Q1 2022 EyePoint Pharmaceuticals Inc Earnings Call

May 4, 2022

Good morning, my name is Josh and I'll be your conference operator today.

Good morning, My name is Josh and I'll be your conference operator today at this.

At this time, I would like to welcome everyone to the EyePoint Pharmaceuticals first quarter 2022 financial results and recent corporate developments conference call.

There will be a question and answer session to follow at the completion of the prepared remarks.

Please be advised that this call is being recorded at the company's request.

I would now like to turn the call over to George Elston, Chief Financial Officer of EyePoint Pharmaceuticals.

Thank you, Josh.

This time I would like to welcome everyone to the <unk> Pharmaceuticals first quarter 2022 financial results and recent corporate developments conference call. There will be a question and answer session to follow at the completion of the prepared remarks. Please be advised that this call is being recorded at the company's request I would now like to turn the call.

Over to George Ellison, Chief Financial Officer of <unk> Pharmaceuticals.

And thank you all for joining us on today's conference call to discuss EyePoint Pharmaceuticals first quarter 2022 financial results and recent corporate development.

Good morning, my name is Josh and I'll be your conference operator today.

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

At this time, I would like to welcome everyone to the EyePoint Pharmaceuticals first quarter 2022 financial results and recent corporate developments conference call.

With me today are Nancy Lurker, President and Chief Executive Officer.

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

Dr. Jay Duker, Chief Operating Officer, and Scott Jones, Chief Commercial Officer.

Nancy will begin with a review of recent corporate updates.

Nancy will begin with review of recent corporate updates Dr. Duker will then discuss clinical plans for <unk> and Scott will comment on our Q1 2022 commercial performance.

Dr. Duker will then discuss clinical plans for EYP 1901 and Scott will comment on our Q1 2022 commercial performance.

I will close with commentary on first quarter financial results and then we'll 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 development.

I'll close with commentary on first quarter financial results and then we'll 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.

A copy of the release can be found in the Investor Relations tab on the company website www.eyepointpharma.com.

A copy of the release can be found in the Investor Relations tab on the company website Www Dot I point to 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 1995.

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.

These include statements about our future expectations, clinical developments, and regulatory matters and timelines.

These include statements about our future expectations clinical developments and regulatory matters and timelines the potential success of our products and product candidates.

The Potential Success of Our Products and Product Candidates.

Financial Projections, and our Plans and Prospects.

Actual projections and our 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 other filings that we may make with the SEC in the future.

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 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 those forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if our views change.

While we may elect to update those 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.

Therefore, you should not rely on these overlooking 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 EyePoint Pharmaceuticals.

There will be a question and answer session to follow at the completion of the prepared remarks.

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

Please be advised that this call is being recorded at the company's request.

Thank you, George, and apologies for my hoarse voice. I'm still getting over a cold.

I would now like to turn the call over to George Elston, Chief Financial Officer of EyePoint Pharmaceuticals.

Thank you George and apologies for my Hoarse voice and still getting over a cold.

Good morning, and I do want to thank you for joining us to discuss the very solid progress <unk> made in the first quarter of 2022 are.

Our team has maintained a positive momentum we had in 2021 and now into 2022 and the company continues to be well positioned to create long term value for our shareholders, particularly should subsequent clinical trials.

I wanted to point out positively.

Thank you, Josh.

We are keenly focused to execute on our goal of becoming a leader in all care joint delivery.

And thank you all for joining us on today's conference call to discuss EyePoint Pharmaceuticals first quarter 2022 financial results and recent corporate development.

In the first quarter I point presented additional validating clinical results of our ongoing phase one trial for our lead pipeline program <unk> 19, one while simultaneously advancing two strategic corporate initiatives refinancing our debt.

And our just announced enhanced.

Pharmaceutical.

We also made important leadership pilot.

<unk> the company for long term successful growth that encompasses our overarching mission of improving the lives of patients.

On bringing our innovative products.

I think and around the world.

So good morning, and I do want to thank you for joining us to discuss the very solid progress EyePoint made in the first quarter of 2022.

With me today are Nancy Lurker, President and Chief Executive Officer.

Prior to turning the call over to my colleagues I would like to highlight a few of our achievements in <unk>.

Our team has maintained the positive momentum we had in 2021 and now into 2022.

Dr. Jay Duker, Chief Operating Officer, and Scott Jones, Chief Commercial Officer.

Nancy will begin with a review of recent corporate updates.

'twenty two so far.

And the company continues to be well positioned to create long term value for our shareholders, particularly should subsequent clinical trials for EYP 1901 report out positive, We are keenly focused to execute on our goal of becoming the leader in ocular joint delivery.

Dr. Duker will then discuss clinical plans for EYP 1901 and Scott will comment on our Q1 2022 commercial performance.

I'm incredibly pleased with it.

This execution.

Phase one clinical trial for AR.

In the first quarter, EyePoint presented additional validating clinical results of our ongoing phase one trial for our lead pipeline program, EYP-19-01, while simultaneously advancing two strategic corporate initiatives, refinancing our debt and our just-announced enhanced agreement with Data Pharmaceuticals.

New pipeline asset <unk> and wet AMD.

We also made important leadership hires that position the company for long-term successful growth that encompasses our overarching mission of improving the lives of patients with serious eye disorders and bringing our innovative products to patients in the United States and around the world.

As many of you know wet AMD is a serious a potentially devastating disorder accounting for approximately 90% of all.

But despite safe and effective FDA approved medications on the market.

Treatment adherence remains an ongoing challenge.

And physician.

Currently most patients with weddings.

Every month or every other month with <unk> injection.

<unk>, one which is a combination of a small molecule <unk> and our proprietary bio erodible drug delivery technology, there a third.

Prior to turning the call over to my colleagues, I'd like to highlight a few of our achievements in 2022 so far. I'm incredibly pleased with the team's consistent execution of our Phase 1 DAVIO clinical trial for our lead pipeline asset, EYP1901, in WET-CAMD.

Has the potential to transform the currently burdensome treatment paradigm for many.

As many of you know, wet AMD is a serious and potentially devastating eye disorder, accounting for approximately 90%.., of all A&E little A's to learn.

A copy of the release can be found in the Investor Relations tab on the company website www.eyepointpharma.com.

We went from 19, one may be able to provide.

<unk> will benefit.

Longer duration between physician office visits.

And injection of up to six months, while maintaining stable visual acuity and macular anatomy.

But despite these safe and effective FDA-approved medications on the market, treatment adherence remains an ongoing challenge for patients and physicians.

We believe based on our interim phase <unk> clinical trial results that a majority of patients quick homesite remain closed with <unk>.

Currently, most patients with wet AMD are treated every month or every other month with EyeInject.

<unk> hundred one for up to six months with no supplemental therapy. After the initial induction period with traditional anti VEGF drugs.

Under this tree to maintain treatment paradigm you went from 19, one provides a number of potential benefit.

UIP-1901, which is a combination of a small molecule TTI-Virolinib and our proprietary bioavailable drug delivery technology, Duracert, has the potential to transform the currently burdensome treatment paradigm for many wet A&E patients.

The new mechanism of action, we think Roland is an anti VEGF tyrosine kinase inhibitor.

Zero order kinetics delivery that provides consistent stable released the below NAV.

EYP 1901 may be able to provide the substantial benefit of a longer duration between physician office visits and eye injections of up to six months while maintaining stable visual acuity and macular anatomy. We believe, based on our interim Phase 1 WHO clinical trial results, that a majority of patients can potentially be maintained with EYP 1901 for up to six months with no supplemental therapy after an initial induction period with traditional anti-vegetative drugs. Under this treat-to-maintain treatment paradigm, EYP 1901 provides a number of potential benefits.

And the potential ability to sustain a majority of patients up to six months.

A new mechanism of action using Borrelinib, an anti-vegetative tyrosine kinase inhibitor, zero-order kinetics delivery that provides consistent, stable release of Borrelinib, and the potential ability to sustain a majority of patients up to six months while potentially significantly reducing the treatment burden for patients with wet A&E.

While potentially significantly reducing the treatment burden for patients with wet AMD.

As Jay will discuss in more detail later in the call, we continue to be pleased with the ongoing Phase 1 W trial results, which showed positive safety data, with no significant information, as well as promising efficacy data at the six and now eight-month follow-up so far.

As Jay will discuss in more detail later in the call. We continue to be pleased with the ongoing phase one trial with both.

Positive safety data.

With no significant inflammation as well as promising efficacy data at the six.

<unk> eight months follow up so far.

We look forward to announcing our 12-month Phase I WDATA at ASRF in July of this year.

We look forward to announcing our 12 months phase one they'll be looking at ASRM in July of this year.

Looking ahead, we expect to initiate our Phase 2 clinical trial for EYP-1901 in WebAMD in the third quarter of 2022, and we anticipate interim six-month results in the second half of 2023.

These include statements about our future expectations, clinical developments, and regulatory matters and timelines.

Looking ahead, we expect to initiate our phase II clinical trial for <unk> hundred.

<unk> and wet AMD in the third quarter of 2022, and we anticipate interim six month results in the second half of 2023.

I'd like to thank the entire EyePoint team for their tireless work focused on bringing this innovative technology to as many patients as quickly as possible, and we look forward to sharing additional updates this year on EYP 1901's exciting progress.

The Potential Success of Our Products and Product Candidates.

I'd like to thank the entire <unk>.

Tireless work focused on bringing innovative technology with many patients as quickly as possible.

Financial Projections, and our Plans and Prospects.

We look forward to sharing additional updates this year on <unk>.

No one's exciting complex.

In addition to advancing a Phase II clinical trial of EYP1901 for wet AMD, we are preparing to expand this innovative treatment to additional indications with a Phase II study of EYP1901 for nonproliferative diabetic retinopathy, or NPDR, beginning in the second half of this year.

In addition to advancing our phase II clinical trial of <unk> hundred one for wet AMD.

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

While we may elect to update those forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if our views change.

We are preparing to expand this innovative treatment to additional indications with a phase two study of <unk> for non proliferative diabetic retinopathy or PDR beginning in the second half of this year.

Therefore, you should not rely on these overlooking 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 EyePoint Pharmaceuticals.

Thank you, George.

Along with our focus on development of EYP 1901 in the U.S., we continue to consider our options for partnering outside of North America.

And apologies for my hoarse voice. I'm still getting over a cold.

Along with our focus on development of <unk> in the U S. We continue to consider our options for partnering outside of North America.

This quarter, we entered into an agreement to develop and commercialize CYP1901 in China and other selected Asian territories with beta pharmaceuticals.

This quarter, we entered into an agreement to develop and commercialize <unk> in China and other selected Asian territory with beta Pharmaceuticals.

This extension of our current partnership is already contemplated as part of our 2020 agreement with BATA, where we secured Barol and the Bright, a critical component of EYP1901. In addition, we expanded our rights to local delivery of Roland and for all of ophthalmology, including DME.

Extension of our current partnership with already contemplated as part of our 2020 agreement with Peter.

We secured for all in the bright a critical component of what we make.

One.

In addition, we expanded our rights to local delivery of rolled in and for all of ophthalmology, including global.

We look forward to continuing our work with BATA, and we also look to additional partnering opportunities outside of North America at the appropriate time.

So good morning.

We look forward to continuing our work with data and we also look for additional partnering opportunities outside of North America at the appropriate time.

Regarding our commercial products, we had a strong first quarter with $9 million in net product revenues, an increase of 32% from the first quarter of last year, along with strong customer demand for both boutiques and executives. This strong start to 2022 supports our strategy for the commercial business franchise to achieve breakeven status this year.

And I do want to thank you for joining us to discuss the very solid progress EyePoint made in the first quarter of 2022.

Our team has maintained the positive momentum we had in 2021 and now into 2022.

This strong start to 2020 to support the strategy.

Virtual business franchise.

Keep breakeven status this year.

Additionally, we wanted to share an update on our Phase 3 trial of U250, a potential six-month sustained delivery for posterior segment of the eye. The FDA has recently updated the regulatory requirements for ophthalmic drug and device combination products, such as UT.

Additionally, we wanted to share an update on our phase III trial.

A potential six month sustained delivery cost serious segment of the eye.

The SBA has recently updated the regulatory requirement for ophthalmic drug device combination product such as <unk>.

These regulatory changes now require EyePoint.

These regulatory changes that require I point to complete an additional clinical trials.

Please complete an additional clinical trial for E260, beyond what was originally communicated for the planned post-approval NDA supplement, resulting in a significant increase in the program's anticipated cost.

Beyond what was originally.

We indicated the plan post approval in the supplement.

Resulting in a significantly increased pool programs anticipated costs.

As a result, we've made the decision to pause enrollment for this study until we can reassess and determine if there's a path forward. I would like to emphasize that this decision is driven by financial considerations only, and continue to focus our resources on EYP 1901's clinical development.

As a result, we've made the decision to pause enrollment for this study until we can reassess and determine if there's a path forward.

I would like to emphasize that this decision is driven by financial considerations only.

Still believe in our safety boutique.

And its potential clinical utility given the proven track record of boutique one eight.

Despite this as an organization we recognize that we must take a disciplined approach to our pipeline investments will continue to focus our resources on the web two <unk> clinical development.

And the company continues to be well positioned to create long term value for our shareholders, particularly should subsequent clinical trials for EYP 1901 report out positive.

I'd also like to add that we remain committed to serving the posterior segment uveitis patient community with UTEQ180 and learning more about this serious eye disorder to improve patient outcomes through our ongoing UTEQ Palm Registry Study, which is the first and only registry trial for posterior uveitis, and our UTEQ Phase IV Synchronicity Study, which is a prospective open-label, uncontrolled, two-year follow-up study designed to evaluate the safety and efficacy of the UTEQ180 interventional implant for posterior segment uveitis.

I'd also like to add that we remain committed to serving the posterior segment uveitis crucial community we can keep 180.

More about this serious eye disorder to improve patient outcomes through our ongoing to keep calm registry study, which is the first and only registrar registry trial for posterior uveitis and our Youtube page four Synchronicity study, which is a prospective open label uncontrolled two year fall.

Hello up study designed to evaluate the safety and efficacy of <unk> hundred 80, <unk> implant port.

Posterior segment uveitis we.

We plan to update the scientific and patient community on these important studies in the months to come.

As you'll hear from George later on, we remain well capitalized to execute on our pipeline, and we remain focused on EyePoint's financial health and cash runway. This included a debt refinancing in Q1 with Silicon Valley Bank, which provided the company with a significant interest rate improvement, resulting in approximately $2.8 million of annual interest savings.

As Youll hear from George layer on we remain well capitalized to execute on our pipeline and we remain focused on our financial health and cash runway. This included a debt refinancing in Q1 with Silicon Valley Bank, which provided the company with a significant interest rate improvement, resulting in approximately $2 8 million.

Interest savings.

Finally, we made important leadership appointments in the first quarter, building out our growing team with two new industry veterans.

Finally, we made important leadership appointments in the first quarter building out our growing team with two new industry veteran.

Earlier this year, we were very pleased to announce the appointment of Michael C. Pyne as Chief Corporate Development and Strategy Officer. He brings more than 20 years of business development and strategy experience to EyePoint Pharmaceuticals and we are thrilled to have him on board during this exciting time in the company's evolution.

Earlier. This year, we were very pleased to announce the appointment of Michael <unk> as Chief corporate development and strategy Officer.

He brings more than 20 years of business development and strategy experienced <unk> pharmaceuticals.

We are thrilled to have him onboard during this exciting time in the company's evolution.

Recently, EyePoint also appointed Isabelle Lefebvre as Chief Regulatory Officer. Ms. Lozev brings over 30 years of global regulatory affairs experience across all phases of drug development, especially in ophthalmic conditions, and we look forward to receiving her guidance on FDA-related matters and global regulatory strategies.

Recently, <unk> also appointed Isabel <unk>.

Regulatory officer.

<unk> brings over 30 years of global regulatory affairs experience across all phases of drug development, especially in ophthalmic condition, and we look forward to receiving the guidance on SBA related matters from global regulatory strategy.

I'd like to thank the talented EyePoint team for our company's clinical, operational, and financial success to date.

I'd like to thank the talented <unk> team for a company of clinical operational and financial success to date.

As we advance the future of sustained ocular drug delivery, we look forward to executing on multiple near-term clinical catalysts so that we can deliver improved ocular treatment and ultimately create a better future for patients living with serious eye disorder.

We are keenly focused to execute on our goal of becoming the leader in ocular door delivery.

As we advance the future of sustaining ocular delivery, we look forward to executing on multiple near term clinical catalysts. So that we can deliver improved onset of treatment and ultimately create a better future for patients living with 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, EYP 1901, as well as other pipeline initiatives.

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

Yes.

Jay?

Thank you Nancy and good morning, everyone.

Before I begin I want to reiterate what an exciting time. This is our team is poised to execute on multiple clinical catalysts. This year, how should we advanced our pipeline.

Thank you, Nancy.

Prior to turning the call over to my colleagues, I'd like to highlight a few of our achievements in 2022 so far. I'm incredibly pleased with the team's consistent execution of our Phase 1 W-clinical trial for our lead pipeline asset, EYP-1901, in wet CMD.

As Nancy stated earlier, we are quite pleased with the results of our phase <unk> clinical trial for our lead pipeline program <unk> hundred one an investigational sustained release delivery treatment for wet age related macular degeneration being studied as a maintenance therapy following induction therapy with an anti VEGF.

A therapeutic approach, which we refer to as street to maintain.

As many of you know, wet AMD is a serious and potentially devastating eye disorder, accounting for approximately 90%.., of all A&E little a's wine.

The largest unmet need in the wet AMD landscape as longevity of action of anti VEGF.

But despite these safe and effective FDA-approved medications on the market, treatment adherence remains an ongoing challenge for patients and physicians.

Our goal is to sustain the majority of wet AMD patients treatment interval up to six months or longer after a single injection of <unk> 19 to one allowing patients and practitioners to flexibility to safely reduce the number of visits to their retina specialist through controlled and sustained your trip it drilled delivery of an anti VEGF.

Drug.

The recent positive eight months safety data and efficacy results give us increased confidence that <unk> may have a differentiated profile for safety efficacy and tolerability in wet AMD.

And good morning, everyone.

Currently, most patients with wet AMD are treated every month or every other month with EyeInject.

Before we review the data I'd like to touch on Ayp 19, once use of the <unk> delivery technology and its differentiation from alternatives in the retinal drug delivery landscape.

<unk> bio erodible <unk> allows for true sustained release of drug was zero order kinetics. After an initial beneficial burst of medication.

And it is non erodible formulation to Richard has best in class track record of proven safety Tolerability and consistent medication delivery.

Before I begin, I want to reiterate what an exciting time this is as our team is poised to execute on multiple clinical catalysts this year as we advance our pipeline.

<unk> has been safely administered to thousands of patients across four U S. FDA approved products and the safety and efficacy results. We have seen so far with the bio erodible formulation used in the <unk> trial bolster our confidence in this differentiated drug delivery system.

As Nancy stated earlier, we are quite pleased with the results of our Phase I DAVIO clinical trial for our lead pipeline program, EYP 1901, an investigational sustained release delivery treatment for wet age-related macular degeneration being studied as a maintenance therapy following induction therapy with an anti-VEGF. A therapeutic approach which we refer to as Treat to Maintain.

The largest unmet need in the wet AMD landscape is longevity of action of anti-VEGF.

EYP 1901, which is a combination of a small molecule TTI varroa in there, and our proprietary bioavailable drug delivery technology, Duracert, has the potential to transform the currently burdensome treatment paradigm for many wet A&E patients.

You might be 19, one combines the bio erodible formulation as a juror search sustained release technology I, just described with <unk>, a small molecule tyrosine kinase inhibitor.

We're rolling it binds to the VEGF receptors blocking all isoforms of that Jeff as well as PDGF. This is different from the antibody fragment entrapped molecules that are there current antibody jeff's on the market today.

These molecules barring fed Jeff this differentiated anti VEGF mechanism of action, coupled with our bio erodible <unk> as your order kinetics technology could potentially change the treatment paradigm to a much less burdensome approach with VIP 19, one, which we have coined treat to maintain.

Our goal is to sustain the majority of wet AMD patients' treatment interval up to six months or longer after a single injection of EYP-1901, allowing patients and practitioners the flexibility to safely reduce the number of visits to their retina specialist through controlled and sustained intravitreal delivery of an anti-VEGF drug. The recent positive eight-month safety data and efficacy results give us increased confidence that EYP 1901 may have a differentiated profile for safety, efficacy, and tolerability in wet AMD.

Before we review the data, I'd like to touch on EYP 1901's use of the Duracert delivery technology and its differentiation from alternatives in the retinal drug delivery landscape. Bioerodible Duracert allows for true sustained release of drug with zero-order kinetics after an initial beneficial burst of medication.

UYP 1901 may be able to provide the substantial benefit of a longer duration between physician office visits and eye injections of up to six months while maintaining stable visual acuity and macular anatomy.

Turning now to our <unk> study.

In its non-erodible formulation, Duracert has best-in-class track record of proven safety, tolerability, and consistent medication delivery. Duracert has been safely administered to thousands of patients across four U.S. FDA-approved products, and the safety and efficacy results we have seen so far with the bioerodible formulation used in the DAWBIO trial bolster our confidence in this differentiated drug delivery system.

We believe, based on our interim phase one WHO clinical trial results, that a majority of patients could potentially be maintained with EYP 1901 for up to six months with no supplemental therapy after the initial induction period with traditional anti-vegetative drugs. Under this treat-to-maintain treatment paradigm, EYP 1901 provides a number of potential benefits. A new mechanism of action using Borrelinib, an anti-vegetative tyrosine kinase inhibitor, zero-order kinetics delivery that provides consistent, stable release of Borrelinib, and the potential ability to sustain a majority of patients up to six months while potentially significantly reducing the treatment burden for patients with wet A&D.

Davita was the phase one open label dose escalation trial that enrolled 17 patients across four dose cohorts. All enrolled patients were previously treated with standard of care anti VEGF therapy, No Reinjection with study drug was performed during the study and typical criteria for supplemental supplementation with a standard of care.

EYP1901 combines a bio-erodible formulation of the DuraSearch Sustained Release technology I just described with Vorolinib, a small molecule tyrosine kinase inhibitor.

You bet, Jeff was employed.

Virolinib binds to the VEGF receptors, blocking all isoforms of VEGF, as well as PDGF.

We look forward to announcing our 12-month phase one WDATA at ASRF in July of this year.

Following a positive six month data readout in October of last year, we reported positive interim eight months safety and efficacy data of the <unk> trial in February at the edge angiogenesis 2022 virtual meeting.

We're quite pleased with the interim results we have observed so far importantly, we've seen impressive efficacy and durability with over 50% of patients supplemental anti VEGF free up to six months and 41% up to nine months as well as significant reduction in treatment burden for patients.

This is different from the antibody fragmented trap molecules that are the current anti-VEGFs on the market today. These molecules bind VEGF.

This differentiated anti-VEGF mechanism of action, coupled with our biorotable Duracert zero-order kinetics technology, could potentially change the treatment paradigm to a much less burdensome approach with EYP 1901, which we have coined Treat to Maintain.

Returning now to our Daw View study.

99% at six months at 75% at eight months. Additionally.

DAVIO is a phase one open-label dose escalation trial that enrolled 17 patients across four dose cohorts. All enrolled patients were previously treated with standard of care anti-VEGF therapy, no reinjection with the study drug was performed during the study, and typical criteria for supplementation with a standard of care anti-VEGF was employed. Following a positive six-month data readout in October of last year, we reported positive interim eight-month safety and efficacy data of the DAVIO trial in February at the Angiogenesis 2022 virtual meeting.

Additionally, we observed stable visual acuity and central subfield thickness as measured by optical coherence tomography, where the updated eight months data showing change in best corrected visual acuity of minus $3 <unk> letters and central subfield thickness change of plus 13 microns.

We're quite pleased with the interim results we have observed so far. Importantly, we've seen impressive efficacy and durability with over 50% of patients supplemental anti-VEGF-free up to 6 months and 41% up to 9 months, as well as significant reduction in treatment burden for patients, 79% at 6 months and 75% at 8 months. Additionally, we observed stable visual acuity and central subfield thickness as measured by optical coherence tomography, with the updated 8-month data showing change in best corrected visual acuity of minus 3 ETDRS letters and central subfield thickness change of plus 13 microns.

In addition, the eight-month data highlighted positive safety with no ocular serious adverse events and no drug-related systemic SAE. Furthermore, no dose-limiting toxicities, no retinal detachments, no cases of endophthalmitis, no occurrences of implant migration into the interchamber, or any posterior segment ocular inflammation was reported.

In addition, the eight months data highlighted positive safety with no ocular serious adverse events and no drug related systemic sce's. Furthermore, no dose limiting toxicities no retinal detachments no cases of endophthalmitis no occurrences of implant migration into the inter chamber or any post your <unk>.

Segment, ocular inflammation, which reported.

As Nancy mentioned, we plan to initiate a randomized controlled phase 2 study of EYP 1901 for previously treated wet AMD in Q3 2022. The WET-AMD Phase II trial is expected to enroll 144 patients, randomly assigned to one of two doses of EYP1901, approximately 2mg or 3mg, or a flibrosept control. The efficacy endpoints are change in best corrected visual acuity, change in central subfield thickness as measured by OCT, time to supplementation and safety.

As Nancy mentioned, we planned to initiate a randomized controlled phase II study of <unk> thousand 19 of one for previously treated wet AMD in Q3 2022.

Wet AMD phase II trial was expected to enroll 144 patients randomly assigned to one of three doses one of two doses of <unk> might be 91, approximately two milligrams or three milligrams or a flipper sept control.

The efficacy endpoints are change in best corrected visual acuity change in central subfield thickness as measured by OTT time to supplementation and safety.

Looking ahead, we anticipate sharing interim six-month data for this Phase 2 trial in the second half of 2023.

Looking ahead, we expect to initiate our Phase 2 clinical trial for EYP 1901 in WebAMD in the third quarter of 2022, and we anticipate interim six-month results in the second half of 2023.

Looking ahead, we anticipate sharing interim six month data for this phase II trial in the second half of 2023.

We are also working to explore the paradigm-changing treatment potential of EYP 1901 and several other severe eye disorders, including diabetic retinopathy, diabetic macular edema, and retinal vein occlusion. In the second half of this year, we plan to initiate a Phase II trial of EYP1901 in non-proliferative diabetic retinopathy. In addition, we now expect our third Phase II trial employing EYP1901 in serious ocular disease will be for the indication of DME. Diabetic macular edema is the most common site-threatening complication of diabetic retinopathy.

We are also working to explore the paradigm changing treatment potential VIP 19, one and several other severe eye disorders, including diabetic retinopathy, diabetic macular edema and retinal vein occlusion.

In addition to advancing a Phase II clinical trial of EYP1901 for wet AMD, we are preparing to expand this innovative treatment to additional indications, with a Phase II study of EYP1901 for nonproliferative diabetic retinopathy, or NPDR, beginning in the second half of this year.

Along with our focus on development of EYP 1901 in the U.S., we continue to consider our options for partnering outside of North America. This quarter, we entered into an agreement to develop and commercialize CYP1901 in China and other selected Asian territories with Beta Pharmaceutical.

In the second half of this year, we plan to initiate a phase II trial of <unk> 91, and non proliferative diabetic retinopathy. In addition, we now expect our third phase III trial, employing <unk> and serious ocular disease will be for the indication of DMV.

This extension of our current partnership was already contemplated as part of our 2020 agreement with BATA, where we secured Barol and the Bright, a critical component of EYP1901. In addition, we expanded our rights to local delivery of roll in and for all of ophthalmology, including DME.

Diabetic macular edema is the most common sight threatening complication of diabetic retinopathy, we expect to initiate this phase two trial in Q1 of 2023, we will continue to provide clinical updates on these additional indications throughout the year as a rapidly growing pipeline advances I will now turn the call over to Scott Jones Chief <unk>.

We expect to initiate this phase two trial in Q1 of 2023.

We will continue to provide clinical updates on these additional indications throughout the year as our rapidly growing pipeline advances.

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

We look forward to continuing our work with ADA, and we also look to additional partnering opportunities outside of North America at the appropriate time. Regarding our commercial products, we had a strong first quarter with $9 million in net product revenue, an increase of 32% from the first quarter of last year, along with strong customer demand for both boutiques and deck boutiques.

<unk> officer for the commercial update Scott.

Thank you, Jay.

This strong start to 2022 supports our strategy for the commercial business franchise to achieve breakeven status this year.

Thank you Jay we're excited to report a strong quarter for our commercial business with $9 million of net product revenue an increase of 32% from the first quarter of last year. Our Q1 net product revenue for Utica and to execute was $4 6 million and $4 4 million respectively.

We're excited to report a strong quarter for our commercial business with $9 million of net product revenue, an increase of 32% from the first quarter of last year. Our Q1 net product revenue for Utique and Dexacue was $4.6 million and $4.4 million, respectively. Customer demand was approximately 14,800 units of Dexacue and 650 units of Utique, compared to approximately 13,800 units and 650 units, respectively, in Q4 2021.

These regulatory changes now require EyePoint. Complete an Additional Clinical Trial, 3260, beyond what was originally communicated for the planned post-approval NDA supplement, resulting in a significant increase in the program's anticipated cost.

Customer demand was approximately 14800 units of execute and 650 units of Utica compared to approximately 13800 units and 650 units respectively. In Q4 2021 custom.

Customer demand for DEXA-Q saw approximately a 7% growth from Q4 2021.

Customer demand for <unk>, so approximately 7% growth from Q4 2021.

Customer demand for Dexi-Q stemmed from our strong commercial presence and our collaboration with our commercial alliance partner, Infamous RX, who has assumed full responsibility for U.S. sales and marketing activity for Dexi-Q as of January 1, 2022.

Demand for the execution from our strong commercial presence and our collaboration with our commercial alliance partner <unk>, who has assumed full responsibility for U S sales and marketing activity for <unk> as of January one 2022.

EyePoint retains the DexQ NDA, revenue recognition, manufacturing, and distribution responsibilities for all markets.

<unk> retains the <unk> NDA revenue recognition manufacturing and distribution responsibilities for all markets <unk> has been a strong partner and we look forward to continued growth for that franchise.

ImprimisRX has been a strong partner and we look forward to continued growth for that franchise.

Customer demand for UTEQ remains strong due to our ongoing expansion of UTEQ sales efforts into the REFL community for the treatment of posterior segment uveitis and from an approved siliconized needle that provides preferred procedural experience for physicians and patients.

Customer demand for Utica remained strong due to our ongoing expansion of the boutique sales efforts into the rental community.

The treatment approach, you said that you'd be honest and from an improved siliconized needle that provides preferred procedural experience for physicians and patients. Although demand for you take was consistent with Q4 2021, it's important to note that historically.

Although demand for UTIC was consistent with Q4 2021, it's important to note that historically first quarter demand numbers usually turned down due to insurance deductible resets for these patients.

First quarter demand numbers, usually turned down due to insurance deductible resets for these patients.

We are incredibly pleased by the progress we've made with our commercial businesses and with the performance of our commercial teams.

As a result, we've made the decision to pause enrollment for this study until we can reassess and determine if there's a path forward.

We are incredibly pleased with the progress we've made our commercial businesses and with the performance of our commercial teams.

Our mission is to continue to provide a unique, sustained delivery system across all platforms that require fewer visits to the doctor's office, a key attribute for each product's value proposition for both patients and doctors.

Mission is to continue to provide a unique sustained delivery system across all platforms that provide that requires fewer visits to the doctor's office key attribute for each product's value proposition for both patients and doctors.

We look forward to updating you on revenues and demand in the quarters to come.

I would now like to turn the call over to George to review the financials.

I would like to emphasize that this decision is driven by financial considerations only.

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

George?

We still believe in the safety of UT50 and its potential clinical utility, given the proven track record of UT180.

Thank you, Scott.

Despite this, as an organization, we recognize that we must take a disciplined approach to our pipeline investments, and continue to focus our resources on EYP 1901's clinical development.

Thank you Scott as the financial results for the three months ended March 31, 2022 were included in the press release issued this morning. My comments today will focus on a high level review for the quarter.

As the financial results for the three months ended March 31, 2022, were included in the press release issued this morning.

I'd also like to add that we remain committed to serving the posterior segment uveitis patient community with UTEQ-180 and learning more about this serious eye disorder to improve patient outcomes through our ongoing UTEQ Palm Registry Study, which is the first and only registry trial for posterior uveitis, and our UTEQ Phase 4 Synchronicity Study, which is a prospective open-label, uncontrolled two-year follow-up study designed to evaluate the safety and efficacy of the UTEQ-180 interventional implant for posterior segment uveitis.

We plan to update the scientific and patient community on these important studies in the months to come.

My comments today will focus on a high level review for the quarter. To begin, in the first quarter, we continued our balance sheet focus and entered into a new loan agreement with Silicon Valley Bank to replace our existing CRG credit facility with improved economic terms. The new loan agreement with Silicon Valley Bank provides for senior secured credit facilities in the aggregate amount of $45 million and reduces the loan interest rate from 12.5% to a blended rate of approximately 5%, resulting in an estimated $2.8 million in annualized interest savings.

As you'll hear from George later on, we remain well-capitalized to execute on our pipeline, and we remain focused on EyePoint's financial health and cash runway. This included a debt refinancing in Q1 with Silicon Valley Bank, which provided the company with a significant interest rate improvement, resulting in approximately $2.8 million of annual interest savings.

To begin in the first quarter, we continued our balance sheet focus and entered into a new loan agreement with Silicon Valley Bank to replace our existing CRE credit facility with improved economic terms.

New loan agreement with Silicon Valley Bank provides for senior secured credit facilities and the aggregate amount of $45 million.

And reduces the loan interest rate from 12, 5% to a blended rate of approximately 5%, resulting in an estimated $2 8 million in annualized interest savings.

For the first quarter ended March 31, 2022, total net revenue was $9.3 million, compared to $7.3 million in the quarter ended March 31, 2021. This includes net product revenue for the first quarter of $9 million, compared to net product revenue for the first quarter ended March 31, 2021, of $6.8 million, an increase of 32%.

Finally, we made important leadership appointments in the first quarter, building out our growing team with two new industry veterans. Earlier this year, we were very pleased to announce the appointment of Michael C. Pine as Chief Corporate Development and Strategy Officer. He brings more than 20 years of business development and strategy experience to EyePoint Pharmaceuticals and we are thrilled to have him on board during this exciting time in the company's evolution. Recently, EyePoint also appointed Isabelle Lefebvre as Chief Regulatory Officer. Ms. Lozev brings over 30 years of global regulatory affairs experience across all phases of drug development, especially in ophthalmic conditions, and we look forward to receiving her guidance on FDA-related matters and global regulatory strategies.

For the first quarter ended March 31, 2022, total net revenue was $9 3 million compared to $7 3 million in the quarter ended March 31, 2021. This includes net product revenue for the first quarter of $9 million compared to net product revenue for the first quarter ended March 31, 2021 of $6 8 million.

An increase of 32%.

Net revenue from royalties and collaborations for the first quarter ended March 31, 2022, totaled $0.3 million, compared to $0.5 million in the corresponding period in 2021.

Net revenue from royalties and collaborations for the first quarter ended March 31, 2022 totaled $3 million compared to $5 million in the corresponding period in 2001.

Operating expenses for the first quarter ended March 31, 2022, total $27.6 million versus $18.3 million in the prior year period, primarily driven by an increase in R&D spending, including clinical trial costs for EYP 1901 and investment in personnel across the organization, including non-cash stock-based comps, non-operating expense total $2.7 million.

Operating expenses for the first quarter ended March 31, 2022 totaled $27 6 million versus $18 3 million from the prior year period, primarily driven by an increase in R&D spending, including clinical trial costs for <unk> thousand 19, and won an investment in personnel across the organization.

Including noncash stock based comp.

Non operating expense totaled $2 7 million.

And net loss was $21 million, or $0.56 per share, compared to a net loss of $12.3 million, or $0.50 per share, for the prior year period.

And net loss was $21 million or <unk> 56 per share compared to a net loss of $12 3 million or <unk> 50 per share for the prior year period.

Cash and Investments at March 31, 2022 totaled $190.8 million compared to $211.6 million at December 31, 2021.

Cash and investments at March 31, 2022 totaled $190 8 million compared to $211 6 million at December 31, 2021.

We expect the cash and investments on hand. March 31, 2022 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.

We expect the cash and investments on hand.

At March 31, 2022, 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 EyePoint's progress in the first quarter of 22 and are well capitalized to advance our product pipeline to key value inflection points.

I'd like to thank the talented EyePoint team for our company's clinical, operational, and financial success to date.

In conclusion, we are pleased with <unk> progress in the first quarter of 'twenty, two 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.

I'll now turn the call over to Dr. Jay Duker, our Chief Operating Officer, to provide an update on our LEAD program, EYP 1901, as well as other pipeline initiatives.

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

Thank you.

To ask a question you will need to press star one on your telephone to withdraw your question press the pound key.

Jay?

Our first question comes from Joe Giordano with Cowen You May proceed with your question.

Thank you.

Thank you, Nancy.

Hi team. Thank you so much for taking our questions and congratulations on all the progress.

As a reminder, to ask a question, you'll need to press star 1 on your telephone.

So maybe just a few on the island.

Now that you have the full data youll data.

<unk> exited still limited number of patients but has this data to help you better refine the commercial opportunity for 19, no. One would you think would be the most optimal patient for a maintenance product.

Like like that and what percentage of the patient population that these patients.

Present.

And then secondly, given the efficacy we've seen from 19 O on <unk>, what do you see as the main risks to a successful registrational trial, and I guess related to that what would be the most optimal trial design that could maximize your chances of success, while still ensuring you get the durability you have demonstrated so far on the.

Our label.

Wow, that's quite a quite a list.

To withdraw your question, press the pound key.

And good morning, everyone.

Our first question goes from George DiOrdono with Cowan.

Good morning.

You may proceed with your question.

Before I begin, I want to reiterate what an exciting time this is, as our team is poised to execute on multiple clinical catalysts this year, as we advance our pipeline.

Let me see if I can't answer an overview and then I'm going to triage it out to the team here.

Hi, team.

Thank you so much for taking our questions and congratulations on all the progress.

If we Miss some of your questions just reiterate them.

So maybe just a few on our end.

<unk>.

I would say definitely as as the data continues to come in of course, it refines our approach because.

Now that you have the full data, appreciating the fact that it's still a limited number of patients, but has this data helped you better refine the commercial opportunity for 1901?

It informs exact better how long this is working and we remain really pleased with what we're seeing anywhere out nine months on which we've reported on rescue eight months on overall safety and efficacy and we continue just to see really good sustainability of treatment.

Now we're going to continue to keep this.

Designed as a six month treatment, just because we want to be able to capture a majority of patients and we still believe obviously dependent on phase II results that a majority of patients can be treated with <unk> thousand 901, I want to just elaborate a bit on this tweet to maintain approach that we're taking.

Who do you think would be the most optimal patient for a maintenance product like that?

And what percentage of the patient population do these patients represent?

It's important to understand that we're not here to replace current anti VEGF.

They are very effective and say the problem as we all know.

The largest unmet need in the wet AMD landscape is longevity of action of anti-VEGF.

They are not.

Durable and long acting and patients really need, particularly given the fact patient coming in all the time, the doctor's offices to get their eyes injected which is a real burden. So the goal is to be able to go ahead and induce your patients with.

And anti VEGF.

The recent positive eight-month safety data and efficacy results give us increased confidence that EYP1901 may have a differentiated profile for safety, efficacy, and tolerability in wet AMD.

As cleared up as possible and then you can put in <unk> thousand 19 on one maintaining that pace. So treat to maintain four we hope a majority of patients up to six months.

Before we review the data, I'd like to touch on EYP 1901's use of the Duracert delivery technology and its differentiation from alternatives in the retinal drug delivery landscape. The bio-erodible Duracert allows for true, sustained release of drug with zero-order kinetics after an initial beneficial burst of medication.

In its non-erodible formulation, Duracert has best-in-class track record of proven safety, tolerability, and consistent medication delivery. Duracert has been safely administered to thousands of patients across four U.S. FDA-approved products, and the safety and efficacy results we have seen so far with the bioerodible formulation used in the DAVIO trial bolster our confidence in this differentiated drug delivery system.

And then for some patients. So we're maybe particularly are resistant to anti VEGF therapy or they just can't get rid of all the fluid you can supplement as needed with existing therapy. So that is and again because we have two different mechanisms of action on board. There is often a benefit could be.

EYP1901 combines a bio-erodible formulation of the DuraSearch Sustained Release Technology I just described with Vorolinib, a small molecule tyrosine kinase inhibitor.

Virolinib binds to the VEGF receptors, blocking all isoforms of VEGF as well as PDGF.

Caveat, we don't know everything yet to having two different mechanisms of action at work on the AI. So we think theres a lot of benefit for patients.

This is different from the antibody fragmented trap molecules that are the current anti-VEGFs on the market today. These molecules bind VEGF.

Turning now to our Davia study.

We continue to have a group headed up by Scott I'm going to let him comment just a bit we just launched a new group.

Early commercial development and Scott can cap it to begin to more fully understand the commercial opportunity and what we need to do that more appropriately develop that commercial opportunity because it is a new treatment paradigm.

So you need to change some of the current mindset now actually and then we will get back to the regulatory trials in just a moment I'm going to ask Dr. Jay Duker comment and then Scott on the commercial opportunity.

And then secondly, given the efficacy we've seen from 1901 in Davio, what do you see as the main risks to a successful registrational trial?

Thanks, Nancy and I think you've covered things well, probably just add a few more.

Thoughts based on the <unk> results.

And I guess related to that, what would be the most optimal trial design that could maximize your chances of success while still ensuring you get the durability you've demonstrated so far on the label?

Following a positive six-month data readout in October of last year, we reported positive interim eight-month safety and efficacy data of the DAVIO trial in February at the Antigenesis 2022 virtual meeting. We're quite pleased with the interim results we have observed so far. Importantly, we've seen impressive efficacy and durability with over 50% of patients supplemental anti-VEGF-free up to 6 months and 41% up to 9 months, as well as significant reduction in treatment burden for patients, 79% at 6 months and 75% at 8 months.

Additionally, we observed stable visual acuity and central subfield thickness as measured by optical coherence tomography, with the updated 8-month data showing change in best corrected visual acuity of minus 3 ETDRS letters and central subfield thickness change of plus 13 microns. In addition, the eight-month data highlighted positive safety with no ocular serious adverse events and no drug-related systemic disease. Furthermore, no dose-limiting toxicities, no retinal detachments, no cases of endophthalmitis, no occurrences of implant migration into the interchamber, or any posterior segment ocular inflammation was reported.

You asked what percentage of wet AMD patients would benefit from this treatment and the way I would answer that is based strictly on the 17 patients from David one would extrapolate that the market would be at least 85% of wet AMD.

Wow, that's quite a list.

As Nancy mentioned, we plan to initiate a randomized controlled Phase 2 study of EYP19-01 for previously treated wet AMD in Q3 2022. The WET-AMD Phase II trial is expected to enroll 144 patients, randomly assigned to one of two doses of EYP19-01, approximately 2mg or 3mg, or a flibricept control. The efficacy endpoints are change in best corrected visual acuity, change in central subfield thickness as measured by OCT, time to supplementation and safety.

All right.

Let me see if I can't answer an overview and then I'm going to triage it out to the team here.

Looking ahead, we anticipate sharing interim six-month data for this phase two trial in the second half of 2023.

So if we missed some of your questions, just reiterate them.

I would say definitely as as the data continues to come in, of course, it refines our approach because it informs exact better how long this is working.

We expect to initiate this phase two trial in Q1 of 2023.

And we remain really pleased with what we're seeing.

I mean, we're out nine months on, which we've reported, on rescue, eight months on overall safety and efficacy.

We will continue to provide clinical updates on these additional indications throughout the year as our rapidly growing pipeline advances.

Now what I mean by that is there was a clear cut benefit to about 85% of the patients who enrolled in the trial either they didn't require any supplemental anti VEGF or if they did require supplemental anti VEGF. It was at a very reduced rate compared to prior to enrollment.

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

And we continue just to see really good sustainability of treatment.

Thank you, Jay.

Customer demand for DEXA-Q saw approximately a 7% growth from Q4 2021.

Customer demand for Dexi-Q stemmed from our strong commercial presence and our collaboration with our commercial alliance partner, InfamousRx, who has assumed full responsibility for U.S. sales and marketing activity for Dexi-Q as of January 1, 2022.

EyePoint retains the DexQ NDA, Revenue Recognition, Manufacturing, and Distribution responsibilities for all markets.

Now, we're going to continue to keep this designed as a six-month treatment, just because we want to be able to capture a majority of patients. And we still believe, obviously dependent on phase two results, that a majority of patients can be treated with EYP-1901. I want to just elaborate a bit on this treat to maintain approach that we're taking.

InfraMistRx has been a strong partner and we look forward to continued growth for that franchise.

Customer demand for UTEQ remains strong due to our ongoing expansion of UTEQ sales efforts into the rehabil community for the treatment of posterior segment uveitis and from an improved siliconized needle that provides preferred procedural experience for physicians and patients.

It's important to understand that we're not here to replace current anti-VEGFs. They are very effective and safe.

Although demand for Utica was consistent with Q4 2021, it's important to note that historically, first quarter demand numbers usually turned down due to insurance deductible resets for these patients.

Now.

I think we can speculate in more of a broad spectrum of wet AMD patients not to spectrum, we enrolled into aveo that the benefit might be greater than that but again thats speculation. That's why we're doing a phase II trial to see.

The problem, as we all know, is they're not as durable and long-acting as patients really need, particularly given the fact patients have to keep coming in all the time to doctor's offices to get their eyes injected, which is a real burden.

We are incredibly pleased by the progress we've made with our commercial businesses and with the performance of our commercial teams.

Our mission is to continue to provide a unique, sustained delivery system across all platforms that requires fewer visits to the doctor's office, a key attribute for each product's value proposition for both patients and doctors.

So, the goal is to be able to first go ahead and induce your patients with an anti-VEGF, get the eye as cleared up as possible, and then you can put in EYP-1901.

In a broader population of wet AMD patients and what we enrolled in <unk>, how what percentage is.

Maintain that patient, so treat to maintain for, we hope, a majority of patients up to six months, and then for some patients, though, who may be particularly resistant to anti-VEGF therapy or they just can't get rid of all the fluid, you can supplement as needed with existing therapy.

So, that is, and again, because we have two different mechanisms of action on board, there is often a benefit, could be, I want to put caveats, we don't know everything yet, to having two different mechanisms of action at work on the eye.

Good benefit.

We are.

Optimistic that that benefit will be a majority of patients.

A major risks of major risks of of any trial or safety and efficacy at a very high level. The good news is with any called <unk>, We really had no safety issues.

Of course, that's a small number.

We're confident though that safety will probably not bubbled up to be a problem and the confidence stems from the experience with duracell and tens of thousands of patients number one and the safety of <unk>, both preclinical and so far.

In patients.

I have to say that in our preclinical studies, we haven't been able to find the maximally tolerated dose in animals for <unk> hundred one and I think that would be a safe thing to say and equals 17 from the phase one that we didn't find an MTBE in humans, either so so far it looks safe again anything can happen.

You expand these trials.

So, we think there's a lot of benefits for patients.

From an efficacy perspective.

The risks.

Number one thing we're trying to hit here is non inferior visual acuity compared to eylea.

We continue to have a group headed up by Scott, and I'm going to let him comment just a bit.

And it's that's the primary endpoint.

And looking at the <unk> trial, and again trying to extrapolate over six months.

We're optimistic that that's a value that we will be able to statistically meat, but obviously, that's the big risk as well that in this population or with whom you enroll that you won't be able to achieve that but.

Certainly extrapolation would suggest that we have a very good chance.

Last question was around trial design and once again the trial designed as an iterative process.

We get more data.

And the data suggests that a trial should be designed in a specific way. That's the way. We go now are wet AMD phase II <unk> trial is.

Really on target to start in the third quarter of this year. The protocol is set in that protocol and inclusion exclusion criteria was largely influenced by the patients that we saw who did well in <unk> one.

And those who didn't and I think those inclusion exclusion criteria.

We will reflect that.

We look forward to updating you on revenues and demand in the quarters to come.

So I hope, we covered everything and I think if theres any commercial comments, perhaps Scott can can weigh in.

Scott go ahead sure.

Thank you for the question.

We just launched a new group, for Early Commercial Development. And Scott and his team's task is to begin to more fully understand the commercial opportunity and what we need to do to more appropriately develop that commercial opportunity, because it is a new treatment paradigm.

As Jay said I think we're still examining the exact percent patients, but certainly a large percent of the currently treated patients that we believe will be key.

Correct.

Our own potential therapy.

So you need to change some of the current mindset.

Just to take a step back to think about why there is such a need for this in the marketplace.

I'm now actually, and then we'll get back to the regulatory trials in just a moment.

As you know that's <unk>, it's very.

I'm going to ask Dr. Jay Duker to comment, and then Scott on the commercial opportunity.

Very large market, but if you think about what's going to occur in the next several years, we have an aging population. We have an expansion of the number of patients with diabetes. We currently have very undertreated diabetic retinopathy market and the number of retinal specialists isn't expanding appreciably to be able to meet those needs. So the demand for more.

Yeah, thanks, Nancy.

Durable therapy, we think.

We're just meeting a need that is growing every day. So we certainly think there is just an enormous opportunity for us to be able to bring a durable therapy to the marketplace.

Again as Joe said.

Currently evaluating which patients we believe will be most appropriate as we move for them.

Certainly we will have more information to come in the coming years.

And I think you covered things.

Hopefully this app should all questions.

Incredibly comprehensive thank you so much really appreciate it and congratulations again.

Thank you.

Well, I probably just add a few more thoughts based on the Davio result.

I would now like to turn the call over to George to review the financials.

Thank you. Our next question comes from Yadkin scenario with Guggenheim You May proceed with your question.

George?

Hey, guys. Congrats on the results just a couple from me first is on the on the.

Iori, you asked, you know, what percentage of what AMD patients would benefit from this treatment?

And the way I would answer that is based strictly on this 17 patients from Davio, one would extrapolate that the market would be at least 85% of what AMD.

91 <unk>.

Now what I mean by that is there is a clear-cut benefit to about 85% of the patients who enrolled in the trial. Either they didn't require any supplemental anti-VEGF or if they did require supplemental anti-VEGF, it was at a very reduced rate compared to prior to enrollment.

<unk> two study.

I think one of the confusion out there is that I think we and the investor community is used to thinking about eylea or <unk> injection as a comparison.

Now, I think we can speculate in more of a broad spectrum of what AMD patients, not the spectrum we enrolled in Davio, that the benefit might be greater than that.

So just help us understand what is the right come to us it seems like port delivery study that was run by the.

The centers might be right to think about how you are conducting the phase III study.

Can you maybe comment on that is that the right way to look at it and then obviously the study is going to start in Q3 can you talk about how long it might take for you to report interim data.

Any any ballpark you could give on the enrollment and data readout time frame that would be very helpful. Thanks.

Sure no problem on that Jay why don't you take those questions.

Sure.

So <unk> thanks.

Thanks for the questions and as usual very insightful.

The first is a comparison of our trial and I would say at a high level.

The <unk>.

Primary endpoint of non inferior visual acuity is what has been used in all the recent wet AMD trials. Once you have a standard of care.

And the standard of care was Lucentis initially.

That was what the comparison needed to be and Thats, how the trials were designed.

Non inferior margins were determined by the prior studies by the size of your study and the statistics involved so at a very high level. One could look at any of the recent studies that were non inferior visual acuity. However, as you point out we're looking at a different patient population the only previous trial that look.

At.

A non naive patient population for maintenance therapy was the port delivery system. So in some ways the port delivery system trials would.

B in some ways comparable to the patient population that were enrolling however, their control group was monthly Lucentis in our control group is monthly I lead times, three and then Eylea every other month after that so we have a bit of a different control group as well.

With the different treatment interval and I'd also like to point out that given that eylea will be dosed. After the first three months as every other month theres the potential for anti VEGF supplemental in our <unk>.

Control group, which I believe is a bit unique for any of these studies.

So while there are comparisons to many of the previous wet AMD trials.

Given the patient population the longevity of action of our drug.

As a rescue criteria. They are also going to be some differentiation.

Thank you, Scott.

But at a very high level, what we're trying to do is inherently different than what some of our previous anti VEGF of.

As the financial results for the three months ended March 31, 2022, were included in the press release issued this morning.

For the first quarter ended March 31st, 2022, total net revenue was $9.3 million, compared to $7.3 million in the quarter ended March 31st, 2021. This includes net product revenue for the first quarter of $9 million, compared to net product revenue for the first quarter ended March 31st, 2021, of $6.8 million, an increase of 32%.

Net revenue from royalties and collaborations for the first quarter ended March 31, 2022, totaled $0.3 million compared to $0.5 million in the corresponding period in 2021.

But again, that's speculation.

We expect the cash and investments on hand. March 31, 2022 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 EyePoint's progress in the first quarter of 2022 and are well capitalized to advance our product pipeline to key value inflection points.

And net loss was $21 million, or $0.56 per share, compared to a net loss of $12.3 million, or $0.50 per share, for the prior year period.

Cash and Investments at March 31, 2022 totaled $190.8 million compared to $211.6 million at December 31, 2021.

Molecules have been trying to do which is again as Nancy pointed out at the beginning we're not necessarily replacing.

<unk> or <unk>.

We are working to maintain the gains that those drugs give patients initially over the long term because were sustained release, which helps to account for.

Patients, who can't make it back for visits or extended intervals that had been extended beyond perhaps what might be safe because we know when the real world patients with these branded drugs.

Still over the year.

Year or two into the into their disease loose loose much of the visual gain that they had so there is a definite unmet need out there for continuous treatment and thats, what we aim to provide.

That's why we're doing a phase two trial to see in a broader population of what AMD patients than what we enrolled in Davio, what percentage is going to benefit.

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

Yes, let me just also add onto your last question, which was we expect that we will report out.

And we're optimistic that that benefit will be a majority of patients, at major risks, you know, major risks of of any trial or safety efficacy at a very high level.

Two wet AMD result.

In the second half of 2023. So we are on track with its of course timing of all the patient to be enrolled.

It's still a variable, but we're pulling out all stops to enroll as quickly as possible and as we stated earlier, we are on track for third quarter. This year to enroll our first patient.

Got it and just one more question if I may with regard to the update on the <unk> that you are pausing.

What exactly can you just provide a little bit more detail on what exactly the FDA asked us to.

That.

Maybe driving the cost of this program.

Thank you.

Yes, good question.

As a reminder, to ask a question, you will need to press star 1 on your telephone.

To withdraw your question, press the pound key.

Again, some people may know, but others may not.

CA.

Our first question comes from Georgie Ordimo with Calum.

<unk> issued new guidance related to drug device combination.

This new guidance was as a result of a.

You may proceed with your question.

Hi, team.

Lawsuit that was filed by another company against the FDA on their particular product and it's called the gene is decision that was handed down by an Apple at court as a result, the FDA issued new guidance.

And as a result of that.

For some products.

Dave one more studies to be done and Thats the case with <unk>. So instead of one study are requiring now two studies.

Don't see any impact right now on 19, one because we already are anticipating that we will be doing multiple phase III pivotal study. So we don't see any impact.

<unk>.

We recognized one unfortunately, we had claims but one study <unk> five.

And the guidance is now that we have to do two studies. So as you can imagine we take as a.

<unk> is a nice steady consistent product growing very nicely in revenues, but it's never going to be a huge drug as I've often said.

Going to deliver some nice profit to the bottom line over an extended period of time, because we don't have to put a lot of money into however.

These are not large.

So as a result, the cost of doing another.

Phase III study or do you think <unk> may become problematic for us to see the ROI on each silo.

Got it so basically more of an auto Iot NPV decision.

It seems like two studies.

But given that for $90. One you will be required to do multiple studies till they can approve should not have any future alright, yes.

Yes, exactly and again, let me just reiterate this is strictly a financial the state here in Uniti fiber has nothing to do with peak nothing to do with what we believe the benefit of a six month steroid delivery is.

For uveitis.

However, again.

This is not a large category so it's an orphan disease and.

Always said, it probably <unk> will probably hit Mac.

Maximum revenues that $80 million to $100 million overtime.

You take 50 is a subcategory of that so when you do the ROI, it's just very hard to do that with two.

Pivotal phase III studies, but again, we see no impact on 19 Juan.

Alright, thank you so much.

Thank you. Our next question comes from Jennifer <unk> with Cantor Fitzgerald. Please go ahead.

Thank you so much for taking our questions and congratulations on all the progress.

Okay.

Hey, everyone. Congrats on all the good work this quarter and Nancy I wish you a fast recovery from your color. Thank you. Thank you.

Yes, I have a few.

Few questions here, maybe to start off I think you mentioned that you are going to present 12 month data Srs given the six months is the fleets about like you said what kind of additional takeaways are you hoping to see in that 12 month data.

So maybe just a few on our end.

Now that you have the full data, appreciating the fact that it's still a limited number of patients, but has this data helped you better refine the commercial opportunity for 1901?

Yeah. That's a great question, Jay why don't you take that yes, so I'll start by saying first of all again the phase one trial.

The good news is in with n equals 17, we really had no safety issues.

Who do you think would be the most optimal patient for a maintenance product like that?

And what percentage of the patient population do these patients represent?

Is primarily safety.

Of course, that's a small number.

And then secondly, given the efficacy we've seen from 1901 in Davio, what do you see as the main risks to a successful registrational trial?

So we want to make sure that there is no longer term safety issues not that we expect any.

We're confident, though, that safety will probably not bubble up to be a problem. And the confidence stems from the experience with DuraCert and tens of thousands of patients, number one, in the safety of varolinib, both preclinical and so far in in in patients.

Certainly if you have a problem thats injection related you'd expect it early in the study.

Wow, that's quite a list.

If you have a problem that dose related once again because.

Good morning, Yorgi.

Let me see if I can't answer an overview and then I'm going to triage it out to the team here.

So if we missed some of your questions, just reiterate them.

I would say definitely as as the data continues to come in, of course, it refines our approach because it informs exact better how long this is working.

And we remain really pleased with what we're seeing.

Because of the burst of <unk> that we get in the first few weeks, we would've expected that early in the study we didn't see either of those so while we wouldn't anticipate any new safety issues in the last three months of the study.

We want to make sure that none exists that's number one number two is we didnt Reinjection 19 O. One during this study and so.

You know, I have to say that that in our preclinical studies, we haven't been able to find a maximally tolerated dose in animals for UIP 1901. And I think that would be a safe thing to say n equals 17 from the phase one that we didn't find an MTD in humans either.

Just on the preclinical and animal and in vitro data, we would expect the implants to release in humans for approximately nine months. So.

I mean, we're out nine months on, which we've reported on rescue, eight months on overall safety and efficacy.

And we continue just to see really good sustainability of treatment.

So we would expect in some patients to get that longevity of action that we saw with 41% supplemental anti VEGF free up to nine months.

But as the implants run out we would expect.

Activation of the disease and need for supplementation, although not necessarily immediately.

Remember when you're given eylea or lucentis shot that drug might be out of the <unk> in weeks, but some patients can go two or even three months between injections and so we would expect to see somewhat of the same.

As the as the drugs run out so while from a safety perspective, we would.

So so far, it looks safe.

Now, we're going to continue to keep this designed as a six-month treatment, just because we want to be able to capture a majority of patients. And we still believe, obviously dependent on phase two results, that a majority of patients can be treated with EYP 1901. I want to just elaborate a bit on this treat-to-maintain approach that we're taking.

Very happy to see minimal if any safety issues really in the first few months, we want to confirm that through the year.

And with respect to efficacy.

Again, what we have.

As we've said and as I think you know, we really anticipating going for a label of every six months in the pivotal trials.

So.

One could argue that the.

The efficacy data beyond six months may not be useful except I will again remind you that retina specialists are happy to allow patients to go longer than the label if they deem it safe. So while we may have a label of six months in some patients was 41% in <unk>, we were able to go eight and up to nine months without supply.

And so that data is important to clinicians so even though they might be able to re injected six months in certain patients. They may choose to extend that a little bit longer.

Okay, Great and maybe another question on your license agreement with beta.

Is there any color you can give on the exact terms of that deal.

On a related note with your amended agreement with equinox.

I guess is the biggest takeaway there that you are now able to plan that phase II trial in DMD.

And are you are you still planning to look into the RVO opportunity are as <unk> sort of taken the priority over that.

Again, anything can happen as you expand these trials.

It's important to understand that we're not here to replace current anti-VEGFs. They are very effective and safe.

Yeah, Let me answer that so as for beta we're very pleased to have the extension of our partnership with them. As you may recall, we struck that agreement in 2020, we in licensed <unk> and it was always anticipated.

And that was part of the original agreement is that they would have the ability to negotiate for rights to China that was all anticipated as well as part of the payment and.

The milestones that we owe them.

In exchange of course that was some reduced payments in exchange for them gaining rights to 19 O. One so we won't go into the details of that but suffice it to say it.

It gives them now the formal rights to $19 one in China.

And of course, there is your typical royalties and milestones that they will pay us for that as well.

In addition.

From an efficacy perspective, from, you know, the risks, number one thing we're trying to hit here is non-inferior visual acuity compared to ILEA.

Back to <unk>, yes. It now gives us rights to all of ophthalmology indications delivered locally with rolling it around the world outside of China and.

And that's the primary endpoint.

We are now going to prioritize in Cape May have mentioned I believe in him his comment that DNA will now be done first.

And looking at the DAVIO trial, and again, trying to extrapolate over six months, we're optimistic that that's a value that we'll be able to statistically meet.

Obviously, that's the big risk as well, that in this population or with whom you enroll, that you won't be able to achieve that.

Before retinal vein occlusion or will be wet AMD, and then and then non pro.

But certainly extrapolation would suggest that we have a very good chance.

The diabetic retinopathy.

Now it will be <unk> as a third study.

Study that we'll initiate we certainly would.

Our last question was around trial design. And once again, the trial design is an iterative process. When we get more data, and the data suggests that a trial should be designed in a specific way, that's the way we go.

Think about RVO.

We have to be careful obviously of our capital management the timing of RVO is yet to be determined but we do expect that we should be able to initiate a global trial sometime early next year.

Now, our WET-AMD Phase 2 W02 trial is, you know, really on target to start in the third quarter of this year, the protocol is set. And that protocol and inclusion exclusion criteria was largely influenced by the patients that we saw who did well in W01, and those who didn't. And I think those inclusion exclusion criteria will reflect that.

So I hope we covered everything, and I think if there's any commercial comments, perhaps Scott can weigh in.

Scott, go ahead.

Okay great.

Sure, thank you for the question.

Yes, yes, that's perfect. One last quick question just on <unk> is there anything I know.

Sort of a small single trial, but is there anything that we should think about in terms of modeling costs now that the.

Trial, that's been put on hold.

Sure why don't you answer that.

And as Jay said, I think we're still examining the exact percent of patients, but certainly a large percent of the currently treated patients we believe will be correct for our potential therapy.

Yes, I think.

Certainly the near term benefit as we're probably going to reduce that spend over the next 12 months to 18 months, we will probably pick up $4 million to $5 million in anticipated spending that we won't spend so that does certainly help our.

But just to take a step back, to think about why there is such a need for this in the marketplace.

Cash runway in the near term.

You know, as you know, it's current, AMD, DME, DR, it's a very large market, but if you think about what's going to occur in the next several years, you know, we have an aging population, we have an expansion of the number of patients with diabetes, we currently have, you know, a very undertreated diabetic retinopathy market, and the number of retinal specials isn't expanding appreciably to be able to meet those needs.

And but.

Even though our cash guidance is unchanged from last quarter, which is into second half of 'twenty four.

That also assumes that we're starting.

So the demand for a more durable therapy, we think we're just meeting a need that is growing every day.

The phase II <unk> in the first quarter of next year. So it's a cash pick up near term.

Which is good news in this environment.

And Nancy.

One more thing about it which is there some.

It might be minor indirect benefits, which is the clinical team. Although these two studies weren't large studies they were still studies, we needed to track.

And therefore, they can focus more on that you might be 91 studies and as well as the manufacturing group.

Yes, yes.

Good point.

Great very helpful. Thanks, guys.

Thank you. Our next question comes from Yale Jen with Laidlaw <unk> Company. You May proceed with your question.

So we certainly think there is just an enormous opportunity for us to be able to bring a durable therapy to the marketplace.

Good morning, Thanks for taking the questions and add my congrats portfolio progress maybe.

But again, as Jay said, you know, we're currently evaluating which patients we believe will be the most appropriate as we move forward, and I'm certain that we'll have more information to come in the coming years.

Maybe just as a follow up from.

The previous one just in terms of the reason Doug.

You guys placed at <unk> ahead of the.

Retinal vein.

<unk> was that the economic or market assessment or other reason.

Curious Paul.

Hello.

Yes.

<unk> is a much much larger market with a higher unmet need.

RVO still had been that need but the EMEA.

<unk> larger market than then RVO. So when you look at where to put the capital. Obviously you have to look at where you can have the most impact for patients the broadest number of patients as well.

On a return basis so.

It was a pretty easy decision to make that prioritize DNA over RVO.

Hopefully we captured all the questions, Jorge.

Okay, Great. That's very helpful. And then two quick ones. The first one is that in terms of you guys going to started those phase II study later this year and next year with the manufacturer aspects of that.

Already been done or is still in progress to prepare for the stock.

Get into the trial.

Now our products all ready to go for the trials.

Okay, Great and maybe the last question here is a housekeeping one.

For this quarter you have extinguishment of debt is that a one time event or that will continue for the remaining of the year.

Sure I'll take that.

So.

What that is it's a noncash it's an unamortized discount.

That was associated with the <unk> loan and with the refinancing with just the noncash accounting.

Accounting entry so it was a one time and won't repeat.

Okay, great well, thanks, Larry appreciate it and congrats photo harvest.

Thank you. Thank you.

Thank you and as a reminder to ask a question you will need to press star one on your telephone. Our next question comes from <unk> Chen with H C. Wainwright you May proceed with your question.

Thank you for taking my questions.

First question just to clarify.

With respect to the new FDA regulations for a combination drug device.

Why does it apply to.

To the non erodible give us a technology as well as the Robo technology.

Yes, let me just reiterate a couple of things, yes, and by the way let me just reiterate it applies to a number of ophthalmology and even non ophthalmology products. This is not.

<unk> two.

Ophthalmology or even our product it's a drug device combination. So regulations. So anytime that you have a drug combined with a device and the destination of the device is quite broad I might add.

The FDA is now.

Have to require more data.

But I want to again reiterate the way that the.

Regulation based on the ruling.

<unk> came out is that it doesn't add anything more to <unk>.

Tier one deal because 19, when it's delivered in a injector and obviously, it's also in an implant.

Qualifies under these regulations, but we always anticipated doing all the work that is being promulgated the difference was in this particular case, we can supply both they need more then.

Just one study because we take FIFO wise.

Had not previously been on the market and we did not have a clinical study around it. So they need two clinical study, which as I said, we always anticipated with multiple indications and 19, one regardless.

Got it thank you and just to confirm there is.

There is no upfront payment for the better pharmaceutical license.

Yeah.

That is correct.

Okay last question for the upcoming MPD, our phase II trial in the <unk>.

Half of the year.

Or will it be will it be the drug used.

True group.

Yes, Jay why don't you answer that.

At this point.

The control group will consist of a sham <unk> 19, one injection. So there will be no active control.

Okay.

Do you think it will be necessary.

So at the point in the future too.

The drug against an active control.

Okay.

We really can't speculate on that at the current time, we believe from a regulatory perspective as of now thats not necessary.

But that could change in the future, but our current belief in discussing this with regulatory advisors is that.

A sham non active control is still permissible.

And that's because while there are two FDA approved products in this space.

For Dr. The usage of the Ms. So minimal.

Okay got it thank you.

Thank you and I'm showing no further questions in the queue at this time, ladies and gentlemen, thank you for participating in today's conference. This does conclude your program and you may now disconnect.

And have a great day.

Thank you everyone.

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Incredibly comprehensive.

Good morning, My name is Josh and I'll be your conference operator today at this time I would like to welcome everyone to the eye point Pharmaceuticals first quarter 2022 financial results and recent corporate developments conference call. There will be a question and answer session to follow at the completion of.

The prepared remarks, please be advised that this call is being recorded at the company's request I would now like to turn the call over to George Ellison, Chief Financial Officer of Iphones Pharmaceuticals.

Okay.

Thank you so much.

So, the goal is to be able to first go ahead and induce your patients with an anti-VEGF, get the eye as cleared up as possible, and then you can put in EYP 1901.

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

We really appreciate it.

Maintain that patient, so treat-to-maintain for, we hope, a majority of patients up to six months, and then for some patients, though, who may be particularly resistant to anti-VEGF therapy or they just can't get rid of all the fluid, you can supplement as needed with existing therapy.

And congratulations again on all.

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

Thank you.

So, we think there's a lot of benefits for patients.

Nancy will begin with review of recent corporate updates Dr. <unk> will then discuss clinical plans for <unk> and Scott will comment on our Q1 2022 commercial performance.

We continue to have a group headed up by Scott, and I'm going to let him comment just a bit.

I'll close with commentary on first quarter financial results and then we'll 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 a copy of the release can be found in the Investor Relations tab on the company website Www Dot <unk> pharma on Dot com.

We just launched a new group, for Early Commercial Development, and Scott and his team's task is to begin to more fully understand the commercial opportunity and what we need to do to more appropriately develop that commercial opportunity, because it is a new treatment paradigm.

So you need to change some of the current mindset.

These include statements about our future expectations clinical developments and regulatory matters and timelines the.

I'm now actually, and then we'll get back to the regulatory trials in just a moment.

Potential success of our products and product candidates financial projections, and our plans and prospects.

Any forward looking statements represent our views as of today only while we may elect to update those 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.

Thank you.

I'm going to ask Dr. Jay Duke for the comment, and then Scott on the commercial opportunity.

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

Our next question comes from Yatin Suneja with Guggenheim.

Yeah, thanks, Nancy.

You may proceed with your question.

And I think you covered things.

Thank you George and apologies for my Hoarse voice I'm still getting over a cold.

Hey guys, congrats on the results, just a couple from me.

Well, I probably just add a few more thoughts based on the Davio results.

Good morning, all I do want to thank you for joining us to discuss the very solid progress <unk> made in the first quarter of 2022.

Our team has maintained a positive momentum we had in 2021 and now into 2022 and the company continued to be well positioned to create long term value for our shareholders, particularly subsequent clinical trials.

I wanted to point out positively.

We are keenly focused to execute on our goal of becoming a leader in all character with delivery in.

First is on the 1901, face to study.

Iori, you asked, you know, what percentage of what AMD patients would benefit from this treatment?

In the first quarter I point presented additional validated clinical result.

Our ongoing phase one trial for our lead pipeline program <unk> 19, one while simultaneously advancing two strategic corporate initiatives refinancing our debt.

We are just now.

It's critical.

Also made important leadership hiring and.

Positioning the company for long term successful growth that encompasses our overarching mission of improving the lives of patients with serious eye disorder, and bringing our innovative products.

And around the world.

Just I think one of the confusion out there is that I think we and investor community is used to thinking about idea or other injection as a comparison.

And the way I would answer that is based strictly on this 17 patients from Davio, one would extrapolate that the market would be at least 85% of what AMD.

Prior to turning the call over to my colleagues I'd like to highlight a few of our achievements in 2022, so far.

So just help us understand what is the right comp to us.

Now what I mean by that is there is a clear-cut benefit to about 85% of the patients who enrolled in the trial. Either they didn't require any supplemental anti-VEGF, or if they did require supplemental anti-VEGF, it was at a very reduced rate compared to prior to enrollment.

Credibly.

Consistent execution.

Phase one clinical trial for our lead pipeline asset.

It seems like port delivery study that was run by run with Los Santos might be the right comp to think about how you are conducting the face to study.

One <unk>.

Can you maybe comment on that?

Now, I think we can speculate in more of a broad spectrum of what AMD patients, not the spectrum we enrolled in Davio, that the benefit might be greater than that.

As many of you know wet AMD is a serious a potentially devastating disorder.

Is that the right way to look at it?

Approximately 90% of all blindness, despite safe and effective FDA approved medications on the market treatment adherence remains an ongoing challenge.

But again, that's speculation.

Painful configuration.

Currently most patients with wet AMD.

Every month or every other month with eye injection.

That's why we're doing a phase two trial to see in a broader population of what AMD patients than what we enrolled in Davio, what percentage is going to benefit.

<unk> hundred 91, which is a combination of a small molecule <unk> in there and our proprietary bio erodible drug delivery technology, there a third.

As potential.

Transformed the currently burdensome treatment paradigm for many wet.

1019, one may be able to provide.

The initial benefit of a longer duration.

Sure.

And injection.

Six months, while maintaining stable visual acuity.

And we're optimistic that that benefit will be a majority of patients, at major risks, you know, major risks of of any trial or safety efficacy at a very high level.

Anatomy.

We believe based on our interim phase <unk> clinical trial results.

A majority of patients.

Homesite remain closed.

One for up to six months.

No supplemental therapy after the initial induction period with traditional anti VEGF drugs.

Under this tree to main coal treatment paradigm.

<unk> provides a number of potential benefit.

The new mechanism of action you can grow in an anti VEGF tyrosine kinase inhibitor.

In Europe order kinetics delivery that provides consistent stable relates to go ahead.

And the potential ability to sustain a majority of patients up to six months.

Potentially.

And the treatment burden for patients with wet AMD.

The good news is in with n equals 17, we really had no safety issues.

As Jay will discuss in more detail later in the call. We continue to be pleased with the ongoing phase one trial with <unk>.

Positive safety data.

With no significant inflammation.

One promising efficacy data at the book and now eight months follow up so far.

Of course, that's a small number.

We look forward to announcing our 12 month phase one there'll be other data at ASRM in July of this year.

And then obviously the study is going to start in Q3.

Looking ahead, we expect to initiate a phase II clinical trial for <unk>.

One in wet AMD in the third quarter of 2022.

We anticipate full term six months of adults in the second half of 2023 I'd.

Can you talk about how long it might take for you to report the interim data?

I'd like to thank the entire <unk>.

Wireless work focused on bringing innovative technology with many cases quickly as possible and we look forward to sharing additional updates this year on <unk>.

No one's exciting progress.

Any ballpark you could give on the enrollment and data readout time frame that we have.

In addition to advancing our phase II clinical trial.

Sure, no problem on that.

No one for wet AMD, we are preparing to expand this innovative treatment to additional indications with <unk>.

Jay, why don't you take those questions?

<unk> study of <unk> in non proliferative diabetic retinopathy or Dr. <unk>.

Sure.

Turning in the second half of this year.

So, Yatin, thanks for the questions, and as usual, very insightful.

Along with our focus on development of <unk> in the U S. We continue to consider our options are partnering outside of North America.

The first is a comparison of our trial, and I would say at a high level, the primary endpoint of non-inferior visual acuity is what has been used in all the recent WET-AMD trials.

Once you have a standard of care, and the standard of care was Lucentis initially, that was what the comparison needed to be, and that's how the trials were designed.

This quarter, we entered into an agreement to develop and commercialize <unk>.

Non-inferior margins were determined by the prior studies, by the size of your study, and the statistics involved.

In China, and other selected Asian territory with beta Pharmaceuticals.

So, at a very high level, one could look at any of the recent studies that were non-inferior visual acuity.

Some of our current partnership with already contemplated as part of our 2020 agreement with Peter.

We secured for all integrate a critical component of what we would like to know.

One.

In addition, we expanded our rights to local delivery of rolling in for all of Ophthalmology, including me.

We look forward to continuing our work with data.

So look for additional partnering opportunities outside of North America at the appropriate time.

However, as you point out, we're looking at a different patient population. The only previous trial that looked at a non-naive patient population for maintenance therapy was the port delivery system. So, in some ways, the port delivery system trials would, you know, be in some ways comparable to the patient population that we're enrolling.

Regarding our commercial products, we had a strong first quarter with 9 million in net product revenues, an increase of 32% from the first quarter of last year, along with strong customer demand for both boutiques and execute.

However, their control group was monthly Lucentis, and our control group is monthly ILEA times three, and then ILEA every other month after that.

This strong start to 2022 and of course, our strategy the commercial business franchise to achieve breakeven status. This year.

Additionally, we wanted to share an update on our phase III trial.

Ah.

Potential six month sustained delivery cost serious segment of the eye.

The FDA has recently upgraded the regulatory requirement for ophthalmic drug device combination product such as Youtube.

These regulatory changes that require I point to complete an additional clinical trials.

Beyond what was originally communicated plan post approval in the supplement resulting in a significant increase from the program anticipated costs.

As a result, we've made the decision to pause enrollment for this study until we can reassess and determine if there's a path forward.

I would like to emphasize that this decision is driven by financial considerations.

We still believe in it.

And its potential clinical utility given the proven track record of you take one.

Despite this as an organization we recognize that we must take a disciplined approach to our pipeline investments will continue to focus our resources on <unk> clinical development.

I'd also like to add that we remain committed to serving the posterior segment uveitis patient community, we can keep 180.

More about this serious eye disorder to improve patient outcomes.

Ongoing boutique Com registry study, which is the first and only registrar registry trial.

<unk> and our Youtube phase four Synchronicity study, which is a prospective open label uncontrolled two year follow up study.

Scientist evaluate the safety and efficacy of the boutique 187 total implant court.

At a segment you'd be items with <unk>.

Plan to update the scientific and patient community on these important studies in the months to come.

As you'll hear from George later on.

And well capitalized to execute on our pipeline and we remain focused on our financial health and cash runway.

This included a debt refinancing in Q1 with Silicon Valley Bank, which provided the company with a significant interest rate improvement, resulting in approximately $2 8 million.

Interest savings.

Finally, we made important leadership appointments in the first quarter building out our growing team with two new industry veteran.

Earlier. This year, we were very pleased to announce the appointment of Michael <unk> as Chief corporate development and strategy Officer.

It brings more than 20 years of business development and strategy experience <unk> pharmaceuticals.

Thrilled to have him onboard during this exciting time in the company's evolution.

Recently, <unk> also appointed Isabella as Chief regulatory officer missiles that brings over 30 years of global regulatory affairs experience.

All phases of drug development, especially in ophthalmic condition, and we look forward to receiving the guidance on SBA related matters and global regulatory strategy.

I'd like to thank the talented <unk> team for our company's clinical operational and financial success to date.

We advanced the future of sustained ocular drug delivery, we look forward to executing on multiple near term clinical catalysts. So that we can deliver improved after treatment and ultimately create a better future for patients living with serious eye disorders.

So, we have a bit of a different control group as well, with a different treatment interval, and I'd also like to point out that given that ILEA will be dosed after the first three months as every other month, there's the potential for anti-VEGF supplemental in our control group, which I believe is a bit unique for any of these studies.

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

So while there are comparisons to many of the previous WET MD trials, I'd say, given the patient population, the longevity of action of our drug, the rescue criteria, there are also going to be some differentiation.

Yes.

Thank you Nancy and good morning, everyone.

Before I begin I want to reiterate what an exciting time. This is our team is poised to execute on multiple clinical catalysts. This year as we advance our pipeline.

But at a very high level, what we're trying to do is inherently different than what some of our previous anti-VEGF molecules have been trying to do, which is, again, as Nancy pointed out at the beginning, we're not necessarily replacing ilea or faricimab.

We are working to maintain the gains that those drugs give patients initially over the long term because we're sustained release, which helps to account for patients who can't make it back for visits or extended intervals that have been extended beyond perhaps what might be safe.

A therapeutic approach, which we refer to as street to maintain.

As we know in the real world, patients with these branded drugs still over the year or two into their disease lose much of the visual gain that they had.

The largest unmet need in the wet AMD landscape as longevity of action of anti VEGF <unk>. Our goal is to sustain the majority of wet AMD patients treatment interval up to six months or longer after a single injection of <unk> 19 to one, allowing patients and practitioners to flexibility to safely reduce.

So there's a definite unmet need out there for continuous treatment, and that's what we aim to provide.

The number of visits to their retina specialists through controlled and sustained your trip it drilled delivery of an anti VEGF drug.

Yeah, let me just also add on to your last question, Yatin, which was, we expect that we will report out the phase two wet AMD results in the second half of 2023.

The recent positive eight months safety data and efficacy results give us increased confidence that <unk> may have a differentiated profile for safety efficacy and tolerability in wet AMD.

So we're on track with this, of course, timing of all the patients to be enrolled is still a variable, but we're pulling out all the stops to enroll as quickly as possible.

We're confident, though, that safety will probably not bubble up to be a problem. And the confidence stems from the experience with DuraCert in 10s of 1000s of patients, number one, in the safety of varolinib, both preclinical and so far in in in patients.

Before we review the data I'd like to touch on the VIP 19, once use of the <unk> delivery technology and its differentiation from alternatives in the retinal drug delivery landscape.

<unk> bio erodible <unk> allows for true sustained release of drug with zero order kinetics. After an initial beneficial burst of medication.

And it's non erodible formulation <unk> has best in class track record of proven safety Tolerability and consistent medication delivery.

19, one combines the bio erodible formulation as a juror search sustained release technology I, just described with <unk>, a small molecule tyrosine kinase inhibitor.

We're rolling it binds to the VEGF receptors blocking all isoforms of that Jeff as well as PDGF.

This is different from the antibody fragment trap molecules that are there current anti VEGF so on the market today.

These molecules bind VEGF this differentiated anti VEGF mechanism of action, coupled with our bio erodible <unk> as your order kinetics technology could potentially change the treatment paradigm to a much less burdensome approach with <unk>, which we have coined treat to maintain.

And as we stated earlier, we're on track for third quarters this year to enroll our first patient.

Just one more question, if I may, with regard to the update.

Turning now to our <unk> study.

<unk> is a phase one open label dose escalation trial that enrolled 17 patients across four dose cohorts.

What exactly can you just provide a little bit more.., that may be driving.

So so far, it looks safe.

Yeah, good question.

Again, anything can happen as you expand these trials.

All enrolled patients were previously treated with standard of care anti VEGF therapy, No Reinjection with study drug was performed during the study and typical criteria for supplemental supplementation with a standard of care anti VEGF what's employed.

As again, some people may know, but others may not.

From an efficacy perspective, from, you know, the risks, number one thing we're trying to hit here is non-inferior visual acuity compared to ILEA, and that's the primary endpoint.

Following a positive six month data readout in October of last year, we reported positive interim eight months safety and efficacy data of the <unk> trial in February at the angiogenesis 2022 virtual meeting.

The FDA recently issued new guidance related to drug-device combinations.

And looking at the DAVIO trial, and again, trying to extrapolate over six months, we're optimistic that that's a value that we'll be able to statistically meet.

This new guidance was as a result of a lawsuit that was filed by another company against the FDA on their particular product, and it's called the Genus Decision that was handed down by an appellate court. As a result, the FDA issued new guidance, and as a result of that, for some products, they want more studies to be done.

And that's the case with UTEQ-50.

Obviously, that's the big risk as well, that in this population or with whom you enroll, that you won't be able to achieve that, but certainly extrapolation would suggest that we have a very good chance.

89% at six months at 75% at eight months. Additionally.

Additionally, we observed stable visual acuity and central subfield thickness as measured by optical coherence tomography with your updated eight months data showing change in best corrected visual acuity of minus three <unk> letters and central subfield thickness change of plus 13 microns.

In addition, the eight months data highlighted positive safety with no ocular serious adverse events and no drug related systemic sce's.

Furthermore, no dose limiting toxicities no retinal detachments no cases of endophthalmitis no occurrences of implant migration into the inter chamber or any post your segment ocular inflammation, which reported.

So instead of one study, they're requiring now two studies.

Now, our WET-AMD Phase 2 W02 trial is, you know, really on target to start in the third quarter of this year, the protocol is set. And that protocol and inclusion exclusion criteria was largely influenced by the patients that we saw who did well in W01 and those who didn't. And I think those inclusion exclusion criteria will reflect that.

As Nancy mentioned, we planned to initiate a randomized controlled phase III study of <unk> thousand 19 of one for previously treated wet AMD in Q3 2022.

We don't see any impact right now on EYP-1901 because we already are anticipating that we will be doing multiple phase three pivotal studies.

So I hope we covered everything, and I think if there's any commercial comments, perhaps Scott can weigh in.

Scott, go ahead.

So we don't see any impact on UTEQ, excuse me, EYP-1901.

Sure.

Unfortunately, we had planned for one study on UTEQ-50, and the guidance is now that we have to do two studies.

So as you can imagine, UTEQ is a nice, steady, consistent product growing very nicely in revenues, but it's never going to be a huge drug, as I've often said. It is going to deliver some nice profits to the bottom line over an extended period of time because we don't have to put a lot of money into it.

However, these are not large drugs.

Okay.

And so as a result, the cost of doing another phase three study for UTEQ-50 may become problematic for us to see the ROI on UTEQ-50, got it.

The efficacy endpoints are change in best corrected visual acuity change in central subfield thickness as measured by OTT time to supplementation and safety.

So basically more of an ROI or NPV decision.

Thank you for the question.

Looking ahead, we anticipate sharing interim six month data for this phase II trial in the second half of 2023.

It seems like two studies.

But given that for 1901, you will be required to do multiple study till it get approved.

Yeah, exactly.

And again, let me just reiterate, this is strictly a financial decision on UTEQ-5.0.

<unk> officer for the commercial update Scott.

It has nothing to do with UTEQ, nothing to do with what we believe the benefit of a six-month steroid delivery is for uveitis.

And, you know, as Jay said, I think we're still examining the exact percent of patients, but certainly a large percent of the currently treated patients we believe will be correct for our potential therapy.

Thank you Jay we're excited to report a strong quarter for our commercial business with $9 million of net product revenue an increase of 32% from the first quarter of last year. Our Q1 net product revenue for Utica and executed was $4 6 million and $4 $4 million respectively cut.

However, again, uveitis is not a large category.

But just to take a step back, you know, to think about why there is such a need for this in the marketplace.

It's an orphan disease.

You know, as you know, it's current, AMD, DME, DR, it's a very large market.

Customer demand was approximately 14800 units execute from 650 units of Utica compared to approximately 13800 units and 650 units respectively. In Q4 2021.

Customer demand for <unk>, approximately 7% growth from Q4 2021.

Customer demand for the execution from our strong commercial presence and our collaboration with our commercial alliance partner improves Rx, who has assumed full responsibility for U S sales and marketing activity for <unk> as of January one 2022.

<unk> retains the Dutch <unk>.

Revenue recognition manufacturing and distribution responsibilities for all markets.

<unk> has been a strong partner and we look forward to continued growth for that franchise.

Customer demand for Utica remains strong due to our ongoing expansion of boutique sales efforts into the replicated.

Treatment of post your segment uveitis and from an approved Siliconized noodle that provides preferred procedural experience for physicians and patients. Although demand for you take was consistent with Q4 2021, it's important to note that historically first quarter demand numbers, usually turned down due to insurance deductible resets for these patients.

We are incredibly pleased by the progress we've made our commercial businesses and with the performance of our commercial teams are.

Our mission is to continue to provide a unique sustained delivery system across all platforms that provide that requires fewer visits to the doctor's office key attribute for each product's value proposition for both patients and doctors.

We look forward to updating you on revenues and demand in the quarters to come.

And, you know, as we've always said, probably UTEQ-180 will probably hit maximum revenues of $80 to $100 million over time.

But if you think about what's going to occur in the next several years, you know, we have an aging population, we have an expansion of the number of patients with diabetes.

We currently have, you know, a very undertreated diabetic retinopathy market. And the number of retinal specials isn't expanding appreciably to be able to meet those needs.

So the demand for more durable therapy, we think we're just meeting a need that is growing every day.

UTEQ-50 is a subcategory of that.

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

So, when you do the ROI, it's just very hard to do that with two.

So we certainly think there is just an enormous opportunity for us to be able to bring a durable therapy to the marketplace.

But again, as Jay said, you know, we're currently evaluating which patients we believe will be the most appropriate as we move forward and I'm certain that we'll have more information to come in the coming years.

Pivotal Phase III Studies.

Hopefully we've captured all the questions, George.

Thank you.

Incredibly comprehensive.

Thank you so much.

Our next question comes from Jennifer Kim with Cantor Fitzgerald.

We really appreciate it.

New loan agreement with Silicon Valley Bank provides for a senior secured credit facilities and the aggregate amount of $45 million and reduces the loan interest rate from 12, 5% to a blended rate of approximately 5%, resulting in an estimated $2 8 million in annualized interest savings.

Please go ahead.

An increase of 32%.

Net revenue from royalties and collaborations for the first quarter ended March 31 2022.

$3 million compared to $5 million in the corresponding period in 'twenty one.

Including noncash stock based comp.

Non operating expense totaled $2 7 million.

And net loss was $21 million or <unk> 56 per share compared to a net loss of $12 3 million or <unk> 50 per share for the prior year period.

Cash and investments at March 31, 2022 totaled $190 8 million compared to $211 6 million at December 31, 2021, we.

We expect the cash and investments on hand.

At March 31, 2022, 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.

And congratulations again on all.

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

Thank you.

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

Thank you.

To ask a question you will need to press star one on your telephone to withdraw your question press the pound key.

Our first question comes from Joe Giordano with Cowen You May proceed with your question.

Thank you.

Hi team. Thank you so much for taking our questions and congratulations on all the progress.

So maybe just to fill in on the R&D.

Now that you have the full data your data.

<unk> as it is still a limited number of patients but has this data to help you better refine the commercial opportunity for 19, no. One could you think would be the most optimal patient for maintenance product.

Like like that and what percentage of the patient population that these patients represent.

And then secondly, given the efficacy we've seen from 19, though on <unk>, what do you see as the main risks to us.

Successful Registrational trial, and I guess related to that what would be the most optimal trial design that could maximize your chances of success, while still ensuring you get the durability you have demonstrated so far on the label.

Hey everyone, congrats on all the good work this quarter, and Nancy, I wish you a fast recovery from your cold.

Thank you.

Our next question comes from Yatin Suneja with Guggenheim.

Wow, that's quite a quite a list.

Thank you.

You may proceed with your question.

Hi, good morning.

Good morning.

Let me see if I can't answer an overview and then I'm going to triage it out to the team here.

Yeah.

I have a few questions here.

Hey guys, congrats on the results, just a couple for me.

If we miss them.

Questions just reiterate them.

I would say definitely as as the data continues to come in of course, it refined our approach because it.

It informs exact better how long this is working and we remain really pleased with what we're seeing anywhere out nine months on which we reported on rescue eight months on overall safety and efficacy and we continue to see really good sustainability of treatment.

Maybe to start off, I think you mentioned that you're going to present 12-month data at ASRS.

Yes.

Given that six months is a sweet spot, like you said, what kind of additional takeaways are you hoping to see in that 12-month data?

Now we're going to continue to keep this.

Yeah, that's a great question.

Designed as a six month treatment, just because we want to be able to capture a majority of patients and we still believe obviously dependent on phase. Two result that a majority of patients can be treated with <unk> thousand 19, Juan I wanted to just elaborate a bit on this tweet to maintain approach that we're taking.

Jay, why don't you take that?

Yeah, so I'll start by saying, first of all, again, the phase one trial is primarily safety.

So we want to make sure that there's no longer term safety issues, not that we expect any.

Certainly, if you have a problem that's injection related, you'd expect it early in the study.

It's important to understand that we're not here to replace current anti VEGF.

They are very effective and safe the problem as we all know.

They are not.

If you have a problem that's dose related, once again, because of the burst of varolatib that we get in the first few weeks, we would have expected that early in the study.

We didn't see either of those.

And anti VEGF.

It is clear it up if possible and then you can put in <unk> thousand 19 on one maintaining that pace. So treat to maintain four we hope a majority of patients up to six months.

And then for some patients.

So maybe particularly are resistant to anti VEGF therapy, or they just can't get rid of all the fluid you can supplement as needed with existing therapy. So that is and again because we have two different mechanisms of action onboard.

There is often a benefit could be I want to caveat, we don't know everything yet.

Having two different mechanisms of action at work on the AI. So we think theres a lot of benefits for patients.

We continue to have a group headed up by Scott I'm going to let him comment just a bit we just launched a new group.

Our early commercial development and Scott.

Is to begin to more fully understand the commercial opportunity and what we need to do it more appropriately develop that commercial opportunity because it is a new treatment paradigm.

We've seen some of the current mindset now actually and then we will get back to the regulatory trials in just a moment I'm going to ask Dr. Jay Duker comment and then Scott on the commercial opportunity.

Thanks, Nancy and I think you've covered things well, probably just add a few more.

Thoughts based on the <unk> results.

Yeah.

Asked what percentage of wet AMD patients would benefit from this treatment.

<unk>.

Way I would answer that is based strictly on the 17 patients from <unk> one.

<unk> would extrapolate that the market would be at least 85% of wet AMD.

Now.

I think we can speculate in more of a broad spectrum of wet AMD patients not the spectrum, we enrolled into aveo that the benefit might be greater than that but again thats speculation thats why were doing a phase II trial to see.

A broader population of wet AMD patients than what we enrolled into aveo.

What percentage is you're just going to benefit.

Sure.

Optimistic that that benefit will be a majority of patients.

So while we wouldn't anticipate any new safety issues in the last three months of the study, we want to make sure that none exists.

Major risks of major risks of any trial or safety and efficacy at a very high level. The good news is with any called <unk>, We really had no safety issues.

Of course, that's a small number.

Confident though.

That safety will probably not bubble up to be a problem and the confidence stems from the experience with <unk> and tens of thousands of patients number one and the safety of <unk>, both preclinical and so far.

That's number one.

Number two is we didn't re-inject 1901 during this study.

And so based on the preclinical and animal and in vitro data, we would expect the implants to release in humans for approximately nine months.

So we would expect, in some patients, to get that longevity of action that we saw with 41% supplemental anti-VEGF-free up to nine months. But as the implants run out, we would expect a reactivation of the disease and need for supplementation, although not necessarily immediately.

In patients.

What they have.

To say that in our preclinical studies, we haven't been able to find the maximally tolerated dose in animals for <unk> hundred one and I think that would be a safe thing to say and equals 17 from the phase one that we didn't find an MTBE in humans, either so so far it looks safe.

Anything can happen as you expand these trials.

Remember, when you give an ILEA or a Lucentis shot, that drug might be out of the eye in weeks, but some patients can go two or even three months between injections.

So we would expect to see somewhat of the same as the drugs run out.

So while from a safety perspective, we would be very happy to see minimal, if any, safety issues really in the first few months, we want to confirm that through the year.

From an efficacy perspective.

The risks.

One thing we're trying to hit here is non inferior visual acuity compared to eylea.

Okay, great.

And it's that's the primary endpoint.

Looking at the <unk> trial, and again trying to extrapolate over six months.

We're optimistic that that's a value that that will be able to statistically meat, but obviously, that's the big risk as well that in this population or with whom you enroll that you won't be able to achieve that but.

And maybe another question on your license agreement with beta.

Certainly extrapolation would suggest that we have a very good chance.

Is there any color you can give on the exact terms of that deal? And on a related note, with your amended agreement with Equinox, I guess, is the biggest takeaway there that you're now able to plan that phase two trial in DME?

Last question was around trial design and once again the trial designed as an iterative process when we get more data.

And are you still planning to look into the RVO opportunity?

And the data suggests that a trial should be designed in a specific way. That's the way. We go now are wet AMD phase II <unk> trial is.

Or has DME sort of taken the priority over that?

Yeah, let me answer that.

So as for beta, we're very pleased to have the extension of our partnership with them.

As you may recall, we struck that agreement in 2020, where we, we in license for all in it, what was always anticipated.

And that was part of the original agreement is that they would have the ability to negotiate for rights to China.

That was all anticipated as well as part of the payments and milestones that we owe them.

In exchange, of course, that was some reduced payments in exchange for them gaining rights in 1901.

And those who didn't and I think those inclusion exclusion criteria.

So we won't we won't go into the details of that.

But suffice it to say, it gives them now the formal rights to 1901 in China.

And of course, there's your typical royalties and milestones that they will pay us for that as well.

We will reflect that.

So I hope, we covered everything and I think if theres any commercial comments, perhaps Scott can can weigh in.

In addition, back to DME.

Yes, it now gives us rights to all of ophthalmology indications delivered locally with varolinib around the world outside of China.

And we are now going to prioritize, as Jay may have mentioned, I believe in his his comments, that DME will now be done first before, excuse me, before retinal vein occlusion.

Scott go ahead sure.

Thank you for the question.

As Jay said I think we're still examining the exact percent of patients, but certainly a large percent of the currently treated patients that we believe will be key.

Correct.

Our potential therapy, but just to take a step back to think about why there is such a need for this in the marketplace.

So we'll do wet AMD, and then the non-perlisive diabetic retinopathy.

As you know with its current AMD <unk>, it's a.

And the thinking now is we'll do DME as a third study that will initiate.

Very large market, but if you think about what's going to occur in the next several years, we have an aging population. We have an expansion of the number of patients with diabetes. We currently have very undertreated diabetic retinopathy market and the number of retina specialist isn't expanding appreciably to be able to meet those needs. So the demand for more.

We certainly would still think about RVO.

We have to be careful, obviously, of our capital management.

Durable therapy, we think it's we're just meeting a need that is growing every day. So we certainly think there is just an enormous opportunity for us to be able to bring a durable therapy to the marketplace.

Again as Joe said.

Currently evaluating which patients we believe will be the most appropriate as we move for them.

Certain that we'll have more information to come in the coming years.

Hopefully these app should all questions George.

Incredibly comprehensive thank you so much really appreciate it and congratulations again.

Thank you.

Thank you. Our next question comes from Yadkin scenario with Guggenheim You May proceed with your question.

Hey, guys. Congrats on the results just a couple from me first is on the on the.

First is on the 1901, face to study.

Just I think one of the confusion out there is that I think we and investor community is used to thinking about idea or other injection as a comparison.

91 <unk>.

<unk> two study just I think one of the confusion out there is that I think we and investor community is used to thinking about eylea or <unk> injection as a comparison.

So just help us understand what is the right comp to us.

It seems like port delivery study that was run by run with Los Santos might be the right comp to think about how you are conducting the face to study.

So just help us understand what is the right come to us It seems like port delivery study that was run by run with Lucentis might be right to think about how you are conducting the phase II study.

Can you maybe comment on that?

Is that the right way to look at it?

Can you maybe comment on that is that the right way to look at it and then obviously the study is going to start in Q3 can you talk about how long it might take for you to report interim data.

And then in obviously the study is going to start in Q3.

Any ballpark you could give on the enrollment and data readout timeframe that would be very helpful. Thanks.

Can you talk about how long it might take for you to report the interim data?

Any ballpark you could give on the enrollment and data readout time frame that we have.

Sure no problem on that Jay wanted to take those questions.

Sure.

So <unk> thanks.

Thanks for the questions and as usual very insightful.

The first is a comparison of our trial and I would say at a high level.

The <unk>.

Primary endpoint of non inferior visual acuity is is what has been used in all the recent wet AMD trials. Once you have a standard of care.

The standard of care with Lucentis initially.

That was what the comparison needed to be and Thats, how the trials were designed.

At.

A non naive patient population for maintenance therapy was the port delivery system. So in some ways the port delivery system trials would.

With a different treatment interval and I'd also like to point out that given that eylea will be dosed. After the first three months as every other month theres the potential for anti VEGF supplemental in our <unk>.

Control group, which I believe is a bit unique for any of these studies.

So while there are comparisons to many of the previous wet AMD trials.

Given the patient population the longevity of action of our drug.

As a rescue criteria. They are also going to be some differentiation.

But at a very high level, what we're trying to do is inherently different than what some of our previous anti VEGF molecules have been trying to do which is again as Nancy pointed out at the beginning.

The timing of RVO is yet to be determined.

Sure, no problem on that.

Not necessarily replacing.

<unk> or <unk>.

We are working to maintain the gains that those drugs give patients initially over the long term, because where sustained release, which helps to account for.

Patients, who can't make it back for visits or extended intervals that had been extended beyond perhaps what might be safe because we know when the real world patients with these branded drugs.

Still over the year.

Year or two into the into their disease lose lose much of the visual gain that they had so there is a definite.

Unmet need out there for for continuous treatment and Thats, what we aim to provide.

But we do expect that we should be able to initiate a DME trial sometime early next year.

Yes, let me just also add onto your last question, which was we expect that we will report out.

Phase II wet AMD results in the second half of 2023. So we're on track with its of course timing of all the patient to be enrolled.

It's still a variable, but we're pulling out all stops to enroll as quickly as possible and as we stated earlier we are on track.

For third quarter this year to enroll our first patient.

Got it and just one more question if I may with regard to the update on the <unk> that you are pausing. The study guide what exactly can you just provide a little bit more detail on what exactly the FDA asked us to do.

Debt.

Okay.

Maybe driving the cost of this program.

Yes, good question.

Again, some people may know, but others may not the FDA recently issued new guidance related to drug device combination.

This new guidance was as a result.

A lawsuit that was filed by another company against the FDA on their particular product and it's called the gene is decision that was handed down by an Apple at court as a result, the FDA issued new guidance and as a result of that.

For some product.

They want more studies to be done and Thats. The case would you take five hours. So instead of one study are requiring now two studies.

Don't see any impact right now on record 19, one because we already are anticipating that we will be doing multiple phase III pivotal study. So we don't see any impact.

<unk>.

We recognized one unfortunately, we had claims but one study five out.

The guidance is now that we have to do two studies. So as you can imagine.

Think of that.

Nice steady consistent product growing very nicely in revenues, but it's never going to be a huge drug as I've often said it is.

Going to deliver some nice profit to the bottom line over an extended period of time, because we don't have to put a lot of money into it. However.

These are not large garage and so as a result, the cost of doing another.

Phase III study or do you think by about May.

Become problematic for us to see the Rois.

Silo.

Got it so basically more of an auto Iot NPV decision.

It seems like two studies.

But given that for $90. One you will be required to do multiple studies till they get approved should not have any veto right.

Yeah, exactly and again, let me just reiterate this is strictly a financial the state hearing you take $5 has nothing to do with peak nothing to do with what we believe the benefit of a six month steroid delivery is.

For uveitis.

However, again.

This is not a large category it is an orphan disease and.

<unk> always said it probably <unk> will probably hit Matt.

Maximum revenues of $80 million to $100 million overtime.

You take 50 is a subcategory of that so when you do the ROI, it's just very hard to do that with two.

Pivotal phase III studies, but again, we see no impact on 19 Juan.

Alright, thank you so much.

Yeah, yeah, that's perfect.

Thank you. Our next question comes from Jennifer <unk> with Cantor Fitzgerald. Please go ahead.

One last quick question just on UTX-50.

Hey, everyone. Congrats on all the good work this quarter and Nancy I wish you a fast recovery from your color. Thank you. Thank you.

Yes, I have a few questions here maybe to start off I think you mentioned that you are going to present 12 month data Srs given that six months is the sweet spot like you said, what kind of additional takeaways are you hoping to see in that 12 month data.

Jay, why don't you take those questions?

Sure.

Yeah. That's a great question, Jay why don't you take that yes, so I'll start by saying first of all again the phase one trial.

So, Yatin, thanks for the questions, and as usual, very insightful.

The first is a comparison of our trial, and I would say at a high level, the primary endpoint of non-inferior visual acuity is what has been used in all the recent WET-AMD trials.

Once you have a standard of care, and the standard of care was lucentis initially, that was what the comparison needed to be, and that's how the trials were designed.

Primarily safety.

Non-inferior margins were determined by the prior studies, by the size of your study, and the statistics involved.

So, at a very high level, one could look at any of the recent studies that were non-inferior visual acuity.

So we want to make sure that there is no longer term safety issues not that we expect any.

Certainly if you have a problem thats injection related you'd expect it early in the study.

If you have a problem that dose related once again.

We want to make sure that none exists that's number one number two is we didnt Reinjection 19 O. One during this study and so.

<unk> on the preclinical and animal and in vitro data, we would expect the implants to release in humans for approximately nine months.

So we would expect in some patients to get that longevity of action that we saw with 41% supplemental anti VEGF free up to nine months.

But as the implants run out we would expect.

<unk> of the disease and need for supplementation, although not necessarily immediately.

However, as you point out, we're looking at a different patient population. The only previous trial that looked at a non-naive patient population for maintenance therapy was the port delivery system. So, in some ways, the port delivery system trials would be in some ways comparable to the patient population that we're enrolling. However, their control group was monthly lucentis, and our control group is monthly ILEA times three, and then ILEA every other month after that.

As as the as the drugs run out so while from a safety perspective, we would.

Very happy to see minimal if any safety issues really in the first few months, we want to confirm that through the year.

And with respect to efficacy again.

As we've said and as I think you know, we really anticipating going for a label of every six months in the pivotal trials.

So.

One could argue that the.

As we know in the real world, patients with these branded drugs still over the year or two into their disease lose much of the visual gain that they had.

So there's a definite unmet need out there for continuous treatment, and that's what we aim to provide.

And so that data is important to clinicians so even though they might be able to re injected six months in certain patients. They may choose to extend that a little bit longer.

Okay, Great and maybe another question on your license agreement with beta.

Is there any color you can give on the exact terms of that deal.

On a related note with your amended agreement with equinox.

I guess is the biggest takeaway there that you are now able to plan that phase II trial in DMD.

And are you are you still planning to look into the RVO opportunity are as <unk> sort of taken the priority over that.

Yeah, let me just also add on to your last question, Yatin, which was, we expect that we will report out the phase two wet AMD results in the second half of 2023.

Yeah, let me answer that.

So we're on track with this, of course, timing of all the patients to be enrolled is still a variable, but we're pulling out all the stops to enroll as quickly as possible.

As for beta we're very pleased to have the extension of our partnership with them. As you may recall, we struck that agreement in 2020, we in licensed <unk> and it was always anticipated.

And as we stated earlier, we're on track for third quarter this year to enroll our first patient.

Just one more question, if I may, with regard to the update on.

What exactly, can you just provide a little bit more detail?

that may be driving.

Yeah, good question.

As again, some people may know, but others may not.

And that was part of the original agreement is that they would have the ability to negotiate for rights to China that was all anticipated as well as part of the payment and <unk>.

The milestones that we owe them.

In exchange of course that was some reduced payments in exchange for them gaining rights to 19 O. One so we won't go into the details of that but suffice it to say it.

It gives them now the formal rights to $19 one in China.

And of course, there is your typical royalties and milestones.

They will pay us for that as well.

In addition.

Back to <unk>, yeah. It now gives us rights to all of ophthalmology indications delivered locally with rolling out around the world outside of China and.

We are now going to prioritize in Cape May have mentioned I believe in him his comment that DNA will now be done first before.

For retinal vein occlusion will be wet AMD, and then and then <unk>.

The diabetic retinopathy and I think now it will be <unk>.

Third.

Study that we'll initiate we certainly would think about RVO.

We have to be careful obviously of our capital management the timing of RVO is yet to be determined but we do expect that we should be able to initiate a global trial.

Early next year.

Is there anything I know is just sort of a small single trial, but is there anything that we should think about in terms of modeling costs now that the trial has been put on hold?

Okay great.

Yes, yes.

One last quick question just on <unk> is there anything I know.

Sort of a small single trial, but is there anything that we should think about in terms of modeling costs now that the.

George, why don't you answer that?

Trial has been put on hold.

Yeah, I think you know that they should certainly the near term benefit is we're probably going to reduce that spend over the next 12 to 18 months, we'll probably pick up four to 5 million in anticipated spending that we won't spend. So that does certainly help our, Cash Runway in the near term.

Unknown Attendee, Yatin Suneja, Yi Chen, David Lally, Richard Wan, Ramiro Ribeiro, EyePoint, the Phase 2 NDME in the first quarter of next year.

George why don't you answer that.

Yes, I think.

So it's a cash pickup near term, which is good news in this environment.

Cash runway in the near term.

And but.

Even though our cash guidance is unchanged from last quarter, which is into second half of 'twenty for.

That also assumes that we're starting.

The phase II and Dnb in the first quarter of next year. So it's a cash pick up near term.

And Nancy, may I add one more thing about it, which is there's some, you know, what I might de-minor, indirect benefits, which is the clinical team.

Which is good news in this environment.

And Nancy Okay May I add one more thing about it which is there some.

Mike D minor indirect benefits, which is the clinical team. Although these two studies weren't large studies. They were still studies, we needed to track and therefore, they can focus more on that you might be 91 studies and as well as the manufacturing group.

Yes, yes.

Very good point.

Great very helpful. Thanks, guys.

Although these two studies weren't large studies, they were still studies we needed to track.

Thank you. Our next question comes from Yale Jen with Laidlaw <unk> Company. You May proceed with your question.

And therefore, they can focus more on the EYP 1901 studies, and as well as the manufacturing group, Yeah, yeah, very good.

Good morning, Thanks for taking the questions and add my congrats portfolio progress maybe.

Great, very helpful.

Thanks, guys.

Maybe just as a follow up from.

The previous one just in terms of the reason Doug.

You guys placed at <unk> ahead of the <unk>.

Thank you.

Retinal vein.

<unk> solution was the other economic or market assessment or other reasoning.

Our next question comes from Yeo Jin with Laidlaw and Company.

You may proceed with your question.

Curious saw.

Hello.

Yes.

<unk> is a much much larger market with a higher unmet need.

RVO still has unmet need but D&B.

<unk> larger market than then RVO. So when you look at where to put the capital. Obviously you have to look at where you can have the most impact for patients the broadest number of patients as well.

On a return basis so.

It was a pretty easy decision to make that prioritize DNA over RVO.

Good morning.

Thanks for taking the questions and my congrats for your progress.

Already been done or is still in progress to prepare for the stock.

Maybe this is a follow-up from the previous one, just in terms of the reason that you guys placed the DME ahead of the retinal vein inclusion.

Get into the trial.

Was that an economical or market assessment or other reasoning?

Our products are ready to go for the trials.

Okay, Great and maybe the last question here is a housekeeping one.

For this quarter you have extinguishment of debt is that a one time event or that will continue for the remaining of the year.

George I'll take that.

So.

What that is it's a noncash it's an unamortized discount.

That was associated with the <unk> loan and with the refinancing with just the noncash accounting.

Accounting entry so it was a onetime that won't repeat.

Okay, great well, that's all I really appreciate it and congrats photo progress.

Just curious, and I have a follow-up.

Thank you. Thank you.

Thank you and as a reminder to ask a question you will need to press star one on your telephone. Our next question comes from <unk> Chen with H C. Wainwright you May proceed with your question.

Yep.

DME is a much, much larger market with a higher unmet need. Not that RVO still has unmet need, but DME is just a substantially larger market than RVO.

Thank you for taking my questions.

The FDA recently issued new guidance related to drug-device combinations.

And that's the case with UTEQ-50.

First question just to clarify.

With respect to the FDA regulations for a combination drug device.

Why does it apply to.

So when you look at where to put your capital, obviously you have to look at where you can have the most impact for patients, the broadest number of patients, as well as on a return basis.

Two the non erodible give us a technology as well as the Robo Duracell technology.

So it was a pretty easy decision to make to prioritize DME over RVO.

So instead of one study, they're requiring now two studies.

Okay, great.

That's very helpful.

Yes, let me just reiterate a couple of things, yes, and by the way let me just reiterate it applies to a number of ophthalmology and even non ophthalmology products. This is not.

And two quick ones.

<unk> two.

Ophthalmology or even our product if they it's a drug device combination.

Regulations, so anytime that you have a drug combined with a device in the definition of a device is quite broad I might add.

The FDA is now.

Have to require more data.

But I want to again reiterate the way that the.

Regulation based on the ruling.

We don't see any impact right now on EYP-1901 because we already are anticipating that we will be doing multiple phase three pivotal studies.

So we don't see any impact on UTEQ, excuse me, EYP-1901.

<unk> came out is that it doesn't add anything more to 19, one Neil because 19, when it's delivered in a in sector and obviously, it's also in an implant.

It qualifies under these regulations, but we always anticipated doing all the work that is being promulgated the difference was in this particular case, we can supply they.

Unfortunately, we had planned for one study on UTEQ-50, and the guidance is now that we have to do two studies.

They need more then.

One study because you take FIFO wise.

However, these are not large drugs.

And so as a result, the cost of doing another phase three study for UTEQ-50 may become problematic for us to see the ROI on UTEQ-50.

Got it.

So basically more of an ROI or NPV decision.

Had not previously been on the market and we did not have a clinical study around it.

It seems like two studies, but given that for 1901 you will be required to do multiple studies until it gets approved.

Yeah, exactly.

And again, let me just reiterate, this was strictly a financial decision on UTIC-5.0.

It has nothing to do with UTIC, nothing to do with what we believe the benefit of a six-month steroid delivery is for uveitis.

However, again, uveitis is not a large category.

Hey everyone, congrats on all the good work this quarter, and Nancy, I wish you a fast recovery from your cold.

It's an orphan disease.

<unk> two clinical study, which as I said, we always anticipated with the multiple indications on 19, one regardless.

And, you know, as we've always said, probably UTIC-180 will probably hit maximum revenues of $80 to $100 million over time.

UTIC-50 is a subcategory of that.

So when you do the ROI, it's just very hard to do that with two.

Thank you.

Pivotal Phase III Studies, but again we see no impact on 1901.

Thank you.

Our next question comes from Jennifer Kim with Cantor Fitzgerald.

Please go ahead.

Got it thank you and just to confirm there is.

There is no upfront payment for the better pharmaceutical license.

The first one is that in terms of you guys going to start those phase two study later this year and next year, was the manufacturer aspect of that already being done or is still in progress to prepare for the stocks get into the trial?

Okay.

That is correct.

Okay last question for the upcoming MPD, our phase II trial in <unk>.

Half of the year.

Or will it be will it be the drug used.

Yeah.

Control group.

We know our product is all ready to go for the trial. Okay, great.

I have a few questions here.

Maybe the last question here is a housekeeping one that you in for this quarter, you have extinguishment of death.

Maybe to start off, I think you mentioned that you're going to present 12-month data at ASRS.

Yes, Jay why don't you answer that.

Is that a one time event or that will be continued for the remaining of the year?

Yes.

Our next question comes from Yi Chen with HC Wainwright.

Certainly, if you have a problem that's injection related, you'd expect it early in the study.

George, I'll take that.

Given that six months is a sweet spot, like you said, what kind of additional takeaways are you hoping to see in that 12-month data?

You may proceed with your question.

If you have a problem that's dose related, once again, because of the burst of varolatib that we get in the first few weeks, we would have expected that early in the study.

So, yeah, what that is, it's a non-cash, it's an unamortized discount.

Yeah, that's a great question.

At this point.

Thank you for taking my questions.

We didn't see either of those.

Transcripts provided by Transcription Outsourcing, LLC.

Jay, why don't you take that?

The first question, just to clarify, with respect to the new FDA regulations for a combination drip device, it applies to the non-erodible Duracell technology as well as the erodible Duracell technology?

So while we wouldn't anticipate any new safety issues in the last three months of the study, we want to make sure that none exists.

Okay, great.

Yeah, so I'll start by saying, first of all, again, the phase one trial is primarily safety.

Yeah, let me just reiterate a couple things.

That's number one.

The control group will consist of a sham <unk> 19, one injection. So there will be no active control.

Well, thanks a lot.

So we want to make sure that there's no longer term safety issues, not that we expect any.

Yes, and by the way, let me just reiterate, it applies to a number of ophthalmology and even non-ophthalmology products.

Number two is we didn't reinject 1901 during this study.

I really appreciate it and congrats for the progress.

This is not specific to just ophthalmology or even our products.

And so based on the preclinical and animal and in vitro data, we would expect the implants to release in humans for approximately nine months.

Thank you.

So, we would expect in some patients to get that longevity of action that we saw with 41% supplemental anti-VEGF-free up to nine months.

Thank you.

But as the implants run out, we would expect a reactivation of the disease and need for supplementation, although not necessarily immediately.

Thank you.

Remember, when you give an ILEA or a Lucentis shot, that drug might be out of the eye in weeks, but some patients can go two or even three months between injections.

We want to confirm that through the year.

And as a reminder, to ask a question, you'll need to press star one on your telephone.

And so we would expect to see somewhat of the same as the drugs run out.

And with respect to efficacy, again, as we've said, and as I think you know, we're really anticipating going for a label of every six months in the pivotal trials.

So while from a safety perspective, we would be very happy to see minimal, if any, safety issues really in the first few months.

So one could argue that the efficacy data beyond six months may not be useful, except I will again remind you that retina specialists are happy to allow patients to go longer than the label if they deem it safe.

So while we may have a label of six months in some patients, it was 41% in Davio, we were able to go eight and up to nine months without supplement.

And so that data is important to clinicians.

Okay.

So even though they might be able to re-inject at six months in certain patients, they may choose to extend that a little bit longer.

Okay, great.

Do you think it will be necessary.

And maybe another question on your license agreement with beta.

And are you still planning to look into the RVO opportunity?

In the future too.

Or has DME sort of taken the priority over that?

It's a drug-device combination, so regulation.

Yeah, yeah.

Yeah, let me answer that.

The drug against an active control.

So anytime that you have a drug combined with a device, and the definition of a device is quite broad, I might add, the FDA now has to require more data.

So as for beta, we're very pleased to have the extension of our partnership with them.

So, but I want to again reiterate, the way that the regulations based on the rulings came out is that it doesn't add anything more to 1901.

As you may recall, we struck that agreement in 2020, where we, we in license parole and it was always anticipated.

Because 1901 is delivered in an injector, and obviously it's also in an implant, it qualifies under these regulations.

And that was part of the original agreement is that they would have the ability to negotiate for rights to China.

But we always anticipated doing all the work that is being promulgated.

That was all anticipated as well as part of the payments and milestones that we owe them.

We really can't speculate on that at the current time, we believe from a regulatory perspective as of now thats not necessary.

The difference was, in this particular case, the UT5O, they need more than just one study because the UT5O was, had not previously been on the market, and we did not have a clinical study around it, so they need two clinical studies.

In exchange, of course, that was some reduced payments in exchange for them gaining rights in 1901.

Which, as I said, we always anticipated with the multiple indications on 1901 regardless.

So we won't go into the details of that.

But suffice it to say, it gives them now the formal rights to 1901 in China.

And of course, there's your typical royalties and milestones that they will pay us for that as well.

In addition, back to DME.

Yes, it now gives us rights to all of ophthalmology indications delivered locally with virolinib around the world outside of China.

And we are now going to prioritize, as Jay may have mentioned, I believe in his his comments, that DME will now be done first before, excuse me, before retinal vein occlusion.

So we'll do wet AMD and then the non-prolific diabetic retinopathy.

And the thinking now is we'll do DME as a third study that will initiate.

But that could change in the future, but our current belief in and discussing this with regulatory advisors is that.

We certainly would still think about RVO.

We have to be careful, obviously, of our capital management.

The timing of RVO is yet to be determined, but we do expect that we should be able to initiate a DME trial sometime early next year.

Okay, that's great.

Yeah, yeah, that's perfect.

One last quick question just on UTX-50.

Is there anything I know is just sort of a small single trial, but is there anything that we should think about in terms of modeling costs now that the trial has been put on hold?

George, why don't you answer that?

Yeah, I think you know, the ship certainly the near term benefit is we're probably going to reduce that spend over the next 12 to 18 months, we'll probably pick up four to 5 million in anticipated spending that we won't spend.

So that does certainly help our, Cash Runway in the near term.

A sham non active control is still permissible.

And even though our cash guidance is unchanged from last quarter, which is into second half of 24, that also assumes that we're starting, which is good news in this environment.

And Nancy, may I add one more thing about it, which is there's some, you know, what I might de-minor indirect benefits, which is the clinical team.

Although these two studies weren't large studies, they were still studies we needed to track.

And therefore they can focus more on the EYP 1901 studies, and as well as the manufacturing group.

And that's because while there are two FDA approved products in this space.

For Dr. The usage of the Ms. So minimal.

Okay got it thank you.

Got it.

Very good.

Thank you.

Great, very helpful.

And just to confirm, there is no up-front payment for the Better Pharmaceutical License. That is correct.

Thanks, guys.

Last question, for the upcoming NPDR Phase 2 trial in the second half of the year, what will be the drug used in the control group?

Thank you.

This does conclude your program, and you may now disconnect.

Yeah, Jay, why don't you answer that?

Our next question comes from Yeo Jin with Laidlaw and Company.

At this point...

You may proceed with your question.

The control group will consist of a sham EYP-1901 injection, so there will be no active control.

Good morning.

Everyone have a great day.

Okay, do you think it will be necessary at a certain point in the future to evaluate the drug against an active control?

Thanks for taking the questions and my congrats for your progress.

We really can't speculate on that.

Maybe this is just a little follow-up from the previous one, just in terms of the reason that you guys placed the DME ahead of the retinal vein inclusion.

At the current time, we believe from a regulatory perspective, as of now, that's not necessary. But that could change in the future.

Was that an economical or market assessment or other reasoning?

Thank you, everyone.

But our current belief in discussing this with regulatory advisors is that a sham non-active control is still permissible.

Just curious.

And that's because while there are two FDA approved products in this space, in this space for DR, the usage of them is so minimal.

Oh, yeah.

And have a great day.

Okay, got it.

Can I have a follow-up?

Thank you.

Yep.

Thank you, and I'm showing no further questions in the queue at this time.

DME is a much, much larger market with a higher unmet need. Not that RVO still has unmet need, but DME is just a substantially larger market than RVO.

Thank you everyone.

Ladies and gentlemen, thank you for participating in today's conference.

So when you look at where to put your capital, obviously you have to look at where you can have the most impact for patients, the broadest number of patients, as well as on a return basis.

So it was a pretty easy decision to make to prioritize DME over RVO.

Okay, great.

That's very helpful.

And two quick ones.

The first one is that in terms of you guys going to start those phase two study later this year and next year, was the manufacturer aspects of that already being done or is still in progress to prepare for the stocks get into the trial?

We know our product is all ready to go for the trial. Okay, great.

Maybe the last question here is the housekeeping one that you in for this quarter you have extinguishment of debt.

Is that a one time event or that will be continued for the remaining of the year?

George, you take that.

I'll take that.

So, yeah, what that is, it's a non-cash, it's an unamortized discount.

Transcripts provided by Transcription Outsourcing, LLC.

Okay, great.

Well, thanks a lot.

I really appreciate it and congrats for the progress.

Thank you.

And as a reminder, to ask a question, you'll need to press star one on your telephone.

Our next question comes from Yi Chen with HC Wainwright.

You may proceed with your question.

Thank you for taking my questions.

The first question, just to clarify, with respect to the new FDA regulations for combination drip device, it applies to the non-erodible Duracell technology as well as the erodible Duracell technology?

Yeah, let me just reiterate a couple things.

Yes.

And by the way, let me just reiterate, it applies to a number of ophthalmology and even non-ophthalmology products.

This is not specific to just ophthalmology or even our products.

It's a drug-device combination, so regulation.

So anytime that you have a drug combined with a device, and the definition of a device is quite broad, I might add, the FDA now has to require more data.

So, but I want to again reiterate, the way that the regulations based on the rulings came out is that it doesn't add anything more to 1901.

Because 1901 is delivered in an injector, and obviously it's also in an implant.

It qualifies under these regulations, but we always anticipated doing all the work that is being promulgated.

The difference was, in this particular case, the UT5O, they need more than just one study because the UT5O was, had not previously been on the market, and we did not have a clinical study around it.

So they need two clinical studies, which, as I said, we always anticipated with the multiple indications on 1901 regardless, got it.

Thank you.

And just to confirm, there's no there's no upfront payment for the better pharmaceutical, That is correct.

Last question, for the upcoming NPDR Phase 2 trial in the second half of the year, what would be the drug used in the control group?

Yeah, Jay, why don't you answer that?

At this point...

The control group will consist of a sham EYP-1901 injection, so there will be no active control.

Okay, do you think it will be necessary at a certain point in the future to evaluate the drug against an active control?

We really can't speculate on that.

At the current time, we believe from a regulatory perspective, as of now, that's not necessary. But that could change in the future.

But our current belief in discussing this with regulatory advisors is that a sham non-active control is still permissible.

And that's because while there are two FDA approved products in this space, in this space for DR, the usage of them is so minimal.

Okay, got it.

Thank you.

Thank you, and I'm showing no further questions in the queue at this time.

Ladies and gentlemen, thank you for participating in today's conference.

Q1 2022 EyePoint Pharmaceuticals Inc Earnings Call

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