Q4 2023 Kodiak Sciences Inc Earnings Call

Okay.

Good day and welcome.

None: Welcome to the Kodiak Sciences business update webcast and conference call. At this time all participants are in a listen only mode. After the speaker's presentation. There will be a cute a question answer session to ask a question. During the session you will need to press star one on your telephone.

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None: I turn the conference over to your first speaker today, John Borgeson Chief Financial Officer. Please go ahead.

John Borgeson: Thank you for joining our conference call and webcast.

John Borgeson: Business updates at Kodiak.

John Borgeson: John Borgeson Kodak's Chief Financial Officer.

John Borgeson: Joining me today are Victor a cold Roth, Chairman and CEO and Pablo with Alaska, as Martin Senior Vice President clinical research and development.

None: For our prepared remarks, we will open the call for Q&A.

None: The webcast portion of this call contains a slide presentation.

None: 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 investors and media section website.

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None: We also like to remind you that remarks made on this call. Today include forward looking statements are Kodiak.

Operator: and conference call. At this time, all participants are in a listen-only mode.

Is subject to risks and uncertainties, which are outlined on this slide.

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None: More complete description of these and other material risks can be unencumbered <unk> filings with the Securities and Exchange Commission, including its 10-K for the year ended December 31st 2023, which has been filed with the SEC.

Operator: To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I will now hand the conference over to your first speaker today, John Borgeson, Chief Financial Officer.

None: Courage encourage you to read those carefully.

None: I will note that Kodiak does not undertake any obligation to update publicly any forward looking statements, whether as a result of new information future events or otherwise.

John A. Borgeson: Thank you for joining our conference call and webcast to discuss recent business updates at Kodiak. I'm John Borgeson, Kodiak's Chief Financial Officer. Joining me today are Victor Perlroth, Chairman and CEO, and Pablo Velasquez-Martin, Senior Vice President of Clinical Research and Development. After our prepared remarks, we will open the call for Q&A. 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 in the Investors and Media section of our website. An archive of this webcast will be available shortly after the event on our website.

None: Now I'm pleased to turn the call over to Victor program Kodiak CEO Victor.

Thank you John.

Victor Perlroth: Good afternoon, everyone. Thanks for joining us I Trust. Many of you have read the Kobe X press release from this morning.

Victor: Announcing our recent business updates together with our financial snapshot.

Victor: For today's discussion is to provide additional context and color around some of our most recent activities that are going forward.

Victor: And we will welcome your questions at the end.

Victor: We're a retina focused company retina, because a challenging area for innovation.

Victor: There should be an increasing return to focus and time and dedication.

John A. Borgeson: We'd also like to remind you that remarks made on this call today include forward-looking statements about Kodiak that are subject to risks and uncertainties, and which are outlined on this slide. 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 10-K for the year ending December 31, 2023, which has been filed with the SEC. [inaudible] I encourage you to read those carefully. I will note that Kodiak does not undertake any obligation to update publicly any forward-looking statements, whether as a result of new information, future events, or otherwise. Now I'm pleased to turn the call over to Victor Perlroth, Kodiak CEO. Victor?

Victor: We sit at top 10, plus years of fine tuning of our ADC platform and our company.

Victor: Also being able to listen and to have the courage to make the important of course corrections needed to get us to the finish line.

Victor: Things that are meaningful for patients and therefore valuable.

Victor: The sector is concentrated with only Roche regeneron dominant players theres room for another major player and that remains our aspiration.

Victor: Look forward today to providing you abroad.

Victor: Today, we are at.

Victor: At a point of departure and we are in motion.

Victor: We have a portfolio of three clinical programs two programs, our ABC platform derived.

Its core science of durability.

Victor Perlroth: Thank you, John. Good afternoon, everyone. Thanks for joining us. I trust many of you have read Kodiak's press release this morning, announcing our recent business updates together with our financial snapshots. The goal for today's discussion is to provide additional context and color around some of our most recent activities in our Going Forward plan. And we will welcome your questions at any time.

Victor: <unk> program is platform independence.

Victor: We think that pipeline represents a healthy diversification both in terms of the opportunity.

Victor: And risk.

For some of you listening today you may see.

Smart enough to know whether Kodiak EDC platform represents a disruptive innovation that can deliver for patients and frankly for investors or not.

Victor: For you and let US show you, but in the meantime, you don't have to believe an easy platform to recognize that ksi 501 represents itself.

Victor Perlroth: We're a retina-focused company. Retina is a challenging area for innovation, but there should be an increasing return to focus, time, and dedication. At Kodiak, we sit atop 10 plus years of fine-tuning our ADC platform in our company. Also, being able to listen and have the courage to make the important course corrections needed to get us to the finish line with medicines that are meaningful for patients and, therefore, valuable. The sector is concentrated, with only Roche and Regeneron as dominant players.

Potential important new branded molecule for retina.

Victor: Highly potent on two powerful mechanisms for patients with inflammation and some residual fluid.

Victor: Call it a greenfield market opportunity.

Victor: And the program building as it does already from the Asa bioactivity efficacy and safety.

Victor: <unk> and the Ksi 501 program.

Victor Perlroth: There's room for another major player, and that remains our aspiration. We look forward to today to providing you the broad... Today, we are at a point of departure, and we are in motion. We have a portfolio of three clinical programs. Two programs are ABC platform-derived with its core science of durability. One program is platform-independent.

Sharing as it does the same broker.

Victor: Kodiak can be a tremendously successful company an investment opportunity on the basis of cash.

Victor: But for ourselves we are big believers also in our ABC platform.

Victor: Why durability remains a key unmet need.

Victor: One durability for all patients.

Victor: <unk> regimen as a maintenance for treatment naive patients and treatment periods and you want the durability without sacrificing immediacy.

Victor Perlroth: We think this pipeline represents a healthy diversification both in terms of opportunity and risk. For some of you listening today, you may say, I'm not smart enough to know whether Kodiak's ABC platform represents a disruptive innovation that can deliver for patients, and, frankly, for investors, or not. For you, let us show you, but in the meantime, you don't have to believe in the APC platform to recognize that KSI-101 represents itself as a potential, important, new branded molecule for retinol, highly potent on two powerful mechanisms, for patients with inflammation and some residual fluid. We call it a greenfield market opportunity.

Victor: They say the real test is whether you could give the drug to your mother and grandmother.

Victor: Stage not being marketed we provide our investigational medicines in context of our clinical trials, but our design. We're proud of the EDC platform. Our novel proteins are bio conjugates are underlying science and designed for durability and now the important adjustments we've made to the person that Prada.

Victor: Products that improve the manufacturer ability in a pre filled syringe and we believe may also enhance the utility of the product.

Victor: And which we are also already flowed into the ksi 501 manufactured material as well.

Victor: We believe now is the time to implement these changes given the additional clinical studies, we plan to conduct.

Victor Perlroth: In the program, building as it does already from the base of bioactivity, efficacy, and safety seen in the KSI 501 program, sharing as it does the same program. Kodiak can be a tremendously successful company and investment opportunity on the basis of KSI 101 alone. But for ourselves, we are big believers in our ABC class as well. Why?

Victor: The FDA has agreed that these additional clinical studies are sufficient to bridge the former material to the go to market material, which wed like to commercialize is going forward.

Victor: <unk> also ksi 501, these represent state of the art molecules and based on our view of our data and these design enhancements I think these medicine.

Grandmother tests.

Victor: And when you look commercially given the rapid pace of our planned development for <unk> and the Ksi 501.

Victor: Well, yes, there is a commercial complexity.

Victor: Are the innovator here and we believe there can be a strong demand for our medicines and their unique design science and their performance in the retina marketplace.

Victor: Taking it back to the top level across these three what I call late phase programs. There is also a significant amount of operational synergy and moving these three programs forward together and as we will see or useful we can't even run them in the same study or studies with low incremental costs.

Victor Perlroth: Durability remains a key unmet need, and we want durability for all people, as an inception regimen as maintenance for treatment, i.e., patients and treatment, and you want the durability without sacrificing an EDSU coder. They say the real test is whether you give the drug to your mother or grandmother. At this stage, not being marketed, we provide our investigational medicines in the context of our clinical trials, but our design. We're proud of the EPC platform. Our novel proteins, our bioconjugates, our underlying science and design for durability. And now, the important adjustments we've made to the Tarkosamep product that improve its manufacturability in a prefilled syringe and, we believe, may also enhance the utility of the product, and which we have also already flowed into the KSI 501 manufactured material as well.

Victor: Group.

So where are we today.

Victor: Let's start with an overview of where we are.

Victor: Number one from a cash position, we have an attractive cash.

Victor: Uh huh.

Victor: Positioned today.

Victor: As of Q4.

Victor: Number two when we look at Kodiak, we see three late phase programs and number three our intention is to bring these three programs two meaningful inflections within our cash runway.

Victor: So <unk>, we have three positive phase III studies that are being completed and diabetic retinopathy and retinal vein occlusion and in wet AMD.

Victor: We have strong and consistent six month's durability signal and favorable safety seen across the pivotal program.

Victor: We have regulatory alignment now that's been achieved on a bridging strategy for our go to market correlation the phase III study below two and diabetic retinopathy is now actively recruiting patients.

Victor: And we've added as an additional arm circosta map to DAYBREAK to validate durability in wet AMD to strengthen <unk> competitive position and to bolster our ex U S regulatory dossier.

Victor: For 501, the phase one study and <unk> met our objectives.

Victor Perlroth: We believe now is the time to implement these changes, given the additional clinical studies we plan to conduct. And, the FDA has agreed that these additional clinical studies are sufficient to bridge the former material to the go-to-market, which we'd like to commercialize going forward. TARCOSIMAP, then, and also KSI501, these represent state-of-the-art molecules, and based on our view of our data and these design intentions, they can be used in a variety of ways. I think these metas..., and Greg.

We're developing it towards the high prevalence retinal vascular diseases.

Victor: To bring durability and the extra mechanisms to there.

Victor: Created the enhanced formulation informed from <unk> commercial manufacturing scale up with many potential benefits and we're in the process of gaining we're finalizing FDA alignment on the design of the phase III study in wet AMD and targeting and enrollment to start midyear.

Victor: And for our diversified, let's say Ksi 101 program for <unk>.

Victor: Developing it in a new area of macular edema associated with inflammation, you see it as a greenfield opportunity outside of the established.

Victor: Class and with risks and opportunities uncoupled from our ADC platform and from our other two molecules.

Phase <unk> study is planned for the second quarter to identify two dose levels.

Victor Perlroth: And when we look commercially, given the rapid pace now of our planned development for TarkoshaMap and KSI501, Well, yes, there is a commercial opportunity. We are the innovators here, and we believe there could be a strong demand for our methods, in their unique design, science, and performance in the retina. Taking it back to the top level, across these three, what I call late-phase programs, there's also a significant amount of operational synergy in moving these three programs forward together. And, as we'll see, where useful, we can even run them in the same study or studies with low incremental costs. So where are we today?

Victor: And rapidly progressing to pivotal studies and we're in the process of gaining FDA alignment on the design of dual phase <unk> III pivotal studies, which also are planned for initiation of this year.

Victor: Yeah.

Victor: Turning to slide six.

Victor: <unk> is our most advanced program and we're one successful trial away from violent registration.

Victor: In a success scenario in the trial of <unk> two will be conducted in a patient population diabetic retinopathy or <unk>.

Victor: <unk> already showed a clear win in our Globe study.

Victor: <unk> is actively recruiting patients.

Victor: At the same time, we plan to advance Ksi 501 <unk>.

Victor: <unk> 101 rapidly.

Victor: Studies this year.

Victor: The phase one study of Ksi 501, demonstrating positive signals in efficacy and safety and support further development.

Victor Perlroth: Let's start with an overview of where we are. Number one, from a cash position, we have an attractive cash position today, as of Q4. Number two, when we look at Kodiak, we see three late-phase programs, and number three, our intention is to bring these three programs to meaningful inflections within our cash runway. So for TARCOSIMAB, we have three positive phase three studies that have been completed in diabetic retinopathy, in retinal vein occlusion, and in wet EMD. We have strong and consistent six-month durability signals and favorable safety seen across the pivotal programs. We have regulatory alignment now, and this has been achieved on a bridging strategy for our go-to-market formulation. The PHLEAS-3 study GLO2 in diabetic retinopathy is now actively recruiting.

Victor: We are in discussion with the FDA on the study design of the Phase III <unk> study in wet AMD and Gwen to initiate it as soon as regulatory lag is achieved targeting mid 2024.

Victor: We also intend to advance ksi 301 into a phase one dose finding study in the second quarter of this year to identify the two dose levels, we want them using our dual pivotal.

We're in the process of meeting regulatory feedback on the pivotal program design.

Victor: And we hope to initiate two phase III studies later this year.

Victor: Our goal is to have four pivotal studies ongoing later this year across the three programs to service, a broad and powerful BLA for <unk>.

Victor: To service, a new and powerful BLA for Ksi 501, and one is half of what's needed for our ksi five O L. A.

Victor: Turning to slide seven.

Victor: Now, let's turn to our most advanced clinical program for Cosan.

Victor: <unk> is an anti VEGF antibody biopolymer conjugate or ABC medicine built on the ABC platform to provide extended durability. It's been studied into six pivotal studies three of which met their primary endpoints across the indications diabetic retinopathy retinal vein occlusion and wet AMD.

Victor Perlroth: And we've added, as an additional arm, Tercosamab into Daybreak to validate the durability and wet EMT to strengthen Tercosamab's competitive position and to bolster our ex-US regulatory for 501, the Phase I study in DME METR objectives. We're developing it for the high-prevalence retinobascular disease, to bring durability and extra mechanisms to this. We've created the enhanced formulation informed from Tercosumab's commercial manufacturing scale-up with many potential benefits, and we're in the process of gaining or finalizing FDA alignment on the design of the Phase III Daybreak Study in wet AMD and targeting an enrollment start mid-year. And for our diversified, let's say, KSI 101, we're developing it in a new area, macular edema, associated with We see it as a greenfield opportunity outside of the established anti-budget class and with risks and opportunities uncoupled from our ABC platform and from our other tools.

Victor: My view is turco cement can bring six months durability.

Victor: The majority of patients across the diseases and that we can get there as an initiating therapy not a maintenance therapy without leaving any patients behind irrespective of disease severity.

That's the future as we see it.

Victor: In our <unk> study in diabetic retinopathy <unk> demonstrated for the first time among anti bad Jets at six months dosing to successfully treat ER patients by improving the disease severity scores and reducing risk of vision threatening complications by about 9%.

And our Beacon study and retinal vein occlusion charcoal mab demonstrated we can bring all RVO patients to once every two months dosing.

Victor: The current standard of care, which is monthly dose.

And importantly in the second six months of the study <unk>, where studies studied head to head against the percent on the same individualized dosing regimen.

Victor: Proximately half of <unk> treated patients were injection free in the second six months compared to about a third of liver septic treated patients.

Victor: Over the entire one year of treatment in <unk> treated patients achieved comparable vision anatomic outcomes, but meaningfully fewer injections compared to us with respect to treated patients.

Victor: Versus <unk>.

Victor: Lastly, in our daylight study in wet AMD or.

Victor: Kosta Amendment met its primary endpoint and demonstrated that the Tencent monthly dosing of <unk> was safe and well tolerated.

Victor Perlroth: A Phase 1b study is planned for the second quarter to identify two dose levels that will then rapidly progress into pivotal studies. And we're in the process of gaining FDA alignment on the design of dual Phase 2b, 3 pivotal studies, which also are planned for initiation, turning into a blank sheet. So COSTOMAP is our most advanced program, and we're one successful trial away from filing a registration. In the trial, GLO2, it will be conducted in a patient population, diabetic retinopathy, where TARCOSA map already showed a clear win in our GLO1 study. GLOBE 2 is actively recruiting people.

Victor: These are important studies in big indications.

Victor: Nonetheless in our turn costs on that program. They are appointed departure and the value comes when you finish things. So to that end. We are also as I mentioned made adjustments to the <unk> products that improve the manufacturer ability and they also enhance the utility of the product and we have received FDA.

Victor: The impact of one additional successful pivotal study using the go to market material.

Victor: Sufficient to bridge to clinical scale material set of go to market material.

Victor: Now just to bring.

Victor: Our go to market formulation.

Victor: Not just to bridge our go to market formulation, but as of today, we have three positive phase III studies of <unk> three different diseases, and we want one more successful pivotal study one of these indications to file for approval.

Victor Perlroth: At the same time, we plan to advance KSI 501 and KSI 101 rapidly into digital studies. The Phase 1 study of KSI 501 demonstrated positive signals of efficacy and safety, and support for their development. We are in discussion with the FDA on the study design of the Phase 3 Daybreak Study in wet AMD and plan to initiate it as soon as regulatory alignment is achieved, targeting mid-2020. We also intend to advance KSI 101 into a Phase I-E dose finding study in the second quarter of this year to identify the two dose levels we want to be using in our dual pivotal. We're in the process of gaining regulatory feedback on the pivotal program design, and we hope to initiate two Phase IIb studies later this year. Our goal is to have four pivotal studies ongoing later this year across the three programs. Two, service a broad and powerful VLA for TARCOSA, and one is half of what's needed for KSI 5, turning to the slide set.

Victor: We plan to evaluate turning to slide eight <unk> and tubing phase III study the <unk> study in diabetic retinopathy.

Victor: And the DAYBREAK study in wet AMD.

Victor: We obtained FDA feedback on the study design of <unk> and it is already actively enrolling patients yes.

Victor: The idea behind the below two was to have a very high probability of success study therefore.

Victor: Therefore, the study design for <unk> to build one.

Victor: And I see it as having a high real and perceived probability of success. So from an investor standpoint, I don't think you need to wait around to see the results have some early confidence in.

Victor: In addition, and after much consideration.

Victor: We also intend to study <unk> is our second investigational arm in our wet AMD DAYBREAK study with three purposes.

Victor: To demonstrate conclusively <unk> durability in wet AMD.

Victor: To strengthen <unk> competitive position.

Given the importance of wet AMD in the anti VEGF market.

Victor: And third to bolster <unk> ex U S regulatory dossier.

Victor: We're in the process of obtaining FDA feedback on the spending side the DAYBREAK to initiate recruitment mid 2024.

Victor Perlroth: Now, let's turn to our most advanced clinical program, Tercosa. Tercosumab is an anti-VEGF-antibiotic biopolymer conjugate, or ABC medicine, built on the ABC platform to provide extended durability. It's been studied in six pivotal studies, three of which met their primary endowments across the indications, diabetic retinopathy, retinoling occlusion, and wet antenna. My view is TARCOSAMAT can bring six-month durability to the majority of patients across these indications, and that we can get there as an initiating therapy, not a maintenance therapy, and without leaving any patients behind, irrespective of disease That's the future as we see it.

Victor: Turning to slide nine.

Victor: The global II study design built from the successful <unk> study with the benefit of a third monthly loading loading dose at week four as highlighted on this slide we believe that three monthly loading dose regimen provides greater flexibility to patients and it's nice to have as part of our BLA package.

The primary endpoint is the proportion of eyes with two steps or greater improvement.

Victor: Drs S at week 48.

Victor: The same is colo.

Turning to slide 10.

Now, let's turn to Ksi 501, our second investigational medicine.

Victor: One is a first in class bi specific antibody biopolymer conjugate.

Victor: Our APC that inhibits both IL six and venture.

Victor: IL six is a pro inflammatory cytokines and growth factor implicated in the past the physiology of retinal vascular diseases. It.

Victor Perlroth: In our GLOW-1 study in diabetic retinopathy, tracosumab demonstrated for the first time among anti-VEGFs that six-month dosing can successfully treat DR patients by improving the disease severity scores and reducing the risk of vision-threatening complications by about In our BEACON study in retinal vein occlusion, TARCOSA map demonstrated we could bring all RVOPs to once-every-two-month dose Approximately half of TARCOSIMAP-treated patients were injection-free in the second six months compared to about a third of liver sept treated patients. Over the entire one year of treatment, TARCOSUMM-treated patients achieved comparable vision and atomic outcomes with meaningfully fewer injections compared to a Flipper Substitute. Iverson.

Victor: It is known to stimulate defective angiogenesis.

Victor: Regulating that Jeff and I imagine.

Victor: It is associated with anti VEGF treatment resistance as well as disease progression and AMD, Dr and RVO.

Victor: 501 is designed with three tiers of being a niche.

First to target mechanism.

Victor: Inhibiting both the dominant VEGF pathway.

Victor: The IL six inflammation pathway.

Victor: Two the potential for six months durability based on Kodiak.

Victor: At four three.

Victor: III and enhanced Ksi 501 formulation informed <unk> commercial manufacturing scale.

We believe the three tiers of innovation position Ksi 501, well to address the unmet needs in a high prevalence retinal vascular diseases, such as the need to target disease mechanisms beyond that Jeff and the need for extended term.

Victor: As I mentioned above the Ksi 501 program.

Victor: As a result of the fine tuning of our ADC platform at the company over the past 10, plus years and the program itself is a fast forward the design to manufacturing clinical planning and the operational expertise.

Victor Perlroth: Lastly, in our daylight study in Wedding Hill, Tercosumab met its primary endpoints and demonstrated that intensive monthly dosing of Tercosumab was safe and well tolerated. These are important studies in vague indications. Nonetheless, in our TARCOSA-MAP program, they are a point of departure, and the value comes when you finish things.

Victor: Turning to slide 11.

Victor: This slide is a reminder of the substantial variability in response to today's anti VEGF standard of care agents.

Victor: And therefore, the need to bring additional disease mechanisms beyond bad yet into our therapies.

As you can see from this data generated in our own pivotal wedding study there are substantial inter patient variability in their response to anti VEGF monotherapy, both in terms of visual acuity gains and.

Victor Perlroth: To that end, we have also, as I mentioned, made adjustments to the TARCOSA-MAP product that improve its manufacturability and may also enhance the utility of the product. And we have received FDA feedback that one additional successful pivotal study using the go-to-market material is sufficient to bridge the clinical scale material to the Not just a brain or go-to-market formulation, but not just to bridge our go-to-market formulation. But as of today, we have three positive phase-3 studies of Tercosumab in three different indications, and we will need one more successful pivotal study in one of these indications to file. We plan to evaluate Tercosumab in two new phase 3 studies, the GLO2 study in diabetic retinopathy and the Daybreak study in WebMD.

Really a reduction of.

Victor: A substantial proportion of patients.

Victor: <unk> vision and oriented pulmicort improvement compared to the immune responses, which highlights the need for additional mechanisms of action and we believe ksi 501.

Victor: Play an important role here.

Turning to slide 12.

The anti IL six VEGF trap by specific protein and Ksi 501 has a unique design that enables it to potently inhibit one or more of NGF diapers and two IL six molecules simultaneously.

Victor: The venture trap portion mimics the native receptor and bind multiple targets, including betcha.

Victor: One <unk> P M central growth factor.

Victor: Anti IL six antibody binds IL six therefore, inhibiting both IL <unk> trends and CIS signaling by its binding to soluble membrane bound IL six receptors perspective.

Victor: Inhibition of IL six blocks IL, six mediated inflammation and immune activation.

Victor Perlroth: We have obtained FDA feedback on the study design of GLO2, and it is already actively enrolling patients. The idea behind GLOW-2 was to have a very high probability of success. Therefore, the study designed for GLOW-2 builds on GLOW-1, and I see it as having a high real and perceived probability of success. So, from an investor standpoint, I don't think you need to wait around to see the results to have some early confidence.

Victor: Normalizes blood retinal barrier.

Victor: Turning to slide 13.

We conducted a phase <unk> study in <unk> patients that is now complete the study was a multiple ascending dose study.

Victor: In gambling patients both treatment naive and pretreated patients.

Victor: Dose levels were studied in the phase one each.

Victor: Each subject received three monthly doses and was followed for 24 weeks, which allowed us to evaluate the safety tolerability and bio activity signals of Ksi 501.

Victor Perlroth: In addition, and after much consideration, we also intend to study Tercosumab as a second investigation alarm in our wet EMD daybreak, with three professionals, first to demonstrate conclusively Tarkosamab's durability in wet hair. Second, to strengthen Tarkusum at a competitive position, given the importance of wet AMD in the anti-VEGF market, and third, to bolster TARCOSAMAP's ex-U We're in the process of obtaining FDA feedback on the study design of daybreak and hope to initiate recruitment mid-2021, turning just like that. The GLOW-2 study design builds from the successful GLOW-1 study, with the benefit of a third monthly loading dose at week 4, as highlighted on the slide. We believe that a three monthly loading dose regimen provides greater flexibility to patients and is nice to have as part of our VLA pack.

Turning to slide 14.

Victor: We are pleased with the phase <unk> study results.

Victor: <unk> Ksi 501 demonstrated strong visual acuity gains in both treatment naive and pretreated <unk> patients that were sustained over the 24 week study period.

Victor: It also demonstrated meaningful CST reductions in patients.

None: So this was a small patient sample size so.

None: We should try not to over interpret the results, but rather we look for the essential signals that suggest it could be a molecule with meaningful therapeutic effect.

None: The phase one study also demonstrated that repeated monthly dosing of <unk> 501 was safe and well tolerated.

None: Overall, we think the phase one study results support further clinical development of 501.

Turning to slide 15.

None: We're planning to advance Ksi 501 into a phase III study in wet AMD called DAYBREAK later this year.

None: There is abundant preclinical.

And clinical evidence for the role of IL six in Colorado near Vascularization, both in terms of driving disease pathogenesis and also in mediating treatment response to anti VEGF agents and disease reactivation.

Victor Perlroth: The primary endpoint is the proportion of eyes with two steps of greater improvement on DRSS and WE48, the same as before. Now, let's turn to KSI 501, our second investigational medicine. 501 is a first-in-class bispecific antibody biopolymer conjugate, or a BC that inhibits both IL-6 and VEGF. IL-6 is a pro-inflammatory cytokine and growth factor implicated in the pathophysiology of retinal vascular disease.

None: We believe three tiered innovation designed into Ksi 501, as mentioned before namely the bite specific mechanism of action the potential for six months durability based on the platform and the enhanced population positioning the molecule well to address the unmet needs in wet AMD.

None: The game break study is intended to be a non inferiority study to evaluate the efficacy durability and safety of Ksi 501 and <unk>.

None: In wet AMD against us with respect to make both 501 <unk> will be dosed on extended regimen from every four to 24 weeks, while the flipper set to make will be dosed per label.

Victor Perlroth: It is known to stimulate defective angiogenesis both by upregulating VEGF and by a VEGF inhibitor. It is associated with anti-vegetative treatment resistance, as well as disease progression in AMD, DR, and ARD. 501 is designed with three tiers of unity. First, the two-target mechanism, potently inhibiting both the dominant VEGF pathway and the IL6 information. 2. The potential for 6-month durability based on Kodiak's ADC platform.

None: This study will use to go to market formulations for both 501 and charcoal that improve the manufacturer ability in a pre filled syringe may also enhance the utility of the products.

None: We are currently in conversation with the FDA to obtain feedback on the study design for DAYBREAK and intend to initiate enrollment as soon as alignment has achieved targeting mid 2020 forward.

None: Turning to slide 16.

None: Now I will turn our attention to our third investigational medicine Ksi 501.

Victor Perlroth: An enhanced KSI-501 formulation informed from Tarkosumab's commercial manufacturing scheme. We believe the three tiers of innovation position KSI501 well to address the unmet needs in high-prevalence retinovascular diseases, such as the need to target disease mechanisms beyond VEGF and the need for extended care. As I mentioned above, the KSI 501 program is the result of the fine-tuning of our ABC platform And the program itself is a fast-forward, the design, the manufacturing, the clinical planning, and the operational experience. This slide is a reminder of the substantial variability to today's anti-veg standard and therefore the need to bring additional disease mechanisms beyond VEGF into our economy. As you can see from this data generated in our own pivotal wetting and de-study, there is substantial interpatient variability in their response to anti-vegetative monoclonal antibodies, both in terms of visual acuity gains and fluid reduction. A substantial proportion of patients underperform in vision and or in anatomical improvement compared to the mean responses, which highlights the need for additional mechanisms of action.

None: This is the Unconjugated protein portion of Ksi 501, with the same anti IL six and venture track design and its unique features as we mentioned previously.

None: This is a greenfield development opportunity for us as it focuses on a market outside if you established anti VEGF market.

None: Cash by 101 also is independent from each platform with opportunities and risks uncoupled from the platform, which presents a healthy diversification.

None: With its by specific anti inflammatory mechanism of action.

None: High potency on both targets and high formulation strength at 100 milligram spread mill. This is a powerful medicine and we are exploring as these difficult conditions, what we call that you'd be at a complex diseases as hallmark have macular edema.

None: Retinal edema, and inflammation and for which no inter vitriol biologic therapies exist today.

None: Turning to slide 17.

None: Current treatments for patients with macular edema associated with retinal inflammation show limited efficacy and many undesirable and potentially serious side effects.

None: Treatment is generally non specifics such as steroids and immune modulators.

Only one approved biologic therapy at <unk>, which is an anti TNF alpha agent that is administered systemically, but it also is associated with limited treatment efficacy serious side effects.

None: There are no approved interim Israel biologic therapies today.

None: That target the underlying disease mechanism.

Victor Perlroth: And we believe KSA501 can play an important role. [Inaudible] The anti-IL-6 VEGF trap by specific protein in KSI501 has a unique design that enables it to potently inhibit one or more VEGF dimers and two IL-6 molecules simultaneously. The VEGF-TRAP portion mimics the native receptor and binds multiple targets, including VEGF1, VEGF-A, VEGF-B, and placental growth factor. The anti-IL-6 antibody binds IL-6, therefore inhibiting both IL-6 trans and cis signaling by its binding to soluble and membrane-bound IL-6 receptors.

None: We believe this disease area is prime for a powerful safe and effective branded <unk> biologic therapy to change the treatment paradigm.

None: Turning to slide eight.

None: We plan to advance Ksi 101 into a dose finding phase <unk> study in the second quarter of this year to identify the two dose levels to progress into our pivotal.

None: We are currently in the process of obtaining FDA feedback on the design of the pivotal program here for Ksi 101, and hope to initiate two phase <unk> slash three pivotal studies later in 2024.

None: Turning to slide 19 and summarize it.

None: In summary, we're excited to be on plan to advance our three clinical programs into phase III studies in 2024.

None: Hello to procure kosta map already enrolling.

None: With DAYBREAK up next and bringing forward two of our molecules Ksi 501, as well as <unk>.

None: And then dual pivotal for Ksi 501.

Victor Perlroth: Inhibition of IL-6 blocks IL-6-mediated inflammation and immune activity and Normalizes Blood Reduction Turning to slide 13. We conducted a phase 1A, 1B type study in DME patients that is now complete. The study was a multiple ascending dose study, and DMV patients, both treatment-naive and pre-treated patients. Ordos levels were studied in phase 1.

None: We are at a point of departure and we're in motion.

None: And we have our eyes focused on delivering meaningful phase III DLH.

None: Al you inflection points within our current cash runway.

None: Now we will open the floor to analysts for questions opt.

None: Operator.

None: As a reminder to ask a question you will need to press star one on your telephone and wait for them to be announced to withdraw. Your question. Please press star one again.

None: Please standby.

None: Roster.

None: One moment for our first question.

Victor Perlroth: Each subject received 3 monthly doses and was followed for 24 weeks, which allowed us to evaluate the safety, tolerability, and bioactivity signals of KSI501. Turning to slide 14, we are pleased with the Phase 1 study results, where KSI501 demonstrated strong visual acuity gains in both treatment-nave and pre-treated DMV patients that were sustained over the 24-week study period. It also demonstrated meaningful CST reductions.

None: And our first question comes from the line of.

None: Michael <unk> from Jefferies. Your line is open.

None: Hi, Good afternoon. This is Jojo went on the line for Michael Thanks for taking my questions.

JoJo: I have two questions regarding the 501 Bispecific pivotal study.

JoJo: Otis that there are multiple arms floor, how closely map and ksi five of Hawaii that study I wonder if those patients will be randomized to each of the arms at the beginning or they would be treated as needed and gave them more flexibility up with Dolby.

JoJo: And what's your estimate of the sample size.

Victor Perlroth: Though this was a small patient sample size, so we try not to over-interpret the results, but rather we look for the essential signals that suggest this could be a molecule with meaningful therapy. The Phase 1 study also demonstrated that repeated monthly dosing of 501 was safe and well-tolerated. Overall, we think the results of the Phase I study support further clinical development of the 501C. Thank you. We're planning to advance KSI 501 into a phase 3 study in wet AMD called Daybreak later this year. There is abundant preclinical and clinical evidence for the role of IL-6 in choroidal neovascularization, both in terms of driving disease pathogenesis and also in mediating treatment response to anti-VEGF agents and disease reactivation.

JoJo: Second question is can you clarify if you're planning to include data from the date part.

JoJo: Face the.

JoJo: The pivotal study for 501 as well in the St BLA filing I've talked about.

JoJo: Yeah.

JoJo: Mhm.

JoJo: Thanks.

JoJo: But to try to make sure that we understand.

JoJo: The question to.

JoJo: To round the DAYBREAK study.

JoJo: And that study is planned to include a flipper set that's the comparator and then to include arms for <unk> as well as Ksi 501.

JoJo: So the first.

JoJo: Objective of including.

JoJo: And experimental arm with <unk> in this study is very efficient.

JoJo: <unk> for us and operationally.

JoJo: But also the data from this study are willing yet to be included in the BLA filing for Taco Smith. So our objective on the timing of the DAYBREAK study and also in the Globe. Two study are from those studies to finish at approximately the same time and to see the same GLA.

Victor Perlroth: We believe the three-tiered innovation designed into KSI501, as mentioned before, namely, a specific mechanism of action, the potential for six-month durability based on the ABC platform, and the enhanced formulation position the molecule well to address the unmet needs in wetting AMD. The Daybreak Study is intended to be a non-inferiority study to evaluate the efficacy, durability, and safety of KSI501 and Tar Both 501 and TARCOSIMEC will be dosed on an extended regimen from every 4 to 24 weeks, while FLIPRCEP 2MIG will be dosed per label. The study will use the go-to-market formulations for both 501 and Tercosumab that improve the manufacturability in a prefilled syringe and may also enhance the utility of the product. We are currently in conversation with the FDA to obtain feedback on the study design for Daybreak and intend to initiate enrollment as soon as alignment is achieved, targeting mid-2024.

JoJo: So thats an important element than on the study design for DAYBREAK, we're still in discussions with FDA to make sure that we get to.

JoJo: The study that meets our needs. Our objective is to include durability for both <unk> and Ksi 501.

JoJo: And to be able to go from monthly dosing all the way through six months dose to be able to showcase.

JoJo: The power of our ADC platform medicines from the standpoint of immediacy, but also their powerful durability.

So does that mean that you would have multiple arms talk working lab as well as 501.

JoJo: And that essentially.

JoJo: Requires a big study.

JoJo: For you to run.

None: We haven't disclosed the precise design of the study yet as you know within ophthalmology, the regulatory landscape is evolving one of our core objectives.

None: For the day break study is that it would be cost effective Kodiak has a substantial amount of experience running.

Victor Perlroth: Now we'll turn our attention to our third investigational medicine, KSI 101. This is the unconjugated protein portion of KSI-501 with the same anti-IL-6 and VEGF-TRAP design and its unique features as we mentioned previously. This is a greenfield development opportunity for us, as it focuses on a market outside the established anti-vegetation market.

None: Many of these studies and the big diseases, and retina and so obviously, we're going to try not to have more groups than we need to have to be able to like achieve our objectives. So lets stay tuned and see where we come out on the study design.

Got it thank you.

None: One moment our next question.

None: Okay.

Yeah.

None: And our next question comes from the line of Michael <unk> from Evercore ISI. Your line is open.

Victor Perlroth: KSI 101 is also independent from the ABC platform, with opportunities and risks uncoupled from the platform, which presents healthy diversity with its life-specific anti-inflammatory mechanism of action, high potency on both targets, and high formulation strength of 100 milligrams per ml. This is a powerful medicine, and we are exploring it in difficult conditions, what we call the uveitic complex of diseases that have the hallmark of macular edema, that is, retinal edema and inflammation and for which no interventory biologic therapies exist today. Turning to slide seven. Current treatments for patients with macular edema associated with retinal inflammation show limited efficacy and many undesirable and potentially serious side effects. Treatment is generally nonspecific, such as steroids and immunomodulators.

Hi, guys. Thanks, so much for doing the call and for taking my question.

Michael: Question for me number one regarding the upcoming phase III DAYBREAK trial.

Michael: I know the design is currently being finalized, but if you could provide any color on what dose will be used.

Michael: And a follow up question to that is how is the enhanced ksi 501 formulation is different.

From the formulation used in the recent prior phase <unk> study.

None: I have a follow up.

Michael: Mhm.

Michael: For the DAYBREAK study the plan is to use a similar 100 microliter volume. So therefore, it will be driven by the formulation strength of the formulations themselves. So both the <unk> and the Ksi 501 formulations are 50 Mig per mill strength.

Michael: Or this pivotal at 100, microliters, so they'll be five milligrams, each and each one of those molecules will be in there what we call kind of go to market formulation or commercial scale up formulation, which as we've mentioned in does include adjustments from what was tested previously.

Michael: With <unk> in our pivotal program and also what was used in the phase one program for Ksi 501, So as I said.

Michael: We're at an important point of departure as we step into these new studies with these adjusted and enhanced formulations.

Michael: And.

Victor Perlroth: There is only one approved biologic, Adalimumab, which is an anti-TNF-alpha agent that is administered systemically, but it also is associated with limited treatment efficacy in serious cytokines. There are no approved intravitreal biologic therapies today that target the underlying disease mechanism.

Michael: And.

Michael: We're we're excited to be able to showcase what these molecules.

Michael: <unk> molecules can do can we use next set of pivotal.

None: Got it that's helpful and I guess my follow up question is.

None: Just want to clarify why exactly iqos matters being added as an active comparator.

None: In the DAYBREAK trial is it correct to assume that the FDA is not requiring this and that Kodiak is proactively doing this in order to have dosing flexibility on the label.

Victor Perlroth: We believe this disease area is primed for a powerful, safe, and effective branded intravitreal biologic therapy to change the treatment paradigm, turning the slide. We plan to advance KSI-101 into a dose-finding Phase 1b study in the second quarter of this year to identify the two dose levels to progress on target. We are currently in the process of obtaining FDA feedback on the design of the pivotal program here for KSI 101 and hope to initiate two phase 2b slash three pivotal studies later in 2020. Turning to slide 19 and summarizing,

None: Okay.

None: We.

None: We really struggled somewhat with what to do to finish the <unk> program and I would say it took us some months to figure out what we wanted to or plan to be.

None: And.

None: On the one hand, we wanted to lean into additional work in wet AMD because that represents a large part of the market right for the anti bad Jeff's on the other hand, we didn't want to run the study where.

None: Let's say different stakeholders, our investors where we.

None: Worried about their probability of success.

None: As we have so much hanging on the outcome. So in the end.

None: We decided to run the <unk> two study as our core study for approval to Arcos from avid.

None: Which we can which will have a very high probability of success given that it's essentially the same study is below one which was a tremendously successful outcome and then in addition, we decided that we would tuck in and additional group into the pivotal study we wanted to run for Ksi five.

Victor Perlroth: In summary, we're excited to be on plan to advance our three clinical programs into phase three studies in 2024, with Glow 2 for Tarkoza Map already in the rolling, with Daybreak up next and bringing forward two of our molecules, kids like Fireball 1 as well as Turcosu, and then Dual Pivotals for KSI 101. We are at a point of departure, and we're in motion, and we have our eyes focused on delivering meaningful Phase 3 DLA-facing value inflection within our current cash run. Now, we will open the floor to analysts for questions, Operator. Thank you. As a reminder, to ask a question, you need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by.

None: So economically it's very cash efficient to tuck that in.

None: Having decided to run that additional wet AMD study.

None: Dan.

None: <unk> ended up with the daylight study as a successful study and we hope to DAYBREAK study also has a successful study for telcos to map and our overall package will then include five successful we hope pivotal studies for <unk>.

None: And at the same time, we're checking the box for Ksi 501, and it will be the first of its two pivotal studies that will need to file a Caribbean late so if you think about Kodiak program with three what I call late phase.

Molecules.

None: With all of them being run through pivotal studies starting imminently.

None: The philosophy that we're bringing to the next several years of Kodiak development.

None: Got it very helpful. Thanks, so much.

None: Thank you one moment our next question.

None: Yeah.

None: Uh huh.

None: And our next question comes from the line of <unk>.

None: Rama from Jpmorgan Your line is open.

None: Alright, Thanks for taking the question this is actually Malcolm on for Alibaba.

Malcolm: So just one from us.

Malcolm: What is being assumed in terms of milestones between now and you're.

Operator: We're going to start the Q&A roster. One moment for our first question. Our first question will come from Lionel. Michael Yee from Jeffries, your line is open.

Malcolm: The editor cash runway into 2026.

Malcolm: Yes.

None: Well certainly the completion.

Jiajun Wen: Hi, good afternoon. This is Jiajun Wen on the line for Michael E. Thanks for taking my questions. I have two questions regarding the 501 bispecific pivotal dose study. I noticed that there are multiple arms for Tarcozumab and KSI 501 in that study. I wonder if those patients would be randomized to each of the arms at the beginning, or they would be treated as needed and given more flexibility in the dosing? And what's your estimate of the sample size?

None: Of the two <unk> pivotal as.

None: As well as the completion of the 501 pivotal.

None: And we're in discussions with FTE currently on the design of the phase two be slashed III studies for 101 and.

None: And depending a little bit on those designs and how they translate.

None: Two enrollment.

None: We were hopeful that we'll be able to get it.

None: Those studies out in that timeframe.

None: As well.

None: Great. Thank you.

None: Thank you.

None: For next question.

Victor Perlroth: And second question is, can you clarify if you plan to include data from the state part, the pivotal study for 501 as well in the same BLA finding for Tarcozumab? Thanks. To try to make sure that we understood the question, to round out the Daybreak Study, and that study is planned to include flimrosept as the comparator and then to include arms for Tercosumab as well as KSI 501. So the first objective of including an experimental arm with Tarcosamab in the study is very efficient economically for us and operations.

None: Yeah.

None: Our next question comes from the line of Andrea <unk> from Goldman Sachs. Your line is open thanks.

Andrea: Thanks for taking the question two Frac pleased maybe as a follow up to a prior comment recognizing that the potency remains the same between the two formulations that you have.

Andrea: Can you share with me or maybe speak to what data you've seen that supports that durability of the original formulation will carry over as you transition from the biopolymer conjugate to now a mix of the conjugate the antibody.

None: Thanks, Andrea well, that's a that's a good question.

None:

We believe more broadly that disease variability in patients is what drives durability.

Victor Perlroth: But also, the data from the study will, yes, be included in the BLA filing for TARCOSMAT. So our objective for the timing of the Daybreak Study and also the GLO2 Study is for those studies to finish at approximately the same time and to feed into the same BLA. So that's an important element.

Andrea: More more strongly than the amount of conjugate that we have so for example in our phase <unk> study, we tested two five mix versus five makes a fully conjugated material and there's very little distinction between the durability that we saw on the two five milligram dose and the five.

Andrea: Milligram dose so as we bring the level of a conjugate down.

To allow a broader amount of free protein.

Andrea: We believe that we can bring the best of both worlds into both the <unk> and the Ksi 501 formulations without impacting durability and creating a powerful medicines for patients.

Victor Perlroth: Then on the study designed for daybreak, we're still in discussions with FDA to make sure that we get to the study that meets our needs. Our objective is to include durability for both TARCOSIMAP and KSI501 and to be able to go from monthly dosing all the way through six-month dosing, to showcase the power of our EDC platform, medicines from the standpoint of the EDC, but also their benefits. So does that mean that you would have multiple arms of the Tarkozy map, as well as 501? And that essentially requires a big study for you to run.

None: Got it and then just maybe one quickly on the phase one data that you have seen in <unk> for that the 16 patients from the Stateline.

None: Could you just share speak a little bit more about what gives you the confidence to move directly from that and in the 16 patients to a phase II trial now in wet AMD.

None: Mhm.

None: Well that's a good question.

None: Important point.

None: About the phase one study with Ksi 501 was to gain safety as well as to gauge bioactivity in terms of vision in OTT and given the broad overlap across the retinal vascular diseases with the existing agents the idea of starting in <unk>, where you can see predictor.

Victor Perlroth: We haven't disclosed the precise design of the study yet. As you know, within ophthalmology, the regulatory landscape is evolving. One of our core objectives for the Daybreak Study is that it would be cost effective. Kodiak has a substantial amount of experience running, you know, many of these studies in the big diseases in the retina. And so obviously, we're gonna try not to have more, you know, groups than we need to have to be able to achieve our objectives.

None: Responses of Bioactivity and safety and then using that kind of as a point of departure.

None: And any number of the different disease.

None: No.

None: I mean, the four reasons that give us confidence to move directly into phase III in wet AMD based on the Ksi 501 phase one is one the durability profile of the platform to the dual mechanism of action right with best in class <unk> inhibition from the trap.

Operator: So let's stay tuned and see where we come out on the study. Got it. Thank you. One moment for our next question. And our next question will come from Michael DiFiore from Evercore ISI. Your line is open. Hi guys, thanks so much for doing the call and for taking my question. A few questions from me.

And where we also target IL, six which is a known culprit of sub optimal response and reactivation of disease in wet AMD third is our enhanced formulation and before the 10 years of design to manufacturing in the clinical and the operational experience that we have.

Michael Gennaro DiFiore: Number one, regarding the upcoming phase three daybreak trial, I know the design is currently being finalized, but if you could provide any color on what dose will be, and a follow-up question to that is, how is the enhanced KSI 501 formulation different from the formulation used in the recent prior Phase I DMA study, and have a follow-up. For the Daybreak Study, the plan is to use a similar 100 L volume, so the strength of the formulations themselves will be driven by the formulation strength.

None: <unk> the three molecules in clinical phase the two first in human studies eight clinical trials.

None: Pivotal so we're not starting from scratch here in Dublin.

Furthermore, in the future we may be thinking of exploring ksi 501 in <unk> in our view as well.

None: Okay. Thanks, so much.

None: Thank you one moment for our next question.

None: And our next question comes from the line of Gena Wang from Barclays. Your line is open.

Victor Perlroth: So both the Tarkosamab and the KSI-501 formulations are 50 mg per ml strength for this pivotal at 100 microliters. So there will be five, and in each one of those, the molecules will be in their what we call kind of go-to-market formulation or commercial scale-up formulation, which as we've mentioned does include adjustments from what was tested previously with Tercosamab in our pivotal program and also So, as I said, we're at an important point of departure as we step into these new studies with these adjusted and enhanced formulations. And we're, you know, we're excited to be able to showcase what these molecules can do in these next set of projects. That's helpful.

Gena Wang: Thank you for taking my questions.

Gena Wang: Victor are based on current data do you believe fiber one is better than the coast map and the related question is for DAYBREAK other than being cost effective volume running an independent phase III study for <unk> will you try to design in a way to power to show six.

Gena Wang: Clinical benefit.

Gena Wang: Frances between 501 versus.

Gena Wang: Mike.

Gena Wang:

None: I don't think its important whether <unk> or 501, whether one is better than the other.

None: There is clearly an opportunity for let's say a twice a year and the majority of patients.

None: Anti VEGF agent and <unk> just needs to get pushed over the finish line and why don't we see how physicians.

None: Like it and by running below two and having that tuck in group and a break study in wet AMD, we're going to be creating a useful amount of data for physicians for <unk>.

None: It is not our objective to power a distinction between <unk> 501, and they break it.

Victor Perlroth: And I guess my follow-up question is, do you want to clarify why exactly Tarcosamab is being added as an active comparator in the daybreak trial? Is it correct to assume that the FDA is not requiring this and that Kodiak is proactively doing this in order to have dosing flexibility on the label? Um, [inaudible] We really struggled somewhat with what to do to finish the TARCOSAMET program, and I would say it took us some months to figure out what we wanted our plan to be.

None: <unk> hundred one showed.

None: Maybe some trend.

None: That it was better than a flipper sector are better than her closer map, we see that as very positive because we are obsoleting those agents with our own agent.

And the question there for the 501 program is going to need a second pivotal and so at what point do we think it would be useful and important to start that such that.

None: It's a molecule that could be on a path.

Victor Perlroth: On the one hand, we wanted to lean into additional work in wet AMD because that represents a large part of the market. On the other hand, we didn't want to run the study where, let's say, different stakeholders or investors were worried about the probability of success because we'd have so much hanging on the outcome. So in the end, we decided to run the GLO2 study as our core study for approval for Tarkosa, which will have a very high probability of success, given that it's essentially the same study as GLOW-1, which had a tremendously successful outcome. And then, in addition, we decided that we would tuck in an additional group into the pivotal study we wanted to run for KSI-5-O. So economically, it's very cash efficient to tuck that in.

None: To enter the market.

None: I mean, both molecules perform as we hoped <unk> 501, showing differentiated durability profile and then both meet the primary endpoint. It's a problem that we would be delighted to have.

Okay. Thank you.

None: Thank you one moment our next question.

None: Our next question comes from the line of Ellie Merle from UBS. Your line is open.

None: Hi, it's Sam on for Ali.

Sam: Two questions I guess first where do you think about how IL inflammation.

Or like where do you think I don't think the inflammation is particularly relevant in the context of this space.

Sam: And then I'll ask my second one.

Well I think.

None: We believe that it's broadly relevant both within the high prevalent diseases that represent the anti VEGF market.

Victor Perlroth: Having decided to run that additional wet AMD study, then we'll end up with the Daylight Study as a successful study, and we hope the Daybreak Study also as a successful study for Tarcosamab. And our overall package will then include five successful, we hope, pivotal studies for Tarcosamab. And at the same time, we're checking boxes for KSI 501, and it will be the first of its two pivotal studies that we'll need to file appropriately. So, if you think about Kodiak's program with three, what I call late-phase molecules. With all of them being run through pivotal studies, starting imminently, that's the philosophy that we're bringing to the next several years of Kodiak's development. Very helpful. Thanks so much.

None: And we believe it's highly relevant outside of that into what we call sort of that greenfield area of macular edema, and inflammation or the complex and we believe those are two different opportunities and that's why we have two different molecules to be able to develop both of them.

None: Right. So the Ksi 101 allows us to have the protein alone, which is really a sledge hammer highly potent on the two mechanisms had very high formulation strength that should have a strong immediacy.

None: So we're excited about that and obviously IL six.

None: <unk> plays a very important role in driving the macular edema in those patients and also in driving that.

None: Within the retinal vascular diseases.

None: Inflammation clearly plays an important role I think the question though.

None: When you think about the drug development.

None: What is necessary to show in a pivotal program.

Michael Gennaro DiFiore: Thank you. One moment for our next question. And our next question will come flying from Anupam Rama from J.P. Morgan. Your line is open. Hi, thanks for taking the question. This is actually Malcolm on behalf of Anupam.

None: And do you want to play around for several years and phase II studies trying to explore what large subgroups within say wet AMD right or what large subgroup within DMV right, where that inflammation is driving element of the efficacy or the lack of efficacy in those patients so rather than.

Operator: So just one from us: what is being assumed in terms of milestones between now and the end of your CAST runway into 2026? and Danieil Gataulin, Huidong Wang, Anupam Rama, Jiajun Wen, Victor Perlroth, Kodiak Sciences Inc....

None: Take that approach what we're planning to do is to run the non inferiority pivotal to get.

None: The molecule.

None: <unk> and the different indications.

None: Based on our expertise in running those studies and then work either in parallel or in smaller studies or investigator sponsored studies or post approval to be able to really hum.

Victor Perlroth: Well, certainly the completion of the two Tarkosamab pivotals, as well as the completion of the 501 pivotal, and we're in discussions with FDA currently on the design of the phase 2b-3 studies for 101. Depending a little bit on those designs and how they translate into enrollment, we're hopeful that we'll be able to get those studies out in that timeframe.

None: Thai patient with high inflammation.

None: To the drug to be able to show some improved level of efficacy.

None: We don't think we need to do that in a phase II setting we can drive these molecules for approval in the non inferiority setting and then work with physicians to showcase the special.

None: The special contribution of the mechanism.

None: Okay, Great makes a lot of fun.

None: And then just a quick follow up for DAYBREAK, you mentioned dosing 501 every four to 24 weeks.

None: Then does incorporate that according to <unk>.

Andrea R. Tan: Thank you. One moment for our next question. Our next question comes from Andrea Tan from Goldman Sachs. Your line is open.

None: What is your I gave on the recent FDA draft guidance regarding the use of a comparable dosing regimen in terms of frequency.

None: Frequency with the active comparator.

Andrea R. Tan: Thanks for taking the question. Two for us, please. Maybe as a follow-up to a prior comment, recognizing that the potency remains the same between the two formulations that you have, can you share or maybe speak to what data you've seen that supports that durability of the original formulation will carry over as you transition from the biopolymer conjugate to now a mix of the conjugate plus free antibody?

None: Yeah, well that's a good question I think we've been in.

None: In constant communication with the agency for all three clinical programs.

None: We'll confirm the study design once we have all the information necessary and that's really all we wanted to share for now in terms of specifics, it's needless to say, but the final study design for all of our pivotal will be based on feedback from the FDA I do think historically looking back Kodiak has.

Victor Perlroth: Thanks, Andrea. Well, that's a good question. We believe more broadly that, you know, disease variability in patients is what drives durability more strongly than the amount of conjugate that we have. So, for example, in our phase 1b study, we tested 2.5 mg versus 5 mg of fully conjugated material, and there was very little distinction between the durability that we saw at the 2.5 milligram dose and the 5 milligram dose.

None: Driven innovation within the study design with.

None: With FDA.

None: <unk> successfully for ourselves and other companies have followed our example.

None: And at this stage we're in.

None: Discussion and we'll see kind of where are we where we end up.

None: Great. Thank you so much.

None: Yeah.

None: Thank you.

None: Once again Thats star one months for questions one moment for additional questions.

None: Yeah.

Victor Perlroth: So as we bring the level of conjugate down on the margin to allow a broader amount of free protein, we believe that we can bring the best of both worlds into both the Tarcosamab and the KSI 501 formulations without impacting durability and creating a powerful medicine for patients. And then maybe just maybe one quickly on the phase one data that you have seen in DME for the 16 patients from phase one. Could you just share or speak a little bit more about what gives you the confidence to move directly from that in the 16 patients to a phase three trial now in wet AMD? Well, that's a good question.

None: And our next question comes from the line of Danielle <unk>.

Danielle: <unk> from Chardan Your line is open.

Hey, good afternoon, and thank you for taking the question.

Danielle: One on.

Danielle: One in wet AMD.

Danielle: Specifically for the second pivotal study.

Chardan: On your guidance.

Chardan: Visit with any timelines when do you plan on starting the trial in Europe that also include the part cost.

Chardan: Do you plan to generate off of course enough data from from DAYBREAK first public we're initiating the second study.

Victor Perlroth: I think the important point about the Phase I study with KSI-501 was to gauge safety as well as bioactivity in terms of vision and OCP. And given the broad overlap across the retinal vascular diseases and, you know, with the existing..., the idea of starting in DME where you can see predictable responses of bioactivity and safety and then using that kind of as a point of departure into any number of different diseases. I mean, the four reasons that give us confidence to move directly into Phase 3 in WET-AMD based on the KSA 501 Phase 1 are, one, the durability profile of the platform, two, the dual mechanism of action, right, with best-in-class VEGF inhibition from the trap, and where we also target IL-6, which is a known culprit of suboptimal response and reactivation, and WetMD. Third, is our enhanced formulation. And four, you know, the 10 years of design, the manufacturing, and the clinical and the operational experience; we have the three INDs, the three molecules in the clinical phase, the two first in human studies, the eight clinical trials, you know, seven of them pivotal. So we're not starting from scratch here.

Chardan: Yes.

None: We haven't disclosed and we haven't we don't have them.

None: We plan.

None: For the second study of wet AMD, we know that we have that we need one or approval for fiber one.

None: In that case, but we havent, we havent, we havent disclosed.

None: Our plan of it sequential or is it somewhat overlap between the two studies.

None: Got it.

None: I have another quick question on <unk>.

None: Well just think of a potential consequences, if a customer does not succeed in a paper study.

None:

None: Well.

None: I guess.

None:

None: We believe that.

None: <unk> can be an important medicine.

For patients with wet AMD, but rather than.

None: Just relying on the results of the daylight study, where we dosed monthly.

None: We've decided that it makes sense to demonstrate that.

None: By having a full.

None: A group in India brake.

None: If we did it meet the endpoint in DAYBREAK and physicians would not feel excited.

None: To use it in wet AMD or presumably maybe based on having two unsuccessful studies in wet AMD, we might not be able to get approval in the indication. So it represents a bet that we're making.

None: We're optimistic and we think it can drive substantial.

None: Demand in wet AMD for.

Victor Perlroth: Furthermore, in the future, we may be thinking of exploring KSI 501 and DME in our view. Okay, thanks so much. Thank you. One moment for our next question. And our next question will come from Gina Wang from Barclays. Your line is open.

None: <unk>.

None: It would be really important so in some way.

None: Reducing <unk> to the DAYBREAK study is.

None: Is that is a gamble, but it's one that's educated based on R&D tailed review of our data.

None: And also.

None: The.

None: Adjustments that we've made to the go to market material and also our.

None: I suppose expertise or lessons learned from having run six.

Huidong Wang: Thank you for taking my questions. Victor, based on current data, do you believe 501 is better than tacosumab? And a related question is, for Daybreak, other than being cost-effective to avoid running an independent phase three study for tacosumab, will you try to design in a way to power to show the clinical benefit differences between 501 versus tacosumab? I don't think it's important whether Tarcosamab or 501 is better than the other. There's clearly an opportunity for, let's say, twice a year in the majority of cases, an anti-VEGF agent, and Tarkosa Mavis just needs to be pushed over the finish line. And why don't we see how physicians like it?

None: So far so.

None: <unk>.

None: We're excited to run <unk> and DAYBREAK.

None: And to see the data hopefully to include that into share that with the community and we think it can be really powerful.

None: Got it thank you very much.

Speaker Change: Thank you and I'm not showing any further questions at this time I would now like to turn it back to our CEO Victor Pro Roth for any closing remarks.

Speaker Change: I think we're done thanks very much.

We look forward to people digesting all of this.

Speaker Change: New information about Kodiak, and our plans and look forward to that.

None: The next.

None: The next sets of of information, especially on the new study designs.

None: As we finalize them. Thanks, thanks, so much.

None: Okay.

None: Thank you for your participation in <unk> Conference. This does conclude the program you may now disconnect everyone have a great day.

Victor Perlroth: And by running GLO2 and having that tuck-in group and the daybreak study in wet AMD, we're going to be creating a useful amount of data for physicians about TARCOSA. It's not our objective to make a distinction, you know, between Tarkosamab and 501 in Daybreak. I mean, if 501 showed maybe some trend that it was better than Libercept or better than Tarkosamab, we see that as very positive because we're obsoleting those agents with our own agents. And the question there for the 501 program is whether it's going to need a second pivotal. And so at what point do we think it would be useful and important to start that, such that it's a molecule that could be on a path to enter the market?

None: Goodbye.

None: Okay.

None: [music].

Huidong Wang: I mean, if both molecules perform as we hope, right, Tarkosamab and 501, showing a differentiated durability profile, and they both meet the primary end, it's a problem that we would be, you know, delighted to have. Okay, thank you. Thank you. One moment for our next question. Our next question comes from Ellie Murrow from UBS. Your line is open. Hi, it's Sam on behalf of El

None: Okay.

Operator: We just had two questions. I guess first, what do you think about how IL-6 inflammation, or like, where does IL-6 inflammation is particularly relevant in the context of this case? And then I'll ask my second question. Well, I think... You know, we believe that it's broadly relevant, both within the high-prevalence diseases that represent the anti-VEGF market. And we believe it's highly relevant outside of that in what we call sort of that greenfield area of macular edema and inflammation, or the uveitic column. And we believe those are two different opportunities, and that's why we have two different molecules to, you know, be able to develop into both.

Victor Perlroth: Right, so KFI-101 allows us to have, you know, the protein alone, which is really a sledgehammer, highly potent on the two mechanisms and a very high formulation strength that should have a strong immediacy. So we're excited about that, and obviously IELTS 6, plays a very important role in driving the macular edema in those patients and also in driving within the retinal vascular disease. Inflammation clearly plays an important role.

None: [music].

None: Okay.

None: Yes.

None: Okay.

None: [music].

Victor Perlroth: I think the question, though, when you think about drug development, what is necessary to show in a pivotal program, and, you know, do you want to play around for several years in Phase II studies trying to explore what large subgroups within, say, WET-AMD, right, or what large subgroup within DME, right, where that inflammation is driving elements of the efficacy or the lack of efficacy in those. So rather than take that approach, what we're planning to do is to run the non-inferiority pivotals to get the molecule approved in the different indications, based on our expertise running those studies, and then you know work either in parallel or in smaller studies or investigator-sponsored studies or you know post-approval to be able to really tie patients with high inflammation to the drug to be able to show some improved level of efficacy.

None: No.

None: [music].

None: Yes.

None: [music].

Okay.

[music].

None: Sure.

None: Okay.

Victor Perlroth: We can drive these molecules for approval and non-admission, and then work with physicians to showcase. (inaudible) that the special contribution of Okay, great. It makes a lot of sense. And then just a quick follow-up. For Daybreak, you mentioned dosing 501 every 4 to 24 weeks and then dosing a flipper set according to the label. What is your perspective on the recent FDA draft guidance regarding the use of a comparable dosing regimen in terms of dosing frequency with the active comparator? Yeah, well, that's a good question.

None: [music].

None: Yes.

None: [music].

None: Yes.

None: Okay.

None: Yes.

None: Yes.

None: Yes.

None: [music].

None: <unk>.

None: [music].

None: Okay.

None: Okay.

None: [music].

None: Okay.

None: Sure.

Victor Perlroth: I think, you know, we've been in constant communication with the agency for all three clinical programs. And, you know, we'll confirm the study design once we have all the information. And that's really all we want to share for now in terms of the school year. It's needless to say, but, you know, the final study design for all of our pivotals will be based on. You know, from the, I do think historically, looking back, Kodiak has driven innovation within study design, you know, with FDA, successfully for ourselves, and you know other companies have followed our example, and at this stage, we're in discussion, and we'll see kind of where we... Great, thank you so much Thank you. Once again, that's star 11 for questions.

Okay.

None: [music].

Operator: One moment for additional questions. And our next question comes from Daniil Gataulin from Chardon. Your line is open. Good afternoon, and thank you for taking the question. I have one on 501 in the AMD section.

None: Okay.

Yes.

None: [music].

None: Okay.

Yes.

None: [music].

Daniil V. Gataulin: Specifically for the second pivotal study, are you giving any guidance with regard to any timelines when you plan on starting the trial and will that also include the TARCOS map? Or do you plan to generate the TARCOS map data from daybreak first before initiating the second study? Yeah, we don't, we haven't, we haven't disclosed, and we haven't, we don't have a complete plan.

None: Yes.

None: Thank you.

None: [music].

None: Okay.

None: Okay.

None: [music].

Victor Perlroth: For the second study of YMD, we know that we need one for approval for 501 in that case, but we haven't disclosed and fully have a plan of if it's sequential or if it's somewhat overlapped between the two. Got it. And I have another quick question: what do you think are the potential consequences if Tercostumab does not succeed in a daybreak study?

None: Yes.

None: Okay.

None: [music].

None: Yes.

None: [music].

None: Okay.

Daniil V. Gataulin: [inaudible] will, I guess. We believe that Trachosomab can be an important medicine for patients with WETI, but rather than just relying on the results of the Daylight Study, where we dose it monthly.

None: [music].

Victor Perlroth: We decided that it makes sense to demonstrate that by having a full group in daybreak. So if we didn't meet the end point in daybreak, then physicians would not feel excited to use it in wet AMD, or presumably, maybe based on having two unsuccessful studies in wet AMD, we might not be able to get approval in the indication. So it represents a bet that we're making. We're optimistic, and we think it can drive substantial demand for wet AMD for, and Tarko Samad, be really important.

None: Yes.

None: [music].

None: Yes.

[music].

None: Okay.

None: Yes.

None: Okay.

None: Yes.

None: [music].

Victor Perlroth: So in some way, you know, introducing Turcosumab into the Daybreak Study is a gamble, but it's one that's educated based on our detailed review of our data and also the adjustments that we've made to the go-to-market material and also our, I suppose, expertise or lessons learned from having run it. We have it all so far. We're excited to run the TARCOSA map in Daybreak and to see the data and, hopefully, to include that and to share that with the community. We think it can be really powerful. Thank you very much. Thank you. And I'm not asking any further questions at this time. I would now like to turn it back to our CEO, Victor Perlroth, for any closing remarks. I think we're done. Thanks very much. We look forward to people digesting all of this new information about Kodiak and our plans and look forward to, you know, the next..., the next sets of information, especially on the new study designs as we finalize them. Thanks. Thanks so much.

None: Yes.

None: Okay.

None: Yes.

None: Yes.

None: Okay.

None: Okay.

None: Please.

None: Yes.

None: Yes.

None: Thanks Julien.

None: Okay.

None: Yes.

None: Thank you.

Okay.

None: Okay.

None: Yes.

None: [music].

None: Yes.

None: Okay.

None: Yes.

Okay.

None: Okay.

None: [noise].

None: Okay.

None: [music].

None: Yes.

Operator: Thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Everyone have a great day. Goodbye.

None: [music].

None: Okay.

None: Yeah.

None: Okay.

None: Yes.

None: Yes.

Operator: Copyright 2020 Mooji Media Ltd. All Rights Reserved. No part of this recording may be reproduced without Mooji Media Ltd.'s express consent. [inaudible] Copyright 2020 Mooji Media Ltd. All Rights Reserved. No part of this recording may be reproduced without Mooji Media Ltd.'s express consent. Copyright 2021 Mooji Media Ltd. All Rights Reserved. No part of this recording may be reproduced without Mooji Media Ltd.'s express consent, and Kodiak Science Inc. www.kodiaks.org.au www.kodiaks.org.au www.kodiaks.org.au www.kodiaks.org.au www.kodiaks.org.au www.kodiaks. BF-WATCH TV 2021, Copyright 2014 Mooji Media Ltd. All Rights Reserved. No part of this recording may be reproduced without Mooji Media Ltd.'s express consent. The Ultimate Parody Site! Copyright 2020, New Thinking Allowed Foundation, Daniil Gataulin, Huidong Wang, Anupam Rama, Jiajun Wen, Victor Perlroth, Kodiak Sciences Inc., [inaudible]

None: Okay.

None: [music].

None: Okay.

None: Yes.