Regenxbio Inc. (RGNX) Q2 2019 Earnings Call Transcript

RGNX earnings call for the period ending June 30, 2019.

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Regenxbio Inc.  (NASDAQ:RGNX)
Q2 2019 Earnings Call
Aug. 07, 2019, 4:30 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good afternoon and welcome to the REGENXBIO Second Quarter 2019 Earnings Conference Call.

[Operator Instructions]

As a reminder, this conference call is being recorded. I would now like to turn the call over to Ms. Sara Garon Berl, Vice President of Law and Policy for REGENXBIO. You may begin.

Sara Garon Berl -- Vice President of Law and Policy

Good afternoon and thank you for joining us today. With us today are Ken Mills, REGENXBIO's President and Chief Executive Officer; Dr. Steve Pakola, our Chief Medical Officer; and Vit Vasista, our Chief Financial Officer.

Earlier this afternoon, REGENXBIO released financial and operating results for the three months ended June 30, 2019. The press release reporting our financial results is available on our website at www.regenxbio.com. Today's conference call will include forward-looking statements regarding our financial outlook, in addition to regulatory and product development plans. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted, and can be identified by words such as expect, plan, will, may, anticipate, believe, should, intend and other words of similar meaning. Any such forward-looking statements are not guarantees of future performance and involve certain risks and uncertainties. These risks are described in the risk factors and the management's discussion and analysis section of REGENXBIO's quarterly report on Form 10-Q for the quarter ended June 30, 2019, which is on file with the Securities and Exchange Commission and available on the SEC's website.

Any information we provide on this call is provided only as of the date of this call, August 7, 2019, and we undertake no obligation to update any forward-looking statements, we may make on this call on account of new information, future events or otherwise. Please be advised that today's call is being recorded and webcast. In addition, any unaudited or pro forma financial information that may be provided is preliminary, and does not purport to project financial positions or operating results of the Company. Actual results may differ materially.

I would now like to turn the call over to Ken Mills, President and Chief Executive Officer of REGENXBIO. Ken?

Ken Mills -- President and Chief Executive Officer

Thank you, Sara. Good afternoon everyone and thanks for joining us.

On today's conference call, we will provide a recap of our recent progress, advancing and expanding our NAV technology platform. Steve will provide an update of our internal clinical programs and Vit will provide an update on financial results for the second quarter of 2019. We'll then open up the call for questions.

Over the course of the past decade, REGENXBIO's mission has remained clear, to improve lives through the curative potential of gene therapy based on our proprietary NAV technology platform. We believe a single administration gene therapy treatments can significantly alter the course of disease in many patient populations, and we are committed to our work with these patients in mind. The past several months have been highly productive at REGENXBIO. We've advanced our internal programs on two treatment modalities, AAV-mediated antibody delivery and monogenic gene replacement. Both modalities utilize our NAV technology to develop treatments for those suffering from rare genetic diseases and expand treatment options for diseases broadly affecting public health.

With clinical development programs across three distinct therapeutic areas, including ophthalmology, central nervous system, and liver-directed, we have a broad and deep pipeline that leverages our NAV technology, which consists of over 100 novel AAV vectors. Our gene therapy product candidate, RGX-314, administered as a one-time treatment, can potentially help treat millions of patients. And today, we're excited to announce further positive interim results from our ongoing RGX-314 Phase I/IIa study trial for wet AMD, which Steve will address in his remarks. We are encouraged by these data and look forward to sharing more new interim data from all five dose cohorts in October.

Our licensee partners continue to make important progress as well. In May, the FDA approved the first gene therapy based on REGENXBIO's NAV technology platform. The approval of Novartis's Zolgensma marked a significant milestone for NAV technology, gene therapy, and patients and families facing spinal muscular atrophy, a debilitating and potentially deadly disease.

REGENXBIO's formula for success has always been driven by breakthrough science, talented people, sound capital and disciplined execution of our plans. Our decade of commitment to making gene therapy a reality for patients has transformed us into a global leader in developing gene therapies that have the potential to transform the way diseases are treated. Today we're driving an expanding pipeline of internal programs for chronic and rare diseases. It's an incredibly exciting time. And we're as motivated as ever to realize the fullest potential of the NAV technology-based gene therapy.

So with that, I'd now like to turn the call over to Steve for a clinical and regulatory update.

Steve Pakola -- Senior Vice President and Chief Medical Officer

Thanks, Ken.

I'm pleased to share advances in our internal programs across ophthalmologic, CNS, and liver-directed therapies. I'll begin with our RGX-314 program for the treatment of wet AMD, a disease that affects more than 2 million patients in the US, Europe and Japan.

Patients with wet AMD usually require anti-VEGF therapy, as frequently as every month indefinitely, to prevent vision loss. Continual long-term therapy with intraocular anti-VEGF injections is a burden to patients and families. And many patients struggle to comply with the recommended therapeutic regimen for current anti-VEGF therapies, leading to undertreatment and ultimately vision loss over time.

RGX-314 utilizes the NAV AAV8 vector to deliver a transgene, encoding an anti-VEGF antibody fab to potentially halt the proliferation of blood vessels in the retina. As we previously announced, we completed dosing for the Phase I/IIa clinical trial of RGX-314 in wet AMD, which included the dosing of 42 subjects in five cohorts at eight leading US retinal surgery centers, and reported durable treatment response from Cohort 3 at one year after a single administration of RGX-314.

50% of patients in Cohort 3 required no intravitreal anti-VEGF injections at one year. We announced today that these patients continue to be injection-free through 18 months. We are particularly encouraged by these results, given the subjects in the study were difficult to treat and had received frequent anti-VEGF therapy, prior to enrollment in the trial. We also are pleased to report that at one month, we see dose-dependent increases in RGX-314 protein expression levels across all doses.

We expect to report clinical data from Cohort 3 out to 18 months and interim data from Cohorts 4 and 5 in October of this year. This month, we also had a Type B meeting with the FDA to discuss our planned Phase IIb trial. We are pleased with the outcome of this meeting, which keeps us on track to initiate a Phase IIb trial in wet AMD by the end of this year. Progress continues toward our planned filing of a new IND for a Phase II trial, evaluating RGX-314 in subjects with diabetic retinopathy in the second half of this year. Phase I/IIa safety data from the ongoing RGX-314 wet AMD trial will be used to support dose selection. Manufacturing is in process to support enrollment in RGX-314 trials for both wet AMD and DR.

Next I'll turn to our gene therapy programs for the treatment of monogenic diseases, including liver-directed and CNS-directed programs. In our liver-directed program, RGX-501 for the treatment of homozygous familial hypercholesterolemia, we have reinitiated screening and enrollment of subjects in Cohort 2 of the Phase I/II clinical trial. We expect to report interim data from Cohort 2 with corticosteroid prophylaxis in the second half of this year.

Turning to our CNS programs. For RGX-121 for the treatment of MPS II, screening, dosing, and activation of additional study sites continues in the first of two dose cohorts in the Phase I/II clinical trial. We expect to present an interim data update in the second half of this year. For RGX-111 for the treatment of MPS I, subject recruitment and additional site activations are ongoing in the Phase I clinical trial. For RGX-181 for the treatment of CLN2 disease, we expect to file an IND or foreign equivalent for the first-in-human clinical trial in the second half of this year.

We will continue our diligent work to drive these programs forward, and we look forward to providing you with updates on our progress. With that, I turn the call back over to Ken.

Ken Mills -- President and Chief Executive Officer

Thank you, Steve.

We're very encouraged by these updates, and especially the new interim data for RGX-314. REGENXBIO has an extensive footprint in the gene therapy space, and our scientific innovation could potentially bring many breakthrough gene therapy treatments to market through not only our own product candidates but also product candidates developed by our licensee network.

And as of June 30, 2019, our technology was being applied in more than 20 partnered product candidates in development by NAV technology licensees. 15 of these partnered product candidates are in active clinical development. And as I mentioned earlier, Novartis's Zolgensma, which uses the NAV AAV9 vector, has been approved by the FDA. It's currently marketed in the US.

Last month, we announced that we added a new NAV technology licensee with a new worldwide license with the Pfizer for the development and commercialization of gene therapy for the treatment of Friedrich's ataxia, the most common hereditary ataxia. This license agreement further validates the strength of our intellectual property portfolio, and we continue to be encouraged by the NAV technology in the treatment of movement disorders. As licensee programs progress and achieve efficacy and safety milestones, they further validate the broad application in the NAV technology platform and provide additional data that collectively drive the advancement of the AAV gene therapy space. You can refer to our press release issued earlier today for specific updates on other external partners.

And finally, to touch on one other update from May, we announced our plan to construct a cGMP production facility in Rockville, Maryland. The new cGMP production facility will be integrated into our previously announced new headquarters, and construction is under way and, when completed, will allow for production of NAV technology-based vectors at scales up to 2,000 liters using our platform suspension cell culture process. The facility will be designed to meet global regulatory requirements, and is expected to be operational in late 2021. The creation of this additional manufacturing capacity, utilizing our platform process, will allow us to more efficiently advance our development programs from research stage to the clinic and ultimately to patients.

This has been a priority for us to develop excellent people, plant, and systems, and we hold ourselves to the highest standards of quality in the development of our gene therapy product candidates. We expect our manufacturing network to be capable of supporting early and late-stage programs, which may require a large-scale vector supply.

With that, I'd like to turn the call over to Vit for a review of the financials. Vit?

Vit Vasista -- Senior Vice President Chief Financial Officer

Thank you, Ken.

REGENXBIO ended the quarter on June 30, 2019 with cash, cash equivalents, and marketable securities totaling $449.7 million compared to $470.6 million as of December 31, 2018. Cash, cash equivalents, and marketable securities, as of June 30, 2019, included $32.1 million of marketable equity securities in Prevail Therapeutics. REGENXBIO is the co-founder of Prevail, and currently owns 2.43 million shares of Prevail common stock. Prior to Prevail's IPO in June 2019, REGENXBIO's equity interest in Prevail had a carrying value of $400,000, and were included in other assets on the consolidated balance sheet.

Upon the completion of Prevail's IPO, the securities were reclassified to marketable securities and subsequently remeasured at fair value. The decrease in cash, cash equivalents and marketable securities during the six months ended June 30, 2019 was primarily attributable to $53 million of net cash used in operating activities during the period, partially offset by the unrealized gain of $31.7 million related to the marketable equity securities of Prevail.

Revenues were $7.9 million for the three months ended June 30, 2019 compared to $40 million for the same period in 2018. The decrease was primarily attributable to$40 million of non-recurring license revenue, recognized during the second quarter of 2018 under our amended license agreement with AveXis. The decrease was partially offset by revenue recognized during the second quarter of 2019 resulting from license options exercised and development milestones achieved by the licensees during the period, as well as royalties on net sales of Zolgensma. Commercial sales of Zolgensma commenced in the second quarter of 2019, and we expect royalties to increase in future periods. We are also eligible to receive a milestone payment of $80 million from AveXis upon the achievement of $1 billion in cumulative net sales of Zolgensma.

Research and development expenses were $29.5 million for the three months ended June 30, 2019 compared to $21.5 million for the same period in 2018. The increase was primarily attributable to increased personnel costs, laboratory and facilities costs, and external expenses associated with conducting clinical trials and manufacturing-related services.

General and administrative expenses were $13.4 million for the three months ended June 30, 2019 compared to $8.3 million for the same period in 2018. The increase was primarily attributable to increased personnel costs and professional fees for advisory and other services.

Net loss was $1.5 million or $0.04 basic and diluted net loss per share for the three months ended June 30, 2019, compared to net income of $10.6 million or $0.33 basic and $0.30 diluted net income per share for the same period in 2018. Net loss for the three months ended June 30, 2019 includes the unrealized gain of $31.7 million on REGENXBIO's marketable equity securities of Prevail recognized during the period.

Based on its current operating plan, REGENXBIO expects its balance in cash, cash equivalents and marketable securities to be at least $350 million as of December 31, 2019.

With that, I will bend the knee and turn the call back to Ken to provide final thoughts and review our upcoming 2019 milestones.

Ken Mills -- President and Chief Executive Officer

Thanks, Vit. That was a good update also, although I liked Steve's update better.

To summarize what we've discussed today, the past quarter marked a highly productive period for the Company. We continue to advance RGX-314 through clinical development for the treatment of wet AMD and DR. Today, we shared additional positive interim update on the RGX-314 program for wet AMD, in which we reported RGX-314 continues to be well tolerated. We observed dose-dependent increases in RGX-314 protein expression across all five dose cohorts. 50% of the subjects treated in Cohort 3 continue to remain free of anti-VEGF injections at 18 months, and we plan to share more new interim updates from all five dose cohorts in the trial in October.

In addition, we remain excited about the anticipated start of the Phase IIb trial in late 2019. We're also on track to file a new IND for our Phase II trial of RGX-314 in diabetic retinopathy in the second half of this year. Our regulatory and clinical progress also includes continuing enrollment for RGX-501 and RGX-101, while our expanding research pipeline includes new programs for the treatment of hereditary angioedema and tauopathies, which we are developing in collaboration with Neurimmune.

We're excited by a new strategic direction to include AAV mediated delivery of antibodies to treat diseases that are affecting larger populations, while also advancing gene therapy programs to treat important rare monogenic diseases. The recent FDA approval of Novartis's Zolgensma, based on our NAV technology platform, was an exciting milestone that further validates NAV technology. After a decade of steadfast effort and focus, we remain dedicated and committed to improving lives through the curative potential of gene therapy.

Before we go to Q&A, take this last moment to recognize the excellent work of our employees, partners, clinical trial investigators, and of course especially every patient and family who've chosen to participate in our clinical trials. With our innovative science, inspired people and partners, and strong cash position, we're well-positioned to achieve future milestones, advanced therapies for patients with significant unmet medical needs.

With that, will turn the call over to the operator for questions.

Operator

Thank you.


Related Articles

Questions and Answers:

Operator

[Operator Instructions]

Our first question comes from Mani Foroohar with SVB Leerink. Your line is Open.

Mani Foroohar -- SVB Leerink -- Analyst

Hey guys, thanks for taking question.

I have a quick financial one around how to think about the royalty stream from Novartis. You guys reported licensee and royalty revenue not breaking out. Could you break out the royalty revenue, either gross royalty or royalty net of what you guys owe out to U Penn for sales of Zolgensma thus far?

And if you're not comfortable doing so, can you tell us at what bar of total royalty revenue you think you would reach the materiality threshold where you would break that royalty revenue out as a single independent line item?

Ken Mills -- President and Chief Executive Officer

Hey, Mani, thanks for the question.

Yes, this quarter obviously we recorded, as Vit described, revenues received on the basis of Zolgensma sales by Novartis in the license and royalty category of our profit and loss statement. And there was not a material GAAP reason to break out that sale number for this period because we really had just a fraction of the quarter that involved the ramp up of those sales. I think we'll have better guidance based on what we see in terms of the ramp over the next several quarters for when that breakout will occur, and also when that breakout will occur in parallel for the cost of sales or cost of product line item associated with that.

Mani Foroohar -- SVB Leerink -- Analyst

Great. And as a quick follow up, like how many patients of data should we expect to see at the first HoFH data release, approximately?

Ken Mills -- President and Chief Executive Officer

Well, we're currently operating on a reenrollment schedule for the dose Cohort 2 with corticosteroid prophylaxis that has an N of three. And we will have a better sense toward the end of the year of what our progress has been, but we're hopeful to have data on that cohort at the end of the year.

Mani Foroohar -- SVB Leerink -- Analyst

Great. Thanks Guys. I will be back in the queue.

Ken Mills -- President and Chief Executive Officer

Sure. Thanks.

Operator

And our next question comes from Gena Wang with Barclays. Your line is open.

Gena Wang -- Barclays -- Analyst

Thank you for taking my questions.

I have two regarding wet AMD program. Ken, you mentioned that cohort 4 and 5, you showed a dose-dependent increase in protein expression. Just wondering, was that proportionally correlated with the dose increase?

Ken Mills -- President and Chief Executive Officer

Gena, to us, dose dependence means increasing from the previously reported cohorts proportional to the doses that have been used in Cohort 4 and Cohort 5.

Gena Wang -- Barclays -- Analyst

Okay. So like say, if double the dose, then you saw double the protein level.

Ken Mills -- President and Chief Executive Officer

Yes, across all five cohorts, we'll be able to show mean values from patients at one month. By the time we report data, that will show that dose dependency.

Gena Wang -- Barclays -- Analyst

And then another question is you said three patients have had 18-months injection-free. So, could you just remind us what is the criteria for rescue injection? And then also, can you remind us the injection rates 12 months prior to the gene therapy for these three patients?

Steve Pakola -- Senior Vice President and Chief Medical Officer

Hi, Gena, Steve here. Thanks for the question.

So it is a key question, what criteria you use in a trial when you're looking at reinjection rates of anti-VEGF therapy. In this Phase I/IIa trial, we had very liberal reinjection criteria. So, basically if a principal investigator sees any decrease in visual acuity due to presence of fluid or an increase in fluid leading to a decrease in visual acuity, they at their discretion, could give a reinjection. So, I think it's important to note that that's a very low bar for reinjecting compared to some other studies that have been done or later stage studies, where you'd have -- let's call it a tougher criteria where you'd need, for example, a 75 micron increase and/or a decrease of a certain amount of best corrected visual acuity letter decrease. So, that's part of why we're so encouraged by these results. Not only is it 50% of the subjects in Cohort 3 that have not needed any reinjection through now 18 months, it's in the face of this very low bar for reinjection for these subjects.

To the second part of your question, which is also critical, how much anti-VEGF need exists for these patients. Since, if they didn't need many injections before, they got gene therapy treatment, you wouldn't expect many injections after. And in this case, we have a very anti-VEGF needy population that's been enrolled in this trial. So, on average, patients have needed 35 injections or more chronically prior to receiving RGX-314. In the last year, one point is that, as part of the inclusion/exclusion criteria, subjects needed to have four injections within the last eight months. So, already right here, you know it's a fairly injection-needy population. And in spite of having those injections, there were still fluid present at entry into the study.

If we look at a year, we previously disclosed some of this for the early cohorts, depending on cohorts anywhere from six to 10 injections in the prior year on average. And we'll have updates on this as well, going forward in October, when we update on all the cohorts. We'll certainly put it in the context of how much the anti-VEGF injection rate was for subjects prior to getting gene therapy.

Gena Wang -- Barclays -- Analyst

Great, thank you very much. If I can just quickly ask one more question regarding the Phase IIb trial design, you said you're in line with FDA. Could you just remind us what is the final trial design for Phase IIb? Thank you.

Steve Pakola -- Senior Vice President and Chief Medical Officer

Yes. Later in the year, when we give the update on the program after we've presented an update on the actual results that we've seen to date, the interim results including all five cohorts, we'll give more details on the actual trial design.

Suffice it to say, now, based on the successful outcome of our Type B meeting, we're very encouraged on the main design elements of our Phase IIb study. And we had a very good constructive discussion with the FDA. So, we feel very confident reiterating our guidance and actually are expeditiously, even more than before, looking forward to move forward with starting the study by the end of the year.

Gena Wang -- Barclays -- Analyst

Thank you very much.

Ken Mills -- President and Chief Executive Officer

Thanks Gena.

Operator

Thank you. Our next question comes from the Matthew Harrison with Morgan Stanley.

Kostas Biliouris -- Morgan Stanley -- Analyst

This is Kostas on for Matthew. I have a question regarding AMD. Could you talk a little bit about the competitive advantages of RGX-314 compared to other gene therapies that are currently in development? Thank you.

Ken Mills -- President and Chief Executive Officer

Hi, Kostas. This is Ken. I'll start and maybe Steve can provide some additional color.

Steve described the origination of the product candidate, which I think has several important features that are differentiators, including the use of our NAV technology, of course the AAV8 vector, which is highly selective for cells in the retina that we want to target for this treatment in wet AMD, and other indications that will be responsive to anti-VEGF therapy. We're also using the sub-retinal route of administration and have initiated, and have now completely enrolled a trial that, to my knowledge, is the largest of its kind. However, you measure it, number of subjects, 42 on treatment, or number of doses, five doses.

And we've also, as Steve was alluding to in his response to Gena, according to our investigators, have enrolled in a population that's referred to as the hardest to treat wet AMD patients. So, designing a program at this stage for Phase I/IIa that helps us evaluate the pharmacology of RGX-314 in a true hard-to-treat natural history background of wet AMD patients and advancing, what in my view, is the current gold standard of sort of safe and effective route of administration for delivery of AAV to the retina, supported by a lot of preclinical and clinical work ourselves and others have done, but also a worldwide product approval, really sets up for I think a large and important study, where we're collecting a lot of data.

And now what we're seeing also is first of its kind, I think in the results, which is dose-dependent response and sustained protein expression. We are among the first, if not the only company, to evaluate a wet AMD population using a gene therapy looking for downstream protein production, protein expression after the gene therapy has been delivered and transduced. And we've demonstrated and we announced today for the first time dose-dependent increases in protein expression across all five cohorts. And durability of expression that we previously talked about of out to 12 months, but durability of effect, clinical effect of up to 18 months, and we continue to follow patients. And we'll have further updates.

Our product candidate in our program is robust. And the product candidate in the route of administration, I think demonstrated to us that there is an important need to advance this into later stages of development. The engagement with FDA, for us, supports our interests. And we're encouraged by the evidence that we're generating based on the pharmacology of this product candidate in patients with very clear and well-characterized wet AMD.

Steve Pakola -- Senior Vice President and Chief Medical Officer

Yes. And I'd add that, if you think of it in terms of the non-gene therapy-based developmental programs that are ongoing, we're very encouraged that -- I think these other programs, like from Kodiak, Graybug, or the ranibizumab port delivery system, for example. I mean, these all show and confirm and validate the need for less frequent injection, but they all still are just incremental advances in terms of, yes, it's moving in the right direction of less frequent dosing, but you still need indefinite reinjection or refills with these different modalities.

And that's where a foundational anti-VEGF platform like gene therapy is a potential game changer. And I'd just second what Ken said, it's in that regard in thinking of gene therapy, we have the gold standard approach for delivering a vector and getting sustained protein expression that we've now shown clinically, and now shown a link between gene expression on a durable basis, and anatomic and functional outcome measures over a longer time horizon that it's also being seen in the setting of a dramatic reduction in anti-VEGF dosing compared to the prior need of these patients. So, we again are quite encouraged, based on these results, to move forward.

Ken Mills -- President and Chief Executive Officer

Yes. And I'd probably add one other piece to the profile that's now emerged clinically, but we established pre-clinically with RGX-314 in the route of administration work that we did at Penn and Johns Hopkins, which is we've demonstrated that we have a product candidate and a route of administration, where we don't need to rule out patients due to risks of ocular inflammation or preexisting neutralizing antibodies, nor do we need to administer any oral inflammatory or anti-inflammatory immunosuppressive medications prophylactically or otherwise to address those conditions. So, we believe that that provides a much clearer path to understand the pharmacology clinically, but also a clearer path in terms of the market opportunity for this product.

Kostas Biliouris -- Morgan Stanley -- Analyst

Thank you so much. This is very helpful.

Ken Mills -- President and Chief Executive Officer

Sure. Thanks Kostas.

Operator

[Operator Instructions]

Our next question comes from Dane Leone with Raymond James. Your line is now open.

Dane Leone -- Raymond James -- Analyst

Alright, thank you for taking the questions and thanks for the updates on the clinical progress.

First one from me, could you update us on the mean number of injections for the other half of Cohort 3? I think at 12 months, they had about 2.3.

Steve Pakola -- Senior Vice President and Chief Medical Officer

We'll be providing quantitative updates for all the cohorts in October. I'm comfortable saying though, that the findings that we're seeing based on the data coming in is very consistent with what we've seen at our one-year readout, but we'll have quantitative details in our October update.

Dane Leone -- Raymond James -- Analyst

Okay. And then could I clarify something from the press release and the comments? Is the follow-up going to be different between Cohort 4 and 5, or are both cohorts going to have a six month follow-up?

Steve Pakola -- Senior Vice President and Chief Medical Officer

So, we think six-month data is very important. So, of course, if you march forward from when we announced completion of recruitment of Cohort 5. if we're updating in October, it's just a matter of how many patients in Cohort 5 will we have at least six-month data on.

Dane Leone -- Raymond James -- Analyst

Okay. I guess, I was asking whether Cohort 4 would have a longer follow-up than six months or not?

Ken Mills -- President and Chief Executive Officer

Yes, those patients will have been enrolled in the study longer than six months by the time we report in October. And certainly, the Cohort 3 we said we've already got patients on average out to 18 months. What we want to do, Dane, at the next announcement of the quantitative data is show those comparisons across cohorts, their dose dependency based on one month protein and as much as possible their six month clinical outcomes, which is where we started with this whole package for this trial, when we made our first announcement, and where we think the best pharmacology and interpretation of the relationship between pharmacology and clinical effect exists.

Dane Leone -- Raymond James -- Analyst

Okay. And then one on the DME program. It sounds like you're kind of implying that, since you have the dose figured out from the wet AMD study, that the DME study should basically accelerate and potentially get on a parallel path with wet AMD, which is more kind of the traditional or registrational approach for the anti-VEGF injectable class. Am I interpreting things right or over interpreting it?

Steve Pakola -- Senior Vice President and Chief Medical Officer

Well, for our diabetic retinopathy development plan, we've discussed our target to start a Phase II DR trial. We feel based on the data that we'll have from the wet AMD study, a separate VEGF-driven retinopathy, although it's a different disease process I think we know enough from all the different anti-VEGF programs that have been done across the different retinopathies that we can utilize that precedent to help us select doses for evaluation in a diabetic retinopathy population, as well as, of course, the safety data that we'll have and tolerability data.

As far as the actual stage of development, I mean, we think of them independently. But certainly by having the Phase I/II data from wet AMD, I think it puts us in a good position to advance a Phase II study already with diabetic retinopathy.

Dane Leone -- Raymond James -- Analyst

I am sorry. In my mind, I flipped the DME for DR.

And then just finally, so into October, this is going to be basically like an event you're hosting versus a medical meeting, correct?

Ken Mills -- President and Chief Executive Officer

Well, I mean, our team, along with our investigators, are evaluating a few options for presentation, including at upcoming events. And we'll plan to announce that when we've completed that process and confirmed a final decision, Dane.

Dane Leone -- Raymond James -- Analyst

Okay great. Thank you guys.

Ken Mills -- President and Chief Executive Officer

Sure.

Operator

Thank you and I am showing no further questions in the queue at this time. I'd like to turn the call back to Ken Mills for any closing remarks.

Ken Mills -- President and Chief Executive Officer

Those were great questions, almost better than the updates we had today. Thanks everyone for participating, thanks operator, thanks for joining us and we look forward to providing you with further updates. Have a great night.

Operator

[Operator Closing Remarks]

Duration: 40 minutes

Call participants:

Sara Garon Berl -- Vice President of Law and Policy

Ken Mills -- President and Chief Executive Officer

Steve Pakola -- Senior Vice President and Chief Medical Officer

Vit Vasista -- Senior Vice President Chief Financial Officer

Mani Foroohar -- SVB Leerink -- Analyst

Gena Wang -- Barclays -- Analyst

Kostas Biliouris -- Morgan Stanley -- Analyst

Dane Leone -- Raymond James -- Analyst

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