Q4 2022 EyePoint Pharmaceuticals Inc Earnings Call

Speaker 3: and one.

Speaker 4: Good day and welcome to the I point pharmaceuticals fourth quarter and full year 2022 financial results conference call. At this time all participants are not listening only mode. After the speaker presentation there will be a question and answer session. To ask a question during the session you will need to press star 111 on your telephone.

Speaker 4: You will then hear an automated message advising that your hand is raised. So with draw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker, Mr. George Elston, Chief Financial Officer. Please go ahead. Thank you. Thank you. And thank you.

Speaker 5: of recent corporate updates. Dr. Dukeer will then discuss pipeline developments and Scott will comment on our commercial activities.

Speaker 5: I will close with commentary on the fourth quarter in full year 2022 financial results. We will then open up the call for your questions.

Speaker 5: Earlier this morning we should press release detailing our financial results in recent corporate developments.

Speaker 5: A copy of the release can be found in the Investor Relations tab on the company website www.iPointPharma.com

Speaker 5: 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 Security's litigation reform act of 1995. These include statements about our future expectations.

Speaker 5: clinical developments and regulatory matters and timelines, the potential success of our products and product candidates, financial projections and our plans and prospects.

Speaker 5: Actual results made different materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the risk factor section of our most recent annual report on Form 10K, which is on file with the SEC, and in other filings that we may make with the SEC in the future.

Speaker 5: 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 display any obligation to do so, even if our views change. Therefore, you should not rely on these forward-looking statements as of representing our views, as of any date subsequent to today. I'll now turn the call over to Nancy Lurker, Chief Executive Officer of I Point Pharmaceuticals.

Speaker 6: Thank you George. Good morning everyone and thank you for joining us as 2022 was really an exceptional year for I point pharmaceuticals. We continue to execute on our goal of being the leader in innovative, sustained, off-cater drug delivery using our best-in-class, DERRASER technology.

Speaker 6: to achieve improved outcomes with more convenient dosing regimens. I'll begin by reviewing our lead development program, EWP 1901, and why we believe this therapies, six to nine-month treatment intervals, zero-order kinetics, and new off-cure mechanism of action could be a game changer in retinal diseases like wet AMD.

Speaker 6: that require lifelong treatment. E-WEP-P1901 is a biorodable neurosurgeon in surf that delivers bralineins, a selective and patented tyrosine kinase inhibitor delivered through a single intravenous injection in the physician's office.

Speaker 6: We have advanced EYP 1901 into two, phase two clinical trials in wet AMD.

Speaker 6: and non-prolificative diabetic retinopathy, otherwise known as NPDR. Based on the positive W. Phase I clinical trial result, result that we reported last year.

Speaker 6: The EYP 1901 has emerged as a promising potential therapeutic for serious eye diseases, bringing key attributes to patients, including

Speaker 6: delivery of the active drug Borrelinib consistently over six to nine months, with the majority of patients not requiring any supplemental therapy up to six months after a single treatment in wet AMD.

Speaker 6: A new mechanism of action to treating retinal eye diseases beyond the current anti-vegetial ligand blockers on the market today. The potential for neuroprotective and anti-phibiotic benefits to the retina.

Speaker 6: A proven drug delivery technology was a very positive safety profile.

Speaker 6: And upon completion of our Phase 2 trials, and importantly, EYP 1901 will have the most robust clinical data for any ocular TKI program, with over 180 patients having been dozed by the end of our Phase 2 programs in both WEDAMD and NPDR.

Speaker 6: This is in addition to a strong off their safety and efficacy data set from clinical trials of rolling it delivered orally in previous trials treating over 150 patients.

Speaker 6: The E-WEP 1901 delivers the TTI role in it, which potentially brings a new mechanism of action to retina disease beyond what currently exists with the current anti-bedgF large molecule therapies on the market today.

Speaker 6: When you look at treatment regimens outside ophthalmology, it's often stand to practice to address multiple mechanisms of action in parallel in order to improve efficacy.

Speaker 6: We believe these retinal eye diseases, with serious consequences such as blindness, should be treated using all resources at our disposal as well, through a multi-con deproze that targets multiple disease drivers.

Speaker 6: Additionally, NYP 1901 sets itself apart by using our proven, best-in-class bio-rotable-duricert technology for good delivery.

Speaker 6: which delivers a drug at zero order kinetics, which provides constant steady dosing over six months for longer.

Speaker 6: Dr. J. Dukeer, what would you EYC-1901's potential? You meet clinical advantages for patients in more detail later on this call. But of note, we look forward to presenting pre-clinical neural protection data for Varyl and IB from a gold standard mouse model of retinal detachment at the 2023 ARVO annual meeting in April .

Speaker 6: Beginning with WED AMD, the current standard of care requires monthly or by-monthly I injections of ligand, locking, anti-bedgF biologics, which can be cumbersome and unpleasant mutations, as is very difficult for patients to maintain this routine to the rest of their lives. Importantly, we know from robust databases that even one missed or skipped a point in it...

Speaker 6: could mean vision loss for the patient. The positive phase when dovidoclinical trial results support our treat to maintain therapeutic approach for this disease with the potential to transition a majority of patients to an every six months treatment with E-WedT 1901.

Speaker 6: This can fundamentally change the way physicians treat the disease and manage patients by having drug consistently delivered providing treatment, which we are confident will enhance patient compliance and improve clinical experience.

Speaker 6: We are actively enrolling patients in the Phase II W2 clinical trial of E-WETP 1901 as a potential six months maintenance treatment for wedding indeed. This is a massive multi-billion dollar market opportunity with millions of patients in the need of new treatments for the blind in eye disease.

Speaker 6: and we aim to bring a life-changing treatment to these patients with E-WEP-901. W-02 is a randomized, faith-liberate-cept controlled, alkanonizalia trial, enrolling approximately 144 previously treated patients.

Speaker 6: To our knowledge, this is the largest phase 2 trial being conducted in Radiant WEDMD among TKI treatments. We anticipate announcing top line six months result, excuse me, late in the fourth quarter of this year.

Speaker 6: The phase 2 pavilla clinical trial presents a compelling and proactive potential therapy for the treatment of non-prolificative diabetic retinopathy.

Speaker 6: The approved large molecule anti-veget followed by a logic to treat NPDR require frequent injections just like what AMD for this disease where patients may not feel symptoms and as a result may forego regular treatment. In fact, nearly 97% of NPDR patients receive no course of treatment.

Speaker 6: apart from observation by the retinal specialist until the disease progresses to vision models.

Speaker 6: Consequently, there's a great unmet need in NPDR patients for a safe, efficacious, and convenient treatment options that would maintain patient vision proactively through zero-order of constant dosing.

Speaker 6: With EYP 1901, we have the opportunity to potentially fulfill this need within every nine months to sustain delivery treatment options for patients that align with their office visits and provide patients and physicians with the comfort of having sustained drug delivery during the period between office visits. The PIVI clinical trial remains on track to complete new roles.

Speaker 6: along with our proven drug delivery system and patent molecule, we'll give I point a significant optionality as we evaluate our pivotal phase three clinical development program path.

Speaker 6: to market and in discussions with strategic global partnerships. Further, we look forward to enrolling our first patient in a third phase 2 trial evaluating diabetic macular edema or DME in late 2023 or early 2024 timeframe.

Speaker 6: Importantly, I point continues to remain actively engaged in expanding our sustained off-thread delivery pipeline beyond TYP-1901.

Speaker 6: We continue to evaluate molecules for potential use in our DERRICERC technology, which can be tailored to each drug and disease indication for future growth.

Speaker 6: We're very excited because this week we also announced a research collaboration with Rally Biles to evaluate their C5 complement inhibitors using our proven duracer technology to develop a sustained delivery treatment option for geographic atrophy. We're very excited to update you on this evaluation over the coming quarter.

Speaker 6: Dr. Ducca will talk further about that as well. Turning now to our commercial results, UT continue to demonstrate strong customer demand in the fourth quarter of 2022, which resulted in a very compelling 55% increase in UT in net product revenue compared to Q4 of 2021. At the upcoming 2023, our annual meeting

Speaker 6: We will present three abstract discussing our UT Calm Studies, which is a Phase 4 Multi-Center Registry Studies, and a collaboration between I-Point and the Collegal Clinic. Scott, our Jones Archie's commercial officer, will provide additional detail on this topic later on. But I'd like to recognize our commercial team for delivering on yet again another strong quarter.

Speaker 6: and a strong year of product revenue for UT's and for I point. Additionally, we're excited to share that in partnership with OccupyMension Therapeutics, you take launch in China in the fourth quarter of 2022.

Speaker 6: This commercial launch marked an important milestone in furthering our mission of improving the lives of patients with serious eye disorders around the world. And we're very pleased to partner with our community. To expand, you take global reach in the emerging Chinese market.

Speaker 6: Finally, we completed a number of other significant corporate milestones in recent months. This February , we entered into a lease agreement to the construction of a commercial manufacturing facility to support global product supply, E-WEP 1901 and E-TEEC.

Speaker 6: The lease is for a 40,000 square foot standalone facility in Northbridge, Massachusetts that will be built to our specifications. I point with awarded 1.9 million of state and local grants for this facility. And I've known lease payments not commencing until completion of construction, which is anticipated in the second half, 2024.

Speaker 6: This investment reflects the confidence we have in E-Weapon 1901's potential for clinical and commercial success. And this level of control over our supply chain will provide an important point of value differentiation for UT, and we hope eventually E-Weapon 1901 in the years to come. E-Weapon 1901 in the years to come.

Speaker 6: In January of this year, we were also delighted to promote J.S. Duke or ABD to the additional role of President. Dr. Duke served as a chief operating officer since November of 2021. And in this expanded role, he will continue to duty as chief operating officer and now will also oversee regulatory affairs.

Speaker 6: Jay has been a tremendous asset to our teams to be joined to COO, and we look forward to continually to benefit from his deep, ophthalmic expertise as an expert in retinal surgery, and strong leadership in his new role as president.

Speaker 6: I'll now turn the call over to Dr. J. Dukeer, our president and chief operating officer, to provide an update on our LEED program, EYP 1901, as well as other pipeline initiatives.

Speaker 6: I'll turn the call over to Dr. J. Dukeer, our president and chief operating officer, to provide an update on our lead program, EYP 1901, as well as other pipeline initiatives. J. Dr. J. Dukeer, our president and chief operating officer, to provide an update on our lead program, EYP 1901, as well as other pipeline initiatives.

Speaker 5: Thank you Nancy and good morning everyone. Before I begin, I'd like to reiterate what important point this is in I point's journey. Our team is positioned to execute on multiple catalysts this year.

as we advance our Phase II clinical programs in growing pipeline opportunities. I am also incredibly grateful to Nancy and the Board of Directors to allow me to take on a new leadership role at I point as President in addition to Chief Operating Officer.

I will begin with reviewing why, as a practicing retinal physician, I'm incredibly excited about the potential of treating patients with EYP 1901 and why it represents a potential huge leap forward in this space, before reviewing our clinical data and our Phase 2 programs in progress. Turning to our lead product candidate.

EYP 1901 is an investigational, sustained release therapy that uses a biodeurotable formulation of our Dyrrissur technology, which we are now referring to as Dyrrissur E for erotable. With Verolinib, a tyrosin-kines inhibitor that acts through intracellular binding of all vascular and dithelial growth factor or Vegef receptors. They are by blocking all Vegef isoporums.

The role in its differentiated MOA versus the standard of care ligand blockers may provide additional treatment benefits beyond anti-vegetive activity with extended longevity between treatments, such as neuroprotection.

compared to other TKIs for rolling up features reduced off-target binding.

specifically minimal activity against TIE II, leading to a potentially improved safety and efficacy profile.

Bioirotable DERRICER E, a miniaturized injectable insert is the same technology used in the non-irotable products like you keep. However, the non-irotable shell is removed. DERRICER products have been delivered to over 80,000 eyes with a consistently strong safety profile. So, to summarize...

Our program features a differentiated molecule, rolinib, coupled with the best in class delivery system, derasert. In Wed AMD, EYP1901 is being studied as a maintenance therapy, suggesting a new treatment paradigm, which we call treat to maintain.

Our goal is to maintain vision and anatomy in the majority of wedding MD patients with a single injection of EYP-1901 for an interval of six months or longer. By providing the sustained delivery therapy and the new mechanism of action, patients and practitioners can potentially have the flexibility to safely reduce the number of visits to the retina specialist.

Last summer, we reported positive 12-month safety and efficacy results at the American Academy of Ophthalmology meeting in Chicago for the Phase 1W trial.

evaluating EYP-1901 and previously treated WEDA-MD. The Dadiotrial enrolled 17 patients and each received a single in-office intra-vitro injection of EYP-1901 at one of four different dose levels.

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

No re-injection with the study drug was performed during the trial and typical criteria for supplementation with a standard of care anti-pitchF was employed.

We were pleased that the 12-month data featured no reports of popular SAE's or drug-related systemic SAE's, no reported events of vitri's floaters, and ophthalmitis, retinal detachment, insert migration into the interchiembar, retinal vasculitis, post-year-signal inflammation, or retinal vascular-clusive events.

5-ET-JRS letters. Coupled with a stable macular anatomy as the central subfield that this change on OCT was only minus 2.7 microns.

After a single injection of EYP1901, 53% of eyes were supplement-free up to six months. And up to one year, one-third of eyes were supplement-free.

Additionally, they're continued to be clinically significant treatment burden reduction of 73 percent of 12 months compared to 75 percent of the six-month visit. On the heels of these positive data, we initiated two separate phase two clinical trials of Emergency wounds learning differ from 9-year? goat to March 10?? 14-pm, multiple clinical hospital witnesses secured three log scales with

one for the treatment of wet, age-related macular degeneration called dovio2, and one studying the drug a non-proliferate diabetic retinopathy or NPDR called the Pavilla study. The dovio2 trials expected to enroll approximately 144 wetting patients previously treated with a standard of care anti-vigia therapy and randomly assigned to one of two doses of EYP1901.

approximately two milligrams or approximately three milligrams. This is versus an unlabeled oblivion control. EYP 1901 is delivered with a single intervittual injection in the physician's office similar to current FDA approved anti-vegetary treatments. The primary efficacy endpoint of the WO2 trial is not inferiority.

of the change in visual acuity compared to the Eiffelibre sub-control as measured at six months after the E-Wi-P1901 injection.

Secondary efficacy influence include change in CSD, as measured by OCT, time to first supplement the length of the Jeff reduction in treatment burden and safety.

2023. Turning to non-prolipidopniopathy or NPDR, it is a very common disease affecting almost one third of diabetic adults over the age of 40, and is projected to impact over 14 million Americans by 2050.

Turning to non-pur with the diabetic retinopathy or NPDR, it is a very common disease affecting almost one third of diabetic adults over the age of 40 and is projected to impact over 14 million Americans by 2050. In NPDR blood vessels are weakened.

potentially leading to swelling of the macula, called diabetic macular edema or DME. And in some cases, growth of abnormal retinal blood vessels or prolific diabetic retinopathy, also called PDR. If left unchecked, NPDR can be the harbinger of severe visual loss.

Because the currently approved therapies for NPDR require a significant visit and treatment burden, 97% of NPDR patients are currently observed. This provides a significant market opportunity for UIP 1901, which may be able to effectively be delivered at nine months intervals or longer in NPDR.

As a practicing retina specialist, I would be excited to have a safe, effective, and tolerable, sustainably therapy to prevent the complications of NPDR.

The first patient was dosed in the Phase II pavilla trial of EYP 1901 for the treatment of NPDR in September of 2022. His trial was expected to enroll approximately 105 patients randomly assigned to one of two doses of EYP 1901, approximately two milligrams or approximately three milligrams, or to the control group, which will receive a sham injection. In this trial as well, EYP 1901 is delivered with a single...

remain on track to complete trial enrolments in the fourth quarter of 2023. Finally, we look forward to initiate a third phase to clinical trial evaluated E-YP-1901 in DME later this year or early next year. And we continue to evaluate potential product candidates through internal discovery efforts, research collaborations.

and in licensing arrangements to continue to build our pipeline. As Nancy noted, we announced an exciting collaboration with Rally Bio to evaluate their C5 complement inhibitor in our DERRASER technology. We have been actively evaluating complement inhibitor mock grills for use in our drug delivery technology as we see a significant opportunity to provide a sustained delivery treatment.

for geographic atrophy and potentially earlier forms of dry indeed. Similar to our approach with EWAP 1901 by providing constant dosing of drug over time, we hope to see improved outcomes and reduce treatment burden for patients.

a perentated mechanism of action in the years to come.

I will now turn the call over to Scott Jones, Chief Commercial Officer for the Commercial Update. Thank you, Jack. We're excited to report a strong year for our commercial business with 39.9 million of net product revenue, a 13 percent increase compared to 2021.

Our Q4 and that product revenue for UTQ was 9 million compared to 5.8 million for the fourth quarter and in December 31st, 2021, a 55% increase.

You take customer demand was approximately 980 units compared to approximately 890 units for the third quarter of 2022, a 10% increase. We are pleased with the continued customer demand increase for you to based on continued utilization by our rental physician and consistent messaging from our marketing and sales teams.

We continue to collect real world data on the benefits of UT for the treatment of chronic non-infectious posterior segment uvitis in the Phase IV Calm Registry Study, which is conducted in collaborative collaboration between I point and the Cleveland Clinic.

Data from the UT Com Registry Study were presented in poster presentation by Dr. Puyah Dianni at the Retina Society's 55th Annual Scientific Meeting in November 2022. And we look forward to presenting an additional update from the COM study and three ABS tracks at the 2023 Arvo Annual Meeting next month. As Nancy previously mentioned, in partnership with OccupyMension Therapeutics,

You take commercially launched in China at the end of last year. Since its approval in the US over four years ago, I-Poin has been able to deliver the innovative, ocular therapy to patients and provide an improved standard of care for patients with up to three years of continuous control in chronic non-infectious UVI as affecting the posterior segment of the eye.

We look forward to continuing to partner with our documentary and expand UTX Global Reach in China. As we work together to improve the lives of patients with serious items of disorders around the world, we're very pleased by the strong 2022 performance and expect a profitable UTX franchise in 2023.

I'd like to thank our commercial team for their dedication to bringing you to take to physicians and patients in need. 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? Thank you, Scott. As the financial results for the three months and full year ended December 31, 2022, we're included in the press release issued this morning. Good morning. My comments today will be focused on a high level review for the quarter.

For the quarter-ended December 31, 2022, total net revenue was 10.5 million compared to 11.5 million for the quarter-ended December 31, 2021. Net product revenue for the quarter-ended December 31, 2022 was 9.9 million compared to net product revenue for the quarter-ended December 31, 2021 of 11.2 million. Despite strong your over-year performance by UTIC,

Total net product revenues were impacted by the anticipated loss of past-through reimbursement for DEXICU at the end of 2022. Net revenue from royalties and collaborations for the quarter ended December 31, 2022 totaled 0.6 million compared to 0.3 million in the corresponding period in 2021. Operating expenses for the quarter ended December 31, 2022 totaled 54.3 million compared to 29.6 million in the prior year period. The increase was primarily driven by at one time.

$20.7 million non-cash impairment charge of the intangible asset associated with DEXQ due to the loss of past through reimbursement by the Centers for Medicare and Medicaid effective January first 2023. Further there was a $6.6 million increase in R&D expense and a $4 million increase in the cost of sales. This was off that by a $1.9 million decrease in sales and marketing expense.

and a .7 million dollar decrease in GNA expense. Non-operating income net totaled .3 million and net loss was $43.5 million or $1.16 per share compared to a net loss of 19.4 million or 59 cents per share for the prior year period. Turning to the full year ended December 31, 2022. Until.

Total net revenue was $41.4 million compared to $36.9 million for the full year ended December 31, 2021. Net product revenue for the full year ended December 31, 2022 was $39.9 million compared to net product revenues for the full year ended December 31, 2021 of $35.3 million. Net revenue from royalties and collaborations for the full year ended December 31, 2022, totaled $1.5 million compared to $1.6 million in the corresponding period.

in 2021. Operating expenses for the full year ended December 31, 2022 told both 141 million versus 92.2 million in the prior year period. Increased was primarily driven by a one-time 20.7 million dollar non-cash impairment charge of an intangible asset associated with DEXICU, which was due to the loss of past the reimbursement by CMS.

effective January 1, 2023. Further, there was a $21.1 million increase in R&D expense, a 9.2 million increase in GNA expense, and a .1 million increase in cost of sales. This was offset by a $2 million decrease in sales and marketing expense.

Non-operating expense net to a little $2.6 million and net loss was $102.3 million or $2.74 per share compared to a net loss of $58.4 million or $2.3 per share for the prior year period. Cash, cash equivalents, and investments in marketable securities at December 31, 2022, totaled $144.6 million compared to $211.6 million at December 31, 2021.

remarks.

Thank you, George. We trust this review has given you a greater understanding of I-Point progress over the past year and our potential moving forward. Over the past year, we've executed the plan and our achievements form the foundation for future growth.

This is a highly experienced management team and we are keenly focused on delivery results on executing well.

FioTech is a rewarding but risky business, and it requires well thought out and methodically executed plans.

2023 promises to be another productive and rewarding year for eye-point pharmaceuticals as we continue to execute on multiple clinical catalysts and strengthen our commercial business. Over the coming year we expected completing enrollment in the Phase 2W2 trial of UIT 1901 and Wedding B and in the Phase 2 Pavia trial of UIT 1901 in non-pulipative diabetic red novice. We expected those are first patients in the Phase 1 clinical trial.

of UIT 1901 and DMV later this year or early next year. We expect to report top line six months data for our FAT2W02 clinical trial. We expect to publish neuroprotective preclinical data for UIT 1901 using growing it. And we continue to grow revenue for YouTube. We've had a great year and we have a terrific team and we're confident that I point will continue to execute. So the core to keep you all updated is we advance these value creating milestones. Before opening the call to your questions, I do want to note how grateful I am for a fantastic team that I point pharmaceuticals who continue to drive our progress and are responsible for our company's clinical.

operational and financial success to date. We've made tremendous progress, as I've mentioned, in the last year, and we're excited and motivated to advance the future of sustained off-grid or drug delivery to benefit. Most importantly, the millions of patients who are at risk of serious vision loss. Thank you all very much for listening this morning, and I'll now turn it over to the operator for questions. Thank you. Thank you. As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. So, withdraw your question, press star 11 again. One moment for our first question. And our first question will come from the line of Gattonsune.

able to initiate the pivotal trials in the second half of 24. The other questions were about injector, I believe.

Any other device worker, nonclinical or areas? I think as we've stated many times publicly, we're developing a new patent, patented state of the art injector that we expect to be used in the Bivville trials and commercially. We anticipate using that injector in our DNA trial as the first trial that it rolls out. That still has some work to be done while we're pleased with the current injection system. It's working quite well. We do like to update it with the state of the art injector and

If DDB would not delay the pivotals if there is any issue with the development of the new injector, but so far the development is going smoothly and we're on target to use it in DME. Yeah, can I just add to that? So let me just reiterate. Number one, we're on track for starting our phase three, as Jay said, something half of the next year. The injector is a phenomenal, really exceptional state of the art injector patent protected. What Jay is trying to also, let me just say is that we're on track for the development of that injector, but because it's a state of the art, we don't want to do on the key that we would actually start right away with that. So we're ready to go with the current injector that we're using on phase two studies. I'm not supposed to just find and we can easily do a bridging study should we need to. So we are well prepared to do that. We're prepared to go forward with our phase three, the pivotals and garlic and we're on track out. So just want to state the list and a couple of things.

If need be, we would not delay the pivotals if there's any issue with the development of the new injector. But so far the development is going smoothly and we're on target to use it in DMA. Yeah, can I just add to that? So let me just reiterate. Number one, we're on track for starting our phase three. As Jay said, something happened next year. The injector is a phenomenal, really exceptional state of the art injector patent protected. What Jay is trying to also, let me just say is that we're on track for the development of that injector, but because it's a state of the art, we don't want to do on the key that we would actually start right away with that. So we're ready to go with the current injector that we're using on phase two studies. And that's working just fine and we can easily do a bridging study should we need to. We are well prepared to go forward with our phase three, the pivotals for garlic. And we're on track. I also just want to say for a listen to a couple of things. Number one.

Getting ready for phase three takes a lot of pre-planning. You have to have clinical supplies ready to go and well developed. Not only the injector, but the actual implants itself. You have to have an end-to-phase two meeting with the FDA. You have to have made sure that you've got your Pivotal well-designed. That all takes a lot of pre-planning and ensure that you get it right. You don't start these trials peacefully because they are very large and they do require substantial investment. We are going to go about this methodically, carefully, and ensure we also are as fast to market as possible given the guardrails that I just mentioned. The last thing you want to do is rushing to phase three trials hastily and end up with problems on your hands. And we're not going to do that. So we think we're going about the right way. We think it's the prudent, but also ensuring that we ensure fast to market. And we're confident that we're on the right track right now. Great. Thank you so much. And then on the ARVO data. Jay, do you want to take that ARVO data? Yes. So.

So the model that was used was a retinal detachment model in animals. After retinal detachment is created, the photoreceptors will degenerate because there's no longer in contact with the retina pigment that's helium. And what you'll see from our data is that ice that was treated with rillinid had much less damage to the photoreceptors and their subsequent visual acuity than the control eyes that were not treated. This is a model for neuroprotection retinal detachment, technically a sub retinal fluid and you may be aware that sub retinal fluid is also a feature of wet macular degeneration and diabetic macular deema. So while this is a general model for neuroprotection, we think there will possibly unlikely be read through to the diseases that we're currently treating with EYP1901.

The model that was used was a retinal detachment model in animals. After retinal detachment is created, the photoreceptors will degenerate because they're no longer in contact with the retina-pigment pizelium. And what you'll see from our data is that eyes that were treated with rillinid had much less damage to the photoreceptors and their subsequent visual acuity than the control eyes that were not treated. This is a model for neuroprotection. Retinal detachment technically is sub retinal fluid and you may be aware that sub retinal fluid is also a feature of wet macular degeneration and diabetic macular deema. So while this is a general model for neuroprotection, we think there will possibly unlikely be re-through to the diseases that we're currently treating with EYP-1901. Thank you so much.

bio acids and then we do have a whole lot on the diet. Yeah, let me just let me make one quick comment. I'm gonna like take it from there. First of all, let me make an statement on this. The rally bio C5 is a acobody. It's a smaller, it's smaller than the large ligand blockers like I Leah that are on the market today. So I want to make that clear. It is not as big as a lot as an antibody.

So that's a key point. Second of all, I'm not going to claim this is going to be easy. It's not, but we do have a stellar scientific team. And they're already going to quickly begin working on this. So we'll see what happens, but I think this team is very, very well-versed in how to deal with this. And hopefully, we can be successful. Jay, you want to go ahead? Yes. So in order to get a drug to work in Dyrrister, there's a lot of different factors. The size of the molecule is really what helps to determine the payload. Obviously, bigger molecules, you're not going to be able to get as many into an insert. So that's one factor. Proteins in general tend to be great at body temperature. And that's why small molecules have been preferable. Our team is optimistic about our ability to deliver this affabody for an assistant release fashion. But until we really have some data to share.

I would say that, you know, again, we are optimistic, but as Nancy said, this is, you know, it has difficult path others have tried and with large molecules and not been able to achieve it, but we're optimistic. And do we have an idea of a heavy discloser when you could potentially hear an update on the progress of this program or? No, we're not going to get that right now, but it's way too early for that. Thank you. Thank you. Yeah. We're very excited about that. I said, and then just finally, can you remind us of the powering assumptions for W2 and specifically if the trial is positive and you hit that thing in terms of inferiority, could it potentially serve as one of the two pivotal studies? Yeah. Let me, we stay the same. I've just before, but I'm going to say it again. This is not powered for a, um, he value of point O five. I want to be very clear about that. And I've said that multiple times. We did not believe, first of all, you also have to go out longer in time. As you saw, the FDA just issued guidance on these phase three pivotal trial in wedding and D and they were very clear. You have to go out nine months.

You have to have two dose arms and a number of other things. The good news is, because we've had our type semen with the FDA, our plan phase 3 pivotal, which takes time I want to reiterate to plan for and develop the right doses and begin to produce the clinical supplies so that you're ready to go. We followed what the FDA said and based on the guidance that was just issued, we feel we are in a great spot in terms of our pre-planning that's occurred and we don't have to deviate at all. So that's the great news. But we do not expect that this will count as a pivotal. And again, why did we do that? Because...

These are expensive, large, global trials. I can point to any number of companies in this space. I shouldn't say any number, but a few, that went from phase one straight to pivotal and failed. You have to have a robust database. You've got to be confident in the data that you've got. And we look forward to the readout of our phase two. As I mentioned, we expect that to be 140 patients, coupled with our phase one, and what was done in the oral database, we think we'll have a robust database to make wise decisions going into pivotal studies. By the way, we do plan to run those both in parallel. And as a result, we still believe that we are in a great spot competitively to get to market in a fast way.

Can I just add one more comment to that. It really won't be a pivotal, and for reasons that Nancy stated, but I think if you look at our phase 2 design and say how will the pivotal differ, basically in just two ways, the major way that it's going to differ is we're going to do re-injection. And the second is the time. You know, the FDA asks for nine months after your study drug is injected at a minimum for efficacy, and they want to your safety. So this, we're having a read out in W2 of six months.

after 1901 goes in. So that's the, will be the, at least in the planning stage right now, the major differences between the phase two and the pivotals. This is great. Thank you so much. It's super helpful. And congratulations again on the progress. Thank you. Thank you. One moment for our next question. And that will come from the line of Jennifer Kim with Cancer Fitzgerald. Your line is open. Hey, everyone. Thanks for taking my questions. I have a few here, maybe to start off with timelines for 1901. I think you said that the date is coming by your end of this year. And I'm wondering, does that language?

stuff happened. So I'm always cautious in making any definitive statements, but right now we're happy with where we sit. And Benjay, why don't you take DME? So with respect to DME, we are looking at that trial in kind of a multi-pronged way. I mentioned already that we expect that to be the first trial that uses our state of the art injector.

And so we would like to, from a timing perspective, have that ejector ready to go with DME. That, again, may or may not be the right limiting step here, or other factors that certainly go into decisions, you know, strategically about when to start a trial and how large, et cetera. So we're still kind of working through that. I think we'll be able to nail down the stark time a little bit more later in this year. But right now it looks like two four-start. And as I said, one of the things we'd like to do along with testing 1901 and DME is literally give it a shot with a new injector. Okay, and then with Pavia, that like the timeline has seemed pretty consistent. Does that reflect anything in terms of what a sustained delivery treatment option could mean for a trial and how large it would be? For this kind of patient population, where I guess the onment needed it?

Pretty clear that you need sustained delivery? Yeah, I think the time of the reflection and time of getting patients in has much more to do with the type of patient that would enroll in an NPDR trial versus a WEDA-MD trial number one. And number two is interestingly, if you've got a patient with WEDA-MD is getting injections, do you ask them, do you have WEDA-MD or are you getting injections? The answer they're going to give is yes. If you ask a diabetic, what level of retinopathy do you have? They have no clue. And therefore, it's a little bit harder for the patients to get interested in the trial and even in some ways for the doctors to identify those patients, because in general, even retinal physicians in their office aren't documenting the diabetic retinopathy scale of their patients. So it means testing a wider net.

to get the appropriate ones. And so, you know, this is a new, you know, we have said before it's probably gonna take about a year to enroll but could be a trial. And, you know, as Nancy said, so far so good our enrollment's going great and the times that we have been talking about for full enrollment and beta readout are still consistent. Okay, and then my second question is, I think during your opening remarks, Nancy, you mentioned having like significant optionality in terms of the global pivotal program. Can you go more into that in terms of how you're thinking about enrollment? Yeah, so look our goal.

is to potentially get a partnership with a strategic partner. And we are in discussions with a number of them as we speak. So it obviously depends on the data, but that's our goal. We want to minimize the loot of financing. And our goal is to be able to go into those individuals with a partner. These are, these again, our large studies. Now we can do it ourselves if we need to, but our preference is to partner this with a large company or mid to large pharma companies. It's all the main ones. Most of you know who those are. And you know, again, it's going to be somewhat dependent. Obviously it's going to be dependent on the readout of our phase two data. So we do expect that anything announced, it should we be able to strike a deal will happen in the first half of 2024.

A data readout, as we said, is towards the end of 2023. Okay, that's helpful. And then my last question, a smaller question. Is there anything that drove the higher cost of sales for the quarters? Yeah, we have a great team. We're just going to say, and I've told our team this. First of all, we have a great product. UTQ is really a terrific product for patients with posterior segment UBIDA. The team is going to have a fantastic job. And they've done a fantastic job as well, reaching out to retinal specialists over and above just UBIDA specialists because they treat posterior segment inflammation as well. And UBIDA. So they've done a fantastic job. I just want to say it's a tribute to having a high quality team, a sound marketing plan, and how you go about talking about the product so that physicians start to realize where the opportunity is.

And the product continues to deliver in terms of efficacy and safety. It just continues to do very well. Now again, I always put caveats because drugs are funny things. Generally, we've got a great track record. We continue to have a great track record. Never come promise if something couldn't happen down the road. But right now, it just continues to look great. Scott, I'm going to ask if you want to add anything to that. That's thinking Nancy. I would reiterate a lot of the comments that you had. I think Jennifer, I heard your question correctly. You were asking about the change in the cost of sales. A lot of that is related to just investment, timing of investments that were made for various meetings and some of the ongoing trials that are going on such as the calm study.

Thank you and our next question will come from the line of Yale Gen with slave law your line is open.

Thank you and our next question will come from the line of Yale Gen with Leyva. Your line is open. Good morning and thanks for taking the question.

My first question in terms of new injector you are developing, could you provide a little more color in terms of the specific, so the benefit attributes that could provide it by this new device? Sure, Jay, go ahead on that. Let me just say that it really is a best in color. Well, my...

It's a state of the art for sure, and I would also say could be best in class. It's just a really, really nice injector. And we've obviously tested that with physicians and moving it, so Jay, you can take it from here. So the current injection system is based on the...

UT conjecture, which was developed well over a decade ago. It's essentially like a syringe with a plunger. And the doctor presses the plunger to get the inserts into the eye. With the state of the art injector, you have a trigger or a button that you press. And the mechanism within the injector delivers in a very controlled manner the inserts. Now remember, we can inject up to three inserts with a single injection. And we want to do that in a safe and controlled manner. This new injector system allows that. What it also will feature is a visual guide to the doctor that lets him or her know that all the inserts have been delivered. So it's in a very ergonomic package.

We're trying to minimize things like disposable items, minimize the size of the packaging, things that really physicians care about for stalking and the environment and things like that. So we're really looking at it kind of from a 360 perspective to provide retinal specialists and ophthalmologists something that they find to be easy, ergonomic, and very reliable even when delivering up to three inserts.

Okay, great. That's very helpful. Maybe two quick ones. The first one is in terms of the deal you announced yesterday. My question is why choose C5 versus other so confirmants, which are also in development? Is there any specific reason for that? Let me take that. Look, Rally Bios is a great company.

They've got a C5 that is validated in some of their other clinical trials. We like a lot of it also depends on the concern that you get the right term and you've got a good partnership. C5 and C3 both are validated targets. Right now I would say we're probably neutral between the two. So our goal was to work with a partner that we had a good collaboration with has a validated target and we are in sync. So I think this is simple as that and look it's a certainly well validated target. I think there's a lot yet to play out between the nuances between C3 and C5 but I want to state both of them are highly validated targets now.

We're still watching very carefully this space and looking at potentially other partnerships and other targets. Other companies are looking at membrane attack complex as a target, as well as complement factor B. And I think both of those are promising. They're clearly not as validated as either C3 or C5. But I don't think from a scientific perspective, you should view this partnership as we believe C5 is validated while C3 or the other ones are not. Not at all. We think that there may be multiple ways to block compliments successfully here. And what we can provide is that zero-order kinetics sustained release, fewer injections, and perhaps because of zero-order kinetics better results.

Okay, great. My last question here is that given UT has a pretty robust border sales. And should we anticipate at least from modeling perspective that 2023 quarterly that will be the fourth quarter number will be a baseline moving forward for 2023? Yeah, first of all, I'm going to reiterate Yale. We don't give guidance. We never have and we're not going to start. Second of all, and by the way, just take the pandemic as a case in point. So in terms of being able to project guidance.

The other issue is that remember, in Medicare Part B drugs, and frankly, probably a lot of Medicare Part D as well, you end up with quarterly to quarterly fluctuations. So first quarter, oftentimes, is lower in most categories of drugs, is lower than fourth quarter of the prior year. And the reason is because insurance resets copays kickback in again. And so patients can, and also you get holiday bills coming in. So what we find is first quarter, patients tend to skimp on their their drug utilization. That being said, we are looking great in first quarter. And we do expect 2020, three overall will be higher than 2022. But I'm not going to sit here and project quarter by quarter by quarter because again, this is a category in Medicare Part B where copays kick in and first quarter can oftentimes.

be a little weaker than fourth quarter. But again, you want to look near over near quarter over yearly quarter, and we expect to continue to have slightly higher highs each quarter over prior year's quarter. OK, great. That's very, very helpful and congrats on all the progress. Yeah, thank you. Thank you. One moment for our next question.

And that will come from the line of EHN with HCW, your line is open. Thank you for taking my questions. Just to clarify, was there any sales product revenue from DEXQ in the false quarter? By George, you want to comment on that? Yeah, there was. We still had DEXQ for, but it dropped off meaningfully. Thank you.

from the up or the year we'll file the cane next week with the receipt. Do you expect any further impairment charge? No, so if you look at the results this morning and you'll see that we've recorded a full impairment of the DEXICU intangible.

And to the earlier question, there was a little bit of incremental inventory that we reserve So from a financial perspective, we start 2023 with a clean slate as it relates to Dexakia. Okay, was there an increase in the price for Yutik?

Yeah, we always have very, very modest price increases. But again, we always take very modest ones. And George, if you want to just comment what we took in 2022, but again, we typically say way below inflation, they're very, very modest. Yeah, I think you just, most of the vast majority of the revenue increase for UTIC is demand, and you could see that in the...

and the details quarter over quarter of the team continues to do incredibly well with that product and price is a very small piece of that. Lastly, shall we expect the gross margin for 2023 to return to the levels observing the third quarter or second quarter of 2022? I would say that you take that carry a much higher margin than DEXAQ so I would expect margins to improve as it relates to just that because it will largely be just that product in 2023. Again, we're not giving full guidance on that but you know, safe to say that and we expect margins to improve because of the waiting higher to the U.T.

quarter of a quarter of the team continues to do incredibly well with that product. And price is a very small piece of that. Got it. And lastly, so should we expect the gross margin for 2023 to return to the levels observing the third quarter or second quarter of 2022? So I would say that, you know, you take that carry a much higher margin than DEXAQ, so I would expect margins to improve as it relates to just that because it will largely be just that product in 2023. Again, we're not giving full guidance on that, but you know, state to say, safe to say that, and we expect margins to improve because of the waiting higher to the U.T. perspective. Okay, thank you.

Thank you. I'm showing no further questions in the queue at this time. I would like to turn the call back over to management for any further remarks. I want to thank everybody for your time. I again want to reiterate, reiterate I'm very proud of our progress. We are very keenly focused on executing methodically and we expect to have hopefully a good year in 2023. So thank you very much. We look forward to keeping you all updated as we continue to make progress especially on our phase 2 clinical programs. Thank you. Thank you all for participating. This concludes today's program. You may now disconnect. Thank you.

I.

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Good day and welcome to the I point pharmaceuticals fourth quarter and full year 2022 financial results conference call. At this time all participants are no listen only mode. After the speaker presentation there will be a question and answer session. To ask a question during the session you will need to press star one one on your telephone. You will then hear an automated message advising that your hand is raised.

So with draw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker, Mr. George Elston, Chief Financial Officer. Please go ahead. Thank you, and thank you all for joining us on today's conference call to discuss I point pharmaceuticals, fourth quarter and full year 2022 financial results and recent corporate developments. With me today is Nancy Lurker, Chief Executive Officer, Dr. Jade Dukeer, President and Chief Operating Officer, and Scott Jones, Chief Commercial Officer. Nancy will begin with a review of recent corporate updates.

Dr. Dukeer will then discuss pipeline developments, and Scott will comment on our commercial activities. I will close with commentary on the fourth quarter in full year 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 in recent corporate developments. We will then open up the call for your questions.

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

Before we begin our formal comments, I'll remind you that various remarks we will make today constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Security's litigation reform act of 1995. 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. Actual results made different materially from those indicated by these forward-looking statements as a result of various important factors.

including those discussed in the risk factor section of our most recent annual report on Form 10K, which is on file with the SEC, and in other filings that we may make with the SEC in the future. Any forward-looking statements represent our views as of today only. While we may elect to update these forward-looking statements at some point in the future, we specifically display any obligation to do so, even if our views change. Therefore, you should not rely on these forward-looking statements as of representing our views, as of any date subsequent to today. I'll now turn the call over to Nancy Lurker, Chief Executive Officer of I-Point Pharmaceuticals. Thank you, George. Good morning, everyone, and thank you for joining us. As 2022 was really an exceptional year for I-Point Pharmaceuticals.

We continue to execute on our goal of being the leader in innovative, sustained, off-grid or drug delivery using our best-in-class, DERRASER technology to achieve improved outcomes with more convenient dosing regimens. I'll begin by reviewing our LEED development program, EWAP 1901, and why we believe this therapies, 6-9-month treatment intervals, zero-order kinetics, and new off-grid mechanism of action could be a game-changer in retinal diseases like wet AMD that require lifelong treatment. EWAP 1901 is a bioreodable DERRASER-D insert they deliver sprawling them. A selected and patented.

Tyrosine kinase inhibitor delivered through a single intra-vitro injection in the physician's office. We have advanced EYP 1901 into two, phase two clinical trials in wet AMD, and non-prolifitive diabetic retinopathy, otherwise known as NPDR. Based on the positive dove, you'll phase one clinical trial result that we reported last year. EYP 1901 has emerged as a promising potential therapeutic for serious eye diseases, bringing key attributes to patients, including delivery of the active drug grown-up consistently over six to nine months with the majority of patients not requiring any supplemental therapy up to six months after a single treatment in wet AMD. A new mechanism of action to treating retinal eye diseases beyond the current anti-vegetics ligand blockers on the market today.

The potential for neuroprotective and antibiotic benefits to the retina. A proven drug delivery technology was a very positive safety profile. And upon completion of our Phase 2 trials, and importantly, EYP 1901 will have the most robust clinical data for any ocular TKI programs, with over 180 patients having been dozed by the end of our Phase 2 programs in both WEDAMB and NPDR. This is in addition to a strong off-the-the-staype at efficacy data set from clinical trials of Verolinids delivered orally in previous trials treating over 150 patients.

CYP 1901 delivers the TTI role in it, which potentially brings a new mechanism of action to retina disease beyond what currently exists with the current anti-dead Jeff large molecule therapies on the market today. When you look at treatment regimens outside ophthalmology, it's often standard practice to address multiple mechanisms of action in parallel in order to improve efficacy. We believe these retinal eye diseases with serious consequences such as blindness should be treated using all resources at our disposal as well.

through a multi-pronged approach that targets multiple disease drivers. Additionally, UIP 1901 sets itself apart by using our proven, best-in-class bio-rotable DERRASER technology for drug delivery, which delivers the drug at zero order kinetics, which provides constant steady dosing over six months for longer. Dr. J. Dukeer, what would you UIP 1901's potential? You need clinical advantages for patients in more detail later on this call. But of note, we look forward to presenting pre-clinical neural protection data from a gold standard mouse model of retinal detachment at the 2023 RVO annual meeting in April .

Beginning with WED AMD, the current standard of care requires monthly or by monthly eye injections of live and locking anti-bedure biologics, which can be cumbersome and unpleasant patients, as is very difficult for patients to maintain this routine to the rest of their lives. Importantly, we know from robust databases that even one missed or skipped appointment could mean vision loss for the patient. The current standard of care requires monthly or by monthly eye injections of live and locking anti-bedure biologics, which can be cumbersome and unpleasant patients, as is very difficult for patients to maintain this routine to the rest of their lives.

The positive phase when dovidal clinical trial results support our treat to maintain therapeutic approach for this disease with the potential to transition a majority of patients to an every six months treatment with E-Wedding 1901.

This can fundamentally change the way physicians treat this disease and manage patients by having drug consistently delivered providing treatment, which we are confident will enhance patient compliance and improve clinical experience. We are actively enrolling patients in the Phase 2 W2 clinical trial of E-WETT 1901 as a potential six months maintenance treatment for WETMD. This is a massive multi-billion dollar market opportunity with millions of patients in need of new treatment.

for the blind and eye disease. And we aim to bring a life changing treatment to these patients with E-web P901. W-2 is a randomized, a flip intercept control, also known as L-L-F trial, enrolling approximately 144 previously treated patients. To our knowledge, this is the largest phase 2 trial being conducted in Radiant WEDMD among TKI treatments. We anticipate announcing top line six months results, results, excuse me, late in the fourth quarter of this year.

The phase 2 pavilla clinical trial presents a compelling and proactive potential therapy for the treatment of non-policative diabetic retinopathy. The approved large molecule anti-vegetal biologic to treat NPDR require frequent injections just like what AMD for this disease where patients may not feel symptoms and as a result may forego regular treatment. In fact nearly 97% of NPDR patients receive no course of treatment.

apart from observation by the retinal specialist until the disease progresses to vision loss. Consequently, there's a great unmet need in NPDR patients for a safe, efficacious, and convenient treatment option that would maintain patient vision proactively through zero order of constant dosing. With EYP 1901, we have the opportunity to potentially fulfill this need within every nine months sustained delivery treatment option for patients that align with their office visits and provide patients and physicians with the comfort of having sustained drug delivery during the period between office visits. The PVA clinical trial remains on track to complete enrollment.

evaluating diabetic macular edema for DME in late 2023 or early 2024 timeframe. Importantly, I point continues to remain actively engaged in expanding our sustained off-ditter delivery pipeline beyond EYP1901.

We continue to evaluate molecules for potential use in our DuraSert technology, which can be tailored to each drug and disease indication for future growth. We're very excited because this week we also announced research collaboration with rally bio to evaluate their C5 complement inhibitors using our proven DuraSert technology to develop a sustained delivery treatment option for geographic atrophy. We're very excited to update you on this evaluation over the common quarter and Dr. Duka will talk further about that as well.

Turning now to our commercial results, UT continues to demonstrate strong customer demand in the fourth quarter of 2022, which resulted in a very compelling 55% increase in UT in net product revenue compared to Q4 of 2021. At the upcoming 2023 Arval Annual Meeting, we will present three abstracts discussing our UT Calm Study, which is a Phase IV multi-center registry study and a collaboration between I point and the Cleveland Clinic. Scott, our Jones, our Chief Commercial Officer will provide additional detail on this topic later on, but I'd like to recognize our commercial team for delivering on yet again another strong quarter.

and a strong year of product revenue for UTQ and for I point. Additionally, we're excited to share that in partnership with Occupy mentioned Therapeutics, UTQ launched in China in the fourth quarter of 2022. This commercial launched marks an important milestone in furthering our mission of improving the lines of patients with serious eye disorders around the world, and we're very pleased to partner with Occupy mentioned. To expand UTQ's global reach in the emerging Chinese market.

Finally, we completed a number of other significant corporate milestones in recent months. This February , we entered into a lease agreement to a construction of a commercial manufacturing facility to support global product supply, EYP-1901 and UT. The lease is for a 40,000 square foot standalone facility in Northbridge, Massachusetts that will be built to our specifications. I point with awarded 1.9 million of state and local grants for this facility and I've known lease payments not commencing until completion of construction, which is anticipated in the second half, 2024. This investment reflects the confidence we have in EYP-1901's potential.

for clinical and commercial success. And this level of control over our supply chain will provide an important point of value differentiation for UT, and we hope eventually EYP 1901 in the years to come. In January of this year, we were also delighted to promote J. S. Duke or MD to the additional role of President.

Dr. Duke, I served as a chief operating officer since November of 2021. And in this expanded role, he will continue to do these chief operating officer and now will also oversee regulatory affairs. Jay has been a tremendous asset to our team since he joined the COO and we look forward to continuing to benefit from his deep, upsellic expertise as an expert in retinal surgery and strong leadership in his new role as president. I'll now turn the call over to Dr. Jay Dukeer, our president and chief operating officer.

to provide an update on our LEED program EYP 1901, as well as other pipeline initiatives. Jay. Thank you, Nancy, and good morning, everyone. Before I begin, I'd like to reiterate what important point this is in I-Point's journey. Our team is positioned to execute on multiple catalysts this year, as we advance our Phase II clinical programs in growing pipeline opportunities. They will be available in the case of our

I am also incredibly grateful to Nancy and the Board of Directors to allow me to take on a new leadership role at I point as president in addition to chief operating officer. I will begin with reviewing why, as a practicing retinal physician, I'm incredibly excited about the potential of treating patients with EYP1901 and why it represents a potential huge leap forward in this space before reviewing our clinical data and our Phase II programs in progress.

Turning to our lead product, Candidate. EYP 1901 is an investigational, sustained release therapy that uses a biodeurotable formulation of our DERRICER technology, which we are now referring to as DERRICER-E for irritable. With Verolinib, a tyrosine-kindness inhibitor that acts through intracellular binding of all vascular and defileal growth factor or VEDGEF receptors.

thereby blocking all VGEF-IS reforms. The rolling of differentiated MOA versus the standard of care ligand blockers may provide additional treatment benefits beyond anti-vGEF activity with extended longevity between treatments, such as neuroprotection.

And we plan to share preclinical data from a mouse model of retinal detachment that suggests this differentiated advantage at the 2023 Arvo Annual Meeting next month. Additionally, compared to other TKI's, Rowland had features reduced off-target binding, specifically minimal activity against TIE II, leading to a potentially improved safety and efficacy profile. Bioirotable DERRICER E, a miniaturized injectable insert is the same technology used in the non-irotable products like you keep.

anatomy in the majority of LED patients with a single injection of EYP1901 for an interval of six months or longer.

By providing the sustained delivery therapy and the new mechanism of action, patients and practitioners can potentially have the flexibility to safely reduce the number of visits to the retina specialist. Last summer, we reported positive 12-month safety and efficacy results at the American Academy of Ophthalmology meeting in Chicago, with the Phase 1W trial evaluating EYP-1901 and previously treated WEDAMD.

The Dadiotrial enrolled 17 patients and each received a single in office intervention of the YP1901 at one of four different dose levels. All enrolled patients were previously treated with standard of care antipagetive therapy. No re-injection with the study drug was performed during the trial and typical criteria for supplementation with a standard of care antipagetive was employed. We were pleased that the 12-month data featured no reports of popular SAE's or drug-related systemic SAE's.

No reported events of the trees floaters and Dr. Midas, retinal detachment, insert migration into the interchamber, retinal vasculitis, post-year segment inflammation, or retinal vascular inclusive events. In November 2021, we presented six month data that confirmed stable, best corrected visual acuity with a change from baseline of only minus 2.5 ET jarous letters. Coupled with a stable, macular anatomy as the central subfield that this change on OCT was only minus 2.7 microns. After a single injection of VWIP 1901, 53% of eyes were supplement free up to six months.

And up to one year, one-third of ice were supplemental antivigia, Jeffrey. Additionally, they're continued to be clinically significant treatment burden reduction of 73% of 12 months compared to 75% at the six month visit. On the heels of these positive data, we initiated two separate phase two clinical trials of the WIP-1901, one for the treatment of wet age-related macular degeneration called WO2, and one studying the drug a non-proliferate diabetic retinopathy or NPDR called the Pavilla study.

The DOVIO2 trials expected to enroll approximately 144 wedding patients previously treated with a standard of care anti-vigia therapy and randomly assigned to one of two doses of EYP1901, approximately two milligrams or approximately three milligrams. This is versus an unlabeled up liver septic control. EYP1901 is delivered with a single intra-vigial injection in the physician's office, similar to current FDA approved anti-vigia treatments. The primary efficacy endpoint of the DOVIO2 trial is non-inferiority of the change in visual acuity compared to the liver septic control as measured at six months after the EYP1901 injection. Secondary efficacy endpoints include change in CST as measured by OCT time to first supplement the recommended Server?

reduction in treatment burden and safety. We look forward to progressing the W02 trial and anticipate top-line results in the fourth quarter of 2023. Turning to non-perliant diabetic retinopathy or NPDR, it is a very common disease affecting almost one-third of diabetic adults over the age of 40 and is projected to impact over 14 million Americans by 2050.

and treatment burden and safety. We look forward to progressing the W02 trial and anticipate top-line results in the fourth quarter of 2023. Turning to non-perliferative diabetic retinopathy or NPDR, it is a very common disease affecting almost one-third of diabetic adults over the age of 40 and is projected to impact over 14 million Americans by 2050. In NPDR, blood vessels are weakened.

potentially leading to swelling of the macula, called diabetic macular d-multordia-me. In some cases, growth of abnormal retinal blood gussles, or prolific diabetic retinopathy, also called PDR. If left unchecked, NPDR can be the harbinger of severe visual loss. Because the currently approved therapies for NPDR require a significant visit and treatment burden, 97% of NPDR patients are currently observed. This provides a significant market opportunity for EYP 1901, which may be able to effectively be delivered at nine months intervals or longer in NPDR.

As a practicing retinus specialist, I would be excited to have a safe, effective, and tolerable, sustainably therapy to prevent the complications of NPDR. The first patient was dosed in the Phase II, the via trial of EYP1901 for the treatment of NPDR in September of 2022. This trial was 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, which will receive a sham injection. In this trial as well, EYP1901 is delivered with a single

The primary efficacy endpoint of the trial is improved of at least two diabetic retinopathy severity score levels at week 36. Secondary endpoints include the occurrence of DME and or PDR, retinal ischemia, and non-perfusion as well as safety. We remain on track to complete trial enrollments in the fourth quarter of 2023. Finally, we look forward to initiate a third phase to clinical trial evaluated EYP 1901 and DME later this year or early next year. And we continue to evaluate potential product candidates through internal discovery efforts, research collaborations.

and in licensing arrangements to continue to build our pipeline. As Nancy noted, we announced an exciting collaboration with Rally Bio to evaluate their C5 complement inhibitor and R-dorusar technology. We have been actively evaluating complement inhibitor mock grills for use in our drug delivery technology as we see a significant opportunity to provide a sustained delivery treatment for geographic atrophy and potentially earlier forms of dry end date. Similar to our approach with the YP1901 by providing constant dosing of drug over time, we hope to see improved outcomes and reduce treatment burden for patients. In summary, we are very proud of the clinically validated results we've seen from the Phase I trial of the YP1901 and we were excited to provide updates on the Phase II W and the Viatrials.

as well as pre-clinical data on the role and its differentiated mechanisms of action in the years to come. I will now turn the call over to Scott Jones, Chief Commercial Officer for the commercial update. Scott? Thank you, Jay. We're excited to report a strong year for our commercial business with 39.9 million of net product revenue. A 13% increase compared to 2021.

Our Q4 and that product revenue for UTQ was 9 million compared to 5.8 million for the fourth quarter and in December 31st, 2021, a 55% increase. UTQ was approximately 980 units compared to approximately 890 units for the third quarter of 2022, a 10% increase. We were pleased with the continued customer demand increase for UTQ based on continued utilization by our retinal physician. And consistent messaging from our marketing and sales teams.

We continue to collect real world data on the benefits of UT for the treatment of chronic non-infectious posterior segment UVitis in the Phase 4 Calm Registry Study, which is conducted in collaborative collaboration between the eye point and the Cleveland Clinic. Data from the UT Calm Registry Study were presented in poster presentation by Dr. Puyah Dianne at the Retinoc Society's 55th Annual Scientific Meeting in November 2022. And we look forward to presenting an additional update from the Calm.

study and three abstracts at the 2023 Arvo Annual Meeting next month. As Nancy previously mentioned, in partnership with Occupy mentioned therapeutics, you take commercially launched in China at the end of last year. Since it's approval in the US over four years ago, I point has been able to deliver the innovative, ocular therapy to patients and provide an improved standard of care for patients with up to three years of continuous control in chronic non-infectious UVI, as affecting the posterior segment of the eye. We look forward to continuing to partner with our dimension and expand UTX Global Reach in China as we work together to improve the lives of patients with serious items of disorders around the world. We're very pleased by the strong 2022 performance and expect a profitable UTX franchise in 2020.

million compared to net product revenue for the quarter ended December 31, 2021 of 11.2 million.

Despite strong year-over-year performance by UTIC, total net product revenues were impacted by the anticipated loss of past-reinversement for DEXICU at the end of 2022. Net revenue from royalties and collaborations for the quarter ended December 31, 2022 totaled 0.6 million compared to 0.3 million in the corresponding period in 2021. Operating expenses for the quarter ended December 31, 2022.

So 54.3 million compared to 29.6 million in the prior year period. This increase was primarily driven by a one-time 20.7 million dollar non-cash impairment charge of the intangible asset associated with DEXICU due to the loss of pass-through reimbursement by the Centers for Medicare and Medicaid, effective January purpose 2023.

Further, there was a $6.6 million increase in R&D expense and a $4 million increase in the cost of sales. This was lost by a $1.9 million decrease in sales and marketing expense and a $0.7 million decrease in G&A expense. Non-operating income net totaled $0.3 million and net loss was $43.5 million or $1.16 per share compared to a net loss of 19.4 million. Or $0.59 per share for the prior year period. Turning to the full year ended December 31, 2022, total net revenue was $41.4 million compared to $36.9 million for the full year ended December 31, 2021. Net product revenue for the full year ended December 31, 2022 was $39.9 million compared to net product revenues for the full year ended December 31, 2021 of $35.3 million.

Net revenue from royalties and collaborations for the full year ended December 31, 2022, totaled 1.5 million compared to 1.6 million in the corresponding period in 2021. Operating expenses for the full year ended December 31, 2022, totaled 141 million versus 92.2 million in the prior year period. This increase was primarily driven by a one-time $20.7 million non-cash impairment charge of an intangible asset associated with DEXICU, which was due to the loss of past the reimbursement by CMS effective January 1, 2023. Further, there was a $21.1 million increase in R&D expense, a $9.2 million increase in GNA expense, and a $1 million increase in cost of sales. This was offset by a $2 million increase in sales and marketing expense, non-operating expense net totaled 2.6 million.

million and net loss was 102.3 million or $2.74 per share compared to a net loss of 58.4 million or $2.3 per share for the prior year period. Cash, cash equivalence and investments in marketable securities at December 31st, 2022, totaled 144.6 million compared to 211.6 million at December 31st, 2021. We expect the cash on hand at December 31st, 2022 and expected net cash in close from our product sales will enable us to fund our current and planned operations into the second half of 2024. In conclusion, we are pleased with I-Points progress in 2022 and are well capitalized to advance our product pipeline to key value and flexion points later this year. I will now turn the call back over to Nancy for closing remarks.

Thank you, George. We trust this review has given you a greater understanding of I-Point progress over the past year and our potential moving forward. Over the past year, we've executed the plan and our achievements form the foundation for future growth. This is a highly experienced management team and we are keenly focused on delivery results on executing well. BioTech is a rewarding but risky business and it requires well thought out and methodically executed planes.

2023 promises to be another productive and rewarding year for eye-point pharmaceuticals as we continue to execute on multiple clinical catalysts and strengths in our commercial business. Over the coming year, we expect to complete enrollment in the Phase 2W2 trial of UIT 1901 and Wedding and B and in the Phase 2 Paviatrial, UIT 1901 in non-pulipative diabetic red novities. We expect to dose our first patient in the Phase 1 clinical trial of UIT 1901 and B and in the later this year or early next year. We expect to report top line six months data for our Phase 2W2 clinical trial.

We expect to publish neuroprotective preclinical data for EYP 1901 using growl in it. We continue to grow revenue for YouTube. We've had a great year and we have a terrific team and we're confident that I point we'll continue to execute. So the forward to keeping you all updated is the advanced value creating milestone.

Before opening the call to your questions, I do want to note how grateful I am for a fantastic team that I point pharmaceuticals who continue to drive our progress and are responsible for our company's clinical operational and financial success to date. We've made tremendous progress as I mentioned in the last year and we're excited and motivated to advance the future of sustained off-year drug delivery to benefit. Most importantly, some millions of patients who are at risk of serious vision loss. Thank you all very much for listing this morning and I'll now turn it over to the Operator for questions.

Your questions, I do want to note how graceful I am for a fantastic team at I point pharmaceuticals who continue to drive our progress and are responsible for our company's clinical operational and financial success to date. We've made tremendous progress as I mentioned in the last year and we're excited and motivated to advance the future of sustained off your drug delivery to benefit. Most importantly, the millions of patients who are at risk of serious vision loss. Thank you all very much for listening this morning and I'll now turn it over to the operator for questions. Thank you.

Thank you. As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. So withdraw your question, press star 11 again. One moment for our first question. And our first question will come from the line of yet in Suneha with Guggenheim. Your line is open. Yeah, good morning. This is Eddie Young for Yachton. Thank you so much for taking my questions. We can grab from all the progress. How soon after the phase two data in 4Q, do you think you'd be able to initiate a Pizzo program? And is there any other non clinical or device work you need to do?

And then if you could give us a little bit more color on what we should be looking for in the R-Vote Neuroprotection data and how it might correlate to human patients and what might add as benefit that might have for 1901 in the future. Thank you so much. Jay, what if you take that question or those two questions? Sure. Hi, Eddie. Thanks for the questions. First, pending the outcome of the data at the end of this year, we would expect to be able to initiate the pivotal trials in the second half of 24.

The other questions were about injector, I believe. Any other device worker, nonclinical? There is. I think as we've stated many times publicly, we're developing a new patent, patented state of the art injector that we expect to be used in the Bivyl trials and commercially. We anticipate using that injector in our DME trial was the first trial.

that it rolls out, that still has some work to be done. While we're pleased with the current injection system, it's working quite well. We do like to update it with a state of the art injector. And if need be, we would not delay the pivotals if there's any issue with the development of the new injector. But so far the development is going smoothly and we're on to...

on the key that we would actually start right away with that, so we're ready to go with the current injector that we're using on phase two studies, and that's working just fine, and we can easily do a bridging study should we need to. So we are well prepared to go forward with our phase three hospitals, regardless, and we're on track. I also just want to say for a list of a couple of things. Number one, getting ready for phase three takes a lot of pre-planning.

You have to have clinical supplies ready to go and well developed. Not only the injector, but the actual implants itself. You have to have an end of phase two meeting with the FDA. You have to have made sure that you've got your Pivotal well designed. That all takes a lot of pre-planning and ensure that you get it right. You don't start these trials hastily because they are very large and they do require substantial investment. We are going to go about this methodically, carefully and ensure we also.

are as fast to market as possible given the guard rails that I just mentioned. The last thing you want to do is rushing to phase three trials hastily and end up with problems on your hands. And we're not going to do that. So we think we're going about it the right way. We think it's the prudent, but prudent, but also ensuring that we ensure fast to market and we're confident that we're on the right track right now.

Great, thank you so much. And then on the Arvo data? J.A. Do you want to take that Arvo data? Yes. So the model that was used was a retinal detachment model in animals. After retinal detachment is created, the photoreceptors will degenerate because they're no longer in contact with the retinal pigment pizelium. And then on the Arvo data, the photoreceptors will degenerate because they're no longer in contact with the retinal pigment pizelium.

And what you'll see from our data is that ice that was treated with Rolunid had much less damage to the photoreceptors and their subsequent visual acuity than the control ice that were not treated. This is a model for neuroprotection.

Retinal detachment, technically, is sub-retinal fluid. And you may be aware that sub-retinal fluid is also a feature of wet macular degeneration and diabetic macular dima. So while this is a general model for neural protection, we think there will possibly unlikely be re-through to the diseases that we're currently treating with EYP-1901.

Thank you. One moment for our next question. And that will come from the line of Georgie Jordanoff with Cowan. Your line is open. Thank you.

Hi everyone and congratulations on all the progress. Thank you for taking our questions. So maybe starting with the Rally Bio partnership, we didn't notice they have two C5 assets based on the AFSI body platform. Maybe can you talk about the requirements?

of putting a large protein into the dirusse. Maybe talk about why some previous attempt to develop long-acting senses, or Ilya, have not been successful. And in general, what gives you confidence that you'll be able to formulate it with one of RELA bio-assets? And then we do have a follow-up on the data trail. Yeah, let me just make one quick comment. I'm gonna like, Jay, take it from there.

First of all, let me make an statement on this. The Rally Bio C5 is a acobody. It's a smaller than the large ligand blockers, like I lea that are on the market today. So I wanna make that clear. It is not as big as an anti-body. So that's the key point. Second of all, I'm not going to claim this is going to be easy. It's not, but we do have a stellar scientific team and they're already going to quickly begin working on this. So we'll see what happens, but I think this team is...

very, very well-burped in how to deal with this. And hopefully, we can be successful. Jay, you want to go ahead? Yes, so in order to get a drug to work in Dyrister, there's a lot of different factors. The size of the molecule is really what helps to determine the payload. Obviously, bigger molecules, you're not going to be able to get as many into an insert. So that's one factor. Proteins in general tend to degrade at body temperature, and that's why small molecules have been preferable. Our team is optimistic.

about our ability to deliver this affabody for an assistant release fashion. But until we really have some data to share, I would say that, again, we are optimistic, but as Nancy said, this has difficult path, others have tried and with large molecules and not been able to achieve it.

but we're optimistic. And do we have any idea of heavy disclosed when you could potentially hear an update on the progress of this program? Or...

No, we're not going to give that right now. It's way too early for that. Thank you. Thank you. We're very excited about that. I said, and then just finally, can you remind us of the powering assumptions for W2 and specifically if the trial is positive and you hit that sick in terms of inferiority, could it potentially serve as one of the two pivotal studies? Yeah, let me, we've stayed this before, but I'm going to state it again.

This is not powered for a P value of .05. I want to be very clear about that. And I've said that multiple times. We did not believe, first of all, you also have to go out longer in time, as you saw, the FDA just issued guidance on these Phase 3 Pivotal Trials in Wedding and D. And they were very clear. You have to go out nine months. You have to have two dose arms.

And a number of other things, the good news is, because we've had our type seeming with the FDA, our plan phase 3 pivotal, which takes time, I want to reiterate, to plan for and develop the right doses and begin to produce the clinical supplies so that you're ready to go. We followed what the FDA said, and based on the guidance that was just issued, we feel we are in a great spot in terms of our pre-planning that's occurred, and we don't have to deviate at all, so that's the great news.

But we do not expect that this will count as a pivotal. And again, why did we do that? Because these are expensive, large global trials. I can point to any number of companies in this space. I shouldn't say any number, but a few that went from phase one straight to pivotal and failed. You have to have a robust database.

You've got to be confident in the data that you've got. And we look forward to the readout of our phase two. As I mentioned, we expect that to be 140 patients coupled with our phase one. And what was done in the oral database, we think we'll have a robust database to make wise decisions going into pivotal studies. By the way, we do plan to run those both in parallel. And as a result, we still believe that we are in a great spot competitively to get to market in a fast way.

Can I just add one more comment to that. It really won't be a pivotal for reasons that Nancy stated, but I think if you look at our phase 2 design and say how will the pivotal differ, basically in just two ways, the major way that it's going to differ is we're going to do re-injection. And the second is the time. You know, the FDA asked for nine months after your study drug is injected at a minimum for efficacy and they want to your safety. So this we're having a read out in W of two of six months after 19 of one goes in. So

That's the, will be the, at least in the planning stage right now, the major differences between the phase two and the pivotals. This is great. Thank you so much. It's super helpful. And congratulations again on the progress. Thank you. Thank you. One moment for our next question. And that will come from the line of Jennifer Kim with Cancer Fitzgerald. Your line is open. Hey everyone. Thanks for taking my questions. I have a few here, maybe to start off with.

timelines for 1901. I think he said that the date is coming by your end of this year, and I'm wondering, does that language reflect anything in terms of, I guess, like what you're seeing in terms of enrollment? And then, same with Pavia, that seems all on track. So how does enrollment look for that trial? And then, DME, I think that timeline, you said later this year or early next year. Is there anything that sort of like pushed that timing? Thanks.

So let me answer first. I'm going to take the DME. So first of all, we are happy with our current enrollment rate. We're on track. We still expect barring any unforeseen circumstances that we will have a readout in the later this year. Now again, I just want to stuff happen. So I'm always cautious in making any definitive statements. But right now, we're happy with where we sit. And Benjay, why don't you take DME? So with respect to DME, we are looking at that trial.

and kind of a multi-pronged way. I mentioned already that we expect that to be the first trial that uses our state-of-the-art injector. And so we would like to, from a time in perspective, have that injector ready to build a DME.

That, again, may or may not be the right limiting step here, for other factors that certainly go into decisions, you know, strategically about when to start a trial and how large, et cetera. So we're still kind of working through that. I think we'll be able to mail down the start time a little bit more later in this year, but right now it looks like two four-start, and as I said, one of the things we'd like to do along with testing 1901 and DME is literally give it a shot with a new injector. Okay, and then with Pavia, that, like, the timeline has seemed pretty...

consistent. Does that reflect anything in terms of what a sustained delivery treatment option could mean for this kind of patient population? Or I guess the unmet need it. Pretty clear that you need sustained delivery? Yeah, I think the time of the reflection and time of getting patients in has much more to do with the type of patient that would enroll in an NPR trial versus a WEDA M.D. trial number one.

because in general, even retinal physicians in their office aren't documenting the diabetic retinopathy scale of their patients. So it means testing a wider net of patients to get the appropriate ones. And so, you know, this is a new, you know, we have said before it's probably going to take about a year to a growl that could be a trial. And, you know, as Nancy said, so far so good our moment's going great in the...

the times that we have been talking about, for full enrollment, and beta readout are still consistent. AMI GodCHUCK Paying ???is,

Okay, and then my second question is, I think during your opening remarks, Nancy, you mentioned having like significant optionality in terms of the global pivotal program. Can you go more into that in terms of how you're thinking about all of that? Yeah, so look, our goal.

is to potentially get a partnership with a strategic partner. And we are in discussions with a number of them as we speak. So it obviously depends on the data, but that's our goal. We want to minimize diluted financing and our goal is to be able to go into those individuals with a partner. These are, these again are large studies. Now we can do it ourselves if we need to, but our preference is to partner this with a large company or mid to large pharma companies.

It's all the main ones. Most of you know who those are. And you know, again, it's going to be somewhat dependent. Obviously, it's going to be dependent on the readout of our phase two data. So we do expect that anything announced, should we be able to strike a deal will happen in the first half of 2024, a data readout, as we said, is towards the end of 2023. Okay, that's helpful. And then my last question is smaller question.

and they've done a fantastic job as well reaching out to retinal specialists over and above just UBI to specialists because they treat posterior segments inflammation as well and UBI to so they've done a fantastic job I just want to say it's a tribute to having a high quality team a sound marketing plan and how you go about talking about the product so that physicians start to realize where the opportunity is.

And the product continues to deliver in terms of efficacy and safety. It just continues to do very well. Now again, I always put caveats because drugs are funny things. Generally, we've got a great track record. We continue to have a great track record. Never can promise that something couldn't happen down the road. But right now, it just continues to look great. Scott, I'm going to ask if you want to add anything to that. That's thinking Nancy. I would reiterate a lot of the comments that you had. I think Jennifer, I heard your question correctly. You were asking about the change in the cost of sales. A lot of that is related to just investment, timing of investments that were made.

for various meetings and some of the ongoing trials that are going on such as the CALM study, etc. So it was really that was more of a timing issue. Okay. All right. Thanks for taking my questions, guys. Thank you. One moment for our next question. This is George just to clarify and cost the sales to Jennifer's question. The big driver, you take as a bigger mix because of the drop off index of Q and cost this fails and Q4 in particular was impact.

impacted by a slate provision for remaining Dexacue inventory because of that drop-off. We don't expect that to continue 23 forward. The items that Scott talked about are below the cost of goods line, just to clarify for the colors. Thank you. Our next question will come from the line of Yale Gen with Leyva. Your line is open. Good morning and thanks for taking the questions. My first question is in terms of the new injector you are developing.

Could you provide a little more color in terms of the specifics or the benefit attributes that could provide it by the new device? Sure, Jay, go ahead on that, but let me just say that it really is a best in well.

It's a state of the art for sure, and I would also say could be best in class. It's just a really, really nice injector. And we've obviously tested that with physicians and moving it, so Jay, you can take it from

Yeah, so the current injection system is based on the UT conjecture, which was developed well over a decade ago. It's essentially like a syringe with a plunger, and the doctor presses the plunger to get the inserts into the eye. With a state-of-the-art injector, you have a trigger or a button that you press, and the mechanism within the injector delivers.

in a very controlled manner, the inserts. Now remember we can inject up to three inserts with a single injection and we want to do that in a safe and controlled manner. This new injector system allows that. What it also will feature is a visual guide to the doctor that lets him or her know that all the inserts have been delivered.

So it's in a very ergonomic package. We're trying to minimize things like disposable items, minimize the size of the packaging, things that really physicians care about for stalking and the environment and things like that. So we're really looking at it kind of from the 360.

perspective to provide retinal specialists and ophthalmologists something that they find to be easy, ergonomic and very reliable even when delivering up to three answers.

Okay, great. That's very helpful. Maybe two quick ones. The first one is in terms of the deal you announced yesterday. My question is why choose C5 versus other so confirmants, which are also in development? Is there any specific reasons for that? Let me take that. Look, Rally Bios is a great company. And...

they've got a C5 that is validated in some of their other clinical trials. We like a lot of it also depends on the future that you get the right term and you've got a good partnership. C5 and C2 both are validated targets. Right now I would say we're probably neutral between the two. So our goal was to work with a partner that we had a good collaboration with has a validated target.

And we are in sync. So I think this is simple as that. And look, it's a certainly well validated target. I think there's a lot yet to play out between the nuances between C3 and C5, but I want to state both of them or highly validated targets now. And if I could add to that, we're still watching very carefully this space in looking at potentially other partnerships and other targets. Other companies are looking at remembering attack complex as a target, as well as complement factor B. And I think both of those are promising. They're clearly...

that given UT has a pretty real-butt border spells. And should we anticipate at least from modeling perspective that 2023 quarterly, that will be the fourth-quarter number will be a baseline moving forward for 20, 20, 20, 3? Yeah, first of all, I'm going to reiterate, Yale, we don't give guidance. We never have, and we're not going to start.

Second of all, and by the way, just take the pandemic as a case in point. So in terms of being able to project guidance, the other issue is that remember, in Medicare Part B drugs, and frankly, it's probably a lot of Medicare Part D as well, you end up with quarterly to quarterly fluctuations.

So first quarter, oftentimes is lower in most categories of drugs, is lower than fourth quarter of the prior year. And the reason is because insurance reset copays kick back in again. And so patients can, and the often you get holiday bills coming in. So what we find is first quarter, patients tend to skimp on their, their delegitization. That being said, we are looking great in first quarter. And we do expect 2020.

3 overall will be higher than 2020-22. But I'm not going to sit here and project quarter by quarter by quarter. Because again, this is a category and Medicare Part B where copays kick in and first quarter can oftentimes be a little weaker than fourth quarter. But again, you want to look year over year quarter over yearly quarter and we expect to continue to have

slightly higher highs each quarter over prior years, quarters. Okay, great. That's very, very helpful and congrats on all the progress. Yeah, thank you. Thank you. One moment for our next question. And that will come from the line of HN with HCW. Your line is open. Thank you for taking my questions. Just to clarify, was there any sales product revenue from DEXQ in the false quarter? I do or if you want to comment on that. Yeah, there was you. We still had DEX Q4 but it dropped off meaningfully from them.

or the year we'll file the cane next week with those. Do you expect any further impairment charge? No, so if you look at the results this morning, and you'll see that we've recorded a full impairment of the DEXICU intangible. And to the earlier question, there was a little bit of incremental inventory that we reserve for as well. So from a financial perspective.

We start 2023 with a clean slate as it relates to DEXIC. Was there an increase in the price for you, Tick? Yeah, we always have very, very modest price increases. But again, we always take very modest ones. And George, if you want to just comment what we took in 2022. But again, we typically say way below inflation. They're very, very modest. Yeah, I think you just think you just, most of the vast majority of the revenue increase for you, Tick, is demand. And you can see that in the...

and the details quarter over quarter of the team continues to do incredibly well with that product. And price is a very small piece of that. Got it. And lastly, so shall we expect the gross margin for 2023 to return to the levels observed in the third quarter of the second quarter of 2022?

So I would say that, you know, you take that carry a much higher margin than DEXQ, so I would expect margins to improve as it relates to just that, because it will largely be just that product in 2023.

Again, we're not giving full guidance on that, but you know, safe to say that and we expect mark this to improve because of the waiting higher to the U.T. Okay, thank you. Thank you. I'm showing no further questions in the queue at this time. I would like to turn the call back over to management for any further remarks. I want to thank everybody for your time. I again want to reiterate. I'm very proud of our progress. We are very keenly focused.

on executing methodically, and we expect to have hopefully a good year in 2023. So thank you very much. Look forward to keeping you all updated as we continue to make progress, especially on our Phase 2 clinical program. Thank you.

Thank you all for participating. This concludes today's program. You may now disconnect.