guarantee, I promise you. But thinking about like the fears that people talk about both on the investment side and maybe or concerns in this [pivotal community] [ph] about inflammation. How in your – when you are thinking about developing your clinical trial plan? Did you think about maybe alleviating those concerns in a clinical trial setting versus having people saying, well, I’m kind of nervous in the real world, if I see some more events. And did that – how you’ve factored that in? Or what kind of trials would you do to help people do that? Do you think it’s even needed? And then 3 questions, am I clear that your bispecific drug, it sounds like it could be in the – when could it really go into patients? And are you hitting as much – I absorbing as much IL-6 as like an average IL-6 drug alone? Do you have a sense of that? And third is probably a really stupid question. So it sounds like you could actually apply it in your BLA. Would you do all 3 of these indications so RVO, DME and AMD all at the same time in a BLA? Is that possible? Thank you.
Victor Perlroth
Hi, Robyn. So I think 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 Beovu. I think an important consideration there is, whether what happened with Beovu is 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, the report 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 FDA databases, back to 2015 under Alcon, right, and under the shortlist of a couple different severe adverse events, you’ll find reports of retinal artery occlusion. So I think it was always present – at a useful yet, 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% et cetera. So I think – given that and then you begin to say, well, is it manufacturing, right? Or is it the actual molecule? And I think even recently, right, some of the new Novartis announcement suggests that they’ve looked at manufacturing and they don’t think that’s the cause. They haven’t found any correlation with manufacturing. I think, you begin to look more at the molecule itself, right. And then you begin to look at more – some complexities around the biology of that molecule, right, very high pre-existing ADA, very high treatment-emergent ADA, lower visual acuity benefits for patients that have ADA, all of these things are unusual for anti-VEGF biologics. It turns out as the European regulators put it, right, as we’ve discussed, Robyn, in their assessment that this type of biology, right, high pre-existing ADA, high treatment-emergent has also been seen for other sort of quote unquote, non-natural antibody fragment platforms, right, like diabodies and [camelids] [ph]. So maybe there’s some whether it’s innate immune or I don’t really know, right. I don’t think anybody understands to date, but a complex biology that accidentally happens to be here with this Beovu format. So we don’t have that, obviously, with KSI-301 were fully antibody, we haven’t had any pre-existing ADA, in terms of what we’ve measured to date and appear to have very low or what we may call spurious at treatment-emergent ADA with our molecule. And with the current clinical experience that we have, which is, north of 100 patient years now, across the 1 billion DA
Jason Ehrlich
Yeah, sure. Thanks, Victor, and thanks, Robyn. Yeah, so – yeah, I think that that’s a – I think, quite a reasonable approach particularly at least in the United States, right. The more – of course, from the agency’s perspective, the more information that you have, the better on your medicine and you need to submit the safety data, all the safety data that you have right at the time, even if it’s across multiple indications. So I think the idea of submitting it in one package where they can really understand the total safety database as well as the efficacy across the different indications. I think that’s a quite nice strategy.
Victor Perlroth
I mean, even beyond that, I mean, Jason, I would say we have in writing from FDA that there – we would look forward basically to receiving, I mean, certainly like the wet AMD and the DME, they expect us to submit those together. So submitting all 3 of them together is something that they – I think they appreciate, because it allows them to make higher quality decisions, I guess.
Robyn Karnauskas
Well, thanks for the color. And thank you.
Victor Perlroth
Thanks, Robyn.
Operator
All right. Thank you. Our next question comes from Gena Wang with Barclays.
Gena Wang
Thank you for taking my questions. I have 3 questions. The first one also follow the single BLA filing, I understand that you talked with FDA. Just wondering, with that 1 wet AMD trial, 2 DME trials and 1 RVO trial was that agreed upon with FDA. And what is the EMA feedback? And my second question with regarding the RVO study, what will be your thoughts on the patient they’ve done between BRVO and the CRVO? My third question is regarding the 5% – less than 5% and missed visits. Just wondering how do you collect the data afterwards? And how do you analyze the data and how would that impact the clinical endpoint data?
Victor Perlroth
Right. Okay, just to summarize the questions, and Jason, maybe you want to hit them? I think the first is well, what we have from FDA specifically, in terms of our kind of what we call the upgraded KSI-301 pivotal plan, right. So where are we in terms of the FDA on that? The second being the expected breakdown within this single RVO pivotal for BRVO and CRVO. And third, when we do have missed visits, how important is that to the integrity of the study, and what are we basically doing to prevent them and if they happen; is it important or material to the study? Yeah.
Jason Ehrlich
Right. Yeah. So I think with regards to the FDA question, Gena. Yeah, I think, we’re quite comfortable with where we are, in terms of the regulatory feedback of what’s in the written feedback, as well as subsequent conversations. The RVO, in the context of a single study, we would stratify the randomization between the 2 different RVO sort of subtypes the branch vein and the central vein. And, this branch vein is more common, we probably have a minimum sort of cap, if you will on the number of CRVO patients to make sure that that category of patients is adequately represented. I mean, in the community, it’s probably, like branch vein is maybe like 3.5 to 4.5 times more common than central vein so that depending on where you are. So probably like a 20%-ish minimum on the central vein patients make sense to make sure that they’re well represented in the study. In terms of the missed visits, and how does that impact the data? I’d say, I mean, at a high level, provided that that’s really one missed visit, say, for a patient or scattershot over time as opposed to like a series of missed visits in a row or many missed visits in a row. Then, I think those data are just handled by the statistical methods as they routinely are, right? I mean, there’s always missing data in every study. And the study is also adequately powered for assuming a certain rate of discontinuation from the study, and our rate of discontinuation as opposed to missing data is also very low. So, I mean, most of the modern statistical methods will – basically have different – there’s different methods for imputing missing data in a study. So it’s really then a question of, if a patient where to miss, like, multiple visits in a row. How do you handle those particular data, and the protocol also specifies, considerations for whether a patient should continue if they’ve missed a certain number of visits. But fundamentally with missed visits at the rate that they are, I think the study will absorb those without any meaningful impact and they’re distributed, fundamentally they should be distributed equally across both groups. But I think, that should really be an important source of bias.
Victor Perlroth
Right. I think even when we look in more detail, right at the design of the DA
Gena Wang
Okay. Very helpful. Just wanted to follow-up, regarding the [bureau file] [ph] or the pivotal study program design, what is the EMA feedback on that?
Victor Perlroth
Right. Well, that’s a good question. Jason?
Jason Ehrlich
Yeah, I’d say, EMA, in terms of like – how many indications you can file at once? I think they were ultimately have to be some more conversations with them, somewhere it depends on sort of national opinions versus EMA scientific advice. So I think that those are topics like how many of these indications can you get in the initial license versus subsequent variation. We’ll need some more discussion with EMA ultimately.
Victor Perlroth
Right. I mean, one thing I think that’s interesting, Gena, is looking at, well, what’s been the response in say, the United Kingdom, in context of COVID-19 for retina, whereas in the United States, although visits have gone down, as Jason mentioned, from the best from data, right, the proportion of visits where there been the anti-VEGF injections has increased. And physicians, of course, are still seeing new treatment naïve patients. But in the UK, the guidance has been for treatment naïve patients, right, basically it’s not to see the patient. It’s basically to – I think, Jason wasn’t the feedback or the new guidance has specifically – basically come back in 4 months. So there’s an important alignment of the target product profile or the differentiation of KSI-301 for Europe. And I think one of the things to do is, I mean, of course, we’re going to be running our pivotal studies in Europe, but also – to maybe look 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 4 months without therapy.
Gena Wang
Thank you.
Operator
Thank you. Our next question will come from Matthew Luchini with BMO Capital Markets.
Matthew Luchini
Hi, good afternoon, and thanks for taking the question. So a couple from me, I guess, first with regard to the revised DME, RVO study timeline, beyond sort of the broader COVID environment, are there any other factors that could impact the start of those trials from the new September/October timeframe that you’re putting forward? And then, secondly, just you touched on it, I think in the last question, but I just wanted to make it explicit. With a single RVO study, the plan is to still get a broad RVO label as opposed to something indication-specific to either BRVO or CRVO. And then, lastly, I wanted to just come back to manufacturing. And so, it’s come up a couple of times. And if you could just remind us a little bit about where you are today, and versus what you think you need for the revised pivotal program, and then, ultimately, where you hope to be over the next, let’s say, 12 to 18 months as these studies are starting to read out. Thank you.
Victor Perlroth
Right. I mean, I think, based on the information that we have today and the decisions that we’re making, and I think, as you mentioned independent of COVID-19, I mean, I think we’re feeling very comfortable about a September/October first in human for the new program. So that’s really what we’re targeting. And it’s going to be nice, because we’re able to follow the DA
Matthew Luchini
Great. Thank you for all the color.
Operator
Thank you. Our next question will come from
Zegbeth Jallah
I just have a quick question with regards to the expectations in terms of the longer-term data from the amended Phase 1b study. What are you hoping to see from that data or what are you hoping that investors would focus on in that next set of data? And any learnings in that, that you could apply to your pivotal? And then, just another follow-up question just out of curiosity here, how did you come up with the idea for OG2072 for COVID-related diseases? And then, can you elaborate on any of the synergism between that program and KSI-501?
Victor Perlroth
Could you repeat the first question again?
Zegbeth Jallah
Yeah, so just wondering in terms of expectations for the amended Phase 1b study, the longer-term data?
Victor Perlroth
All right, well, I think our core focus this year is on what we call kind of the durability of the durability, right. So the early Phase 1b was sort of through the loading phase, and then coming out of the loading phase, it was a bit that time to that first retreatment across the 3 diseases. And now, we’re sort of looking at the durability of that durability, and when people, who got retreated at, say, 4 months, do they get retreated at 4, 6 or 2 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 exploring. We’re, of course, extending the study, as you realize, out to, say, 3 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, of the patients and the medicine over time. And also, of course, it helps to extend like kind of the safety database that we want to have and a little bit of that safety experience. So that’s really the rationale and then to be following them in the background. And hopefully, publishing on that and learning more and providing quite a lot of transparency in terms of how this medicine and anti-VEGF biologics work in a population that we track very carefully. And, of course, we’re trying to encourage as many of the patients to stay in the study through the 3-year period to maximize the utility of the data generated.
Zegbeth Jallah
Thank you. I think that’s really helpful, I suppose in terms of physicians’ comfort with the level of safety to want to continue to treat these patients even longer term.
Victor Perlroth
Yeah, yeah. And then, in terms of like the OG2072, the bispecific protein, like I mentioned, there’s a lot of ancillary benefits to the overall KSI-501 program. But I’d say, the context of the synergy of some of this kind of activity of these two mechanisms is maybe a little bit surprising, the anti-IL-6 and the anti-VEGF; certainly, anti-IL-6, right, in COVID-19 for like the cytokine release syndrome component. But I think maybe what we see from some of the more recent Regeneron data is that, 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 caused directly by the virus in the tissues or is related to like the cytokine release, you get this vascular permeability in the tissues and you get that edema. Well, don’t forget that anti-VEGF. It’s really maybe not an anti-angiogenic 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 in this disease, you can kind of get the anti-IL-6 piece in this anti permeability piece with a molecule that’s showing synergy. And that’s quite potent. And so we’re going to do a drug product run of our antibody, as a release drug substance, which is how we manufacture it anyway. And look to try and make that available in some of these basket clinical studies while we, of course, continue on our core mission in retina and ophthalmology.
Zegbeth Jallah
Thanks, Victor.
Victor Perlroth
Sure.
Operator
All right, thank you. [Operator Instructions] All right, speakers, and at this time there are no further questions in the queue. I’d like to turn it back over for closing remarks.
Victor Perlroth
Well, thanks, everybody, for participating. And, hopefully, it gives you a very up-to-date view of Kodiak and the activities for the remainder of this year. Thanks so much. Bye.
Transcript from May 13, 2020

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Mar 28
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2020

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May 13
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