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Adverum Biotechnologies, Inc. (NASDAQ:ADVM)
Q4 2019 Earnings Call
Mar 12, 2020, 4:30 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good afternoon and welcome to Adverum Biotechnologies' Fourth Quarter and Year-End 2019 Corporate Update Conference Call. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session after the prepared remarks. As a reminder, this conference call is being recorded. I would now like to hand the call over to Myesha Lacy, Vice President of Investor Relations and Corporate Communications of Adverum. Please go ahead.

Myesha Lacy -- Vice President of Investor Relations and Corporate Communications

Thank you, operator and welcome everyone. Today, we issued a press release reporting our financial results for the fourth quarter of 2019. A copy of this release is available on the Press Releases page of the Investor Relations section of our corporate website at www.adverum.com. Please note that a replay of today's call also will be available on the Events and Presentations section of our website.

Joining me for the prepared remarks portion of the call today is Leone Patterson, President and Chief Executive Officer and Dr. Aaron Osborne, Chief Medical Officer. Then Leone, Aaron and our Chief Financial Officer, Thomas Leung will be available for the Q&A portion of the call.

As a reminder, we will be making forward-looking statements regarding our product development plans, research activities and operations, as well as our financial outlook. These statements are subject to risks and uncertainties that may cause actual results to differ materially from those forecasted. A description of these risks, can be found in our 10-K which was filed this afternoon. I would now like to turn the call over to our President and CEO, Leone Patterson.

Leone Patterson -- President, Chief Executive Officer and Director

Thank you, Myesha. Good afternoon everyone and thank you for joining us today. Before we dive into our business progress, I'd just like to acknowledge the fluid situation as it relates to coronavirus and the broader community. Like many companies, we are taking necessary precautions to support our employees and our business and we will continue to monitor the situation closely.

During this call. we will review the significant momentum in advancing our lead gene therapy candidate ADVM-022 and also provide a corporate update. Aaron will then review the significant clinical progress with ADVM-022 targeting wet AMD, including recent data presentations and our plans for advancing a second indication, Diabetic Retinopathy or DR. We will then open the call for questions. This is an exciting time to be working in gene therapy and to be part of what many consider to be a gene therapy revolution in treating serious diseases. At Adverum, we are focused on delivering what we believe can be transformative therapies for patients living with serious ocular and rare diseases. We believe our lead gene therapy program ADVM-022 has the potential to be a onetime intravitreal injection gene therapy approach for our lead indication, wet AMD.

This past year, we have gained significant momentum with our clinical progress in the development of our 022 in the OPTIC Phase 1 dose-ranging study. As a reminder, we have been exploring two doses in the OPTIC Trial at 6 x 10^11 and a three-fold lower dose of 2 x 10^11. We have presented data from our Phase 2 cohorts and I'm excited to announce that we recently completed dosing all nine patients in our third cohort. We can now focus on completing enrollment in cohort 4 and screening of patients has begun. The clinical data presentations on OPTIC cohorts 1 and 2 have been very promising where ADVM-022 demonstrated robust efficacy and evidence of a dose response. We look forward to present a new clinical data from OPTIC in May this year. Additionally, we plan to present data from all four cohorts in OPTIC the second half of this year.

We also plan to develop 022 in a second indication, Diabetic Retinopathy, or DR with an IND submission in the first half of 2020 and a Phase 1, 2 beginning in the second half of the year. We are positioning our company to be a leader in gene therapy. Beyond, ADVM-022, we are focused on developing a pipeline of novel gene therapies. Our industry-leading AAV platform provides us with a number of compelling options for expansion and we look forward to talking about this progress during the course of this year.

Also, we are making great strides in other areas of our business. First, at the beginning of the year, we moved to our new headquarters in Redwood City. This move supports our growth plans and enables us to expand our core capabilities, including process development, and manufacturing. Next, we appointed Angela Thedinga as Chief Technology Officer. Angela brings deep and relevant experience in gene therapy, as she led at AveXis, efforts in developing the early manufacturing strategy, which enable them to transition to early stage AAV manufacturing process to a scalable commercial manufacturing process. Angela will focus on leading our manufacturing strategy as we advance toward later stage clinical trials and prepare for potential commercialization.

And finally, we are in a strong financial position with over $300 million in cash after completing a public follow-on offering last month, raising net proceeds of approximately $141 million, which together with our year-end cash of $166 million is expected to fund operations into 2022. Before turning the call over to Aaron, I wanted to just share how excited I am to be leading this company where we are at the cutting edge of developing a potential one-time treatment for patients with wet AMD, and DR. We are committed to our mission to advance these programs and our pipeline of novel gene therapies for patients with serious ocular and rare diseases. I'd now like to turn the call over to Aaron, who will provide further details on our clinical progress for ADVM-022. Aaron?

Aaron Osborne -- Chief Medical Officer

Thanks, Leone. Our primary focus as a company is always on the needs of our patient population. In this regard, today, we are not aware of any specific coronavirus impact on the OPTIC trial. We are continuously monitoring the evolving situation with coronavirus and are in regular communication with our clinical trial sites and our vendors involved in our clinical trials. Our thoughts and wishes are with everyone who has been impacted by COVID-19.

Now turning to OPTIC, this has been a truly exciting time for ADVM-022 as we advance OPTIC for wet AMD and develop plans for a second clinical indication in Diabetic Retinopathy. OPTIC continues to progress very well. As Leone mentioned, we recently completed patient dosing cohort 3 and open screening for cohort 4. There is strong support from the investigators and clinical sites to quickly enroll this cohort to allow us to share data from all four cohorts in a total of 30 patients later this year.

In January of this year, Dr. Charles Wykoff presented detailed efficacy and safety data from cohort 1 patients. Then, in February, Dr. David Boyer presented a further update from OPTIC including data from patients in cohort 2 who received a threefold lower dose of ADVM-022. To briefly summarize the data from cohorts 1 and 2, ADVM-022 demonstrated the robust efficacy signal and evidence of the dose response, which we measured as follows.

In cohort 1, using a dose of 6 x 10^11 vector genomes per eye, six of six patients remained rescue-injection-free at a median follow-up of 50 weeks with three of those patients out to 52 weeks or beyond. In cohort 2, using a three-fold lower dose of 2 x 10^11, four of six patients were injection-free at 24 weeks. This provides us further evidence of robust efficacy in addition to a dose response.

In both cohorts combined, 10 of 12 patients or 83% of patients remained rescue-injection-free. For these patients, vision was generally maintained as demonstrated by stable mean best corrected visual acuity compared to baseline. Retinal anatomy improvements were achieved and maintained as demonstrated by mean central subfield thickness compared to baseline. It's important to remember the patients in OPTIC previously required frequent anti-VEGF injections to maintain their vision.

In cohorts 1 and 2, patients had received an average of over nine anti-VEGF injections in the 12 months prior to receiving our ADVM-022 in OPTIC. The assessment of safety is of paramount importance in early phase clinical trials and we are pleased to report ADVM-022 continues to demonstrate a favorable safety profile with no drug related or procedure-related serious adverse events, no drug-related systemic adverse events and no adverse events meeting the criteria for dose limiting toxicity. Low grade information that is responsive to steroid eye drops treatment has been commonly reported. Importantly, we have seen no evidence of vasculitis, retinitis, or choroiditis following intravitreal ADVM-022 administration.

In cohorts 3 and 4 of OPTIC, we are administering prophylactic steroid eye drops instead of prophylactic oral steroids as were used in cohorts 1 and 2. We believe that the use of steroid eye drops will decrease the systemic exposure to steroids and allow for a longer period of steroid coverage, potentially reducing the occurrence of the generally mild inflammatory events that have been reported after cessation of oral steroids in cohorts 1 and 2. We look forward to sharing the data from cohort 3 and 4 later this year.

Given the promising data on ADVM-022 presented to date, we are excited to move forward with our plans to explore a second indication, Diabetic Retinopathy. Diabetic Retinopathy represents another large and underserved market that may benefit from a one-time long lasting intravitreal anti-VEGF gene therapy. Of the estimated 8 million people with Diabetic Retinopathy in the U.S., only 2 million are diagnosed and only 1 million are treated. Retina specialists are very excited by the potential that a one-time intravitreal anti-VEGF therapy could offer. Currently, most patients with Diabetic Retinopathy do not receive anti-VEGF therapies due to concerns around the short duration of effect and subsequent risk of Diabetic Retinopathy progression and sight loss. Diabetic Retinopathy is the leading cause of vision impairment and blindness among working age adults. As the prevalence of diabetes continues to grow, the prevalence of Diabetic Retinopathy is expected to increase. There is significant unmet needs for more effective and more durable anti-VEGF therapies that can reduce the incidence of sight threatening complications and improve outcomes.

We believe, maintaining consistent levels of VEGF suppression with ADVM-022 could be particularly important for this rapidly progressing disease, potentially improving treatment outcomes over currently available therapies and allowing for an earlier time point of intervention. I will now turn the call back over to Leone.

Leone Patterson -- President, Chief Executive Officer and Director

Thanks, Aaron. We will now open the call to questions. Operator?

Questions and Answers:

Operator

Thank you. [Operator Instructions] Our first question comes from Alethia Young with Cantor. You may proceed with your question.

Alethia Young -- Cantor Fitzgerald -- Analyst

Hey, guys, thanks for taking my questions, one or two and congrats on the progress from Angiogenesis. So maybe two from me. I just wanted to maybe talk a little bit about, kind of potential state of enrollment in cohort 4. I don't know, I think that there was probably good demand in cohort 3. So just wanted to see if there is any kind of perspective you could give on how fast that could enroll or do you kind of already have the people staked out?

And then my second question is on Diabetic Retinopathy. Can you talk about any kind of potential read-throughs that we might be able to start making from the AMD data that we've seen, and when we start thinking about potential efficacy there? And then maybe just -- can you touch upon how you think this therapy might be potentially more impactful and competitive than like perhaps, let's say, like a monthly dosing drug like an EYLEA or something like that, versus kind of the standard of care, which still remains pretty prevalent in that population? Thanks.

Leone Patterson -- President, Chief Executive Officer and Director

Sure. This is, Leone. So in terms of state of enrollments, I'll start and see if Aaron has anything to add. But we are currently screening patients. Obviously, we're focused really heavily on getting those patients enrolled as soon as possible. And that's very much part of what we are focused on primarily is to get that enrollment done. And at 6 x 10^11, as you may recall, the efficacy we had with the first cohort, which is the same dose of cohort 4 is that we are still with really showing robust efficacy durability out to the longest time point now 50 week median. So we believe that there is a lot of interest and we continue to hear that from investigators to enroll patients in that cohort, 6 x 10^11. Aaron, see if you have anything to add on that and we can go to the other two points as well.

Aaron Osborne -- Chief Medical Officer

Just to add that, we're in sort of in daily contact with the investigators. We've got sites in the U.S., we know these investigators really well and that they're truly excited about cohort 4 and we're actively screening patients. We have many lined up and hope to rapidly enroll cohort 4.

Leone Patterson -- President, Chief Executive Officer and Director

Right. And then in terms of DR and the potential read-through, I think, first of all, obviously from a safety perspective, the Phase 1 for OPTIC is a Phase 1 safety study. And so therefore the first and foremost thing is due to the safety profile and that's why I think cohorts 3 and 4 are important because we're using prophylactic steroid eye drops, which will hopefully manage the steroids -- sorry, the inflammation that might have been seen earlier on in cohorts 1 and 2. So we do believe that there are some read-through that will be apparent from even the data we presented on, when it comes to safety, along with what we'll see in cohorts 3 and 4 using steroid eye drops as a prophylactic measure.

As relates to efficacy, yes, I think there can be some read-through and I'll have Aaron speak to the disease -- difference in the disease between wet AMD and DR, because there is obviously some differences and whether the doses that we would use in DR would be the same as what we would use in wet AMD. I think it would be useful to talk about the levels of VEGF and compare with the two in the patient profile. Aaron?

Aaron Osborne -- Chief Medical Officer

Yeah. Thanks, Leone. Yeah. So, the anti-VEGF patients that are approved at the moment, most of them are approved for use in diabetic macular edema, as well as in wet AMD and those doses have generally been the same. So drugs -- the dose of anti-VEGF as effective in wet AMD will generally be effective in treating diabetic macular edema and also improve -- and also in improving Diabetic Retinopathy and there's a lot of evidence around that, that exists already. So the efficacy that we're seeing in OPTIC is really exciting in terms of its possible applicability to Diabetic Retinopathy and diabetic macular edema.

And I think just the second part of the question, which was on the difference between 022 and currently available anti-VEGF which are approved for Diabetic Retinopathy, but are not currently used to any great extent. I think this really comes back to the durability and Diabetic Retinopathy is a disease that lasts for several years and what can happen with the anti-VEGF therapies that are available is that they can superficially give the appearance to have improved the disease, but because of their short duration of action, then the patient can actually experience a complication, if they do not come back to the clinic. And I think this is the promise of a sustained delivery approach in Diabetic Retinopathy that you can provide long lasting sustained anti-VEGF, which can hopefully tie that patient through the most active period of that Diabetic Retinopathy and could reduce the risk of those sight threatening complications.

And importantly, it's something that lasts for several months or years, rather than something that lasts for just a few weeks. But that's for when it starts to wear off -- if it does starts to wear off, this would happen much further down the line and the patient would be much less likely to experience the sight threatening complications. And I think that's why the retina community is really excited about the potential of intravitreal gene therapy to make a big difference in Diabetic Retinopathy.

Alethia Young -- Cantor Fitzgerald -- Analyst

Awesome, guys. Thanks a lot for all the detail.

Aaron Osborne -- Chief Medical Officer

Okay.

Operator

Thank you. Our next question comes from Tara Bancroft with Piper Sandler. You may proceed with your question.

Tara Bancroft -- Piper Sandler -- Analyst

Hi, guys. It's great to hear your progress so far and also really promising to hear that you guys don't seem to be experiencing any delays with OPTIC due to COVID. That's great. So I was just wondering if maybe I could get your thoughts on the recent safety signals that we're seeing with Beovu and what it was about the product that you think may have led to that. And do you think there's any read-through to intravitreal therapy in general and how this may affect sentiment toward a longer lasting therapy like 022 could be? Thanks.

Leone Patterson -- President, Chief Executive Officer and Director

Yeah, great question, Tara. Thank you. So I think I'll start off and then Aaron will obviously, with his experience as an ophthalmologist and having worked on a number of the other anti-VEGF, I think he could answer more specifically. But what I can say is that it's very different, the type of inflammation that we are experiencing, which as you know, is low grade manageable with topical steroids. It's very different than the type of inflammation that has been experienced by those patients who are on Beovu. So with that, I'll turn it over to Aaron to talk about some of the hypothesis on what's happening, but I think it will be really important to emphasize the difference of where we are incurring the types of inflammation we have versus Beovu, but also where the inflammation is occuring. So, I'll hand it over to you, Aaron.

Aaron Osborne -- Chief Medical Officer

Thanks, Leone. Yeah. Obviously, we're concerned to hear those reports and the inflammation with Beovu, which has been associated with sight loss has been reported to be a posterior inflammation. So an inflammation in the back part of the vitreous body but most worryingly, there's been a vasculitis. So that means an inflammation affecting certain retinal vessels, which has resulted in the blood not being able to get to the retina and patients losing vision and that could potentially be permanent and that's called a vasculitis.

So this is what really concerns. I think the retinal community -- and there was a lot of discussion about that at a recent ophthalmology meeting. So in terms of what that potential root cause could be, we're focused on 022, but some of the things that come up, potentially, something around -- this is -- let's remember that Beovu is a novel therapy, which is a different class with a single chain antibody fragment and those are not used that widely. So it's conceivable that there could be an issue with the production and there could be some contaminant that -- or it could be related to that -- another thought is that it could be related specifically to it being a single chain fragment which may penetrate deeper into the retina and may be causing some problems in certain patients.

And I think the third theory that people discussed is the fact that it's a very high dose of anti-VEGF, it's around 24 times the dose of Ranibizumab or 12 times the dose of an EYLEA intravitreal injection. So those are sort of three areas that people are looking at to potentially explain what's happening here. I think importantly, with 022, we have not seen any evidence of retinal vasculitis. We've not seen any evidence of any sort of retinal inflammation. We do commonly see a low-grade inflammation, which affects the front part of the eye following intravitreal injection of 022 and this is expected. We're injecting viral material and we expect some degree of immune response, but that inflammation is very low grade. It predominantly affects the front part of the eye and it's something that lasts over a longer period of time and it's manageable with topical steroids. So a very different type of inflammation, and we have not seen any evidence of that type of inflammation with ADVM-022.

Tara Bancroft -- Piper Sandler -- Analyst

Great, thank you.

Operator

Thank you. Our next question comes from Phil Nadeau with Cowen & Co. You may proceed with your question.

Phil Nadeau -- Cowen and Company -- Analyst

Good afternoon. Thanks for taking my questions. Maybe a couple on that inflammation that you've seen. Have you decided on the steroid regimen that you're going to use in the DR trial now or does that await data from cohorts 3 and 4?

Leone Patterson -- President, Chief Executive Officer and Director

So basically, I think -- thank you for bringing that up. So a couple of things, one, as I just mentioned earlier, we've -- cohort 3, we've completed dosing. Obviously, this is an open label study, and we have rolled drive into our cohort 4 using the same protocols, steroid eye drops over six-week -- prophylactic steroid eye drops over six-week tapering. So it gives you a sense of our level of confidence and comfort to move forward with that approach in that cohort 4, which is at 6 x 10^11.

The second part in terms of the -- what we would be using going forward for DR, DME, obviously, we haven't submitted. We're still in the process of submitting IND in which we said we would get that done in the first half of this year and then we would have [Indecipherable] to share a little bit more about the protocol design. But it's safe to say, that given this is a patient population that would benefit from using oral steroids -- I'm sorry, topical steroids as opposed to oral, that we'll be clearly looking at that as a potential way of managing any inflammation that we would see in that study. But we would -- in terms of hearing that definitively, we'll need to wait until we actually get to the protocol design and willing to share that.

Phil Nadeau -- Cowen and Company -- Analyst

Got it. And just to follow up on your comments about the open label nature of cohort 3. Could you talk to that maybe in a bit more detail? What are you seeing there? And I guess, in particular, how many patients are past the six-week end of the prophylactic steroid regimen today so you can see what the long term efficacy is of the six-week cohort, I mean the six-week dosing paradigm?

Leone Patterson -- President, Chief Executive Officer and Director

I think what I can say is that obviously at some point we'll release the real data, Phil. But I think what we can say is, just to remind you that there were nine patients that were enrolled. We enrolled our first patient in November. We announced enrollment in November. So you can -- it's fair to say that we have a number of those patients out beyond the six weeks. And I think the only thing I can say to that, since we haven't presented data is to say that we felt confident with what we're seeing to proceed with dosing up back to 6 x 10^11 using that same steroid regimen of topical steroids over six weeks.

Phil Nadeau -- Cowen and Company -- Analyst

And can you remind us the dose of your topical steroids? Would it be possible to increase the dose for cohort 4 if that was necessary?

Leone Patterson -- President, Chief Executive Officer and Director

I'll have Aaron answer that question. Go ahead, Aaron.

Aaron Osborne -- Chief Medical Officer

Yes. So we're giving four times a day drops for three weeks and then three times a day for a week, twice a day for a week, once a day for a week and then stop. So the maximum frequency is four times a day and eye drops can potentially be given more frequently than that. So that certainly would be one option if we needed to increase the amount of steroids being given. But based on the experience in cohorts 1 and 2, the inflammation that we've seen has been manageable with those topical steroids. So obviously, we're not doing that experiment in cohorts 3 and 4 and look forward to getting the data as quickly as possible.

Phil Nadeau -- Cowen and Company -- Analyst

Got it. That's very helpful. Thanks for taking my questions.

Leone Patterson -- President, Chief Executive Officer and Director

Thanks, Phil.

Operator

Thank you. [Operator Instructions] Our next question comes from Patrick Dolezal with LifeSci Capital. You may proceed with your question.

Patrick Dolezal -- LifeSci Capital -- Analyst

Hi, thanks for taking the questions. I was just hoping you could guide expectations about the ARVO data update.

Leone Patterson -- President, Chief Executive Officer and Director

Sure. So, as you may probably heard today that ARVO, officially, the in-person meeting it had, was canceled today. However, you will also see that we wrote in our press release and what we said today in our remarks that we do still plan to present data on the OPTIC trial in May. In terms of the ways that we will do that, obviously we're waiting to hear back from ARVO and they are offering different ways to present data. It's still part of -- under ARVO. But without saying that we would still present data, we're still trying to present data on OPTIC in May, as we've said. And either, it will be as part of the ARVO umbrella in whatever way they plan to allow presentation to still occur virtually or whatever way that happens or it will be -- and/or it will be some form of a webcast that we would do to support that as we have done previously and when we had done presentations of data.

Patrick Dolezal -- LifeSci Capital -- Analyst

Great, thank you. And then I guess kind of playing off of Phil's question. If possible, could you provide any additional color on the status of the tapering of steroid use in cohorts 1 and 2?

Leone Patterson -- President, Chief Executive Officer and Director

So we -- I think what I'll do is -- what we can talk about is, what did we present at Angio. I think in terms of any updates, we'd be providing that in a later time point. But I think it's fair to say that as we continue forward with the protocol in cohort 3 and 4, that does give some level inside that we are comfortable with using steroid eye drops as a measure of prophylactically managing any inflammation that we see. But I have to see if Aaron has anything more to add there on the tapering and I think the reminder of what the investigators can do beyond the tapering period might be useful as well.

Aaron Osborne -- Chief Medical Officer

Sure. So if you remember in cohort 1, we had all patients were treated with prophylactic oral steroids and it was really a learning process. And after that, different types of topical steroids were given and some patients even got some more oral steroids and the timing of that was kind of variable among the group. But through December 1, which was the last time point that we analyzed the data, we had one patient who had, had an unrelated serious adverse event of a retinal detachment and was post surgery and actually that one patient -- he remains on the follow-up in OPTIC. That was the only patient that had any cellular inflammation, which potentially was post-surgical. You would expect some cellular inflammation post retinal detachment surgery. The five others, none of those had any cellular inflammation at that time point and we had two other patients -- two of those five patients were on a tapering amounts of steroid, which was two drops a day each and the other three were no longer on any topical steroids.

So certainly the cellular inflammation was resolving or resolved and we had two patients remaining of those -- outside of the one who was post-surgical, we had two patients who were taking topical steroids. That's cohort 1 and the other -- the other data point that we have is cohort 2 which was at the lower -- at the lower dose, a three-fold lower dose, if you remember. And we had -- there we had, out of the six patients through 24 weeks follow up, two of the patients have not required any steroid eye drops after their initial oral course and that had zero or next to zero inflammation. And we had two other patients who had absolutely minimal inflammation of a maximum of half plus and those that had short courses of topical steroids and the inflammation had resolved. And then we had another two patients who'd had more significant inflammation, but that had -- was improving or resolved and they were on tapering eye drops. So we had two patients in cohort 2 who are on drops at Week 24.

The cohort 3 obviously comes next and there we have all of the patients are getting the six weeks of topical eye drops and we're hoping that those six weeks of topical eye drops can reduce the occurrence of having any adverse events or spikes in inflammation early on and can, hopefully for the patients, on a better course. But it is important to remember that this inflammation has been low grade. The vast majority of it has been asymptomatic, nothing affecting the back of the eye. So it's a predictable inflammation that seems to be very manageable with the topical steroid approach.

Patrick Dolezal -- LifeSci Capital -- Analyst

Great.

Operator

Thank you. I will now turn the call back to Adverum's President and CEO, Leone Patterson.

Leone Patterson -- President, Chief Executive Officer and Director

All right. Thank you again for joining our call today. We have made significant progress this past year. Looking ahead, key catalysts for Adverum this year are presenting new data from OPTIC in May, submitting an IND in Diabetic Retinopathy in the first half of this year, initiating our Phase 1, 2 clinical trial in DR in the second half of the year, and finally, presenting data for all four cohorts of OPTIC in the second half.

We look forward to further sharing our clinical progress and continued execution as we advance the development of our novel gene therapy ADVM-022 for the treatment of serious ocular diseases. In closing, I'd like to thank the patients, caregivers and retinal specialists who are participating in the OPTIC trial. And last but certainly not least, I want to thank the Adverum employees for their tireless efforts. Our achievements at Adverum wouldn't be possible if it weren't for the dedication of this team. Thank you for your time. And this concludes our call.

Operator

[Operator Closing Remarks]

Duration: 31 minutes

Call participants:

Myesha Lacy -- Vice President of Investor Relations and Corporate Communications

Leone Patterson -- President, Chief Executive Officer and Director

Aaron Osborne -- Chief Medical Officer

Alethia Young -- Cantor Fitzgerald -- Analyst

Tara Bancroft -- Piper Sandler -- Analyst

Phil Nadeau -- Cowen and Company -- Analyst

Patrick Dolezal -- LifeSci Capital -- Analyst

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