Q4 2021 EyePoint Pharmaceuticals Inc Earnings Call

[music].

Operator: Good morning. My name is Jonathan, and I will be your conference operator today. At this time, I would like to welcome everyone to the EyePoint Pharmaceuticals fourth quarter of full year 2021 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. Please go ahead.

Yeah.

Good morning, My name is Jonathan and I will be your conference operator today at this time I would like to welcome everyone to the <unk> Pharmaceuticals fourth quarter and full year 2021 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.

<unk> recorded at the company's request I would now like to turn the call over to George Elston, Chief Financial Officer of <unk> Pharmaceuticals. Please go ahead.

George Elston: Thank you. Thank you and thank you all for joining us on today's conference call to discuss EyePoint Pharmaceuticals' fourth quarter and full year 2021 financial results and recent corporate developments. With me today is Nancy Lurker, President and Chief Executive Officer, Dr. Jay Duker, Chief Operating Officer, and Scott Jones, Chief Commercial Officer. Nancy will begin with a review of recent corporate updates.

Thank you and thank you all for joining us on today's conference call to discuss <unk> Pharmaceuticals fourth quarter and full year 2021 financial results and recent corporate developments.

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

George Elston: Dr. Duker will then discuss pipeline developments for EYP 1901, and Scott will comment on recent progress made in our commercial activities. I will close with commentary on the fourth quarter and full year 2021 financial results. We will then open up the call to your questions.

Nancy will begin with a review of recent corporate updates Dr. <unk> will then discuss pipeline developments for <unk> might be 91, and Scott will comment on recent progress made on our commercial activities.

I will close with commentary on the fourth quarter and full year 2021 financial results. We will then open up the call for your questions.

George Elston: 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 on the Investor Relations tab on the corporate website www.eyepointspharma.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.

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

A copy of the release can be found on the Investor Relations tab on the corporate website Www Dot <unk> pharma dot com.

George Elston: These include statements about our future expectations, clinical developments, regulatory matters, and timelines, as well as the potential success of our products and product candidates, financial projections, and plans, and prospects. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the risk factors section of our most recent annual report on Form 10-K, which is on file with the SEC, and in other filings that we may make with the SEC in the future.

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.

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

Projections and plans and prospects.

Actual results may differ materially from those indicated.

These forward looking statements as a result of various important factors, including those discussed in the risk factors section of our most recent annual report on Form 10-K , which is on file with the SEC and in other filings that we may make with the SEC in the future.

George Elston: Any forward-looking statements represent our views as of today only. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if our views change. Therefore, you should not rely on these forward-looking statements as representing our views as of any date subsequent to today. I'll now turn the call over to Nancy Lerker, President and Chief Executive Officer of EyePoint Pharmaceuticals. Thank you, George. Good morning, everyone.

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

I'll now turn the call over to Nancy Lurker.

And Chief Executive Officer of <unk> Pharmaceuticals.

Nancy Lurker: And thank you for joining us as 2021 was truly an exceptional year for EyePoint Pharmaceuticals on all fronts. Let me begin by emphasizing the continued positive momentum we had in the fourth quarter of 2021 and into 2022. We are well positioned to create long-term value for our shareholders, and we continue to execute on our goal of being the leader in off-year drug delivery. In 2021, EyePoint made transformational strides across its business. Presenting Validating Clinical Results for our LEAD Pipeline Program, EYP-1901. Significantly strengthening our balance sheet, extending our cash runway, and growing our commercial revenue.

Thank you George Good morning, everyone and thank you for joining us as 2021 was truly an exceptional year for <unk> pharmaceuticals on all fronts. Let me begin by emphasizing the continued positive momentum we have had in the fourth quarter of 2021 and into 2022.

We are well positioned to create long term value for our shareholders and we continue to execute on our goal of being that leader in ocular drug delivery.

In 2021, I point made transformational stride across our business presenting validating clinical results for our lead pipeline program <unk> 19, O one significantly strengthening our balance sheet.

Attending our cash runway and growing our commercial revenues.

Nancy Lurker: Throughout this exciting time, we remain committed to our overarching mission, which is improving the lives of patients with serious eye disorders and bringing our innovative products to patients in the United States and around the world. Prior to turning the call over to my colleagues, I'd like to highlight a few of our achievements from 2021 and this year so far. The Phase 1 Davio trial for our lead pipeline asset, EYP-1901, is a great example of our team's execution.

Throughout this exciting time, we remain committed to our overarching mission, which is improving the lives of patients with serious eye disorders, and bringing our innovative products to patients in the United States and around the world.

Prior to turning the call over to my colleagues I would like to highlight a few of our achievements from 2021 and this year so far.

The phase <unk> trial for our lead pipeline asset <unk> hundred one is a great example of our team's execution.

Nancy Lurker: EYP-1901 has the potential to be a new treatment paradigm, potentially providing patients with the substantial benefits of longer-term disease maintenance, with EYP-1901 administered every six months for a majority of patients, while supplementing, as needed, with large-molecule anti-VEGF treatments for those patients who require more intensive therapy. This is a substantial improvement from today's current treatment paradigm, where most patients are treated every month or every other month. We believe, based on Davio results, that a majority of patients can be maintained for up to six months with no supplemental therapy after an initial induction period with traditional anti-VEGF drugs.

<unk> has the potential to be a new treatment paradigm potentially providing patients the substantial benefits of longer term disease maintenance with <unk> administered every six months for a majority of patients while supplementing as needed with large molecule anti VEGF treatments for those.

Patients who require more intensive therapy.

This is a substantial improvement from today's current treatment paradigm, where most patients are treated every month or every other month. We believe based on <unk> results that a majority of patients can be maintained up to six months with no supplemental therapy. After an initial induction period with traditional anti VEGF drugs.

Nancy Lurker: EYP 1901 is a true 6-month sustained release treatment that provides a new mechanism of action with virolinib, a TKI that binds the VEGF receptor, coupled with our proven viral rotable DuraCert technology that delivers virolinib with zero-order kinetics. The combination of the new MOA and zero-order kinetics delivered with Duracert could sustain a majority of patients up to six months and greatly reduce the treatment burden for patients with wet age-related macular degeneration or wet AMD.

<unk> is a true six month sustained release treatment that provides a new mechanism of action with <unk> T.

The bind with EGF receptor sector, coupled with our proven bio erodible <unk> technology that delivers we're all in it was zero order kinetics, the combination of a new MLA and zero order kinetics delivered with terrorists or could sustain a majority of patients up to six months and.

Greatly reduce the treatment burden for patients with wet age related macular degeneration or wet AMD.

Nancy Lurker: In 2021, we dosed the first patient with EYP 1901, completed phase one trial enrollment, reported positive 30-day and three-month safety data, and presented positive interim six-month safety and efficacy data, all in under one year's time. Additionally, last month, in February, we followed up with continued positive interim eight-month safety and efficacy data at the Angiogenesis, Exudation, and Degeneration 2022 virtual meeting. We believe EYP 1901's potential to transform the treatment paradigm for wet AMD is more important than ever, as we continue to see significant unmet need across the wet AMD treatment landscape, especially in the longer duration treatment category.

In 2021, we dose the first patient with <unk> hundred one completed phase <unk> trial enrollment reported positive 30 day in three months safety data and presented positive interim six month safety and efficacy data all in under one year's time.

Additionally, last month in February we followed up with continued positive interim eight months safety and efficacy data at the angiogenesis excitation and degeneration 2022 virtual meeting.

We believe <unk> hundred one's potential to transform the treatment paradigm for wet AMD is more important than ever as we continue to see significant unmet need across the wet AMD treatment landscape, especially in the longer duration treatment category.

Nancy Lurker: AMD is a serious and potentially devastating eye disorder, accounting for approximately 90% of all AMD related blindness, but despite safe and effective FDA-approved medications on the market, treatment adherence and thus long-term compliance and effects remains an ongoing challenge for patients and physicians.

Wet AMD is a serious and potentially devastating high disorder accounting for approximately 90% of all AMD related blayne, there, but despite that safe and effective FDA approved medications on the market treatment adherence and thus long term compliance and effects remains an ongoing challenge for patients and.

Physicians.

Nancy Lurker: As Jay will discuss in more detail later in the call, we are incredibly pleased with the interim Phase 1W trial results, which showed positive safety data with no significant inflammation, as well as promising efficacy data at the 6- and 8-month follow-up so far. EYP 1901's results thus far demonstrate the sustained delivery potential of what our DuraCert technology can accomplish for patients, and we're confident that EyePoint is on the right path to becoming the leader in ocular drug delivery.

As Jay will discuss in more detail later in the call. We are incredibly pleased with the entry interim phase <unk> trial results, which showed positive safety data with no significant inflammation as well as promising efficacy data at the six and eight months follow up so far.

<unk> results, thus far demonstrate the sustained delivery potential of what our <unk> technology can accomplish for patients and we're confident that I point is on the right path to becoming the leader in ocular drug delivery.

Nancy Lurker: In December 2021, we also concluded a positive and informative Type C meeting with the U.S. FDA, and we expect to initiate our 12-month Phase II study for EYP1901 in wet AMD in the third quarter of 2022, with a first look at interim six-month results in the second half of 2023. The impressive execution and dedication demonstrated by our team to reach this milestone emphasizes the entire organization's commitment to patience, and through the EyePoint team's combined efforts, we aim to bring this innovative technology to many eyes as quickly as possible.

In December 2021, we also concluded a positive and informative type C meeting with the U S. FDA and we expect to initiate our 12 month phase III study for <unk> hundred one in wet AMD in the third quarter of 2022 with a first look at interim six month results in the second half of 2023.

The impressive execution and dedication demonstrated by our team to reach this milestone emphasizes the entire organization's commitment to patients and to the <unk> teams combined efforts. We aim to bring this innovative technology to many eyes as quickly as possible.

Nancy Lurker: In addition to advancing a Phase II trial of EYP-1901 for wet AMD, we look forward to expanding this potential paradigm-changing treatment to additional indications. For example, with a Phase II study of EYP-1901 for non-proliferative diabetic retinopathy or in... NPDR, beginning in the second half of this.

In addition to advancing a phase two trial of <unk>.

<unk> thousand $90, one for wet AMD, we look forward to expanding this potential paradigm changing treatment to additional indications with the phase III study of <unk> thousand 19, one for non proliferative diabetic retinopathy or in.

NPD are beginning in the second half of this year.

We look forward to providing you all with an update on future indications in clinical activities for <unk> thousand 19, and one in the months to come.

Nancy Lurker: We look forward to providing you all with an update on future indications and clinical activities for EYP 1901 in the months to come. Turning to our commercial product pipeline, we are very pleased to report record customer demand for both our commercial products in the fourth quarter of 2021 and a 70% increase in net product revenue compared to 2020. Additionally, we expanded our U.S. commercial alliance with ImprimisRx, which has been a strong partnership since August 2020, as we've been able to focus our efforts internally on our pipeline program while continuing to grow our commercial business despite the ongoing pandemic.

Turning to our commercial product pipeline, we are very pleased to report record customer demand for both our commercial products in the fourth quarter of 2021, and a 70% increase in net product revenue compared to 2020.

Additionally, we expanded our U S commercial aligns with Imprimis Rx, which has been a strong partnership since August 2020, as we've been able to focus our efforts internally on our pipeline program, while continuing to grow our commercial business. Despite the ongoing pandemic, we look forward to bringing our approved commercial products to more patients in need.

Nancy Lurker: We look forward to bringing our approved commercial products to more patients in need of transformative ophthalmic therapy. As you'll hear from George later on, 2021 was also an exceptional year financially, as we successfully completed two upsized follow-on equity offerings during the first and fourth quarters, raising 230 million, allowing us to end the year with over 210 million in cash and investments. Finally, we continue to grow our organization and leadership.

Of transformative ophthalmology therapies.

As Youll hear from George later on 2021 was also an exceptional year financially as we successfully completed two upsides follow on offerings equity offerings. During the first and fourth quarters, raising our $230 million, allowing us to end the year with over $210 million of cash and.

What's on hand.

Finally, we continue to grow our organization and leadership team earlier. This year, we were very pleased to announce the appointment of Michael <unk> as Chief corporate development and strategy Officer.

Nancy Lurker: Earlier this year, we were very pleased to announce the appointment of Michael Pine as Chief Corporate Development and Strategy Officer. In this role, Mr. Pine will be responsible for overseeing all of EyePoint's business development and strategy.

In this role Mr. <unk> will be responsible for overseeing all of <unk> business development and strategy. He brings almost 20 years of business development and strategy experience to <unk> pharmaceuticals, and we are thrilled to have him onboard during this exciting time in the company's evolution.

Nancy Lurker: He brings almost 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. I also want to sincerely thank our fantastic team at EyePoint Pharmaceuticals for our company's clinical, operational, and financial success to date. We've made tremendous progress in the last year, and we're so excited and motivated to advance the future of sustained ocular drug delivery.

Also want to sincerely, thank our fantastic team at <unk> Pharmaceuticals for our company's clinical operational and financial success to date, we have made tremendous progress in the last year and we're so excited and motivated to advance the future of sustained ocular drug delivery.

Nancy Lurker: 2022 promises to be another productive and rewarding year for EyePoint Pharmaceuticals, and we are committed to continuing to execute on multiple clinical catalysts and continue to strengthen our commercial business. 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.

2022 promises to be another productive and rewarding year for <unk> pharmaceuticals, and we are committed to continue to execute on multiple clinical catalysts and continue to strengthen our commercial business I'll now turn the call over to Dr. Jay Duker, Our chief operating officer to provide an update on our lead program <unk> thousand 19 on one.

As well as other pipeline initiatives Jay.

Jay Duker: Thank you, Nancy, and good morning everyone. Before I begin, I want to reiterate what an exciting point this is in EyePoint's journey. Our team is positioned to execute on multiple clinical catalysts this year as we advance our pipeline. And, as Nancy stated earlier, we're quite pleased with the results of our Phase I DAVIO 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 a standard-of-care anti-VEGF.

Thank you Nancy and good morning, everyone.

Before I begin I want to reiterate what an exciting point decision points journey.

Our team is positioned to execute on multiple clinical catalysts. This year as we advance our pipeline and.

And as Nancy stated earlier, we're quite pleased with the results of our phase <unk> 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 the standard of care anti VEGF.

Jay Duker: Our goal is to sustain the majority of wet AMD patients' treatment interval up to six months or longer. EyePoint's clinical and regulatory teams have been highly focused on successfully executing this Phase 1 trial, and the recent positive 8-month safety data and efficacy results give us increased confidence about EYP1901's 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 Duracert technology and its differentiation from alternatives in the retinal drug delivery landscape. Duracert allows for true, sustained release of a drug with steady, zero-order kinetics.

Our goal is to sustain the majority of wet AMD patients treatment interval up to six months or longer.

<unk> clinical and regulatory teams have been highly focused on successfully executing this phase one trial and the recent positive eight months safety data and efficacy results give us increased confidence about <unk> 19 to <unk> differentiated profile for safety efficacy and Todd.

Their ability in wet AMD.

Jay Duker: In its non-erodible form, DuraCert has a best-in-class proven track record of safety, tolerability, and consistent medication delivery. It has been safely administered to thousands of patients' eyes across four U.S. FDA-approved products. And the safety and efficacy results we have seen so far with the bioerodible form used in the DAWBIO trial bolster our confidence in this differentiated drug delivery system. EYP 1901 combines a bio-erodible formulation of the Dura-Cert sustained release technology I just described with virolinib, a small molecule tyrosine kinase inhibitor. Borrelia binds to the VEGF receptors, blocking all isoforms of VEGF as well as PDGF.

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

<unk> allows for true sustained release of a drug with steady zero order kinetics and its non erodible form <unk> has a best in class proven track record of safety Tolerability inconsistent medication delivery Juris.

<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 form Houston the W trial bolster our confidence in this differentiated drug delivery system.

He might be 90 to one combines a bio erodible formulation of the Dura 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 Ed, Jeff as well as PDGF.

Jay Duker: This is different from the antibody and antibody fragment molecules that are current anti-VEGFs on the market today because these bind to the VEGF ligand. Thus, this differentiated anti-VEGF mechanism of action, coupled with our bio-erodible Duracert zero-order kinetic technology, can potentially change the current treatment paradigm up to a much less burdensome approach with EYP19. Turning now to our DAWBIO study, DAWBIO is a Phase I open-label dose-escalation trial that enrolled 17 wet AMD patients across four dose groups. All enrolled patients were previously treated with standard of care anti-VEGF therapy. No re-injection with the study drug was performed during the study, and standard criteria for supplementation with the standard of care anti-VEGF were employed.

This is different from the antibody an antibody fragment molecule. So that our current anti VEGF is on the market today. These bind VEGF why gains. Thus this differentiated anti VEGF mechanism of action, coupled with our bio erodible tourists or zero order kinetic technology can potentially change the current tree.

<unk> paradigm of to a much less burdensome approach with <unk> hundred one.

Turning now to our <unk> study <unk> is a phase one open label dose escalation trial that enrolled 17 wet AMD patients across four dose groups. All enrolled patients were previously treated with standard of care anti VEGF therapy, No Reinjection with study drug was performed during.

This study and standard criteria for supplementation with the standard of care anti VEGF, where it's employed.

Jay Duker: We reported positive interim six-month safety and efficacy data for the DAVIA trial at the American Academy of Ophthalmology meeting in November of last year and updated this with eight-month data more recently in February of this year at the Angiogenesis 2022 virtual meeting. We are quite pleased with the interim results we've observed so far. Importantly, we've seen impressive efficacy and durability with over 50% of patients supplemental anti-VEGF-free for up to 6 months and 41% free up to 9 months, as well as a significant reduction in treatment burden for patients.

We reported positive interim six month safety and efficacy data of the <unk> trial at the American Academy of Ophthalmology meeting in November of last year and updated this with eight months data more recently in February of this year at the angiogenesis 2022 virtual meeting.

We are quite pleased with the interim results we've observed so far.

<unk>, we've seen impressive efficacy and durability with over 50% of patients supplemental anti VEGF free up to six months and 41% free up to nine months as well as the significant reduction in treatment burden for patients 79% reduction.

Jay Duker: 79% reduction at six months and 75% reduction at eight months. Additionally, we saw stable visual acuity and central subfield thickness as measured by OCT, with the updated eight-month data showing best corrected visual acuity of minus three ETDRS letters and central subfield thickness on OCT of approximately plus 13 microns. Furthermore, as demonstrated in the six-month data release, the eight-month data highlighted positive safety with no ocular serious adverse events and no drug-related systemic SAE. Furthermore, no dose-limiting toxicity, no retinal detachments, no cases of endophthalmitis, no occurrence of implant migration in the anterior chamber, or any significant ocular inflammation was reported.

At six months and 75% reduction at eight months.

<unk>, we saw stable visual acuity and central subfield thickness as measured by OTT with the updated eight months data showing best corrected visual acuity of minus three <unk> letters and central subfield thickness on OTT of approximately plus 13 microns.

Furthermore, as demonstrated in the six months data release, the eight months data highlighted positive safety with no ocular serious adverse events and no drug related systemic sce's.

Furthermore, no dose limiting toxicity no retinal detachments no cases event at the Midas no occurrence of implant migration at the inter chamber or any significant ocular inflammation was reported.

Jay Duker: Taken together, these promising early data represent EYP 1901's differentiated clinical profile as a potential six-month treatment in the wet AMD treatment landscape. As Nancy mentioned, we plan to initiate a randomized controlled Phase 2 study of UIP-1901 for previously treated wet AMD in the third quarter of this year. The WET-AMD Phase II trial is expected to enroll 144 patients randomly assigned to one of two doses of EYP-1901, either approximately 2 milligrams or approximately 3 milligrams, or a Fliverset control with an efficacy endpoint of change in best corrected visual acuity, change in central subfield thickness as measured by OCT, time to first supplemental anti-VEGF, and overall safety.

Taken together these promising early data represent <unk> differentiated clinical profile as a potential six months treatment in the wet AMD treatment landscape.

As Nancy mentioned, we plan to initiate a randomized controlled phase two study of <unk> thousand 19 of one for previously treated wet AMD in the third quarter of this year.

The wet AMD phase two trial is expected to enroll 144 patients randomly assigned to one of two doses of <unk> thousand 19 O. One either approximately two milligrams for approximately three milligrams or a flipper set control with efficacy endpoint of change in best corrected visual acuity change in central subfield thickness.

Sure by OTT timed to first supplemental anti VEGF and overall safety.

Jay Duker: Looking ahead, we anticipate sharing interim six-month data from this phase two trial in the second half of 2023. We are also working towards clinical trial initiation, exploring the potential application of EYP1901 for the treatment of other severe eye disorders, including non-proliferative diabetic retinopathy and retinal vein occlusion. In the second half of this year, we plan to initiate a Phase 2 trial of EYP1901 in non-proliferative diabetic rhinopathy.

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

We are also working towards clinical trial initiation exploring the potential application of <unk> thousand 19, one for the treatment of other severe eye disorders, including non proliferative diabetic retinopathy and retinal vein occlusion.

In the second half of this year, we plan to initiate a phase two trial of <unk> hundred one in non proliferative diabetic retinopathy, we will continue to provide clinical updates on these additional indications throughout the year as a rapidly growing pipeline advances.

Jay Duker: 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. Thank you, Jay.

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

Thank you Jay.

Scott Jones: We're excited to report a strong year for our commercial businesses with $35.3 million of net product revenue, a 70% increase compared to 2020, including record customer demand for both of our commercial products in the fourth quarter of 2021. We're pleased to see patients return to their doctor's offices and schedule their previously delayed surgeries and procedures. Our Q4 net product revenue for Utique and Dexacube was $5.8 million and $5.4 million, respectively.

Excited to report a strong year for our commercial businesses with $35 3 million of net product revenue, a 70% increase compared to 2020, including record customer demand for both of our commercial products in the fourth quarter of 2021.

Scott Jones: Customer demand was approximately 13,800 units of Dexacube and 650 units of Utique compared to approximately 13,200 units and 555 units, respectively, for Q3 2021 customer demand. Demand for DEXECUE stemmed from our strong commercial presence and our collaboration with our commercial alliance partner, Informis Rx. We were pleased to expand the original partnership that was established in August 2020 when, in the fourth quarter of 2021, we announced an expanded US commercial alliance for DEXECUE.

We're pleased to see patients returned to their doctor's offices and scheduled were previously delayed surgeries and procedures.

Our Q4 net product revenue for Utica, and execute was $5 8 million and $5 4 million respectively.

Customer demand was approximately 13800 units have to execute and 650 units a boutique compared to approximately 13200 units and 550000 units respectively for Q3 2021 customer demand.

Demand for <unk> stemmed from a strong commercial presence and our cooperation with the commercial launch.

From a SAR rates, we were pleased to expand the original partnership that was established in August 2020, when in the fourth quarter of 2021, we announced an expanded U S commercial launch would execute.

Scott Jones: Under the terms of the amended agreement, IMPROMIS-Rx gains full responsibility for U.S. sales and marketing activities at Dexacue, and they absorb the majority of EyePoint's Dexacue commercial organization. EyePoint Pharmaceuticals will retain the Dexacue NDA, revenue recognition, manufacturing, and distribution responsibility for all markets. Customer demand for Utique remains strong, in part as a result of the improved siliconized needle our commercial team rolled out last year, providing a consistently improving procedural experience for physicians and patients. We're incredibly pleased by the progress we've made this past year with our commercial businesses.

Under the terms of the amended agreement <unk> gains full responsibility for U S sales and marketing activities to execute and to absorb the majority of high points execute commercial organization.

<unk> pharmaceuticals will retain that execute NDA revenue recognition manufacturing and distribution responsibility for all markets customer demand for you take remained strong in part a result of the improved siliconized needle all customer team commercial team rolled out.

Last year.

Adding a consistently improving procedural experience for physicians and patients.

We're incredibly pleased by the progress we've made this past year with our commercial businesses.

George Elston: EyePoint's mission is to provide a unique, sustained delivery system across all of our products that requires fewer visits to the doctor's office, a key attribute of each product's value proposition that both patients and doctors rely on. We'd also like to thank all of our patients and physicians for their continued support and use of our products. 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 discuss the financials. George?

Submission to provide a unique sustained delivery system across all of our products while requires fewer visits to the Doctor is also a key attribute of each product's value proposition that both patients and doctors reward. We'd also like to thank all of our patients and physicians for their continued support and usable product we look forward to update.

Are 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 George.

George Elston: Thank you, Scott. As the financial results for the three months and full year ended December 31, 2021, were included in the press release issued this morning, my comments today will be focused on a high-level review of the quarter. To begin, in November 2021, we executed an upsized underwritten public offering with gross proceeds of $115.4 million, bringing total equity financing to over $230 million last year. Funds raised provide us with additional capital to roll out our pipeline strategy and strategically pursue potential opportunities for the company's future growth.

Thank you Scott.

George Elston: For the quarter ended December 31st, 2021, total net revenue was $11.5 million compared to $7.1 million for the quarter ended December 31st, 2020. Net product revenue for the quarter was $11.1 million compared to net product revenues for the fiscal year ended December 31, 2020 of $6.7 million. Net revenue from royalties and collaborations for the quarter ended December 31, 2021 totaled $0.4 million compared to $0.5 million in the corresponding period in 2020

As the financial results for the three months and full year ended December 31, 2021 were included in the press release issued this morning. My comments today will be focused on a high level review for the quarter.

George Elston: Operating expenses for the quarter ended December 31st 2021 totaled $29.6 million versus $19.9 million in the prior year period. This increase was primarily due to a 3.7 million increase in R&D expense, 3.4 million increase in G&A expense, 2 million increase in sales and marketing expense, and a $0.6 million increase in cost of sales. Non-operating expense net totaled $1.4 million, and the net loss was $19.4 million or $0.59 per share compared to a net loss of $11.5 million or $1.07 per share for the prior year period.

To begin in November 2021, we executed an upsized underwritten public offering with gross proceeds of.

$115 4 million, bringing total equity financings to over $230 million last year.

The funds raised provide us with additional capital to rollout our pipeline strategy and strategically pursue potential opportunities for the companys future growth.

For the quarter ended December 31, 2021, total net revenue was $11 5 million compared to $7 1 million for the quarter ended December 31 2020.

Net product revenue for the quarter was $11 1 million compared to net product revenues for the fiscal year ended December 31, 2020 of $6 $7 million net.

Net revenue from royalties and collaborations for the quarter ended December 31 2021.

$4 million compared to $5 million in the corresponding period in 2020.

Operating expenses for the quarter ended December 31, 2021 totaled $29 6 million versus $19 9 million in the prior year period.

This increase was primarily due to a one.

$3 7 million increase in R&D expense of $3 4 million increase in G&A expense of $2 million increase in sales and marketing expense.

And a $6 million increase in cost of sales.

Nonoperating expense net totaled $1 4 million and net loss was $19 4 million or 50.

<unk> 59 per share compared to a net loss of $11 5 million or $1 seven per share for the prior year period.

George Elston: Turning to the full year ended December 31st, 2021, total net revenue was $36.9 million compared to $34.4 million for the full year ended December 31, 2020. Net product revenue for the full year ended December 31, 2021 was $35.3 million compared to net product revenues for the full year ended December 31, 2020 of $20.8 million. Net revenue from royalties and collaborations for the full year ended December 31, 2021 totaled $1.6 million compared to $13.6 million in the corresponding period in 2020.

Turning to the full year ended December 31 2021.

Total net revenue was $36 9 million compared to $34 4 million for the full year ended December 31 2020.

Net product revenue for the full year ended December 31 2021.

Was $35 3 million compared to net product revenues for the full year ended December 31, 2020 $28 million.

Net revenue from royalties and collaborations for the full year ended December 31 2021.

Total $1 6 million compared to $13 6 million in the corresponding period in 2020.

George Elston: Operating expenses for the full year ended December 31, 2021 totaled $92.2 million versus $71.7 million in the prior year period. This increase was largely due to an $11.1 million increase in R&D expense, a $4.8 million increase in G&A expense, a $2.4 million increase in cost of sales, and a $2.2 million increase in sales and marketing expense. Non-operating expense net totaled $3.1 million, and the net loss was $58.4 million or $2.03 per share compared to a net loss of $45.4 million or $3.54 per share in the prior year period.

Operating expenses for the full year ended December 31, 2021 totaled $92 2 million versus $71 7 million in the prior year period. This increase was largely due to an $11 1 million an increase in R&D expense, a $4 8 million increase in G&A expense of $2 4 million.

Increase in cost of sales and a $2 2 million increase in sales and marketing expense.

Nonoperating expense net totaled $3 1 million and net loss was $58 4 million or $2 <unk> per share compared to a net loss of $45 4 million or $3 54 per share in the prior year period.

Operator: Cash and Investments on December 31, 2021 totaled $211.6 million compared to $44.9 million on December 31, 2020. We expect the cash and investments on hand. At on December 31st, 2021 and expected 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 2021 and are well capitalized to advance our product pipeline to key value inflection points.

Cash and investments on December 31, 2021 totaled $211 6 million compared to $44 now.

$9 million on December 31, 2020.

We expect the cash and investments on hand.

On December 31, 2021, and expected cash inflows from our product sales will enable us to fund our current and planned operations into the second half of 2024.

In conclusion, we are pleased with <unk> progress in 2021 and are well capitalized to advance our product pipeline to key value inflection points.

Operator: Thank you all very much for listening this morning, and I now turn the call over to the operator for questions. Certainly. Ladies and gentlemen, if you have a question at this time, please press star and then one on your touchtone telephone. If your question has been answered and you'd like to remove yourself from the queue, please press the pound key.

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

Certainly ladies and gentlemen, if you have a question at this time. Please press Star then one on your Touchtone telephone. If your question has been answered and you'd like to remove yourself from the queue. Please press the pound key our first question comes from the line of Jennifer <unk> from Cantor Fitzgerald. Your question. Please.

Jennifer Kim: Our first question comes from the line of Jennifer Kim from Cantor Fitzgerald. Your question, please. Hey, everyone. Good morning.

Nancy Lurker: Thanks for taking my questions, and congrats on some really amazing progress since your last earnings. I have a few questions here. First, I'm wondering what your thoughts are on, I guess, some of the recent shortfalls we've seen from competitors like Kodiak, and what that means for you guys? And on a similar vein, what are your thoughts ahead of potential TKI competitors that could come up with some Phase I data in the second half of this year? And then my second question is, on your cash runway, does that include the RVO trial still set for the first quarter of next year? Thanks. Hi Jennifer, it's Nancy.

Hey, everyone. Good morning, Thanks for taking my questions and congrats on some really amazing progress since your last earnings I have a few questions here.

First I'm wondering what are your thoughts on.

I guess some of the recent shortfalls, we've seen from competitors like Kodiak and what does that mean for you guys and on a similar vein. What are your thoughts ahead of potential teekay at competitors that could come up with some phase one data in the second half of this year and then my second question is.

On your cash runway does that include the RVO trials still set for the first quarter of next year. Thanks.

Nancy Lurker: Okay, so I thought I heard three questions. One is, I believe you said, the recent Kodiak data and how that might affect our thoughts on that, if I'm correct. Yeah, or the competitor shortfalls, and then other TKIs coming up, their data readouts, and then last is cash, which George will handle. Let me give a quick overview, and then Jay can discuss it more in depth. I want to be very careful because, obviously, I don't really want to get into data on our competitors. It's just an A; it's not appropriate.

Hi, Jennifer it's Nancy.

I thought I heard three questions. One is I believe you said the recent kodiak data and how that might or thoughts on that if I'm correct.

Are the comparator shortfalls.

And then other pki's coming up their data readout and then last is on cash, which George will handle let me give a quick overview and then Jay can opine.

More in depth I want to be very careful because obviously I don't really want to get into data on our competitors. It's just a it's not appropriate b, we certainly don't have insights like they do.

Nancy Lurker: B, we certainly don't have insights like they do. Just generally speaking, you know, if you look at what's been happening, unfortunately, and I think it is difficult for patients, and I would say physicians, and investigators, that, you know, this is a tough landscape. It's a tough field to be in, and unfortunately, you're seeing dropouts occur with companies struggling with either drug delivery technology or just their APIs, their active drugs, which are just not able to either have safe profiles or they can't hit efficacy endpoints.

Just generally speaking.

Look at what's been happening.

Unfortunately, I think it is difficult for patients and I would say physicians and investigators.

This is a tough landscape tough.

<unk> to be in and so unfortunately, youre seeing dropouts occur with companies struggling with either drug delivery technology or just there Derek.

API or active drugs, which are just not able to either have safe profiles or theyre, just they can't hit efficacy endpoints.

Nancy Lurker: So, you know, you're starting to see this field really start to whittle down. Obviously, we had very good phase one results; our eight and nine month data continue to look really good. So, you know, we have fewer competitors.

You're starting to see this field really start to whittle down.

Obviously, we had very good phase one results are eight nine month data look continue to look really good so we have fewer competitors.

Nancy Lurker: Ultimately, that's probably good for us, but I don't think it's good for the community overall. As for the other TKIs, look, we look forward to their readouts. I think that what you'll see is, as more TKIs read out, you're going to start to see how validated the tyrosine kinase inhibitor target is. Now, serving, we've seen with not only our varolinib TKI, but the oral wet AMD study that our partner did, it showed efficacy in wet AMD, and delivered it for Ocularly.

Ultimately, that's probably good for us, but I don't think it's good for the community overall.

On as to the other <unk>, we look forward to their Readouts I think that what Youll see is.

As more Teekay I've read out youre going to start to see how validated as a tyrosine kinase inhibitor target certainly.

Certainly you've seen with.

Not only with our.

Roanoke PKI with the overall wet AMD study that.

Our partner did it showed efficacy in wet AMD and delivered it for Ocularly.

Nancy Lurker: That was an oral study, though. And then we just announced, obviously, our DAWEO studies, which confirmed efficacy in wet AMD. If you look at the others, you know, I'll name them, ClearSide, and Ocular, they both have shown good results with their TKI so far, and I would even say GrayBug did.

That was an oral study, though and then we just announced obviously, our <unk> studies, which confirmed efficacy in wet AMD. If you look at the others that are named in clear sight ocular they both have shown.

Good results with their Teekay I, so far and I would even say, great, but theyre, probably more a joint delivery issue.

Nancy Lurker: Their problem was more a drug delivery issue. So I think that the target has been validated, which is terrific. Because, again, you want to be able to give different targets, mechanisms of action for physicians to use on patients and not just continue to have only one target. Now, again, if you look at the large molecules, they attach at the ligand level.

I think that the.

Target has been validated which is terrific because again you want to be able to give different target mechanisms of action for physicians to use on patients and not just continue to have only one target. Yes again, if you look at the large molecules they attach it to ligand level to <unk>.

Nancy Lurker: The TKIs, as you know, attach at the receptor level, and they cover a much broader number of kinase receptors. We don't know the effects of all those, but certainly there are some hints that you might have some positive differentials there. So I think it's good that we have different targets for patients that physicians can use. And so far, the TKA targets look quite good. I'm gonna ask Jay if he wants to add anything to that. Well, hi Jennifer.

Attach at the receptor level and they cover a much broader number of.

Chinese receptors, we don't know the effects of all those but certainly there is some hints that you might have some positive differentials. There. So I think it's good that we have different targets for patients that physicians can use and so far the TK targets look quite good I'm going to ask if Jay wants to add anything to that.

Hi, Jennifer Nancy summarized it really well at the high end.

Jay Duker: Nancy, you've summarized it really well. You know, at the high end, what we're all trying to do here is really thread the needle of safety and improved efficacy or longevity for our patients. But with respect to what our EYP-1901 is looking for, it really isn't to be the next ILEA or the next Faricimab. We are really looking at our drug being a maintenance therapy, taking patients who are stable but unable to be treated less frequently than, say, a month or two, and hopefully taking the majority of them and able to treat them much less frequently, maybe up to every six months or even longer.

What we're all trying to do here is really thread the needle of safety and improved efficacy or longevity for our patients.

But with respect to what our.

<unk> thousand 900 <unk>.

He is looking for it really isn't to be a the next eylea or the next for risk map.

We're really looking at our drug being a maintenance therapy, taking patients who are stable, but unable to be treated less frequently than say a month or two and hopefully taking the majority of them and able to treat that much less frequency.

Frequently maybe up to every six months or even longer.

Jay Duker: So while, again, the failure of CODIACS phase three is disappointing for practitioners and patients in the community, there are some learnings for us as well in how we may choose to design our pivotal trial. And again, as you all know, this is a very big space. And so having, you know, active competitors is fine, and it probably pushes us all forward to really improve things for our patients. The other question, I think, was financial.

So while again the failure and Kodiak phase III is disappointing for practitioners and patients and the community. There are some learnings for us as well.

How we may choose to design a pivotal trial.

And again as you all know this is a very big space and so having.

Sure.

Active competitors.

<unk> is fine and it probably pushes us all forward to really improve things for our patients.

The other question I think was financial.

George Elston: Hi Jennifer and George, thank you for dialing in. So, yeah, we, on our cash guidance today, into the second half of 24, that premise does include the initiation of three phase two studies with 1901 in wet AMD, non-proliferative diuretic retinopathy, and then RVO, and the way we've managed the business in the process is we've always wanted to have at least one year of cash on hand when that wet AMD study reads out, and that's sometime New York, NY Transcripts provided by Transcription Outsourcing, LLC.

Hi, Jennifer George.

The dialing in so yes, we on our cash guidance today into the second half of 'twenty four.

That premise does include the initiation of.

Three studies three phase II studies with 19 in one in wet AMD.

Proliferative diabetic retinopathy, and then RVO at some point next year and.

Our the way, we manage the business and the processes. We've always wanted to have at least one year of cash on hand, when that wet AMD study reads out and Thats sometime in the second half of next year, which we updated on our earnings release. This morning.

Scott Jones: Okay, thanks. If I could sneak one more in for Scott, was there anything that particularly drove Utica and Dexacue's sales this quarter? Was this more of a one-time pent-up demand, or is this demand sustainable? Thanks. Thank you Jennifer for the question. We certainly hope that the demand is sustainable. Obviously, we know there is some seasonality in the ophthalmology market, especially as a Medicare market where patients are trying to get all their procedures in for the end of the year and their benefits reset at the beginning of the year. So we do see some seasonality, but we've seen a pretty consistent growth curve despite the pandemic, and we certainly think that that will continue moving forward, and certainly that is our hope. Okay, great. Thanks, everyone.

Okay. Thanks, if I could sneak one more in for Scott was there anything that particularly drove you to can to execute sales. This quarter was this more of a onetime pent up demand or is this demand sustainable. Thanks.

Thank you Joseph for the question, we certainly hope that the demand is sustainable obviously, we know there is some seasonality in the ophthalmology market.

Especially as the <unk>.

Medicare market, where patients are trying to.

Get all the procedures and for the end of the year.

Are there benefits reset at the beginning of the year. So we do see some seasonality, but we've seen a pretty consistent growth. Despite the pandemic and we certainly think that that will continue moving forward certainly that is our hope.

Okay, great. Thanks, everyone.

Operator: Thank you. Our next question comes from Georgia Yordanoff from Cowan. Your question, please. Hey guys, thank you so much for taking our questions and congratulations on all the progress. So maybe to start, could you talk about some of the initial observations from the Phase 1 trial that you had some longer follow-up period for 1901, specifically, there were patients who saw vision improvement despite the presence of fluctuating subretinal fluid.

Thank you. Our next question comes from the line of Joe Giordano from Cowen Your question. Please.

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

Operator: How do you explain this result and also how do you think some of these observations could change medical practice, especially once we start having multiple longer-acting options on the market? And then just to follow up on the competitive disclosure question, one of the things that we found interesting from that data was that it did seem like it was confirmation that there is a sizable subset of wet AMD patients who are inadequate VEGF responders and could really benefit from a broader mechanism such as a TKI.

So maybe to start could you talk about some of the initial observations from the phase one trial.

<unk> had some longer follow up periods for <unk>, specifically, there are patients who saw vision improvement. Despite the presence of coach leading sub retinal fluid. How do you explain this result, and also how do you think some of these observations could change medical practice, especially once we start having multiple longer.

<unk> options on the market.

And then.

Just to follow up on the competitive disclosure.

<unk> one of the things that we found interesting from that data was that it did seem like.

It was a confirmation that there is.

Sizable subset of wet AMD patients, who are inadequate responders could really benefit from our broader mechanisms such as the T. Cai.

Operator: Maybe if we could just hear your thoughts on this and if you thought that this was kind of like possible to see from their data and really the potential size of that patient population of inadequate VEGF responders in wet AMD. Well, those are excellent questions, and I'll try to start at the top.

Maybe if we can just curious thoughts on on destiny.

Thought that this was kind of like possible to see from their data.

Really the potential size of that patient population of inadequate VEGF responders in wet AMD.

Jay Duker: And you asked about learnings from our phase one trial. First of all, you know, we're very pleased that there were really no safety signals at all because it's very clear in this space. If you don't have safety, it doesn't matter what your efficacy looks like. And I would say so far, so good with an NF17 and a follow-up, you know, getting close to 10 months in everybody. Things look quite good.

Well those are excellent questions.

I'll try to start at the top and you asked about learnings from our phase one trial first of all we're very pleased that there were really no safety signals at all because it's very clear in this space.

You don't have safety it doesn't matter what your efficacy looks like.

I would say so far so good with an end of 2017 and a follow up getting close to 10 months and everybody things look quite good.

Our other learnings are there is a significant percentage of wet AMD patients that appear to be able to be maintained with our drug for six months or longer without any supplemental anti VEGF and maintained beans, again, primarily visual acuity.

Jay Duker: Our other learnings are, there's a significant percentage of wet AMD patients that appear to be able to be maintained with our drug for six months or longer without any supplemental anti-VEGF therapy. And maintained means again, primarily visual acuity. Fluid is important, and we use fluid via OCT as a marker for VEGF activity. But there is not a one-to-one relationship. We've known that for years.

Fluid is important and we use fluid via OTT as a marker for VEGF activity, but there is not a one to one relationship we've known that for years you can go way back in the earliest anti VEGF in OTT study show that the correlation coefficient between retinal thickness.

Jay Duker: You can go way back; the earliest anti-VEGF and OCT studies show that the correlation coefficient between retinal thickness and vision is only about 0.6, which means it's good, not great. And we all have patients with a little bit of subretinal fluid who see pretty well. Stability in visual acuity and stability in anatomy is what we're trying to accomplish with EYP 1901. We also heard from the recent Regeneron high dose study that 50% of ILEA patients still have fluid in their bodies, the current dose of ILEA, even when they are treated monthly.

Tennis and vision is only about <unk>, six which means it's good not great and we all have patients with a little bit of separate more fluid who see pretty well.

Stability in visual acuity in stability and Adam Anatomy is what we're trying to accomplish with VIP 19 O. One we.

We also heard from the recent Regeneron Hydro study that 50% of Eylea patients still have fluid the current dose of eylea, even when treated monthly so we strive to get our patients dry, but theres a lot of patients out there that you just can't get all the fluid to go away and if it is a little.

Jay Duker: So we strive to get our patients dry, but there are a lot of patients out there that you just can't get all the fluid to go away. And if it's just a little sliver of subretinal fluid, that actually may be okay.

Sliver of separate in the fluid that actually may be okay. So again, what we're trying to do is not necessarily drive better we're trying to keep patients stable longer.

Jay Duker: So again, what we're trying to do is not necessarily dry up better. We're trying to keep patients stable long-term. Your second question was about learnings from, Oh yeah, so yeah, you know, again, I think specifically you were asking about Kodiak's results, and given that that, We're really just looking at a slide deck and press releases, it's hard to really know for sure, but you're looking at the early OCT data when the Kodiak drug was given monthly.

Your second question was about learnings from.

Inadequate Vinci Oh, yes so.

Again, I think specifically you are asking about Kodiak results.

And given that.

Just looking at our slide deck and press releases, it's hard to really know for sure but youre looking at the early OTT data when when the Kodiak drug was given monthly it does look like they are not as good at improving visual acuity and OTT as Eylea is now that's not to <unk>.

Jay Duker: It does look like they are not as good at improving visual acuity in OCT as Hylia is. Now that's not to say that a certain percentage of patients can't do well long-term with their drug, but that's not how they tested it.

Say that a certain percentage of patients can't do well long term with their drug, but that's not how they tested they tested it is naive patients all commerce.

Jay Duker: They tested it as, you know, naive patients all common. And for a good percentage, it looked like over 50%, you know, they could be maintained long term. But the problem is, there were another 40% that really overall did not do as well with the drug as ILEA. That's how I interpret the data. So yeah, we've known for a long time, number one. Yatin Suneja, Yi Chen, David Lally, Richard Wan, Ramiro Ribeiro, and others, you know, you can dry them up, and then they can go three months and sometimes even longer.

First a good percentage it looked like over 50% they could be maintained long term, but the problem is there was another 40% that really overall did not do as well with the drug as eylea that that's how I interpret the data. So yes, we've known for a long time the number one.

Determinant in the fluid free interval in a patient is not the drug it's the patient and there are some patients who have probably a high VEGF load if they need a lot of anti VEGF since some of those you can treat a monthly with the best drying agent out there and those still going to have fluid.

Others, you can dry them up and then they can go three months and sometimes even longer.

Jay Duker: But the trouble is, that's only a minority of the patients with the current products available. And that's what we're trying to help, get it from, you know, 20%, 30%, perhaps who can go three months or longer to 60% or more who can go longer than that. And all along, again, one of our goals is to try to identify the patients who are going to do well with our drug and direct the physicians, hopefully once we have a label, to say, these are the patients who you're going to do really well with, that's the ones you want to treat with 1901.

But the trouble is is thats only a minority of the patients with the current products available and Thats what were trying to help us get it from 20%, 30%, perhaps who can go three months or longer to 60% or more who can go longer than that in all along again one of our goals is to try to identify the patients who are going to do.

Well with our drug and direct the physicians hopefully once we have a label to say these are the patients who are going to do really well with that's the ones you want to treat with $19 one.

Jay Duker: Yorgi, let me just add to that as well, and I'm going to see if Jay can comment further on this, which is one of the other things that we've talked about, I want to emphasize, and it's a little bit back to your question about whether patients could benefit from a different mechanism of action. That's where we believe we're trying to change the thinking and potentially the treatment paradigm. Not only will these patients get on these longer-acting extended delivery therapies like EYP1901, but then you just continue to have that on board every six months. Some of these patients might need supplemental support from a large molecule antibody occasionally, some more than others.

Let me just add to that as well and I'm going to save Jake can comment further on that switches.

One of the other things that we've talked.

Talking about I want to emphasize and it's all of it back to your question of that patients benefit from a different mechanism of action.

That's where we believe we are trying to change the.

The thinking and the potentially the treatment paradigm.

Not only will these patients get on these longer acting extended delivery therapies like <unk> thousand 19 on one but then you just continue to have that onboard every six months. Some of these patients might need supplemental support from a large molecule antibody occasionally some more than others, but you continue to have that.

Nancy Lurker: But you continue to have the tyrosine kinase inhibitor, hopefully EYP1901, on board providing that protective maintenance therapy longer term. So again, it's not back to you either putting a patient on this drug or that drug. In some cases, it might be that we think a majority of patients. You continue to have EYP1901 on board after the patient's been treated and is dry or relatively dry as it can

The tyrosine kinase inhibitor, hopefully wiping 19, one onboard providing that protective maintenance therapy longer term. So again, it's not back to you either put a patient on this drug or that drive in some cases it might be that we think a majority of patients you continue to have <unk> 91 on board after.

The patient has been treated and dry a relatively dry it can get and then you provide the supplemental therapy as needed.

Jay Duker: And then you provide supplemental therapy as needed if they can't be maintained. But we do think a majority of patients will be able to be maintained. I'm going to see if Jay wants to comment on that. Yeah, no, I think that summarized it really well.

If they cant be maintained but we do think the majority of patients will be able to be maintained I'm going to see if jay wants to comment.

I think that summarized it really well and obviously it in other areas of medicine. This is quite common.

Jay Duker: And obviously, in other areas of medicine, this is quite common. Look at high blood pressure, for example, and so there are a lot of analogies out there for saying you've got a way to keep a lot of patients on, hopefully, a safe and effective drug. But even if some of the patients break through with a little fluid, they're still at an advantage with a different mechanism of action where you can add another drug on top of that, but hopefully with a much less onerous schedule than what they were on. That's the goal. Thank you so much. That was really great.

We look at high blood pressure for example.

And so that there are a lot of analogies out there for seeing you've got a way to maintain a lot of patience on hopefully a safe and effective drug, but even if some of the patients break through with a little fluid.

There is still at an advantage with a different mechanism of action, where you can add another drug on top of that but hopefully with a much less onerous schedule as what they were on before that's the goal.

Thank you so much dose that was really great and again congratulations on all the progress.

Thank you.

Operator: And again, congratulations on all the progress. Thank you. Thank you. Our next question comes from the line of Yatin Suneja from Guggenheim. Your question, please. Hi, this is Eddie.

Thank you. Our next question comes from the line of your teams in Asia from Guggenheim. Your question. Please.

Eddie Hickman: I'm for Yatin. Thank you guys for taking my question this morning, and congratulations on the quarter. Just a few for me.

Yes, Hi, this is Eddie on for yacht and Thank you guys for taking my question. This morning, and congrats on the quarter. Just a few for me can you remind us if they're using the same injection device and procedural techniques in the phase two as you did in <unk> and if there any other changes youre, making to the learnings from <unk>, including how you are thinking about patient selection and avoiding potential non responders.

Jay Duker: Can you remind us if we're using the same injection device and procedural techniques in Phase 2 as you did in Dalvio and if there are any other changes you're making due to learnings from Dalvio, including how you're thinking about patient selection and avoiding potential non-responders? And then, just as a follow-up, are you thinking about adding an arm in any future studies where you put in the device earlier, before six months, or a six-month interval, the goal across all the proposed indications? Thanks.

And then just as a follow up are you thinking about adding an arm in any future studies, where you put in the device earlier before six months in six months intervals goal across all of the proposed indications. Thanks.

Jay Duker: So great questions, thank you. First of all, yes, we've learned quite a bit even from the 17 patients that we enrolled in Davio. And just to remind everybody, our drug is delivered in the office intravitrially, a single injection with local anesthesia. It is a 22 gauge needle, and we are able to inject up to three inserts with a single injection.

So great questions. Thank you.

First of all yes.

We've learned quite a bit even from the 17 patients that we enrolled into aveo and just to remind everybody. Our drug is delivered in the office introvert truly a single injection with local anesthesia. It is a 22 gauge needle and we're able to inject up to three.

Jay Duker: So the medium dose for our phase 2 wet AMD trials, approximately two milligrams, that would be two inserts. The high dose for the Phase II is approximately three milligrams, so obviously three inserts. We do need to educate the investigators on the fact that injecting three inserts takes a few seconds to do successfully, as opposed to a liquid which can be injected in very, very rapidly with a quick bolus into the eye. That's really the only, I would say, any kind of change from the standard injection that retina specialists are used to. From the perspective of the interval.

Inserts with a single injection so the medium dose for our phase II wet AMD trials approximately two milligrams that would be two inserts the high dose for the phase II is approximately three milligrams. So obviously three inserts.

We.

Do need to educate the investigators on the fact that injecting three inserts takes a few seconds to do successfully as opposed to.

Illiquid, which can be injected in.

Three very rapidly with a quick bolus into the eye.

That's really the only I would say.

Any kind of change from the standard injection that retina specialists are used to.

From the perspective of.

The intervals.

Jay Duker: I don't think it's likely that we would study an interval less than every four months. And we may not, you know, again, in full disclosure, even look at every four months. We certainly believe that the sweet spot for our drug and for what retina specialists want is every six months. In saying that, we clearly can go longer than six months with some patients. In Davio, we got 41% out to nine months.

I don't think it's likely that we would study an integral less than every four months and we may not again in full disclosure even look at every four months. We're certainly believes that the sweet spot for our drug and for what retina specialist want is every six months in saying that.

We clearly can go longer than six months with some patients and <unk>, we got 41% out to nine months so that.

Jay Duker: So this is, you know, again, in the retina, we call this individualized therapy. I think that if we get a label and are used, doctors will figure out which patients can go for how long in kind of a modified treat and extend version of what they're used to. But if our drug is differentiated by both the delivery system and methods of action from what we have out there.

This is again.

We call. This individualized therapy, I think that if we get a label and we're being used I think the doctors will figure out which patients can go how long in kind of a modified treat and extend version of what they are used to.

But if our drug.

<unk> is differentiated by both the delivery system and methods of action from what we have out there.

Jay Duker: And injecting it monthly or every other month would not really be that differentiated. So again, I think we have a lot of potential schedules for the injections that we're going to look at in the future. And we're going to let the data and the market drive where we go with that. Thanks.

<unk> it monthly or every other month would not really be that differentiate it so.

Again, I think we have a lot of potential schedules for the injections that were going to look out in the future and we're going to let the data and the market drive where we go with that.

Jay Duker: And then can you just talk about the imaging criteria or how you might be enriching the population? Oh, sure. Yeah, I'm sorry.

Thanks, and then can you just talk about the inclusion criteria or how you might be enriching sure.

Jay Duker: Yep, so, if you look at our phase one data, the 17 patients, we had three patients who required supplemental anti-VEGF at month one. Now, just to remind everybody, everybody in that study had previously been treated for wet AMD, they could have had fluid coming in or no fluid, it didn't matter, but everybody got a standard of care injection on day zero. And about a week later, they got 1901.

Yes. So there were clearly if you look at our phase one data of the 17 patients we had three patients who required a supplemental anti VEGF at month, one now just to remind everybody everyone. In that study had previously treated wet AMD. They could have had fluid coming in or no fluid it didn't matter.

But everybody got a standard of care injection on day zero and about a week later, they got 19 O. One so if they had 75 microns of new fluid or more at month. One that was five weeks after standard of care injection. So what that tells US is those eyes. They werent doing well not just with 19, one they werent doing well with standard of care.

Jay Duker: So, if they had 75 microns of new fluid or more at month one, that was five weeks after a standard of care injection. So, what that tells us is that those eyes weren't doing well not just with 1901, they weren't doing well with standard of care. And again, I think it's logical to assume that the investigators are not going to put their best patients who are doing well into a phase one trial of a new drug.

Sure.

Again, I think it's logical to assume that the investigators are not going to put their best patients who were doing well into phase one trial of a new drug they're going to put the patients who aren't doing well and I think thats, our <unk> skewed towards that and in those patients.

Jay Duker: They're going to put the patients who aren't doing well. And I think that our DAVIO trial skewed towards that end, and those patients, you know, obviously are evidence of that. So, in doing the analysis of who did well and who didn't, it certainly looks like patients who have been previously treated but still have more than 400 microns of CSD are patients who are failing, in my mind, standard of care also, and they're probably not going to do as well with our drug.

Obviously are evidence of that so in doing the analysis of who did well and who didn't.

It certainly looks like patients who had been previously treated but still have more than 400 microns of CST. Those are patients who are failing in my mind standard of care also and they're probably not going to do well on our drug now you could argue well maybe if they are being treated monthly and still have 400 microns with CST and you put 19, one on board maybe you.

Jay Duker: Now, you could argue, well, maybe if they're being treated monthly and still have 400 microns of CSD and you put 1901 on board, maybe you could treat them every two or three months with a standard of care on board along with that. Well, that may be true, but that's not the paradigm that we're going for for FDA approval at this point. So we also made the observation that patients who still had significant intraretinal fluid, despite that anti-VEGF and previous treatment, as I explained, those patients required early retreatment also, so we're excluding them.

Could treat them every two or three months with <unk>.

Standard care onboard.

Along with it well that may be true, but that's not the paradigm that we are going forward for FDA approval at this point. So we also make the observation that patients who still had significant intra retinal fluid despite that anti VEGF in previous treatment as I explained those patients required early retreat.

<unk> also so we're excluding them.

Jay Duker: In that fashion, along with the timing of the diagnosis of wet AMD for this next trial, I think we're going to get a much broader patient population that more closely reflects the wet AMD population out there, as opposed to what we got in Davio, which I think was more skewed toward patients who weren't doing well. Thank you.

In that fashion, along with the timing of the diagnosis of wet AMD for this next trial I think we're going to get a much broader.

Patient population that that reflects more the empty population out there as opposed to what we got in <unk>, which I think was more skewed towards patients who weren't doing well.

Thank you.

Yi Chen: Your next question comes from the line of Yi Chen from HC Wainwright. Your question, please. Thank you for taking my questions.

Thank you. Our next question comes from the line of <unk> Chen from H C. Wainwright Your question. Please.

Okay.

Thank you for taking my questions.

Jay Duker: Could you comment on whether about 50% of patients who do not require a supplemental anti-VEG if taken for up to six months would be good enough from a commercial perspective? And in real-world practice, even though if a product says that only about 50% of patients could have maintained FXA up to six months, do you think doctors will still see these patients before six months? Thank you.

Could you comment on whether about 50% of patients.

That did not require a supplemental anti VEGF up to six months will be good enough from a commercial perspective.

We'll we'll punches even though if a product says.

The.

Fifth on label, 50% patients could.

Have maintained efficacy up to six months do you think Doug just where do you see these patients before six months. Thank you, yes, so excellent questions and I think that that we can.

Jay Duker: Yes, excellent questions. And I think that we can kind of look into the mentality of the retina specialists and see how we have adopted new treatments for these diseases in the past. So, if we have a safe, effective, and tolerated drug, and 50% of the eyes can go every six months or longer, we have a terrific commercial opportunity, fantastic, especially if we can identify ahead of time who those 50% are.

Kind of looking to the mentality of the retina specialists and see how we adopted new treatments for these diseases in the past.

So 50, if we have a safe effective and tolerate the drug and 50% of the ice can go every six months or longer we have a terrific commercial opportunity fantastic, especially if we can identify ahead of time, who those 50% of our because all of a sudden your success rate is going to be greater than 50%.

Jay Duker: Because all of a sudden, your success rate is going to be greater than 50%. You're going to ask the doctors not to do injections necessarily on the patients who aren't going to do well, just pick out the ones who will. Of course, retina specialists figure it out. So how do we initiate new drugs? We don't necessarily go on label.

We're going to ask the doctors not to do injections necessarily on the patients who aren't going to do well just just pick up the ones, who will of course retina specialist figure it out so how do we initiate new drugs we don't.

We don't necessarily go on label, we often will take the patients who we think will do best on it and we will try them out and often we try them out monthly.

Jay Duker: We often take the patients who we think will do best on it and we'll try them out. And often, we try them out monthly, and we watch them, and we see if the new drug is safe and seems to work better than the older drug. So while we don't have a monthly drug, I don't think that's gonna be any different for 1901. I think patients who we help identify with the retina community who are likely to do well will try those patients on 1901, and they might get 50, 60, 70% of those patients to go six months without recurrent fluid or drop in vision, in which case, terrific. They'll continue every six months. Now, at the beginning, do I think they'll let them go six months without a visit? No, I don't think so at all.

And we watch them and we see if the new drug is safe and it seems to work better than the older drug. So while we don't have a monthly drug I don't think thats going to be any different for $19. One I think patients who we help identify with the retina community who are likely to do well they'll try those patients on 19 O one and they might get 50 60, 70% of those patients.

To go six months without recurrent fluid or drop in vision in which case terrific.

They will continue every six months now at the beginning to I think to let them go six months without a visit no I don't think so at all although if home OTT is widely available by then I think that might be a nice adjunct to help monitor these patients at home, but certainly at the beginning we're going to want to watch the patients a little more carefully and even in the end what I wanted.

Jay Duker: Although if home OCT is widely available by then, I think that might be a nice adjunct to help monitor these patients at home. But certainly, at the beginning, we're gonna wanna watch the patients a little more carefully. And even in the end, would I want to not see a wet AMD patient every six or eight months? Probably not. I wanna monitor the fellow eye to see if they convert to wet AMD, because the fellow eye may be acting differently.

<unk> see a wet AMD patient every six or eight months, probably not I want to monitor the fellow eye to see if they convert to wet AMD to fellow I may be acting differently. I think these patients will still be observed at least.

Jay Duker: I think these patients will still be observed at least several times a year, even if they only require an injection every six to eight months. Now, there will be another group of patients, and those are probably, you know, the ones who might be treated even with Ileo or Lucentis or perhaps Frissomab every four weeks, every six weeks, every seven weeks. And every time we try to extend them more than that, we see fluid.

Several times a year, even if they only require an injection every six to eight months now there'll be another group of patients and those are probably the ones who might be treated even with eylea or lucentis or perhaps for some out of every four weeks every six weeks every seven weeks and every time, we try to extend the more than that we see fluid.

Jay Duker: Those are patients who may benefit from 1901 as well because, based on the DAWBIO trial, we had several of those patients who required supplemental anti-VEGF at four months or five months into the study and never required another one up to nine months. So we cut their injection rate from every, you know, six weeks or so to every three or four months. And so that's going to be a benefit to those patients as well.

Those are patients who may benefit from 19, one as well because based on the <unk> trial, we had several of those patients who required a supplemental anti VEGF at four months or five months into the study and never required another one up to nine months. So we cut their injection rate from every six.

<unk> or so to every three or four months.

So that's going to be a benefit to those patients as well so even if they do require an early rescue or supplement before the six month period.

Jay Duker: So even if they do require an early rescue or supplement before the six month period, it still may be beneficial, especially because it's a different mechanism of action. It's not adding, you know, a ligand blocker to another ligand blocker. It's a different MOA.

Still may be beneficial, especially because it's a different mixes of action.

Not adding.

<unk> blocker to another like Amp Walker, it's a different MLA.

Jay Duker: And I think there's going to be another benefit as well, that I think there's going to be a certain peace of mind that retina specialists and patients will have, knowing that they have a long-term anti-VEGF on board. So what if they miss a visit? What if they get sick and go to the hospital? What if we have another pandemic, and they can't get in?

And I think theres going to be another benefit as well.

I think theres going to be a certain peace of mind that retina specialists.

Jay Duker: So they're not going to be as worried that one or two missed visits may result in a significant drop in their vision. Thank you for the answer. Second question, could you give us an update on UT50? Yeah, so right now, we are continuing to enroll patients and waiting for the enrollment to complete, which is taking some time, and we're continuing to monitor the study. How many patients will be enrolled in Phase 3? I think we aimed for 60, that's correct. Okay, so the faith-based study will report results in the second half of this year? No, that was never the plan.

Patients will have knowing that they have a long term anti VEGF onboard so what if they miss a visit what if they get sick and get to the hospital, what if we have another pandemic and they can't get in so theyre not going to be as worried that one or two mis visits may result in a significant drop in their vision.

Thank you for the answer second question could you give us an update on Youtube <unk>.

Yes, so right now we are continuing to enroll patients and.

We're waiting for the enrollment to complete it.

Is taking some time.

And we're continuing to monitor the study.

How many patients will be in growth for the phase III.

I think we aimed for at $60 60, that's correct.

Okay. So.

The phase II study will report results in the second half of this year.

No that was nevertheless, we.

We haven't guided on yeah. Okay.

Jay Duker: No, we haven't guided on that. Yeah. Okay. Remember, it's an orphan disease, so we... Right. It's hard to find these...

Its remember its an orphan disease. So it's hard to find these to be exactly these patients are.

Jay Duker: Exactly. These patients are a little harder to find and locate because, again, as Georgia said, it's an orphan disease. And there are currently good treatments out there, including RUT-180. Okay. And lastly, could you provide any general comments regarding the trend of prescriptions for U-Expect, for Utique, and Dexacue for 2022? I'm going to ask you to turn this over to Scott.

A little harder to find them locate because Georgia since an orphan disease and there are currently good treatments out there, including our Youtube ATM, yes.

Yes.

Okay.

And lastly could you provide any general comments regarding the trend of prescriptions for you expect.

Our Utica and to execute for 2022.

Scott Jones: I just want to caution you that we don't give forward guidance. So, I'll let Scott just comment on sort of the general environment that we're operating in right now. Thanks for the question. And, you know, as Nancy said, we're not going to provide specific guidance relative to the number of prescriptions that we expect to receive in 2022.

I'm going to ask you to turn this over to Scott I just wanted to caution we don't give forward guidance.

No.

I'll, let Scott comment on sort of the general environment that we're operating in right now.

Thanks for the question and.

And as Nancy said, we're not going to provide specific guidance relative to the number of prescriptions that we expect to receive in 2022, what I can say and I'll start with Utica specifically is that we are seeing an expansion of our customer base.

Scott Jones: But what I can say, and I'll start with Utique specifically, is that we are seeing an expansion of our customer base. We had a 57% increase in our customer base in 2021, and we expect to continue to see that occur. And I would say specifically that we're seeing an expansion within the retina segment, so not just the traditional uveitis segment of the business. So I think that would lead us to believe that we're certainly expanding the market, and we expect to continue doing so in 2022.

We had a 57% expansion of our customer base in 2021, and we expect to continue to see that occur and I would say specifically we are seeing the expansion within the redness segment. So not just the traditional uveitis.

Segment of the business, so I think that.

Would lead us to believe that we're certainly expanding the market and we expect to continue doing so in 2022 on the <unk> side.

Scott Jones: On the Dexacue side, you know, we've again seen an increase in our customer base. More importantly, within that customer base, we're seeing an expansion of the utilization at each one of those ambulatory surgery centers. So the number of units per ambulatory surgery center did increase in 2021, and we certainly would like to see our commercial partner, Inframus Rx, continue with that trend into 2022.

Again, we've seen an increase in our customer base more importantly within that customer base, we're seeing an expansion of the utilization at each one of those ambulatory surgery centers. So the number of units per ambulatory surgery centers did increase.

In 2021, and we certainly would like to see our commercial partner <unk> continue with that trend into 2022.

Okay. Thank you.

Thank you. Thank you. Our next question comes from the line of Yale Jen from Laidlaw. Your question. Please.

Operator: Okay, thank you. Thank you. Our next question comes in line from Gail Jen from Laidlaw. Your question, please. Good morning and thanks for taking the questions. I'm going to start with a quick housekeeping question, which is for the fourth quarter. SG&A seems to grow significantly quarter over quarter. Should we anticipate that number to be a baseline for 2022 in each quarter, or simply is it just some one-time event to occur at that time?

George Elston: Yeah, I think that's probably a good base run rate we have invested across not just the organization but IP as well, so I would probably blend the two quarters. [inaudible] I'm happy to follow up with you on your model. Sure, and the second question is that I know you guys are gonna start an AMD phase two study in the third quarter. What are currently the gating factors for you guys to complete before a formally started trial?

Good morning, and thanks for taking the questions I'm going to start with.

Housekeeping, one which is for the fourth quarter, the SG&A growth significantly quarter over quarter should we anticipate that number to be a base for.

Slide 22 in each quarter or simply digest some of one time.

Events to occur at that time.

Yes, I think that's probably a good base run rate, we have invested across our.

Not just the organization but.

IP as well, so I would probably look to blend the two quarters.

If youre looking to me and I'm happy to follow up with you on your models.

Yes.

Sure.

The second question is that.

I know you guys don't have started.

<unk> phase III study in third quarter.

Currently the gating factors for you guys to complete before.

When you start the trial.

George Elston: Well, there's a lot of kind of behind the scenes things that need to be done to initiate a trial and things like manufacturing, packaging, and distribution of the drug, which we have already accomplished. You have to choose a CRO, which we have already done.

Well, so theres a lot of kind of behind the scenes things that need to be done to initiate a trial.

And things like manufacturing packaging and distribution of the drug which we have already accomplished you have to choose a CRO, which we've already accomplished the CRO has to contact the sites the sites have to agree to be in the study than the.

Jay Duker: The CRO has to contact the sites, the sites have to agree to be in the study, then the protocols need to be approved by their IRBs, drugs need to be shipped directly to the sites, and then we can get things going. So all of that is moving at a very nice pace. Again, it... All of it, you know, again, it's a complicated dance that all companies do to get these studies up and running. And I'll just remind the audience that our last patient was enrolled in Davio last May. And so we only got six months results in November, and that was just about four months ago.

Costs need to be approved by their irb's drugs need to be shipped directly to the site and then we can get things going so all of that is moving in a very nice pace again.

All of it again.

Complicated dance that all companies do to get these studies up and running and I'll just remind the audience that our last patient.

Was enrolled in <unk> last may and so we only got six months results in November .

Jay Duker: And we are well along with the plans to initiate the phase two trial. So we're really pleased with the choice of CRO. We're really pleased with the interest in the sites out there.

And that was just about four months ago, and we are well along with the with the plans to initiate the phase II trial.

No.

We're really pleased with the with the choice of CRO, We're really pleased with the interest and the sites out there obviously.

Jay Duker: Obviously, for a trial of this size, we had 11 sites in our phase one trial. We're aiming to have, you know, multiples more sites for this trial. And that all takes a little bit of time. So there's no one gating thing.

Obviously for a trial of this size, we had 11 sites in our phase one trial.

Aiming to have multiples more sites for this trial and that all takes a little bit of time. So there is no. One gating thing. These are all occurring in parallel but as of today.

Jay Duker: These are all occurring in parallel. But as of today, I remain confident that that third quarter start is on track. Okay, great. And maybe my last question here is that at recent medical meetings, there was a reporting of the earlier, I believe, Aminogram data. What do you think about that? And any impact on your thoughts in terms of the 1901 development?

Remain confident that that third quarter.

Start is on track.

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

At the recent medical meetings.

Reporting of the Alere I believe eight milligrams.

Data.

Do you and what do you think about that and then any impact on your thoughts in terms of the net tailwind development.

Jay Duker: Yeah, so the data is interesting in that, again, safety is number one. It did appear to be safe. There were a couple of ocular AEs in the high dose that weren't seen in the regular dose, but, you know, I don't think they didn't appear to be significant. It does appear to dry better, maybe even give better visual acuity.

So the data is interesting in that.

Again safety is number one it did appear to be safe.

There were a couple of.

Ocular aes in the high dose that werent seen in the regular dose, but I don't think it didn't appear to be significant.

It does appear to dry better maybe even give better visual acuity, but again thats not a competitor to us.

Jay Duker: But again, that's not a competitor to us. We're agnostic about who dries out the retina for us, whether it's faricimab, high dose ILEA, regular ILEA, or KSI's drug. Once doctors get the patients, you know, induced to as good as they feel the retina can look, that's when we'd like them to step in with 1901 to see if we can provide that longevity and assurance that there's a long-term anti-VEGF with zero order kinetics that's safe on board. So yeah, we welcome, you know, anything that's going to help patients in this space. That'd be terrific. And if the drying effect is better, that I think would work very nicely in conjunction with our drug.

We're agnostic to who drives the retina out for us whether it's for risk map, it's high dose eylea, it's regular eylea or is its ksi drug once doctors get the patients induced to as good as they feel the retina can look that's when we'd like them to step it with $90.

I want to see if we can provide that longevity and.

An assurance that there is a long term anti VEGF with zero order kinetics that safe onboard so yes, we welcome.

Anything thats going to help patients in this space that would be terrific and if the drawing effect is better that I think would work very nicely in conjunction with with our drug.

Jay Duker: Okay, great. Maybe squeeze one more in, just follow up on what you just said. In terms of potentially initiating your maintenance therapy after the initial induction treatment, were there any factors or when you think the, obviously depends on the patient, but how long you think the patient could start the maintenance therapy when you can guide it? Okay. Yes, so that's a really good question.

Okay, great and maybe it's $1 million.

Just follow up what you just said.

In terms of potentially initiating Europe maintenance therapy. After the initial induction treatment.

Was there any factors or.

How long do you think the.

Obviously it depends on patient how long you think that the patient could start the maintenance therapy.

When you see when.

When you can guide up.

Jay Duker: And, you know, again, I can put on my clinical investigator hat and say, boy, there's a whole lot of questions I'd like to answer about how 1901 works and which patient population and when to give it, but we're really focused on getting the drug FDA approved as quickly as possible. And some of those clinical questions are going to have to wait until FDA approval occurs. And, you know, the obvious one is, you know, are you going to test your drug in treatment IU patients?

Yes, so that's a really good question and again I can put on my clinical investigator hat and say boy Theres, a whole lot of questions I'd like to answer about how <unk> works in which patient population and wind to give it but we're really focused on getting the drug FDA approved as quickly as possible and some of those clinical questions are going to have to.

Think wait until FDA.

FDA approval occurs and the obvious one is.

Are you going to test your drug in treatment naive patients.

Jay Duker: Eventually, if the answer is probably yes, either we will or the retina community will test it that way. But we have no immediate plans to do it because, in some ways, whether we work in nave as well as we work as maintenance is kind of irrelevant. As long as we offer something that none of the current drugs offer, which is the ability to go out for six months or longer without another shot in the majority of patients.

Eventually if the answer is probably yes, either we will or the retina community will test it that way, but we have no immediate plans to do it.

Because it's again in some ways, whether we work in naive as well as we work as maintenance is kind of irrelevant.

As long as we offer something that none of the current drugs offer which is the ability to go out six months or longer without another shot in the majority of patients.

Jay Duker: Okay, great. That's very, very helpful. And again, congrats on all the progress. I look forward to you guys starting the trial soon.

Okay, Great. That's very very helpful and again congrats on all the progress I look forward to you guys to start a trial.

Operator: Thank you. Thank you. This concludes the question and answer session of today's program as well as today's conference. Thank you, ladies and gentlemen, for your participation. You may now disconnect. Good day. [music] Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music

Thanks, Thank you for the questions.

Thank you. This does conclude the question and answer session of today's program as well as today's conference. Thank.

Thank you, ladies and gentlemen for your participation you may now disconnect good day.

Yes.

Okay.

Okay.

Okay.

EMEA.

Okay.

Yes.

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