Q2 2023 Ocular Therapeutix Inc Earnings Call
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Thank you just send out good afternoon, everyone and thank you for joining us on our second quarter 2023 financial results and business update conference call. This afternoon. After the close we issued a press release, providing an update on the company's product development programs and details of the company's financial results for the second quarter ended June 32012.
Three the press release can be accessed on the investors portion of our website at investors Ocu, TX Dot com.
The call today will be <unk>, our president and Chief Executive Officer, who will provide an update on our pipeline development and commercial progress of DEXTENZA.
Speaking on the call today will be Dr. Robert Ashton, our Chief Medical Officer, and Steve Myers, Our senior Vice President commercial following their remarks, I will provide an overview of the financial highlights for the quarter before turning the call back over to Anthony for a summary and questions.
As a reminder, on today's call certain statements, we will be making may be considered forward looking for the purposes of the private Securities Litigation Reform Act of 1995 <unk>.
In particular any statements regarding our anticipated debt product revenues, and our regulatory and product development plans as well as our research activities are forward looking statements.
These statements are subject to a variety of risks and uncertainties that may cause actual results to differ from those forecasted including those risks described in our Form 10-Q filed this afternoon with the SEC and our most recent annual report on Form 10-K filed March six 2023.
I will now turn the call over to Nancy.
Thanks, Tom.
Hello, and welcome everyone to our second quarter 2023 earnings call.
We're pleased to share with you the tremendous progress we've made over the past three months to build on our previous successes and to provide clarity on our plans going forward.
First of all we're pleased to report that we achieved a new record of $15 million in DEXTENZA net product revenues in the second quarter of this year 'twenty.
24% over same quarter previous year, and 14% sequential growth over the previous quarter.
Most importantly end market unit volume growth quarter over quarter for the last three quarters has been 21% eight.
8% and 7% signaling a consistent growth trend that gives us confidence and extends its future potential to augment funding of our fast developing pipeline.
Based on the trends, we're seeing we anticipate DEXTENZA net product revenue guidance for the full year 2023 will now come in at the upper end of the current 55 million to $60 million range provided at the start of the year.
Steve Myers, our senior Vice President commercial will talk I'll walk you through the drivers behind this growth and our determination to further accelerate revenue growth.
Locking of a facility payment for CPG 68841, the procedure code for insertion of DEXTENZA.
Second we.
We are confirming our previous guidance that we plan to initiate our first pivotal trial for <unk> T. K I before the end of this quarter using a superiority design.
The trial, we have developed will be a prospective multicenter randomized.
Parallel group pivotal trial, it will be run primarily U S sites.
Trial is designed to enroll approximately 300, evaluable wet AMD subjects, who are treatment naive and the study on it.
It will compare a single implant of O T X T K I have.
To a single injection of our percept and assess the safety and efficacy of Otrexup or T X T K I in subjects with wet AMD.
By imaging best corrected visual acuity and central subfield thickness.
Feedback from the FDA made the security pathway the preferred choice for O T X T K R and wet AMD.
Under the new draft guidance advice from the FDA has evolved.
Particularly for products with expected durability advantages given their reduced dosing frequency over current therapy.
Most notably from our interpretation of the feedback we received from the agency are.
Our traditional two arm sham controls comparison trial against treatments with established non inferiority margins.
Either have labors after ranibizumab dosed. According to their labels is no longer acceptable for investigational drugs.
With reduced dosing frequency as the FDA requires at least one additional comparative arm in which the dosing frequency criterion for dosing adjustments and criterion for interventions are the same as in the investigational drug arm.
This means that an additional arm with actual non sham injections.
Given with the same frequency F O T X is the <unk> arm, which would be nine to 12 months in Arcata weed.
It would need to be included.
And that <unk> T K I would be required to show superiority over this arm as well as non inferiority to the on label Apple ever stepped our Ranibizumab arm.
Under the new draft guidance. However, the FDA also accepted a pivotal design.
It would simply show superiority alone to any treatment dose identically to the investigational drug in this case <unk>.
Since we believe we can demonstrate superiority over a single injection of any approved pulse dose antibody treatment with approximately 300 evaluable subjects at.
At a cost of approximately $50 million moving forward with a superiority trial has become the clear and compelling choice compared to our noninterest you're already trialed. It would according to our interpretation of direct feedback from the FDA.
Require us to demonstrate both noninterest you're already and superiority in a single trial.
And discussions with key opinion leaders and clinical trial as we believe that we have a pivotal design that will satisfy the FDA requirements and be enrolled in an acceptable timeframe and has achievable endpoints. Additionally.
Additionally, we expect that the trials will be primarily enrolled in the United States for our discussions with many key investigators.
Finally, we were pleased to announce that we have secured the funding that allows us to initiate this pivotal trial.
Given the recent share price.
We have consistently stated our desire to pursue non dilutive or minimally dilutive financing pathways to bring <unk> to NDA filing.
Securing a debt facility of $82 5 million, we have obtained the funding that allows us to initiate our first pivotal trial for <unk> and extends our cash runway into the into 2025 through non dilutive means.
Donald not been our CFO will go over the details of this debt facility later in the call.
Another lever of non dilutive funding that we continue to pursue as the securing of a strategic partner.
I want to be clear that our new debt facility and the initiation of our first pivotal in wet AMD.
Does not alter our strategy of aligning with a strategic partner.
To date, we have been very pleased with the quality and level of engagement as we focused discussions with potential partners that have the ability to globally optimize a product with the potential of <unk>.
We believe that getting started with our first pivotal trial and demonstrating solid execution could add tremendous value to <unk> and enhance our ability to generate a partnership that reflects oh, TX teekay is value.
So before handing off to Arabia I.
I wanted to mentioned a major milestone we achieved recently with O T X T IC, our travel cost containing intra cameral implant for the treatment of glaucoma.
We recently completed enrollment in our phase II program, keeping us on track to present interim results in the first quarter of 2024.
With the recent interest around the Idose program Macacos, we are excited about the prospects of bringing a fully by a resorbable prostaglandin delivery implant that is designed to be suitable for chronic dosing into pivotal programs as our next step.
Lastly, I wanted to highlight the recent addition of Dr. Adrian Graves to our board Dr. Graves is well known in the Ophthalmology community is both a front and back of the eye expert.
As the former CEO of Santana, Inc. She successfully brought multiple ophthalmic products through development to approval and commercialization.
More recently as chairwoman of the board for <unk> bio.
I believe the company through late stage development of de Mora, and the eventual $5 $9 billion acquisition of the company by Astellas.
With that let me turn the call over to Ravi for a deeper discussion of our ongoing clinical trials.
Thank you Anthony.
Beginning with the old T X T. J I recently shared these data from our multicenter prospective masked randomized controlled U S based clinical trial.
<unk>, one subjects evaluating a 600 microgram or TX Teekay Eidos.
A single incident containing oxytonic visit two milligram <unk> injection four weeks after the implant.
Pair to.
Administered every eight weeks in control with AMD subjects previously treated with anti VEGF therapy.
Trial was designed to assess the safety.
And Tolerability of <unk>, TX PKI, Angela assist biological activity in subjects by measuring anatomical and functional changes of the retina.
We sure are.
Most recent.
To that month update in June at the clinical trials at this summit to ante to run to three meeting.
Looking at safety in each of the trials analysis time points 710, and 12 months.
No direct related ocular or systemic serious adverse events in <unk> treated subjects.
Turning to biological activity.
T X T J I continued to pack format.
703, 8% of subjects remaining rescue free up to month, 10, and 60% optima to that.
Overall, and 89% reduction in treatment burden was observed in the <unk>, TX PKI treated subjects.
Months.
In addition data shops subjects treated with the single RPX PKI in Atlanta.
Continue to demonstrate sustained best corrected visual acuity and central subfield thickness, which was comparable the day after the Sept arm at Mark to that.
For subjects, who received rescue therapy for the first time at month 12 and indicate it is we would anticipate the greening of the old PX T. J I stood up a tick effect and potential disease, the activation which helps.
Mitch hubs established and re dosing timeline for patients.
Overall, we believe the data highlights the potential of all TXT, Jr to become a differentiated product capable of providing a durable anti VEGF response that improves upon today's standard of care in the management of wet AMD.
Look forward to initiating shortly.
First of two planned pivotal trials.
Moving to RPX Teekay AI for the treatment of non proliferative diabetic retinopathy.
We announced in June the completion of enrollment of our phase one Helios trial.
<unk> is a multi center prospective masked randomized controlled phase II trial into wanted two subjects, eliminating its 600 microgram or T X T. J I dose in a single implant containing oxytonic compared to a sham injection procedure.
We believe the same attributes that make old TX PKI, a compelling product candidate for the treatment of wet AMD. The ease of use vulgar office space injection and potential long term durability could establish Olivier <unk> TK.
First on that don't care in the treatment of diabetic retinopathy.
Dan to share interim six month data from the Helios trial in Q1 of two anti <unk> four and subject to this data and additional financing we believe that we will be well positioned to initiate the.
Pivotal clinical trial for this program as early as Q1, two anti to answer flush.
We are also making excellent progress with another one of our late stage pipeline programs <unk> IC.
You have across intra tumoral implants being developed for the treatment of patients with primary open angle glaucoma or ocular hypertension.
While there are many medications available to lower intraocular pressure or IOP glaucoma remains the leading cause of blindness.
In part because of unwanted side effects improper technique or symphony forgetting to take their daily drops we believe most patients fail to comply and may ultimately do they envision.
Or ph D. C is being dosed up to close the gap between clinical trial and yogurt outcomes by taking patient compliance out of the equation.
This prospective multi center randomized controlled phase II clinical trial is evaluating the safety tolerability and efficacy of <unk>, TX PRC for the reduction of IOP in subjects with primary open angle glaucoma or ocular hypertension.
<unk> is designed to observe the changes in diurnal IOP from baseline at two six and two athletes.
And Paulo duration of IOP response over time compared to Dirty step.
We are happy to report that the phase two trial.
While enrollment is now complete.
We look forward to sharing phase II top line clinical data in the first quarter of two wanted to answer for assessing the safety efficacy durability of <unk> IC.
I'm also very pleased to report that we had initiated a self study to evaluate the safety of AG deep dose of RPX TICC two added six microgram.
It's small subset of the subjects in the ongoing phase II clinical trial.
After receiving the repeat dose a second example, both TX TICC 286 microgram this subject.
Paul wrote for at least six months after the enrollment in the sub study to elevate their endothelial sat at the data on the preservation of <unk> SaaS hat on this pilot repeat dose sub study could provide preliminary support that the pro.
That candidate is suitable for repeat dosing.
Regarding our ocular surface disease programs, we remain committed to the development of our two dry eye programs or <unk> at a low dose <unk> insert.
Training dexamethasone for the short term treatment of the signs and symptoms of dry eye disease, and <unk> CSI is cyclosporin <unk> insert for the chronic treatment of patients with dry eye disease.
We initiated a small study in the second quarter to evaluate the performance of <unk> versus placebo inserts maintenance tasks dissolving colajanni plots and no <unk> at all we plan to use the results of this trial to inform the selection of it.
Appropriate placebo comparator for use in future.
Future clinical trials for both D. R. <unk> D and the <unk> side that could potentially help de risk the pivotal programs moving forward.
I would now like to turn the call over to Steve for a commercial update.
Thank you Ravi and.
In Q2, 2023, DEXTENZA recorded net product revenue sales of $15 million, which is over 14% ahead of Q1, 2023, and approximately 24% higher than the same period last year.
Also in market unit volume unit sold to ambulatory surgery centers and hospital outpatient departments was up over 2400 units from Q1 2023 and finished at 36902 units, which represent a 36% increase.
Over Q2 2022.
The 7% increase over Q1 2023.
Importantly, this is now the third consecutive quarter DEXTENZA recorded organic growth of end market unit sales.
We believe that the extensive growth has been anchored by its strong efficacy and safety profile. The strong clinical profile has allowed our teams to create contracted strategic account partnerships.
Also helped increase utilization amongst single site surgery centers.
Additionally, our market access team has achieved exceptional market access coverage that is providing our customers with strong reimbursement confidence. These.
These data among others are helping.
The extends of continue its growth in 2023.
Now I'll provide a brief update to CMS consideration of CPT 68841, a code that describes the insertion procedure for DEXTENZA.
We're hopeful that CMS will change the inequity that currently exists with the assignment of the Q1 status indicator to CPT 68841.
In the AFC setting separate payment continues to be rent rendered for the DEXTENZA unit itself by Bill and Jay $10 96, and we do not expect that to change.
However, the Q1 status indicator assigned to $6 88 for one means that there is no separate facility payment for the actual procedure to insert DEXTENZA.
Large abdominal societies surgeons ASC administrators, and many others have a shared interest in providing the gold standard of care and many have chosen to make their voice heard by request and CMS to change the status indicator.
It is our belief that facility should be compensated for the additional time and resources required to administer DEXTENZA and as such we're also strongly encourage in CNS to assign a status indicator to 688 for one that would provide a separate facility payment in the ASC.
<unk>.
We expect CMS will provide a final ruling late this year.
Finally, as Anthony noted earlier based on DEXTENZA trends over the last several months in our first half net product revenue of $28 $2 million. We now believe that extends a net product revenue for the full year 2012, 23 should come in at the upper end of the current <unk>.
5% to $60 million guidance range, representing potential growth at the high end.
Of approximately 10% to 20% over 2022.
With that let me turn the call back to Donal to discuss our financial results.
Thank you Steve total net revenue, which includes both gross extensive product revenue net of discounts rebates and returns, which the company refers to as net product revenue.
And collaboration revenue was $15 2 million for the second quarter of 2023, an increase of approximately 24% over the second quarter of 2022 net revenues of $12 3 million and an.
<unk> grew approximately 13% over first quarter net revenue of $13 4 million.
For the second quarter of 2023, DEXTENZA net product revenue grew to $15 million from $12 1 million over the comparable period in 202022.
While collaboration revenue increased $2 2 million from $1 million.
Research and development expenses for the second quarter of 2023 were $15 1 million.
Versus $13 1 million for the comparable period in 2022.
Driven primarily by an increase in expenses associated with clinical trial programs.
Selling and marketing expenses in the second quarter of 2023 were $11 2 million as compared to $10 1 million for the comparable quarter in 2022, reflecting primarily an increase in field force personnel.
General and administrative expenses were $8 2 million for the second quarter of 2023 versus $7 $8 million in the comparable quarter of 2022, primarily due to an increase in personnel related costs, including stock based stock based compensation and professional fees.
The company reported a net loss for the second quarter of 2023 of $20 7 million or a loss of 26 per share on both a basic and diluted basis.
<unk> to a net loss of $18 8 million or a net loss of 24 per share on a basic basis and a loss of 25 per share on a diluted basis for the comparable period in 2022.
Net loss in the second quarter of 2023 included a $1 1 million.
Non cash item attributable to a change in the fair value of the derivative liability associated with the company's convertible notes decreasing total other expenses is the price of the company's common stock decreased during the quarter.
Non cash charges for stock based compensation and depreciation and amortization were $5 1 million in the second quarter of 2023 versus $4 $8 million for the comparable quarter in 2022.
As Anthony referenced the company has just closed on an $82 $5 million non dilutive debt facility from Barings LLC.
That facility was fully funded at close $80 million. After original issue discount and has a six year term debt is interest only until bullet repayment at the end of six years and bears interest at one month, one month, so for two of 675%.
So for floor of not less than one 5%.
Additionally, the facility includes a royalty fee equal to $82 5 million payable in installments equal to three 5% of U S extends the net revenues until such time as bearings as received total payments.
Interest payments principal prepayment fees and royalty fee payments equal to the funded loan amount. This threshold is reduced to either 20% or 30% of the funded loan amount depending upon the circumstances.
A change of control were to occur within 12 months of closing.
And the remaining balance of the royalty fee is payable in connection with a change of control thereafter.
The debt facility also includes customary affirmative and negative covenants as well as a $20 million minimum liquidity requirement.
Currently with the closing, we repaid our existing $25 million debt facility with mid cap and extended the maturity date of the company's existing $37 $5 million convertible notes to date three months following the maturity of the new debt facility.
We believe we believe that our existing cash and cash equivalents of $66 6 million as of June 32023.
Plus the net cash received from the borrowing under the bearings credit facility. After the repayment of the midcap credit facility and reflecting the $20 million minimum cash covenant in the bearings credit agreement.
Will enable us to fund our planned operating expenses debt service obligations and capital expenditure requirements into 2025.
This estimate is based on our current operating plans, which includes estimates of anticipated cash inflows from DEXTENZA product sales and cash outflows from operating expenses, including clinical trials.
With the new resources available under the bearings credit facility, we have the funding to initiate the first of two planned pivotal clinical trials for <unk> for the treatment of wet AMD. Our planned operating expenses exclude expenses necessary to complete the first of the two planned pivotal trials for TX <unk> for the treatment of wet AMD and <unk>.
<unk> is to initiate the second of our two planned pivotal trials.
For <unk> for the treatment of wet AMD or any other planned trials for our other product candidates, including <unk> for the treatment of non proliferative diabetic retinopathy, which we do not intend to commence until we obtain additional efficiency.
As of August three 2023, the company had approximately $79 4 million shares outstanding.
I would now like to turn the call back to Anthony for some final thoughts.
Thanks Donal.
Before opening the call up for questions. Let me do a quick summary.
$15 million in net sales for the extended in the second quarter, 24% over same quarter prior year, and 14% sequential growth quarter over quarter.
We believe we have the opportunity to further accelerate our growth trend for DEXTENZA. If the <unk> PPS final rules in November allow for facility payment for CPT code related to DEXTENZA insertion.
We are expecting to initiate our first pivotal trial for <unk> in wet AMD in the United States in the third quarter of this year.
We have secured a debt facility of $82 $5 million that puts the funding in place to allow us to initiate our first pivotal for <unk> in wet AMD and we will extend our runway into 2025.
We have completed enrollment of the Helios trial and plan to share that data in the first quarter of 2024.
We have completed enrollment of the phase II trial for <unk> in glaucoma, and we plan to provide data in the first quarter of 2024 <unk>.
Additionally, we have started a pilot repeat dose sub study within the current phase II trial.
With that I'll turn the call over to the operator for questions.
Thank you we will now conduct a question and answer session. As a reminder to ask a question. Please press star one on your telephone and wait for your name to be announced to withdraw your question. Please press star one again.
<unk>, while we compile the Q&A roster.
Okay.
Our first question is from Dane Leone of Rgs.
Hi, Congrats on all the progress and momentum with the DEXTENZA launch.
Popular focus from lessors from your update today, we will be the go forward clinical development pathway for <unk> for the treatment of patients with wet AMD. Specifically do you think we're keen could please expand on the phase III trial protocol that youre, considering and highlighted.
And maybe specifically discuss how the trial design could avoid running at odds with the per USDA label.
<unk> protocol by we are that does recommend three monthly doses for wet AMD patients that are treatment naive.
Thank you.
I'll hand that over to Ravi to go over the what we can in the clinical trial design and clearly we've done a lot of work had a lot of discussions some of which we feel we'd like to keep proprietary for a brief period of time.
Until the trial initiated.
But I'll pass it over to Robyn to further talk about what she can on the clinical trial protocol.
Sure.
Thank you Dan.
The first of all.
<unk> sorry.
At eight.
The what.
The change in the FDA guidance and I heard.
Dan you said.
On label use IV.
<unk> <unk>.
<unk>.
I'd like to share is that the in the most recent pivotal non inferiority designs for example of the buys mall or high dose Eylea Sham injection provided in the treatment arm to mask the patients at time points by the control on receipts.
<unk> care injections every four weeks or eight weeks, depending on the <unk> and also the.
<unk>.
<unk>.
The loading doses.
FDA no longer equal months Sham injections.
They believe that using a sham does not provide complete masking therefore elicit patient base.
Instead of Shannon.
Neil.
It.
<unk> injection and RPX PKI every month or bi monthly dosing.
<unk>.
Then they would be able to do a standard non inferiority.
Non inferiority design that we own.
You used to see so far.
They.
The FDA could be in the states in the draft guidance.
The origin design tool.
And injection it could be any injection it doesn't have to be in.
Anti VEGF as long as its superiority.
<unk> is already that design is acceptable.
<unk>.
You May 10 and early.
Like the Santos.
The scientist approval.
That actually use and superiority of design.
Building injections et cetera.
What we are planning to do instead of doing a three arm non inferiority design, we cannot do <unk> need to show non inferiority to all labels are up and superiority to that commentary there arm.
Planning to do our plan is to do this.
<unk> superior wanted to design four now.
Details zero not if.
If you can share this much.
And then this initiate the trial, we're going to share that.
Details of the design.
Yep.
Does this answer your question Jay.
Yes that was that provides a lot of detail on it.
Maybe just one follow up.
From what we're kind of getting in.
From Gaza receptors.
Once we get the details of the full trial design from your team as you go into starting the study.
Yes.
I guess some of the details that you might not be disclosing today.
We could take those helping to allow enrollment into the study I think that's where maybe some investors are struggling and all of that right. Now it's just understanding from our clinical site in the U S to Wade who would kind of comment.
Maybe not get the three loading doses.
The treatment naive patients.
Yes, we haven't disclosed whether we are going to give loading doses.
One two or three loading doses.
Whats changed that you might have realized I'm sure you recognize since we spoke last was that we looked at it the superiority design and with the design that we were working with we believe that we would have to perform that outside of the U S. And we've had some fantastic discussions over the last three months with clinical trial this and that.
U S and key opinion leaders.
Working on clinical trial designs.
Would allow us to establish superiority over a single injection.
The comparator.
But would be acceptable to do in the United States with of course patient safety being the of Paramount importance.
It was very clear and working with these U S. Key opinion leaders was first of all that there are very.
Very interested in working with us they are very eager to have a product like <unk> make it to market.
Deeply understood the ramifications of.
The FDA guidance that that superiority was going to have to be demonstrated no matter, which trial design we use.
And we were able to work on rescue an entry criteria that allowed them to feel comfortable to be able to run those trials in the U S.
And once again, we're not saying, we're not giving given Dr. <unk> dose, we're not saying, how many or what we're going to do it precisely at the moment because we'd like to hold that proprietary at least for the next until the until the trial initiated.
Excellent. Thank you so much for the detail. Thank you Dan.
You.
Please hold for our next question.
Okay.
Our next question comes from John <unk> of JMP.
Hi, good afternoon, thanks for taking the questions a couple for me on the wet AMD trial.
Just wondering how youre thinking about measuring visual acuity as a primary.
When you would be collecting that data.
We could be seeing data from the first pivotal.
Wondering about the formulation really choosing for this trial and if youre thinking about an identical design for the subsequent pivotal trial.
Right.
Sure I'll hand that over to Robyn.
Yes.
John Thank you for the questions.
I will start fit.
<unk>.
Visual acuity.
It is clear from the draft guidance the end points you can choose for wet AMD design.
For the AMD pivotal studies.
Our listeners and the three options that and we cannot disclose which one.
Use ni.
Children design going forward.
Randy after vini.
Study design.
Two can you repeat.
The second part of your question, which.
Sure.
Formulation or are you guys electing to move forward here and then if the second study is going to be identical or different anyway, yeah I mean.
The second our plans now about that the second pivotal would be the exactly this similar design.
Current knowledge for but.
And the formulations.
Have a formulation of <unk> formulation now and we also as we disclosed before the backup.
Backup formulation, maybe Anthony may want to give more color on this.
Yes, I mean, essentially we have two formulations to choose from and we have confidence in both of them.
So we'll make a decision.
Later on.
In about a month or so before before we launched where we will have IP materials for both formulations.
Okay.
In your prior commentary it seemed like diabetic retinopathy is getting more and more interesting to you guys internally.
But now it sounds like Youre going to hold off on starting that pending subsequent financing just wanted to check about how youre thinking youre thinking changed at all with this new superiority to that for wet AMD.
The ability to potentially start that study as well early next year. Thanks.
Yes, as with most things with biotech you really have to choose the things you invest in and clearly wet AMD.
Now if its superiority pathway is open in the U S to us.
Becomes our number one investment priority now.
And we've talked a lot about our sensitivity to dilution at the current stock levels that we have.
So we're making no firm choices about what we fund Additionally beyond this.
This first pivotal and of course, then the second pivotal.
That would be our primary path to market.
Wet AMD is you know as much larger market I think we have a really.
Interesting.
And an interesting possibility to become the standard of care in that in that $15 billion global marketplace.
So that is our number one priority we're still extremely excited about both diabetic macular edema and diabetic and.
In non proliferative diabetic diabetic disease.
But that's something that we will make a decision later on whether we're going to fund or not a lot of this depends on whether we.
Are able to align with a partner by that time the companies with whom were speaking are all <unk>.
Large strategics that would have an interest in not only looking at.
In PDR, but also <unk> and also a retinal vein occlusion.
So there'll be a number of other things that could be brought online as well I'm looking at the possibilities of this of this drug in the overall marketplace, but right now we're deciding to fund the trial that's in front of us.
Got it thanks again for taking my question. Thanks for asking the question.
Thank you please hold for our next question.
Okay.
Our next question comes from Joe Catanzaro of Piper Sandler.
Hey, everybody. Thanks for taking my questions, maybe two on sort of design and feasibility first on design I know youre not disclosing whether you will include loading doses or not but I guess, when we look back at prior experience with <unk> and how it performed in patients with <unk>.
Control that disease at baseline.
What would be a reason why you wouldn't include loading doses across both arms of the study thanks, and I have a follow up.
You bet.
Fantastic question Joe.
Why don't I am not going to choose not to answer but certainly we will.
We have data both in <unk> and knives that are uncontrolled and we have data in previously treated who have been control and clearly we are using all the data that we have in order to be able to anticipate.
The likely response to the OTC <unk> and we think we've come up with a great solution, which will make you aware of in the relatively short future.
Maybe if I can add Joe.
Again to Anthonys point, we are not saying we are doing loading delivers are not being loading doses and this design is absolutely very carefully taught out.
Many thought leaders Inc.
Involved and that's why when you see the design.
Just appreciate the way that is designed that way.
We are designing this we told you about three things one is patient safety. The second is the.
The exhibit acceptable it to two recent acquisitions in the states and all that.
It is to make it.
A good design that we show the TK.
Teekay <unk> activity.
At the end of the trial just wanted to give that color as far.
Okay.
Okay. Thanks, that's helpful and maybe <unk>.
Follow up I guess on.
Feasibility, but I guess it depends on exactly what the primary endpoint is and when but I guess I'm thinking about.
The rescue criteria and similarity of difference relative to what you've been using I know theres been some discussion around setting the criteria in a way that would give <unk> the best chance of success, but in a way where physicians are comfortable.
<unk> patients to lose some degree of.
Our vision.
I hope there's a question in there, but hopefully you got.
I think that Joe I mean, that's exactly the question on everyone's mind and V and it was.
Well this was.
The biggest hurdle getting to this design.
That's why with respected process of disease that reactivation and yields are attractive patterns. There are.
Are all driven by fluid changes is captured by the <unk>.
<unk> mentioned, but the sba's endpoints acceptable endpoint is vision.
That's exactly what we have been working at last two or three months four months since the guidance came at box, how big can strike a balance between what's acceptable to FDA, what is acceptable to investigators for their patients and for patient safety and.
At the end the gift too.
The.
The endpoint that's exactly we spend and we do believe we have that design.
Okay. Thank you I guess looking forward to more details on design. Thanks for taking my questions. Thanks, Joe.
Thank you please hold for a next question.
Okay.
Okay.
Our next question comes from Kelly Crusade.
Great. Thanks, good afternoon, and thanks for taking our questions have you discussed the trial design with the FDA and can you comment on what expectations you have around the enrollment timelines for the superiority trial and then I have a follow up please.
Sure I'll hand that over to Ravi here, yes.
We have extensive discussions.
And communications I should say Colin.
FDA several different design options.
And we don't believe that.
And did the design we have now.
<unk>.
Is it reasonable designed to FDA and Thats exactly what we heard from them. That's why we believe in our design and also designs acceptable to FDA not just one meeting several communications type C meetings and discussion.
EMEA on the exchanges.
For us.
That's helpful. Thank you and any expectations on enrollment timelines.
I mean, what.
Tim This is Mike.
Again with our discussions with the key opinion leaders, especially for critical drivers.
Yes.
Design could enroll.
On the patient population, we are going for is actually available.
<unk>.
At this point and that's why we do think that it should enroll under reasonable periods of time.
Yes, I think you got it.
I know, obviously has had a lot of debate around how difficult. It has been for them to enroll there are naive trial.
And we would be looking for a very different type of patient we'd be looking for patients with better vision.
Rather than what Theyre looking for and we would be looking.
Okay with any type of lesions, so there's a much broader population.
Our discussions with key opinion leaders the available naive population would be exactly the population that we would be enrolling in this trial.
So we are our expectations are that they would enroll relatively quickly and obviously the largest driver of enrollment is really the number of patients and we would we expect 300 evaluable patients would be able to power this trial appropriately.
That's helpful. Thank you and then last follow up from US I think you mentioned that the second phase three would be a similar design so just to clarify.
The pivotal program include any re dosing of <unk> and how do you think that would play out in the commercial opportunity.
Well the thing that's going to drive I'll take that last part of the thing is going to drive our re dosing is really the the PK. I mean this is a different paradigm than an antibody therapy now antibodies are removed from the eye very very quickly and youre really timing.
At the time it takes for disease reactivation, when there's no drug present.
So the idea of being able to dose more rapidly is very important from an antibody standpoint.
It continuously dose therapy, it's actually the re dosing is really should be driven by the PK of the product.
And we know that we can give continuous drug delivery between nine and 12 months.
That being said there are commercial reasons, why we may want to re dose slightly earlier, even though we don't think it would be necessary.
Just to give flexibility for.
For doctors to be able to use it if they needed to four.
For other reasons, but I think we'd like to stay pure to the re dosing.
Based upon the qualities of the drug.
We're not going to score the re dosing.
The pivotal trial today.
Understood. Thanks for taking my questions.
Thanks Colin.
You. Please hold for our next question.
Our next question comes from Kelly <unk> of Jefferies.
Thank you for taking my questions I'm curious what are the second trial of wet AMD has the same Todd trial design as the first one.
And have you discussed with FDA on this front and.
Secondly, regarding the patient enrolment criteria patient baseline characteristics is it more similar to the U S phase one trial. Thank you.
Our second pivotal trial would be this.
Same design as the first pivotal trial.
That's in.
Intention.
Now.
At this point towards the FDA discussions.
<unk> mentioned the head.
Several meeting afterwards communications with the FDA for the current design, we are going now.
We are going to initiate soon.
That's why our discussions.
Just provided us that they plan design.
Is it reasonable pivotal design and.
Your last question around <unk>.
<unk>, whether it would be like similar to our U S. Phase one trial again, we would like to disclose our design design details and highlights of the eligibility.
All of those details.
After we initiate the trial to Australia.
Thanks looking forward to more details.
Thank you Kelly Thank you Kevin.
Thank you.
<unk> next question.
Our next question comes from Tara Bancroft of TD Cowen.
Hi, Good afternoon, I was hoping can you say what time point. The primary endpoint is that this is going to be run and treatment naive patients.
Injection to these patients typically get in that amount of time that the primary endpoint is being measured and I'm asking because I'm trying to get an idea like Dane and Joe said poly will convince patients to enroll in the trial and how youll control for dropouts when patients progressed.
Yes again.
Thank you for the question some of the things I may not be an answer because of the design, but what I can say that zombie disgusted design again. This is ed durability design and deliver to design for.
Teekay <unk> versus <unk>.
Single injection again loading doses or not.
You will see that when we get that but this design to our understanding with extensive discussions with the preclinical try this is.
Acceptable to designed to them and also they are patients that being said.
The the dropouts and et cetera.
With the criteria, we have our recruitment criteria when you see those and then you see the eligibility criteria you would see why.
And this study would be acceptable to the patients because the all of this.
The detail.
Targeted would be accepted.
And our physicians and to patients all discussed.
Top clinical trial.
And they come from they have patients and they have patients enrolled in the trial.
Thank you.
Please go to our next question.
Okay.
Our next question comes from <unk> Chen of H C Wainwright.
Hey, everyone Congrats on progress.
This is <unk> on behalf of each and.
Just a quick one on <unk>.
When would you ideally like to initiate the.
They can see what those study.
And then.
One on dry eye disease any comments on the <unk> program I know you indicated that.
<unk> initiated a small study during the quarter.
Evaluating VEB so any comments on that would be helpful. Thank you.
Ravi you want.
Maybe start with BP and because I'm going to ask for a clarify clarification for Ti.
Dry eye programs, we have two programs in dry eye and.
B, what he has seen.
Phase two.
Phase two programs in boat that we need.
Let's see ball because our.
Inserts interact cannot declare insect.
<unk> worked really well state actually in the kernel it cost more than we expected and that's why our CSI was inconclusive and D. D. Although this shows a statistically significant significant sign the Sims.
Was not statistically significant and the reason for our.
<unk> is that the placebo did Sheila.
What we are doing now is actually.
Running a small trial.
You come up with the more proper placebo like very short.
Short life Colajanni plots that they would just be.
Completely gone like in two to three days to supply stays makes Chile, and then like use debt in a pivotal trial.
I want to start the pivotal trial before constantly derisking that issue because.
In our pivotal as we would like to hit but sign and symptom.
Does that answer your question.
The dry eye program.
Yes. Thank you.
And can you repeat your Teekay all my questions.
The ideal timeframe for the second <unk> study.
I mean.
Really I would like to start this trial first and.
You heard the financed all the trial from Anthony and then as we go along.
I will now.
Partnering processes or other financing.
And we will start the second for now we are starting this first trial.
And then the second trial, we cannot inform you when we get Dash Anthony do you want to add more to this.
I think it's important to note that we're going to learn a lot from the initiation of this trial.
Going to learn a lot by and see how quickly it can enroll we're going to learn a lot from the massive data.
To be able to see how patients are doing in the trial.
Which would give us the confidence in the data to be able to understand when is the right time to pull the trigger on the second trial.
But what we're not going to do is commit to funding that trial until until we see how the first trial is moving so we have.
The appropriate discussions with with other funding sources that could help us expand into a second pivotal but.
But we would be ready from a AR.
Standpoint of clinical trial material to start to start very soon after the initial after initiation of our first pivotal but we're not committing to the start time of that second pivotal yet.
That makes a lot of sense. Thank you. Thank you so much.
Thank you.
Thank you please hold for our next question.
Our next question comes from Caroline Pollo Mchugh of Amber capital markets.
Hi, Good afternoon, I'm, just wondering if and thanks for taking my question just wondering if you could confirm that.
<unk> on the estimated cost of the two pivotal trials in wet AMD.
In the past it was somewhere between 50 and $100 million, but then I've also seen from different numbers just wondering if you could just.
Just to comment on that.
Thank you the number we've been quoting is 50 approximately $50 million per trial, So 100 million two NDA filings.
Got it thanks.
I am showing no further questions at this time. This concludes today's conference. Thank you for participating you may now disconnect.
Okay.
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Yeah.
Okay.
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