Ladies and gentlemen, thank you for standing by, and welcome to the Altira Therapeutics First Quarter 2021 Financial Results Conference Call. At this time, all participants are in a listen only mode. After the speakers' 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 Doctor. Todd Brady, President and Chief Executive Officer of Aldeyra. 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.aldeyra.com.
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 submission of potential new drug applications, potential commercialization, the anticipated timing of results from our clinical trials, our projected cash runway, 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 Aldeyra'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 Aldeyra'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 Aldeyra's continuing review and quality control analysis of clinical data.
As a result of the COVID-nineteen pandemic, clinical site availability, staffing and patient recruitment have been negatively affected and the timelines to complete our clinical trials may be delayed. 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, including the current and potential future impact of the COVID-nineteen 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 Doctor.
Brady.
Thank you, Joshua. The remarkable top line results we reported last week from our Phase 3 INVIGORATE trial in allergic conjunctivitis set up what we expect to be a catalyst rich year for Aldeyra in 2021. Reproxalap 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 reproxalap's clinical utility in reducing ocular itching, redness and tearing, which are the hallmark symptoms and signs of allergic conjunctivitis.
To our knowledge, reproxalap 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 and patient reported ocular itching score at all 11 pre specified time points, each with a p value of less than 0 point 1. 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 tiering 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 aproxolap 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 reproxalap 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, reproxalap has now been tested in over 1200 patients with no clinically significant safety signals. With the INVIORATE 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 reproxalap in dry eye disease. Similar to the key secondary endpoint of INVIGRATE, the primary endpoint of the 2 day TRANQUILITY trials is ocular redness, which indicates of TRANQUILITY is assessed over 90 minutes in a dry eye chamber with TRAP levels, Schirmer'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 2, 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 ADX-six 29 are expected in the second half of this year in asthma, psoriasis and COVID-nineteen.
ADX-six twenty nine is a 1st 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 reproxalap for the treatment of anterior segment inflammation, but we remain equally excited about the possible therapeutic potential for RASP inhibition broadly, especially as Aldeyra 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 $187,000,000 through 2 underwritten public offerings, including last month's offering that raised $125,000,000 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 Q1 financial
results. Thank you, Todd. As Todd noted, we recently sold 10,000,000 shares of common stock at a price of $12.50 per share in an underwritten public offering. The offering generated net proceeds of approximately $117,300,000 after deducting offering discounts, commissions and estimated expenses. Cash and cash equivalents as of March 31, 2021 were $138,400,000 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 reproxalap, initial commercialization of reproxalap 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 Q1 2021 results. Research and development expenses were $7,700,000 compared with $6,600,000 for the same period in 2020. The increase of $1,100,000 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 $3,100,000 for the quarter compared with $3,000,000 for the same period in 2020. The net loss for the Q1 of 2021 was $11,300,000 or $0.25 per share, compared with a net loss of $9,900,000 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. Your first question comes from Justin Kim of Oppenheimer. Your line is open.
Hi, good morning. Thanks for taking the questions. Just a couple from me. Just maybe touching on the cash balance, as the team reviews the overall pipeline and sort of the robust cash position, are there areas of the pipeline where we might see or expect a greater focus on potential pipeline adds via BD M and A? I mean, is there any thinking in terms of which programs might sort of have that growth given sort of the 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 reproxalap, 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 ADX-two thousand one hundred and ninety one, which as you know is currently in Phase 3 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. Todd has it right. I think with RAS inhibition, we expect continued development there. And certainly, we brought in ADX-two thousand one hundred and ninety one 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 2?
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 running cohort of Tranquility, where we saw statistical significance in the primary endpoint after only 23 patients.
The primary endpoint for TRANQUILITY and TRANQUILITY II is also supported by the redness readout from Invigorate, as you know.
Okay, got it. And maybe just as sort of a follow-up to that. In light of the stagger and potential to have, let's say, some information around TRANQUILTI 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 1 IND at a time, one program at a time. In the pre NDA meeting 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 are very interested in working with the agency and 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.
Your next question comes from Kelly Hsieh of Jefferies. Your line is open.
Good morning. Thank you for taking my questions. So my question is regarding ADX-six twenty nine. It's an older version of reguxorab. My question is, even though there are 2 different administration rules, but what is the ratio to 629 programs from the positive results so far from reproxalab?
And also, strategically, how do you think about prioritize indications for these 2 molecules? Thank you.
Thanks for the question, Kelly. And I'm glad you mentioned ADX-six twenty nine, 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 viproxalap and ADX-six twenty nine, 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 that 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. Reproxalap and ADX-six twenty nine 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 3 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 reproxalap in dry eye disease, not just with dry eye score, not with dryness score, not just 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 reproxalap 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 questions, I mentioned RASP inhibition as it may apply to the retina and systemic diseases.
We're really thrilled about ADX-six twenty nine 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 ADX-six twenty nine until we see the results of those trials. But I think you can hear in our voices today that we are optimistic given the success of reproxalap as you point out about the prospects of ADX-six twenty nine, in a way the front of the eye for Aldeyra has been a model of inflammation. I think it's very clear with Invigorate and the success we've had in dry disease that reproxalap is active and safe.
And therefore, I think there is considerable read through to the potential success of ADX-six twenty nine. And that's why we're so excited about keeping you up to date regarding the Phase 2 results later this year.
Your next question comes from Marc Goodman of SVB Leerink. Your line is open.
Yes, morning guys. Two questions. First, for TRANQUILITY's trials, I mean, obviously everybody is 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? If something happens that's just it doesn't go the way we were thinking, what do you think would be the reason?
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 is going and stuff. Thanks.
For sure. Thanks for the questions, Mark. And thanks for your recent activity regarding redness and your known to long ago clients. 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 healthcare providers care about. I have never heard a patient say, I'm really interested in increasing my Schirmer 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 reproxalap 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 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 3 trials and Aldeyra 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, 1 and 2, which are we believe conservatively powered, at least 90% powered to detect changes in ocular redness based on the activity we saw in the run-in 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. Continuing to move forward with ADX-two thousand one hundred and ninety one in terms of enrollment and proliferative vitreoretinopathy, which as you know is a disease that has no therapy today for which we have received orphan designation and for which ADX-two thousand one hundred and ninety one has been fast tracked by the FDA. We continue to expect completion of enrollment this year. There is a 6 month readout per patient that is the primary endpoint is retinal detachment over 6 months after initiation of therapy.
So that we would expect that 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, but RASPs 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 or metabolized by the cells in the retina and therefore lead to the accumulation of retinal aggregates.
An example might be adrusin in dry age related bacterium 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 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. Your next question comes from Ygal Nochomovitz of Citi. Your line is open.
Great. Good morning. This is Carly on for Ygal. Thank you for taking our questions. Just 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 dry eye 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 Aldeyra have a preference at this point between those two filing strategy? 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 2 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 not 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 2 NDAs. Outside of oncology, I don't know of many companies that have been fortunate enough to file 2 NDAs at one time and we're thrilled. I think the fact that we've generated data in 2 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 1200 patients that have been exposed to reproxalap. All is remarkable. And we are hoping that our colleagues at the FDA recognize the breadth of activity across 2 different diseases, as well as the safety advantages I've mentioned of reproxalap in getting this drug in the hands of patients and physicians.
Your next question comes from Edwin Zhang of H. C. Wainwright. 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 reproxalap.
Are you looking for partners ex U. S? Also related to this, does the European regulator accept chamber studies for pivotal trial and the EMA approval in dry eyes and allergic conjunct devices? Thank you.
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 why reproxalap that 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, 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 reproxalap 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 imminently possible for small companies to achieve. However, the question for Aldeyra what is optimal for reproxalap, 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 pros and cons of an internal launch of reproxalap versus a partnered launch of reproxalap. 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.
Your next question comes from Esther Hong of Berenberg. Your line is open.
Hi, good morning. I wanted to ask about pipeline candidate, ADX-sixteen twelve. 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 me 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 2 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 platinum therapy that could be beneficial for patients. We await the results of those investigations in the IST and obviously would be communicated to The Street once we hear back.
Okay. Thanks.
Your next question comes from prakar agrawal of JonesTrading. 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 Repoza Lab 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 reprosadap?
And then I had a follow-up on ADA-six twenty nine.
Perfect, Kart. 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 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 raspin 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 reproxalap and ADX-six twenty nine. 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 addition clinical pipeline across a number of different diseases.
And then I believe you had a follow-up question for Carr.
Yes. So on ADX-six twenty nine, the Phase 2 trial in mild allergic 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.
Question. I'm thrilled to receive so many questions on our pipeline. I think too often the street values Aldeyra as a dry eye disease company. Our pipeline, as you know, extends well beyond the two indications that we're moving forward for reproxalap. 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-nineteen are proof of concept of Phase 2 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 reproxalap 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 ADX-six twenty nine.
Your next question comes from Yale Jen of Laidlaw and Company. Your line is open.
Good morning and thanks for taking the questions. I just want to first just want to confirm that in terms of reporting the TRYCAR T1 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 1 and the 10 for the 2nd? 2nd, I'm sorry, 2.
Right. Good morning, Gail. Our goal is to keep you as busy as possible. So I would suspect that we will report. You did?
Yes, I would suspect that we will report both TRINQUILIO I and TRINQUILIO II 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 a 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 that of any drug obstructs based on this target or systems that will not impact on the individual?
Yale, that is an excellent question. I can tell you because I was there that the first institutional investment in the company which was 2,005 which was led by Domain Associates and Johnson and Johnson, the question of systemic toxicity was 1st and foremost. That is what are the safety ramifications of inhibiting RASP broadly throughout the body. As we said in our 10 ks now for many years that we know of there are only 2 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. That 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 2 molecules. What appears to be the case then is that RASP 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 1 trial with high doses of ADX-six twenty 9.
We saw no adverse events related to drug. And those data support the safety profile of ADX-six twenty nine. 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-one hundred and one lectures.
You're welcome, Yale. It's my pleasure.
We have reached the end of the Q and A session. I will now turn the call back to Doctor. 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 Jefferies 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. You may now