Q3 2022 EyePoint Pharmaceuticals Inc Earnings Call

November 2, 2022

The conference will begin shortly to raise your hand during Q&A you can dial star one one.

Okay.

I don't see the odd 0.3rd quarter 2022 financial results Conference call. At this time, all participants are in a listen only mode.

After the speaker's presentation, there will be a question and answer session to ask a question at that time. Please press star one one on your Touchstone telephone.

As a reminder, today's conference call is being recorded.

Now I'll turn the conference Mr. George Ellison, Chief Financial Officer of iPhone Pharmaceuticals. Please go ahead Sir.

Thank you and thank you all for joining us on today's conference call to discuss <unk> Pharmaceuticals third quarter 2022 financial results and recent corporate developments.

With me today are Nancy Lurker, President and Chief Executive Officer, Dr. Jay Duker, Chief operating Officer, and Scott Jones, Chief Commercial Officer Nancy.

Nancy will begin with a review of recent corporate updates.

Dr. <unk> will then discuss phase II clinical trials for <unk> and Scott will comment on our third quarter 2022 financial performance commercial performance.

I will close with commentary on the third quarter of 2022 financial results and we will then open up the call for your questions.

Earlier. This morning, we issued a press release detailing our financial results as well as commercial and operational developments.

Copy of this release can be found in the Investor Relations tab on our corporate website Www Dot <unk> pharma dot com.

Before we begin our formal comments I'll remind you that various remarks, we will make today constitute forward looking statements for the purposes of the Safe Harbor provisions under the private Securities Litigation Reform Act of 1095.

This includes statements about our future expectations clinical time clinical developments and regulatory matters and timelines the potential success of our products and product candidates financial projections and other plans and prospects.

Actual results may differ materially from those indicated by these forward looking statements as a result of various important factors, including those discussed in the risk factors section of our most recent annual report on Form 10-K, which is on file with the SEC.

And in other filings that we may make with the SEC in the future.

Any forward looking statements represent our views as of today only.

While we may elect to update these forward looking statements at some point in the future. We specifically disclaim any obligation to do so even if our views change. Therefore, you should not rely on these forward looking statements as representing our views as of any date subsequent to today.

I'll now turn the call over to Nancy Lurker, President and Chief Executive Officer of Highpoint in Pharmaceuticals.

Thank you George Good morning, everyone and thank you for joining us to discuss the continued progress that.

That I would point made in the third quarter of 2022.

Despite the challenging macroeconomic conditions, we are well funded to reach our critical readouts.

And we remain optimistic about the direction, we're headed in as they work to bring innovative ocular therapies to patients with serious eye disorders.

Prior to turning the call over to my colleagues I would like to highlight a few of our achievements last quarter.

We continue to consistently and successfully execute important milestones across our pipeline with the first patient dose in our phase II <unk> clinical trial evaluating <unk> thousand 19, one for non proliferative diabetic retinopathy.

<unk> and PDR in September .

Notably this was our second phase III clinical trial for <unk> thousand 19 at one initiated in the third quarter.

As a reminder, in July we dosed the first patient in our phase III <unk> clinical trial for wet age related macular degeneration also known as wet AMD.

In the 18 months since initiating our phase <unk> trial, we completed the trial and reported positive six and 12 months data held a type C meeting with the FDA for our phase II and III clinical trial plans and initiated our phase III <unk> clinical trial for wet AMD in phase III <unk> trial for <unk>.

In PDR, respectively.

I am very proud of these achievements and we will continue to execute consistently and effectively.

<unk> 19 O. One combines the VEGF receptor binding tyrosine kinase inhibitor for <unk> and a bio erodible formulation of our proprietary <unk> technology.

<unk> 19, one has the potential to provide patients a duration between treatments of six months or longer while maintaining stable visual acuity and macular anatomy.

As important to highlight that we view 19 O one not as a replacement for current standard of care large molecule anti VEGF treatments, but as a maintenance therapy with a different mechanism of action.

Under this treat to maintain strategy patients can potentially be extended six months or longer with you by 2019 O. One after becoming stabilized with anti VEGF standard of care treatment.

We are extremely excited to have successfully dosed. The first patients in both <unk> 19 O. One phase II clinical trials as planned and look forward to providing updates on these trials in the quarters to come Dr.

Dr. Jay Duker will review <unk> unique value proposition for patients in more detail later on the call.

Turning to our commercial business data from the Utica Com registry strike Tox study will be presented at a poster presentation at the retina Society 50, 55th annual scientific meeting, which is taking place right now in Pasadena, California.

The calm study is a phase four multi center registry study and a joint collaboration between <unk> and the Cleveland clinic that will become a valuable resource in furthering the understanding of posterior segment uveitis.

Importantly, our commercial team delivered another strong quarter for Youtube with $7 3 million in net product revenue an increase of 85%, 85% excuse me from the third quarter of last year, along with continued strong customer demand for Utica.

Scott will provide additional detail for this topic later on.

Finally, we wanted to share an update on our <unk> franchise.

October at the company and implements Rx mutually terminated an agreement for the commercialization of <unk> effective.

Remember 31 2022.

This was a result of Cms's proposed hospital outpatient rule published in July which did not contain an extension of the pass through payment period protect acute beyond December 31 of this year.

The final 2023, CMS <unk> PPS rule, which was published yesterday November <unk> does not modify the proposed rule. This loss of pass through status at the end of this year will significantly reduce the amount of Medicare reimbursement provided to the company's execute customers and will result in a significant reduction.

<unk> in the companies to execute product revenues, we are actively looking at all the strategic options for the asset and we will provide additional updates in subsequent quarters.

So that we can become the leader in sustained ocular delivery and ultimately create a better future for patients living with these serious eye disorders.

I'll now turn the call over to Dr. Jay Duker, our chief operating officer to provide an update on our lead program <unk> thousand 19 O one as well as other initiatives Jay.

Thank you Nancy and good morning, everyone.

Before I begin I want to reiterate what a productive quarter. This has been for the <unk> clinical team as we executed on multiple milestones further advancing our innovative pipeline.

To our product pipeline you might be thinking one is an investigational sustained release therapy, using a bio erodible formulation of our Duressor technology with <unk> tyrosine kinase inhibitor that binds to the receptor therefore blocking all isoforms of that Jeff.

For rolling the differentiated mechanism of action and the standard of care ligand blockers may provide additional benefits such as neuro protection.

To other Teekay is boroughs and it features reduce off target binding leading to a potentially improved safety.

Profile with no reported ocular toxicity.

<unk> as a proven and shapes sustained release delivery platform differentiates <unk> from other agents targeting <unk> mediated retinal disease as this bio erodible insert allows for true sustained release of the drug was zero order kinetics with up to nine months duration of activity.

In wet AMD you IP 19, one is being studied as a maintenance therapy following induction therapy with the standard of care anti VEGF therapeutic.

A new treatment paradigm, which we called treat to maintain.

Our goal is to sustain the majority of wet AMD patients treatment interval up to six months or longer with a single injection of <unk> one.

By providing the sustained delivery therapy patients and practitioners.

Essentially have the flexibility to safely reduce the number of visits to the retina specialists through controlled and sustained intradermal delivery of a differentiated anti VEGF drugs.

Turning to non proliferative diabetic retinopathy or NPD or it is a very common disease affecting almost one third of diabetic adults over the age of 40 and its projected to impact over 40 million Americans by 2050.

In NPD, our blood vessels are weakened and this may lead to both swelling of the macula and abnormal blood vessel growth.

If left unchecked and <unk> to be the harbinger of severe visual loss as well as other ocular complications.

Because the currently approved therapies for NPD or require a significant visit and treatment burden, 97% of Npdor patients are currently observed.

This provides a significant market opportunity for <unk>, one, which may be able to be effectively delivered at a nine month interval or longer and NPR.

Revisiting the phase <unk> clinical trial for <unk>, We recently reported positive 12 month safety and efficacy results at the American Academy of Ophthalmology meeting in Chicago.

<unk> trial with mold 17 patients and each received a single intravenous injection of <unk> at one of four different dose levels. All enrolled patients were previously treated with standard of care anti VEGF therapy.

Reinjection, but the study drug was performed during the trial and typical criteria for supplementation with the standard of care anti said, Jeff was employed.

We were pleased that the 12 months that are featured no reports of ocular aes or drug related systemic sce's no reported events. The vitreous floaters endophthalmitis retinal detachment insert migration to the inter chamber of retinal vasculitis post your segment inflammation or retinal vascular clues.

Live events.

Further it's a 12 month follow up confirmed stable best corrected visual acuity of minus four one to each of Europe's letters and stable central subfield thickness on OTT of minus $2 76 microns.

Interestingly, one third of eyes, where supplemental anti VEGF free up to 12 months. After a single injection of <unk> up to six months, 53% advisory or supplement free.

Additionally, there continued to be positive treatment burden reduction of 73% at 12 months compared to 75% at the six month visit.

On the heels of these positive data we enrolled our first patients in two separate phase two clinical trials of you might be making a one one for the treatment of wet age related macular degeneration called W. Two and one studying the drug in non proliferative diabetic retinopathy called the <unk> study.

<unk> two trial is expected to enroll approximately 150 wet AMD patients previously treated with the standard of care anti VEGF therapy and randomly assigned to one of two doses of <unk> hundred one approximately two milligrams or approximately three milligrams versus an on label of Liberty Controle.

<unk> what is delivered with a single intravenous injection in the physician's office similar to current FDA approved anti VEGF treatments.

Primary efficacy endpoint of the W. Two trial is non inferiority to just deliberate ship control as measured by change in best corrected visual acuity six months after the net one injection.

Secondary efficacy endpoints include change in CST as measured by OCD time to first supplemental answer that Jeff reduction in treatment burden and safety. We look forward to progressing the W. Two trial and anticipate topline results in the fourth quarter of 2023.

The first patient was dosed in the phase II <unk> clinical trial of <unk> 91 for the treatment of NPD are in September of 2022.

The trial is expected to enroll approximately 105 patients randomly assigned to one of two doses of <unk> thousand 19, one approximately two milligrams or approximately three milligrams or to the control group, which will receive a sham injection.

In this trial as well we might be 19, one is delivered with a single <unk> injection in the physician's office. The primary efficacy endpoint of the trial was improvement of at least two diabetic retinopathy severity scale levels at week 36.

Secondary endpoints include onset of vision, threatening complications occurrence of diabetic macular edema, Angelo proliferative disease, retinal ischemia nonprofessional and safety.

In summary, we are very proud of the clinically validating results we've seen from the phase one trial with <unk>, one and we are excited to provide updates on the <unk> trial in the quarters to come.

I'll now turn the call over to Scott Jones, Chief Commercial officer for the commercial update Scott.

Thank you Jay.

Cited to report a strong quarter for our commercial business with $9 7 million of net product revenue an increase of 13% from the third quarter of last year.

Our Q3 net product revenue for Utica and to execute with $7 3 million and $2 4 million respectively.

Customer demand for the third quarter was approximately 819 units. So you take 14100 units to execute.

Customer demand for you too continues to grow as we see positive traction from our focus on retinal specialists for posters segment inflammation and continued used by uveitis specialists, we hope to see increased demand continue in the quarters to come with further support from the ongoing phase four studies that are currently underway.

As Nancy previously discussed in October 2022, the company mutually terminated an agreement with <unk> for the commercialization of <unk> effective December 31, 2022, as a result of the Medicare hospital outpatient prospective payment system.

C payment system proposed rule, which was published in the Federal Register by the center for Medicare and Medicaid services on July 26 2022.

The final rule published yesterday did not contain an extension of the pass through payment period for <unk> beyond December 31 2022.

We will work with the Imprimis Rx team supporting with execute franchise through Q4, while also actively looking at all strategic options available to us for the asset.

We're very pleased by the progress that we've made with our commercial business and remain on track for breakeven for the franchise in 2022 I'd like to thank our commercial teams for their dedication in bringing our ophthalmic therapies to physicians and patients in need I would now like to turn the call over to George to review the financials George.

Thank you Scott as the financial results for the three months ended September 32022 were included in the press release issued this morning. My comments today will be focused on a high level review of the quarter.

For the third quarter ended September 32022, total net revenue was $10 million compared to $9 1 million for the quarter ended September 32021.

Includes net product revenue for the third quarter of $9 7 million compared to net product revenue of $8 6 million for the prior year period, an increase of 13%.

Net revenue from royalties and collaborations for the third quarter ended September 32022 totaled <unk> 3 million compared to $5 million in the corresponding period in 2021.

Operating expenses for the third quarter ended September 32022 totaled $28 4 million versus $24 4 million in the prior year period, primarily driven by an investment in personnel across the organization, including noncash stock compensation and ongoing clinical trial and development costs for <unk>.

Nonoperating expense net totaled 0.0 $2 million and net loss was $18 4 million or <unk> 49 per share compared to a net loss of $16 7 million or <unk> 58 per share for the prior year period.

Cash and investments at September 32022 totaled $157 3 million compared to $171 2 million at June 32022.

We expect cash cash equivalents and investments on hand.

At September 32022, and expected net cash inflows from our product sales will enable us to fund our current and planned operations into the second half of 2024.

In conclusion, we are pleased with <unk> progress in the third quarter of 2022 and are well capitalized to advance our product pipeline to key value inflection points.

Thank you all very much for listening this morning, and I'll now turn the call over to the operator for questions.

Thank you.

Ladies and gentlemen, if you would like to ask a question. Please press star one on your Touchtone telephone again to ask a question. Please press star one one our first question comes from Jennifer <unk> of Cantor. Your line is open.

Hey, good morning, and thanks for taking my question I have a few here maybe to start off how do you think about the positioning of sustained release therapies on the back of the detailed high dose Eylea data.

Yeah. So first of all I want to stress a couple of things and then I'm going to have Dr Duke or elaborate.

It's very important that people realize this is meant as maintenance therapy, he might be 19 O. One.

No we've never viewed ourselves as a competitor to the large molecule anti bad Jeff.

And as we also have shown in our phase one data we are able to get a majority of patients out beyond six months. The other thing to consider is that as we further develop the product we're continuing to work on the mechanism of action and it is a different mechanism of action and generally speaking that.

Can be a positive when you look at approaching a disease from multiple angles and we've got some interesting preclinical animal data that Jay can elaborate on which we believe further highlight there could be some additional benefit to using a different mechanism of action. While you occasionally may need to supplement with a large molecule.

Antibody excuse me antibody the anti Pat Jeff Okay.

Well thanks for the question Jennifer on to elaborate a little bit more on what Nancy said and just to go over the data.

Regeneron announced at about 77% of their wet AMD patients within the study could be dosed at.

Out of extended.

<unk> frame up to four months in our <unk> trial, we have 76% of eyes co op that log. In addition of course, we had 53% go up too.

Six months without a rescue or supplement and we had a third device go one year.

Those are finding said really the likelihood blockers are unable to achieve so to.

Differentiate on just the basis of longevity I think that we have the possibility of going significantly longer with a single injection.

We don't have to do that and everybody to have a very successful product. If you again look at our <unk> data, even the patients who required a supplement before six months in.

In general those patients received much less treatment than they had been getting pryor.

So that reduction in treatment burden from every month or two will still be a benefit to patients even if they require treatment every three to four months with <unk>.

And finally, the differentiated mechanism of action I think.

Nancy touched on this but we do have some preclinical data and a retinal detachment model that suggests that roll in there which is our <unk> inhibitor.

Neuro protection, both measuring vision.

Effected animals as well as <unk>.

Looking at the OCD findings of the outer retina and this retinal detachment model. So we're certainly encouraged by that and we're looking at other preclinical evidence of other.

Cause of action that may differentiate <unk> from the standard of care and of course, the clinical data, we hope will bear that out as well.

Okay. That's very helpful. Thanks. My second question is I know, it's a little early but any color around the rate of enrollment in <unk> and I know it even earlier, but in <unk>, yes.

Go ahead Jay.

Yes so.

I would say the.

Onset the first patient dosed in.

In the W. Two trial was.

Exactly where we planned.

In saying that I think the initial enrollment has been a bit slower than what we hope for that had a lot to do with the rolling out of the sites now.

Now we have a lot of sites up and running and we.

We are now enrolling.

At <unk>.

A respectable clip.

We still at this point I believe we will have top line data to share and approximately a year in the fourth quarter of next year.

Pavia again right on target at this point.

I think because of.

Yes, you used the term macroeconomic because of macroeconomic factors that both the <unk> and the sites, it's been a little slower getting the sites up and running but once the sites are up and running then the enrollment is going just fine.

Okay very helpful. And then my last question is you mentioned actively looking for alternative paths around execute could you give a bit more color on that end.

When we might get an update.

Ah.

So let me just comment on that which is that we're going to look at potential partnerships because I just want to remind everyone.

CMS has indicated they will provide reimbursement.

Do you have a pain indication and given that we have an FDA approved drug.

Still retain significant value with a patent life out till at least 2035. So we are going to be looking at various options to potentially complete those pain studies, but nothing definitive yet and we will be back as soon as the investors as soon as we are.

Nail down exactly what we're doing.

Okay, great. Thanks again guys.

Thank you one moment please.

Our next question comes from the line of Georgia Donovan of Cowen Your line is open.

Hi, Eric how are you.

On.

Regarding some of the interesting data that you presented the subset analysis from <unk> in patients with no residual fluid.

So maybe we're just wondering if you can kind of like.

Dive deeper into those results.

They seem very impressive do they in any way kind of like in forum.

Future design of the pivotal trials or and kind of like any way clarified the opportunity there.

And then we have a couple of follow ups.

Yes happy to answer that so first of all what youre referring.

Referring to is we went back and the <unk> data of the phase one data and looked at the patients who entered the study dry with no excess fluid remember we didn't have any fluid cutoffs in the <unk> trial for enrollment.

Enrolled patients who are under good control back control really took all comers are nine of the patients of the 17th or dry going into those patients that exceptionally well.

With.

67% I think up to six months without a supplement within the first six months of the three that did need supplement only needed one.

The change in visual acuity in the first six months was about a letter minus.

So in the Ott's were looked good and so that that subset of patients did very well. So parenthetically I got asked the question by Jennifer earlier about.

Hydro say Leah will hydro Leah if you look at the data about 50% of regular dose eylea patients at 16 weeks or dry hydro slightly at 60%. So if this data holds for <unk> 90 to one that dry rice do better in some ways high dose Eylea may actually have better a better drug to lead into 19.

One than regular Eylea is because more ICP dry.

How does this inform us well again.

We're really trying to enroll patients who are basically doing well on anti VEGF therapy and top Youtube.

And we're not excluding a little bit of fluid because there is certainly evidence that a little bit of sub retinal fluid is maybe protective division with you wouldn't want to them.

But you also may recall, and I'll remind everybody on the call that every patient and W. Two is getting a loading dose of <unk>.

And so even though these are patients who were previously treated with <unk>.

Loading up everybody with three monthly injections and that should also increase the number of patients who want the time, they GED <unk> hundred one our dry and so that that should we hope result in more robust findings GW to them than what we saw on top of the old one.

Great. Thank you so much that's super helpful and then.

Another follow up.

I guess just broadly on the technology has really shown that there are certain technologies are powerful platforms. So maybe can you speak to that.

Your.

<unk>.

Opportunities to bring any other molecules <unk> one area. We've been following dosing could be particularly beneficial would be GAA. So can you maybe just talk through the strategic considerations of potentially exploring that area.

Well I'll comment on that and thank you for the question. We're actively engaged in that however, these things take time.

And beyond that we're not going to go into specifics because obviously, we want to keep things confidential in terms of some of the specifics that we'd look at.

But we do believe that that could be a significant opportunity and ill, let jay comment on the opportunity with <unk> with D. A N a longer treatment duration.

Well I think we all hope that we will have it approved drug for geographic atrophy in the near future.

And if we do.

It looks as if the approved drugs the ones that are being looked at.

Well, we hope shortly approved drugs.

Have to be delivered quite frequently probably every month to be effective. So clearly if there is a delivery system that can deliver an anti complement that's safe and effective that could go out longer than that that would be a tremendous advantage I think that's obvious.

So in order for us to be a differentiator, we have to be able to take a molecule and put it into duressor can be able to deliver it for that period of time.

And so there's a lot that goes into the evaluation of such a molecule.

Size solubility.

The dose you actually need to achieve the clinical endpoint and so as Nancy indicated this is an area that we are actively looking at.

When we have some positive reduce we will certainly announce it I will add though neuro protection, which I touched on briefly is another area that is a bit of a holy Grail for pushed your segment disease and while neuro protection as a mechanism of action is a little less defined I would say then complement inhibitor.

<unk> in geographic atrophy neuro protection opens up a lot of other markets and so that's another area in general where we're looking at molecules that can provide euro protection to the retina, which the ganglion cells in a sustained release delivery system.

Great. Thank you so much for all the details and congratulations on all the progress.

Yes.

Thank you one moment please.

Our next question comes from a lot of you churn of H C. Wainwright. Your line is open.

Okay.

Thank you for taking my questions.

For the.

Patients enrolled into the phase two half year trial.

NPD R R.

Newly diagnosed patients or existing patients, who are receiving active treatment or existing patients who are not receiving accurate.

Okay go ahead.

Active treatment would be an exclusion so NPT our patients in general.

Well.

And had minimal symptoms.

<unk> is diagnosed in the Doctor's office based on examination of the fund US we do know that <unk> is a progressive disease and left unchecked it will <unk>.

Actually progress and in many cases go onto diabetic macular edema or proliferative diabetic retinopathy. So these patients could be newly diagnosed if they're newly diagnosed it doesn't mean, they just had.

Diabetes for short period of time in order to get moderate to severe NPD are you really have to have diabetes for a while but they may have just come into the doctor's office for the first time, so and essentially it could be newly diagnosed but if they are being actively treated for the complications of the <unk> or PDR then they wont be eligible for the study.

Okay.

These are moderate to moderately severe to severe <unk> patients.

They usually reject treatment even after diagnosis, but the ophthalmologist correct, yes, I think the two.

Hey.

I'm not sure they reject it more than most retina specialists still are reluctant to offer it.

And so there are two approved drugs.

For the treatment of non proliferative diabetic retinopathy and our research to the market suggests that no more than 2% to 3% of patients are actually getting the drugs because they require at the beginning monthly treatment and after a while you can cut back a little but if you go too far the cutback of treatment, then youre going to lose the ifs.

So it really has to be something like a sustained release that would enable these patients to go on with their lives normally and not be tied into the doctor's office because remember these NPD. Our patients are not patients who are typically visiting the doctor every month or two they may be on a six month to one year schedule. So if theyre asymptomatic with good <unk>.

<unk> asking them to undergo an injection monthly for <unk>.

Asymptomatic condition is a big lift and so I don't think it's just patient reluctance I think there is some physician reluctance there too.

Got it got it thank you.

And.

I don't know if you can provide any color around.

Potential growth trajectory of the Utica in 2023 at this point.

Yeah.

Yeah, sorry about that I was on mute.

So I'll, let Scott comment on it, but we don't give forward guidance.

However, we continue to have some.

Very good quarters, and Scott you want to just comment a little bit on our approach to make sure.

Thinking Nancy.

As Nancy mentioned, we will not provide guidance for the fourth quarter or for future quarters. However, I would say that's a month into the fourth quarter, we're very pleased with the performance.

Of the product.

And what we have seen coming out of the third quarter is that physicians kind of fully back in the office and we're starting to see a lot more patients flowing through and as you can imagine that provides a lot of more opportunities for treatment.

I would say that as I mentioned previously and in the discussion.

We have been really pleased with the uptake of boutique overall in the marketplace, especially within the retinal segment as we are.

Seeing a lot of retina physicians, a lot of new retina physicians come onboard in terms of utilizing Utica and so we see that as a nice harbinger for the future.

Got it thank you.

Thank you.

One moment please.

Our next question comes from the line of Yale Jen of Laidlaw and company. Your line is open.

Good morning, and thanks for taking the question.

My first question is that for the <unk> two study humming.

How many sites currently being wrote and what will be the target of number of sites.

To be eroded in the study.

Hi, Yeah, Yeah, we're not going to disclose that.

But suffice it to say it's typical.

So we don't go into that level of detail on our clinical studies.

[laughter].

Okay no problem thanks for that.

Two more quick ones. The first one for the previous study and the.

The readout is the two asset level changes.

Thus this endpoint also could be used for the future pivotal study or are you thinking about something else.

Go ahead.

That would be as of now the endpoint for the future pivotal studies.

That is a approvable endpoint both.

Both Lucentis and Eylea were approved for <unk> based on that endpoint.

And so that the plan right now would be to use that as the endpoint in the pivotal.

Okay, Great and maybe the last question here is that.

The assumption for the runway.

Would that include very minimum execute revenue.

The base case.

Sure.

Yes, I can answer that yes, thank you for that.

We guided about execute in Q2, we kind of knew that the pass through.

Extension was unlikely and so that's always been the <unk>.

Reduction in debt execute revenues has always been part of our cash projection recall that.

Brought in <unk> as a commercial alliance partner.

Back in 2020, so it's been a non core program for us and while it yes, it's been breakeven.

The significant component of our cash generation.

Okay, great. Thanks, a lot and look forward to see the progress. Thank you. Thank you.

Operator, please make sure your phone is on mute our next.

Question comes from the line of Danielle <unk> of Chardan.

Hey, good morning, guys. Thanks for taking the question.

Just a quick one on <unk>.

On a bigger trend long term can you comment on the plans with regard to other anti VEGF indications such as plans for RVO.

Yes go ahead, yes.

Yes, so the next indication, which we plan on pursuing as diabetic macular edema and the current plans, we expect to initiate that study in the second half of next year.

We will probably do RVO at some point, we don't have it built into our models yet.

Again, our view is a much smaller market than the others.

And while we think there probably will be benefit that's not in our current plan, but we expect as.

We unfold with the pivotal trials.

For wet AMD and in <unk> that will come more into focus I'll also add theres other smaller indications, which we will probably layer on eventually as well like myopic Choroidal Neovascular nation, we expect at 19 O. One would do very well in that indication and we're also looking at the possibility.

Of using <unk> hundred one in a high risk in other words and I that has dry macular degeneration, but has not yet converted to wet macular degeneration.

Using <unk> as a preventative maintenance therapy to prevent the conversion to wet.

There is considerable evidence from the oral studies of ERO would've been wet AMD that there was a protective effect of the LOI. So thats another potential indication that we will be modeling and looking out in the future.

Got it. Thank you that was very helpful.

Thank you.

Next question one moment please.

Our next question comes from the line of <unk> of B Riley Your line is open.

Good morning.

Hi, thank.

Thank you for taking our question can.

Can you remind us the market opportunity.

<unk> patients and when you look at the treatment landscape, what do you think could it be the standard of care. Two years later when you are planning on initiating you a potential phase III trials E&P Dr. Thank you.

Yes, Scott you can answer the <unk>.

Market opportunity and then Jay on the clinical side.

Thank you for the question yes.

As you are certainly well aware of the diabetes population with diabetes is continuing to grow and is a substantial number of patients at this point it could be numbering as many as 15 million patients who are flowing through.

Some form of.

Ophthalmology practice or optometrist practice.

We believe that certainly the opportunity as we said is extremely large J I think did a really good job of laying out kind of the current conundrum as it relates to the treatment paradigm, which we believe we certainly offer a really unique opportunity moving forward.

Okay.

Yes, so it's hard to project anything in this day and age, but looking realistically at the two FDA approved drugs for NPD are it's hard to believe that the market is going to open up substantially in the next two years I think in roads will be made I think more of the young doctors might be more <unk>.

Interested in.

In pursuing.

And aggressive treatment of MPD or by aggressive I mean frequent injections, but again in this patient population, who are generally younger and working it's hard to think in an asymptomatic disease, they're going to want to come in that frequently and subject themselves to the small but finite risk of multiple injections.

Other sustained release products are going to I'm sure look at the NPD market, but this again is a risk benefit kind of thing.

The Ah Refillable Port technology.

I would expect if lucentis is effective it would be as well.

That may not meet the standard of risk versus benefit and again I think some of the other products out there.

<unk> therapy is potentially a pathway to have sustained release of any drug too but that remains to be tested. So we think that theres still going to be in two years substantial opportunity for in every nine months or perhaps even once a year intra vitriol in office bio erodible injection.

That could substantially all through the course for the positive in many patients within PDR.

Yeah.

Thank you that's very helpful.

Thank you.

I am showing no further questions at this time, ladies and gentlemen. This does conclude today's conference. Thank you all for participating you may now disconnect have a great. Thank you Youre welcome. Thank you.

Yeah.

[music].

Consider I 0.3rd quarter 2022 financial results conference call at this time, all participants are in a listen only mode.

After the speaker's presentation, there will be a question and answer session to ask a question at that time. Please press star one one on your Touchstone telephone.

As a reminder, today's conference call is being recorded.

Now I'll turn the conference host Mr. George Ellison, Chief Financial Officer of iPhone Pharmaceuticals. Please go ahead Sir.

Thank you and thank you all for joining us on today's conference call to discuss <unk> Pharmaceuticals third quarter 2022 financial results and recent corporate developments.

With me today are Nancy Lurker, President and Chief Executive Officer, Dr. Jay Duker, Chief operating Officer, and Scott Jones, Chief Commercial Officer Nancy.

Nancy will begin with a review of recent corporate updates.

Dr. <unk> will then discuss phase II clinical trials for <unk> and Scott will comment on our third quarter 2022 financial performed commercial performance.

I will close with commentary on the third quarter of 2022 financial results and we will then open up the call for your questions.

Earlier. This morning, we issued a press release detailing our financial results as well as commercial and operational developments.

Copy of this release can be found in the Investor Relations tab on our corporate website Www Dot <unk> pharma dot com.

And in other filings that we may make with the SEC in the future.

Any forward looking statements represent our views as of today only.

I'll now turn the call over to Nancy Lurker, President and Chief Executive Officer of <unk> Pharmaceuticals.

George Good morning, everyone and thank you for joining us to discuss the continued progress that I point made in the third quarter of 2022 despite.

Despite the challenging macroeconomic conditions, we are well funded to reach our critical readouts.

And we remain optimistic about the direction, we're headed in as they work to bring innovative ocular therapies to patients with serious eye disorder pre.

Prior to turning the call over to my colleagues I would like to highlight a few of our achievements last quarter.

We continue to consistently and successfully execute important milestones across our pipeline.

With the first patient dose in our phase II <unk> clinical trial evaluating <unk> thousand 19, and one for non proliferative diabetic retinopathy or PDR in September .

Notably this was our second phase III clinical trial for <unk> thousand 19 at one initiated in the third quarter.

As a reminder, in July we dose the first patient in our phase III <unk> clinical trial for wet age related macular degeneration also known as wet AMD.

In the 18 months since initiating our phase <unk> trial, we completed the trial and reported positive six and 12 month data held a type C meeting with the FDA for our phase II and III clinical trial plans and initiated our phase III <unk> clinical trial for wet AMD in phase III <unk> trial for <unk>.

In PDR, respectively.

I'm very proud of these achievements and we will continue to execute consistently and effectively.

<unk> 19 O. One combines the VEGF receptor binding tyrosine kinase inhibitor of <unk> and a bio erodible formulation of our proprietary <unk> technology.

Our P 19, one has the potential to provide patients a duration between treatments of six months or longer while maintaining stable visual acuity and macular anatomy.

Under this treat to maintain strategy patients can potentially be extended six months or longer with you by 2019 O. One after becoming stabilized with anti VEGF standard of care treatment.

Dr. Jay Duker will review <unk> unique value proposition for patients in more detail later on the call.

Scott will provide additional detail for this topic later on.

Finally, we wanted to share an update on our <unk> franchise in October at the company and implements Rx mutually terminated on agreements for the commercialization of <unk> effective December 31 2022.

This was the result of Cms's proposed hospital outpatient rule published in July which did not contain an extension of the pass through payment period protector Q beyond December 31 of this year.

The final 2023, CMS <unk> PPS rule, which was published yesterday November one did not modify the proposed rule. This loss of pass through status at the end of this year will significantly reduce the amount of Medicare reimbursement provided to the company's execute customers and will result in a significant reduction.

<unk> in the companies to execute product revenues, we are actively looking at all the strategic options for the asset and we will provide additional updates in subsequent quarters.

I'd like to thank the talented <unk> team for our company's success to date as we advance the FERC the future of sustained ocular drug delivery. We look forward to continued execution on multiple near term clinical catalysts. So that we can become the leader in sustained ocular delivery and ultimately create a better future for patients living.

With these serious eye disorders.

I'll now turn the call over to Dr. Jay Duker, our chief operating officer to provide an update on our lead program <unk> 19 O one as well as other initiatives.

<unk>.

Thank you Nancy and good morning, everyone.

Before I begin I want to reiterate what a productive quarter. This has been for the <unk> clinical team as we executed our multiple milestones further advancing our innovative pipeline.

Turning to our product pipeline you might be thinking one is an investigational sustained release therapy using the bio erodible formulation of our <unk> technology with <unk> tyrosine kinase inhibitor that bind the receptor.

Core blocking all isoforms of that Jeff.

We're rolling its differentiated mechanism of action and the standard of care <unk> blockers may provide additional benefits such as neuro protection.

Compared to other Teekay is boroughs and it features reduce off target binding leading to a potentially improved safety profile.

Profile with no reported ocular toxicity.

<unk> as a proven safe sustained release delivery platform differentiates <unk> from other agents targeting <unk> mediated retinal disease as this bio erodible insert allows for true sustained release of the drug with zero order kinetics with up to nine months duration of activity.

In wet AMD you might be 19, one is being studied as a maintenance therapy following induction therapy with the standard of care anti VEGF therapeutic.

New treatment paradigm, which we called treat to maintain.

Our goal is to sustain the majority of wet AMD patients treatment interval up to six months or longer with a single injection of <unk> right.

By providing this sustained delivery therapy patients and practitioners can potentially have the flexibility to safely reduce the number of visits to their retina specialists through controlled and sustained intradermal delivery of a differentiated anti VEGF drug <unk>.

In NPD, our blood vessels are weakened and this may lead to both swelling of the macula and abnormal blood vessel growth.

If left unchecked and PDR to be the harbinger of severe visual loss as well as other ocular complications.

Because the currently approved therapies for <unk> require a significant visit and treatment burden, 97% of NPD. Our patients are currently observed.

This provides a significant market opportunity for <unk>, one, which may be able to be effectively delivered at a nine month interval or longer and NPR.

Revisiting the phase <unk> clinical trial for <unk>, We recently reported positive 12 month safety and efficacy results at the American Academy of Ophthalmology meeting in Chicago.

<unk> trial with <unk> 17 patients and each received a single <unk> injection of <unk> at one of four different dose levels. All enrolled patients were previously treated with standard of care anti VEGF therapy.

<unk> injection with the study drug was performed during the trial and typical criteria for supplementation with the standard of care anti said, Jeff was employed.

We were pleased that the 12 month data featured no reports of ocular Aes were drug related systemic sce's no reported events, the vitreous floaters and up the Midas retinal detachment insert migration to the anterior chamber of retinal vasculitis post your segment inflammation or retinal vascular clues.

Live events.

Further the 12 month follow up confirmed stable best corrected visual acuity of minus $4, one to each of Europe's letters and stable central subfield thickness on OTT of minus $2 76 microns.

Interestingly, one third of Ais, where supplemental anti VEGF free up to 12 months. After a single injection of <unk> up to six months, 53% of ice where supplement free.

Additionally, there continued to be positive treatment burden reduction of 73% at 12 months compared to 75% at the six month visit.

On the heels of these positive data we enrolled our first patients in two separate phase II clinical trials of you might be $90. One one for the treatment of wet age related macular degeneration called Sofia, two and one studying the drug in non proliferative diabetic retinopathy called the previous study.

<unk> two trial is expected to enroll approximately 150 wet AMD patients previously treated with the standard of care anti VEGF therapy and randomly assigned to one of two doses of <unk> 19 O. One approximately two milligrams or approximately three milligrams versus an on label of Liberty Controle.

<unk> what is delivered with a single intravenous injection in the physician's office similar to current FDA approved anti VEGF treatments.

Primary efficacy endpoint of the W. Two trial is non inferiority to the deliberate shift control as measured by change in best corrected visual acuity six months after the 19 one injection.

Secondary efficacy endpoints include change in CST as measured by OCD time to first supplemental Lindsay that Jeff reduction in treatment burden and safety, we look forward to progressing the <unk> II trial and anticipate top line results in the fourth quarter of 2023.

The first patient was dosed in the phase II <unk> clinical trial with <unk> 91 for the treatment of <unk> in September 2022.

The trial is expected to enroll approximately 105 patients randomly assigned to one of two doses of <unk> thousand 19, we won approximately two milligrams or approximately three milligrams or to the control group, which will receive a sham injection.

And this trial is well we might be 19, one is delivered with a single intravenous injection in the physician's office.

Primary efficacy endpoint of the trial was improvement of at least two diabetic retinopathy severity scale levels at week 36.

Secondary endpoints include onset of vision, threatening complications occurrence of diabetic macular edema, antelope proliferative disease retinal ischemia non profession and safety.

In summary, we are very proud of the clinically validated results we've seen from the phase one trial with <unk>, one and we are excited to provide updates on the W. Two and for the trial in the quarters to come.

I will now turn the call over to Scott Jones, Chief Commercial officer for the commercial update Scott.

Thank you Jay.

Cited to report a strong quarter for our commercial business with $9 7 million of net product revenue an increase of 13% from the third quarter of last year.

Our Q3 net product revenue for Utica and to execute was $7 3 million and $2 4 million respectively.

Customer demand for the third quarter was approximately 819 units. So you take 14100 units to execute.

Customer demand for Youtube continues to grow as we see positive traction from our focus on retinal specialists were posters segment inflammation and continued used by uveitis specialists, we hope to see increased demand continue in the quarters to come with <unk> support from the ongoing phase four studies that are currently underway.

As Nancy previously discussed in October 2022, the company mutually terminated the agreement with <unk> for the commercialization of execute effective December 31, 2022, as a result of the Medicare hospital outpatient prospective payment system.

Yossi payment system proposed rule, which was published in the Federal Register by the center for Medicare and Medicaid services on July 26 2022.

The final rule published yesterday did not contain an extension of the pass through payment period for to execute beyond December 31 2022.

We will work with the <unk> team supporting did execute franchise through Q4, while also actively looking at all strategic options available to us for the asset.

Now I'd like to turn the call over to George to review the financials George.

For the third quarter ended September 32022, total net revenue was $10 million compared to $9 1 million for the quarter ended September 32021. This includes net product revenue for the third quarter of $9 7 million compared to net product revenue of $8 6 million for the prior year period, an increase of 13%.

<unk>.

Net revenue from royalties and collaborations for the third quarter ended September 32022 totaled <unk> 3 million compared to $5 million in the corresponding period in 2021.

Nonoperating expense net totaled 0.0 $2 million and net loss was $18 4 million or <unk> 49 per share compared to a net loss of $16 7 million or <unk> 58 per share for the prior year period.

Cash and investments at September 32022 totaled $157 3 million compared to $171 2 million at June 32022.

We expect cash cash equivalents and investments on hand.

At September 32022, and expected net cash inflows from our product sales will enable us to fund our current and planned operations into the second half of 2024.

In conclusion, we are pleased with <unk> progress in the third quarter of 2022 and are well capitalized to advance our product pipeline to key value inflection points.

You all very much for listening this morning, and I'll now turn the call over to the operator for questions.

Thank you.

Again, ladies and gentlemen, if you'd like to ask a question. Please press star one on your Touchtone telephone again to ask a question. Please press star one one our first question comes from Jennifer Chemo Cantor Your line is open.

Hey, good morning, and thanks for taking my question I have a few here maybe to start off.

How do you think about the positioning of sustained release therapies on the back of the detailed high dose Eylea data.

Yeah. So first of all I want to stress a couple of things and then I'm going to have Dr. Duker elaborate.

It's very important that people realize this is meant as maintenance therapy, he might be 19 O. One.

No we've never viewed ourselves as a competitor to the large molecule anti bad Jeff.

Can be a positive when you look at our protein a disease from multiple angles and we've got some interesting preclinical animal data that Jay can elaborate on which we believe further highlight there could be some additional benefit to using a different mechanism of action. While you occasionally may need to supplement with a large molecule.

Antibody excuse me antibody the anti bet Jack.

Jay.

Well thanks for the question Jennifer on to elaborate a little bit more on what you said and just to go over the data.

Regeneron announced that about 77% of their wet AMD patients within the study could be dosed.

Added extended timeframe up to four months in our <unk> trial, we had 76% of eyes go out that long and in addition of course, we had 53% go up to six months without a rescue or supplement and we had a third of eyes go one year.

Those are findings that really the ligand blockers are unable to achieve so.

Differentiate on just the basis of longevity.

That we have the possibility of going significantly longer with a single injection.

We don't have to do that and everybody to have a very successful product. If you again look at our <unk> data, even the patients who required a supplement before six months in general those patients received much less treatment than they had been getting pryor.

So that reduction in treatment burden from every month or two will still be a benefit to patients even if they require treatment every three to four months with <unk>.

And finally, the differentiated mechanism of action I think.

Nancy touched on this but we do have some preclinical data.

<unk> detachment model that suggests that roll in there, which is our <unk> inhibitor should narrow protection both measuring vision.

Effected animals as well as looking at the OCD findings of the outer retina and this retinal detachment model. So we're certainly encouraged by that and we're looking at other preclinical evidence of other.

And because of action that may differentiate <unk> from the standard of care and of course, the clinical data, we hope will bear that out as well.

Okay. That's very helpful. Thanks. My second question is I know, it's a little early but any color around the rate of enrollment in <unk> and I know, even earlier, but and Pavia.

Yes go ahead Jay.

Oh, yes so.

I would say the.

Onset the first patient dosed in.

In the W. Two trial was.

Exactly where we planned.

In saying that I think the initial enrollment has been a bit slower than what we hope for that had a lot to do with the rolling out of the sites now.

Now we have a lot of sites up and running and we.

We are now enrolling.

At a.

A respectable clip.

And we still at this point I believe we will have top line data to share and approximately a year in the fourth quarter of next year.

Pavia again right on target at this point.

Because of <unk>.

Let's use the term macroeconomic because of macroeconomic factors that both the <unk> and the sites, it's been a little slower getting the sites up and running but once the sites are up and running then the enrollment is going just fine.

Okay very helpful. And then my last question is you mentioned actively looking for alternative paths around execute could you give a bit more color on that end.

And when we might get an update.

So let me just comment on that which is that we're going to look at potential partnerships because I just want to remind everyone.

CMS has indicated they will provide reimbursement.

Do you have a pain indication and given that we have an FDA approved drug.

Nail down exactly what we're doing.

Okay, great. Thanks again guys.

Thank you one moment please.

Our next question comes from the line of Georgia Donovan of Cowen Your line is open.

Hi, Eric how are you.

On.

Regarding some of the interesting data that you presented the subset analysis from <unk> in patients with no residual fluid.

So maybe we're just wondering if you can kind of like.

Dive deeper into those results.

They seemed very impressive do they in any way kind of like in forum.

Future design of the pivotal trials or in kind of like any way clarified the opportunity there.

And then we have a couple of follow ups.

Yes, I'd be happy to answer that so first of all to what you're doing.

Enrolled patients who are under good control back control, if we really took all comers.

Nine of the patients of the 17th where dry going into those patients that exceptionally well.

With.

About 67% I think up to six months without a supplement within the first six months of the three that did need supplement only needed one.

The change in visual acuity in the first six months was about a letter minus.

So in the Occ's were looked good and so that that subset of patients.

Well, so parenthetically I got asked the question by Jennifer earlier about Hydro Leah will hydrous Eylea. If you look at the data about 50% of regular dose eylea patients at 16 weeks or dry hydro slightly at 60%. So if this data holds for <unk> 90 to one that dry <unk>.

In some ways high dose Eylea may actually have better a better drug to lead into <unk> than regular eylea is because more ice will be dry.

How does this inform us well again.

Really trying to enroll patients who are basically doing well on anti VEGF therapy and W. Two.

And we're not excluding a little bit of fluid because there is certainly evidence that a little bit of sub retinal fluid is maybe protective to visual acuity in the long term.

But you also may recall and I'll remind everybody on the call that every patient in <unk> two is getting a loading dose of.

Of Eylea and so you'd lose these are patients who were previously treated were loading up everybody with three monthly injections and that should also increase the number of patients who want the time, they get <unk> hundred one our dry and so that that should we hope result in more robust findings <unk>.

Then what we saw on top you have one.

Great. Thank you so much super helpful.

Other follow up.

I guess just broadly on the technology has really shown that there are certain technologies are powerful platform. So maybe can you speak to that.

Your.

<unk>.

Opportunities to bring any other molecules <unk> one area, we've been following or duress, there could be particularly beneficial would be GAA. So can you maybe just talk through the strategic considerations of potentially exploring that area.

Well I'll comment on that and thank you for the question. We're actively engaged in that however, these things take time and beyond that we're not going to go into specifics because obviously, we want to keep things confidential in terms of some of the specifics that we'd look at.

But we do believe that this could be a significant opportunity and ill, let jay comment on the opportunity with <unk> with D. A N a longer treatment duration.

Well.

We all hope that we will have it approved drug for geographic atrophy in the near future.

And if we do.

It looks as if the approved drugs to the ones that are being looked at.

Well, we hope shortly approved drugs.

So in order for us to be a differentiator, we have to be able to take a molecule and put it into duressor can be able to deliver it for that period of time.

And so there's a lot that goes into the evaluation of such a molecule.

Size solubility.

The dose you actually need to achieve the clinical endpoint and so as Nancy indicated this is an area that we are actively looking at.

When we have some positive reduced we will certainly announce it I will add though neural protection, which I touched on briefly is another area that is a bit of a holy Grail for pushed your segment disease and while neuro protection as a mechanism of action is a little less defined I would say then complement inhibitor.

<unk> in geographic atrophy neuro protection opens up a lot of other markets and so that's another area in general where we're looking at molecules that can provide euro protection to the retina or to the ganglion cells in a sustained release delivery system.

Great. Thank you so much for all the details and congratulations on the progress. Thank you.

Thank you one moment please.

Our next question comes from the line of each of HC Wainwright. Your line is open.

And thank you for taking my question.

The.

Patients enrolled into the phase two half year trial for MPD or are these newly diagnosed patients or existing patients who are receiving active treatment or existing patients who are not receiving treatments.

Okay go ahead.

<unk> active treatment would be an exclusion so NPT our patients in general.

Well.

And had minimal symptoms.

PDR is diagnosed in the Doctor's office based on examination of the fund us.

We do know that <unk> is a progressive disease and left unchecked. It will eventually progress and in many cases go onto diabetic macular edema or proliferative diabetic retinopathy. So these patients could be newly diagnosed if they're newly diagnosed it doesn't mean, they just had.

Diabetes for a short period of time in order to get moderate to severe and PDR you really have to have diabetes for a while but they may have just come into the doctor's office for the first time, so and essentially could be newly diagnosed but if they are being actively treated for the complications of the <unk>.

<unk> or PDR, then they wont be eligible for the study.

Okay. So these are moderate to moderately severe to severe <unk> patients.

We usually.

Reject treatment, even after diagnosis by the ophthalmologists correct, Yes, I think.

To say.

I'm not sure they reject it more than most retina specialists still are reluctant to offer it.

So there are two approved drugs.

Asking them to undergo an injection monthly floor.

Symptomatic condition is a big lift and so I don't think it's just patient reluctance I think there is some physician reluctance there too.

Got it got it thank you.

And I.

I don't know if you can provide any color on.

The potential growth trajectory up Utica in 2023 at this point.

Yeah, sorry about that I was on mute.

So I'll, let Scott comment on it, but we don't give forward guidance.

However, we continue to have some.

Very good quarters, and Scott you want to just comment a little bit on our approach we can take sure.

Thinking Nancy.

As Nancy mentioned, we will not provide guidance for the fourth quarter or four.

Future quarters, However, I would say that.

Into the fourth quarter, we're very pleased with the performance of.

The product and what we have seen coming out of the third quarter is that physicians kind of fully back in the office.

Turning to see a lot more patients flowing through and as you can imagine that provides a lot of more opportunities for treatment.

I would say that as I mentioned previously in the in the discussion.

We have been really pleased with the uptake of boutique overall in the marketplace, especially within the retinal segment.

We're seeing a lot of retina physicians a lot of new retina physicians come onboard in terms of utilizing Utica and so we see that as a nice harbinger for the future.

Got it thank you.

Thank you.

One moment please.

Our next question comes from the line of Yale Jen of Laidlaw <unk> Company. Your line is open.

Good morning, and thanks for taking the question.

My first question is that for the <unk> two study.

How many sites currently being wrote and what will be the target of number of sites.

To be a road in this study.

Yeah, we're not going to disclose that.

But suffice it to say it's typical.

So we don't go into that level of detail on our clinical studies.

Okay, no problem and thanks for that.

Just two more quick ones. The first one for the previous study and the readout is the two tier asset level changes.

This endpoint also could be used for the future of pivotal study or are you thinking about something else.

Okay go ahead.

That would be as of now the endpoint for the future pivotal studies.

That is a approvable endpoint.

Both Lucentis and Eylea were approved for <unk> based on that endpoint.

And so that the plan right now would be to use that as the endpoint in the pivotal.

Okay, Great and maybe the last question here is that the.

The assumption for the runway.

Would that in crude very minimum to exit Q revenue.

Our base case.

Sure, Yes, I can answer that thank you for that.

We guided about execute in Q2, we kind of knew that the pass through.

Extension was unlikely and so that's always been the reduction in debt execute revenues has always been part of our cash projection recall that.

Brought in <unk> as a commercial alliance partner.

Back in 2020, so it's been a non core program for us and while I guess, it's been breakeven.

The significant component of our cash generation.

Okay, great. Thanks, a lot and look forward to see the progress. Thank you. Thank you.

Operator, please make sure your phone is on mute. Our next question comes.

From the line of Danielle <unk> of Chardan.

Hey, good morning, guys. Thanks for taking the question.

Just a quick one on.

On a bigger big trend long term can you comment on the on the plans with regard to other anti VEGF indications such as plans for RVO.

Yes go ahead Jay.

Yes, so the next indication, which we plan on pursuing as diabetic macular edema and the current plans, we expect to initiate that study in the second half of next year.

We will probably do RVO at some point, we don't have it built into our models yet.

Again, our view is a much smaller market than the others.

And while we think there probably will be benefit of that.

It's not in our current plan, but we expect as.

We unfold with the pivotal trials.

For wet AMD and in <unk> that will come more into focus.

There's other smaller indications, which we will probably layer on eventually as well like myopic Choroidal Neovascular station, we expect at 19 O. One would do very well in that indication and we're also looking at the possibility of using <unk> hundred one in a hurry.

High risk in other words is that has dry macular degeneration, but has not yet converted to wet macular degeneration.

Using <unk>, one as preventative maintenance therapy to prevent the conversion to wet.

Got it. Thank you that was very helpful.

Thank you.

Our next question one moment please.

Our next question comes from the line of one <unk> of B Riley Your line is open.

Good morning.

Morning.

Thank you for taking my question can.

Can you remind us the market opportunity.

<unk> patients and when you look at the treatment landscape, what do you think could it be the standard of care. Two years. Later, you are planning on initiating a potential phase III trials E&P Dr. Thank you.

Yes, Scott you can answer the <unk>.

Market opportunity and then Jay on the clinical side.

Thank you for the question yes.

Some form of.

Ophthalmology practice or optometrist practice.

Okay.

Interested in.

In pursuing.

And aggressive treatment of MTR by aggressive I mean frequent injections, but again in this patient population, who are generally younger and working it's hard to think in an asymptomatic disease, they're going to want to come in that frequently and subject themselves to the small but finite risk of multiple injections.

Other sustained release products are going to I'm sure look at the NPD market, but this again is a risk benefit kind of thing.

The Ah Refillable Port technology.

I would expect if lucentis is effective it would be as well.

That may not meet the standard of risk versus benefit and again I think some of the other products out there.

Gene therapy is potentially a pathway to have sustained release of any drug too but that remains to be tested. So we think that theres still going to be in two years substantial opportunity for in every nine months or perhaps even once a year intra vitriol in office bio erodible injection.

And that could substantially all through the course for the positive in many patients within PDR.

Yeah.

Thank you that's very helpful.

Thank you.

Im showing no further questions at this time, ladies and gentlemen. This does conclude today's conference. Thank you all for participating you may now disconnect have a great. Thank you Youre welcome. Thank you.

Q3 2022 EyePoint Pharmaceuticals Inc Earnings Call

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