Q3 2021 EyePoint Pharmaceuticals Inc Earnings Call

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Operator: Good day, and thank you for standing by. Welcome to the I-Point third quarter 2021 Financial Results Conference call.

Operator: At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during

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Operator: telephone. Please be advised that today's conference is being recorded. If you're requiring any further assistance, please press star zero. I would like to hand the conference over to your speaker today, George Elston, Chief Financial Officer.

George O. Elston: Please go ahead. Thank you all for joining us on today's conference call to discuss IPoint Pharmaceuticals, its third quarter 2021 financial results, and recent corporate developments. With me today is Nancy Lurker, President and Chief Executive Officer, Dr. J. Duker, Chief Operating Officer, and Scott Jones, Chief Commercial Officer. Nancy will begin with a review of recent corporate updates.

We continue to combine thank you for your patience.

[music].

Good day, and thank you for standing by and welcome to the eye 0.3rd quarter 2021 financial results Conference call. At this time all participants are in a listen only mode. After the speaker's presentation, there will be a question and answer session.

Ask a question during the session you will need to press star one on your telephone. Please be advised that today's conference is being recorded.

George O. Elston: Dr. Duker will then discuss pipeline developments for EYP 1901, and Scott will comment on recent progress made in our commercial activities. I will close with commentary on the third quarter 2021 financial results, and we will then open up the call to your question. 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 under the investor relations tab on the company website, www. Ipointfarmah.com.

You require any further assistance. Please press star zero I would now like to hand, the conference over to your Speaker today, George Ellison, Chief Financial Officer. Please go ahead.

Thank you all for joining us on today's conference call to discuss <unk> Pharmaceuticals third quarter 2021 financial results and recent corporate developments with me today is Nancy Lurker, President and Chief Executive Officer Dr.

Jay Duker, Chief operating Officer, and Scott Jones, Chief Commercial Officer.

Nancy will begin with a review of recent corporate updates Dr. Duker will then discuss pipeline developments for <unk> hundred one and Scott will comment on recent progress made on our commercial activities I will close with commentary on the third quarter of 2021 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 in the Investor Relations tab on our company website Www Dot <unk> pharma dot com before.

George O. 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 in 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 the various important factors, including those discussed in the risk factor section of our most recent annual report on Form 10K, which is filed, and on-file with the SEC, and in other filings that we may make with the SEC and the, Any forward-looking statements represents 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.

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

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

Projections, and our plans and prospects.

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

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

Any forward looking statements represents 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.

George O. Elston: Therefore, you should not rely on these forward-looking statements as representing our views as at any date subsequent to today. I'll now turn the call over to Nancy Lurker, President and Chief Executive Officer of IPoint Pharmaceutical. Thank you, George.

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 <unk> Pharmaceuticals.

Nancy S. Lurker: Good morning, everyone, and thank you for joining us. We are pleased with our progress during the third quarter, as I point out pharmaceuticals continue to make progress across our ocular pipeline to treat serious ocular diseases as well as maintaining customer demand across our commercial business. We remain laser-focused on executing on our overarching mission of bringing innovation to patients with serious ophthalmic diseases. Prior to turning the call over to my colleagues, I'd like to discuss a few of our recent achievements from this past quarter.

Thank you George Good morning, everyone and thank you for joining US we are pleased with our progress during the third quarter as I point Pharmaceuticals continued to make progress across our ocular pipeline to treat serious ocular diseases as well as maintaining customer demand across our commercial business, we remain laser focused.

First on executing on our overarching mission of bringing innovation to patients with serious ophthalmic diseases.

Prior to turning the call over to my colleagues I would like to discuss a few of our recent achievements from this past quarter.

Nancy S. Lurker: Importantly, our team continues to advance our Phase 1 W.O trial for our lead pipeline asset, EYP-1901, a potential twice-yearly treatment for wet age-related macular degeneration or wet AMD, and we're very much on track to report interim data in the coming week. To reiterate our progress throughout 2021, we initiated our phase one trial, dosed the first patient, and completed trial enrollment. Notably, last month, we were pleased to report preliminary three-month safety data for all doses from the Davio trial at the American Society of Retinal Specialties, citing no serious adverse events, ocular or systemic, no adverse events related to significant ocular inflammation or best corrected visual acuity reduction, nor an elevation of interocular pressure in all 17 patients enrolled. Additionally, no events of endoptimalitis, retinal detachment, or migration into the interior chamber were reported.

Importantly, our team continues to advance our phase <unk> trial for our lead pipeline asset <unk> 19 O. One a potential twice yearly treatment for wet age related macular degeneration or wet AMD and we're very much on track to report interim data in the coming weeks.

To reiterate our progress throughout 2021, we initiated our phase one trial.

Dose the first patient and completed trial enrollment, notably last month, we were pleased to report preliminary three months safety data for all doses from the <unk> trial at the American Society of retinal specialists.

<unk> no serious adverse events ocular or systemic adverse events.

<unk> related to significant ocular inflammation or best corrected visual acuity reduction nor an elevation of inter ocular pressure and all 17 patients enrolled Additionally, no events of adopting our lightest retinal detachment or migration into the anterior chamber where reported we're incredibly excited about our progress and we're looking for.

Nancy S. Lurker: We're incredibly excited about our progress, and we're looking forward to reporting interim safety and efficacy results later this month. Should the results of our Davio interim data prove to be positive, we anticipate starting phase two trials next year. In addition to our focus on EYP 1901, we remain committed to the initiation of a phase three trial for Utique 50, a potential six-month sustained delivery treatment for UVitis affecting the posterior segment of the eye, in the fourth quarter of this year.

Forward to reporting interim safety and efficacy results later this month.

Should the results of our Davia interim data proved to be positive we anticipate starting phase II trials next year.

In addition to our focus on <unk> 19 O. One we remain committed to the initiation of a phase III trial for <unk> in the fourth quarter of this year.

<unk> is a potential six month sustained delivery treatment for uveitis affecting the posterior segment of the.

Nancy S. Lurker: Utique 50 will be filed as an SMDA upon completion of this single phase three clinical trial. Utique 50 represents an important part of our expanding pipeline, and we look forward to updating you on our progress in the upcoming quarter. Also included at ASRS was an ePoster presentation highlighting our Utique Calm, real-world registry study, collecting data on patients who have received UTKAM. This study included patients 18 years of age and older with a diagnosis of non-infectious uveitis affecting the posterior segment.

You take 500 will be filed as an S. NDA upon completion of this single phase III clinical trial, you take fiber represents an important part of our expanding pipeline and we look forward to updating you on our progress in the upcoming quarters.

Also included in ASR S with an E poster presentation, highlighting our Utica corn real World Registry study collecting data on patients who have received the Utica implant.

This study included eight patients 18 years of years of age and older with a diagnosis of non infectious uveitis affecting the posterior segment.

Nancy S. Lurker: The importance of the UT Calm Real World Registry study cannot be understated. The study is the first of its kind, as I point out, will be diligently tracking patients suffering from posterior uveitis for up to five years and possibly beyond. The longitudinal data from the Calm Study provide scientists and physicians with a unique opportunity to, for the first time, understand the etiology and disease progression of this devastating eye disease.

Importance of U T Com real World Registry threat study cannot be understated. This study is the first of its kind as I point will be diligently tracking patients suffering from posterior uveitis for up to five years and possibly beyond.

The longitudinal data from the calm study provide scientists and physicians with a unique opportunity to for the first time understand the etiology and disease progression of this devastating disease.

Nancy S. Lurker: Most importantly, the study should show how UTIC is positively impacting patients' disease compared to standard of care, therefore serving as a foundation for continued innovation in the treatment of posterior segment UVI. At ASRS, we were very pleased to report that most patients had relatively controlled intraocular inflammation, excuse me, the hallmark of udiitis, and the registry study continues to progress as we enroll and follow the patients. Turning to our commercial business, we're pleased to report continued growth in underlying customer demand for both products and net product revenues from our shipments to distributors, up 49% from Q3 2020.

Importantly, the study should show how Utica is positively impacting patients' disease compared to standard of care. Therefore, serving as the foundation for continued innovation in the treatment of posterior segment uveitis at ASRM. We were very pleased to report that most patients had relatively controlled intra ocular and play ins.

Formation excuse me the hallmark of Uveitis and the registry study continues to progress as we enroll and follow up more patients.

Turning to our commercial business. We're pleased to report continued growth in underlying customer demand for both products and net product revenue to our shipments to distributors up 49% from Q3 2020. This continued recovery from the pandemic represents an important shift in our patients comfort level of returning to the Doctor's office and we look forward to.

And our products to more patients in need of transformative ophthalmic therapies.

Finally on Monday, I was very pleased to announce the appointment of Dr. Jay Duker is chief operating officer at <unk>.

Nancy S. Lurker: This continued recovery from the pandemic represents an important shift in our patients' comfort level with returning to the doctor's office, and we look forward to bringing our products to more patients in need of transformative ophthalmic therapy. Finally, on Monday, I was very pleased to announce the appointment of Dr. Jay Duker as Chief Operating Officer at IPA, taking on a full-time, expanded role as we continue to develop and advance our innovative pipeline program.

Taking on a full time expanded role as we continue to develop and advance our innovative pipeline programs Jay's extensive entrepreneurial experience coupled with his decades of service as chair of the Ophthalmology Department at Tufts University and his many publications on retinal eye diseases proved invaluable the ipod.

And we're thrilled to have him onboard in this new role.

I'd like to thank our fantastic team at <unk> Pharmaceuticals.

For our company's clinical operational and financial success today, we're very proud of our work thus far across all fronts and look forward to continuing our momentum into the fourth quarter of 2021 and throughout 2022.

We're excited about the future of high point pharmaceuticals, as we execute on multiple clinical catalysts and strengthen our commercial business, while maintaining a strong balance sheet I'll now turn the call over to Dr. Jay Duker, our chief operating officer to provide an update on our lead program <unk> thousand 19 O one as well as other pipeline initiatives.

Nancy S. Lurker: Jay's extensive entrepreneurial experience coupled with his decades of service as chair of the ophthalmology department at Tufts University and his many publications on retinal eye diseases proves him invaluable to eye point, and we're thrilled to have him on board in this new role. I'd like to thank our fantastic team at IPoint Pharmaceuticals for our company's clinical, operational, and financial success today. We're very proud of our work thus far across all fronts and look forward to continuing our momentum into the fourth quarter of 2021 and throughout 2020.

Jay.

Thank you Nancy and good morning, everyone.

Before I begin I would like to see early thank Nancy and the entire I'd point Pharmaceuticals organization for their continued trust in me and overarching support as I begin my new role as Chief operating officer.

I look forward to building <unk> into an even more successful clinical and commercial company as we continuously build out our pipeline and grow our business.

As Nancy stated earlier, we are excited with the progress thus far on our phase <unk> trial for our lead asset <unk> 19 O. One a potential twice yearly treatment for wet age related macular degeneration.

Jay S. Duker: We're excited about the future of I-Point Pharmaceuticals as we execute on multiple clinical catalysts and strengthen our commercial business while maintaining a strong balance sheet. I'll now turn the call over to Dr. Jay Duker, our chief operating officer, to provide an update on our lead program, EYP 1901, as well as other pipeline initiatives.

We continue to underscore the pride, we feel for our clinical and regulatory teams, who have so far flawlessly executed our phase one trial.

Our team managed to initiate and complete enrollment of all 17 patients in under four months.

We're pleased with the recent very encouraging positive three months safety that report and we are looking forward to reporting further safety and initial efficacy data later this month on Saturday November 13th at the American Academy of Ophthalmology in New Orleans.

Jay S. Duker: Thank you, Nancy, and good morning, everyone. Before I begin, I would like to sincerely thank Nancy and the entire I Point Pharmaceuticals organization for their continued trust in me and overall support as I begin my new role as chief operating officer. I look forward to building I Point into an even more successful clinical and commercial company as we continuously build out our pipeline and grow our business. As Nancy stated earlier, we are excited with the progress thus far on our Phase 1 Davio trial for our lead asset, EYP 1901, a potential twice-yearly treatment for wet age-related macular degeneration.

Wet AMD is a chronic progressive and potentially devastating disorder.

Hallmark is the development of abnormal blood vessels under the macula, which is the center of the retina that leak fluid and blood.

Typically presents with blurred and distorted vision and can result in a permanent blind spots in the Central Division.

It is the leading cause of vision in people over 65 years of age in the United States and other developed countries, despite safe and effective FDA approved medications on the market to treat wet AMD, there was a significant opportunity for longer lasting therapies than those currently available.

<unk> seeks to provide a reliable see long term sustained release treatment option that would allow fewer visits to the doctor's office and the current standard of care.

Our lead asset he might be 19, no. One has a potential twice yearly sustained delivery <unk> anti VEGF treatment for wet age related macular degeneration.

Jay S. Duker: We continue to underline the pride we feel for our clinical and regulatory teams who have so far flawlessly executed our phase one trial. Our team managed to initiate, then complete enrollment of all 17 patients in under four months. We are pleased with the recent, very encouraging, positive three-month safety data report, and we are looking forward to reporting further safety and initial efficacy data later this month at the American Academy of Ophthalmology meeting in New Orleans.

He might be 19, one combines a bio erodible formulation of <unk> proprietary <unk> sustained release technology, which has been utilized and four FDA approved products combined with Brilinta.

<unk> kinase inhibitor.

The phase one the RVO trial is an open label dose escalation trial that enrolled 17 patients across four dose groups. All enrolled patients were previously treated with standard of care anti VEGF therapy.

The positive three months safety data, we reported in October at the American Society of retina specialists for the phase <unk> trial with <unk> thousand 19, Juan highlighted some critical safety observation.

Jay S. Duker: WETAMD is a chronic, progressive, and potentially devastating eye disorder. Its hallmark is the development of abnormal blood vessels under the macula, which is the center of the retina, that leak fluid in the blood. It typically presents with blurred and distorted vision and can result in a permitted blind spot in the central vision.

Most importantly, there were no serious adverse events ocular or systemic amongst any of the patients thus far in the trial.

In addition, there were no reported adverse events related to severe inter ocular inflammation best corrected visual acuity reduction or any elevation of intraocular pressure in any of the 17 patients.

Jay S. Duker: It is the leading cause of vision loss in people over 65 years of age in the United States and other developed countries. Despite safe and effective FDA-approved medications on the market to treat wet A&D, there is a significant opportunity for longer-lasting therapies than those currently available. IPoint seeks to provide a reliable, safe, long-term, sustained release treatment option that would allow fewer visits to the doctor's office than the current standard of care. Our lead asset, EYP 1901, is a potential twice yearly sustained delivery and tributary anti-vege-tept treatment for wet age-related macular degeneration.

The post dosing follow up also showed no events of endophthalmitis migration of the <unk> 19, when inserted into the inter chamber retinal vasculitis or betrayed us with.

With this very clean safety data in hand, we remain excited about he might be 19, no one's potential to alter the paradigm for patients with wet AMD as well as the potential application of the White P. 19, one to other should be your eye disorders, including diabetic retinopathy and retinal vein occlusion.

As we've discussed in prior quarters, we are on track to initiate a phase III 60 person six month clinical trial for <unk> 50, a potential six month sustained delivery treatment for uveitis affecting the pusher segment of the eye in the fourth quarter of this year.

You take 50 will use the same non erodible duressor and corticosteroid doses used in boutique, which has a proven track record as a clinically and commercially viable product Houston thousands of buys across the country.

The fifties design offers intra vitriol insert with a shorter duration of action that provides fish positions with the flexibility to dose over shorter intervals compared to the three year interval that Utica currently provides.

Jay S. Duker: EYP1901 combines a bioerodable formulation of iPoint's proprietary DURSRSRT Sustade Release Technology, which has been utilized in four FDA-approved products. Combined with Borolino, a tyrus and kinase inhibitor, the Phase 1 Dobrio trial is an open-label dose escalation trial that enrolled 17 patients across four dose groups. All rural patients were previously treated with standard of care anti-vege therapy.

We plan to file an S NDA with the FDA and we expect to initiate our phase III trial in the fourth quarter of this year, we look forward to providing an update on <unk> 19 O one as well as our other pipeline initiatives over the upcoming quarters.

As Nancy Nancy mentioned at the American Society of Retina specialists meeting, we reported preliminary data from our Utica call a real World Registry study of the personal loan implant and chronic non infectious posterior uveitis.

Jay S. Duker: The positive three-month safety data we reported in October at the American Society of Retina Specialists for the Phase 1 Davio trial with EYP 1901 highlighted some critical safety observations. Most importantly, there were no serious adverse events, ocular or systemic, amongst any of the patients thus far in the trials. In addition, there were no reported adverse events related to severe intraocular inflammation, best corrected visual acuity reduction, or any elevation of intraocular pressure in any of the 17 patients. The post-dosing follow-up also showed no events of endophthalmitis, migration of the EYP-1901 insert into the interior chamber, retinal vasculitis, or vitrida.

This real World Registry study is collecting data on patients who have received the fusin alone implant. This study includes patients 18 years of age and older with a diagnosis of non infectious uveitis affecting the post your segment with no contra indications to the implant.

We're excited to see that most patients had relatively good control of their inter ocular inflammation as measured by interchange or sell vitreous haze that registry is ongoing and we look forward to reporting additional data at upcoming meetings.

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

Thank you Jay we're pleased the third quarter customer demand sustained it draws from pre COVID-19 levels, and we reported 49% increase in net product revenues for commercial products excuse me too.

Compared to Q3 2020.

Like many commercial companies, our net product sales and underlying customer demand were negatively impacted by the COVID-19 pandemic in 2020 and into 2021.

Pleased to see patients returned to doctors' offices and scheduled a previously delayed surgeries and procedures.

Jay S. Duker: With this very clean safety data in hand, we remain excited about EYP 1901's potential to alter the paradigm for patients with wet AMD, as well as the potential application of EYP 1901 to other severe eye disorders, including diabetic retinopathy and retinaclusion. As we've discussed in prior quarters, we're on track to initiate a phase three, 60-person, six-month clinical trial for UT50, a potential six-month sustained delivery treatment for UVitis affecting the posterior segment of the eye, in the fourth quarter of this year. Utique 50 will use the same non-erodable duracert and corticosteroid as is used in Utique, which has a proven track record as a clinically and commercially viable product used in thousands of eyes across the country.

Our Q3 net product revenues of $8 6 million increase from $5 8 million in Q3 2020.

This includes net product revenues of $4 7 million and $3 9 million predict secure and Utica respectively.

Customer demand was approximately 13100 units of to execute 560 units grew due to increases of 175% and 22% respectively from Q2 2021.

Customer demand for <unk> continues to stem from both our strong sales and marketing team and our collaboration with our commercial alliance partner Imprimis Rx customer demand for your take remained strong in part a result of the improved silicone is new commercial team rolled out this year.

Putting a more optimal procedural experience for physicians and patients.

We are incredibly pleased by the progress we've made during the third quarter to return to executing to pre pandemic levels. <unk> mission is to provide a unique sustained delivery system across all of our products that require fewer visits to the doctor's office. The key attribute for each product's value proposition that both patients and doctors rely on.

And wed.

We'd also like to thank all of our patients and doctors for their continued support and use of our products. We look forward to updating you on revenues and demand in the quarters to come.

Jay S. Duker: Utique 50's design offers an intravital insert with a shorter duration of action that provides physicians with the flexibility to dose over shorter intervals, compared to the three-year interval that Utique currently provides. We plan to file an SNDA with the FDA, and we expect to initiate our phase three trial in the fourth quarter of this year. We look forward to providing an update on EYP1901 as well as our other pipeline initiatives in the upcoming quarter.

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

Thank you Scott.

The financial results for the three months ended September 32021 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 three months ended September 32021, total net revenue was $9 1 million compared to $15 7 million for the three months ended September 32020.

This includes net product revenue for the third quarter of $8 6 million compared to net product revenues for the third quarter ended September 32020, a $5 8 million.

Net revenue from royalties and collaborations for the third quarter ended September 32021 totaled $1 5 million compared to $9 $9 million in the corresponding period in 2020.

Jay S. Duker: As Nancy mentioned at the American Society of Retina Specialist meeting, we reported preliminary data from our unique Calm, a real-world registry study of the flicinolone implant in chronic, non-infectious posterior uveitis. This real-world registry study is collecting data on patients who have received the Plucinilon implant. This study includes patients 18 years of age and older with a diagnosis of non-infectious ubiitis affecting the posture segment who have no contraindications to the implant.

This decrease was driven by one time milestone payments received in Q3 2020 that did not recur in 2021.

Operating expenses for the quarter ended September 32021 totaled $24 4 million versus $17 7 million in the prior year period.

This increase was primarily due to a $4 4 million increase in R&D expense of $2 1 million increase in sales and marketing expense and a <unk> 3 million increase in G&A expense offset by a <unk> one decrease in cost of sales.

Nonoperating expense net totaled $1 4 million and net loss was $16 7 million $4 58 per share compared to a net loss of $3 8 million or <unk> 30 per share for the prior year period.

Scott Jones: We're excited to see that most patients had relatively good control of their intraocular inflammation as measured by interchambered cell in vitreous haze. The registry is ongoing, and we look forward to reporting additional data at upcoming meetings. I will now turn the call over to Scott Jones, Chief Commercial Officer, for the Commercial Update. Scott?

Cash and cash equivalents at September 32021 totaled $119 7 million compared to $44 9 million at December 31, 2020.

We expect the cash on hand at September 32021, and expected net cash inflows from our product sales will enable us to fund our current and planned operations through the end of 2022.

Scott Jones: Thank you, Jay. We're pleased the third quarter customer demand sustained its rise from Creek COVID levels, and we reported a 49% increase in net product revenues for commercial products, Dexs KU and Utique, compared to Q3 2020. Like many commercial companies, our net product sales and underlying customer demand were negatively impacted by the COVID-19 pandemic in 2020 and into 2021. And we're pleased to see patients return to doctors' offices and schedule their previously delayed surgeries and procedures.

In conclusion, we are thrilled with <unk> progress in the third quarter and first nine months of 2021 and are well capitalized to advance our product pipeline to key value inflection points. Thank you all very much for listening this morning, and I'll now turn the call over to the operator for questions.

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

Withdraw your question press the pound key.

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

Yeah.

Our first question comes from the line of Ken Cacciatore from Cowen <unk> Company. Your line is now open.

Hi, everyone. This is gil on for Ken. Thank you so much for taking our questions and congratulations on all the progress.

So maybe you can start with Dr. Duker given the highly anticipated readout next week for <unk> could you maybe frame what are the most important aspects of the results investors should focus on given that it will be the first time, we will be seeing data from 19 O arm and then I have a few more follow ups.

Scott Jones: Our Q3 net product revenues of 8.6 million increased from 5.8 million in Q3 2020. This includes net product revenues of 4.7 million and 3.9 million for Dexecu and Utique, respectively. Customer demand was approximately 13,100 units of DECQ and 560 units for UT, increases of 175% and 22%, respectively, from QT 2021. Demand for DECQ continues to stem from both our strong sales and marketing team and our collaboration with our commercial alliance partner, Impromis RX.

Sure.

Thank you very much for the question and given that this is a phase one trial.

Whose primary endpoint is safety that is the most important thing to focus on is does the product appeared to be safe. In these 17 patients remember also we hope to enter a market that has several FDA approved products that are very safe and therefore safety really is.

Paramount.

Beyond safety I think we'd all hope to see some signs that the U N. P. 19 O. One insured is controlling wet macular degeneration. So given that this is a previously treated population of patients.

We would.

Scott Jones: Customer demand for Utique remains strong, in part a result of the improved siliconized needle, which a commercial team rolled out this year, providing a more optimal procedural experience for physicians and patients. We are incredibly pleased by the progress made during the third quarter to return to execution UT to pre-pandemic levels. I point's mission is to provide a unique sustained delivery system across all of our products that require fewer visits to the doctor's office, a key attribute for each product's value proposition that both patients and doctors rely on.

Anticipate that if there is some sign of efficacy it would mean stable visual acuity.

And stable fluid on OCG.

Beyond that we do hope to show.

Hey.

Significant number of patients who are able to go at least four months without having a standard of care rescue.

And we'd also hope that there is some reduction in what we would refer to as treatment burden treats.

Treatment burden means Cal.

Calculation of the ratio of how many injections that the patients get prior to enrolling in our study.

Against how many did they get for the six months following enrollment.

George O. Elston: We'd also like to thank all of our patients and doctors for their continued support and use of our products. We look forward to updating you on revenues and demand in the quarters to come. I would now like to turn the call over to George to review the financials.

So I think those five issues with safety being by far the most important or what we all should look closely at.

Thank you. This is very helpful. And then maybe could you also reminders of the number of patients and doses or the four cohorts will be seeing data from.

How long of a follow up should we expect for the higher dose groups.

George O. Elston: Thank you, Scott. As the financial results for the three months ended September 30th, 2021, were included in the press release issued this morning. My comments today will be focused on a high-level review of the quarter. For the three months ended September 30th, 2021, total net revenue was $9.1 million compared to $15.7 million for the three months ended September 30th, 2020. This includes net product revenue for the third quarter of $8.6 million, compared to net product revenues for the third quarter ended September 30th, 2020, of $5.8.

Sure. So we have 17 patients enrolled.

Three patients were enrolled in the lowest dose which was 400 micrograms.

One patient was enrolled in a low medium dose, which was approximately one milligram.

Eight patients received approximately two milligrams.

And five patients were in the high dose, which is approximately three milligrams.

We should have.

Virtually all of the six month visits occur prior to data.

Again, we have them scheduled for prior to the a O but.

Given that the patients don't necessarily all come in for their visits when they're scheduled we certainly can't guarantee that but the vast majority well over 90% of the visit should have occurred by the time, we released the data.

Yes, that's great.

So if you look you have to add up.

All witches that.

We're going to be looking at.

George O. Elston: Net revenue from royalties and collaborations for the third quarter ended September 30th, 2021, was 0.5 million compared to 9.9 million in the corresponding period in 2020. This decrease was driven by one-time milestone payments received in Q3 2020 that did not recur in 2021. Operating expenses for the quarter ending on September 30th, 2021 totaled $24.4 million versus $17.7 million in the prior year period. This increase was primarily due to a 4.4 million increase in R&D expense, a 2.1 million increase in sales and marketing expense, and a 0.3 million increase in GNA expense, offset by a 0.1 decrease in cost of sales.

How far we can get patients out obviously, it's four months five months six months and beyond so I just wanted to add that it's not just four months.

Yeah got it. Thank you so much and we're looking forward to seeing the data.

Thank you.

Thank you. Our next question comes from the line of Jennifer <unk> from Cantor Fitzgerald. Your line is now open.

Hey, good morning, Congrats on everyone and thanks for taking my questions I have a couple of here. The first one is just on the quarterly numbers.

The implied ASP piece looks to be a bit lower for Utica and to execute just looking at the number of units sold compared to the revenue performance and in particular, the equity units I think we're up around 20% quarter over quarter, but sales were up around 2%. So I'm. Just wondering if you have any color here on how we should think about.

I guess, that's the sales price of our product going forward.

My second question is SG&A and R&D, both ticked up a bit this quarter.

Do you have any color on what drove that and how we should think about modeling those going forward and I have one more about the wait until.

After.

George why don't you take those sure.

Jennifer a couple of things first with revenue keep in mind that the.

Units that we report in the earnings release is underlying customer demand.

George O. Elston: Non-operating expense net totaled $1.4 million, and the net loss was $16.7 million or $0.58 per share, compared to a net loss of $3.8 million or $0.30 per share for the prior year period. Cash and cash equivalents at September 30, 2021, were 119.7 million compared to $44.9 million at December 31, 2020. We expect the cash on hand at September 30th, 2021, and expected net cash inflows from our product sales will enable us to fund our current and planned operations through the end of 2022.

We recognize revenue based upon purchases by distributors from US and then we report the demand to show the underlying.

Business and so there's always going to be a disconnect between what we show on customer demand and what actually gets purchased by distributors and so that straight it's not perfect. There's always inventory swings in between so doing a straight calculation on ASP.

Is it really that easy based on those numbers I will say that product mix.

Does come into play a little bit.

Because a much higher price.

And then <unk>.

<unk> and so I think from a general perspective, our unique pricing has stayed pretty consistent that product is not discounted execute does.

Go through some level of rebates and discounting.

For the customer base, and so we're going to see a swing in asps.

Hum.

On a total calculations simply simply because of the way that unfolds, but.

And I would say that execute well certainly wait any swings in that more than Youtube.

On the on the P&L side.

R&D is up.

Really driven based upon the ongoing phase one study as we continue to focus on rebuilding our pipeline and so certainly clinical costs associated with new IP and 19, one are a big component of that.

Theres also some underlying.

Non cash spending related to stock compensation.

And that's affected both R&D and G&A as we've continued to build out the R&D organization.

George O. Elston: In conclusion, we are thrilled with high points progress in the third quarter and first nine months of 2021 and are well capitalized to advance our product pipeline to key value inflection points. Thank you all very much for listening this morning, and I now turn the call over to the operator for questions.

That's the that's the quick answer there.

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

Operator: Question, press the pound key. Please stand by when we compile the Q&A roster.

Operator: Our first question concerns the line of Ken Katetor.

Unknown Speaker: Ken Katitori from Cowan and Company. Your line is now open. Hi everyone, this is Georgian for Ken.

Unknown Speaker: Thank you so much for taking our questions and congratulations on all the progress. So maybe we can start with Dr. Duker, given the highly anticipated readout next week for Davio, could you maybe frame what are the most important aspects of the results investors should focus on, given that it will be the first time we'll be seeing data from 1901, and then I have a few more follow-ups. Sure.

Having responsibilities of of Ah moving programs forward I think they're still gonna have a lot to learn because there's a lot about the corporate side of things that despite having been a part of the company for almost a year and a half I've I've still got to really get a handle on but essentially and a very high level or what what I'm trying to do.

Jay S. Duker: Thank you very much for the question. And given that this is a phase one trial whose primary endpoint is safety, that is the most important thing to focus on, is does the product appear to be safe in these 17 patients? Remember also that we hope to enter a market that has several FDA-approved products that are very safe, and therefore, safety really is paramount. But, beyond safety, I think we'd all hope to see some sign that the EYP 1901 insert is controlling wet macular degeneration.

Save People's site.

Great and are are you more excited I guess in terms of where your excitement is is it on 1901 or is it really on driving I guess, the technology and and you know, giving your previous experience with Humira. Yeah. My work site early pipeline Yep.

Yeah, it's even beyond that yeah. I mean those are those are all things that are exciting <unk> technology is really terrific.

And taking a step back and looking at it from the outside having seen it for you know and use for almost 30 years I think it's a eight a highly underutilized asset I think there's a lot more that we can do with it but it goes beyond the research because we are committed to be the leader in drug delivery in the eye.

Jay S. Duker: So given that this is a previously treated population of patients, we would anticipate that if there is some sign of efficacy, it would mean stable visual acuity and stable fluid on OCT. Beyond that, we do hope to show a significant number of patients who are able to go at least four months without having a standard of care rescue. And we also hope that there is some reduction in what we would refer to as the treatment burden.

And so we are evaluating other potential drug delivery systems, but in the end those are all tools to achieve.

Better vision better life easier.

Times for patients' families and and frankly for insurers as well I mean, we have a whole constituency that we're trying to help here. So the delivery system or tools E Y P. 19 O. One is the first step if we can show that a small molecule like rolling Mtv's safely and successfully delivered to the I I think.

Jay S. Duker: Treatment burden is a calculation of the ratio of how many injections did the patients get prior to enrolling in our study against how many did they get for the six months following enrollment. So I think those five issues, with safety being by far the most important, are what we all should look closely at.

There's a wealth of other similar type of molecules whether mechanism of action that we can potentially deliver.

But at a high level and a personal level I like challenges and I'd like to.

Take on things and and be successful with him. So I don't think that taking just a single program our single molecule or a single delivery system is what excites me, it's moving the company forward with a common goal.

Jay S. Duker: Thank you. This is very helpful. And then maybe could you also remind us of the number of patients and doses for the four cohorts we'll be seeing data from? And how long of a follow-up should we expect for the higher dose groups? Sure.

Awesome, great. Congrats again, thanks, everyone.

Thank you. Our next question comes from Athens in Asia. Some Guggenheim Your line is open.

Okay. Thank you for taking my questions and they're Gonna rats for my son is just a couple of for me. So F. L. We're gonna get the five Monday for the high those would you believe six Monday that for all those is once it is available that day in December cause you have to wait.

Jay S. Duker: So we have 17 patients enrolled. Three patients were enrolled in the lowest dose, which was 400 micrograms. One patient was enrolled in a low medium dose, which was approximately one milligram. Eight patients received approximately two milligrams, and five patients were in the high dose, which is approximately three milligrams. We should have virtually all the six-month visits occur prior to data. Again, we have them scheduled for prior to the AAO, but given that the patients don't necessarily all come in for their visits when they're scheduled, we certainly can't guarantee that. But the vast majority, well over 90% of the visits, should have occurred by the time we released the data.

Or.

Scientific conference for a full six months later.

Yeah I'll take that question. So we were always just a bit cautious in what we wanted to commit to in terms of what music show at a L. Because you never know if patients will make their business in a timely way. The good news is they have and so what we expect to show at a L is all cohort.

Well, let me back up we're gonna show the logos, the low mid dose and the and the mid goes all the way through six months for safety and efficacy and then in the high dose we will show all patients. There's one patient who has not yet come into their visit if we can get that patient in before a L will show.

[noise] that patient otherwise, we'll be shy, one patient and we'll show the four out of five patients through six months and that high does cohort with one patient at five months.

Jay S. Duker: Yeah, Sergey, let me take that. Sergey, let me add a question as well, which is that we're going to be looking at how far we can get patients out, obviously, at four months, five months, six months, and beyond. So I just want to add that it's not just four months.

So basically we're going to be able to show almost all the data three six months Oh excuse me up to six months, let me be clear up to six months and then perhaps one patient will be still at five months in the high dose cohort.

Got it very good very helpful. Then a couple more so obviously you know the blood seems to be very very safe and one of the questions that I have gone from Investor is that what is your view on those.

Unknown Speaker: Thank you so much, and we're looking forward to seeing the data. Thank you. Thank you. Our next question comes from the line of Jennifer Kim from Cantor Fitzgerald. Your line is now

Those level or is it is are these get the fact that we are seeing such a good safety profile could that'd be a function of that you are under dosing patient or do you think these these doses relatively active and you should be able to reach the therapeutic window that you a whole thing with.

One of these three.

Operator: The airline is now open. Hey, good morning. Congratulations to everyone and thanks for taking my questions. I have a couple here.

Scheduled that you know.

Yeah, Let me, let me comment real quickly and then I'm Gonna turn the turn it over to J. So first of all we're not going to give any forward guidance I won't be expect to say so I wanted to be very clear about that and then of course, there's always in in any therapeutic area you always have that tradeoff between safety and efficacy.

Jennifer M. Kim: The first one is just on the quarterly numbers; the implied ASPs look to be a bit lower for Udick and Dexskech, just looking at the number of units sold compared to the revenue performance. And in particular, the Dexskew units, I think, were up around 20% a quarter of a quarter, but sales were up around 2%. So I'm just wondering if you have any color here and how we should think about, I guess, the sales price per product going forward. And then my second question is SG&A and R&D both ticked up a bit this quarter, and do you have any color on what they are? and how should we think about modeling those going forward?

With that being said as you know we have a very remarkably good safety profile and frankly, I think you'll just have to wait and see what the data shows when we roll it out at a okay I'm Gonna, let you <unk>.

Expand on that if you have anything else you'd like to add.

Not a lot except to state that in our preclinical models and R. I N D. Enabling studies there was a very good safety profile for both Verona and you might be 19 O enrollment had been to research and.

And we never found the maximally tolerated dose in animals.

And so that I will.

Agree with Nancy that we will have some efficacy data to share in another week and a half or so and we'll leave it at that.

George O. Elston: I've won more, but I'll wait until after.

George O. Elston: George, why don't you take those? Sure. Yes, Jennifer, a couple of things, first with revenue. Keep in mind that the units that we report in the earnings release are underlying customer demand. We recognize revenue based upon purchases by distributors from us, and then we report the demand to show the underlying business. And so there's always going to be a disconnect between what we show in customer demand and what actually gets delivered. purchased by distributors. And so that straight, you know, it's not perfect.

But it just one final question if I may so with regard to the I think J you spoke about it today what are you on a little bit later, so with regard to the changes in a b.

N O C T.

I I think you mentioned about five letter plus or minus would be okay, and 50 microns would be okay.

Just trying to get a sense of how likely a letter or an old city, you don't loss would be.

I'm not sure if like five let her you know positive would be fine, but Ah drop I dunno holiday.

Don't know how that we shouldn't be thinking about that.

So I I think you need to think about it in a couple of ways.

The there's really three kind of views of this and the first view is what is the F. D. A think.

Because ultimately we need to get the product if they approved so.

George O. Elston: There's always inventory swings in between. So doing a straight calculation on ASP isn't really that easy based on those numbers. I will say that, you know, product mix, does come into play a little bit, you know, Utique has a much higher price than Dexecue and so I think from a general perspective our Utique pricing has stayed pretty consistent that product is not discounted Dexcq does go through some level of rebates and discounting for that customer base and so we're going to see a swing in ASP On a total calculation simply simply because of the way that unfolds, but and I would say that Dexecue will certainly wait any swings in that more than Utique will I don't know.

So the F D. A if the F D. A says that and again. This is you pick a number it doesn't matter 2347, 10 letters is an approvable and 0.4.

Even for a loss and then the FDA spoken.

The second thing is what to the retina specialist field, what is an acceptable safety profile and efficacy profile to use the product now remember we report data across a large population or certainly the phase one I wouldn't call. It a large population, it's and equal 17, it's a smallpox.

Relation, but that doesn't mean that you can't pick out even if in a large population the efficacy doesn't look strong but in individuals' subgroups. It does and you can identify those subgroups. Then you can have a very successful product by choosing the patience you use it on <unk>.

George O. Elston: On the P&L side, R&D is really driven based upon the ongoing phase one study as we continue to focus on building our pipeline. And so certainly, the clinical costs associated with EYP19 and 1 are a big component of that. There's also some underlying non-cash spending related to stock compensation, and that's affected both R&D and GNA as we've continued to build out the R&D organization. Um, that's the quick answer there.

Oh, and that's no different than than any other drug product what's different in this in this area is we didn't have an option before it was an injectable empty bed, Jeff Lucentis Eylea a vast in in if you inject the monthly they all work about the same and they're all about the same safety so that <unk>.

This is a paradigm shift now because what we hope to accomplish is true sustained-release for many months and not just a month or two and if it doesn't need to work perfectly and every patient as long as it's safe and one can identify groups of patients that it does work Whelan and so the.

George O. Elston: Okay, great. And then one more question. Jay, first of all, congrats again on your new role. For you, I'm just wondering what you are most excited to do in your new role? What are your priorities? And I guess what you would highlight in terms of where your focus is? Well, thanks.

Last group that needs to be satisfied of course is the patients they need to see the value in having a visit perhaps every four five or six months instead of every one or two months I think that would be obvious, but but they if there's a change in the revision plus or minus at it.

Really needs to be something that they can liberally so back to the question specifically about visual acuity. If you followed the space you know that her newly diagnosed with AMD all the visual acuity just need in the first three months and.

Jay S. Duker: Well, thanks for the congratulations. It's my third day on the job, so I'm trying to find out where the coffee maker is.

And if you look at the Kurds after that for basically flat wedding D and in fact in the real World to go down in a couple of real World Studies show that after three months in the real world, where on average patients get six injections year by the perch year out as a group they've given back all the visual acuity games.

Jay S. Duker: But, you know, my priorities at a high level are kind of doing what I've been doing for 30, 31 years, which is helping people to see better. This is just a different way of doing it. We are focusing on a large population, not an individual sitting in front of me in my office. So I think with success, this type of position is able to really help people in a very, very large fashion as opposed to one at a time.

So that if you had a control group, which we do not interfere with one that was standard of care you would expect that there might be over six months some loss of letters.

How much is significantly kind of have to go back to those three groups, what's significant pretty F. D. A was significant for the retina specialist to use the and what's significant for the patients you have to be seen octa's. The same and in fact O C. T gains are almost always in the first month or two.

Jay S. Duker: The skill set that I bring, I think I've homed for the last 30 years running a large department and starting companies and having responsibilities for moving programs forward. I think they're still going to have a lot to learn because there's a lot about the corporate side of things that, despite having been a part of the company for almost a year and a half, I've still got to really get a handle on. But essentially, at a very high level, what I'm trying to do is save people.

So if you've got a group of patients who have been diagnosed for three or four months, they're stable, presumably they they may or may not a fluid they've gotten all the visual and so that's a successful products should be able to keep that group relatively stable.

So that was a long winded answer, but I hope I answered your question.

No that's very good thank you so much.

Thank you. Our next question comes down the line <unk> Chan Laidlaw and company airline is now then.

[noise] good morning, and thanks for taking the questions and congrats on the progress.

Jay S. Duker: Great, and are you more excited, I guess in terms of where your excitement is, is it for 1901 or is it really driving the technology, I guess, and given your previous experience with Himera, are you more excited about the early pipeline? Yeah, it's even beyond that. Yeah, I mean, those are.

In terms of my first question in terms of the 19 O. One you have.

Oh.

The three milligrams and too many grams groups and Oh, so you'll you'll highlight some of the efficacy inflammation sort of categories to be to be pay attention to do you anticipate most of the <unk> signals a sign of efficacy will likely be in those high those groups.

Jay S. Duker: Yeah, I mean, those are all things that are exciting. The DuraC technology is really terrific. In taking a step back and looking at it from the outside, and having seen it in use for almost 30 years, I think it's a highly underutilized asset. I think there's a lot more that we can do with it. But it goes beyond DuraCert because we are committed to being the leader in drug delivery in the eye.

Or you may even think that even at one milligrams you could start to see some sort of directional changes.

We can't speculate there really is no kind of guidance, we can give here about efficacy for for for any of the groups.

Okay. That's fine I appreciate that and then maybe just one more question in terms of you take Ah Kam.

Think that was very useful information is there any follow up in terms of reporting or what should we anticipate maybe sometime in 2022 additional sort of update from that.

Jay S. Duker: And so we are evaluating other potential drug delivery systems. But in the end, those are all tools to achieve better vision, better life, easier times for patients, families, and frankly, for insurers as well. I mean, we have a whole constituency that we're trying to help here. So the delivery systems are tools. EYP1901 is the first step.

Yeah, we expect to give continuous updates on that date is that that's going to go out for a minimum of five years, and <unk> and possibly even B L. L.

L. As we as I said in the press release, it's really an incredible amount of data that we're going to be able to capture on the longitudinal etiology of the progression of the disease with no. One has right now so we feel like we're contributing not only to the overall understanding of posterior segment.

Jay S. Duker: If we can show that a small molecule like rural can be safely and successfully delivered to the eye, I think there's a wealth of other similar molecules with other mechanisms of action that we can potentially deliver. But at a high level and at a personal level, I like challenges and I like to take on things and be successful with them. So I don't think that taking just a single program, or single molecule, or single delivery system is what excites me. It's moving the company forward with a common goal.

<unk>.

But then also how you teak helps to manage that Dizzy. So we expect it will be getting regular consistent updates on that longitudinal study is at progressive.

Okay, Great and then maybe the one final question here is in terms, though you tea six months to trial to start in this quarter, what should we anticipate b the primary endpoint for the study and thanks.

It's going to be run identical to our faith three programs for that you take three year program. So it will be a reduction in you. The Arctic flares. Obviously, you always are going to be looking at other secondary endpoint, obviously safe day of course, and but but yeah, and obviously some vision maintenance.

Jennifer M. Kim: Awesome, great. Congratulations again. And thanks, everyone.

Operator: Thank you. The next question comes from Yassim Senei.

Or how you control the vision if these patients progress with their disease.

Operator: Yassim Sanejah from Guggenheim, your line is open.

The primary endpoint will be reduction in you the attic flares.

Unknown Speaker: Hi, guys, thank you for taking my questions and, Jay, congrats on a couple from me. So at AAO, we're going to get the five-month data for the high dose. Will you data for all? Yeah, I'll take that question. So we're always just a bit cautious in what we want to commit to in terms of what we would show at AAO, because you never know if patients will make their visits in a timely way. The good news is that they have.

Okay, great cause long congrats on what to look for where to three to date us.

Thank you.

Thank you. Our next question comes from the line of E. Chan from a ceiling right. Your line is Alison [noise].

[noise]. Thank you for taking my questions could you come in the volume of.

<unk> surgery in the current quarter, whether it has returned to the the normal volume compared to pre Coca touch.

Yeah I can.

Yep, one answer that.

Can you repeat that question was a little hard to understand Oh.

Jay S. Duker: And so what we expect to show at AAO is all cohorts, well, let me back up. We're going to show the low dose, the low mid-dose, and the mid-dose all the way through six months for safety and efficacy. And then in the high dose, we will show all patients that there is one patient who has not yet come in for their visit. If we can get that patient in before AEO, we'll show that patient; otherwise, we'll be shy about showing that patient. And we'll show four out of five patients through six months in that high dose cohort with one patient at five months. So basically, we're going to be able to show

I Wonder if you can come in whether the volume of all Chris surgeries have returned to the normal levels.

I'm Gonna.

Alright for that night.

Yeah, I I I think the answer is probably not but I'm not sure that.

There's any central place one could look for that data.

You know this soon you know you can look at claims data, but that usually takes a while to find.

So I'm just off the coughing it here talking to my colleagues and knowing what's going on at least in the new England area and outside I think the volumes are close to to preclude COVID-19 in the 90%, but not quite there, but again that is non scientific.

Jay S. Duker: almost all the data through six months, oh, excuse me, up to six months.

I thought you want to comment on that has or had a sales and what you're saying with the field is seen out out in the the the real world as well.

Jay S. Duker: to six months, let me be clear, up to six months, and then perhaps one patient will still be at five months in the high-dose cohort. Very good, very helpful. Then a couple more.

Absolutely Thanks Nancy.

Yeah.

Specifically to cataract surgery, rather than focusing on Oh, ophthalmic surgery, but what we're seeing in the cataract market. It is slowly returning back to normal. We are seeing you know certain areas that will pop up specifically related to COVID-19.

Unknown Speaker: So obviously, you know, the drug seems to be very, very safe. And one of the questions that I have gotten from Investor is that those levels are, is it, the fact that we have such a good safety profile could that be a function of you being underdosing? Are these doses relatively active. Yeah, let me comment real quickly, and then I'm going to turn it over to Jay.

Covid, having a an outbreak in particular is where we see a slowdown so while I can't give you a specific number of cataracts that occurred during the second or third quarter. We are seeing most areas of the country slowly returned back to normal levels.

Thank you. My next question is F. D. A recently approved so it's V O R D pork delivery system.

<unk> for the treatment of what M D for up to six months. So what this 19 O one need to demonstrate to out compete supposed female on the market in the future.

Nancy S. Lurker: So, first of all, we're not going to give any forward guidance, and we'll be expecting to see. So I want to be very clear about that. And, of course, in any therapeutic area, you always have that tradeoff between safety and efficacy. But with that being said, as you know, we have a very remarkably good safety profile.

So I'll take that yeah.

So a couple of things first of all from a safety issue.

Yeah, we all need to be aware that to place. This implant surgery involved and there's always some risk to just surgical operation of.

The second thing is.

Starting to eat it in the phase one where one out of 20 patients and their phase one trial got endophthalmitis, which is a serious infection of the the inside of the eye, 1.5% of the patients approximately in the phase three trials got endophthalmitis, and so that is something where we hope that.

Jay S. Duker: And frankly, I think you'll just have to wait and see what the data shows when we roll it out at AAO. I'm going to let you expand on that if you have anything else you'd like to add. Not a lot except to state that in our preclinical models and our I and D enabling studies, there was a very good safety profile for both varolinib and EYP-190 in varolid endurisert, and we never found a maximally tolerated dose in animals.

<unk> in office injectable could do better from a safety perspective.

Uncertainly back to the surgical part of it you know, we think that from a convenience perspective, not having to go to the operating room and relatively elderly patients is going to be an advantage as well.

Jay S. Duker: And so I will agree with Nancy that we will have some efficacy data to share in another week and a half or so, and we'll leave it at that. Got it. Just one final question. So with regard to Jay, you spoke about it today, but I joined a little bit later.

Remember also are drug is different the mechanism of action is different and so that there may be some efficacy around receptor blockage and being able to block all ice of forms of that you that we may see as further studies are performed so that.

Congratulations to the company that was that was a tough slog to get that through it's really a game changer and potential paradigm shifts, but we believe that if our product can can show.

Unknown Speaker: So with regard to the changes in B and OCT, I think you mentioned about five letters plus or minus would be okay. Just trying to get a sense of how likely a letter or an OCT loss would be. Not sure if, like, five positive would be fine, but a drop. I don't know how. So I think you need to think about it in a couple of ways. There's really three kind kinds of views of this.

Safety in similar efficacy that because we're non surgical and because we're likely to have you were cases of endophthalmitis that we will be able to carve out marketshare.

Got it thank you.

[noise]. Thank you at this time I'm showing no further questions I would like to turn the call back over that Nancy Lurker C. L for closing remarks.

Jay S. Duker: And the first question is, what is the FDA thing? because ultimately, we need to get the product if the FDA approves it. So the FDA, if the FDA says that, and again, this is, you pick a number, it doesn't matter, two, three, four, seven, ten letters is an approvable endpoint, even for a loss, and then the FDA spoke. The second thing is what the retina specialists say is an acceptable safety profile and efficacy profile to use the product. Now, remember, we report data across a large population, or certainly in phase one, I wouldn't call it a large population. It's an equal 17.

Thank you everyone for joining today and we very much look forward to giving you an update at post or a L date of release. Thank you again.

This concludes today's conference call. Thank you for participating you may now disconnect.

[music].

Jay S. Duker: It's a small population, but that doesn't mean that you can't pick out, even if in a large population, the efficacy doesn't look strong, but in individual subgroups it does, and you can identify those subgroups. Then you can have a very successful product by choosing the patients you use it on well. And that's no different than any other drug product. What's different in this area is we didn't have an option before. It was an injectable anti-vegetative, yes, Lucentis, Ilya, Avastin, and if you inject them monthly, they all work about the same, and they're all about the same state.

Jay S. Duker: So this is a paradigm shift now because what we hope to accomplish is true sustained relief for many months and not just a month or two. And it doesn't need to work perfectly in every patient as long as it's safe and one can identify the groups of patients that it does work well in. And so the last group that needs to be satisfied, of course, is the patient. They need to see the value in having a visit perhaps every four, five, or six months instead of every one or two months. I think that would be obvious.

[music].

Jay S. Duker: But if there's a change in their vision, plus or minus, it really needs to be something that they can live with. So back to the question specifically about visual acuity. If you follow the space, you know that for newly diagnosed wet AMD, all the visual acuity is gained in the first three months, and if you look at the curves after that, they're basically flat and wet. But in the real world, they go down.

Jay S. Duker: And a couple of real world studies show that after three months, in the real world, where on average patients get six injections a year, by the first year out, as a group, they've given back all the visual acuity games, so if you had a control group, which we do not in phase one, that was standard of care, you would expect that there might be some loss of letters over six months. How much is significant? Again, I have to go back to those three groups. What's significant for the FDA? What's significant for the retina specialist to use, and what's significant for the patients? Yet to be seen.

Jay S. Duker: OCT's the same, and in fact, OCT gains are almost always in the first month or two. So if you've got a group of patients who've been diagnosed for three or four months, they're stable, presumably. They may or may not have fluid.

Jay S. Duker: They've gotten all their visuals, and so a successful product should be able to keep that group relatively stable. So that was a long-winded answer, but I hope I answered your question. No, that's very good. Thank you so much.

Unknown Speaker: Thank you. Our next question comes from the line of Yale Chen from Laid Law and

Operator: company. Your line is now

Operator: is now open.

Operator: Good morning and thanks for taking the questions and congratulations on the progress. In terms of the 1901, you have, Uh.

Unknown Speaker: 3 milligrams and 2 minigrams groups, and also you will highlight some of the efficacy information sort of categories that need to be paid attention to. Do you anticipate most of the efficacy or signals or signs of efficacy will be more likely in those high dose groups, or do you even think that even at 1 milligrams you could start to see some sort of directional changes? We can't speculate. There really is no kind of guidance we can give here about efficacy for any of the groups.

Unknown Speaker: Okay, that's fine. I appreciate that. And then, maybe just one more question.

Unknown Speaker: In terms of Utica.com, I think that was very useful information. Is there any follow-up in terms of reporting, or what should we anticipate maybe sometime in 2022 as an additional update from that? Yeah, we expect to give continuous updates on that data set that's going to go out for a minimum of five years and possibly even beyond. So, as I said in the press release, it's really an incredible amount of data that we're going to be able to capture on the longitudinal etiology of the progression of the disease, which no one has right now. So we feel like we're contributing not only to the overall understanding.

Unknown Speaker: of the posterior segment UVitis.

Unknown Speaker: also how Utique helps to manage that disease. So we expect that we'll be giving

Unknown Speaker: that we'll be giving regular, consistent updates on that longitudinal study as it progresses.

Unknown Speaker: Okay, great, and maybe one final question here is in terms of UT, six months per trial to start this quarter, what should we anticipate be the primary endpoint for that study? And thanks. It's going to be run identical to our phase three programs for the Utique three-year program, so there will be a reduction in uveitic flares. Obviously, you are always going to be looking at other secondary endpoints, obviously safety, of course, and obviously some vision maintenance or how you control the vision as these patients progress with their disease. But the primary endpoint will be a reduction in uveitic flares.

Unknown Speaker: Okay, great. Thanks a lot and congratulations, and we look forward to Shreda Datas. Thank you. Thank you. Our next question comes from the line of Yi Chen from H.C. Wainwright. Your line is now open. Thank you for taking my questions. Could you comment on the volume of ocular surgery in the current quarter, whether it has returned to the normal volume compared to pre-coct?

Yi Chen: Again, it's just one answer.

Yi Chen: Can you repeat that question? It was a little hard to understand.

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Yi Chen: Oh, I wonder if you can comment on whether the volume of ocular surgeries has returned to normal levels. I'm going to... I'm going to... I'm going to...

Jay S. Duker: I think the answer to that is probably not, but I'm not sure that there's any central place one could look for that data, you know, this soon. You can look at claims data, but that usually takes a while to find.

Scott Jones: So I'm just wing it here, talking to my colleagues and knowing what's going on, at least in the New England area and outside. I think the volumes are close to pre-COVID levels in the 90%, but not quite there. But again, that is non-science. Scott, do you want to comment on that as our head of sales and what you're seeing, and what the field is seeing out in the real world as well? Absolutely. Thanks, Nancy.

Scott Jones: And, you know, specifically for cataract surgery rather than focusing on all ophthalmic surgeries. But what we're seeing in the cataract market, it is slowly returning back to normal. We are seeing, you know, certain areas that will pop up, and specifically related to COVID having an outbreak in particular areas where we see a slowdown. So while I can't give you a specific number of cataracts that occurred during the second or third quarter, we are seeing most areas of the country slowly return back to normal. Thank you.

Yi Chen: My next question is FDA recently approved SESVEMO or the port delivery system with RANDI for the treatment of wet AMD for up to six months. So what does 1901 need to demonstrate to out-compete CSIMO on the market in the future? So a couple of things.

Jay S. Duker: First of all, from a safety point of view. We all need to be aware that to place this implant, there's surgery involved, and there's always some risk involved in this surgical operation. The second thing is, Starting even in phase one, where one out of 20 patients in their phase one trial got endophthalmitis, which is a serious infection of the inside of the eye, 1.5% of the patients in the phase three trials got endophthalmitis.

Jay S. Duker: And so that is something where we hope that an in-office injectable could do better from a safety perspective. And certainly back to the surgical part of it, we think that from a convenience perspective, not having to go to the operating room and, you know, relatively elderly patients is going to be an advantage as well. Remember also that our drug is different, the mechanism of action is different, and so there may be some efficacy around receptor blockage and being able to block all isoforms of VEGF that we may see as further studies are performed.

Jay S. Duker: So, you know, congratulations to the company that was a, you know, a tough slog to get that through. It's a really game changer and potential paradigm shift. But we believe that if our product can show safety and similar efficacy, that because we're non-surgical and because we're likely to have fewer cases of endoplamitis, we will be able to carve out market share.

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Operator: Thank you. At this time, I'm showing further questions. I would like to turn the call back over to Nancy Lurker, CEO, for closing remarks.

Nancy S. Lurker: Thank you everyone for joining today, and we very much look forward to giving you an update at the post-RAO data release.

Operator: This concludes today's conference call. Thank you for participating. You may now disconnect.

Unknown Speaker: Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you.

Unknown Speaker: Thank you. Thank you. Thank you. Thank you, and so on the same, and so on the same. Thank you.

Unknown Speaker: Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you, and so on the way. Thank you. Thank you. Thank you.