Aldeyra Therapeutics, Inc.

Standing by, and welcome to the Aldera Therapeutics First Quarter 2021 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. I would now like to hand the conference over to the company's Chief Financial Officer, Joshua Reed. Please, go ahead, sir.

Good morning, everyone. With me is Dr. Todd Brady, President and Chief Executive Officer of Aldera. This morning, we issued a press release reporting our financial results for the quarter ended March 31, 2021. A copy of the press release is available on the Investors and Media section of our website, www.aldera.com. Please note that this morning's conference call contains forward-looking statements regarding future events and the future performance of Aldera. Forward-looking statements include statements regarding submission of potential new drug applications, potential commercialization, the anticipated timing of results from our clinical trials, our projected cash runaway, our possible or assumed future results of operations, expenses and financial position, and potential growth opportunities, among other things. These statements are based upon the information available to the company today. These statements reflect ALDERA's current views with respect to future events and are based on assumptions and subject to risks and uncertainties, including the development, clinical, and regulatory plans or expectations for ALDERA's product candidates and systems-based approaches. The risks that results from clinical trials or portions of clinical trials may not accurately predict results of future trials for the same or different indications, and Aldera's continuing review and quality control analysis of clinical data. As a result of the COVID-19 pandemic, clinical site availability, staffing, and patient recruitment have been negatively affected, and the timelines to complete our clinical trials may be delayed. Aldera 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, including the current and potential future impact of the COVID-19 pandemic on our business, results of operations, and financial position. 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 this morning and our filings with the SEC. I would now like to turn the call over to Dr. Brady.

Thank you, Joshua. The remarkable top line results we reported last week from our phase three invigorate trial and allergic conjunctivitis set up what we expect to be a catalyst rich year for Aldera in 2021. Reproxilab achieved statistically significant improvement over vehicle for the primary endpoint. of patient-reported ocular itching, the key secondary endpoint of investigator-assessed ocular redness, and the secondary endpoints of patient-reported ocular tearing and total ocular severity score. The clarity of the p-values achieved in the invigorate allergen chamber further suggests Reproxilab's clinical utility in reducing ocular itching, redness, and tearing which are the hallmark symptoms and signs of allergic conjunctivitis. To our knowledge, Reproxilab is the first allergic conjunctivitis compound that has been observed to show activity versus vehicle across symptoms and signs in a large, well-controlled allergen chamber trial. Invigorate achieved the primary endpoint of improvement over vehicle in patient reported ocular itching score at all 11 pre-specified time points, each with a p-value of less than 0.0001. Over the duration of the allergen chamber, improvement over vehicle for the key secondary endpoint of ocular redness was achieved, as were the secondary endpoints of patient reported ocular tearing score and total ocular severity score. Consistent with the primary endpoint, p-values for all secondary endpoints were less than 0.0001, indicating superiority of a proxlap over vehicle and potential clinical utility across symptoms and signs of allergic conjunctivitis in a setting of continuous moderate to high pollen exposure. Consistent with the prior clinical experience of Reproxilab and other prescription ophthalmic solutions, mild and transient installation site discomfort was observed. But importantly, there were no observed safety or tolerability concerns in the trial and no discontinuations due to adverse events. Reproxilab has now been tested in over 1,200 patients with no clinically significant safety signals. With the Invigorate trial completed, we look forward to meeting with the FDA in the second half of this year to discuss the results and the potential submission of a new drug application. Based on the results of Invigorate, we're very encouraged about the potential of our Phase III Tranquility and Tranquility II trials of Raproxilab in dry eye disease. Similar to the key secondary endpoint of Invigorate, the primary endpoint of the two-day Tranquility trials is ocular redness, which, in the case of Tranquility, is assessed over 90 minutes in a dry eye chamber with tear rasp levels, Shermer's test, and dry eye symptoms as secondary endpoints. There is substantial documented clinical overlap between allergic conjunctivitis and dry eye disease. Approximately half the patients who complain of ocular dryness also complain of ocular itching and vice versa. In addition, ocular redness may be the only objective sign of allergic conjunctivitis and dry eye disease that is of considerable importance to patients. Patient enrollment in the Tranquility Trial is underway. Both Tranquility and Tranquility II, which are identical and are expected to enroll approximately 100 patients per arm, remain on track to read out top-line results in the second half of this year. Turning to our systemic disease programs, initial Phase II clinical trial results from ADX629 are expected in the second half of this year in asthma, psoriasis, and COVID-19. ADX629 is a first-in-class, orally available, and irreversible covalent inhibitor of pro-inflammatory RASP and potentially represent a new paradigm in the understanding and treatment of immune-mediated disease that could be broadly applicable across a myriad of clinical indications with unmet clinical need. As I noted in our Q4 call, we are also evaluating new and potentially more important, more potent RASP-inhibiting compounds for retinal and systemic disease, the lead molecules of which could be in clinical development as early as next year. We remain excited about the potential first-line commercial prospects for aproxilab for the treatment of anterior segment inflammation, but we remain equally excited about the possible therapeutic potential for RASP inhibition broadly, especially as Aldera advances programs in inflammatory retinal and systemic diseases, the number and scope of which are far greater than that of anterior ocular disease. Our pipeline and clinical development plans are supported by a strong and well-capitalized balance sheet. Since the beginning of the year, we have generated combined net proceeds of more than $187 million through two underwritten public offerings, including last month's offering that raised $125 million in gross proceeds. We are extremely appreciative of the support from both the current and new institutional investors who have participated in these offerings. With that, I'll turn the call back over to Joshua to review our first quarter financial results.

Thank you, Todd. As Todd noted, we recently sold 10 million shares of common stock at a price of $12.50 per share in an underwritten public offering. The offering generated net proceeds of approximately $117.3 million after deducting offering discounts, commissions, and estimated expenses. Cash and cash equivalents as of March 31, 2021 were $138.4 million. Based on our current operating plan, including the net proceeds from the recent underwritten public offering, we believe that existing cash and cash equivalents will be sufficient to fund currently projected operating expenses through the end of 2023. including potential NDA submission for Reproxilab, initial commercialization of Reproxilab if approved, and continued and late-stage development of the company's product candidates in ocular and systemic immune-mediated diseases. Turning now to our first quarter 2021 results. Research and development expenses were $7.7 million, compared with $6.6 million for the same period in 2020. The increase of $1.1 million is primarily related to higher clinical development and manufacturing costs, partially offset by lower personnel-related costs and a decrease in preclinical costs. General and administrative expenses were $3.1 million for the quarter, compared with $3 million for the same period in 2020. The net loss for the first quarter of 2021 was $11.3 million, or 25 cents per share, compared with a net loss of $9.9 million, or $0.34 per share, for the quarter ended March 31, 2020. Now I'll hand the call back over to Todd for closing comments.

Thank you, Joshua. We have continued to make significant strides in advancing our lead program toward commercialization and anterior ocular inflammatory diseases, and we do so from a position of financial strength We're focused on executing our mission of improving the lives of patients by developing novel immune-mediated therapies that satisfy unmet medical need. With that, Joshua and I would be happy to take your questions. Operator?

Thank you. In order to ask a question, press star and the number 1 on your telephone keypad. Your first question comes from Justin Kim of Oppenheimer. Your line is open.

Hi, good morning. Thanks for taking the question. Just a couple from me. Just maybe touching on the cash balance, if the team reviews the overall pipeline and the robust cash position, are there areas of the pipeline where we might see or expect a greater focus on potential pipeline ads via BDM&A? Is there any thinking in terms of which programs might have that growth given additional cash?

Well, let me, Justin, thanks for the question. And let me start off, and perhaps Josh can provide some color. I think we are rich in pipeline assets at this point. As I mentioned in my prepared comments, we're very excited about the potential for RASP inhibition broadly. which is reflected not only in Reproxilab, our lead asset that I hope is close to the goal line in terms of submission of a marketing application, but also in terms of retinal disease and systemic disease, both of which are likely to relate to RASP inhibition. So I think, as Josh may mention, a lot of the proceeds that have been raised this year are earmarked for continued development of RASP inhibition broadly, as well as our retinal program with ADX2191, which, as you know, is currently in Phase III testing for proliferative vitreoretinopathy. We are always opportunistic in terms of assessment and licensing of new assets I think we've proven to investors over the years that we're capable of evaluating in licensing and developing novel assets. But with that, perhaps I will turn it over to Josh for further color.

No, I think that – so, Justin, thanks for the question. You know, Todd has it right. I think with RAP inhibition, we expect continued development there. And certainly, we brought in ADX 2191 via an acquisition that we completed in 2019, so we will continue to be opportunistic where we see an asset that may fit with our portfolio.

Understood. Got it. Great. And maybe just on Tranquility, can you discuss sort of what steps may be required prior to the initiation of Tranquility II?

There are no additional steps required prior to the initiation of Tranquility 2. Tranquility 2 is identical to Tranquility 1. At this point, the initiation of Tranquility 2 is a matter of sequencing. We do wish to have a slight stagger between the two trials so that we can adjust analysis plans and so forth if need be. However, I do not expect us to do so based on the strength of the run-in cohort of Tranquility, where we saw statistical significance in the primary endpoint after only 23 patients. The primary endpoint for Tranquility and Tranquility 2 is also supported by the redness readout from Invigorate, as you know.

Okay, got it. And maybe just sort of a follow-up to that. In light of the stagger and potential to have, let's say, some information around Tranquility prior to an NDA, pre-NDA meeting on AC, Is that a hope of sort of the team to discuss dry eye in addition to sort of the AC program at that first meeting with the FDA around filing?

Yes. As you know, the FDA typically desires to discuss one IND at a time, one program at a time. In the pre-NDA meetings, for allergic conjunctivitis, which I would argue could happen early second half of this year. One of the questions we're going to ask is, how does the agency wish to receive NDA filings for allergic conjunctivitis and dry eye disease? Because we as a sponsor are very interested in working with the agency making sure that those submissions are performed in a manner that is optimal for the agency to review. So that I expect we will be guiding the street as to the precise mechanisms of those two filings later in the second half of this year.

Got it. Great. So thanks for taking the questions and congrats on the progress.

Thank you, Justin.

Your next question comes from Kelly Shee of Jefferies. Your line is open.

Good morning. Thank you for taking my questions. So my question is regarding ABX629. It's an oral version of Reflexolab, and my question is, even though they are through different administration routes, but what is the rate through to 629 programs from the positive results so far from the Praxilab? And also, strategically, how do you think about prioritized indications for these two molecules? Thank you.

Thanks for the question, Kelly, and I'm glad you mentioned ADX629, which we view as a hidden gem in our pipeline. When we started this company many years ago, we were excited about RASP as a target. Not only do Reproxilab and ADX629, which are closely related structurally, represent new molecules, And not only do those new molecules represent targeting new physiologic mediators of disease, but the entire pharmacology is different. From 99% of drugs available today, most of drugs that we take today bind to proteins, receptors, enzymes. cytokines, or they're directly involved in making proteins, such as the case with gene therapy. Most drugs available today affect single targets, a particular receptor, a particular enzyme. Reproxilap and ADX629 are different in that those drugs target a variety of non-protein that is small molecule inflammatory mediators. And therefore, we've classified RASP inhibition as a systems-based approach. The challenge with the drugs available today is that inhibiting a single target, that is taking a single molecule out of a physiological cascade, leads to toxicity. Analogous to driving your car with three tires. Whereas modifying a system without inhibiting a single target could have safety advantages and efficacy advantages. One reason that we believe we have seen the broad-based symptomatic activity of reproxilap in dry eye disease, not just with dry eye score, not with dryness score, not just with with the ocular discomfort score, not just with burning, not just with stinging, but across the board, is due to the fact, we believe, that riproxilab affects a variety of the small molecule mediators of inflammation. So this kind of systems-based approach could have efficacy advantages as well. There's no reason why RASP inhibition should only apply to the eye or the front of the eye. which is why in response to Justin's question, I mentioned RASP inhibition as it may apply to the retina and systemic diseases. We're really thrilled about ADX629 and the potential thereof. We are currently testing the drug across different forms of inflammation, asthma representing more allergic or TH2 type inflammation, psoriasis representing more autoimmune or TH1 type inflammation. To your question, Kelly, it's really difficult to prioritize diseases or kinds of inflammation as they relate to treatment with ADX629 until we see the results of those trials. But I think you can hear in our voices today that we're optimistic Given the success of Reproxilab, as you point out, about the prospects of ADX629, in a way, the front of the eye for Aldera has been a model of inflammation. I think it's very clear with Invigorate and the success we've had in dry disease that Reproxilab is active and safe. And therefore, I think there is considerable read-through to the potential success of ABX629. And that's why we're so excited about keeping you up to date regarding the Phase II results later this year.

Very insightful. Thank you, Todd.

Thank you, Kelly.

Your next question comes from Mark Goodman of SVB Lerink. Your line is open.

This morning, guys, two questions. First, for tranquility trials, I mean, obviously everybody's very excited about seeing the secondary endpoint of redness in the previous trial we just saw a few weeks ago and gives us more confidence. But I guess just flipping that around, when you think about these trials, what do you worry about the most? You know, if something happens that's just, you know, it doesn't go the way we were thinking, you know, what do you think would be the reason? I'm just curious how you're thinking about that. And second question is, can you just give us an update on the retina program? We haven't talked about that really, so just how enrollment's going and stuff. Thanks.

For sure. Thanks for the questions, Mark. And thanks for your recent activity regarding retinas and your notes along those lines. We were particularly interested, prior to the readout of Invigorate, about how ocular redness would turn out because, as I said in my prepared comments, I do think there is a tremendous clinical relationship between allergic conjunctivitis and dry eye disease. And if you're going to pick a sign, you might as well pick something that patients care about, and that is ocular redness. It is difficult for us to think of another sign that patients care about, and by extension, that health care providers care about. I have never heard a patient say, I'm really interested in increasing my Shermer score, or my inferior corneal staining score, or any other objective signs that we usually use to assess dry eye disease. We're fortunate that Reproxilab seems to have anti-redness activity, not only because that activity indicates immune-mediating efficacy in part, but also because it is commercially desirable and that patients and physicians are interested in reducing redness. What can go wrong? Well, in the clinical trial business, those of us that have been around for decades have had lots go wrong. It is always possible for clinical trials to read out sideways and in unexpected manners In dry eye disease, there is considerable variability. This is why many companies developing drugs today for dry eye disease perform a number of phase three trials. And Aldera is no different. One way to combat variability is numerous trials. And that's exactly what we've done. with the RENEW trials, with the Phase 2B formulation trials that we believe will satisfy our requirements for symptom control over 12 weeks in dry disease, but also the TRANQUILITY trials, one and two, which are, we believe, conservatively powered, at least 90% powered, to detect changes in ocular redness based on the activity we saw in the running cohort for TRANQUILITY and, as I mentioned, in response to Kelly's question and also based on the activity in redness that we saw from Invigorate. On the retina program, we are continuing to move forward with ADX 2191 in terms of enrollment in proliferative vitreoretinopathy, which as you know is a disease that has no therapy today. for which we have received orphan designation and for which ADX2191 has been fast-tracked by the FDA. We continue to expect completion of enrollment this year. There is a six-month readout per patient. That is, the primary endpoint is retinal detachment over six months after initiation of therapy. so that we would expect results from the PVR GARD1 trial. That is the first part of GARD at some point next year. I have not spent a lot of time talking about the RASP retina program. I've mentioned it briefly a few times today. RASP are particularly interesting in retinal diseases for two reasons. The obvious reason is the anti-inflammatory effect of RASP inhibition. But the other reason is that RASP are involved in binding to other small molecules which are, in some cases, not digested or metabolized by the cells in the retina and therefore lead to the accumulation of retinal aggregates. An example might be a drusen. in dry age-related bacteria generation and related diseases such as Stargardt disease. So I think that there are at least two good reasons mechanistically to test RASP inhibition in the retina. We're currently preparing for IND submission at some point in the near future. And as I mentioned in my prepared comments, we expect to potentially be in clinical testing with our RASP retina program next year.

Thanks.

Thanks, Mark.

Your next question comes from . Your line is open.

Great. Good morning. This is Carly. I'm for . Thank you for taking our questions. To follow up on an earlier question regarding the upcoming FDA discussions, can you comment on what you see as the advantages and disadvantages of filing one NDA for tri-I and allergic conjunctivitis versus the advantages and disadvantages of filing separate NDAs for each indication? And I guess the second part of the question is, does Aldera have a preference at this point between those two filing strategies?

Thank you. Hi, Carly. Good morning and thanks for your question. There are no obvious advantages or disadvantages that we're aware of regarding filing separately or at the same time. And the reason for that is that in the event that there are two separate NDAs, one NDA will reference the other. such that we don't have to replicate a good deal of work across NDAs. What we're most interested in is what the agency prefers. I'll just take a step back to say how fortunate are we as a sponsor and as investors that we're in a position that we can file to NDAs. Outside of oncology, I don't know of many companies that have been fortunate enough to file two NDAs at one time, and we're thrilled. I think the fact that we've generated data in two different anterior segment inflammatory diseases, that those data have been positive, that the drug has been well tolerated, that there are no clinically relevant safety signals now in more than 1,200 patients that have been exposed to Reproxilab. All is remarkable. And we are hoping that our colleagues at the FDA recognize the breadth of activity across two different diseases, as well as the safety advantages I've mentioned of Reproxilab in getting this drug in the hands of patients and physicians.

Okay, perfect. Thank you for taking the questions, Bob.

Thanks, Carly.

Again, if you would like to ask a question, press star then the number one on your telephone keypad. Your next question comes from Edwin Zhang of HC Wingright. Your line is open.

Hi, thanks for taking my questions. First, congrats on the solid quarter. A quick question on international expansion. What's your current thinking on geographical expansion after the recent clinical success of Reproxalab? Are you looking for partners ex-US? Also, related to this, Does the European regulator accept chamber studies for pivotal trial and EMA approval in dry eyes and allergic conjunctivitis? Thank you.

Edwin, good morning, and I will say I have enjoyed discussing with you over the years our potential outside of the United States. I think too often biotechnology companies focus only on the United States. I guess that is easy to do, given that many biotechnology companies are domiciled exclusively in the United States. But there really is no reason why ritroxilab couldn't be a first-line option across the world. Ocular diseases such as allergic conjunctivitis may be even more prevalent outside of the United States, particularly in Asia. I can tell you that as a result of our continued progress in allergic conjunctivitis and dry eye disease, Aldera has received a considerable amount of inbound interest regarding regional partnering outside of the United States. The direct answer to your question is yes, we would intend to partner with Proxilab outside of the United States. Inside of the United States, we have many options. As I've mentioned in other calls, one of the attractive elements of ocular surface inflammation is that commercial launches are feasible for small companies generally. based on what other companies have done. Sales forces are in the 1 to 200 to 300 rep range. This is eminently possible for small companies to achieve. However, the question for Aldera is what is optimal for Reproxilab, which, as you know, has broad applicability in allergic conjunctivitis and dry eye disease. So we, like any other responsible biotechnology company, will continue to evaluate the pros and cons of an internal launch of Verproxilab versus a partnered launch of Verproxilab. Our most recent financing from last week gives the company considerable flexibility. to evaluate both a go-it-alone and partnered strategy. And we're thrilled to be in such a position of financial strength for obvious reasons. Thank you.

Thanks, Edwin.

Your next question comes from Esther Hong of Barenburg. Your line is open.

Hi. Good morning. I wanted to ask about pipeline candidate ADX1612. Any updates there? It looks like data is going to be released in about 2022 from an investigator-sponsored study in ovarian cancer. So any expectations and future plans in that indication? Thanks.

Hi, Esther. Good morning. Thanks for asking about 1612 because we often don't have time to discuss that compound. You're absolutely correct. 1612 is primarily now the subject of a Phase II ovarian cancer trial that is being run across multiple centers in Europe in combination with PARP inhibitors. We're not exactly sure of the timing of the results of that trial because that trial is investigator-sponsored, as you mentioned. However, I think there's considerable preclinical reason to believe that the activity of HSP90 inhibition, which is the mechanism of 1612, in combination with PARP inhibition and potentially platen therapy could be beneficial for patients We await the results of those investigations in the IST and obviously would communicate to the street once we hear back.

Thanks.

Your next question comes from Prakhar Agrawal of Jones Trading. Your line is open.

Hi, good morning, and thanks for taking my questions. First, a CMC-related question. Do you have the stability data for ReproZap in-house? If not, when do you expect to have this data, and how long do you expect the product to be stable? And second, on some of the early-stage pipeline on the new molecules that could enter the clinic next year, could you give more details on what could be the differentiation for these molecules versus ReproZap? And then I had a follow-up on ADA 629.

Perfect, Prakash. Thank you. I'll see if I can remember all those questions. Regarding chemistry manufacturing and controls, stability has not been a concern to date. Our registration batches are in excellent shape. And to date, we would expect a 24-month stability as is standard in NDA filings. So in conclusion, I don't think that there are any CMC roadblocks at all at this point. We have guided that NDAs are possible for dry eye disease and allergic conjunctivitis, but by the end of this year or early next year, I think the gating factors for those NDA submissions more likely relate to the standard NDA safety studies, which in dry eye disease are 12 months long. Nonetheless, I still think that we're in a good position to meet the NDA submission timelines that I have mentioned. Your next question relates to new molecules regarding RASP inhibition and the potential advantages thereof. As I mentioned in my prepared comments, we have consistently developed new chemical entities with similar pharmacophores that are designed to irreversibly bind to RASP. Some of those new molecules are considerably more potent than Reproxilab and ADX629. The advantages of potency remain to be proven in the clinic. However, we are committed as a company to developing new intellectual property around compositions associated with RASP inhibition, as well as generating a robust, novel RASP inhibition clinical pipeline across a number of different diseases. And then I believe you had a follow-up question, Prakhar.

Yeah. So on ADX169, the Phase II trial in mild allergen asthma, given it's a small proof-of-concept trial with limited treatment duration, Could you frame expectations on what could we expect to see on various endpoints and any biomarker data that you will be measuring? Thank you.

Prakash, thanks again for the excellent question. I'm thrilled to receive so many questions on our pipeline. I think too often the street values Aldera as a dry eye disease company. Our pipeline, as you know, extends well beyond that. the two indications that we're moving forward for Ruproxilab. And as we look forward to the future, I think that there will be a lot to say about not only anterior ocular inflammation, but also retinal and systemic disease. In terms of asthma specifically, Asthma, psoriasis, and COVID-19 are proof of concept that phase two clinical trials. As you point out, not only are clinical endpoints assessed, but also a biomarker assessment that represents a large portion of the output of those trials. Asthma is particularly interesting not only because it is a TH2 allergic type inflammation where we have, at least with roproxilab, consistently demonstrated activity, but also because of the number of clinical biomarker endpoints that can be assessed associated with asthma. Two examples are the standard pulmonary function tests associated with most asthma clinical trials and eosinophil sputum counts, which is a measure of inflammatory cell counts in the sputum of patients. We're also intending to measure plasma cytokine profiles, plasma RAS profiles, and I'm really excited to assess all these different data, which will point us to mechanistically appropriate clinical indications in the future for ADX629.

Your next question comes from Yale Jen of Laidlaw & Company.

Your line is open. Good morning, and thanks for taking the question. I just want to first just want to confirm that in terms of reporting the Tranquility 1 and 2 data, are you guys going to just blend into one reporting of the outcome, or you will do one after another? In other words, the first for one and then for the second, Tranquility 2.

Right. Good morning, Yale. Our goal is to keep you as busy as possible. So I would suspect that we would report both Tranquility 1 and Tranquility 2 separately, just given the timing and the stagger between the two trials that I have previously mentioned.

And one follow-up question here is actually follow up with your earlier comments in terms of the RAS basically is the systemic approach, the flip side of that actually is the safety. So how would, in addition to empirical studies, how would you guys thinking about the safety of any drugs based on this target or system that will not impact on the individual?

Yeah, that is an excellent question. I can tell you because I was there, that the first institutional investment in the company, which was 2005, which was led by domain associates in Johnson & Johnson, the question of systemic toxicity was first and foremost. That is, what are the safety ramifications of inhibiting RASP broadly throughout the body? As we've said in our 10K now for many years, that we know of, there are only two RASP targets that are physiologic, that is, involved in non-inflammatory metabolic processes. And those are retinaldehyde, which is a form of vitamin A, and pyridoxal and pyridoxal phosphate, which are forms of vitamin B6. Both of those molecules are highly chaperoned. or highly protected, we've had no evidence in animals or humans that our RASP inhibitors are capable of even approaching those molecules. And we have seen no clinical evidence, either with topical ocular administration or oral administration, that RASP inhibition affects those two molecules. What appears to be the case then is that RASPs that are available systemically and in the eye are pro-inflammatory. And those RASPs are the targets of our drug. We've now been through a rigorous phase one trial with high doses of ADX629. We saw no adverse events related to drug. And those data support the safety profile of ADX 629. We look forward to monitoring the efficacy and safety of 629 in larger trials and in disease patients. And rest assured that the results of those investigations will be shared with investors, we hope, by the end of this year.

Okay, great. Thanks for the Bio 101 presentation.

lectures. You're welcome, Gail. It's my pleasure.

We've reached the end of the Q&A session. I will now turn the call back to Dr. Brady for closing comments.

Thank you, Operator, and thank you all for joining us again this morning. As always, we look forward to keeping you updated on our progress. Next month, we will be participating in the Jeffries virtual healthcare conference, please check our website for the scheduled presentation time. And for those of you that are participating, we look forward to meeting with you soon. Thanks again.

This concludes today's conference call. Thank you for your participation.