Kodiak Sciences Inc Common Stock Study result
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Thank you for joining the Kodiak Sciences DAYBREAK Top Line Data Results conference call. I'm Victor Perlroth, Kodiak's Chairman and CEO. 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 may do so on the investor relations section of the Kodiak website. An archive of the webcast will be available on our website. Let's turn to slide number 2. I would also like to remind you that remarks made on this call today include forward-looking statements about Kodiak. A more complete description of these and other material risks can be found in Kodiak's filings with the Securities and Exchange Commission, including its Form 10-Q for the quarterly period ended June 30, 2026, which has been filed with the SEC.
Kodiak does not undertake any obligation to update publicly any forward-looking statements, whether as a result of new information, future events, or otherwise. Turning to slide number 3. It's with pleasure that I welcome all of you to our DAYBREAK primary endpoint results webcast. Turning very briefly to the slide number 4, where we can take a moment to reflect on the length and also the importance of the journey that we have been traveling together with our Kodiak stakeholders of employees, patients, physicians, financiers, family, and friends. In particular, we like to refer to this four-quadrant plot here on slide 4. As Dr. Brown said it nicely in his quote in our press release, "20 years after LUCENTIS was approved for wet AMD, the holy grail remains the same. Robust anatomic disease control and maximal visual acuity gains, i.e. immediacy/efficacy, sustained with less frequent dosing, i.e.
durability." Before DAYBREAK, and in particular Zenkuda in DAYBREAK, durability always came with great sacrifice. And despite best efforts over these 20 years, our results as a community have been incremental. But today and together, we describe a tremendous step forward, a step that builds on Kodiak's 17-year history, following what I like to call the gentle arrows of science and the harmony of company-building and retinal medicines development. On this plot, the upper-right quadrant has always been our target zone. I think we've hit the target directly in the middle, in the upper-right quadrant. On that note, we'd like the data to speak for itself. Turning to slide number 5. Joining me today from Kodiak is Pablo Velazquez-Martin, Kodiak's Chief Medical Officer. And joining us today also are Dr. Charles Wykoff and Dr. David Brown. Both are distinguished physician-scientists with an important history of retinal drug development.
After our prepared remarks, we will open the call for Q&A. Turning to slide number 6. I'm now pleased to turn the call over to Dr. Velazquez-Martin.
Pablo? Thank you, Victor. I would like to take a minute to bring us all the way back 2 years ago, and we can move to slide 7.
Almost to this date of Investor R&D Day for Kodiak in September 2024 in New York City, to remind us how we got here to this moment. At that time, we emphasized our focus to be a learning organization and strengthen our commitment to the journey from data, to insights, to learning, to action. At that time, we made a variety of critical course correction decisions that led us here. In slide 7, continue this intentional journey got us here today. It is my privilege, in slide 8, to introduce this presentation.
The primary endpoint results of the DAYBREAK Phase III study in treatment-naïve with wet age-related macular degeneration, exploring both of our Antibody Biopolymer Conjugate investigational therapies, Zenkuda and tabirafusp-ted, which will also be called during this presentation as tabirafusp-ted. One important reminder in slide 9. The DAYBREAK innovative design enabled an independent evaluation of Zenkuda and of tabirafusp-ted at full clinical and statistical significance. This is important because each molecule had a different objective in this trial. Aligned with this principle, Dr. Wykoff will present the DAYBREAK results for each molecule compared to aflibercept separately in independent sections. We move to slide 10, please. With that, I am happy to pass the presentation to Dr. Wykoff, who will present the efficacy and safety results for Zenkuda first.
Charlie? Good morning. Can you hear me?
We can hear you, sir.
Please proceed. Thank you. Good morning.
Great to be here with you. It's an exciting time in retina. A lot of ongoing clinical trial programs. Always enjoyable to digest new data, particularly when it's as positive as I think you will see that this is. You can go forward to the next slide. DAYBREAK, fascinating phase III clinical trial for many reasons. First is that it compared two different therapeutics to the same control arm, so a very efficient trial design to digest a tremendous amount of data. We'll first unpack the tarcocimab data and then dive into the tabirafusp-ted data. With tarcocimab, the comparator here was aflibercept fixed Q8 week dosing, 2 milligrams every eight weeks after three monthly loading doses, 225 patients, really the gold standard EYLEA control arm. Always important to think about the control arm first.
Secondly, the tarcocimab arm was four monthly loading doses up front, 225 patients, and then a highly differentiated trial design here, and we'll go into detail about that on the next slide in just a moment. These patients were then evaluated every four weeks and could receive dosing as frequently as every four weeks, but could also be observed at those visits, depending on their disease activity. We've talked a lot about disease activity criteria in this space for the last many years, and this trial was extremely strict on when patients were retreated, and we'll dive into that. The primary endpoint was change in visual acuity there across three of the time points, weeks 40, 44, and 48, again, comparing tarcocimab with aflibercept, ultimately, though, a two-year trial. Again, all of these were treatment-naive wet AMD patients. You can go forward. In many ways, this may be the most important slide.
Can you go to slide 12, please? Thank you. The retreatment criteria in any clinical trial trying to look at durability are critically important, and most clinical trials use a retreatment threshold of increased CST of a certain threshold, 50, 75, 100 microns, for example, associated with visual acuity loss, usually 5, 10, even 15 letters of visual acuity loss. This trial was highly unique and none of those requirements were necessary. Specifically, we did not wait for patients to experience visual acuity loss, and there was no CST threshold that would drive retreatment. Instead, we used an AI-based fluidics analysis to look for the smallest amount of intraretinal and/or subretinal fluid to initiate a therapy. We were trying to use practical criteria.
In the real world, when we see fluid, we reinject, and we don't go longer in between injections. That's what we tried to recapitulate in this clinical trial using a point-of-care deployed AI algorithm. On this slide, you can see examples of what this looks like. On the left is an eye that was dry, that did not have significant intraretinal or subretinal fluid. In fact, you see no fluid on that central B-scan. On the right, you see those small intraretinal cystic spaces highlighted in red, which is an indication of recurrent disease activity that would not have met any of the other retreatment criteria that I'm aware of in any advanced clinical trial used in retina previously.
It did cross the threshold for volumetric increase, and therefore that eye was retreated at that time point before there was vision loss and before there was a meaningful increase in CST. You can go forward one slide. Baseline characteristics for the tarcocimab versus aflibercept comparison were balanced. Visual acuity was about 20/60, and there was balance in the BCVA category, the low limits visual acuity deficit, and CST was about 350 microns in both arms. About 40% of all patients were phakic. You can go forward one slide. This slide demonstrates mean visual acuity change over time. Absolute visual acuity actually plotted here on the y-axis between both of the arms. Importantly, you can see the primary endpoint was met with high statistical significance, demonstrating not only non-inferiority, but equivalence of tarcocimab versus aflibercept.
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