Q3 2021 Iveric Bio Inc Earnings Call

After todays presentation, there will be an opportunity to ask questions to ask a question you May Press Star then one on your telephone keypad to withdraw.

Your question. Please press Star then two please note. This event is being recorded I would now like to turn the conference over to Kathy Galante Senior Vice President Investor Relations. Please go ahead.

Good morning, and welcome to <unk> Conference call, representing Eid Verifier today are Mr. Glenn <unk>, Chief Executive Officer, Dr. Praveen Doodle President Mr. Keith Westby, Chief Operating Officer, Mr. David Carroll, Chief Financial Officer, Dr. Double decide Chief Development Officer and Mr. Christian.

And Chief commercial Officer I.

I would like to remind you that today, we will be making statements relating to <unk> bio's future expectations regarding operational financial and research and development matters. These statements constitute forward looking statements for the purposes of the Safe Harbor provision under the private Securities Litigation Reform Act of 1095. These statements cover many events and that.

Matters that are subject to various risks that could cause actual results to differ materially from those expressed in any forward looking statements.

I refer you to our SEC filings and in particular to the risk factors included in our current report on form 8-K filed on October 21, 2021 for a detailed description.

Scripting of the risk factors affecting our business that could cause actual results or events to differ materially from the forward looking statements that we make.

In addition, any forward looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date, while we may elect to update these forward looking statements at some point in the future. We disclaim any obligation to do so as except as required by law I will now turn the call over to Glenn.

Thanks, Kathy and good morning, everyone. Thank you for joining us for our third quarter conference call.

2021 has been a pivotal year of five Eric bio as we set in motion our plans to accelerate the opportunity for some more to be first in class <unk>.

Best in class for the treatment of geographic atrophy or <unk>.

Secondary to age related macular degeneration or AMD.

Didn't gather to our second pivotal clinical trial of Zamora and G. A secondary to AMD patient retention continues to exceed our expectations.

We are targeting the 12 month injection fidelity rate to be greater than 90%.

We are entirely committed to maintaining patient retention and the gather two clinical trial, which Keith will discuss in a few moments.

In parallel preparation of a new drug application or NDA and building a commercial infrastructure are well underway for the potential launch of <unk>.

Tomorrow for the treatment of secondary to AMD if approved.

We're also in the process of assembling a seasoned commercial team with experience launching retina drugs with blockbuster potential.

In August we welcome Christopher Sims, Senior Vice President and Chief Commercial officer, and the hiring of the commercial leadership team has already begun.

Chris is an accomplished health care leader with more than 20 years of diverse commercial experience leadership experience and Chris joins us from Novartis, where he successfully manage the commercial operations for the U S. Ophthalmic franchise launching be a view for wet AMD.

For Novartis. He served as marketing league for Genentech's, ophthalmic business, which included creating a new brand positioning and launching a new campaign for.

For Lucentis.

We are thrilled to have achieved several major milestones regarding the execution or is it more of a pivotal program.

First in July we completed patient enrollment and gather two four months ahead of our original schedule.

We are on track for initial topline data from gatherer too to be available during the second half of 2022, approximately one year after the enrollment of the last patient plus.

Plus the time needed for database closure and analysis.

Second we received a written agreement from the FDA under a special protocol assessment for S. P. A for the overall design of gathered too.

We believe that this is the first and only S. P. A N G E.

For those who are not familiar the SBA process procedure by which the FDA provides clinical the clinical trial sponsor within official evaluation.

Written guidance from the design of our proposed protocol.

Intended to form the basis for an NDA.

<unk> will provide additional details on the SBA in a moment.

And third.

We did a post hoc analysis of the gather one trial.

Where we looked at druse.

Nathan GAA, which showed that some maura has the potential to impact earlier stages of AMD.

Based on this analysis, we plan to accelerate development of the more intermediate AMD by initiating a phase III clinical trial in 2022.

Praveen will also provide more details on this trial in a few moments.

We also strengthened our balance sheet by raising approximately $108 million and $163 million in net proceeds with public offerings in July and October 2021, respectively.

Dave will cover our cash runway later in this call.

We believe these fundraisers enable us to prepare some more for what could be.

First to market and best in class opportunity.

Also accelerate our preparations for potential commercial launches of Lora and continue to invest in manufacturing capacity.

In addition, we plan to invest in additional lifecycle initiatives for us more in order to expand the patient population with additional indications.

Such as accelerating our plans for intermediate AMD and investing in multiple sustained release delivery technologies for some more.

The main priorities first today are the retention of patients and gather to.

Preparing for the potential commercialization of some more in the U S.

This is an exciting time for the company as we continue to execute on or is it more.

Of a pivotal program with the potential to create long term shareholder value.

I'll now turn the call over to Keith.

Thank you Glenn and good morning, everyone.

As Glenn mentioned, we completed patient enrollment and gather two in July 2021, with 448 patients enrolled four months ahead of our original schedule.

Based on this timeline, we expect topline gather to data to be available in the second half of 2022.

<unk> one year after the enrollment of the last patient plus the time needed for database lock and analysis.

If the 12 month results are positive we plan to file applications with the U S FDA and the European Medicines agency for marketing approval of similar core GE a secondary to AMD.

Major priority for us is to aggressively drive patient retention and thereby further de risk the gather two clinical trial.

We are targeting patient retention for the gatherer to clinical trial as measured by injection fidelity rate through month 12 of greater than 90% we.

We are thrilled with the enthusiasm resiliency and dedication of patients physicians and their staff and they are far exceeding our expectations as of today, we continue to maintain an injection fidelity rate of greater than 95%.

Merely exceeding our goal of greater than 90%.

As a comparison the 12 month injection fidelity rate for our gather one trial, which showed a statistically significant reduction in G&A progression at 12 months was 87%.

Injection fidelity is calculated by dividing the total number of actual injections drug and sham by the total number of expected injections drug and Sham, we consider injection fidelity to be the most important and stringent measure of patient retention because it reflects the timely administration of drug or sham into the patient side.

We continue to focus on injection fidelity not only to protect the integrity of our data, but also to potentially absorb the early and increasing treatment effect. We previously observed in gathered one.

With the reduction in the mean rate of Gi growth over 12 months at 20, 738% a P value of 0.0072.

Is it more a two milligram group as compared to the corresponding Sham control group and gathering one clinical trial. We believe many principal investigators are enthusiastic and committed to participating in the gather two clinical trial leveraging the quality of the positive gather bond results and maximize patient retention for gatherer too.

These positive 12 month data are further supported by positive 18 month efficacy results and the safety profile that was maintained throughout the 18 months trial.

Further we believe that the early and increasing treatment effect observed in gathered one is a key motivator for retention and gather too.

There are currently no therapies approved for GA secondary to AMD in either the us or EU.

Turning to Star Guard disease.

Enrollment in our phase <unk> screening trial of even more after the treatment of autosomal recessive <unk> disease referred to as the Star trial is ongoing we.

We plan to enroll approximately 25 additional patients for a total of approximately 120 patients.

The results are positive and statistically significant we believe this clinical trial could potentially support an application for marketing approval.

From this clinical trial are expected after the 12 months initial top line results from gather too.

There are currently no therapies approved for <unk> disease in either the U S or EU.

Thank you for your time I will now turn the call over to <unk>.

Thank you Keith Thank you all for joining the call. This morning, I hope that you're all well.

The SBA, which Glenn highlighted earlier marks a significant development for Zamora as it underscores our alignment with the FDA and a formal agreement for the overall design of gathered two which we believe reflects the fda's thinking.

SBA agreement further solidifies our plans.

File an application with the FDA for marketing approval of Zamora for Gea secondary to AMD is the ongoing gathered two clinical trial meets its primary endpoint at 12 months.

Is it more a met its prespecified primary efficacy endpoint at 12 months with statistical significance in the previously completed gather one pivotal clinical trial.

In parallel discussions with those for the gather to SBA the FDA indicated to us that that's part.

Part of the future NDA submission poised tomorrow. The gather one results will be considered using the original pre specified primary efficacy endpoint analysis together with a post hoc analysis using the same FDA preferred method that will be used for the gathered two trial.

Mean rate of growth or slope estimated based on GE area measured by fund us article restaurants in the relevant time points.

The gather one results.

When analyzed using the FDA preferred analysis are highly consistent with and strongly supportive of the results from the original pre specified analysis.

We believe that a positive 12 month result, and gather two would allow us to file an NDA with the FDA and an MAA with the EMA.

We also believe subject to obtaining the gather to results.

Zamora has the potential to be a safe and effective therapy for <unk>, which is the leading cause of blindness in this country for which there are no approved treatments available for patients.

In our gather clinical program, our inclusion criteria satisfied patients with extra <unk>.

And we excluded patients with full deal involving G H.

As part of the gathered program. In addition to evaluating the overall weight of Gea group, we look forward to investigating through supportive analyses, whether zamora has the potential to slow down the progression of <unk> into the fold, yet, thereby preserving central vision, which would otherwise be lost in this.

Progressive blinding.

As Glenn mentioned, we're also.

Accelerating the development plan for is the Mora in patients with intermediate AMD.

Stage prior to the occurrence of GAA with plans to initiate a phase III clinical trial in 2022.

We believe that our competitors, who recently reported results.

In which a greater different rates of progression for patients with extra full deal versus bogey affecting GAA was observed.

Our assertion that complement inhibition is more important in earlier stages of GE.

We believe that these results potentially de risk or gathered some clinical trial by further validating the selection of our target patient population only extra ferrovial Juliet.

We also believe that these results further support our hypothesis for studying Zamora in intermediate AMD before <unk>, even occurs where we believe complement activation maybe driving disease progression.

We plan to initiate a phase III trial in intermediate AMD in 2022.

We are fully committed to delivering treatments for AMD, including early stages of A&D such as intermediate AMD.

Post hoc analyses that gather one Dr. Asada Doheny Eye Institute at UCLA reported that were more of a two milligram was associated with slowing the progression of intermediate GE with decreased rate of progression of IRA or incomplete RP and outer retinal atrophy to seaworld or complete.

RPM outer retinal atrophy.

At a decreased rate of progression of gruesome to iron ore and or single are being observed in.

In both analyses and increasing difference between the two milligram group and the Sham group was observed over time consistent with the results we observed with the pre specified analysis and gather one.

Therefore, we believe some of that may have the potential to not only slow down the progression of <unk>, but also to prevent or slow down the progression of GAA altogether by changing the course of the disease.

These post hoc analyses should be considered hypothesis seeking.

Nonetheless.

If these results are substantiated with prospective randomized studies.

Essentially site saving impact of Zamora on high risk AMD patients could be a significant leap forward in treating this disease.

We estimate that by 2039, there will be approximately 6 million individuals with <unk> in the United States and eight Midland individuals', which was and in the EU five countries, France, Germany, Italy, Spain, and United Kingdom.

The population, we would look to enrol form for the intermediate AMD trial is a subset of the prevalent.

Population.

We expect this intermediate AMD trial to be an international randomized double masked sham controlled multicenter trial with approximately 200 patients per treatment group.

We expect to treat and follow all patients for 24 months.

We expect that data from this trial if positive together with other supportive data may be sufficient to file a supplemental new drug application with the U S FDA and supplemental marketing authorization application with the European Medicines agency.

The positive gather one data in post hoc analyses of gather one data in earlier stages of AMD were recently presented at major medical conferences around the world, including the annual meeting with your retina.

The retina Society, and the American Society of retina specialists.

We have previously stated that we intend to execute a development strategy that will involve both zamora and IC 500.

Complementary fashion to impact multiple forms and stages of AMD.

We have initiated a number of preclinical tolerability and pharmacokinetic and target engagement studies for IC 500, and are planning additional preclinical studies we.

We expect to submit an investigational new drug application or IND to the FDA for IC 500, NGA secondary to AMD and the second half of 2022.

On the business development front.

We plan to continue to evaluate on a selective and targeted basis opportunities to potentially obtain rights to additional product candidates and technologies for retinal diseases with a focus on sustained release delivery technologies.

Zamora.

We believe that we are well positioned.

<unk> indications.

<unk> and AMD franchise, and subject to regulatory approval commercialize them more for Jay.

As a market leader.

Thank you for your time.

I'll now turn the call over to date.

Thank you Praveen and good morning, everyone.

To highlight a few items from our press release of this morning, and update our expected year end cash balance and our expected cash runway.

For the quarter, our net loss totaled $24 6 million or 23 per share compared to a net loss of $25 5 million or 27 cents per share for Q3 2020.

This decrease in net loss was driven primarily by a decrease in R&D expenses.

R&D expenses decreased due to a reduction gene therapy expenses offset by the commencement and progression of patient enrollment in our ongoing gather two trial increased manufacturing activities presume Lora and increases in additional R&D personnel.

Turning to our expected year end cash balance and cash runway.

Tober, we raised approximately $163 million in net proceeds in an underwritten public offering we now estimate our year end cash to range between $375 million and $385 million.

We also estimate that our cash will be sufficient to fund our planned capital expenditures and operating expenses through at least mid 2024.

These estimates are based on our current business plan, including the continuation of our ongoing clinical development programs for some more NGA and star Guards.

The initiation of intermediate AMD clinical trial preparation potential filing of an NDA and MAA for is it more NGA.

Continuing preparations for the potential commercial launches and more NGA investing in sustained release delivery technologies for tomorrow.

The advancement of our IC 500 development program.

Data from these estimates or any potential approval or sales milestones payable to the arguments corporation, where potentially expenses. So the actual launch tomorrow, such as Salesforce expenses and additional expenditures related to potentially studying zamora in indications outside of GAA, sorry, <unk> disease and intermediate A&D.

Resulting from the potential in licensing or acquisition of additional product candidates or technologies and any associated development that we may pursue.

I'll now turn the call back over to Glenn. Thank you for your time.

Well, thank you Dave.

As the year comes to a close we're excited with the progress we made in 2021.

As we look ahead to 2022, we will continue to focus on the execution of the gather two trial with retention of patients and also preparing for the potential commercialization of some more in the U S. These two will be our top priorities.

We're also accelerating development plan for some more in patients with intermediate AMD and investing in additional lifecycle initiatives such as sustained release delivery technologies for Nomura.

Thank you for your time this morning, and your continued support we look forward to providing you with updates as we progress.

I'll now turn the call over to the operator, so we can open up the lines for any questions operator.

We will now begin the question and answer session.

To ask a question you May press Star then one on your telephone keypad.

If you were using a speakerphone please pick up your handset before pressing the keys.

If at any time. Your question has been addressed and you would like to withdraw. Your question. Please press Star then two at this time, we will pause momentarily to assemble our roster.

The first question comes from Annabel <unk> with Stifel.

Please go ahead.

Hi, guys. Thanks for taking my questions and congratulations on the progress.

Yeah I had a quick question on the fidelity right. So obviously it remains very high greater than 95% and I know how that compares to gather one I guess.

Maybe you can help us understand.

How that changes your powering for gatherer too.

I guess technically how powerful that is for your statistical analysis.

And it's so high and second how does it compare to.

The fidelity rate competing programs, you've seen if they've reported the data.

If I could ask a similar question.

Many patients from gather one have moved since gathered two and is there a way to see how these patients have progressed.

From one study into the next if there are in fact patients from gather one.

Thanks.

Good morning, it's Glenn Thank you for the questions. So three questions I think we'll deal with the powering question first.

Keith do you want to take that for Annabel.

Sure happy to do that thanks for the question so.

So the power of gather two is actually based on safety. So we're over powered for efficacy. If you look at the results from our gather one clinical study.

We're actually over powered for efficacy and they're based on safety. So the FDA requires at least 300 subjects treated for at least one year at the dose we plan to commercialize where a higher dose and we would have sufficient patients based on the numbers enrolled and gather two as well as counter one.

So it continues to shore up our assumptions on there too.

So.

How weird powered for gathered too.

Does that answer your question.

Yeah, and do you have any sense of how it compares to other trials that were conducted and.

Okay.

And about the question compared to other trials.

You had asked about the injection to deliver is that correct. Yes, yes, yes, yes, so I'm going to let <unk> answer that but I think since this is something.

Actually prevent had come up with in terms of a metric I'll, let him provide some color for you in terms of.

How we look at it and also the comparison to others.

Hi, Annabel good morning.

Thank you for your question Yeah. Thank you Glen and ended up good morning. Thank you for the question. So I don't know that this this parameter anabelle has ever been provided before at least in the 26 years or so that I've been at various studies. This has never been provided certainly not.

In an ongoing study.

The reason for US providing this is really very straightforward there were concerns regarding the global epidemic or pandemic aware patient may come in and then may not be able to come in for a while and injection would be missed and then patients may come back and those patients despite the gap.

And treatment would be technically counted as being retained.

And that was good enough.

But we really wanted to give a parameter that as transparent and as stringent as possible. So we really came up with.

What we believe is the most stringent and transparent parameter and injection fidelity.

Which is the expected number of and the number of injections b therapeutic or Sam that's given divided by the actual number that would be expected in active patients.

That's about as transparent as you can possibly get I don't know that that parameter has ever been used before however, I'm, hoping that others will will use it for the same reasons that we have and provide that information I think we because it really is the best measure of the drug or the sham actually being utilized in the patients.

Hi.

Okay, and then and then the last question about any patients from gather one moving in together care. These are a fresh patients.

Catherine.

Yes, Bill I can answer that Theyre, all new patients since if I believe thats correct I don't think we had anybody move from kind of the one together too.

Correct, yes.

Again.

Okay. Thanks, Thank you Annabel I'll get back in line.

Again, if you have a question. Please press Star then one.

The next question comes from George <unk> with Cowen and company. Please go ahead.

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

As you mentioned in your prepared remarks, your competitors' results really show the dramatic impact complement inhibition could have an extra full bill lesion growth.

Could you maybe talk about what percentage of gea patients have extra foveal lesions.

It is to diagnose these patients just given the division impacted phobia and.

Do expect at all you are unable to be limited to only patients with extra fulvio lesions.

With two successful.

And then I have a follow up.

Okay, great. Thank you for that prevent you want to take that one.

Yes. Good morning, everybody. Thank you for the question, so theyre clearly exponentially greater patient number of patients with extra phobia lesions in patients that have been stage for the involving lesions.

Theres no doubt about that the estimates range.

Arrange a much much higher now, but the bigger question really is where are those patients and those patients really are not so much in the retinal specialist office because those patients are not necessarily referred in unless unless they are quite severe.

<unk> really are right now and the general Ophthalmologists office, the Optometrists office.

And this is very much like a movie we've seen before which is what the anti VEGF.

Patients with Neovascular AMD.

I started practice really werent in the retinal specialist office they were really at the general ophthalmologists and Optometrists office.

And those patients had no treatment that's why they were not referred in and as soon as there is treatment. The same thing that happened with Neovascular macular degeneration, we're convinced it will happen.

With dry macular degeneration, which is that those patients will be referred into the retinal specialists now as far as making a diagnosis is concerned it's fairly straightforward.

One can look at the fund as one can see geographic atrophy occurring.

These are patients with.

With with symptoms their vision, maybe 2020.

But there are patients who are usually in the workforce.

In earlier stages of disease that may not be able to see a straight line or it may not be able to finish reading a sentence because theres a blind spot.

As far as the labeling questions are concerned I wanted to make it very clear that we haven't had any formal labeling discussions with the FDA it would be premature to have that but.

But it's clear from our results as well as from our competitors' results that the earlier you treat in this disease because at the end of the day. It is a chronic inflammatory process the better the results and what we've done here with extra foveole patients is not only target at the proper patient population we believe.

To show that there could be complement inhibitor has the delta, but we've also slowed down the fastest growing geographic atrophy very safely and if we're able to slow down the fastest growing geographic atrophy, which is the extra OBL type. We believe theres no reason that we wouldn't get a.

Approval, we're slowing down as slower growing geographic atrophy, which is the <unk> affecting geographic atrophy. So I emphasize again that we haven't had any formal discussions with the FDA regarding labeling it would be premature to do so but our expectation is that we would have a broadly.

Thank you. So mark this is incredibly helpful. And then from a strategic perspective, any updates for a potential European or Asia partnerships.

And can you.

I guess reminders.

Do you expect the regulatory requirements differ X U S versus U S.

I'll take the first part of their career and I will let Keith answer the second part.

Yeah as I mentioned in the prepared remarks, the focus right now is really too.

Complete chapter two and prepare.

Our commercial.

Infrastructure and strategy, so thats sort of priorities right now.

I think we're in a very good position at the right time to talk about partnering outside of the U S.

But still a small organization and aggressively hiring.

<unk> is working.

Diligently on getting gather too.

Completed so let's look at the right time, we will.

Look too.

Partner ex U S.

We'll let you know that my time is.

Keith do you want to talk about the second part of the question.

Sure happy to do that so I think the question was related to ex U S regulatory.

And I'll just preface this with we Havent had formal discussions with ex U S. Regulators at this point, but we do believe that the gather two study design would be sufficient for approval ex U S.

This is great. Thank you so much and again congratulations on all the progress and thank you for the questions.

This concludes our question and answer session I would like to turn the conference back over to Glenn <unk> for any closing remarks.

Thank you operator, and thank you everyone for listening in today.

As you've heard from the team we remain focused on execution and we look forward to speaking to you throughout the rest of the year and early next year.

The conference has now concluded. Thank you for attending today's presentation you may now disconnect.

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