IVERIC bio, Inc.
Q2 2019 Earnings Call Transcript

Published: 2 Aug 2019

[Operator:]

Good day, and welcome to the IVERIC bio Second Quarter 2019 Results Conference Call. Today's conference is being recorded. And now at this time, I would like to turn the conference over to Kathy Galante. Please go ahead.

[Kathy Galante:]

Good morning, and welcome to IVERIC bio's Second Quarter 2019 Earnings Call. Representing IVERIC bio today are

[Glenn Sblendorio:]

Thanks, Kathy, and good morning, everybody. We appreciate you joining our call this morning. First, we're excited to be hosting our first Gene Therapy R&D Investor Day on September 13. We hope you all will be able to join us at this event, where we have several highly recognized gene therapy scientists and key opinion leaders in retinal diseases. And we'll also provide an update on the state of inherited retinal diseases in our gene therapy programs. Kourous will talk more about this in a few moments.We're pleased with the company's progress as we continue to advance and expand our orphan inherited retinal diseases, or IRD, gene therapy pipeline. We're on track to bring our portfolio of IRD programs into the clinic, starting in the second half of 2020 with our lead candidate, IC-100, for rhodopsin-mediated autosomal-dominant retinitis pigmentosa. We also entered into an exclusive global license agreement with the University of Pennsylvania and the University of Florida Research Foundation for rights to develop and commercialize gene therapy products for candidates for the treatment of BEST1-related IRDs, including Best vitelliform macular dystrophy, also known as Best disease.We're also encouraged by new research data from our minigene CEP290 collaboration for Leber Congenital Amaurosis type 10, or LCA10, with the University of Massachusetts Medical School, which we believe supports our plans to move forward with this program. We just announced that we expanded our gene therapy portfolio with the addition of minigene sponsored research program for USH2A-related IRDs, including Usher syndrome type 2A and USH2A-associated nonsyndromatic autosomal recessive retinitis pigmentosa. And we have also engaged Paragon to do our gene therapy manufacturing. Paragon, now a part of Catalent Biologics. And they will manufacture both our IC-100 and IC-200, our 2 lead gene therapy candidates, for preclinical and planned Phase I/II supply.We continue to make progress with our minigene programs. Last week, we announced that we exercised our option and entered into an exclusive global license agreement with the University of Massachusetts for rights to develop and commercialize mutation-independent, novel, adenosine-associated virus minigene therapy product candidates for the treatment of LCA10 due to CEP290 gene mutations. LCA10 is the most common of all LCAs.Further, we announced that we are expanding our gene therapy portfolio by entering into a sponsored research agreement with UMass Medical School and an exclusive option agreement with the University of Massachusetts for rights to develop and commercialize mutation-independent, novel, adenosine-associated virus minigene therapy products for the treatment of USH2A-related IRDs. This is a group of orphan IRDs that include Usher syndrome type 2 and USH2A-associated nonsyndromatic autosomal recessive retinitis pigmentosa.A cornerstone component for advancing our gene therapy pipeline is to have a solid GMP manufacturing strategy in place. In June, we announced that we have entered into a strategic manufacturing relationship with Paragon Gene Therapy, now a part of Catalent Biologics. This agreement is for the manufacture of AAV vectors for preclinical and planned Phase I/II clinical supply of IC-100 and IC-200. Our relationship with Paragon has given us access to state-of-the-art manufacturing capabilities that we believe will pave the way to enter the clinic with IC-100 in the second half of 2020 and with IC-200 in the first half of 2021.The execution of our therapeutic programs continues to stay on track as we look forward to receiving and reporting initial top line data from our ongoing randomized, double-masked, sham-controlled Phase IIb clinical trial assessing the safety and efficacy of Zimura monotherapy in patients with geographic atrophy secondary to dry AMD in the fourth quarter of this year. As we stated in the past, if this data from this trial is positive, we plan to seek partnership opportunities for further development of Zimura.I'd now like to turn the call over to Kourous to provide more details about the Gene Therapy R&D Investor Day and to review our programs in more detail. Kourous?

[Kourous Rezaei:]

Thanks, Glenn, and good morning, everyone. As Glenn mentioned, I would like to remind everyone that we are hosting our first Gene Therapy R&D Investor Day on Friday, September 13 in New York from 8

[David Carroll:]

Thank you, Kourous, and good morning, everyone. I'd like to highlight a few items from our press release of this morning and also reaffirm our year-end cash guidance. For the quarter, our net loss totaled $14.4 million or $0.35 per share compared to a net loss of $13.2 million or $0.37 per share for Q2 2018 as Q2 2018 reflected $1 million tax benefit associated with the settlement of a local tax audit. Year-to-date, our net loss totaled $26.9 million or $0.65 per share compared to a net loss of $26.3 million or $0.73 per share for 2018. This increase in net loss is driven again primarily by the aforementioned tax benefit associated with our settlement of a local tax audit.Turning to our expected year-end cash balance. Our cash balance at June 30 was approximately $107 million, a $10 million decrease from Q1. The company reaffirms its estimate that year-end cash will range between $80 million and $85 million based on our current 2019 business plan, which includes the expansion of our gene therapy programs, including our recent UMass agreements, expansion of our HtrA1 development program and the continuation of our clinical development programs for Zimura. Of course, these estimates do not reflect any additional expenditures, including any associated development costs in the event that the company in-licenses or acquires any new product candidates or technologies or commences any new research programs.I now turn the call back over to Glenn. Thank you for your time.

[Glenn Sblendorio:]

Well, thanks, Dave. In conclusion, I want to reiterate our commitment to progressing our company to our goal to potentially become a leader in the development of transformative gene therapies for inherited retinal diseases. We believe we are well positioned to bring our gene therapy orphan IRD portfolio forward.We look forward to keeping you updated on the execution and progress of our company. We also hope to see you at our Gene Therapy R&D Day on September 30 -- 13. And if anybody has questions about that or would like an invitation, please contact Kathy with any questions that you may have about this event.I want to again thank you for joining our call today and would like to open the lines for questions.

[Glenn Sblendorio:]

Thank you again. Look forward to engaging everybody throughout the summer, and see you on September 13. Goodbye.

[Operator:]

Ladies and gentlemen, this will conclude your conference for today. We do thank you for your participation, and you may now disconnect.