Q2 2020 Iveric Bio Inc Earnings Call

Okay and welcome to Ivor <unk> second quarter Twentytwenty results Conference call. Today's conference is being recorded at this time, let's turn the conference over it to Kashagan. Please go ahead.

Good morning, and they'll controlling third Bios conference call, representing <unk> bio today, let's Windoor Yell, Chief Executive Officer, President Dr., David Guy or executive Chairman Mr., Dave Carroll, Chief Financial Officer, Dr., Truebeam do adult chief strategy and business Officer Dr.

Of course insight Chief Medical Officer, Dr., Abraham Scarier, Chief Scientific Officer, and that's the key West Beach, Chief operating Officer.

I would like to remind you that today, we will be making statements relating triferic blessed future expectations regarding operational financial and research and development matters, including statements regarding the impact of the cold in 19 pinned down on our research and development program operations or financial position and on the practices of retinal physicians.

And the conduct of clinical trial.

Dictation choose gather one oh previously announced clinical trials with anymore, but the treatment of geographic atrophy.

Phase three clinical trial, I would development and regulatory strategy for they Laura and no other product candidates, including our expectations for a second phase three clinical trial gather to evaluating some work for the treatment of geographic atrophy and our expectations of a phase two beach screening trial evaluating some more.

For the treatment of what is only reset but strong about disease.

I want hypothesis, we got in complement and the age grew one inhibition as a mechanism of action for the treatment of geographic atrophy and potentially other retinal diseases.

Rejected use of cash and cash balances the timing progress in result, clinical trials and other research and development activity and regulatory submission the protests bloody and development potential about product candidate.

Size of the potential market for indications our product candidates are intended to treat and the potential about business development strategy.

These statements constitute forward looking statements for the purposes, the safe Harbor provisions under the private Securities Litigation Reform Act at 1995. These statements cover many events and matters. So subject to various risks that could cause actual results could differ materially from those expressed in any forward looking statements, including risks relating to.

The future progression coping Nike pandemic and its impact on our research and development programs operations and financial position initiation of the progress of research and development programs and clinical trials availability of data from these programs reliance on contract development and manufacturing organization.

University collaborators and other third parties establishment of manufacturing capabilities expectations, the regulatory matters need for additional financing in negotiation and consummation of business development transaction and other risks.

I refer you to our FCC filings and in particular to the risk factors included in our current report on form 8-K filed on June 17, Twentytwenty for a detailed description of the risk factors affecting your business.

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 except as required by law.

I'll now turn the call over to blood.

Hey, Thanks, Cathy and good morning, everyone. We appreciate it thank you for Germany or call. This morning.

So first I hope you and your families or stage and healthy as we continue to navigate through these very challenging times.

You are dr., Eric we're very pleased with the level of execution is a true during the second quarter.

We're thrilled to have reached another major milestone, which are more drew we announced positive 18 months results from jobs, one well first of phase three clinical trials is more a novel problem and see flaws inhibitor for the treatment of geographic atrophy, well Gee I.

Secondary to age related macular degeneration more A.M.D.

The other acquisition for the more phase three clinical trials <unk> represents.

Sure.

18 month results from the other ones indicated continues the more treatment benefits as a favorable safety profile in patients with GE a secondary.

We take this is an impressive achievements, which we believe the other ones currently only phase three clinical trial chose portion of June girls with continuous treatment.

He mobs.

Let me follow the positive results from Joe the warm we initiated patient enrollment gathered true or second phase three clinical trial, which is more for the treatment of GE age secondary to indeed.

Well, then probably already just aggressively draws patient recruitment and retention come together to clinical trial.

The primary endpoint was achieved 12, we intend to filed for approval of the more because U.S. food and drug administration and the European Medicines Agency.

This year should pay from the moment Catholic true brings us another step closer to potentially delivering its wonderful meaningful therapy safely to patients would you yet where there's currently no treatment.

We continue to work closely with the FDA and we're pleased to receive 58 fast track designation for some more for the treatment of GE, a secondary to a and b.

In addition to the complements what since the petrol G.A. installed work this and we believe.

I suppose scientific data, that's a more than they have potentially.

Personally part cool and treating intermediate Andy is what is what as well as what they can be.

We believe there were strong scientific rationale to support the development of the more multiple for a and b early and advance dry and wet.

We believe H.T. already won for high temperature required a ceiling stepped it up but did they spoke in one could be another important told you in the treatment of any Andy.

The coldest program all she 500.

Yeah. It's good ones is a small molecule inhibitor that is partly is promising a promising compounds in our pipeline HDR a warm regulation that's been syndicated there's a strong risk factor and the development of draw you D.

Particularly encouraged I see fossil group's ability to gauge the target both extra it's been trip. So certainly early preclinical work.

So I'm, telling toward logs and you're pointing to submit indeed.

He was 58 I see plugs on good G., a secondary a and B 2021.

Well go brings the board patience is a top priority we continue to focus on a gene therapy program.

Inherited retinal diseases courseware, we view the details of our gene therapy pipeline in a few moments.

Following the policy to gather 118 month period.

Strengthens our balance sheet with underlying underwritten public offering and a concurrent private placement would be built capital.

Observable capital raising approximately 160 million gross proceeds stable cobalt, yes, we're.

That's cool.

We believe this fund raising enables us to further execute on our strategy to develop and deliver redbook treatments.

Or is it more.

Mhm provides a more argued therapy programs and I see 500.

The perpetual to create long term shareholder value.

At the beginning of the second quarter, we welcome Dr. being people, who many of you know towards our volume for being as a globally recognized retinal specialists wasn't extensive network longstanding relationships with the bio and former ophthalmic.

Sure.

As our executive Vice President and Chief strategy, and business office or previous experience and that work will be instrumental in helping us build alliances with potential future collaborators investors and stakeholders.

For vein is helping to lead the company strategy as Weve dancer portfolio Therapeutics.

Gene therapy, R&D programs targeting multiple retinal diseases.

In July we had the privilege of announcing the addition of Dr. Mark Blooming credence to our board of directors Mark is a biotech industry leader internationally known so that's real wet mill specialists with a notable.

<unk> pharmaceuticals for age related macular degeneration, and Oculus gene therapy.

Mark is fulfilled the multiple biotech and medical technology companies, whose experience expertise and leading a building biotech companies, which further strengthens our board.

I'd now like to turn the call over the for me.

Good morning, everyone I hope, you're all well thank you Glen for the kind introduction.

This is an exciting time at the company and my great pleasure to work closely with Glenn David gross and all my colleagues.

We're very excited by these 18 bulk of gathered one result, this is a significant milestone for zamora and potentially significant advancement for patients with GE a secondary to A.M.B.

We believe <unk> 18 month data that we reported this past June further validates our 12 month results regarding more it's continuous positive treatment effect.

Favorable safety profile than G., a secondary to A.M.D. and I'd like.

Tenfold role of complement <unk> five inhibition in this disease.

In the gather one clinical trials.

More and better.

That's the thought primary efficacy endpoint, a 12 month and reach statistical significance in the international multi center randomized double map Sham controlled phase three clinical trial in G., a secondary to the ASV.

The reduction in the meeting rate of GE a group for over 12 months was 27.

8%.

The value of 0.007 too because it's been more two milligram group as compared to the corresponding Sham control group at 27.81% with a P value of 0.0051 sort of do more four milligram group, that's compared to the corresponding Sham control group.

These data will both those groups were statistically significant.

<unk> positive 12 month data or further supported by the 18 month results, which we reported in June.

Over 18 months the reduction in the media weight of GE, a growth was 28.11% for them to more two milligram group, that's compared to its corresponding shrunk group and 29.97% for this anymore for medical group as compared to corresponding Sham control group.

The primary efficacy endpoint, which specify the 12 month <unk> all of the Howard.

Statistically significant difference.

Therefore, the P values at the 12 month, because the Philadelphia or descriptive in nature.

The script <unk> P value for the treatment effects that month 12 work.

Oh, you absorbed 0.02 or one four for the remainder of two milligram group and a P value of 0.00 to one.

Jim or four milligram group.

We believe having 18 look positive data.

Continuous treatment due the key differentiating factor for us when compared to other product candidates.

Okay.

Another key differentiating factor for this trial.

That the treatment effect was observed in the very first measurement at six months we can.

Absolutely difference between the treated group and the show HM.

Subsequent measurement time points in other words.

These results are replicated and gathered some trials, we believe a doctor who would be able to help gives all her patients that this drug has been has shown that effect as early as thick smoke.

And then maybe haven't increasing the effect with every subsequent injection thereafter.

We do not believe that's been park for efficacy profile has been observed in any other clinical trial to be.

Zimura favorable safety profile another potential differentiating factor was maintained.

Al <unk> 18 month trials with no investigator reported some work related adverse events no cases of end up from items and news anymore related inflammation.

Reported incidents of CMB, and B and who the fellow I was 11 patients good 0.8% on.

And then the study I was communications, 2.7% in a sham controlled.

Two patient 7.7% in the do more one milligram.

Eight patients 11.9% in a similar to little glam group and 13 patients, 15.7% invisible a four milligram boots.

Note <unk> <unk>, we wouldn't be were lower than what has been published sports and three inhibition. Despite the fact that there were more more injection administered over a longer period of time, when a patient population with faster progressive disease.

This is the took a little bit. Please when you look at the ratio of <unk> incidents in the treatment arms versus show.

The most frequently.

We reported popular adverse event.

The other one were related to the injection procedure and not the drugs.

These gather one reports are from the.

Cool that Sarah leaking the trial, what we believe the only war on coal the positive things can lead clinical trial in GA.

We believe there is the new wouldn't buy them up.

Clinical trial execution.

That's the robust data from gather one maybe help drive recruitment and retention of patients gathered to an end future trials, we make comes up towards the more.

In the challenge and coupled with nine to pandemic. However.

We believe that investigators will be more enthusiastic uncomfortable recruiting and retaining pollution in a clinical trial with a drug that already have high quality positive phase <unk> data.

We recognize the challenges that retinal physicians things with their practices and conducting clinical trials in a cold.

And we're working closely to support collaborating positions.

Who is we'll discuss how we plan to leverage the quality of the gather ones adults and maximize patient recruitment and retention for gathered to they could lead clinical trial.

Turning to our business development.

We plan to continue our aggressive but selective afterwards as we continue to explore our option for future development and potential commercialization of the more including potential out license and collaboration opportunities.

Thank you for your time.

I'll now turn the call Google to coolers.

Thank you for being a good morning, everyone.

Let it flow to help the robust world gather one results presented association for research individually homology ARVO animal data and what does the call shocking.

T. Boone Pickens studio scientists and director of the molecular pathology laboratories Aboriginal Foundation about the southwest.

I'm also presented at the American Society of retinal specialists I guess, all that's ongoing moving rub two weeks ago product.

Cooperman.

Turning up with the problem colleges.

So, California Irvine.

In the coming months Youre climbing put out there that's been presented like key opinion leaders at the major wed tell me then you can go out and around the world.

The positive data one clinical trial data how did not have been significant enthusiasm no investigators to participate enrolled patients and to gather to clinical trial.

Further we believe that the early onset and continuous treatment effect that most of them together, one clinical trial would be a Q motivator for retention and the other two trial.

Our experience clinical trials team has worked tirelessly in the past few months to support this book of expeditious initiation of the job or two clinical trial.

Some of them as opposed to include.

Hosting both people do till websites with distributors I'm study coordinators ers in the U.S. and around the world.

Glenn Communications with the clinical trial starts coordinators to myself some support the preparedness for corporate banking and minimizing any potential disruption.

Making arrangements for patients with the multi perform certain public the tasks to minimize the time spent quite a patient other clinical trial sites.

To reduce their exposure Russ I mean for a flip environment for all patients.

With die all levels since one investigators other stuff.

With that and she was and support for the gather to clinical trial.

Now I would like to provide some detail regarding the design of the gathered from trial.

The other two international randomized double about shots on sold multicenter phase two clinical trial.

Obama would be but safety and efficacy of Zimura up two milligram in patients with geographic atrophy secondary issued a good luck of of the generation.

Yes, London to enroll approximately 400 patients in this clinical trial.

Sessions with the randomized one to 102 cohorts. The first go over to the bumped up insertion of Zimbra too. Many brown for 12 months I'm just struggling cohort listed in bumpy administration of shop.

Yeah, Chris specified primary ticketing and coined the moon rate of change in geographic atrophy growth over 12 months.

But fundus autofluorescence topped three talking points baseline bunk books about 12, but it's still but also the gallagher watching nickel trial.

It's the primary efficacy endpoint is much more htwo look lobbying to solve for marketing approval of Zamora for the treatment of geographic atrophy second due to age related macular degeneration would this be idea though.

Among Paul we plan to randomize patients to do more of tumor the breadth or do we see positive monthly or every other month administrations, obviously moved up to men as well.

The final safety evaluation, we did perform I'm I'm 24 for all patients.

Turning now to start disease, causing have an ongoing seems to be screening cubicle trial assessing the safety and efficacy of Zamora in patients with all those all Muslims says it starts our cousins.

Let me show when gold medal type versions of this trial, we have we opened the enrollment begins trial club approximately 25 patients with the goal of enrolled a total of one of them 20 patients we shouldn't be turned that into political for this trial.

We do my mouse for this trial on plan to perform data analysis like all the patients have reached a bump eightci talking points.

Regarding our genes thatll be programs, we continue with our eye and be enablement activities a much on history studies for I C 100.

Our call that time today for Firdapse, and maybe get autosomal dominant looking back and so we've been told us Oh plenty to initiate a phase one clinical trial for the first half of 2021.

We also continue with the IB enablement activity natural history studies for I see 200, our public company. They pull this one where they get rid of diseases and are planning to really should the phase one two clinical trial next year in 2021.

Our religion programs continue to move forward what caused the optimizing the moving to construct for our maybe set to evaluate Cobra and plan to select the least construct later this year.

Thank you for your time on T. stuff, So I would now turn to called over today.

Thank you Chris Good morning, everyone I'd like to highlight a few items from a press release of this morning, and also update our yearend cash guidance and are expected cash runway.

Crude or our net loss totaled 18.6 mean, the 32 cents per share compared to a net loss of 14.4 million or 35 cents per share for Q2 2019.

<unk> increased net loss was driven primarily by an increase in R&D expenses offset by a favorable settlement of a state income taxes on it.

You can see our net loss totaled 33.7 million or 61 cents per share compared to a net loss of 26.9 million for 65 cents per share for the same period between 19.

Again due to an increase in R&D expenses offset by favorable settlement and the state tax on it.

Turning to our expected you were in cash balance of cash runway you reached approximately $150 million No June 2020, public offering a concurrent private placement.

We now expect our yearend cash balance would range between.

15 million in 220 million.

Yes to meet that our casualty sufficient to fund our capital expenditures in operating expenses. That's currently plan currently make 2024, excluding any potential approval or sales milestones table to the arguments corporation or any potential commercialization expenses was a more.

Estimates are based on a current business plan, which includes the continuation of our clinical development programs for some more.

Progression I C 102 hundred gene therapy program, it's the clinic.

And he that's been about I see 500 development program.

<unk> estimates assume that will move a little approximately 200 patients for the gather to trial.

Facts and circumstances change well just or guidance accordingly.

Acoustic estimates do not reflect any additional expenditures, resulting from the potential in licensing or acquisition of additional product candidates were technologies, where do you still see development that the company pursue.

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

Well, thanks, Dave and I appreciate that so club just to recap of the second quarter. Despite these very challenging times or what's a good quarter for their <unk>. There's a number of key takeaways, we completed or 18 months results for the other one and as you soon and we discussed.

Today, a with continuous affected and it could safety profile second.

We raised 160 million in gross proceeds.

Further strengthening our balance sheet and adding to our cash from runway and surge. Although it was a difficult to scale back and in March when we decided to pause.

The true trial, we have now become the trial.

And Ah or Rob recruiting patients so good quarter for us so I'd like to thank all of you for listening today or two or the call and for your continued support and now I'll turn the call over to the operator, so that we can open up along for any questions.

Thank you and if you wish ask a question casing all by pressing star one I got another star one to ask a question.

We will now take our first question from stay secure of Cowen. Please go ahead.

Good morning. Thank you for taking my question, Doug Congratulations on the progress.

First question, given the times or sites, because I understand screen. The recent trial initiation <unk>, how should be thinking at that pace of enrollment that you'd be willing to give us some guidance on timing.

And my second question goes on.

Briefly touched upon dang aren't prepared remarks that curious because a lot right [laughter] architecture is thinking in terms that potential actually last partnerships and what you fantasies compositions. Thanks.

Yes. Thank you Stacy it's Glenn Thanks for the questions. So first on the up but the timing together to I mentioned a couple things. It. So it's early days. So this is also very competitive environment and I think you've seen our execution in the past the what we are dealing with.

Your next situation here with with Kobe, then I think as we've updated the true through the second quarter, they've kept a very active and continuous dialogue with the investigators. So if the current time, we're not gonna provided the guidance as to when we we finished the trial.

So, but we will continue to move at a pace. So that's a as quick as we can you know the key to that success will be given the number of sites the quality of the sites.

And obviously oh, the patient enrollment so I am going to provide you detailed guidance at this point of view. The fact that we've got a pretty experience to doing this has for the second question as it relates to the collaborations I think a pervasive in his prepared statements to talk about that.

Getting priority, one close todays recruitment and retention of patients in debit too.

But we or are going to continue even stronger options for potential commercialization or was it more including a potential out license as you know we do not have operations overseas, even with the successful capital raise a small company to partnership but at the right time will be an import.

<unk> efforts to commercialize some more [noise].

Thanks for the calls, but thanks for the questions coming soon.

Yeah.

I don't even know take or next question from David Nierengarten of Wedbush. Please go ahead.

Please go ahead, David you may be on me.

I'm, sorry, I wasn't good policies.

Couple of questions from me herself to be.

[noise] to David at score and I'm not sure. We can hear you are we did hear you.

Well, you're a brief introduction can you repeat the questions.

It appears David has actually just disconnected.

Okay.

Yes.

Hi, there I know further questions I was like on the call back to you.

Well operator, thank you for your help the sporting and thank you everybody for listening and look forward to speaking to go into third quarter, that's a bikes.

Thank you if that does conclude the call. Thank you all for your participation you may now disconnect.

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