Q3 2020 Iveric Bio Inc Earnings Call
Good day and welcome to the I break my old car wash or Twentytwenty results conference call.
Today's conference is being recorded.
At this time I would like to turn the conference over to Kathy Galante. Please go ahead.
Good morning, and welcome to like their five conference call.
Nothing I'd Barrick bio today are Mr. nice Windoor young Chief Executive Officer, and President Dr., David Guyer Executive Chairman Mr., Dave Carroll, Chief Financial Officer, Dr., Probeam, Dugle, Chief strategy and business Officer, Dr. courses <unk>, Chief Medical Officer, Dr., Abraham Galleria Chief Scientific Officer.
I missed the teach westby chief operating officer.
I would like to remind you that today, we will be making statements relating to I bet. It's good.
<unk> expectations regarding operational financial and research and development matters, including statements regarding the impact of the COVID-19 pandemic on our research and development programs and the conduct of clinical trials.
Ricky confuse gathered one Oh previously announced clinical trial for the treatment of geographic atrophy at the phase three clinical trial.
Patients for and the progress gather true our second phase three clinical trial evaluating some more for the treatment of geographic atrophy, our development and regulatory strategy for Demora and no other product candidates, including our expectations to additional indications for which we may put to the dollar.
Has that been more oh hypothesis regarding complementary nature, one inhibition as a mechanism of action for the treatment of Andy and potentially other <unk>.
Is it a projected use of cash and cash balances the timing progress and results of clinical trials and other research and development activity and regulatory submissions the potential utility and development potential about product candidate the size of the potential market. The indications our product candidates are intended to treat and the book.
Central for our business development strategy.
These statements constitute forward looking statements for the purposes of the Safe Harbor provision under the private Securities Litigation Reform Act of 1995. These statements cover many events and matters that are subject to various risks that could cause actual results to differ materially from those expressed in any forward looking statements including.
Risks related to future progression of the COVID-19 pandemic and its impact on our research and development programs operations and financial condition initiation and the progress that research and development programs in clinical trial availability of data from these programs reliance on concept development and now.
Are you factoring organization University collaborators and other third party establishment of manufacturing capability expectations for regulatory matters need.
For additional financing a negotiation and consummation of business development transactions and other risks.
I refer you to our SEC filings and in particular to the risk factors included in our quarterly report on form 10-Q filed on August six twinkie, probably teach for a detailed description of the risk factors affecting our 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 as required by law I would now like to turn the call over to Glenn.
Well, thanks, Cathy and good morning, everybody and thank you for joining our call. This morning.
We're excited with the level of execution, we have a cheap we don't therapeutics and our gene therapy programs. We're thrilled to have reached several milestones with some more in the past year.
First we reported positive 12 month 18 month results from or gather one phase three clinical trial of some more for the treatment of geographic atrophy secondary.
To age related macular degeneration. We think this is an impressive achievement since we believe gather one is currently the only completed phase three clinical trial, showing suppression of GA lesion growth continuous treatment effect over 18 months.
Second the gather one data was published a highly respected journal.
Ophthalmology, which was the journal of the American Academy of Ophthalmology.
And we initiated patient enrollment in job there too.
Second phase three clinical trial for the treatment of GE a secondary to Andy.
The primary endpoint is a cheap at most 12, we intend to file for marketing approval, it's more that the U.S. food and drug administration and the European Medicines Agency.
The initiation of patient enrollment in Cabot to brings us another step closer to potentially deliver a clinically meaningful therapy safely the patients which yeah.
Well also continue to move our older programs forward, we have advanced our two lead gene therapy product candidates I see 100, which is intended to treat rhodopsin mediated ERP and I see 200, which is intended to treat that's one related retinal diseases.
We expect both product candidates to be on track to enter into clinical trials next year.
We have also identified a lead compound for all I see 100 or HDR, a one inhibitor program.
In June 2020, we strengthened our balance sheet with an underwritten public offering, but a concurrent private placement with vivo capital and some sort of bio capital raising approximately 160 million gross proceeds.
He's successful capital raises in addition to our previous follow on offering in December 29, two that resulted in net proceeds to the company of approximately 42.6 million enable us to further execute on our strategy to develop and deliver retinal treatments for Zamora gene therapy.
H.T.R.A. won programs with the potential to create long term shareholder value.
We've also assembled a team of experienced experience, we oh sorry.
We have also experienced a team of seasoned a board of directors and thought leadership, we believe could have a major impact on the future treatment of retinal diseases.
Over the past several months, we continue to strengthen our team by well welcome me three well known respected veterans in the retinal community to our team first Dr. Mark Bloomfield crabs, who joined our board of directors in July Mark.
Mark is a biotech industry leader.
They don't nationally no central retinal specialists with notable expertise and pharmaceuticals am Dave and ocular gene therapy Mark.
Mark is also co founded multiple biotech and medical technology companies.
Dr. Probing Dugel joined Us in April as Chief strategy and business Officer.
He has been a tremendous addition to the two previous a retinal expert recognized globally.
Both the medical community and the biotech pharma ophthalmic industry.
And most recently doubled the site formally medical unit had at Novartis I care joined divert bio as chief of staff.
Double is well known throughout the retinal community.
Well they priority is to grow simply drive patient recruitment and retention in the gather two clinical trial.
Meanwhile, we continue to monitor the cobot my team has done that closely engage with our clinical trial sites to support the health and safety of our clinical trial patients.
He will bring some more to patients is our top priority, we continue to focus on potential opportunities to expand and advance our footprint in AOMT, which presumably will address in a moment.
After that of course will review our gather one gather to clinical trials and our gene therapy pipeline orphan inherited retinal diseases.
Thank you and I'd like to now turn the call over to spring.
Thank you Glenn good morning, everyone.
I hope that you all though.
As Glenn mentioned that we have accomplished quite a lot over the past year.
Were extremely enthusiastic about our mission to blame transformative treatments to patients with men retinal diseases for which no treatments currently exists.
Hey, Andy is the most common causes of vision loss in developed countries, especially <unk>.
People older.
50 years of age.
Our worldwide population continues to live longer.
We expect the prevalence of a and B what are you going to be.
Please.
Projection.
70 million in 2020, and 288 million and 2040 worldwide.
Why am it's reported to account for 85% to 90% of all AMC cases.
Let him do which accounts for approximately 10%.
15% of all easy cases has very good anti VEGF treatment options available to patients.
There are no. There are currently no SD eight or email me sweetens the g. eight.
Which is the advanced or end stage, where they ended.
Based on a comprehensive at BBB All Lucky study published in 2004 in archives walk them or would you.
We estimate that there maybe there are currently 1.5 million people.
The United States alone, but yet.
As the size of our aging population continues to increase we believe.
Based on an annual U.S. population growth of approximately <unk>, 0.25%. This.
This number may grow to approximately 1.8 million like.
Like 2030.
Our goal that I've shared by it.
<unk> expenses and Oh.
All of America the degeneration.
Why and what.
We intend to do this by evaluating potential clinical trials is a more in additional indications and by advancing the development of ICICI life.
Our Ht RT one inhibitor.
We believe the solid scientific evidence to studies anymore.
What neovascular AMD.
As well as.
Stages of dry AMD.
We have already completed two exploratory study of Zamora administered in combination with expenses in patients with letting them do.
We believe the results were encouraging and consistent in both studies.
The more two milligram was sentenced groups in both studies, 60% of patients gain three lines are more vision as measured by the Pdrs letters.
We also believe the association between complement activation and earlier stages of driving and well established there.
Therefore, the available sites supports the investigation and see more Oh, what Andy.
Earlier stages.
Dr. Andy.
Our strategy is focused on developing not just one but multiple complementary assets to establish an eight A.M.D. webshots.
Our excitement largely more if they gather program carries over to another one of our top priorities.
Our H.T. Ali one program known as I've seen five.
H.T. already won.
They find their way to treat that is widely expressed into that.
And the target not that compelling genetic association with a and B.
We believe that I keep I believe it has the potential to be best in class H T. R. Eight inhibitor.
Due to our unique characteristics and sites.
We continue to advance the development of IC bus.
And plan to submit and I am going to the FDA.
Oh I see quite whether it is you eight seconds is a and b in the second half of 2021.
Taking together.
Recently, Zamora and I can fight.
Will complement each other very well.
We believe that a true targeting downstream in the complement cascade such as a more should be agnostic genetic sub types of a and b and.
And the inclusion criteria.
Gather warm and or you can gather to or.
Were not limited by genetic subs.
On the other hand, I seems like when did they have a more specific application to the proportion of patients.
I am doing well.
Expression, but H.T. already one identified a genetic subs.
Who are believed to get higher risk.
Continued development and progression.
They can be.
Mm hmm to execute the development strategy that was involved though.
Laura and I see 500 in a complementary fashion.
Impact multiple forms and stages of a and b.
Turning to business development.
We plan to continue our aggressive but selective efforts as we continue to explore all options for the future development and potential commercialization of Zamora.
Including potential out license and collaboration opportunities.
We expect to make strides through though.
That's the 2020 and is it 2021 as we continue to move up pipeline that for a few weeks and gene therapy product candidates fall.
We look forward to keeping you updated on our progress in the months to come.
Thank you for your time.
I will now turn the call over to calls.
Thank you Bobby and good morning, everyone.
We are excited to have people about remote I've Gotta Love results recently published in the draw no apologies one.
One of the leading ophthalmology drawn all the journal of the American Academy of apologies.
All the gold entitled Cfivea inhibitor of a few dropped off clinical hold geographic atrophy due to age related macular degeneration.
A randomized pivotal phase two three Paul it's publicly available online at Www dot.
Drawn all laborde.
We are excited to announce that the previously reported positive Gotta one data will be presented at the American Academy of what that knowledge, yet or maybe they read about subspecialty day on November 13th I got the dhananjay the make whole professor I've traveled Kamala Jeep was Cornell Medical College.
Oh and put them all of this in chief of the New Yorkers Retiree and hospital.
Additionally, Gotta one data were recently presented at medical conferences around the world, including individual ideal day to give you right now, but that the cycles Professor and chair of the Department will come all Legit University a bottom.
But decided to adopt the Kroger JLL, she's a very conservative at world that hospital.
The prestigious meeting of the club deals going on about the blend job for you Robert Mccarthy has it all from all of you on the member of the Detroit Faculty at Duke University Hospital.
And the American Society of retina specialists, but that the body Cooperman chairman of the department from all of you I didn't hear that.
As far as I said before that and they've got a one clinical trial the modem that its pre specified primary efficacy endpoint at 12 months, which is the physical significance in this international multicenter randomized double Matt Szot uncontrolled phase three clinical trial, so G.H. to them due to a and b.
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The reduction to the vagaries of GDP growth over 12 months or 27.38%.
A P value of 0.00 to them too, but as you move up to me, we've got a group of compared to the corresponding Sham control group of 27.81% with a P value of <unk> 0.005 wall, but if you need a form of the drug group as compared to the corresponding Sham control group.
The data for both groups were statistically significant.
These positive 12 month data further support the 18 month results, which were which we reported in June.
The more favorable safety profile well maintained throughout the 18 month trial.
As Glen mentioned earlier of June Thirtyth, we announced that the first version had been dosed with L. together two clinical trial.
Got it to me the international randomized double blind Sham controlled multi center phase three clinical trial evaluating the safety and efficacy of Zimura tumor regrowth in patients with geographic atrophy seconded to pay a b.
In total we are planning to enroll approximately 400 patients this clinical trial.
Patients are randomized one to 102 cohorts. The first of all just sitting monthly administration of the move up to really grab for 12 months and the second cohort receiving monthly administration of shop.
The trend the pre specified primary efficacy end point.
The main break of change or G., a grow over 12 months.
Mr about fundus Autofluorescence, a three time points.
Hey, slide six I'd like Htwo Timolol, so they've got to walk through the trial.
If the primary efficacy endpoint, but I'd love to all its gone too far for marketing approval of Zamora for the treatment of GE, a secondary to a and b the F.D.A. and USA.
About 12, we plan to leave on device patient visits were up two milligram arm to receive either monthly or every other month I'd be curious just gives you more about two milligram.
The final safety evaluation here to perform above 20 for all patients.
We believe many principal investigators are enthusiastic about enrolling patients would gather to clinical trial never.
Leveraging the quality of the Gotta one's results to Lucky about picture of the treatment of the pension for the other two trial.
Further we believe that the early onset of continuous treatment effect demonstrated you Gotta one trial will be a key motivator, probably 10% of the data to trial.
He's got all the principal investigators and their staff.
Yeah, Judy has about support for the data to a clinical trial.
Extra dimension, we are excited about our IC tough on the program.
Good I think that's what's your sense studies in vitro study histologic studies of eyes, you can be have indicated the potential role of it still won't give a and b.
I see thought on the potential to block both interest settle our excess are likely to see how they want to execute the GE. They provide additional advantages as a potential treatment option for G.A.O. potentially other state was up a and b.
Our preclinical all the other big after the D. I C pulse on that I'll probably be ongoing.
Having pulled zamora and I see probably hard drugs in our pipeline, what you're gonna have G.H., you're going to do a and b divisions are very valuable to potentially provide treatment for patients who bought his thoughts on the stages of age related macular degeneration.
The leading cause of vision loss in other words.
Regarding other gene therapy programs, we continue with our I'd be enabling activities for I see 100 and are planning to file an idea with the FDA early 2021, and initiate a phase one of the clinical trial in the first half of 2021.
We're also continuing with the idea that activity and natural history study told I see 200 or planning to file it I'd XT eight and a bit of a flood of genuine and initiate a phase one two clinical trial in the second half of 2021.
Our religion programs country. If you will for work yeah, optimizing the managing costs jobs, but automotive was up to 90 program and plan to select the leap can stop in the Fourq was up 2020 or early 2021.
I would like to thank you for your time I would now turn the call over to date.
Thank you, Chris and good morning, everyone I'd like to highlight a few items from our press release. This morning, and also update a yearend cash guidance in our expected cash runway.
For the quarter, our net loss totaled 25.5 million or 27 cents per share compared to a net loss of 14.1 million or 35 cents per share for Q3 2019 because.
This increase in net loss was driven primarily by an increase in R&D expenses associated with those and were clinical programs, our preclinical gene therapy programs and progression of our IC.
500 program during the quarter, we could you sort of.
Year to date, our net loss totaled 59.1 million or 87 cents per share compared to a net loss of 41.4 million or dollar per share for the same period in 2019 again, primarily due to an increase in R&D expenses.
Turning to our expected you're in cash balance and cash run rate. We now expect our yearend cash bound to range between 210 million and 215.
We estimate that our cash will be sufficient to fund our capital expenditures and operating expenses. As currently planned threatened mid 2024, excluding any potential approval or sales milestones payable to our connex right commercialization expenses prism weren't you.
Estimates are based on the current business plan, which includes a continuation of our ongoing clinical development programs. Furthermore, the progression of our gene therapy programs into the clinic and advancement of our IC 500 development program.
And let's assume that we will enroll approximately 400 pitches gather too.
Yes, it does not reflect any additional expenditures related to potentially starting somewhere in other indications, resulting from the potential in licensing or acquisition of additional kind of carriage or technologies or any other I suppose he didn't <unk> company pursue.
Now I'll turn the call back over to Glenn. Thank you for your time.
Well, thanks, David and thank you everyone for the time this morning and for your continued support I'd now like to turn the call over to the operator, so that we can open up the line for questions.
Operator, thank you.
If you would like to ask a question on todays call. Please press star one on your telephone keypad.
<unk> Star one to ask a question.
We can now take our next question.
From T. ankle asphalt from credit Suisse. Please go ahead.
Great. Thanks, so much for taking the question and congrats on the progress I just have a couple.
My first one is related to any regulatory interactions that you might have thought it should we expect any updates from formal regulatory interactions before together too.
Ralph month results by by any chance and another question on the later today, but for I see 100, with an eye and he kind of kind of coming fairly shortly.
Wondering if you could just perhaps talk about what could be expected data flow or any early insights on the trial design for for that program and how can we really.
Kind of follow the progression there. Thank you.
So if I could say I got for the out of the question and as to the regulatory interactions, but I think we have put in our disclosures that we've had a number of informal conversations with the regulators that we.
We are comfortable that there is a path forward with with gather too.
As to whether or not there'll be other interactions more to come on that but right now we're comfortable with the progress of our clinical program offers a more.
When I see 500, all class both coro somebody Privy to talk a little bit about that program as you heard from the script. We're very excited about that early days and looking forward to a possible I N D next year of course.
I think a geography, if I heard you correctly. The question was regarding I see one I'd read is that correct, yes, that's correct.
Yeah, Joe is there I guess.
<unk>.
Regarding the I feel 100, well it is for the Boston, maybe a joke.
It's all about the minute by minute that could actually speaking the products, which is an orphan indication the design is.
Because they want to be very similar to other gene therapy trials for orphan indications, where you look at the dose escalation.
Different dose levels.
And of this it's an orphan indication so it's going to be a a smaller size clinical trial and then the one would look at to see bulk or slow down a progression or potential improvement.
Got it okay. Thanks very much.
Next question comes from Stacy come from Cowen and company. Please go ahead.
Good morning, and thanks for taking my questions I guess, yeah. So a point of clarification can you remind us of your European approval strategy or discuss your conversations with the M. <unk> should we be expecting relatively close tightening in terms of potential trip offering them.
But the U.S. and actually watch.
Then a question on enrollment.
Given the initiation of enrollment in late June we see a clinical trials are not showing up I like listen date of June 2022. So wondering if we can interpret this as a base case enrollment to be complete in roughly one year and do you guys have any plans to disclose completion of enrollment.
Yeah.
So if I stay say first on the E. U I think you know as we've said in the past where our footprint is largely U.S. based although we are doing sites in Europe fit well together two we've also done those for forget the one so at the appropriate time.
Potentially look for someone to help us out with that.
There are two European regulatory strategy I think we're checking all the boxes.
In our trials to be prepared for that test for the timing I think that that's something that we'll talk about as we get a little bit closer to the end of our primary focus has been to talk about.
Okay are there too.
He was strategy here, but as I did mentioned in our call.
The strategy is twofold, not only to seek approval here, but to seek approval in Europe.
As well as to the enrollment timing I'm going to ask for being too to address that question for you.
Thank you for your question. They are enrollment is going very well we're on target.
Repaired ourselves meticulously for the potential of any kind of cool that Nike with surgeons during the wintertime.
And we put together a plan to maximize patient safety, while maintaining the momentum.
Sometimes attention to.
To give an example, if you'll be.
The procedures that were putting in place providing private transportation for our patients were providing.
Egypt as well as minimizing the amount of time these patients than during the study the opening.
We've been in very close communication with our investigators and our network study coordinators and have direct feedback on that little bit situation that each of these sites.
We also have an increased number of participating sites.
Countries to mitigate the impact or any kind of local surgeries and there are certainly very much on the lookout constantly for any kind of change in the code that situation.
Thats the time I want to take the opportunity to thank the investigators and their staff working very closely with US I also want to let you know force that yet.
We've experienced clinical staff that said let die.
Keep less the have Lynn Harrison as well as as our CMO oculus resign so.
So we're very confident that were taking a strategic path.
Given the current situation that is as efficient as possible for both recruitment as well as retention.
If I could ask I follow up on that if you have plans for this glass compression at the moment.
[noise] Stacy led us to this point I know in Clin trials that go there. So there's always a bit a date, there, but I think as we progress, we'll consider updating or the actual progress but.
But as of this current time, they're not giving a specific timeline for completion I think what's it is important is the discussion in this call the discussion to questions that a recruitment and retention.
Remains the highest priority of the company and I think is preventing just said no we.
We have a very experienced team working on this but to do this as quickly and efficiently as possible. So as time goes on we'll continue to update but no specific comment to disclose at this point.
Got it. Thank you so much and congrats on the progress. Thank you. Thank you Stacy.
There are no further questions at this time I would now like to turn the call back to the host for any additional or closing remarks.
Yes, operator, thank you and thank you for hosting today, Alex as I always say I appreciate everybody listening into our call we're focused on execution and bringing these programs forward for patients.
Thank you and appreciate.
Appreciate everybody listening today bye bye.
Thank you that concludes today's conference. Thank you for your participation ladies and gentlemen, you may now disconnect.
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