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Edited Transcript of ALDX earnings conference call or presentation 7-Nov-19 1:00pm GMT

Q3 2019 Aldeyra Therapeutics Inc Earnings Call

Burlington Nov 18, 2019 (Thomson StreetEvents) -- Edited Transcript of Aldeyra Therapeutics Inc earnings conference call or presentation Thursday, November 7, 2019 at 1:00:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Joshua Reed

Aldeyra Therapeutics, Inc. - CFO

* Todd C. Brady

Aldeyra Therapeutics, Inc. - CEO, President & Director

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Conference Call Participants

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* Adam Anderson Walsh

Stifel, Nicolaus & Company, Incorporated, Research Division - MD & Senior Analyst

* Esther Lannie Hong

Janney Montgomery Scott LLC, Research Division - Director of Biotechnology

* Matthew David Cross

JonesTrading Institutional Services, LLC, Research Division - Research Analyst

* Sudan Naveen Loganathan

Cantor Fitzgerald & Co., Research Division - Analyst

* Yigal Dov Nochomovitz

Citigroup Inc, Research Division - Director

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Presentation

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Operator [1]

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Good morning, and welcome to the Aldeyra Therapeutics Third Quarter 2019 Financial Results Conference Call. My name is Andrea, and I will be your operator today. (Operator Instructions) At this time, I would like to turn the call over to Mr. Joshua Reed, the company's Chief Financial Officer. Please go ahead, sir.

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Joshua Reed, Aldeyra Therapeutics, Inc. - CFO [2]

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Good morning, everyone. With me today is Dr. Todd Brady, Chief Executive Officer. Todd will begin today's call with an overview of our strategy and recent highlights. I will discuss our Q3 results. Todd will make some concluding comments, and then we will be happy to take your questions.

Please note that this morning's conference call contains forward-looking statements regarding future events and the future performance of Aldeyra. Forward-looking statements include statements regarding Aldeyra's possible or assumed future results of operations, expenses and financial position, business strategies and plans, research and development and commercial plans or expectations, trends, market sizing, competitive position, industry environment and potential growth opportunities, among other things.

These statements are based upon the information available to the company today. And Aldeyra assumes no obligation to update these statements as circumstances change. Future events and actual results could differ materially from those projected in the company's forward-looking statements. Additional information concerning factors that could cause results to differ materially from our forward-looking statements are described in greater detail in the company's press release issued earlier this morning containing financial results for the third quarter of 2019, and the company's filings with the SEC.

Now I will turn the call over to our President and Chief Executive Officer, Dr. Todd Brady.

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Todd C. Brady, Aldeyra Therapeutics, Inc. - CEO, President & Director [3]

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Thank you, Josh, and thank you all for joining us today. Aldeyra continued to make great progress across our novel clinical programs in immune-mediated diseases during the quarter. As you heard last week, we've reached agreement with the FDA on the innovative design of our INVIGORATE Phase III clinical trial in allergic conjunctivitis, which we plan to initiate in the first half of 2020. In addition to discussing our recent accomplishments and upcoming milestones this morning, I'd like to highlight an area that a number of investors have asked us to expand on, as we move into next year, which is our strategy and vision for Aldeyra.

As many of you know, Aldeyra is an immunology-focused biotechnology company, developing novel pharmacotherapies to treat immune-mediated diseases. We're advancing a broad pipeline of drug candidates designed to downregulate pro-inflammatory signaling that is linked to serious medical conditions, not adequately addressed by current treatments. By inventing, developing, acquiring and commercializing next-generation therapies, our goal is to reduce the burden of disease and help patients lead healthier lives.

Our growth strategy is anchored by 3 pillars: first, researching, discovering and acquiring first-in-class compounds that target large markets as well as orphan indications; second, building and developing an innovative pipeline of clinical stage drug candidates with novel mechanisms that focus on the regulation of immune cell activation or proliferation; and third, advancing multiple late-stage programs that have significant advantages over current standard of care and readying those programs for commercialization. Much of our late-stage clinical work to date has focused on anterior ocular inflammatory disease with reproxalap, the lead asset in our platform. Reproxalap is designed to target and inhibit pro-inflammatory molecules called RASP, which are elevated in a range of diseases, including dry eye disease and allergic conjunctivitis where we have Phase III programs underway.

To give you some context for the size of these markets, according to a recent study from current opinion in allergy and clinical immunology, anterior ocular inflammatory disease affects more than 40% of the population in the U.S. alone. And last year, accounted for nearly $11 billion in prescription drug expenditures.

Based on reproxalap's favorable therapeutic profile and highly differentiated activity versus standard of care, we believe it has the potential to be the next novel entrant in dry eye disease, and also the next novel entrant in allergic conjunctivitis for the approximately 30 million allergic conjunctivitis sufferers in the United States, who do not respond adequately to or are dissatisfied with antihistamines.

The safety and efficacy profile of topical ocular reproxalap is well established. To date, more than 1,000 patients have been dosed across 12 clinical trials with no observed safety concerns. Reproxalap has demonstrated a clinically significant and durable response in allergic conjunctivitis, and broad and clinically relevant improvement in symptoms and signs of dry eye disease. As a result, our pipeline of ocular disease therapies has generated strong interest and attention from ophthalmologists, optometrists, researchers and other key opinion leaders.

In October, we presented at the Ophthalmology Innovation Summit, and at The American Academy of Ophthalmology annual meeting in San Francisco. At AAO, our Chief Medical Officer, Dr. David Clark, presented the results of our ALLEVIATE Phase III clinical trial in allergic conjunctivitis. The primary and secondary end points of ALLEVIATE were highly statistically significant and clinically relevant.

Last week, we released expanded results from our completed allergen chamber clinical methods trial of topical ocular reproxalap in allergic conjunctivitis. Consistent with the positive results of ALLEVIATE, reproxalap demonstrated highly statistically significant and clinically relevant improvement over vehicle for ocular itching, the approvable end point in allergic conjunctivitis as well as for ocular redness and tearing, all of which, in aggregate, comprised the primary symptoms and signs in patients suffering from allergic conjunctivitis.

In addition to sharing the results, we discussed the design and primary end point for upcoming INVIGORATE Phase III clinical trial in allergic conjunctivitis. As in the earlier clinical methods trial, ocular itching in INVIGORATE will be assessed in an allergen chamber, an innovative and rigorous method that we believe is optimal for testing drug activity in allergic conjunctivitis, combining the real-world exposure of a field trial with the controlled allergen exposure of directly administering allergen to the eye.

The primary end point of INVIGORATE will be achieved if statistically significant reduction in ocular itching between drug and vehicle is demonstrated at the majority of 11-time points in a prespecified range from 110 to 210 minutes following chamber entry. In the completed allergen chamber trial, reproxalap was statistically superior vehicle at every time point

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be prespecified in INVIGORATE.

In other recent highlights, Part 1 of our adaptive Phase III RENEW clinical trial in dry eye disease, remains on track for completion this quarter at which time we expect to report on the end points, dosing regimen and sample size planned for Part 2 of the trial.

Dry eye disease, which afflicts an estimated 34 million patients in The United States is a persistently disturbing condition that represents one of the largest markets in ophthalmology, and physicians and patients agree that currently available therapies are inadequate.

From the front of the eye, we are expanding our ocular disease pipeline into the posterior segment, with the initiation of the GUARD Phase III clinical trial of ADX-2191 in proliferative vitreoretinopathy, or PVR. PVR is a rare inflammatory disorder of the retina that leads to severe retinal scarring and blindness, occurring most commonly following retinal detachment repair surgery for ocular injuries. Approximately 4,000 patients per year are diagnosed with PVR in The United States, and nearly double that number in Europe and Japan. There is no approved treatment for PVR. A fact highlighted by the FDA's recent decision to grant fast track designation for ADX-2191. The fast track designation allows us to engage in regular communications with the FDA about the development plan and qualifies ADX-21 for priority review and rolling new drug application submission.

The GUARD trial will compare recurrence rates of PVR-related retinal detachment across patients treated with ADX-2191 or standard of care following surgical repair of retinal detachment. Initiation of patient enrollment for Part 1 of the trial is expected this quarter.

Beyond the eye, we're advancing novel immune-mediated systemic portions of our pipeline on multiple fronts. Phase I clinical testing is underway for ADX-629, a novel orally administered RASP inhibitor for the treatment of systemic autoimmune disease, a class of conditions that, in aggregate, affects an estimated 50 million Americans.

In addition, Phase II clinical testing of the chaperome inhibitor ADX-1612 is planned to start later this quarter in patients with post-transplant lymphoproliferative disorder, a rare and potentially fatal immunological disease that can occur following solid organ transplant.

Now I will turn the call over back to Josh for the financial review, which I will -- after which, I will close with a look of our anticipated clinical milestones and upcoming events. Josh?

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Joshua Reed, Aldeyra Therapeutics, Inc. - CFO [4]

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Thank you, Todd. Turning to our Q3 results, we reported a net loss for the quarter of approximately $18.7 million compared to a net loss of approximately $10.8 million for the third quarter of 2018. Basic and diluted net loss per share was $0.69 for the quarter compared to $0.52 per share for the same period last year. Losses have resulted from the costs of research and development programs as well as from our general and administrative expenses.

Research and development expenses were $16.2 million for the third quarter of 2019 compared to $7.9 million for the same period in 2018. The increase of $8.3 million is primarily related to the increase in clinical and preclinical development costs, manufacturing, personnel costs and noncash compensation costs related to a portion of upfront acquisition consideration that is subject to vesting based on continued service.

General and administrative expenses were $2.8 million for the third quarter of 2019 compared to $3.1 million for the same period last year, a decrease of $300,000 is primarily related to a decrease in consulting costs.

In the third quarter of 2019, total operating expenses were $19 million compared to $10.9 million in the prior year. Cash, cash equivalents and marketable securities at September 30, 2019, were $76.2 million, which includes $15 million drawn from our debt facility in September of 2019.

Based on our current operating plan, we expect our current cash, cash equivalents and marketable securities will be sufficient to fund our operations into 2021.

Now I will turn the call over to Todd for concluding remarks prior to opening the call for questions.

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Todd C. Brady, Aldeyra Therapeutics, Inc. - CEO, President & Director [5]

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Thank you, Josh. In summary, Aldeyra continued to make great progress in Q3 in advancing our immunology platform towards the goal of reducing the burden of disease and helping patients lead healthier lives.

Looking ahead, this quarter, we expect to achieve several key milestones, including completion of Part 1 of the RENEW Phase III clinical trial in dry eye disease, followed by announcement of the end points, dosing regimen and sample size for Part 2. Initiation of Part 1 of the GUARD Phase III clinical trial of ADX-2191 in PVR and initiation of the Phase II clinical trial of ADX-1612 for posttransplant lymphoproliferative disorder.

In addition, I want to let you know about a couple of upcoming events. We will be presenting and hosting one-on-one meetings at the Stifel Healthcare Conference in New York on Tuesday, November 19, and at the Jefferies Healthcare Conference in London on Thursday, November 21. For those attending, we look forward to meeting with you.

Now, we'd be happy to take your questions. Operator, please open the line.

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Questions and Answers

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Operator [1]

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(Operator Instructions) You have a question from Yigal Nochomovitz of Citigroup.

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Yigal Dov Nochomovitz, Citigroup Inc, Research Division - Director [2]

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Just with respect to the RENEW Phase III trial in dry eye and specifically with respect to Part 1, could you just help bracket the scenarios for how Part 1 could complete? You mentioned end points, dosing regimen and sample size planned for Part 2 but could you just comment a little bit more specifically on what you see is the most likely outcome for Part 1? And additionally, what you might -- what might represent an upside case with respect to those variables?

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Todd C. Brady, Aldeyra Therapeutics, Inc. - CEO, President & Director [3]

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Yes. So far, I think, sufficiently outlined the goal of Part 1, which is to clarify the dosing regimen and the end points and the sample size for Part 2. As you recall, Part 1 has really 2 trials embedded within 1 trial that is a 4 times a day dosing regimen versus a 4 times a day vehicle regimen. And a 4 times a day regimen tapered down to twice a day regimen versus a corresponding vehicle control. So the goal of the trial primarily is not only to confirm the primary end point for the pivotal section of the trial that is Part 2, but also to clarify the dosing regimen, which we'll [expand.] So one of those dosing regimens that I described will advance to Part 2, and that will certainly be disclosed this quarter in the next few weeks.

I will say that there are a variety of scenarios in any clinical trial, adaptive clinical trials are particularly interesting, because the first parts of those trials, in this case, RENEW Part 1 are really designed to power the subsequent parts of the trial. In this case, RENEW Part 2. There's always the possibility that an end point can be hit, but I think the expected outcome of RENEW 1 is that we will proceed to Part 2 and that the nature of Part 2 be described.

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Yigal Dov Nochomovitz, Citigroup Inc, Research Division - Director [4]

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Okay. Great. And then just 1 question on vitreoretinopathy. And you mentioned you have the fast track designation. Do you believe that having breakthrough would be additionally beneficial? Have you applied for breakthrough? Or are you sort of satisfied with how the FDA is positioning this fast track approach?

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Todd C. Brady, Aldeyra Therapeutics, Inc. - CEO, President & Director [5]

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We're obviously pleased about the FDA granting breakthrough status for ADX-2191 in PVR. It's easy to understand how that came about, there is no approved therapy for PVR. There is no treatment that's widely used for PVR aside from repeat surgeries, which lead to further instances of PVR. I think breakthrough therapy is often an extension of fast track and as we receive data from the GUARD trial, which is also an adaptive trial, I expect that applying for breakthrough would be a possibility.

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Operator [6]

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Your next question comes from the line of Louise Chen of Cantor Fitzgerald.

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Sudan Naveen Loganathan, Cantor Fitzgerald & Co., Research Division - Analyst [7]

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This is Sudan Loganathan in for Louise. I have a few. So I wanted to touch on the systemic disease indications for reproxalap. Are we still expecting to initiate on the Sjögren-Larsson Syndrome after discussion with regulatory authorities? And when do you expect that to -- the timing for that to occur? And what other indications on the systemic diseases are you very interested in for reproxalap going forward? And then secondly, I wanted to ask on the cash runway, are there any other abilities in 2020 to access more cash? Or how do you see that going forward, as you [indiscernible] these clinical trials in Phase III development?

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Todd C. Brady, Aldeyra Therapeutics, Inc. - CEO, President & Director [8]

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Thanks for the questions. I'll let Josh answer the cash question in a moment. Let me comment on reproxalap. Obviously, reproxalap continues to excel in ocular surface disease, which represents, as I've described in the call today, massive underserved markets, not only in The United States but also worldwide. In terms of Sjögren-Larsson Syndrome, we have disclosed that we're in the process of discussing with regulatory authorities not only in The United States, but also in Europe, about the path for subsequent advancement and the timing thus is unpredictable and will depend on the nature of those discussions.

I do not envision other indications for reproxalap at this point given the late stage, as I've described, that we're in, in terms of ocular surface disease. We are obviously very excited, though, about other systemic applications of the RASP platform. And as I mentioned today, we've begun a Phase I clinical testing of ADX-629, which is a novel orally administered RASP inhibitor that has, we think, broad applicability to a variety of diseases systemically.

Autoimmune disease is one of the most common classes of diseases worldwide. And even further inflammation and inflammatory signaling is prominent in many, if not most diseases that afflict human beings. So we are obviously excited about the potential for ADX-629, other novel RASP inhibitors that I think you'll hear about shortly when administered orally or otherwise systemically. Josh, I'll turn it over to you to talk about cash?

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Joshua Reed, Aldeyra Therapeutics, Inc. - CFO [9]

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Sure. Thanks, Todd. Thanks, Sudan. Our cash position is strong. As I noted earlier, based on our current plan, we've got enough cash and marketable securities to take us into 2021 and pay for the RENEW, GUARD and INVIGORATE trials. This does not include access to additional capital under our credit facility or the ATM, but these vehicles along with potential nondilutive financing from partners provide flexibility if needed.

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Operator [10]

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Your next question comes from the line of Esther Hong of Janney.

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Esther Lannie Hong, Janney Montgomery Scott LLC, Research Division - Director of Biotechnology [11]

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So my question is on PVR. Can you talk a little bit more about the current standard of care and discuss any other therapy approaches that are in development for PVR? And then also will 2191 only be used in patients after the first instance of detachment or can it be used in patients who have failed retinal detachment surgery?

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Todd C. Brady, Aldeyra Therapeutics, Inc. - CEO, President & Director [12]

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Thank you, Esther. PVR is a terrible situation for patients in today's market. There is no approved therapy for PVR that we are aware, there are no products in development for PVR, which is -- represents clearly, a clear unmet medical need. The sort of pathogenesis of PVR relates to retinal detachment. So in patients, either for idiopathic reasons or due to trauma, the retina will detach from the posterior segment of the eye. Reattaching the retina is generally not a problem surgically, either air or oil can be inserted into the eye to hold the retina back on the ocular surface or the back -- the posterior segment. The problem comes in a minority of patients that develop scarring as a result of that.

And as you mentioned, we think there are about 4,000 patients in The United States every year and about double that number outside the U.S. that developed PVR. PVR causes scarring, it's aberrant fibrogenesis, it leads to further retinal detachments. There are 2 issues with the scarring, one is you cannot see through a scar. And the second is, the scarring pushes the retina back off the posterior segment of the eye, leading to other retinal detachment surgeries and the cycle continues.

In our trial, to your question, we're enrolling patients that have had 1 retinal detachment due to PVR. And the other group that we're enrolling are patients that have suffered open globe injury, those -- that has resulted in retinal detachment. Those patients are at high-risk for PVR. The end point, as I mentioned on the call is recurrence, that is the recurrence of retinal detachment due to PVR. And we'll be monitoring that end point over 6 months.

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Operator [13]

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(Operator Instructions) Your next question comes from the line of Adam Walsh of Stifel.

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Adam Anderson Walsh, Stifel, Nicolaus & Company, Incorporated, Research Division - MD & Senior Analyst [14]

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We look forward to having you at our conference as well, Todd. In terms of the RENEW Phase III clinical trial design in dry eye disease and the data that are coming up from Part 1. How important is it for you, Todd, do you think to get a BID dosing regimen, obviously, doing a tapering arm in the trial. So I'm curious to know how important you think that is, if at all, some docs that we've talked to have suggested that in dry eye disease that perhaps a QID dosing regimen is actually potentially preferred.

And then on the tapering schedule, it looks like you go QID for weeks 1 to 4 and then BID for weeks 5 to 12. How did you come up with that? And then the final question is on the formulation trial that you're running to increase residence time in the eye, will those data be put out at the same time as the RENEW Part 1? And are those data gating for a Phase III?

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Todd C. Brady, Aldeyra Therapeutics, Inc. - CEO, President & Director [15]

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Adam, thank you, and thanks again for the invitation to the conference. We look forward to seeing you there. The Part 1 of RENEW is really designed to assess 2 different dosing regimens for a couple of reasons: Number one, we're big believers in the loading dose maintenance dose concept. And for those of us with medical backgrounds, this is a very familiar pharmacologic mechanism. I will say the QID dosing, that is increasing the dosing early on, could be a very beneficial thing for many of these patients that report to physicians in more or less an exacerbated state. And so typically with diseases, not just ocular diseases, you'll often treat patients with a higher dosing frequency initially to control symptoms, but patients don't always require that increased dosing frequency over time. And that is exactly what you've described with the QID to BID taper arm in RENEW Part 1. We also noticed that in the Phase IIb trial, a lot of

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self-tapered, meaning that after their symptoms improved, they tended to take a less drug over time. And I think that's quite reflective of the real world. We've done a considerable amount of market research not only with physicians but also with patients and with any ocular surface disease, whether it would be allergic conjunctivitis or dry eye disease, but what we find is, practically in the real world, we meet patients who dosed-as-needed almost on a PRN basis. So RENEW Part 1 is really designed to get at all these concepts. And frankly, we'd be thrilled to have either dose arm work, the key for us really is an early onset of activity, which gets at the loading dose maintenance dose concept. A problem in today's market with the currently available therapies is they often take weeks or months to work. And so to put a patient on a drug, to ask that patient to deal with persistently disturbing symptoms over weeks to months, just to see if the therapy is active, seems a fairly untenable and difficult position. We hope with reproxalap to solve that issue where we -- such that we can generate symptomatic improvement early.

The formulation trial -- I want to talk about your formulation trial question. The formulation trial is ongoing, and you can read more about it on clinicaltrials.gov. We will not disclose results from the formulation trial with Part 1, to the extent that we disclose anything, I would expect that would be a first half of 2020 event.

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Adam Anderson Walsh, Stifel, Nicolaus & Company, Incorporated, Research Division - MD & Senior Analyst [16]

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And Todd, I mean obviously, you're going to be launching a phase -- another study. Is the formulation gating for the pivotal?

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Todd C. Brady, Aldeyra Therapeutics, Inc. - CEO, President & Director [17]

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No. Absolutely not. We're always opportunistic, not only in terms of formulation, but different trial approaches and different molecules and different mechanisms. I think the formulation trial represents 1 of those opportunistic approaches to modestly modify the formulation to

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residence time in drug in the front of the eye. Topical ocular administration is challenging because as human beings, we're good at getting rid of foreign substances in front of our eyes. We blink, we tear, drug often runs down the nasolacrimal duct and any efforts that drug formulators can make to increase ocular residence time, I'm sure, would be well received from patients and physicians alike.

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Operator [18]

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Your next question comes from the line of Matthew Cross of JonesTrading.

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Matthew David Cross, JonesTrading Institutional Services, LLC, Research Division - Research Analyst [19]

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I had a couple I wanted to ask about the new nonocular trial initiations that have just been started or on the verge of doing so. So I guess starting with the Phase I trial of ADX-629 in systemic autoimmune disease. Clearly, a big step here to be getting into the systemic usage of RASP. And wanted to get a sense for what we may see from this trial on 2 fronts: First, am I correct that this is expected to be sort of an all-comers trial for various autoimmune and metabolic indications? And if so could you maybe describe what you're hoping to see from this Phase I outside of safety in order to measure success, specifically, are there particular RASP related biomarkers, you'll be looking for to gauge activity or do you look for something more general like regulatory T cell or cytokine behavior?

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Todd C. Brady, Aldeyra Therapeutics, Inc. - CEO, President & Director [20]

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Yes, Matt, I'm glad you asked that question. I hope you can feel our enthusiasm about our systemic RASP program. To our knowledge, this is the first time ever that a RASP inhibitor has been tested in humans in a systemic basis. So we're thrilled to be right at the Vanguard of exploiting this novel mechanism for autoimmune and inflammatory disease, which I mentioned on the call, it's probably a component of most diseases. So I think our potential indications are broad here, as you point out in your question.

This is a Phase I trial with ADX-629. So there are no diseased patients in particular, these are normal healthy human volunteers. Obviously, with Phase I trials, the goal is to assess pharmacokinetics, safety and tolerability. And we are obviously looking at a variety of outcomes, not only standard PK and safety and tolerability end points biomarkers, the RASP mechanism, as you pointed out, allows for the assessment of a variety of different parameters, not only RASP, but also the downstream effects of RASP immunologically, which would include standard things such as cell counts, inflammatory cell counts and cell activity and so forth.

So I think what you could expect to hear as a result of the Phase I trial, I hope, in the first half of next year, is a variety of different, I would say, pharmacodynamic outputs from the trial. And then from there, I think, based on those outputs, along with safety, tolerability, PK will decide what Phase II programs to pursue.

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Matthew David Cross, JonesTrading Institutional Services, LLC, Research Division - Research Analyst [21]

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Perfect. No, that's very helpful to frame things. And I guess kind of building on your point about this being the first study of RASP and obviously, systemically, and focus on PK here. Can you comment on your expectations maybe for bioavailability of ADX-629? I know back in the days, discussing the aldehyde trap mechanism, you'd raise the point that RASP needs to be targeted with something like a 1:1 ratio of inhibitor to aldehyde. So I'm wondering what kind of exposure level is reasonably expected to be active or more generally, how 629 may differ from the reproxalap formulation to achieve the kind of PK you're looking for systemically?

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Todd C. Brady, Aldeyra Therapeutics, Inc. - CEO, President & Director [22]

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We'll certainly comment on pharmacokinetics at the end of Phase I. You're correct stoichiometrically there's a 1:1 ratio between the RASP inhibitor and the RASP. What that means, though, I think can only be answered empirically in diseased patients. These pharmacologic half-life of RASP inhibitors has proven to be quite long. An example is our Phase III ocular programs, where we've demonstrated long pharmacologic clinically relevant activity that obviously greatly exceeds pharmacokinetics and

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for our RASP inhibitors. We'll have to see in Phase II, how various dosing paradigms affect disease, but because RASP are so proximal and so upstream and so early in the inflammatory cascade, one could expect that RASP inhibition has many long-term, persistent downstream effects that would last much longer than drug residence

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Matthew David Cross, JonesTrading Institutional Services, LLC, Research Division - Research Analyst [23]

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Got it. Okay. Fair enough. And I'll look forward to ultimately seeing those results to kind of draw some of these conclusions for Phase 2. I just wanted to squeeze in one more quick one on 1612 as that kicks off here shortly. Is there any update you've received on the mesothelioma and ovarian cancer ISTs, maybe just guidance on when you're hoping to have more to say on those programs? And as you start your own company sponsored trial in PTLD, are there any learnings from your investigators' experience with 1612 in these first 2 indications that you feel may be applicable to PTLD, despite the fact that these are obviously rather different indications?

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Todd C. Brady, Aldeyra Therapeutics, Inc. - CEO, President & Director [24]

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Right. So the cancer programs, ovarian cancer and mesothelioma were inherited from the previous developer of ADX-1612. We're obviously not a cancer company, but we do see significant potential value if our programs in mesothelioma and ovarian cancer work out. The ovarian cancer trial is called EUDARIO. That has begun enrolling patients. That is an investigator-sponsored trial that'll run in Europe. The mesothelioma trial, we also expect to begin next year, that's also an investigator-sponsored trial. So the timing of that depends on the investigator. One reason that we shifted those programs to investigator-sponsored trial was to conserve resources and focus on our immunological programs that we have internally. These -- the

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Both of those programs is really a synergy that has been observed preclinically between a chaperome inhibition and DNA-damaging agents. So both the ovarian cancer and mesothelioma programs are testing the combination of ADX-1612, which is a chaperome inhibitor and DNA-damaging agents. In this case [indiscernible]. The reason why there is a presumed synergy there is because indiscernible which damage DNA, will require DNA repair, which itself requires the chaperome. So without proper chaperome activity, which is inhibited by 1612, it's difficult to repair DNA, which is the main mode of action of DNA-damaging agents such as indiscernible , and both of those trials that feature that combination clinically.

Are there any learnings from PTLD, probably not. I don't think that -- I think these are vastly different diseases. To begin with, PTLD is not necessarily frank cancer. PTLD is an aberrant proliferation of immune cells that follow a transplant. And in some cases, PTLD can involve -- evolve into a lymphoma. But we view ovarian cancer and mesothelioma as pathologically distinct from PTLD. That doesn't mean we're not excited about PTLD. We're really with 1612 attempting to focus on immune diseases, where there is an aberrant proliferation of immune cells, which is featured in a lot of immune diseases as our bodies mount immune responses. One way we do that is to increase

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[inflammatory] cell proliferation. That can go haywire in diseases such as PTLD, where there are excessive amounts of immune cell replication. And that's exactly what 1612 is targeting in PTLD and potentially other diseases

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Matthew David Cross, JonesTrading Institutional Services, LLC, Research Division - Research Analyst [25]

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Great. No. I appreciate the detail here and the overall update today. So looking forward to the update on RENEW.

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Todd C. Brady, Aldeyra Therapeutics, Inc. - CEO, President & Director [26]

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Thanks, Matt.

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Operator [27]

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Thank you. I will now turn the call back to Dr. Brady for any closing comments.

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Todd C. Brady, Aldeyra Therapeutics, Inc. - CEO, President & Director [28]

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Thank you, operator, and thank you all for joining us again today. As always, we look forward to keeping you informed of our progress and advancing our late-stage pipeline of product candidates for the treatment of immune-mediated disease.

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Operator [29]

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Thank you for your participation. This concludes today's call. You may now disconnect.