Q3 2025 EyePoint Pharmaceuticals Inc Earnings Call

Clubs 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 <unk> Executive Vice President and Chief Financial Officer of I point. Please go ahead.

Thank you and thank you all for joining us on today's conference call to discuss <unk> third quarter 2025 financial results and recent corporate developments.

With me today is Dr. Jay Duker, President and Chief Executive Officer of <unk>.

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

Speaker #1: Good morning. My name is Antoine, and I will be your conference operator today. At this time, I would like to welcome everyone to the EyePoint Pharmaceuticals, Inc. third quarter 2025 financial results and recent corporate developments conference call.

Jay will begin with a review of recent corporate updates and discuss our clinical programs for <unk> and wet AMD and DMA Ivy.

I will close with commentary on the third quarter 2025 financial results. We will then open the call for your questions, where we will be joined by Dr. Ramiro Ribeiro, our Chief Medical Officer.

Speaker #1: 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.

Earlier. This morning, we issued a press release detailing our financial results and recent corporate developments a copy of this release can be found in the Investor Relations tab on the company website Www Dot <unk> pharma dot com.

Speaker #1: I would now like to turn the call over to George Elston Executive Vice President and Chief Financial Officer of Eyepoint . Please go ahead .

Speaker #2: Thank you , and thank you all for joining us on today's conference call to discuss its third quarter 2025 financial results in recent corporate developments .

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 $19 95.

Speaker #2: With me today is Doctor Jay Duker , President and Chief Executive officer of Eyepoint . J will begin with a review of recent corporate updates and discuss our clinical programs for review in wet , AMD and DME .

George Elston: 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 Dr. Jay Duker, President and Chief Executive Officer of EyePoint Pharmaceuticals.

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

Speaker #2: I will close with commentary on the third quarter 2020 financial results . We will then open the call for your questions , where we will be joined by Doctor Ramiro Ribeiro , our chief Medical officer .

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.

Speaker #2: Earlier this morning , we issued a press release detailing our financial results and recent corporate developments . A copy of this release can be found in the Investor Relations tab on the company website .

Jay Duker: Thank you, George. Good morning, everyone, and thank you for joining us. I am pleased to discuss with you today the tremendous progress we've made during the past quarter, continuing our strong track record of execution. As you will hear, our momentum underscores our confidence in the differentiated clinical profile of Duraview, our lead program, and its potential to transform the treatment paradigm in the two largest retinal disease markets: wet age-related macular degeneration, or wet AMD, and diabetic macular edema, or DME. I'd like to start with a brief overview of our recent highlights. Duraview is on track to be the first to file and first to market among all current investigational sustained delivery wet AMD and DME programs, positioning Duraview at the forefront of the treatment landscape with potential first-mover advantage.

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

Speaker #2: W-w-w-w-wait . 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 .

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.

Speaker #2: These include statements about our future expectations , clinical developments , and regulatory matters , and timelines . The potential our products and product candidates .

I'll now turn the call over to Dr. Jay Duker, President and Chief Executive Officer of high point.

Speaker #2: success of Financial projections and our plans and prospects . Actual results may differ materially from those indicated by these forward looking statements . As a result of various important factors , including those discussed in the risk Factors section of our most recent annual Report on Form 10-K , which is on file with the SEC .

Thank you George.

Morning, everyone and thank you for joining us I am pleased to discuss with you today the tremendous progress we've made during the past quarter, continuing our strong track record of execution.

As you will hear our momentum underscores our confidence in the differentiated clinical profile of <unk> review, our lead program and its potential to transform the treatment paradigm and the two largest retinal disease markets.

Speaker #2: And in other filings that we have made or may make with the SEC in the future . Any forward looking statements represent our views as of today , only .

Jay Duker: We completed enrollment of the LUCIA trial, the second phase 3 trial for Duraview and wet AMD, in July. Both trials, Lugano and LUCIA, were enrolled in seven months, and together recruited over 900 patients, making them among the fastest-enrolling wet AMD pivotal programs to date. Top-line data for Duraview and wet AMD is expected in mid-2026. Following the positive end-of-phase 2 meeting in July for DME, we were pleased to align with the FDA on a non-inferiority trial design that we believe is clinically rigorous, efficient, and de-risked. As a reminder, Duraview is the only tyrosine kinase inhibitor, or TKI, in development for DME. We are rapidly moving forward with a pivotal phase 3 DME program, with first patient dosing expected in Q1 2026. The phase 3 DME trials, COMO and COPRI, will leverage our existing wet AMD clinical trial infrastructure and our enthusiastic network of investigators.

Speaker #2: 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 .

H related macular degeneration, or wet AMD, and diabetic macular edema or <unk>.

Speaker #2: 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 Doctor Jay Duker , President and Chief Executive Officer of Eyepoint .

I'd like to start with a brief overview of our recent highlights.

The review is on track to be the first to file and first to market. Among all current investigational sustained delivery wet AMD and DNP programs positioning do review at the forefront of the treatment landscape with potential first mover advantage.

Speaker #2: Thank you , George . Good morning , everyone , and thank you for joining us . I am pleased to discuss with you today the tremendous progress we've made during the past quarter , continuing our strong track record of execution .

We completed enrollment of the Lucci a trial the second phase III trial for <unk> to review in wet AMD in July.

Speaker #2: As you will hear , our momentum underscores our confidence in the differentiated clinical profile of DUR review . Our lead program and its potential to transform the treatment paradigm in the two largest retinal disease markets .

Both trials Lugano in lucido were enrolled in seven months and together recruited over 900 patients making them among the fastest enrolling wet AMD pivotal programs to date.

Speaker #2: Wet age related macular degeneration , or wet AMD and diabetic macular edema , or DME . I'd like to start with a brief overview of our recent highlights .

Topline data for Dura view in wet AMD is expected in mid 2026.

Following the positive end of phase two meeting in July for Dnb, we were pleased to align with the FDA on a non inferiority trial design that we believe is clinically rigorous efficient and de risked.

Speaker #2: During is on track to be the first to file and first to among all current investigational sustained delivery , wet market DUR review at the forefront of the treatment landscape with potential first mover advantage .

Jay Duker: We announced new preclinical data showing that virolimib, the active drug in Duraview, is unique among TKIs being tested in retinal diseases as it inhibits both VEGF-mediated vascular permeability and interleukin-6, or IL-6, mediated inflammation. This multi-mechanism of action has the potential to be particularly effective in the treatment of multifactorial diseases such as wet AMD and DME. These new data underscore the impressive phase two results of the VIRONA trial in DME, and strengthened our confidence in our clinical programs. Finally, our path to potential success in phase three is supported by our strong balance sheet. We ended September 2025 with over $200 million in cash and equivalents, and closed a $172 million follow-on offering in October. Our cash is now expected to fund operations into Q4 2027, well beyond phase three wet AMD data anticipated in 2026.

As a reminder to review was the only tyrosine kinase inhibitor or <unk> in development for DNA.

Speaker #2: We completed enrollment of the Lucia trial , the second phase three trial for review in wet AMD in July . Both trials Lugano and Lucia were enrolled in seven months and together recruited over 900 patients , making them among the fastest enrolling wet AMD pivotal programs to date .

We are rapidly moving forward with a pivotal phase III <unk> program with first patient dosing expected in Q1 2026.

The phase III <unk> trials, Como, and Capri will leverage our existing wet AMD clinical trial infrastructure and are enthusiastic network of investigators.

Speaker #2: Top line data for dura in Wet AMD is expected in mid 2026 , following the positive end of phase two meeting in July for DME , we were pleased to align with the FDA on a Non-inferiority trial design that we believe is clinically rigorous , efficient , and de-risked .

We announced new preclinical data showing that we're rolling in the active drug and to review is unique among teekay is being tested in retinal diseases as it inhibits both VEGF mediated vascular permeability and interleukin six or IL six mediated inflammation.

Speaker #2: As a reminder , to review is the only tyrosine kinase inhibitor , or TKI , in development for DME . We are rapidly moving forward with a pivotal phase three DME program with first patient dosing expected in Q1 2026 .

Asian this multi mechanism of action has the potential to be particularly effective in the treatment of multifactorial diseases, such as wet AMD and <unk>.

These new data underscore the impressive phase II results of the Verona trial, and DMA and strengthened our confidence in our clinical programs.

Jay Duker: With this continued exceptional track record, EyePoint will enter an eventful 2026 from a position of strength. Now, I'd like to take a closer look at the current market landscape for wet AMD and DME. With a combined current global market of $10 billion and growing, these indications make up the vast majority of the global branded retinal disease market. Despite the size and scale of these diseases, they are dominated by a single treatment modality: monotherapy anti-VEGF biologics. Due to the high burden of frequent injections, many patients remain undertreated, even with the addition of recently approved extended duration options. Additionally, these current standard-of-care anti-VEGFs demonstrate subpar real-world efficacy in DME, with growing literature supporting the role of not only VEGF activation, but also IL-6 signaling and inflammation driving disease severity.

Speaker #2: The phase three DME trials Como and Capri will leverage our existing wet AMD clinical trial infrastructure and our enthusiastic network of investigators . We announced new preclinical data showing that Vorolanib , the active drug in Der review , is unique among Tkis being tested in retinal diseases as it inhibits both VEGF mediated vascular permeability and interleukin six or IL six mediated inflammation .

Finally, our path to potential success in phase III is supported by our strong balance sheet.

We ended September 2025, with over $200 million in cash and equivalents and closed a $172 million follow on offering in October.

Our cash is now expected to fund operations into Q4, 2027, well beyond phase III wet AMD data anticipated in 2026.

Speaker #2: This multiple mechanism of action has the potential to be particularly effective in the treatment of multifactorial diseases , such as wet AMD and DME .

With this continued exceptional track record I point will enter an eventful 2026 from a position of strength.

Now I'd like to take a closer look at the current market landscape for wet AMD and <unk>.

Speaker #2: These new data underscore the impressive phase two results of the Verona trial in DME , and strengthened our confidence in our clinical programs .

With a combined current global market of $10 billion and growing these indications make up the vast majority of the global granted retinal disease market.

Speaker #2: Finally , our path to potential success in phase three is supported by our strong balance sheet . We ended September 2025 with over $200 million in cash and equivalents , and closed a $172 million follow on offering in October .

Despite the size and scale of these diseases. They are dominated by a single treatment modality monotherapy anti VEGF biologics.

Jay Duker: We believe our lead product candidate, Duraview, is well-positioned to deliver much-needed innovation in both wet AMD and DME. As a differentiated sustained-release TKI, Duraview is designed to improve the current standard of care by providing durable disease control while reducing the treatment burden. Further, Duraview's potential multi-MOA-blocking VEGF, PDGF, and IL-6 signaling may be uniquely suited to effectively address multifactorial retinal diseases such as DME and wet AMD. Beyond its unique MOA, Duraview offers a compelling product profile that supports strong competitive positioning in both wet AMD and DME. Unlike other sustained-release options in development, Duraview is formulated in our Duracert E technology, a bio-erodible sustained-release insert specifically designed to prevent free-floating drug particles. Additionally, Duraview is shipped and stored at ambient temperature and administered via a standard intravitreal injection. Duraview features the most robust clinical data package among all investigational sustained-release programs.

Due to the high burden of frequent injections many patients remain undertreated, even with the addition of recently approved extended duration options.

Speaker #2: Our cash is now expected to fund operations into Q4 2027 . Well beyond phase three . Wet AMD data anticipated in 2026 . With this continued exceptional track record , Eyepoint will enter an eventful 2026 from a position of strength .

Additionally, these current standard of care antibody Jeff's demonstrate sub par real world efficacy than DMA with growing literature supporting the role of not only VEGF activation, but also IL six signaling and inflammation driving disease severity.

Speaker #2: Now , I'd like to take a closer look at the current market landscape for wet AMD and DME with a combined current global market of $10 billion and growing .

We believe our lead product candidate <unk> to review is well positioned to deliver much needed innovation in both wet AMD and DMA.

Speaker #2: These indications make up the vast majority of the global branded retinal disease market . Despite this size and scale of these diseases , they are dominated by a single treatment modality monotherapy , anti-VEGF biologics .

As a differentiated sustained release PKI to review is designed to improve the current standard of care by providing durable disease control, while reducing the treatment burden.

Speaker #2: Due to the high burden of frequent injections , many patients remain undertreated even with the addition of recently approved extended duration options . Additionally , these current standard of care anti-vegfs demonstrate subpar real world efficacy in DME with growing literature supporting the role of not only VEGF activation , but also IL six signaling and inflammation driving disease severity .

Further drove us potential multi M OE blocking VEGF PDGF and IL six signaling may be uniquely suited to effectively address multifactorial retinal diseases, such as <unk> and wet AMD.

Beyond its unique MLA day review offers a compelling product profile that supports strong competitive positioning in both wet AMD and DMA.

Jay Duker: This includes phase 2 wet AMD and DME data, demonstrating meaningful visual and anatomic improvements from a single Duraview dose in a consistent and favorable safety and tolerability profile, with no safety signals observed in over 190 patients across four completed clinical trials. Given its advantageous clinical profile, multi-target MOA, and unique storage and administration conveniences, we are confident that Duraview offers a differentiated value proposition that is meaningful to physicians and patients and, if approved, would present a compelling option within the current and future landscape for retinal disease treatment. Let me now walk through recent updates for our phase 3 programs, beginning with wet AMD. Our fully enrolled phase 3 pivotal program remains on track to deliver top-line data starting in mid-2026. As a reminder, in July, we completed enrollment of the phase 3 program with over 900 patients randomized across the two trials.

Speaker #2: We believe our lead product candidate , Dr. Review is well positioned to deliver much needed innovation in both wet AMD and DME . As a differentiated , sustained release TKI due review is designed to improve the current standard of care by providing durable disease control while reducing the treatment burden further .

Unlike other sustained release options in development to review was formulated in our <unk> <unk> technology, a bio erodible sustained release insert specifically designed to prevent free floating drug particles.

Additionally to review is shipped and stored at ambient temperature and administered via a standard <unk> injection.

Speaker #2: Dervieux potential multi MOA blocking VEGF , Pdgf and IL six signaling may be uniquely suited to effectively address multifactorial retinal diseases such as DME and wet AMD .

<unk> features the most robust clinical data package, among all investigational sustained release programs.

This includes phase II, wet AMD, and <unk> data, demonstrating meaningful visual and anatomic improvements from our single to review dose and a consistent and favorable safety and Tolerability profile with no safety signals observed in over 190 patients across four.

Speaker #2: Beyond its unique MOA due review offers a compelling product profile that supports strong competitive positioning in both wet AMD and DME . Unlike other sustained release options in development , the review is formulated in R , e technology , a bioerodible sustained release insert specifically designed to prevent free floating drug particles .

<unk> completed clinical trials.

Given its advantageous clinical profile multi target MAA and unique storage and administration conveniences. We are confident that the review offers a differentiated value proposition that is meaningful to physicians and patients and if approved would present a compelling option within the car.

Speaker #2: Additionally , Dr. review is shipped and stored at ambient temperature and administered via a standard Intravitreal injection . During review . Features . The most robust clinical data package among all investigational sustained release programs .

Jay Duker: To ensure we are positioned for commercialization, we are highly focused on our manufacturing capability and CMC submission for an NDA. We have already produced Duraview registration batches at our state-of-the-art GMP-compliant manufacturing facility in Northbridge, Massachusetts. The 41,000sq ft facility was built to both US FDA and EMA standards, and will have capacity to support the commercial launch. Moving on to the recently initiated phase three program in DME, our program consists of two non-inferiority trials, COMO and COPRI, evaluating Duraview 2.7mg versus on-label aflibercept control. Each trial will enroll approximately 240 patients. Additionally, given the established non-inferiority pathway, as well as our ability to leverage our existing phase three clinical trial infrastructure, we believe the program is significantly de-risked. We look forward to dosing our first patient in Q1 2026.

Current and future landscape for retinal disease treatment.

Let me now walk through recent updates for our phase III programs, beginning with wet AMD.

Speaker #2: This includes phase two wet AMD and DME data demonstrating meaningful visual and anatomic improvements from a single Do review dose in a consistent and favorable safety and tolerability profile , with no safety signals observed in over 190 patients across four completed clinical trials .

Our fully enrolled phase III pivotal program remains on track to deliver top line data starting in mid 2026 as a reminder, in July we completed enrollment of the phase III program with over 900 patients randomized across the two trials.

Speaker #2: Given its advantageous clinical profile , Multi-target , MOA and unique storage and administration conveniences , we are confident that Dr. Review offers a differentiated value proposition that is meaningful to physicians and patients , and if approved , would present a compelling option within the current and future landscape .

To ensure we are positioned for commercialization, we are highly focused on our manufacturing capability and CMC submission for an NDA.

We have already produced to review registration batches at our state of the art GMP compliant manufacturing facility in Northbridge, Massachusetts to.

41000 square foot facility was built to both U S FDA and EMA standards and will have capacity to support the commercial launch.

Speaker #2: For retinal disease treatment . Let me now walk through recent updates for our phase three programs , beginning with wet AMD , our fully enrolled phase three pivotal program remains on track to deliver top line data starting in mid 2026 .

Moving on to the recently initiated phase III program in Dnb. Our program consists of two non inferiority trials Como and Capri evaluating <unk> $2 seven milligrams versus on label, a flipper set to control <unk>.

Jay Duker: As I mentioned earlier, there is growing clinical evidence supporting the multifactorial nature of retinal vascular diseases, with both VEGF-mediated vascular leakage and inflammation contributing to disease pathogenesis. IL-6, a pro-inflammatory cytokine, is a key driver of this inflammation and is found at significantly higher levels in DME and wet AMD patients versus healthy individuals. Recent preclinical findings, which we presented at the American Academy of Ophthalmology meeting in October, demonstrate that virolimib, the active ingredient in Duraview, inhibits IL-6 signaling through JAK1 receptor blockage, in addition to its known inhibition of PDGF and all VEGF receptors. In vitro data shows a meaningful reduction in IL-6 activity of more than 50% with virolimib, suggesting a multi-MOA capability. This data may explain the rapid fluid reduction and vision improvements observed as early as week four in the Duraview arms in the phase 2 VIRONA trial.

Speaker #2: As a reminder , in July we completed enrollment of the phase three program with over 900 patients randomized across the two trials to ensure we are positioned for commercialization .

Each trial will enroll approximately 240 patients. Additionally.

Additionally, given the established non inferiority pathway as well as our ability to leverage our existing phase III clinical trial infrastructure. We believe the program has significantly de risked.

Speaker #2: We are highly focused on our manufacturing capability and CMC submission for an NDA . We have already produced due review , registration batches at our state of the art GMP compliant manufacturing facility in Northridge , Massachusetts .

We look forward to dosing our first patient in Q1 2026.

Speaker #2: The 41,000 square foot facility was built to both US , FDA and EMA standards and will have capacity to support the commercial launch .

As I mentioned earlier, there is growing clinical evidence supporting the multifactorial nature of retinal vascular diseases with both VEGF mediated vascular leakage and inflammation contributing to disease pathogenesis.

Speaker #2: Moving on to the recently initiated phase three program in DME , our program consists of two Non-inferiority trials Como and Capri . Evaluating Dir review 2.7mg versus on label Aflibercept control .

IL six a pro inflammatory cytokine is a key driver of this inflammation and is found at significantly higher levels in dnb and wet AMD patients versus healthy individuals.

Speaker #2: Each trial will enroll approximately 240 patients . Additionally , given the established Non-inferiority pathway as well as our ability to leverage our existing phase three clinical trial infrastructure , we believe the program is significantly derisked .

Recent preclinical findings, which we presented at the American Academy of Ophthalmology meeting in October demonstrate that <unk>. The active ingredient interview inhibits IL six signaling through JAK one receptor blockage in.

Jay Duker: In summary, we are well-positioned to extend our clinical leadership in sustained-release therapy for the two largest retinal disease markets. We remain focused on reporting top-line phase 3 data for both LUGANO and LUCIA starting mid-next year, positioning Duraview to be the first to file and potentially first to market among all investigational sustained-release programs in wet AMD. Our phase 3 DME program is now underway, and we expect first patient dosed during the first quarter of 2026. We are moving swiftly and confidently to bring Duraview to patients in need while continuing to ensure our progress follows a de-risked, clinically rigorous, and patient-centric approach.

Speaker #2: We look forward to dosing our first patient in Q1 2026 . As I mentioned earlier , there is growing clinical evidence supporting the multifactorial nature of retinal vascular diseases with both VEGF mediated vascular leakage and inflammation contributing to disease pathogenesis .

In addition to its known inhibition of PDGF and all that Jeff receptors.

In vitro data shows a meaningful reduction in IL six activity of more than 50% with for rolling up suggesting a multi <unk> capability.

Speaker #2: IL six , a pro-inflammatory cytokine , is a key driver of this inflammation and is found at significantly higher levels in DME and wet AMD patients versus healthy individuals .

This data may explain the rapid fluid reduction envision improvements observed as early as week four in the day review arms in the phase III Corona trial.

In summary, we are well positioned to extend our clinical leadership and sustained release therapy for the two largest retinal disease markets. We remain focused on reporting top line phase III data for both Lugano and Luciano starting mid next year positioning to review to be the first to file and potentially first to market.

Speaker #2: Recent preclinical findings , which we presented at the American Academy of Ophthalmology meeting in October , demonstrate that Vorolanib , the active ingredient in Der review , inhibits IL six signaling through Jak one receptor blockage in addition to its known inhibition of Pdgf and all VEGF receptors in vitro data shows a meaningful reduction in IL six activity of more than 50% , with Vorolanib suggesting a multi MOA capability .

Jay Duker: Before passing it over to George to review our financials, I want to thank the entire EyePoint Pharmaceuticals team for your dedication to improving patients' lives through better vision, as well as the patients, study coordinators, and clinical investigators outside of our organization who enable our clinical research. We are grateful for your confidence, and we are proud to advance our therapeutics for the benefit of the entire retina community. We look forward to continued progress towards our upcoming milestones as we further our leadership in sustained ocular drug delivery. I will now turn the call over to George. George. Thank you, Jay. To begin, we continue disciplined financial management and good stewardship of our resources, ending the third quarter with $204 million in cash and investments. As Jay mentioned, in October, we completed a $150 million.

Among all investigational sustained release programs in wet AMD.

Our phase III <unk> program is now underway and we expect first patient dosed during the first quarter of 2026.

We are moving swiftly and confidently to bring <unk> to patients in need while continuing to ensure progress follows a derisked clinically rigorous and patient centric approach.

Speaker #2: This data may explain the rapid Fluid reduction in vision improvements observed as early as week four . In the review , arms in the phase two Verona trial .

Before passing it over to George to review, our financials I want to thank the entire <unk> team for your dedication to improving patients' lives through better vision as well as the patients study coordinators and clinical investigators outside of our organization, who enable our clinical research. We are grateful for your confidence and we are proud to.

Speaker #2: In summary , we are well positioned to extend our clinical leadership and sustained release therapy for the two largest retinal disease markets . We remain focused on reporting top line phase three data for both Lugano and Lucia starting mid next year .

Jay Duker: Follow-on financing, plus the exercise of the underwriter's green shoe option on 29 October for a total of approximately $172 million in gross proceeds, adding to our cash position and enabling the execution of the phase 3 DME program. We expect that cash and investments as of 30 September, along with net proceeds of the financing, will support our operations into the fourth quarter of 2027, well beyond key data readouts from the phase 3 Lugano and LUCIA pivotal trials anticipated in mid-2026. As the results for the three months ended 30 September 2025 were included in the press release issued this morning, my comments today will be focused on a high-level review for the quarter. For the quarter ended 30 September 2025, total net revenue was $1 million compared to $10.5 million for the quarter ended 30 September 2024.

Speaker #2: Positioning Durovic to be the first to file and potentially first to market among all investigational sustained release programs in wet AMD . Our phase three DME program is now underway , and we expect first patient dosed during the first quarter of 2026 .

Our therapeutics for the benefit of the entire retina community Wheeler.

We look forward to continued progress towards our upcoming milestones as we further our leadership and sustained ocular drug delivery.

I will now turn the call over to George George.

Thank you Jay to begin we continued disciplined financial management and good stewardship of our resources ending the third quarter with $204 million in cash and investments.

Speaker #2: We are moving swiftly and confidently to bring review to patients in need while continuing to ensure our progress follows a De-risked clinically rigorous and patient centric approach before passing it over to George to review our financials , I want to thank the entire Eyepoint team for your dedication to improving patients lives through better vision , as well as the patience study coordinators and clinical investigators outside of our organization who enable our clinical research , we are grateful for your confidence and we are proud to advance our therapeutics for the benefit of the entire retina community .

As Jay mentioned in October we completed a $150 million.

Follow on financing plus the exercise of the underwriters Green shoe option on October 29 for a total of approximately $172 million in gross proceeds adding to our cash position and enabling the execution of the phase III <unk> program.

We expect that cash and investments as of September 30th along with net proceeds of the financing we will support our operations into the fourth quarter of 2027 will be on key data readouts from the phase III Lugano and Luciano pivotal trials anticipated in mid 2026.

Jay Duker: This decrease was primarily driven by the recognition of deferred revenue related to the company's 2023 agreement for the license of Utique product rates in the prior year period. Operating expenses for the quarter ended 30 September 2025 totaled $63 million, compared to $43.3 million in the prior year period. This increase was primarily driven by clinical trial costs related to the ongoing phase 3 Lugano and LUCIA clinical trials of Duraview for wet AMD. Net non-operating income totaled $2.3 million, and net loss was $59.7 million, or $0.85 per share, compared to a total net loss of $29.4 million, or $0.54 per share, in the prior year period.

Speaker #2: We look forward to continued progress towards our upcoming milestones as we further our leadership in sustained ocular drug delivery . I will now turn the call over to George .

Speaker #2: George . Thank you . Jay . To begin , we continue disciplined financial management and good stewardship of our resources . Ending the third quarter with $204 million in cash and investments .

As a result for the three months ended September 32025 were included in the press release issued this morning. My comments today will be focused on a high level review for the quarter.

Speaker #2: As Jay mentioned in October , we completed a 150 million . Follow on financing , plus the exercise of the underwriters greenshoe option .

For the quarter ended September 32025, total net revenue was $1 million compared to $10 5 million for the quarter ended September 32024.

Speaker #2: On October 29th for a total of approximately 172 million . In gross proceeds . Adding to our cash position and enabling the execution of the phase three DME program , we expect that cash and investments as of September 30th , along with net proceeds of the financing , will support our operations into the fourth quarter of 2027 .

This decrease was primarily driven by the recognition of deferred revenue related to the company's 2023 agreement for the license of the unique product rates in the prior year period.

Jay Duker: As I noted earlier, cash and investments on 30 September 2025 totaled $204 million compared to $371 million as of 31 December 2024, which, along with net proceeds from the October financing, we expect will enable operations into Q4 2027. In conclusion, we are very pleased with our progress and continued execution in 2025, and are well capitalized to deliver Duraview phase 3 wet AMD data in 2026, while advancing our phase 3 DME program with the COMO and COPRI clinical trials. I will now turn the call back over to Jay for closing remarks. Thank you, George. As you've heard this morning, EyePoint Pharmaceuticals is on the cusp of a milestone year in 2026. Our decades of drug development experience, clinical track record, next-generation technology, and blockbuster potential of our Duraview franchise underscore our exciting growth story.

Operating expenses for the quarter ended September 32025 totaled $63 million compared to $43 3 million in the prior year period. This.

Speaker #2: Will be on key data readouts from the phase three . Lugano and Lucia pivotal trials anticipated in mid 2026 . As a results for the three months ended September 30th , 2025 were included in the press release issued this morning .

This increase was primarily driven by clinical trial costs related to the ongoing phase III Lugano in nutria clinical trials of <unk> for wet AMD net non.

<unk> income totaled $2 3 million and net loss was $59 7 million or <unk> 85 per share compared to a total net loss of $29 4 million or <unk> 54 per share in the prior year period.

Speaker #2: My comments today will be focused on a high level review for the quarter . For the quarter ended September 30th , 2025 , total net revenue was 1 million compared to 10.5 million for the quarter ended September 30th , 2024 .

As I noted earlier cash and investments on September 32025 totaled $204 million compared to $371 million as of December 31, 2024, which along with net proceeds from the October financing, we expect will enable operations into Q4 2027.

Speaker #2: This decrease was primarily driven by the recognition of deferred revenue related to the company's 2023 agreement for the license of unique product rights in the prior year period , operating expenses for the quarter ended September 30th , 2025 totaled 63 million , compared to 43.3 million in the prior year period .

In conclusion, we are very pleased with our progress and continued execution in 2025 and are well capitalized to deliver <unk> phase III wet AMD data in 2026, while advancing our phase III <unk> program with Docomo and Capri clinical trials I will now turn the call back over to Jay for closing remarks.

Jay Duker: With our strong balance sheet and disciplined cash management, along with our thoughtful de-risk development strategy, we are prepared to execute through our key upcoming milestones, including top-line data for the phase 3 Lugano trial anticipated in mid-2026, with LUCIA data to closely follow, positioning us for a potential NDA submission for Duraview in wet AMD. The first patient dosing in our pivotal phase 3 DME program is anticipated in Q1 2026, with full enrollment expected in the second half of 2026. Thank you all for your attention this morning. I will now turn the call over to the operator for your questions. Thank you. At this time, we will conduct a question-and-answer session. As a reminder, to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again.

Speaker #2: This increase was primarily driven by clinical trial costs related to the ongoing phase three . Lugano and Lucia clinical trials of review for wet AMD net non-operating income totaled 2.3 million , and net loss was 59.7 million , or $0.85 per share , compared to a total net loss of 29.4 million , or $0.54 per share , in the prior year period .

Thank you George.

As you've heard this morning, I point is on the cusp of a milestone year in 2026.

Our decades of drug development experience clinical track record next generation technology and blockbuster potential of our <unk> franchise underscore our exciting growth story.

Speaker #2: As I noted earlier , cash and investments on September 30th , 2025 totaled 204 million , compared to 371 million as of December 31st , 2024 , which , along with net proceeds from the October financing we expect will enable operations into Q4 2027 .

With our strong balance sheet and disciplined cash management, along with our thoughtful Derisk development strategy, we are prepared to execute through our key upcoming milestones including <unk>.

Speaker #2: In conclusion , we are very pleased with our progress and continued execution in 2025 and are well capitalized to deliver , do review phase three wet AMD data in 2026 .

Topline data for the phase III Lugano trial anticipated in mid 2026 with lucida data to closely follow positioning us for a potential NDA submission for <unk> and wet AMD.

Speaker #2: While advancing our phase three DME program with the Como and Capri clinical trials . I will now turn the call back over to Jay for closing remarks .

Jay Duker: As usual, we'll try to get to as many questions as we can during the course of the call. Please limit the number of questions you ask to one to give others a fair chance to participate. Please stand by while I compile the Q&A roster. Our first question comes from Tess Romero from JP Morgan. Please go ahead. Thank you. Good morning, Jay and team. I wanted to ask a market sizing question today. Can you just refresh us for the wet AMD population overall here in the US? What percent of patients are treated every four weeks, every six weeks, every eight weeks, or longer? What is your latest view on how the doctors will use Duraview, if available, in that context? Thanks so much. Good morning, Tess. Thanks for the question. It is insightful. As you may surmise, the data is not strong.

And the first patient dosing in our pivotal phase III <unk> program anticipated in Q1 2026 with full enrollment expected in the second half of 2026.

Speaker #2: Thank you George . As you've heard this morning , I point is on the cusp of a milestone year in 2026 , our decades of drug development experience , clinical track record , next generation technology and blockbuster potential of our franchise underscore our exciting growth story with our strong balance sheet and disciplined cash management , along with our thoughtful de-risked development strategy , we are prepared to execute through our key upcoming milestones , including top line data for the phase three Lugano trial , anticipated in mid 2026 , with Lucia data to closely follow , positioning us for a potential NDA submission for review in wet AMD and the first patient dosing in our pivotal phase three DME program in in Q1 2026 , with full enrollment expected in the second half of 2026 .

Thank you all for your attention. This morning, I will now turn the call over to the operator for your questions.

Thank you at this time, we will conduct a question and answer session.

As a reminder.

To ask a question you will need to press star one on one of your telephone and wait for your name to be announced to withdraw. Your question. Please press star one again as usual, we'll try to get to as many questions as we can during the course of the call.

Please limit the number of questions you ask to one to give others a fair chance to participate please.

Please stand by while a compile the Q&A roster.

Our first question comes from tests Ramiro from JP Morgan. Please go ahead.

Thank you good mining game team.

Jay Duker: To give exact numbers for each of those intervals, what we do know is approximately 20% of wet AMD patients have to be treated monthly, regardless of the drug that they're using. If you look at the clinical trial data, even with the newer extended duration agents, 50% of the eyes can't go longer than every eight weeks. Depending on a doctor's toleration for fluid, some patients can certainly go three and four months in between injections. Again, it's individualized to the patient and oftentimes individualized to the doctor's tolerance of fluid and adherence to the label. I don't, off the top of my head, have exact numbers to give you for those other percentages. I'll pause and see if Romero has any other insight. Yeah. No, thanks, Tess, for the question. I think when we think about Duraview.

I wanted to ask a marking the market sizing question today can you just refresh us on the wet AMD population overall here in the U S. What percent of patients are treated every four week every six weeks every eight weeks or longer.

Speaker #2: Thank you all for your attention this morning . I will now turn the call over to the operator for your questions .

Speaker #1: Thank you . At this time , we'll conduct a question and answer session . As a reminder to ask a question , you will need to press star one one on your telephone and wait for your name to be announced .

And what is your latest view on how the doctors will use <unk> in that context. Thanks, so much.

Speaker #1: To withdraw your question , please press star one one again . As usual , we'll try to get to as many questions as we can during the course of the call .

Good morning tests, thanks for the question it.

Speaker #1: Please limit the number of questions you ask to one to give others a fair chance to participate . Please stand by while I compile the Q&A roster .

It is insightful and as you may surmise the data is not strong.

To give exact numbers for each of those intervals.

Speaker #1: Our first question comes from Tess Romero from J.P. Please go ahead.

What we do know is approximately 20% of wet AMD patients have to be treated monthly regardless of the drug that they're using.

Speaker #3: Thank you . Good morning , Jay and team . I wanted to ask a market sizing question today . Can you just refresh us for the wet AMD population overall here in the US , what percent of patients are treated every four weeks ?

If you look at the clinical trial data, even with the newer extended duration agents, 50% of the ice can't go longer than every eight weeks.

Speaker #3: Every six weeks ? Every eight weeks , or longer . And what is your latest view on how the doctors will use Dr. .

Depending on a doctor's toleration for fluid.

Jay Duker: In our phase 2 data, we showed that after dosing Duraview, about 65% of patients did not require any supplement injection with anti-VEGF. Even when we look at zero or one injection over that six-month period, the number is about 90%. We believe that Duraview is really well-positioned. If we see the results in the phase 3 study being replicated, to be in the market for wet AMD patients. To answer the second part of your question, Tess, I don't think you can look at it as an either/or, meaning if Duraview is approved, doctors will be limited to just using one agent. We're a different MOA, and clearly, the more recent data with IL-6 inhibition suggests that we may offer an MOA that the ligand blockers cannot. That would open up the market tremendously to us. As Romero just explained, physicians, I'm sure.

Speaker #3: Review if available in that context ? Thanks so much .

Some patients can certainly go three and four months.

In between injections.

Speaker #2: Good morning Tess . Thanks for the question . It is insightful and as you may surmise , the data is not strong . To give exact numbers for each of those intervals , what we do know is approximately 20% of wet AMD patients have to be treated monthly , regardless of the drug that they're they're using .

But again, it's individualized to the patient and oftentimes individualized to the doctors tolerance so fluid.

And adherence to the label so.

I don't off the top of my head have exact numbers to give you for those other percentages.

And I'll pause and see if.

Speaker #2: If you look at the the clinical trial data , even with the newer extended duration agents , 50% of the eyes can't go longer than every eight weeks , depending on a doctor's toleration for fluid .

Romero has any other insight.

Yes, no. Thanks for the question I think when we think about <unk>.

In our phase II data.

We showed that after dosing towards you.

About 65% of patients do not require any supplement injection with anti VEGF.

Speaker #2: Some patients can certainly go three and four months . In between injections . But again , it's individualized to the patient and oftentimes individualized to the doctor's tolerance of fluid and adherence to the label .

And even when we look at zero or one injection over that six month period.

The number is about 90%.

So we believe that review is really well positioned.

If we see the results in the phase III study being replicated to bring to market for wet AMD patients.

Speaker #2: So I don't off the top of my head have exact numbers to give you for those other percentages . And I'll pause and see if Romero has any other insight .

Jay Duker: Would be willing to take advantage of two MOAs. We do that in chronic diseases all the time. Therefore, the market share for Duraview, when you speak to some of the KOLs on the podium even recently, have said up to 80% of their patients would be eligible. We're really optimistic that the acceptance of a multi-MOA TKI with sustained release in both wet AMD and DME is going to be high. Great. Thanks so much. Thank you. Our next question comes from Yigal Nochomovitz from Citigroup. Please go ahead. This is Jordan Kim on for Yigal. Thanks for taking our question. Regarding DME, can you provide any additional color on how you're structuring your enrollment criteria to provide the broadest reach in the DME marketplace relative to competitors in the long-acting TKI space? Thanks. Sure. I'll let Ramiro Rivero answer that question. Thank you very much for it.

And to answer the second part of your question tests I don't think you can look at it as an either or meaning if the review is approved doctors will be limited to just using one agent.

Speaker #4: Yeah . No thanks , Tesla , the question . I think when we think about drug review in our phase two data , we showed that after dosing review , about 65% of patients did not require any supplemental injection with anti-VEGF .

Different MAA and clearly the more recent data with IL six inhibition suggests that we may offer an moe that the logjam blockers cannot.

Speaker #4: And even when we look at 0 or 1 injection over that six month period , then the number is about 90% . So we believe that during review is really well positioned .

That would open up market tremendously to us.

As Ramiro just explained.

<unk> I'm sure.

Would be willing to take advantage of <unk>, we do that in chronic diseases all the time.

Speaker #4: If we see the results in the phase three study being replicated , to be in the market for wet AMD patients .

And therefore, the market share for <unk>.

Speak to some of the Kols on the podium even recently have set up to 80% of their patients would be eligible so we're really optimistic that.

Speaker #2: And to answer the second part of your question , Tess , I don't think you can look at it as an either or meaning .

Speaker #2: If the review is approved , doctors will be limited to just using one agent . We're a different MOA and clearly the more recent data with IL six inhibition suggests that we may offer an MOA that the ligand blockers cannot .

The acceptance of our multi moh, PKI, which sustained release in both wet AMD and dnb is going to be hot.

Jay Duker: I can quickly answer the second part of the question. We're the only TKI sustained release that has a DME program. That part's easy. Romero, why don't you talk a little bit about how we've designed the trial? Yeah. First, to give an overview on our phase 3 DME program, COMO and COPRI, we are going to be enrolling patients with active DME, both treatment naive and previously treated. As a control arm, we're going to use aflibercept on-label, and then Duraview is going to be dosed every six months. We are very fortunate to have a strong infrastructure here at EyePoint. As we conducted our wet AMD study, we have also a very strong relationship with investigators. For our DME program, we're going to be able to leverage those strengths into a hopefully rapid enrollment for the DME program.

Alright, thanks, so much.

Thank you.

Our next question comes from Hugo <unk>.

Speaker #2: That would open up market tremendously to us . And as Romero just explained , physicians , I'm sure , would be willing to take advantage of two Moas .

From Citi. Please go ahead.

They've been strong Ken Andre Thanks for taking our question regarding <unk> can you provide any additional color on how you're structuring your enrollment criteria to provide the broadest reach in the <unk> marketplace relative to competitors in the long run I think PKI space. Thanks.

Speaker #2: We do that in chronic diseases all the time . And therefore the market share for Dr. . Review . When you speak to some of the colleagues on the podium even recently have said up to 80% of their patients would be eligible .

Sure I'll, let <unk> answer that question. Thank you very much for it.

Speaker #2: So we're really optimistic that the acceptance of a multi MOA TKI with sustained release in both wet AMD and DME is going to be high .

And again.

<unk> answered the second part of the question.

We're the only teekay <unk> sustained release.

That has a D&B program, so that part's easy, but Ramiro why don't you talk a little bit about how we've designed the trial.

Speaker #3: Great . Thanks so much .

Yes, so first with an overview on our phase III <unk> program Cortland copy.

Speaker #1: Thank you . Our next question comes from Yigal Nikolayevich from Citi . Please go ahead .

So we are going to be enrolling patients with active <unk>, both treatment naive and previously treated.

Jay Duker: I think it's our understanding that we might be the only phase 3 program enrolling patients next year for this indication. Again, I think we expect to see a rapid enrollment, similar strength as we did for the wet AMD program. Regarding enrollment, just for clarification, I believe I heard you say second half 2026. Is that for both COMO and COPRI? I think what we're guiding now is that both studies are going to be starting Q1 of next year, 2026. Got it. Thank you so much. Appreciate it. Thank you. Our next question comes from Tyler Van Buren from TD Cowen. Please go ahead. Hi. This is Sam on for Tyler. Thanks for taking our question. I wanted to ask about the use of the blended endpoint, which you guys have remained consistent on with the pivotal wet AMD and DME trials.

Speaker #5: Hey this is John Kim on for you . Thanks for taking our question regarding DME . Can you provide any additional color on how you're structuring your enrollment criteria to provide the broadest reach in DME marketplace relative to competitors in the long acting TKI space ?

As the control arm are going to use a 3% one April and then there's going to be being dose every six months.

We are very fortunate to have a strong infrastructure here at <unk>.

Speaker #5: Thanks .

We conducted our wet AMD study, we have also a very strong relationship with investigators so far our DMD program, we're going to be able to leverage those trains into a hopefully rapid enrollment towards the DMD program.

Speaker #2: Sure . I'll let Romero answer that question . Thank you very much for it . And again , I can quickly answer the second part of the question .

Speaker #2: We're the only TKI sustained release that has a DME program . So that part's easy . But , Romero , why don't you talk a little bit about how we've designed the trial ?

I think it's our understanding that.

Speaker #4: Yeah . So first , to give an overview on our phase three DME program , Coleman Capri . So we are going to be enrolling patients with active DME .

We might be the only phase III program enrolling patients next year for this indication.

So again I think we expect to see a rapid enrollment.

Speaker #4: Both treatment-naive and previously treated patients will serve as a control arm. We're going to use Aflibercept's own label, and then the review is going to be conducted with dosing every six months.

Seamless is shrinking due to four new web program.

Yeah.

And regarding enrollment just for clarification I believe I heard you say second half 'twenty six is that for both Colo footprint.

Speaker #4: We are very fortunate to have a strong infrastructure here at EyePoint. As we conducted our wet AMD study, we also have a very strong relationship with investigators.

Jay Duker: We've seen the FDA greenlight a single endpoint more recently. Curious if you thought about using a single endpoint at all for the DME studies and why you believe the blended endpoint is the best approach. Thanks. Thanks, Sam. Appreciate the question. I'll let Romero go into the details. To answer quite simply, did you think about a single endpoint? Quick answer is no. Romero, why don't you talk a little bit about our interactions with the FDA over endpoint and why the blended endpoint is actually de-risking? Yeah, thanks, Sam, for the question. For both our wet AMD program and our DME program, we are using blended endpoint, meaning that for the primary endpoint, we're counting two visits. The benefit of that is that we prevent missing data. In this type of study,

So I think what we're guiding now is that both studies are going.

To be star team Q1 of next year 2026.

Speaker #4: So for our DME program , we're going to be able to leverage those strength into a hopefully rapid enrollment for DME program . I think it's our understanding that we might be the only phase three program enrolling patients next year for this indication .

Got it. Thank you so much appreciate it.

Thank you.

Our next question comes from Tyler Van Buren from TD Cowen. Please go ahead.

Hi, This is Sam on for Tyler. Thanks for taking our question I wanted to ask about the use of the blended and client, which you guys have remained consistent with the pivotal wet AMD and gain new trials.

Speaker #4: So again , I think we expect to see a rapid enrollment similar strength as we did for the Wet program .

<unk> seen the FDA Green light a single endpoint more recently so curious.

Speaker #5: And regarding enrollment , just for clarification , I believe I heard you say second half 26 . Is that for both Como and Capri ?

Have you thought about using a single endpoint it off of the <unk> studies and why you believe the blended unemployment the best approach. Thanks.

Speaker #4: So I think what what we're guiding now is that both studies are going to be starting Q1 of next year , 2026 .

Thanks, Sam I appreciate your question and I'll, let <unk> go into the details but to answer quite simply did you think about a single endpoint quick answer is no.

Jay Duker: It's not uncommon to see patients missing the visit because they have medical appointments or they're in the hospital for some systemic disease. By having two visits, we reduce the amount of missing data. Also, very important, if a patient has, for any reason, a loss in vision in one of the visits, it has the ability to capture the recovery of that vision in the next visit. The use of blended endpoint has been common in clinical trials for wet AMD disease for the past few years, with the main goal of decreasing the variability and increasing the power of the study. That's why we feel confident on using the blended endpoint for both wet AMD and DME. Of course, we have the green light from the FDA to do so. Great. Thank you for that clarification. Really appreciate it. Thank you.

Speaker #5: Got it . Thank you so much . Appreciate it .

Speaker #1: Thank you . Our next question comes from Tyler Van Buren from TD Cowen . Please go ahead .

<unk> why don't you.

Talk a little bit about our interactions with the FDA over endpoint and why the blended endpoint is actually de risking.

Yes, and thanks have further question so for both our wet AMD program and our DMD program.

Speaker #6: Hi . This is Sam on for Tyler . Thanks for taking our question . I wanted to ask about the use of the blended endpoint , which you guys have remained consistent on with the pivotal wet AMD and DME trials .

We are using blended endpoint, meaning that for the primary endpoint, we're counting to visit.

Speaker #6: We've seen the FDA greenlight a single endpoint more recently . So curious if you thought about using a single endpoint at all to the DME studies and why you believe the blended endpoint is the best approach ?

The benefit of that is that we prevent missing data.

In these type of study.

Not uncommon to see patients missing the visit because they have.

Speaker #6: Thanks .

Speaker #2: Thanks , Sam . Appreciate the question , and I'll let Romero go into the details . But to answer quite simply , did you think about a single endpoint ?

Medical point things are they're in the hospital for some.

Systemic disease, so by having two visits.

Speaker #2: Quick answer is no . Romero wanted to talk a little bit about our interactions with the FDA over endpoint , and why the blended endpoint is actually de-risking .

Reduce the amount of missing data.

And also very important if a patient has for any reason.

And last and vision one of the visit.

Speaker #4: Yeah , and thanks him for the question . So for both our wet AMD program and our DME program , we are using blended endpoint , meaning that for the primary endpoint , we're counting two visits .

Has the ability to capture new recover off debt at up that piece in vision next visit.

Jay Duker: Our next question comes from Clara Dong from Jefferies. Please go ahead. Hi. Good morning. Thanks for taking our questions. This is Jana for Clara. Could you talk about the differentiation in IL-6 inhibition, and could you help us kind of elaborate on how that could translate into clinical benefit in DME versus an anti-VEGF-only approach? Thank you. Thanks for the question, Jana. This is really timely because you may be aware there's some recent data from Genentech, who used an IL-6 blocker in a DME trial combined with an anti-VEGF. Both were delivered monthly, and the arm with the IL-6 blocker along with the anti-VEGF had better vision as early as week four and sustained through the trial. We were able to show a very similar vision improvement and course of improvement in our VIRONA trial.

The U S Gulf blended endpoint has been calm.

Carmen.

Speaker #4: The benefit of that is that we prevent missing data . So in this type of study is not uncommon to see patients missing the visit because they have medical appointments or they're in the hospital for some systemic disease .

Clinical trials for retinal disease for the past few years with the main goal of decreasing the variability and increasing the power of the study.

And Thats why we feel confident on using the blended endpoints for both weapons in the EMEA and of course, we have the green light from the FDA to do so.

Speaker #4: So by having two visits , we reduce the amount of missing data . And also very important , if a patient has for any reason , a loss in vision in one of the visit , it has the ability to capture the recovery of that visit of that vision .

Alright, Thank you for that clarification appreciate it.

Thank you.

Our next question comes from Clara Dong from Jefferies. Please go ahead.

Hi, good morning, Thanks for taking our questions. This is jana for Clorox.

Speaker #4: Vision . In the next visit , the use of blended endpoint has been common in clinical trials for retinal disease . For the past few years , with the main goal of decreasing the variability and increasing the power of the study .

Could you talk about the differentiation.

Thank you Michelle.

And could you help us.

Robert how that could translate into clinical benefit in PMA.

Okay.

If only approach thank you.

Speaker #4: And that's why we feel confident on using the blended endpoint for both wet and and DME . And of course , we have the green light from the FDA to do so .

Thanks for the question Jenna and this is really timely.

Jay Duker: Using just two injections over six months as opposed to 12 injections over six months. When we looked into it more closely, we discovered that, in fact, Virolimib is a potent inhibitor of the IL-6 pathway by blocking the JAK1 receptor. There is substantial evidence in both wet AMD and DME that IL-6 plays a pathogenic role, especially in eyes that are not responding. Therefore, the ability to block both the VEGF pathway and the inflammatory IL-6 pathway could be a significant improvement over what we have now, especially coupled with sustained release so that you're not having to give two biologics on a monthly basis. Thank you. Okay. Thank you. That's helpful. All right. Our next question comes from Yatin Suneja from Guggenheim. Please go ahead. Hey, guys. Thank you for taking my question. Maybe two questions for me. One is on the mechanism regarding the IL-6.

You may be aware there.

Some recent data from Genentech.

Who used an IL six blocker and of Dnb trial, combined with an anti VEGF or both were delivered monthly and.

Speaker #6: Great . Thank you for that clarification . Really appreciate it .

Speaker #1: Thank you . Our next question comes from Clara Dong from Jefferies . Please go ahead .

Armed with the IL six blocker.

Along with the anti VEGF.

Speaker #7: Hi . Good morning . Thanks for taking our questions . This is Jenna for Clara . Could you talk about the differentiation in IL six inhibition ?

Better vision.

Early as week, four and sustained through the trial.

We were able to show a very similar vision improvement and course of improvement and our Verona trial.

Speaker #7: And could you help us kind of elaborate on how that could translate into clinical benefit in DME versus an anti-VEGF only approach ? Thank you .

Using just two injections over six months as opposed to 12 injections over six months and when we looked into it more closely we discovered that in fact rolling it is a.

Speaker #2: Thanks for the question , Gena . And this is really timely because you may be aware there's some recent data from Genentech who used an IL six blocker in a DME trial combined with an anti-VEGF .

A potent inhibitor of IL six pathway by blocking the JAK one receptor.

There is substantial evidence in both wet AMD and D&B that IL six place a pathogenic role, especially in eyes that are not responding and therefore, the ability to block both VEGF pathway and inflammatory IL six pathway.

Speaker #2: Both were delivered monthly and the the armed with the IL six blocker , along with the anti-VEGF , had better vision as early as week four and sustained through the trial .

Could be it could be a significant improvement over what we have now, especially.

Speaker #2: We were able to show a very similar vision improvement and course of improvement in our Verona trial , using just two injections over six months , as opposed to 12 injections over six months .

Jay Duker: Jay, if you can comment on the relevance of it in one disease versus the other, do you think there is more relevance in DME versus AMD? That is one. The second question is now more around the expectation. Now that the studies, wet AMD expectations, right? Now the studies are enrolled. I think our investors are sort of beginning to think about what we should be expecting from the data. I think there is focus on three things. One is the BCVA and non-inferiority, what sort of injection burden you can produce, and how should we think about rescue rate. If you can comment on that, that would be very helpful. Thank you. Thanks, Yatin. Two great questions. Let me start with the IL-6 question. IL-6 has been implicated in inflammatory macular edema for well over a decade, and additional data.

Coupled with sustained release, so that youre not having to give two biologics on a monthly basis.

Speaker #2: And when we looked into it more closely , we discovered that in fact , Vorolanib is a potent inhibitor of IL six pathway .

Thank you. Thank you.

Alright.

Our next question comes from <unk> <unk> from Guggenheim. Please go ahead.

Speaker #2: By blocking the Jak one receptor , there's substantial evidence in both wet AMD and DME that IL six plays a pathogenic role , especially in eyes that are not responding and therefore the ability to block both VEGF pathway and inflammatory pathway could be could be a significant improvement over what we have now , especially coupled with sustained release .

Okay.

Hey, guys. Thank you for taking my question two questions from me one is on the mechanism regarding the IL six.

Okay. If you can comment on.

Is that a relevant so.

Ed.

<unk> this is versus the other thing that is more around events in <unk> versus <unk>.

And.

So that's one and then the second question is more around the expectation now that the studies are wet AMD expectations right now the studies at adult.

Speaker #2: So that you're not having to give two biologics on a monthly basis .

Jay Duker: Suggests that IL-6 levels in the vitreous are much higher in DME patients than in diabetics with no diabetic retinopathy. In addition, there's data that suggests high IL-6 levels in aqueous humor portend a worse outcome in both DME and wet AMD. Overall, the evidence for a role of IL-6 as an inflammatory pathway in DME is very strong. While it's there in wet AMD as well, it appears to be a prognostic factor in the percentage of eyes that aren't doing well with VEGF blockage alone. We believe that if the preclinical data we have shown and the rapid, early, and sustained response in our VIRONA DME trial can be shown in phase 3, this would be an exceptional result, which would put us at the forefront of both wet AMD and DME therapies. As for.

I think on unless Josh I've sort of beginning to think about what we should be expecting from the data and I think that is focused on putting things one is the <unk>.

Speaker #7: Thank you . Thank you .

<unk> non inferiority, what sort of injection burden you can.

Speaker #1: Our next question comes from Yatin Suneja from Guggenheim . Please go ahead .

Produce and how should we think about rescue that so if you can comment on that.

Speaker #8: Hey .

Speaker #9: Hey , guys . Thank you for taking my question . Maybe two questions for me . One is on the mechanism regarding the IL six .

Very helpful. Thank you.

Thanks, a lot and two great questions.

Let me start with the IL six question.

Speaker #9: J . If you can comment on , you know , the the relevance of it in one disease versus the other , do you think there is more relevance in DME versus AMD ?

<unk> has been implicated in inflammatory macular edema for well over a decade.

And additional data.

Speaker #9: So that's one . And then the second question is , you know , now more around the expectation now that the studies wet AMD expectations right now , the studies are enrolled , I think our investors are sort of beginning to think about what we should be expecting from the data .

Suggests that IL six levels in the vitreous are much higher in dnb patients than in diabetics with no diabetic retinopathy.

In addition, there is data that suggest a high IL six levels, an aqueous humor portend, a worse outcome in both DMA and wet AMD.

Speaker #9: And I think there is focus on three things . One is the , you know , bcv and non-inferiority . What sort of injection burden you can produce and how should we think about rescue rate .

So overall the evidence for <unk>.

<unk> of IL six as an inflammatory pathway and DMA is very strong and while it's there in wet AMD as well it appears to be a prognostic factor in.

Speaker #9: So if you can comment on that , I'll be very helpful . Thank you .

Jay Duker: The clinical trial results, which we expect, again, the first trial, Lugano, mid next year, second trial, LUCIA, soon to follow. Based on our strong phase 2 data, we would expect non-inferiority to the on-label aflibercept control, with continued safety. Safety is of paramount importance here, as I'm sure you all know. Based on the ongoing masked safety that we've seen in these two phase 3 trials, as well as the extensive safety database we have for both Duraview and VIRONA IV, we're confident that the safety will be quite good. As for reduction in treatment burden, again, that's important. There's no specific cutoff that says it has to be above or below a certain level. Based on our discussions with KOLs and the design of the trials, we think a 50% reduction in treatment burden will, again, put us into the forefront of.

Speaker #2: Thanks . You two great questions . Let me start with the IL six question . IL six has been implicated in inflammatory macular edema for well over a decade , and additional data suggests that IL six levels in the vitreous are much higher in DME patients than in diabetics , with no diabetic retinopathy .

The percentage of ice that arent doing well with veg up blockage alone.

We believe that.

If the preclinical data.

We have shown.

And the rapid and early and sustained response in our Verona D&B trial can be shown in phase III.

Speaker #2: In addition , there's data that suggests a high IL six levels in aqueous humor portend a worse outcome in both DME and wet AMD .

This would be an exceptional result, which would put us at the forefront of both wet AMD and dnb therapies.

As for.

Speaker #2: So overall , the evidence for a role of IL six as an inflammatory pathway in DME is very strong . And while it's there in wet AMD as well , it appears to be a prognostic factor in the percentage of eyes that aren't doing well with VEGF blockage alone .

The clinical trial results, which we expect again the first trial Lugano mid next year second trial with <unk>.

Soon to follow.

Based on our strong phase II data.

We would expect non inferiority to the on label Eylea control with.

Speaker #2: We believe that if the preclinical data we have shown and the rapid and early and sustained response in our Verona DME trial can be shown in phase three , this would be an exceptional result which would put us at the forefront of both wet AMD and DME therapies .

With continued safety and again safety is of Paramount importance here as Im sure you all know.

But based on the.

The ongoing mask safety that we've seen in these two phase III trials as well as the extensive safety database, we have for both to review and <unk>.

Jay Duker: Therapies for wet AMD. Thank you. Our next question comes from Debanjana Chatterjee from JonesTrading. Please go ahead. Hi. Thanks for taking my question, and congrats on all the progress. Assuming Lugano and LUCIA meet their non-inferiority endpoint, does your statistical analysis plan allow for testing superiority? If so, how do you expect clinicians to interpret those data related to on-label aflibercept compared to potential competitors pursuing superiority claims based on less frequent dosing? Romero, why don't you answer that? Thanks, Jay Duker. I appreciate the question. Yeah, thanks for the great question. As you mentioned, our analysis plan does allow for testing superiority against aflibercept if our non-inferiority is met. It's a hierarchical test, so we have the ability to test for that. Of course, if we see that Duraview produces superior visual outcomes compared to on-label aflibercept.

We're confident that the safety will be.

Will be quite good.

Speaker #2: As for the clinical trial results , which we expect again , the first trial Lugano mid next year , second trial Lucia soon to follow based on our strong phase two data , we would expect Non-inferiority to the on label Eylea control with continued safety and again , safety is of paramount importance here as as I'm sure you all know , but based on the ongoing mask safety that we've seen in these two phase three trials , as well as the extensive safety database , we have for both the review and Vorolanib , we're confident that the safety will be will be quite good .

As for reduction of treatment burden again, that's important.

There is no specific cutoff that says it has to be above or below a certain level.

And based on our discussions with Kols and the design of the trials, we think a 50% reduction in treatment burden will again put us into the forefront of.

<unk> therapies for wet AMD.

Thank you.

Our next question comes from.

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Cherokee from Jones. Please go ahead.

Hi, Thanks for taking my question and congrats on all the progress. So as you all know me Lugano and Lucien needs.

Speaker #2: As for reduction in treatment burden , again , that's important . There's no specific cutoff that says it has to be above or below a certain level .

Non inferiority endpoint does your statistical analysis plan allows for testing to pay RMB and if so how do you expect in Asia.

Those data as related to omni with eylea compared to potential competitors.

Speaker #2: And based on our discussions with Kols and the design of the trials , we think a 50% reduction in treatment burden will again put us into the forefront of of therapies for wet AMD .

He claims based on like next week when do you think.

Jay Duker: I think it would be an outstanding result for the retinal humidity and wet AMD patients. It would allow us to position Duraview as a premium medication. Of course, having a superiority claim against on-label aflibercept, I think from a retina specialty perspective, is much more relevant than having a superiority versus a single dose of aflibercept. We continue to be optimistic with our Lugano and LUCIA study. We were very fortunate to have the W2, our phase two study, to support the design of the phase three programs, a lot of the learnings coming from there. We're looking forward to see the results mid next year. Very helpful. Thank you. Thank you. This concludes the question and answer session. I will now turn it over to Jay Duker for closing remarks. Thanks very much.

So Ramiro why don't you answer that thanks, John I appreciate the question.

Yes, thanks for the Great question. So our as you mentioned our analysis plan.

<unk> allow for testing superiority again to <unk>.

Speaker #1: Thank you . Our next question comes from Bojana Chatterjee from Jones . Please go ahead .

<unk> is Matt So you see higher co testing.

So we have the ability to test for that.

Speaker #10: Hi . Thanks for taking my question . And congrats on all the progress . So assuming Lugano and Lucia meets its , you know , there noninferiority endpoint , does your statistical analysis plan allow for testing superiority and if so , how do you expect clinicians to interpret data relative to on label Eylea compared to potential those pursuing superiority claims based on like less frequent dosing ?

Of course, if we see that too if you produce peer visual outcomes compared to only <unk>.

Then of course, I think would be an outstanding results form the retina community in wet AMD patients and it would allow us to position to review as a premium medication.

Speaker #2: So Romero , why don't you answer that ? Thanks , John . I appreciate the question .

Of course, having a superiority claim against only about 3%.

Speaker #4: Yeah , thanks for the great question . So our as you mentioned , our analysis plan does allow for testing superiority . Again , the Aflibercept , if our Non-inferiority is met .

I think from a retina specialty perspective is much more relevant than heavy superiority versus a single dose of <unk>.

Jay Duker: Before we close, I do want to mention a tremendous honor that EyePoint Pharmaceuticals received this week. We were voted a 2026 Best Places to Work by Biospace. In fact, we were in the top five best biotech companies nationally. This is a testament to the incredible team and culture we built here at EyePoint Pharmaceuticals. Exceptional execution does not come in a vacuum. I want to thank all of our amazing team for this honor, but especially our human resources group led by our Chief People Officer, Jen Leonard. Thank you all for your time and attention this morning. Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

So we will continue to be optimistic with our Lugano Chief study.

Speaker #4: So is a hierarchical testing . So we have the ability to test for that . Of course if we see that do review produce superior visual outcomes compared to on label aflibercept , then of course I think would be an outstanding result for the retina community .

We were very fortunate to have the diabetes, our phase III study to support.

The design of the phase III programs, a lot of the learnings coming from there.

Q4 to see the results mid next year.

Very helpful. Thank you.

Speaker #4: And wet AMD

Speaker #4: patients and would allow us competitors to position the review as a premium medication . Of course , having a superiority claim against own label Aflibercept I think from a retina , specialist is much more relevant than having a superiority versus a single dose of aflibercept .

Thank you.

This concludes the question and answer session I will now turn it over to Jay Duker for closing remarks.

Thanks very much.

Before we close I do want to mention a tremendous honor that I point received this week.

We were voted a 2026 best places to work by bio space and.

In fact, we were in the top five best biotech companies nationally.

Speaker #4: So we are , you know , we continue to be optimistic with our Lucia study . We were very fortunate to have the W two , our phase two study to support the design of the phase three programs .

This is a testament to the incredible team and culture, we built here at high point.

Exceptional execution does not come in a vacuum.

Speaker #4: A lot of the learnings coming from there and looking forward to see the results . Mid next year .

I want to thank all of our amazing team for this honor, but especially our human resources group led by our Chief people Officer Jen Leonard.

Speaker #10: Very helpful . Thank you .

Thank you all for your time and attention this morning.

Speaker #1: Thank you . This concludes the question and answer session . I will now turn it over to Jay Duker for closing remarks .

Thank you for your participation in today's conference. This does conclude the program you may now disconnect.

Speaker #2: Thanks very much . Before we close , I do want to mention a tremendous honor that I point received . This week . We were voted a 2026 Best Places to Work by Biospace .

Speaker #2: In fact , we were in the top five best biotech companies nationally . This is a testament to the incredible team and culture we built here at Eyepoint .

Speaker #2: Exceptional execution does not come in a vacuum . I want to thank all of our amazing team for this honor , but especially our human resources group led by our Chief People , Officer Jen Leonard .

Speaker #2: Thank you all for your time and attention this morning .

Speaker #1: Good morning . My name is Antoine and I will be your conference operator today . At this time , I would like to welcome everyone to the Eyepoint third quarter 2025 financial results and recent corporate developments .

Speaker #1: 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 .

Speaker #1: I would now like to turn the call over to George Elston Executive Vice President and Chief Financial Officer of Eyepoint . Please go ahead .

Speaker #2: Thank you , and thank you all for joining us on today's conference call to discuss its third quarter 2025 financial results in recent corporate developments .

Speaker #2: With me today is Doctor Jay Duker , President and Chief Executive officer of Eyepoint . J will begin with a review of recent corporate updates and discuss our clinical programs for review in wet , AMD and DME .

Speaker #2: I will close with commentary on the third quarter 2025 financial results . We will then open the call for your questions where we will be joined by Doctor Ramiro Ribeiro , our chief Medical officer .