Q2 2022 EyePoint Pharmaceuticals Inc Earnings Call

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

Operator: The conference will begin shortly.

[music].

Good morning, My name is Michelle and I'll be your conference operator today at this time I would like to welcome everyone to the <unk>.

Operator: To raise your hand during Q&A, you can dial star 1-1.

I appoint pharmaceuticals second quarter 2022 financial results and recent corporate developments conference call.

It'd be a question answer session to follow at the completion of their prepared remarks. Please be advised that this call is being recorded at the company's request.

I would now like to turn the call over to George Ellison, Chief Financial Officer of five point Pharmaceuticals.

Okay.

Operator: Good morning.

Thank you and thank you all for joining us on today's conference call to discuss <unk> Pharmaceuticals second quarter 2022 financial results and recent corporate developments with me today are Nancy Lurker, President and Chief Executive Officer, Dr. Jay Duker, Chief operating Officer, and Scott Jones Chief.

Operator: My name is Michelle, and I'll be your conference operator today.

Operator: At this, time, I would like to welcome everyone to the EyePoint Pharmaceutical second quarter 2022 financial results and recent corporate development conference call.

Officer.

Nancy will begin with a review of recent corporate updates Dr. <unk> will then discuss clinical plans for <unk> thousand 19 of one and Scott will comment on our 20 <unk> 2022 commercial performance.

I'll close with commentary on the second quarter of 2022 financial results. We will then open up the call for your questions.

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

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

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.

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

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

Actual projections and our plans and prospects actual results may differ materially from those indicated by these forward looking statements as a result of various important factors, including those discussed in the risk factors section.

Our most recent annual report on Form 10-K, which is on file with the SEC and in other filings, we may make with the SEC in the future.

Any forward looking statements represent our views as of today only while we may elect to update these forward looking statements at some point in the future. We specifically disclaim any obligation to do so even if our views change.

Therefore, you should not rely on these forward looking statements as representing our views as of any date subsequent to today I'll now turn the call over to Nancy Lurker, President and Chief Executive Officer of high point Pharmaceuticals.

Operator: I would like to turn the call over to George Elston, Chief Financial Officer of EyePoint Pharmaceutical.

George Elston: Thank you, and thank you all for joining us on today's conference call to discuss EyePoint

George Elston: Pharmaceutical second quarter 2022 financial results and recent corporate developments.

Thank you George Good morning, everyone and thank you for joining us it's been an exciting quarter for <unk> Pharmaceuticals, and we are very proud of the work we've done to bring ocular therapies to patients with serious eye disorders and at the same time create long term value for our shareholders. It's been a busy quarter and I will now review our recently.

George Elston: With me today are Nancy Lurker, President and Chief Executive Officer, Dr. Jay Duker, Chief Operating Officer, and Scott Jones, Chief Commercial Officer.

George Elston: Nancy will begin with a review of recent corporate updates.

George Elston: Dr. Duker will then discuss clinical plans for EYP 1901, and Scott will comment on our 2Q 2022 commercial performance.

Accomplishments.

We continue to execute on our pipeline with the first patient dosed and we're very excited about this last week and our phase two <unk> clinical trial evaluating <unk> 19 O. One for wet age related macular degeneration or wet AMD.

Reminder, you went through 19 O. One is a combination of the small molecule tyrosine kinase inhibitor rolling it.

And a bio erodible formulation of our proprietary <unk> technology, we look forward to providing an update on our phase II hobby a trial for <unk> thousand 19 of one in a second indication non proliferative diabetic retinopathy also known as N. P. D. R. Later this quarter.

<unk>.

In July we presented positive 12 month safety and efficacy data from the phase <unk> clinical trial at the American Society of retinal specialists annual meeting.

What AMD is a serious and potentially devastating disorder accounting for approximately 90% of all AMD related blindness.

Although there are safe and effective FDA approved medications on the market. The treatment paradigm remains a challenging one for patients and physicians as most patients with wet AMD are treated every month or every other month, we cryo requiring frequent trips to the doctor's office and countless injections over their lifetime.

You went through and 19 O. One has the potential to provide the substantial benefits of allowing patients are longer duration between doctors offices and visits of up to six months, while maintaining stable visual acuity and macular anatomy.

It is important to highlight that we view 2019 O one knock as replacement therapy for existing large molecule anti VEGF therapy, such as Eylea, it flip receptor or Lucentis ranibizumab, but is a treat to maintain therapy with a different mechanism of action a receptor versus like a bond.

<unk> that can potentially act as maintenance therapy and use current treatments as supplemental support as needed.

Dr. Jay Duker will review in more detail the results of our 12 months W. Two data later in the call.

As I've mentioned in quarters past I'm very proud of our team's execution of our phase <unk> clinical trial, just 18 months. After we begin our trial, we have disclosed positive 12 month data have aligned with the FDA for a phase II trial and now dosed the first patient in our phase.

<unk> two <unk> two clinical trial for wet AMD.

Additionally, we were pleased to have hosted our first Investor day event, where we featured commentary from high points management team as well as guest speakers Dr. Carl <unk> Professor of Ophthalmology, Thomas Jefferson University and Dr. Charlie White collar director of research retina consultants of Texas.

We discussed the incredible science behind our <unk> drug delivery platform clinical results and phase two plans for <unk> thousand 19 O. One and gave a commercial update on Utica. Please send alone a set of night inter vitro implant for the treatment of chronic non infectious uveitis affecting the posterior segment of the eye.

Turning to our commercial products, we announced the approval of boutique in China with documents and Therapeutics Utica is the first drug for commercial use in occupant Inaki mentioned innovative pipeline.

We're very pleased to partner with documents and to expand Utica global reach in the emerging Chinese market and there will now be marking an important milestone and furthering our mission of improving the lives of patients with serious eye disorders around the world.

George Elston: I will close with commentary on the second quarter 2022 financial results.

Finally, we saw record net product revenues in Q2, 2022, primarily driven by a strong second quarter for Youtube, which youll hear more about from Scott and George later on.

George Elston: 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 company website, www.eyepointpharma.com.

On the corporate front, we announced two new board appointments in June and July and we continue to strategically build out our board and leadership team as our company grows and evolves first in June we elected Dr. Tony Davis to the board of Directors, who is a pioneer in the discovery and early development of anti VEGF drugs.

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.

George Elston: 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.

For the treatment of ophthalmic diseases.

Tony is best known for his co discovery of the role of vascular endothelial growth factor veg F in ocular diseases, including wet AMD and diabetic retinopathy.

In July we welcomed Karen <unk>, who currently serves as <unk>, President and CEO to our board of directors Karen is a pharmaceutical industry veteran who brings more than 35 years of biopharmaceutical and medical device leadership and commercial experience to the role. We also think the contribution that Ron Eastman.

On EW healthcare partners made to the board during his four year tenure.

I am indebted to and grateful for the talented <unk> team, which continues to execute quarter over quarter on all clinical operational and financial aspects of our business.

We are steadfast in our mission to become the leader in sustained ocular delivery in order to deliver improved retinal treatment and bring much needed therapies to patients around the world 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.

George Elston: 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 we may make with the SEC in the future.

Other initiatives Jay.

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.

Thank you Nancy and good morning, everyone.

George Elston: I'll now turn the call

Before I begin I want to reiterate what an incredible quarter. This has been for the <unk> clinical team as we executed on multiple milestones and we expect to continue to do so as we advance our pipeline.

George Elston: over to Nancy Lerker, President and Chief Executive Officer of Eyepoint Pharmaceuticals.

To provide a brief overview of our product candidates and pipeline as we discussed at our recent Investor Day, you might be 91 is an investigational sustained release anti VEGF treatment.

Nancy Lurker: Thank you, George.

Nancy Lurker: Good morning, everyone, and thank you for joining us.

We deliver for rolling up a small molecule tyrosine kinase inhibitor, which is the active ingredient <unk> using <unk> proprietary drug delivery technology <unk>.

Nancy Lurker: It's been an

<unk> differentiates <unk> from other currently approved anti VEGF drugs as this bio erodible insert allows for true sustained release of the drug with zero order kinetics. After initial beneficial burst the medication.

For relative bonds to all veg F receptors utilizing a differentiated mechanism of action.

Compared to other TK ice paroling of features reduced off target binding leading to a potentially improved safety profile with so far no reported ocular toxicity.

Nancy Lurker: exciting quarter for Eyepoint Pharmaceuticals, and we are very proud of the work we have done to bring ocular therapies to patients with serious eye disorders and at the same time create long-term value for our shareholders.

And our first indication wet AMD <unk> 19 O. One is being studied as a maintenance therapy. Following induction therapy with an anti VEGF therapeutic approach, which we refer to as treat to maintain.

Nancy Lurker: Holders.

With regards to wet AMD. Our goal is to sustain a majority of wet AMD patients treatment interval up to six months or longer after a single injection of <unk>, one as the largest unmet need in wet AMD landscape is the longevity of anti VEGF therapy.

By providing this sustained delivery treatment patients and practitioners could potentially have the flexibility to safely reduce the number of visits to their retina specialists through controlled and sustained intra vitriol delivery of an anti VEGF drug.

Nancy Lurker: It's been a busy quarter, and I'll now review our recent accomplishments. We, continue to execute on our pipeline with the first patient dose, and we're very excited about this, last week in our Phase II W02 clinical trial, evaluating EYP1901 for wet age-related macular degeneration, or wet AMD. As a reminder, EYP1901 is a combination of the small-molecule tyrosine kinase inhibitor, Voronib, and a bioerodible formulation of our proprietary Duracert technology.

Turning to our most recent data update we reported positive 12 month results of the <unk> <unk> phase one clinical trial for the treatment of wet AMD at the American Society of retinal specialists in mid July .

Nancy Lurker: We look forward to providing an update on our Phase II PAVIA trial for EYP1901 in a second indication, nonproliferative diabetic retinopathy, also, known as NPDR, later this quarter.

Nancy Lurker: In July, we presented positive 12-month safety and efficacy data from the Phase I DAVIO clinical trial at the American Society of Retinal Specialists annual meeting.

The <unk> trial enrolled 17 patients and each received a single intravenous <unk> injection of <unk> 19 O. One at one of four different dose levels.

Nancy Lurker: Wet AMD is a serious and potentially devastating eye disorder, accounting for approximately 90% of all AMD-related blindness. Although there are safe and effective FD-approved medications, on the market, the treatment paradigm remains a challenging one for patients and physicians, as most patients with wet AMD are treated every month or every other month, requiring frequent trips to the doctor's office and countless injections over their lifetime.

All enrolled patients were previously treated with standard of care anti VEGF therapy.

No reinjection with the study drug was performed during the trial and typical criteria for supplementation with a standard of care anti VEGF was employed.

We are pleased that the 12 months data demonstrated no reports of ocular aes or drug related systemic sce's <unk>.

No reported events have vitreous floaters endophthalmitis retinal detachment.

Migration into the anterior chamber retinal vasculitis post your segment inflammation or retinal vascular occlusive events.

Further the 12 month follow up confirm staple best corrected visual acuity of minus four <unk> <unk> letters and stable central subfield thickness on optical coherence tomography minus two 706 microns.

As expected there was an observed increase in supplemental anti VEGF therapy. After nine months, given the inserts expected drug depletion, however, 35% of eyes or supplemental anti VEGF free up to 12 months after injection with <unk>.

Up to six months, 53% of ice where supplement free.

Additionally, there continues to be a positive treatment burden reduction of 74% at 12 months versus 79% at six months.

We're very pleased with our <unk> phase <unk> results, which demonstrate that <unk> has the potential to maintain a majority of patients for up to six months with no supplemental anti VEGF therapy.

Nancy Lurker: EYP1901 has the potential to provide the substantial benefit of allowing patients a longer duration, between doctor's offices and visits of up to six months, while maintaining stable visual acuity and macular anatomy.

On the heels of this positive data we have enrolled our first patient in the phase II clinical trial of <unk> hundred one for wet age related macular degeneration called <unk>.

Nancy Lurker: It's important to highlight that we view EYP1901 not as replacement therapy for existing large-molecule anti-VEGF therapy, such as ILEA, Iflivercept, or Lucentis Renovizumab, but as a treat-to-maintain therapy with a different mechanism of action, a receptor, versus ligand binding, that can potentially act as maintenance therapy and use current treatments as supplemental support as needed.

Nancy Lurker: Dr. Jay Duker will review in more detail the results of our 12-month Davio II data later in the call.

Nancy Lurker: As I've mentioned in quarters past, I'm very proud of our team's execution of our Phase I Davio clinical trial.

The trial is expected to enroll approximately 150 wet AMD patients previously treated with standard of care anti VEGF therapy and randomly assigned to one of two doses of <unk> thousand 19 O. One approximately two milligrams or approximately three milligrams. This is versus an on label a flavor soft control.

Nancy Lurker: Just 18 months after we began our trial, we have disclosed positive 12-month data, have aligned, with the FDA for our Phase II trial, and now dosed the first patient in our Phase II Davio II clinical trial for wet AMD.

Nancy Lurker: Additionally, we were pleased to have hosted our first Investor, Day event, where we featured commentary from iPoint's management team, as well as guest speakers, Dr. Carl Regillo, Professor of Ophthalmology, Thomas Jefferson University, and Dr. Charlie Wyckoff, Director of Research, Retina Consultants of Texas.

Nancy Lurker: We discussed the incredible science, behind iPoint's DuraCert drug delivery platform, clinical results, and Phase II plans for EYP 1901, and gave a commercial update on Utique, a flucinolone acetonide intravitreal implant, for the treatment of chronic noninfectious uveitis affecting the posterior segment of the eye.

<unk> 19, no one is delivered with a single <unk> injection in the physician's office similar to current FDA approved anti VEGF treatments.

The primary efficacy endpoint of the <unk> trial is non inferiority to the flipper set control as measured by change in best corrected visual acuity six months after the <unk> injection.

Secondary efficacy endpoints include change in CST as measured by <unk>.

To first supplemental anti VEGF and safety.

We look forward to progressing our phase II trial, and anticipate topline results in the second half of 2023.

We are also looking forward towards potentially paradigm changing exploration of VIP 19, one and other severe eye disorders, including our phase II Parthia trial of <unk> in non proliferative diabetic retinopathy also known as N PDR.

NPD our effects almost one third of adults over the age of 40 with diabetes and is projected to impact over 14 million Americans by 2050.

In NPD, our blood vessels are weakened in may leak fluid into the retina, causing swelling of the macula and lead to vision changes if left uncontrolled it can lead to severe visual loss in other ocular complications. The current standard of care includes intra vitriol injections or laser photo coagulation, which can be burdens.

Some for patients.

The <unk> trial is a 12 month randomized controlled phase II trial of <unk> hundred one for N PDR, which is expected to enroll approximately 105 patients randomly assigned to one of two doses of <unk> 19 O. One approximately two milligrams or approximately three milligrams or to the control group, receiving a sham and <unk>.

<unk>.

He might be 19, when it's delivered with a single <unk> injection in the physicians' office. The primary efficacy endpoint of the trial is improvement of at least two Drs, yes.

Or diabetic retinopathy severity score severity levels as of week 36, after the VIP 19, one injection.

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

We look forward to providing updates on the clinical trial and subsequent quarters.

In conclusion, we are very proud of the clinically validating results we've seen from the phase one trial of <unk> and we are excited to have initiated <unk> <unk> 91 last week with the phase III <unk> trial plan for NPD or later this quarter.

We will continue working to provide potentially life altering therapies to patients with serious eye disorders as we further explore the potential of <unk> one.

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

Nancy Lurker: Turning to our commercial products, we announced the approval of Utique in China with Occumention, Therapeutics. Utique is the first drug for commercial use in Occumention's innovative pipeline. We're very pleased to partner with Occumention to expand Utique's global reach in the emerging, Chinese market.

Nancy Lurker: And they will now be marking an important milestone in furthering our mission of improving, the lives of patients with serious eye disorders around the world.

Nancy Lurker: Finally, we saw record net product revenues in Q2 2022, primarily driven by a strong second, quarter for Utique, which you'll hear more about from Scott and George later on.

Thank you Jay.

We're excited to report a strong quarter for our commercial business with $11 3 million of net product revenue an increase of 30% from the second quarter of last year.

Our Q2 net product revenue for Utica and to execute was $7 4 million and $3 $9 million respectively cut.

Customer demand was approximately 900 units for you tube.

An approximate 40% increase from Q1 of 2022 and 14700 units so to execute consistent with the first quarter.

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

Customer demand for <unk> was strong and consistent with Q1 of 2022.

As our commercial alliance partner in <unk> continues to drive strong demand.

In July of 2022, I point announced the CMS dropped hospital outpatient perspective payment rule did not extend pass through status for expiring drugs, thus impacting to execute.

If the draft rules finalized <unk> pass through status will expire on December 31, 2022, CMS did clarify that they intend to offer ongoing pass through to non opioid pain alternatives and that they will require a pain indication in order for a product to be eligible for continued reimbursement.

In light of this recent news we are evaluating next steps for a potential execute pain indication.

We're very pleased by the progress we've made with our commercial businesses and remain on track for breakeven for the franchise in 2022 I'd like to thank our commercial teams for their dedication to bring our ophthalmic therapies to physicians and patients in need.

Nancy Lurker: On the corporate front, we announced two new board appointments in June and July, and we, continue to strategically build out our board and leadership team as our company grows and evolves.

Nancy Lurker: First, in June, we elected Dr. Tony Ademus to the board of directors, who is a pioneer, in the discovery and early development of anti-VEGF drugs for the treatment of ophthalmic diseases. Tony is best known for his co-discovery of the role of vascular endothelial growth factor, VEGF, in ocular disease, including wet AMD and diabetic retinopathy.

Nancy Lurker: Second, in July, we welcomed Karen Siderich, who currently serves as Oxygen's president, and CEO, to our board of directors. Karen is a pharmaceutical industry veteran who brings more than 35 years of biopharmaceutical, and medical device leadership and commercial experience to the role.

We look forward to updating you on revenues and demand in the quarters to come I would now like to turn the call over to George to review the financials George.

Nancy Lurker: We also thank the contribution that Ron Eastman, EW Healthcare Partners, made to the board, during his four-year tenure.

Nancy Lurker: I am indebted to and grateful for the talented iPoint team, which continues to execute quarter, over quarter on all clinical, operational, and financial aspects of our business.

Nancy Lurker: We are steadfast in our mission to become the leader in sustained ocular delivery in, order to deliver improved retinal treatment and bring much-needed therapies to patients around the world.

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

Nancy Lurker: I'll now turn the call over to Dr. Jay Duker, our chief operating officer, to provide an

Jay Duker: update on our LEAD program, EYP 1901, as well as other initiatives.

For the second quarter ended June 32022, total net revenue was $11 6 million compared to $9 million for the quarter ended June 32021. This includes net product revenue for the second quarter of $11 3 million compared to net product revenue of $8 7 million for the prior year period, an increase of 30.

Jay Duker: Jay?

Jay Duker: Thank you, Nancy, and good morning, everyone.

Jay Duker: Before I begin, I want to reiterate what an incredible quarter this has been for the iPoint, clinical team as we executed on multiple milestones, and we expect to continue to do so as we advance our pipeline.

Jay Duker: To provide a brief overview of our product candidates and pipeline, as we discussed at, our recent Investor Day, EYP 1901 is an investigational, sustained-release anti-VEGF treatment. We deliver Virolinib, a small-molecule tyrosine kinase inhibitor, which is the active ingredient, in EYP 1901, using iPoint's proprietary drug delivery technology, Duracert. Duracert differentiates EYP 1901 from other currently-approved anti-VEGF drugs, as this, bio-erodible insert allows for true, sustained release of the drug with zero-order kinetics after initial beneficial burst of medication. Virolinib binds to all VEGF receptors, utilizing a differentiated mechanism of action.

Jay Duker: Compared to other TKIs, virulent features reduced off-target binding, leading to a potentially improved safety profile with so far no reported ocular toxicity.

Jay Duker: In our first indication, wet AMD, EYP1901 is being studied as a maintenance therapy, following induction therapy with an anti-VEGF therapeutic approach, which we refer to as treat to maintain. With regards to wet AMD, our goal is to sustain a majority of wet AMD patients' treatment interval up to six months or longer after a single injection of EYP1901, as the largest unmet need in wet AMD landscape is the longevity of anti-VEGF therapy. By providing this sustained delivery treatment, patients and practitioners could potentially have the flexibility to safely reduce the number of visits to their retina specialist through controlled and sustained intravitreal delivery of an anti-VEGF drug.

<unk> net.

Net revenue from royalties and collaborations for the second quarter ended June 32022 totaled <unk> 3 million consistent with the corresponding period in 2021.

Jay Duker: Turning to our most recent data update, we reported positive 12-month results of the EYP1901, Davio Phase I clinical trial for the treatment of wet AMD at the American Society of Retinal Specialists in mid-July. The Davio trial enrolled 17 patients and each received a single, intravitreal injection of EYP1901 at one of four different dose levels. All enrolled patients were previously treated with standard of care anti-VEGF therapy.

Jay Duker: No reinjection with the study drug was performed during the trial and typical criteria for supplementation with a standard of care anti-VEGF was employed.

Jay Duker: We are pleased that the 12-month data demonstrated no reports of ocular SAEs or drug-related systemic SAEs, no reported events of vitreous floaters, endophthalmitis, retinal detachment, insert migration into the anterior chamber, retinal vasculitis, posterior segment inflammation, or retinal vascular occlusive events.

Jay Duker: Further, the 12-month follow-up confirmed stable best corrected visual acuity of minus 4.12 ETDRS letters and stable central subfield thickness on optical coherence tomography of minus 2.76 microns.

Jay Duker: As expected, there was an observed increase in supplemental anti-VEGF therapy after nine months given the insert's expected drug depletion.

Operating expenses for the second quarter ended June 32022 totaled $30 8 million versus $20 million in the prior year period, primarily driven by an increase in R&D spending, including clinical trial costs for <unk> hundred one and investment in personnel across the organization and noncash stock based.

Jay Duker: However, 35 percent of eyes were supplemental anti-VEGF free up to 12 months after injection with EYP 1901.

Jay Duker: Up to six months, 53 percent of eyes were supplement free.

<unk>.

Nonoperating expense net totaled $2 million and net loss was $19 4 million or <unk> 52 per share compared to a net loss of $10 million or <unk> 35 per share for the prior year period.

Cash and investments at June 32022 totaled $171 2 million compared to $211 6 million at December 31, 2021, we.

We expect the cash cash equivalents and investments on hand at June 32022, and expected net cash inflows from our product sales will enable us to fund our current and planned operations into the second half of 2024.

Jay Duker: Additionally, there continued to be a positive treatment burden reduction of 74 percent at 12, months versus 79 percent at six months.

In conclusion, we are pleased with <unk> progress in the second quarter of 2022 and are well capitalized to advance our pipeline to key value inflection points. Thank you all very much for listening in this morning, and I'll now turn the call over to the operator for questions.

Jay Duker: We're very pleased with our GAVIO Phase 1 results which demonstrate that EYP 1901 has the potential to maintain a majority of patients for up to six months with no supplemental anti-VEGF therapy.

Jay Duker: On the heels of this positive data, we have enrolled our first patient in the Phase 2 clinical trial of EYP 1901 for wet age-related macular degeneration called GAVIO 2. The trial is expected to enroll approximately 150 wet AMD patients previously treated with, standard of care anti-VEGF therapy and randomly assigned to one of two doses of EYP1901, approximately 2 milligrams or approximately 3 milligrams.

Jay Duker: This is versus an on-label of liver CEP control. EYP1901 is delivered with a single intravitreal injection in the physician's office, similar to current FDA approved anti-VEGF treatments.

Jay Duker: The primary efficacy endpoint of the W02 trial is non-inferiority to the liver CEP control, as measured by change in best corrected visual acuity six months after the EYP1901 injection. Secondary efficacy endpoints include change in CST as measured by OCT, time to first supplemental anti-VEGF, and safety. We look forward to progressing our phase two trial and anticipate top line results in the second half of 2023.

As a reminder, if you'd like to ask a question. Please press star one one.

Jay Duker: We are also looking forward to our potentially paradigm changing exploration of EYP1901 and, other severe eye disorders, including our phase two PAVIA trial of EYP1901 and non-proliferative diabetic retinopathy, also known as NPDR. NPDR affects almost one third of adults over the age of 40 with diabetes and is projected to impact over 14 million Americans by 2050. In NPDR, blood vessels are weakened and may leak fluid into the retina causing swelling of the macula and lead to vision changes. If left uncontrolled, it can lead to severe visual loss and other ocular complications. The current standard of care includes intravitreal injections or laser photocoagulation, which can be burdensome for patients.

Our first question comes from Stacy <unk> with Cowen Your line is open.

Jay Duker: The PAVIA trial is a 12-month randomized controlled phase two trial of EYP1901 for NPDR, which is expected to enroll approximately 105 patients randomly assigned to one of two doses of EYP1901, approximately two milligrams or approximately three milligrams, or to the control group receiving a sham injection. EYP1901 is delivered with a single intravitreal injection in the physician's office.

Thanks, so much for taking our questions and congratulations on the progress.

The first question is do you plan.

To provide quarterly enrollment updates for your phase <unk>.

Trial, So I believe you've got it six months, so just some color around that.

<unk>.

Yes.

Maybe you could speak to the level of physician awareness and engagement so far as the U S.

Thanks.

Jay Duker: The primary efficacy endpoint of the trial is improvement of at least two DRSS or diabetic retinopathy severity score severity levels as of week 36 after the EYP1901 injection.

Jay Duker: Secondary endpoints include vision threatening complications, occurrence of diabetic macular edema and or proliferative disease, retinal ischemia, non-perfusion, and safety.

Yeah, Hi, Thank you for that Stacy no.

Have not ever done that for Davita, one we don't plan to for <unk> as you know these <unk>.

Clinical trial enrollments can be like sine waves and so you can get a big bolus come in and then a valley and it just doesn't give much insights I think to investors. So we obviously will issue a press release, when we have complete enrollment.

But that's always been our target and I'm going to actually have Dr. Jay Duker comment on.

Just sort of how the trial is going so far yesterday physician engagement is at very high.

Well over 100 sites interested in being.

Participating in the study.

I think at this point.

The.

PKI in the delivery system that we feature is resonating with physicians and I think our phase one clinical trial data has been very well received so I think theres a lot of excitement out there in the retina community about the potential for <unk> hundred one.

Jay Duker: We look forward to providing updates on the clinical trial and subsequent quarters. In conclusion, we are very proud of the clinically validating results we've seen from the phase one trial of EYP1901, and we are excited to have initiated EYP1901 last week with the phase two PAVIA trial plan for NPDR later this quarter.

Jay Duker: We will continue, working to provide potentially life-altering therapies to patients with serious eye disorders

Okay perfect.

Jay Duker: as we further explore the potential of EYP1901.

Two more questions on the Davita to first what are the powering assumptions versus Eylea arm. So 19, one versus eylea to achieve non inferiority and the second question on W. Two how close do you expect the design will be with the pivotal trials.

Jay Duker: I will now turn the call over to Scott Jones,

Scott Jones: Chief Commercial Officer for the commercial update.

Scott Jones: Scott.

Scott Jones: Thank you, Jay.

At the Investor Day, we talked about the potential six months with treatment for phase III. So any additional details would be appreciated. Thank you so much.

Scott Jones: We're excited to report a strong quarter for our commercial business

Scott Jones: with $11.3 million of net product revenue, an increase of 30% from the second quarter of last year. Our Q2 net product revenue for Utique and Dexacue was $7.4 million and $3.9 million, respectively. Customer demand was approximately 900 units for Utique, an approximate 40% increase from Q1 of 2022, and 14,700 units of Dexacue, consistent with the first, quarter.

Scott Jones: In light of this recent news, we're evaluating next steps for a potential Dexacue pain indication.

Scott Jones: Customer demand for Utique continues to grow as we see positive traction from our focus on retina specialists for posterior segment inflammation and continued use by uveitis specialists.

Scott Jones: We're very pleased by the progress we've made with our commercial businesses and remain, on track for breakeven for the franchise in 2022. I'd like to thank our commercial teams for their dedication to bring our ophthalmic therapies to physicians and patients in need.

Scott Jones: We hope to see increased demand continue in the quarters to come with further support from our ongoing phase four studies that are underway.

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

Scott Jones: I would

Scott Jones: Customer demand for Dexacue was strong and consistent with Q1 of 2022, as our commercial alliance partner, ImprimisRx, continues to drive strong demand.

George Elston: now like to turn the call over to George to review the financials.

Scott Jones: In July of 2022, EyePoint announced that the, CMS Draft Hospital Outpatient Prospective Payment Rule did not extend pass-through status for expiring drugs, thus impacting Dexacue. If the draft rule is finalized, Dexacue's pass-through status will expire on December 31st of 2022. CMS did clarify that they intend to offer ongoing pass-through to non-opioid pain alternatives and that they will require a pain indication in order for a product to be eligible for continued reimbursement.

George Elston: George?

And so we haven't publicly announced.

Statistics around RVO to at this point Theyre descriptive only.

George Elston: Thank you, Scott.

George Elston: As the financial results for the three months ended June 30th, 2022 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 second quarter ended June 30th, 2022, total net revenue was $11.6 million compared to $9 million for the quarter ended June 30th, 2021. This includes net product revenue for the second quarter of $11.3 million compared, to net product revenue of $8.7 million for the prior year period, an increase of 30%.

George Elston: Net revenue from royalties and collaborations for the second quarter ended June 30th, 2022, totaled $0.3 million consistent with the corresponding period in 2021.

George Elston: Operating expenses for the second quarter ended June 30th, 2022, totaled $30.8 million versus $20 million in the prior year period, primarily driven by an increase in R&D spending, including clinical trial costs for EYP 1901 and investment in personnel across the organization and non-cash stock-based compensation.

George Elston: Non-operating expense net totaled $0.2 million and net loss was $19.4 million or $0.52 per, share compared to a net loss of $10 million or $0.35 per share for the prior year period.

George Elston: Cash and investments at June 30, 2022 totaled $171.2 million compared to $211.6 million, at December 31, 2021.

Given the end of the study the study.

George Elston: We expect the cash, cash equivalents and investments on hand at June 30, 2022 and expected net, cash inflows from our product sales will enable us to fund our current and planned operations into the second half of 2024.

George Elston: In conclusion, we are pleased with EyePoint's progress in the second quarter of 2022 and, are well capitalized to advance our pipeline to key value inflection points.

There is not necessarily powered to a high enough level to be.

Confident to that 95% level.

The results of the statistics again are descriptive.

Sure.

The <unk>.

Reinjection issue again at this point there is no.

<unk> injection <unk> two trial, we do it.

The study that in patients prior to the pivotal trial and we still anticipate that in our wet AMD pivotal trials the pace of Reinjection will be every six months, that's the anticipated testing.

George Elston: Thank you all very much for listening this morning and I now turn the call over to the

We had a very productive type C meeting with the FDA several months ago and at that meeting we asked some very specific questions around the structure of the pivotal trials. So we have a pretty good idea of what the pivotal trials might look like but in saying that one of the reasons you do a phase II trial is to inform your pivotal around dosing.

Operator: operator for questions.

Other things and so we do expect to learn things from Davita to that certainly may altered the structure of the pivotal trials be them now but.

We are comfortable and the FDA is comfortable with the outline of what the pivotal trials might look like.

Yes, let me just add to that I want to make sure that we're very clear on this we have not designed this to be a pivotal trial or even have the chance of hitting a statistical endpoint. Our goal is to understand better the dosing what dose we take into phase III.

As well as entry criteria et cetera, and what types of patients perform best.

Our goal is to make sure that we get this study done and.

And not have a large number of patients. So that we can potentially hit pivotal we really do need to learn just a few things to make sure. We have optimum success in phase III.

So we have no intentions of releasing statistics around this because it would be meaningless.

Okay. That's super helpful. Thank you so much.

Operator: As a reminder, if you'd like to ask a question, please press star 11.

Your next question comes from Eddie Hickman with Guggenheim Partners. Your line is open.

Operator: Our first question comes from Stacey Koo with Cohen.

Stacey Koo: Your line is open.

Stacey Koo: Thanks so much for taking our questions and congratulations on the progress.

Good morning, and thanks for taking the question. This is Eddie on for you. This morning.

Then on 19, one for the diabetic Retinopathy study what does the work have you done to make you choose those two and three milligram dose for the study.

And then for that study the endpoints are a bit different how are you going to handle the rescue criteria as compared to the <unk> study.

And then just quickly on decks when will you know about that CMS pass their decision and how long does that extension fee. If it does get approved.

Stacey Koo: The first question is, do you plan to provide quarterly enrollment updates for your Phase, 2 W-2 trial?

Jay Let me start with the.

The first two questions and thank you very much for discussing the <unk> trial.

Stacey Koo: I believe you've got it to six months, so just some color around the gating of enrollment, and maybe you could speak to the level of physician awareness and engagement so far as you initiate the sites.

Stacey Koo: Thanks.

Unknown Executive: Yeah.

Unknown Executive: Hi.

First of all we haven't found a maximally tolerated dose for USD 901, and either any animal studies or humans and since we don't know what doses will be effective we elected to go with the two highest doses that we used in <unk> for the <unk> trial.

Unknown Executive: Thank you for that, Stacey.

Unknown Executive: No, we have not ever done that for W-1.

Unknown Executive: We don't plan to for W-2.

Unknown Executive: As you know, these clinical trial enrollments can be like sine waves.

Unknown Executive: You can get a big bolus come in and then a valley and it just doesn't give much insights, I think, to investors.

Unknown Executive: So we obviously will issue a press release when we have complete enrollment, but that's, always been our target.

So it's certainly possible that a lower dose will be just as effective but we do hope to learn something about dosing from the <unk> trial.

There is no rescue criteria in a diabetic retinopathy study the control group as observation in the real world, although their labels for two anti VEGF for treatment.

Moderate to severe FTR.

We believe that only 2% to 3% of patients in the real world that are actually getting treated with anti VEGF and therefore using a <unk>.

Active control a sham injection.

We believe is appropriate for this indication and therefore rescue criteria would only really be applied to any patient who progressed too.

Center involving macular edema, or proliferative diabetic retinopathy.

Unknown Executive: I'm going to actually have Dr. J. Duke or comment on just sort of how the trial is going, so far.

Yes, I'll make one comment and then I'll have Scott on the pass through with execute but remember the final rules come out in November . So that's when we would expect to know, but Scott you want to add anything further on some color around sure.

Jay Duker: Yes.

Jay Duker: The physician engagement has been very high. We had well over 100 sites interested in participating in the study.

Jay Duker: I think at this point, the TKI and the delivery system that we feature is resonating with, physicians and I think our phase one clinical trial data has been very well received.

Jay Duker: So I think there's a lot of excitement out there in the retina community about the potential, for EYP 1901.

Unknown Executive: Okay.

So when we talk about pass through we're actually talking about two separate.

Unknown Executive: Perfect.

Opportunities for pass through extension, one is related to extending the public health emergency, which as we saw in 2020 to allow for extension to our tolling period, which is the period of which data is collected on the utilization of the product outside of the bundle so that would be potentially in the final rule.

Unknown Executive: And so two more questions on the W-2.

<unk>, which was November the second part of the pass through related to the non opioid.

Pain indication.

<unk> sparing products.

Excuse me non opioid bearing products related.

Related to pain and.

There is certainly that we saw draft rules in the 'twenty to rule in the 'twenty three proposed rule. We do believe there will be a finalization of those rules in the final rule, which comes out again in early November .

Unknown Executive: First, what are the powering assumptions versus the ILEA arm?

Unknown Executive: So 1901 versus ILEA to achieve non-inferiority.

Thank you.

Our next question comes from Jennifer Kim with Cantor Your line is open.

Unknown Executive: And the second question on W-2, how close do you expect the design will be with the, pivotal trials?

Hey, good morning, Thanks for taking my question I have two here. The first is just a clarification on how we should think about re injection data in the pivotal for wet AMD I think at the Investor Day. You said you would expect a readout nine months. After the last injection and then you anticipate reinjection with what's happened at six months does that mean.

Unknown Executive: I know at the investor day, we talked about potential six-month retreatment for phase, three. So any additional details would be appreciated.

Unknown Executive: Thank you so much.

Later on the re injected dose would only go out to three months.

And then my second question is just on the pain indication to execute it can go forward with exploring that what would the anticipated cost.

And I guess timing around that thanks.

Unknown Executive: So we haven't publicly announced the statistics around W-2.

Thanks.

Unknown Executive: At this point, they're descriptive only.

Unknown Executive: Given the end of the study, the study is not necessarily powered to a high enough level, to be confident to that 95% level.

Jennifer it's Jay Thanks for the questions and I'll take the first part.

Your summary of the pivotal structure Bret.

Unknown Executive: The results, the statistics, again, are descriptive.

The initial efficacy readout would be approximately nine months after the initial dose of <unk> 19 in one.

Unknown Executive: The re-injection issue, again at this point, there is no planned injection in the DAVIO2, trial.

At about.

Six months after that initial however, we would anticipate giving a second dose so the math works.

Unknown Executive: We do expect to study that in patients prior to the pivotal trial, and we still anticipate, that in our wet AMD pivotal trials, the pace of re-injection will be every six months.

Most wet AMD studies at this point are approximately one year efficacy trial and trial and we do anticipate taking the pill.

Unknown Executive: That's the anticipated testing.

Unknown Executive: We had a very productive type C meeting with the FDA several months ago, and at that meeting, we asked some very specific questions around the structure of the pivotal trials. So we have a pretty good idea of what the pivotal trials might look like.

As for safety.

<unk> also means that we would plan on Reinjecting, a total times within that study.

Unknown Executive: But in saying that, one of the reasons you do a phase two trial is to inform your pivotals, around dosing and other things. And so we do expect to learn things from DAVIO2 that certainly may alter the structure of, the pivotal trials as we see them now.

But the readout would be before two yes, the efficacy readout would.

Unknown Executive: But we're comfortable, and the FDA is comfortable, with the outline of what the pivotal trials, might look like. Yeah.

Unknown Executive: Let me just add to that.

It would be at approximately one year after the initiation of the study as it's currently structured or plants.

Unknown Executive: I want to make sure that we're very clear on this.

Jennifer.

To execute so number one not made any decision I want to be clear on that number too.

Unknown Executive: We have not designed this to be a pivotal trial nor even have the chance of hitting, a statistical end point. Our goal is to understand better the dosing, what dose we take into phase three, as well, as entry criteria, et cetera, and what types of patients perform best.

The cost of the.

Studies would be in the mid teens.

But there are various options.

Decide to go forward with it that we would look at some potential non dilutive ways to access that capital.

Wanted to careful that we do not expect in any way that if we go forward, we would impact our cash runway.

And then finally, obviously you can imagine.

<unk> been very clear.

That they want sure that they have non opioid pain products available and.

They gave.

Extended if you want to call it almost permanent pass through for some of these drugs that have it.

Pain indications so they've been very good.

You get a pain indication youre going to get extended pass through FERC.

Permanently through so.

The IRR as you can imagine is quite robust.

And the risk of doing a pain indication for dexamethasone is relatively low because dexamethasone is unknown.

<unk>. So we feel confident that if we decide to go forward our odds of achieving a successful outcome are quite high. Nevertheless notices have been made we are going to be very thoughtful about how we approach. This this is not a core asset and we recognize that and our goal is to make sure that we have the capital and the runway.

Unknown Executive: Our goal is to make sure that we get this study done ASAP and not have a large number, of patients so that we can potentially hit pivotal.

Unknown Executive: We really do need to learn just a few things to make sure we have optimal success in phase, three.

Unknown Executive: So we have no intentions of releasing statistics around this because it would be meaningless.

Unknown Executive: Okay.

To execute on our <unk> thousand 19 on one program.

Unknown Executive: That's super helpful.

Unknown Executive: Thank you so much.

Okay, great. Thanks, actually if I could sneak one more question you've also talked about exploring other molecules, which are like complement inhibitors are there other molecules that you're also exploring and also what are you looking for in a partner to take this forward. Thanks.

So yes, there are other molecules that we're looking at and the beauty about <unk> is to say you can.

We've said before many small molecules in and possibly up to some small peptide.

There's a number of opportunities.

Like to go after assets that have proof of concept because remember we're not a research driven company. We are a drug delivery and development stage company, we don't really want to take brand new mechanism of action risk on API.

Im going to actually have Jay comment further on any other specifics that we find interesting. Please note as well we have in licensed in the tie too.

Bob.

Activators, and we have both we have two molecules associated with that small molecule antibody specific so clearly that is one pathway that we are potentially exploring.

Just to add a little more color, we have a very active BD outreach right now and.

We are looking to partner with companies who have.

A.

The release problem, let's call it that they have a molecule that has a differentiated for proven MAA, but they.

Have a short life in the eye or they are giving it systemically and have systemic side effects, that's kind of the perfect partner for us in <unk>.

There are certain areas of unmet need that we're really interested in you mentioned complement and I would just even extend that to dry macular degeneration in general on neuro protection is another area that we are actively interested in.

There were several other smaller niche areas of the post your segment of the eye diseases that were ongoing and have ongoing talks with other potential partners to develop other molecules that have been de risked through other programs.

Eddie Hickman: Our next question comes from Eddie Hickman with Guggenheim Partners.

Alright, great. Thanks, so much guys.

Our next question comes from Yale Jen with Laidlaw. Your line is open.

Eddie Hickman: Your line is open.

Eddie Hickman: Good morning, and thanks for taking the question.

Good morning, and thanks for taking the questions.

Eddie Hickman: This is Eddie on for Yatin this morning.

My first question is for the.

David to study that.

I remember you guys talked about earlier that that you might enriched.

Eddie Hickman: Question on 1901.

Patients that.

It has been better managed by the <unk>.

Hey, Jeff therapies.

Any color you can share on this or adult.

Okay.

Sure.

Excellent question, and I think perhaps I am not sure enriching is quite the right word.

Eddie Hickman: For the diabetic retinopathy study, what dosing work have you done to make you choose those, 2- and 3-milligram doses for the study?

We looked very carefully at the patients who enrolled in the phase <unk> trial, who did well with <unk> 19 O one versus those in whom the benefit of <unk> 19, one was not as apparent.

Eddie Hickman: And then, for that study, since the end points are a bit different, how are you going to, handle the rescue criteria as compared to the clinical trials?

Eddie Hickman: I'm sorry.

And.

What was clear from that evaluation is that patients who were failing standard of care in other words, we're getting and I Leo or Lucentis injection every four or five or six weeks, but still had a lot of fluid or increasing fluid or decreasing vision to.

Despite that frequency of standard of care injections. It didn't appear that <unk> offered a lot of benefit to those patients and therefore, the inclusion exclusion criteria for <unk> to try to eliminate best we could the patients who are not doing well on standard of care.

So by doing that we hope that the benefit of <unk> hundred one is more apparent in <unk> than it was in <unk>.

Okay, Great that's very helpful.

And in terms of W. Two and have you.

There are many clinical sites, you anticipate to be overlapping or there will be.

Or that's not the case.

That's really good question and off the top of my head I don't know the answer I mean I've seen both lists.

You think I could probably put it together for that but suffice it to say that they are different diseases are treated by retinal specialists, but there is geographic.

Geographic diversity I would say with respect to these diseases. There are certain patient populations in areas of the country, where macular degeneration is more common in other areas, where the population isn't as elderly and may have more incidents of diabetes. So I fully expect that there is.

Going to be some overlap.

But not necessarily 100%.

Okay, Great. That's helpful. And then maybe the last question here is dead.

Kevin the Utica.

Yes.

And use that you're seeing.

Appears to be pretty good this quarter.

What.

<unk> outlook you guys may.

Anticipate or hope for.

Just for the remaining of the year and then thanks.

Yeah. Thanks for the question and thanks for your comments relative to <unk>, obviously, we're not providing any additional guidance.

Towards the sales the remainder of the year, we are happy that the.

Customer demand remains strong we continue to have really good.

Our customers and really good feedback. So we are happy with the performance of the product and with the sales force.

Okay great.

Very helpful and again, thanks a lot.

Eddie Hickman: So, this is excuse me.

Thank you.

Our next question comes from <unk>, Chen with H C. Wainwright Your line is open.

Eddie Hickman: The final question I wanted to make was back toward the bridge that Jay described and how, can our developers perform and how they can make a big difference in that compared to the DAWBIO studies?

Alright, Thank you for taking my question.

So in the <unk> trial within those 53% up to.

<unk> requires permits are.

Up to six months, 35% up to 12 months do they share any.

Similar characteristics.

Those patients that could help you.

And grow better and grow the patient support that go to trial.

So I would say there was.

Some disparity in the patients.

Length of time that they had disease and their own <unk> appearance at enrollment.

But one of the characteristics that they all had was a positive response to standard of care anti VEGF and by positive I don't I don't mean, just a little reduction in fluid that these people were generally under good control with the standard of care anti VEGF now retina specialists have a hard time to <unk>.

Finding good control some of us would say those monthly.

Monthly injections and are completely drives good vision are under good control. Despite the frequency of injection and so I would include patients in that category patients who did not have a lot of fluid and had good vision.

But required frequent injections and I think that Thats a.

Niche that we really hope you <unk> Phil.

Patients that are well treated require frequent injections.

And what would be the minimum.

Prior injections are minimum length of treatment.

Before getting routing to the tango.

Two trial.

So one.

One of the inclusion criteria is the diagnosis of wet AMD has been made less than nine months prior to screening.

And the patients have had to have a minimum of two standard of care anti VEGF.

And according to the enrolling investigators they've had two showed a positive response to those injections.

Got it thank you.

Eddie Hickman: And then, just quickly on DEX, when will you know that that CMS passed their decision and, how long would that extension be if it does get approved?

Our next question comes from Danielle <unk> with Chardan. Your line is open.

Eddie Hickman: Thanks.

Hey.

Hi, Good morning, Thank you for taking the question.

One on the injection device I believe at the Analyst Day, you mentioned that you were fine tuning or finalizing.

The snacks for the injection device, so that it can reliably deliver.

The.

Yes.

The implant.

Wanted to ask what the status of that is in.

The remaining regulatory requirements are.

Jay Duker: Jay, let me start with the first 2 questions and thank you very much for discussing the, pawbia trial.

So the status as the project is moving along very nicely.

Jay Duker: First of all, we haven't found the maximally-tolerated dose for UIP 1901 in either AI studies or, human.

We believe we've developed state of the art injection system that will have the inserts preloaded.

Jay Duker: We don't know what doses will be effective. We elected to go with the 2 highest doses that we used in DAWBIO for the NPDR trial.

Jay Duker: It's certainly possible that a lower dose will be just as effective, but we do hope, to learn something about dosing from the pawbia trial.

Jay Duker: There is no rescue criteria in a diabetic retinopathy study.

The device.

Jay Duker: The control group is observation.

Jay Duker: In the real world, although there are labels for 2 anti-VEGFs for treatment of moderate, to severe NPDR, we believe that only 2 to 3% of patients in the real world are actually getting treated with anti-VEGFs, and therefore, using an inactive control, a sham injection, we believe is appropriate for this indication, and therefore, rescue criteria would only really be applied to any patient who progressed to a center involving maxillaredema or proliferative diabetic retinopathy.

<unk> is designed to handle both Utica and he might be 19 Juan.

Jay Duker: Yeah, I'll make one comment and then I'll have Scott on the pass-through with DEXA-Q.

Unknown Executive: But remember the final rules come out in November, so that's when we would expect to know.

Unknown Executive: But Scott, you want to add anything further on, some color around?

And we are on track.

Scott Jones: Sure.

To have that we hope.

Tested in humans in the very near future.

Scott Jones: So, when we talk about pass-through, we're actually talking about two separate opportunities, for pass-through extension. One is related to extending the public health emergency, which, as we saw in 2022, allowed, for extension to our tolling period, which is the period of which data is collected on the utilization of the product outside of the bundle.

The regulatory part.

It is as you may know.

The FDA has made things a little more complicated in that were now considered a drug device combination.

Scott Jones: So that would be potentially in the final rule, which would be in November.

Scott Jones: The second part of the pass-through is related to the non-opioid pain indication or pain, sparing products, excuse me, non-opioid sparing products related to pain.

Scott Jones: And there's certainly, we saw draft rules in the 22 rule and in the 23 proposed rule.

Scott Jones: We do believe there will be a finalization of those rules in the final rule, which comes, out again in early November.

Scott Jones: Thank you.

However, with respect that you might be 90, 901, we anticipated that to be the case from the start and they're therefore, we have developed from the initial start up <unk> 19 O. One.

As a drug device combination along with the new injector, we're doing all of the regulatory things that we'll need to get done to make sure that thats met I believe that that regulatory issues also exist within the EMEA and therefore, we are.

<unk> to making sure that.

These regulatory requirements are met.

With respect to Utica, because <unk> is a prior approved product.

When we do change the injection system, we will have to supply the FDA with background in that including.

Details around what the injection system development program consists of once again I think we are as a company we are right on.

And we don't anticipate that that aspect.

Will slow down the program at all.

The added.

Our.

Our filing robust patents around this device that will be proprietary.

Got it thank you.

Very helpful and I have one.

To your question too.

In terms of your confidence for <unk>.

19, one in <unk> and <unk>.

How does that confidence from the mechanistic standpoint, a comparable comparison in contrast.

And P D R.

So.

Every other product.

That's an anti VEGF thats work in one indication has worked at all indications.

I think that that.

Suggest that for rolling it.

As it's released.

Juress search should be the same we think that the real advantages.

In a disease like NPD are and which.

Clearly anti VEGF have a positive role in the disease course, but really not getting them because of the frequency of injection.

And I would expand that the <unk>. While there is certainly evidence that that Jeff is not the only mediator in diabetic macular edema early on in the disease, it's primarily felt to be a bit Jeff mediated disease.

Also think that it's possible that paroling of May have some alternative benefits patients other than just anti VEGF benefits because it blocks VEGF receptor one theres, probably some heightened inflammatory benefits and as we disclosed at Investor Day, We just recently.

<unk> are pretty strong preclinical evidence and a retinal detachment model that we're rolling it actually has neuro protection receptors.

So those other potential mixes of action may also be beneficial in diabetes, both diabetic macular edema, and diabetic retinopathy and again, the sheer order kinetics release combined with the ability to lengthen the cycle of injection.

Jennifer Kim: Our next question comes from Jennifer Kim with Cantor.

Should have a benefit.

Alright, Thank you very much.

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

Jennifer Kim: Your line is open.

Jennifer Kim: Hey, good morning.

Jennifer Kim: Thanks for taking my question.

Thank you for taking our question just one question from US can you clarify for <unk> to 12 months trial is there a follow up here.

Jennifer Kim: I have two here.

Jennifer Kim: The first is just a clarification on how we should think about re-injection data in the, pivotal for wet AMD.

Jennifer Kim: I think at the investor day, you said you would expect a readout nine months after the, last injection.

Jennifer Kim: And then you anticipate re-injection would happen at six months.

Jennifer Kim: Does that mean data on the re-injected dose would only go out to three months?

Jennifer Kim: And then my second question is just on the pain indication, if you go forward with exploring, that, what would the anticipated cost and I guess timing around that be?

Jennifer Kim: Thanks.

Jay Duker: Jennifer, it's Jay again.

The 12 months is to look into <unk> antiviral function. Thank you.

Jay Duker: Thanks for the questions and I'll take the first part.

Jay Duker: I think your summary of the pivotal structure is correct.

Jay Duker: The initial efficacy readout would be approximately nine months after the initial dose of UIP-1901. At about six months after that initial dose, however, we would anticipate giving a second, dose.

Jay Duker: So the math works.

Excellent question, Thanks for bringing that up at present, there is not a plan to extend this study beyond 12 months.

Jay Duker: Most wet AMD studies at this point are approximately one year efficacy trial and two year safety, trial.

Jay Duker: And we do anticipate taking the pivotal out for a full two years for safety, which also, means that we would plan on re-injecting a total of four times within that study.

Jay Duker: But the readout would be before two years?

Jay Duker: Yes.

Jay Duker: The efficacy readout would be at approximately one year after the initiation of the study, as it's currently structured or planned.

Jay Duker: Jennifer, on DexEQ, so number one, we have not made any decision.

Unknown Executive: I want to be clear on that.

Unknown Executive: Number two, the cost of the studies would be in the mid-teens.

Unknown Executive: But there are various options, if we decide to go forward with it, that we would look, at for some potential non-dilutive ways to access that capital.

I think potentially that's something we may consider.

Unknown Executive: We want to be careful that we do not expect in any way that if we go forward we would, impact our cash runway.

Unknown Executive: And then finally, obviously you can imagine, it has been very clear, that they want to, make sure that they have non-opioid pain products available.

Jay Duker: We don't really want to take brand-new mechanism-of-action risk on APIs.

Unknown Executive: And in fact, they gave extended, if you want to call it almost permanent, pass-through, for some of these drugs that have a pain indication.

Jay Duker: I'm going to actually have Jay comment further on any other specifics that we find interesting.

But again, we don't plan on.

Unknown Executive: So they've been very clear on this.

Jay Duker: Please note, as well, we have licensed in the Ti2 activators, and we have two molecules, associated with that, a small molecule and a bispecific.

Unknown Executive: You get a pain indication, you're going to get extended pass-through, permanently through.

Jay Duker: So clearly, that is one pathway that we are potentially exploring.

Unknown Executive: The IRR, as you can imagine, is quite robust, and the risk of doing a pain indication for, dexamethasone is relatively low because dexamethasone is a known pain reliever.

Jay Duker: Just to add a little more color, we have a very active BD outreach right now, and we, are looking to partner with companies who have a release problem, let's call it, that they have a molecule that has a differentiated or proven MOA, but they have a short life in the eye, or they are giving it systemically and have systemic side effects.

Unknown Executive: So we feel confident that if we decide to go forward, our odds of achieving a successful, outcome are quite high. Nevertheless, no decisions have been made.

Doing anything thats going to negatively impact the start of the pivotal trial.

Jay Duker: That's kind of the perfect partner for us in DuraCert.

Unknown Executive: We're going to be very thoughtful about how we approach this.

Jay Duker: There are certain areas of unmet need that we're really interested in.

Unknown Executive: This is not our core asset, and we recognize that, and our goal is to make sure that we, have the capital and the runway to execute on our EYP-1901 program.

Jay Duker: You mentioned complement, and I would just even extend that to dry macular degeneration, in general.

Jennifer Kim: Okay, great.

Jay Duker: Neuroprotection is another area that we're actively interested in, and there are several, other smaller niche areas of the posterior segment of the eye diseases that we have ongoing talks with other potential partners to develop other molecules that have been de-risked through other programs.

Jennifer Kim: Thanks.

Jay Duker: All right.

Jennifer Kim: Actually, if I could sneak one more question.

Jennifer Kim: Great.

Jennifer Kim: You've also talked about exploring other molecules with DERR-SERT, like complement inhibitors.

Jennifer Kim: Thanks so much, guys.

Yes got it thank you.

Jennifer Kim: Are there other molecules that you're also exploring?

Yeo Jin: Our next question comes from Yeo Jin with Laidlaw.

Jennifer Kim: And also, what are you looking for in a partner to take this forward?

Jay Duker: Thanks.

Jay Duker: So, yes, there are other molecules that we are looking at, and the beauty about DERR-SERT, is that you can, as we've said before, put many small molecules in, and possibly up to some small peptides.

Jay Duker: So there's a number of opportunities.

Jay Duker: We like to go after assets that have proof of concept, because remember, we're not a, research-driven company.

Jay Duker: We are a drug delivery and development stage company.

Yeo Jin: Your line is open.

Yeo Jin: Good morning, and thanks for taking the questions.

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

Yeo Jin: My first question is that for the W2 study that I remember you guys talking about earlier, that you might enrich some patients that has been better managed by the current VEGF therapies.

Yeo Jin: Any other color you can share on this regard?

Yeo Jin: Thank you, Jan.

Jay Duker: Sure, it's an excellent question and I think perhaps, I'm not sure enriching is quite the, right word. We looked very carefully at the patients who enrolled in the Phase 1 DAVIO trial who did, well with EYP 1901 versus those in whom the benefit of EYP 1901 was not as apparent.

Yi Chen: Our next question comes from Yi Chen with HC Wainwright.

Jay Duker: And what was clear from that evaluation is that patients who were failing standard of, care, in other words, were getting an ILEA or Lucentis injection every four or five or six weeks, but still had a lot of fluid or increasing fluid or decreasing vision despite that frequency of standard of care injections, it didn't appear that EYP 1901 offered a lot of benefit to those patients.

Yi Chen: Your line is open.

Jay Duker: And therefore, the inclusion-exclusion criteria for DAVIO 2 tried to eliminate, best we could, the patients who were not doing well on standard of care.

Yi Chen: Hi, thank you for taking my question.

Jay Duker: So by doing that, we hope that the benefit of EYP 1901 is more apparent in DAVIO 2 than, it was in DAVIO 1.

Operator: Everyone, have a great day.

Yi Chen: So, in the W trial, within those 53% of eyes that

Yeo Jin: Okay, great.

Yi Chen: do not require supplemental anti-veg up to 6 months, and 35% up to 12 months, do they share any similar characteristics within those patients that could help you enroll, or better enroll the patients for W2 trial?

Yeo Jin: That's very helpful.

Yi Chen: So, I would say there was some disparity in the patient's length of time that they had disease, and their OCT appearance at enrollment.

Yeo Jin: And in terms of DAVIO 2 and PAVIO, are there many clinical studies you anticipate to be, overlapping or that's not the case?

Jay Duker: But one of the characteristics that they all had was a positive response to standard of care anti-veg F. And by positive, I don't mean just a little reduction in fluid, that these people were generally under good control with the standard of care anti-veg F. Now, retina specialists have a hard time defining good control.

Jay Duker: You know, that's a really good question, and off the top of my head, I don't know the answer.

Jay Duker: Some of us would say those that are getting monthly injections and are completely dry with good vision are under good control despite the frequency of injection. And so, I would include patients in that category.

Jay Duker: I mean, I've seen both lists, and so you'd think I could probably put it together, but, suffice it to say that they are different diseases, both treated by retinal specialists, but there's a geographic diversity, I would say, with respect to these diseases.

Jay Duker: Patients who did not have a lot of fluid, and had good vision, but required frequent, injections. And I think that that's a niche that we really hope EYP 1901 will fill, patients that are well treated, but require frequent injections.

Jay Duker: There are certain patient populations in areas of the country where macular degeneration, is more common, and other areas where the population isn't as elderly and may have more incidence of diabetes. So I fully expect that there's going to be some overlap, but not necessarily 100%.

Jay Duker: What would be the minimum of prior injections or minimum lengths of treatment before getting, enrolled into the W2 trial?

Yeo Jin: Okay, great.

Jay Duker: So, one of the inclusion criteria is the diagnosis of what AMD has been made less than nine months prior to screening.

Yeo Jin: That's helpful.

Jay Duker: And the patients have had to have a minimum of two standard of care anti-veg Fs.

Yeo Jin: And maybe the last question here is that given the utique sales and usage appears to be pretty, good this quarter, what types of outlook you guys may anticipate for just for the remaining of the year?

Jay Duker: And according to the enrolling investigator, they've had to show a positive response to those injections.

Scott Jones: And thanks.

Jay Duker: Got it.

Scott Jones: Yeah, thanks for the question, and thanks for your comments relative to utique.

Yi Chen: Thank you.

Scott Jones: Obviously, we're not providing any additional guidance towards the sales the remainder of, the year.

Danil Gotland: Our next question comes from Danil Gotland with Chardon.

Scott Jones: We are happy that the customer demand remains strong.

Danil Gotland: Your line is open.

Scott Jones: We continue to have really good outlook with customers and really good feedback.

Danil Gotland: Hi, good morning.

Scott Jones: So we are happy with the performance of the product and with the sales force.

Danil Gotland: Thank you for taking the question.

Yeo Jin: Okay, great.

Danil Gotland: I have one on the injection device.

Yeo Jin: That's very helpful.

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

Danil Gotland: I believe that the analyst that you mentioned that you were fine tuning or finalizing the specs for the injection device so that it can reliably deliver the implant.

Yeo Jin: And again, thanks a lot.

Jay Duker: I just wanted to ask what the status of that is, and what are the remaining regulatory requirements are?

Jay Duker: So, the status is the project is moving along very nicely.

Jay Duker: We believe we've developed a, state-of-the-art injection system that will have the inserts preloaded. The device is designed to handle both UTEQ and EYP 1901.

Jay Duker: And we're on track to have that, we hope, tested in humans in the very near future.

Jay Duker: The regulatory part is, as you may know, the FDA has made things a little more complicated, in that we're now considered a drug-device combination.

Jay Duker: However, with respect to EYP-1901, we anticipated that to be the case from the start, and therefore, we have developed from the initial start of EYP-1901 as a drug-device combination along with the new injector, we're doing all the regulatory things that we'll need to get done to make sure that that's met.

[music].

Jay Duker: I believe that regulatory issues also exist within the EMA, and therefore we are attuned to making sure that these regulatory requirements are met.

Jay Duker: With respect to UTEQ, because UTEQ is a prior-approved product, when we do change the, injection system, we will have to supply the FDA with background in that, including details around what the injection system development program consists of.

Jay Duker: Once again, I think we're, as a company, we're right on track, and we don't anticipate that that aspect will slow down the program at all. To add, as we are filing robust patents around this device, it will be proprietary.

Danil Gotland: Got it.

Danil Gotland: Thank you.

Danil Gotland: Very helpful.

Okay.

Jay Duker: I have one big-picture question to Jay.

Jay Duker: In terms of your, confidence for EYP-1901 in DME, and how does that confidence from the mechanistic standpoint compare and contrast with NPDR?

Okay.

Jay Duker: So, every other product that's an anti-VEGF that's worked in one indication has worked in, all indications.

Jay Duker: I think that that, you know, suggests that virulent, as it's released through a surge, should be the same.

Jay Duker: We think that the real advantages in a disease like NPDR, in which clearly anti-VEGFs have a positive role in the disease course, but patients are really not getting them because of the frequency of injection. And I'd expand that to DME.

Jay Duker: While there is certainly evidence that VEGF is not the only mediator in diabetic macular edema, early on in the disease, it's primarily felt to be a VEGF-mediated disease.

Jay Duker: We also think that it's possible that virulent may have some alternative benefits, to patients other than just its anti-VEGF benefits. Because it blocks VEGF receptor 1, there's probably some anti-inflammatory benefits.

Jay Duker: And as we disclosed at Investor Day, we just recently some pretty strong preclinical evidence in a retinal detachment model that virulent actually has neuroprotection receptors.

Jay Duker: So, those other potential measures of action may also be beneficial in diabetes, both diabetic macular edema and diabetic retinopathy.

Jay Duker: And again, the zero-order kinetics release combined with the ability to lengthen the cycle of injection should have a benefit.

Danil Gotland: All right.

Danil Gotland: Thank you very much.

Yuan Ji: Our next question comes from Yuan Ji with B Raleigh.

Yuan Ji: Your line is open.

Yuan Ji: Thank you for taking our question.

Yuan Ji: Just one

Yuan Ji: question from us.

Yuan Ji: Can you clarify for W2 12-month trial, is there a follow-up period beyond the 12 months to look into safety and viral function?

Yuan Ji: Thank you.

Jay Duker: Excellent question.

Jay Duker: Thanks for bringing that up.

Jay Duker: At present, there's not a plan to extend, the study beyond 12 months.

Jay Duker: I think potentially that's something we may consider.

Jay Duker: But again, we don't plan on doing anything that's going to negatively impact the start of the pivotal

Jay Duker: trial.

Yuan Ji: Yeah, got it.

Yuan Ji: Thank you.

Operator: And I'm showing no further questions in the queue at this time.

Operator: Ladies and gentlemen,

Operator: thank you for participating in today's conference.

Operator: This does conclude your program and you may now disconnect.