Earnings Call Transcript - ALDX Q3 2022

Bruce Greenberg, Interim CFO

Good morning, everyone. With me today is Dr. Todd Brady, our President and Chief Executive Officer. This morning we issued a press release reporting our financial results for the quarter ended September 30, 2022, and recent corporate highlights. A copy of the press release is available on the Investors & Media section of our website at 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, but are not limited to, statements regarding the 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. These statements are based on the information available to us today and reflect our current views concerning future events. They 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 result from clinical trials or parts of clinical trials may not accurately predict the 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-19 pandemic, clinical site availability, staffing, and patient recruitment have been negatively affected and the timelines to complete our 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 our 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 our press release issued this morning and in our filings with the SEC. I will now turn the call over to Dr. Brady.

Todd Brady, President and CEO

Thank you, Bruce, and good morning, everyone. Today, I would like to share with you the progress we have made in advancing our lead pre-commercial product candidates, reproxalap and ADX-2191 toward regulatory approval. Individually, these products have the potential to provide us with unique revenue streams, while together, they represent an opportunity to build a formidable ocular franchise, encompassing large and rare retinal diseases that are significantly underserved by currently available treatments. The success to date in developing reproxalap and ADX-2191 and the commercial potential of both product candidates serve as evidence of Aldeyra's position as a leader in the developments of systems-based therapies for diseases characterized by inflammation. Leading off with reproxalap in September, we had a successful pre-NDA meeting with the U.S. Food and Drug Administration, gaining alignment on the key aspects of the planned NDA submission. In the fourth quarter of 2022, we plan to submit what we believe will be the most comprehensive regulatory package ever for a dry eye disease drug candidate with results based on five adequate and well-controlled completed clinical trials. We intend to submit the NDA with data for ocular dryness symptom score, ocular redness, Schirmer test, and Schirmer test ≥10 mm responder analysis. The NDA efficacy package is expected to include activity ranging from within minutes of drug administration to up to 12 weeks of treatment, crossover and parallel-group clinical trial designs, and assessment in dry eye chamber challenges and natural environment settings. The NDA package will also include up to 12 months of reproxalap safety data. As a reminder, reproxalap has been studied in more than 2,000 patients with no observed clinically significant safety concerns, with the most commonly reported adverse event being mild and transient instillation site irritation. Complementing our dry eye disease program, we're also advancing reproxalap toward a potential supplemental NDA submission in allergic conjunctivitis. Results from INVIGORATE-2 allergen chamber trial, which could represent our final clinical trial of reproxalap in allergic conjunctivitis, are expected in 2023. In October, the previously completed Phase 3 INVIGORATE trial was the subject of a presentation at the American Academy of Ophthalmology 2022 Annual Meeting. Moving to our clinical development programs targeting diseases in the back of the eye, several planned milestones are approaching for ADX-2191, our pre-commercial product candidate for rare retinal disease. ADX-2191 is the first sterile, non-compounded formulation of methotrexate designed to meet the unique requirements of intravitreal administration. It is intended to be vitreous compatible and optimized for excipient composition, viscosity, density, tonicity, pH, active ingredient concentration, and volume of administration. Importantly, the volume of administration is less than that of compounded methotrexate, potentially resulting in an improved safety profile. Although compounded methotrexate is injected into the vitreous today, ADX-2191, if approved, would represent the first GMP manufactured methotrexate drug product for intravitreal administration. Our ADX-2191 platform is targeting three indications, all of which have received U.S. FDA orphan drug designation. Primary vitreoretinal lymphoma is a rare, aggressive, and fatal cancer that is diagnosed in approximately 300 to 600 patients in the United States per year. Proliferative Vitreoretinopathy or PVR, the sight-threatening condition and the leading cause of failure of retinal reattachment surgery that affects approximately 4,000 patients in the U.S. per year. And retinitis pigmentosa is a group of rare genetic eye diseases characterized by cell death and loss of vision affecting an estimated 82,000 individuals in the United States and approximately one in 4,000 people worldwide. We've scheduled a pre-NDA meeting with the FDA in the fourth quarter of 2022 to discuss ADX-2191 for the treatment of primary Vitreoretinal Lymphoma. Pending the results of the pre-NDA meeting, NDA submission may occur as soon as the end of 2022. For PVR, this quarter, we announced that ADX-2191 met the primary endpoint in part one of the Phase 3 GUARD Trial. ADX-2191 was statistically superior to historical control for the prevention of retinal attachment due to PVR over six months with a p-value of 0.024. Although not statistically powered for secondary or exploratory endpoints, the results of the GUARD Trial demonstrated numerical superiority of ADX-2191 over routine surgical care and reducing every assessed dichotomous endpoint of ocular disease with an overall p-value of 0.047. The most common adverse event associated with ADX-2191 treatment was punctate keratitis, a well-known side effect of intravitreal methotrexate, that was most commonly mild in severity. Across all other treatment-emergent adverse events occurring in at least 10% of patients in either treatment arm, relative to patients treated with routine surgical care, ADX-2191-treated patients had numerically fewer side effects, with an overall p-value of 0.0002. We plan to discuss the completion of clinical development for PVR and a Type C meeting with the FDA in the first half of 2023. We also expect to announce Phase 2 clinical trial results of ADX-2191 in retinitis pigmentosa in the first half of next year. Eight patients are expected to be enrolled in the trial with half receiving monthly intravitreal injections and the other half receiving twice monthly intravitreal injections over a period of three months. Turning to ADX-629, our oral RASP modulator platform targeting systemic inflammatory disease, we remain on track to report top-line results this year from a Phase 2 clinical trial in acute alcoholic hepatitis. In addition, by year-end, we also plan to initiate Phase 2 clinical trials in Sjogren-Larsson syndrome and minimal change disease. Top-line results of the Phase 2 clinical trial in chronic cough are anticipated in the first half of 2023. Now, I'll turn the call over to Bruce for the financial review.

Bruce Greenberg, Interim CFO

Thanks, Todd. Cash, cash equivalents, and marketable securities as of September 30, 2022, were $185.3 million. Based on our current operating plan, we believe that existing cash, cash equivalents, and marketable securities will be sufficient to fund currently projected operating expenses through the end of 2023, including NDA submissions and initial commercialization of both reproxalap and ADX-2191, if approved, and continued early and late-stage development of Aldeyra's product candidates in ocular and systemic immune-mediated diseases. Net loss for the three months ended September 30, 2022, was $14.6 million or $0.25 per share, compared with a net loss of $15.8 million or $0.27 per share for the comparable period of 2021. Losses have primarily resulted from the cost of clinical trials in research and development programs, as well as from general and administrative expenses. Research and development expenses for the three months ended September 30, 2022, were $11.5 million, compared with $12.9 million for the same period in 2021. The decrease of $1.4 million is primarily related to a decrease in external clinical development costs, offset by increases in our external preclinical development costs, drug product manufacturing expenditures, personnel costs, and consulting expenditures. General and administrative expenses for the three months ended September 30, 2022, were $3.2 million, compared with $2.5 million for the same period in 2021. The increase of $0.7 million was primarily related to higher personnel costs and consulting expenditures. Total operating expenses for the three months ended September 30, 2022, were $14.8 million, compared with total operating expenses of $15.4 million for the same period in 2021. Now, let me turn the call back to Dr. Brady for closing remarks.

Todd Brady, President and CEO

Thank you, Bruce. The remainder of 2022 and the beginning of 2023 are shaping up to be an exciting catalyst-rich period for Aldeyra, marked by two planned NDA submissions and multiple data readouts. With two late-stage candidates in anterior ocular and rare retinal diseases representing potential revenue streams in 2023, and our clinical stage RASP modulator platform and systemic immune-mediated diseases, Aldeyra's pipeline represents an innovative opportunity to positively affect patient care in both large and rare diseases. With that, we'll be happy to take your questions.

Operator, Operator

Thank you. Our first question today comes from Yigal Nochomovitz from Citi. Please go ahead. Your line is now open.

Unidentified Analyst, Analyst

Hi. This is Carly on for Yigal. Thank you so much for taking our questions. Can you elaborate on what still needs to happen before submitting the reproxalap NDA by the end of the year? Which components of the filing still need to be completed? And we're also curious if at any point you had considered a rolling NDA or was that not really an option with the division of ophthalmology?

Todd Brady, President and CEO

Good morning, Carly, and thanks for your question. My answer to what needs to be completed prior to the submission of the reproxalap NDA is very little. That NDA submission process from our end is well underway. We are reiterating our guidance that NDA will be submitted during this quarter. A rolling NDA is typically reserved for rare and or fatal diseases where lack of therapy is a part of the unmet medical need. I don't think that typically would apply for a dry eye disease. Although I will say that dry eye disease is persistently disturbing, and as a society, I think we can do more to address diseases like dry eye disease, which aren't necessarily fatal but do affect tens of millions of people on a daily basis and are responsible for a significant amount of economic costs as a result.

Unidentified Analyst, Analyst

Okay, got it. That's helpful. And then for the ADX-629 data, in acute alcoholic hepatitis later this year, can you just talk about what you want to see there to establish proof of concept to continue the program? Is this a situation where you sort of have a clear idea of what is needed or do you need to see the data and then sort of make an assessment after seeing it?

Todd Brady, President and CEO

Well, we certainly want to see the data before deciding what to do next. A couple of comments about alcoholic hepatitis. This is a disease which really hasn't been addressed pharmacologically by the drug industry. The irony is it affects many millions of people and the unmet need is considerable. There is no drug approved for alcoholic hepatitis. In terms of RASP modulation, the mechanism is particularly appropriate to alcoholic hepatitis. When we consume alcohol, alcohol is metabolized to a RASP, particularly acetaldehyde, which is reactive, immunogenic, toxic, and proinflammatory. Our RASP modulator platform, including ADX-629, in theory would reduce acetaldehyde levels and thereby prevent some of the toxicity that we see following chronic exposure to ethanol. In terms of the trial itself, we're assessing both symptoms and signs after acute alcohol exposure. Criteria for advancement typically involve achievement of either a symptom or a sign so that the drug can be studied in a larger trial. A variety of trial designs are under consideration, but as you point out, Carly, I think we need to see the data to speak with the key opinion leaders in the space. We need to gauge the level of excitement for moving forward given the data, and then make a decision, and we'll update the Street accordingly along those lines.

Unidentified Analyst, Analyst

Okay, great. Thank you for taking our questions.

Todd Brady, President and CEO

Pleasure.

Operator, Operator

Thank you. The next question today comes from the line of Marc Goodman from SVB Securities. Please go ahead. Your line is now open.

Marc Goodman, Analyst

Todd, how are you thinking about reproxalap and the commercialization of the product and just the market that it would be entering and how that market's evolved? Over the past year, we've had some new products that have entered over the past couple of years and just your thoughts on what the differentiation and what those products did, and what those products didn't do? Thanks.

Todd Brady, President and CEO

Marc, that's a great question. As I often mention on these calls, we've been reflecting a lot on the commercialization and positioning of reproxalap, particularly in light of the evolving dry eye landscape. Dry eye remains a significant unmet medical need, impacting millions of individuals in the United States alone. We have long maintained that existing treatment options for dry eye disease fall short, as recognized by both healthcare providers and patients. Looking toward 2023, we anticipate several new entrants in the dry eye market. These include a novel oil-like product for Meibomian gland dysfunction with an NDA submitted, another version of cyclosporine also with an NDA filed, a treatment targeting the eyelid, and a recently approved nasal spray for dry disease. However, among these options, Aldeyra stands out as the only novel drug, meaning it is a new chemical entity with a new target. Crucially, Aldeyra is the only company that has consistently shown rapid activity with its eye drops, demonstrating effects within minutes, as I noted earlier. I believe reproxalap is well positioned in this evolving market, and you can expect Aldeyra to focus on promoting the rapid onset of symptomatic relief, which is supported by our chamber trials and the 10 millimeter responder analysis along with the Schirmer test, both of which indicate symptomatic improvement.

Operator, Operator

Thank you. The next question today comes from the line of Justin Kim from Oppenheimer. Please go ahead. Your line is now open.

Justin Kim, Analyst

Hi, good morning, Todd and team. Thanks for taking the questions. We have two for you. Regarding the upcoming pre-NDA meeting for PBR, what broad topics or outcomes are you aiming to address or reach an agreement on? Additionally, as a follow-up to a previous question, I’m interested in whether the safety study for reproxalap has met the necessary requirements and how that has been progressing.

Todd Brady, President and CEO

Hi, Justin. Good morning. I think typically for pre-NDA meetings, the main objective is to avoid any sort of misunderstandings between the sponsor and the agency in terms of what is required for submission, in particular, efficacy and safety data. Obviously, those questions about the adequacy of the package in terms of efficacy and safety are first and foremost. Other questions often involve what can we submit at the time of the submission versus what can we submit at the 120-day update, which occurs post-submission. Typically, the FDA broadly across all divisions will accept certain things at the time of the first submission and other things at the time of the 120-day update, and that's something that we intend to clarify as we did with the reproxalap pre-NDA meeting. Given that methotrexate is the standard of care in ocular lymphoma, given our discussions with the agency previously in ocular lymphoma, the material aspects of which we have already disclosed, I don't expect a vigorous discussion on the utility of methotrexate to treat lymphoma; rather, I think the pre-NDA meeting will be focused on process and structure and to some extent that content. Your second question, the safety trial for reproxalap. Thank you for asking. As I've said before on these calls, investors and analysts often forget that it's not just about efficacy for NDA submissions, it's also about safety and CMC. I think in this case regarding the safety trial, we are very well positioned. The FDA guidance in dry disease is very clear as it relates to safety trials. 300 drug-treated subjects must complete six weeks of treatment and approximately 100 drug-treated subjects must complete 12 months of treatment. Our safety trial is moving along nicely. I think it's safe to assume that the trial is practically complete; otherwise, we wouldn't be guiding a submission at this quarter. All-in-all, I think our package is robust. I think it's in excellent shape and I look forward to the submission.

Justin Kim, Analyst

Thanks so much. And looking forward to the update later this year.

Operator, Operator

Thank you. The next question today comes from Kelly Shi from Jefferies. Please go ahead. Your line is now open.

Unidentified Analyst, Analyst

Hi, this is someone filling in for Kelly. Thank you for taking our questions. I have a question about the new candidates for RASP modulation. Can you provide more details about this new candidate? What improvements does it have over reproxalap and 629? Additionally, what indications are you planning to pursue? Thank you.

Todd Brady, President and CEO

Hi, Sean. Good morning. Thanks for asking about our systemic platform. I feel like often we get lots of questions about reproxalap and lots of questions about ADX-2191 because those two compounds are the subjects of NDAs that are potential near-term revenue generators for our company, but really the core of our development pipeline is RASP modulation as it relates to retinal and systemic disease. As you know, ADX-629, which is the vanguard of that effort, is involved in clinical trials for alcoholic hepatitis and chronic cough and soon Sjögren-Larsson Syndrome and minimal change disease, we hope. Other related molecules that are RASP modulators, and we have a platform of RASP modulators, will be in the clinic that we hope as soon as next year or soon thereafter for the treatment of other autoimmune and inflammatory diseases where RASP are elevated. I think what's so interesting about Aldeyra is that we seem to be the leader in RASP modulation, and that we are aware no other company is working on modulating RASP. RASP represents a novel pharmacological target. It is one of, if not the only pharmaceutical target and biotech today that is not a protein. RASP for small molecules, we aim to affect not just one, but many small molecules that comprise the family of RASP. And RASP are broadly inflammatory and are involved in a large number of diseases. So, this is a true novel platform with novel drugs, novel targets, and really a novel pharmacology that has broad implications for not only a variety of diseases with unmet medical need but also our understanding of how inflammation occurs and evolves within the body potentially leading to new insights further down the road.

Unidentified Analyst, Analyst

Thank you very much.

Todd Brady, President and CEO

Thanks, Sean.

Operator, Operator

Thank you. The next question today comes from the line of Yale Jen from Laidlaw & Co. Please go ahead. Your line is now open.

Yale Jen, Analyst

Good morning and thanks for taking the questions. Just a follow-up of the earlier question regarding 629 in acute alcoholic hepatitis concerning the endpoints and what sort of anticipation you may have on this data release?

Todd Brady, President and CEO

Good morning, Yale, and thanks for the question. Well, as I mentioned, we have a variety of endpoints associated with symptoms—how subjects feel after consuming what I would characterize as a large amount of alcohol—as well as signs. The signs would include objective measures of intoxication and metabolic profiling. I mentioned acetaldehyde; obviously, that is one. Cytokines and a variety of tests that can be performed on individuals after alcohol administration. We're familiar with some of them: proprioception tests, Romberg test. How many steps can you walk in a straight line? How long can you balance on one foot? So, I think we'll be able to present the Street with a very interesting collection of endpoints. We'll have to see exactly how the drug performs in an acute setting. Obviously, in the real world, no one wakes up one day and decides to drink a lot of alcohol and never drinks again. I think most individuals that suffer from alcoholic hepatitis have been drinking for many, many years, and how the drug performs in those settings I think would need to be assessed in different types of clinical trials.

Yale Jen, Analyst

Okay, great. That's very helpful. Maybe just one more quick question. I recall that the disease you had way back as a topical drug showed very promising outcomes. And what do you think that impacts on the current 629 development indication, which you're going to start early next year or later this year?

Todd Brady, President and CEO

Right. Yale, you've been around long enough to remember our previous clinical development in Sjögren-Larsson Syndrome. For those of you that don't know, many, many years ago reproxalap was developed not only as an eye drop but also as a dermatologic formulation that we applied in a couple of clinical trials to patients with Sjögren-Larsson Syndrome. Sjögren-Larsson Syndrome is an interesting condition as it relates to RASP because it's an in-born error metabolism where RASP are not sufficiently metabolized, resulting in high levels of particularly fatty aldehydes. As a result, patients suffer from a severe skin disease called Ichthyosis, which is a fancy way of saying scaly, itchy, inflamed skin. Additionally, the patients suffer from neurological compromise, spasticity, cognitive deficits, and so forth that increases gradually over time. With reproxalap, we saw activity, and at the same time, we began generating the positive data in dry disease and allergic conjunctivitis and decided to advance reproxalap as a molecule in dry disease and allergic conjunctivitis, and then move the treatment of Sjögren-Larsson Syndrome to a systemic treatment. Why a systemic? Well, a systemic treatment could in theory affect both the skin and the neurological compromised characteristics of Sjögren-Larsson Syndrome. As a result, we're thrilled with the potential of ADX-629, which is administered orally. ADX-629 by binding and sequestering the fatty aldehydes could make a difference broadly in Sjögren-Larsson Syndrome patients. This trial will initially assess both skin and neurological outcomes, particularly as they relate to a variety of biomarkers, including the fatty aldehydes and fatty alcohols, and other markers of the Sjögren-Larsson Syndrome neurologically, which have been fairly well-characterized in the past for various reasons, not only the proof-of-concept evidenced by reproxalap. We're excited about ADX-629 and its potential in Sjögren-Larsson Syndrome.

Yale Jen, Analyst

Okay, great. Thanks a lot and congrats on the other progress.

Todd Brady, President and CEO

Thank you, Yale.

Operator, Operator

Thank you. The next question today comes from the line of Catherine Novack from Jones Research. Please go ahead. Your line is now open.

Catherine Novack, Analyst

Hi. Good morning, Todd. Thanks for taking my questions. Just curious about any further clarity on when in 2023 we expect INVIGORATE 2 data? I understand there's a seasonality component when conducting this trial. And then once you have the data package in hand, what are the steps in terms of when will you be able to file?

Todd Brady, President and CEO

Catherine, good morning. You're absolutely right about the seasonality component in allergic conjunctivitis. Allergic conjunctivitis is a very common disease. It probably affects something like one-third of the world. Typically, we think of allergy being caused by histamine, although antihistamines, which we can now buy over the counter, don't work in about a third of the patients. So, there's considerable unmet need. That's the good news. The bad news from a clinical trial standpoint is you can't test allergic conjunctivitis during pollen season. And the reason for that is, if there's pollen in the air, that will confound the results of our allergen chamber. So, allergen chamber trials need to be performed mostly during the winter when there is no pollen—no ambient pollen. So, a hint to the answer to your question is, I do expect that INVIGORATE 2 will be enrolling significantly after the end of this upcoming winter. That is, as we enter spring and summer, our expectation is that enrollment in INVIGORATE 2 would be largely complete, which probably tells you something about the timing of the data for INVIGORATE 2. As I mentioned in my prepared comments, allergic conjunctivitis would be the subject of a supplemental NDA. Supplemental NDAs are filed or submitted after the first NDA is approved, given that we're submitting for dry eye disease in this quarter and a standard FDA review. One could expect a supplemental NDA going in for allergic conjunctivitis towards the end of next year.

Catherine Novack, Analyst

Got it. That's very helpful. And then just one final question on 629, curious how you're thinking about prioritizing multiple development programs? And then how will the alcoholic hepatitis data be useful for informing future indications in Sjögren-Larsson or MCD?

Todd Brady, President and CEO

Well, alcoholic hepatitis, as I mentioned, is interesting because the disease is largely the function of a RASP that we generate when we metabolize alcohol. Activity, either symptomatically or in a sign in alcoholic hepatitis would suggest to me, at least target engagement, which is important for every condition. We're testing with 629 and soon to be testing with analogs of 629. Your question about program prioritization is also interesting. We have a little bit of an embarrassment of riches. RASP, as I mentioned previously, are involved in a large number of diseases characterized by inflammation—most diseases are characterized by inflammation to some degree—and so I think we as a biotech need to think carefully about resources and time constraints when we're selecting indications. Our indication selection process from the very beginning has been systematic because RASP modulation is a new approach, a new pharmacology. We're quite keen to establish exactly how these drugs are working—what kinds of inflammatory diseases might optimally respond to RASP inhibition. Our current programs in alcoholic hepatitis and SLS and minimal change disease and chronic cough are an extension of that systematic effort to define our pharmacology and activity. I would expect that we'll read out the data from said trials. We'll make a decision about how to advance ADX-629 in particular. The good news is we have backup molecules and analogs and brothers and sisters of ADX-629 that will be able to allocate to other diseases where we think the therapeutic index is sufficient for advancement.

Catherine Novack, Analyst

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

Todd Brady, President and CEO

Thanks, Katherine.

Operator, Operator

Thank you. The next question today comes from the line of Thomas Shrader, BTIG. Please go ahead. Your line is now open.

Unidentified Analyst, Analyst

Hey, good morning, Todd. This is Sung Hong on for Tom. So, regarding the PBR, could you provide some additional color on which patients will be considered low-hanging fruit? And what do you need to broaden its views? And also, is there like a subset of patients that are at a high risk for surgery? Thanks.

Todd Brady, President and CEO

Hi, Sung. Good morning. PBR has the potential to reach a wide range of patients. In the GUARD Trial, we included two distinct types of patients: those with recurrent retinal detachments, known as rhegmatogenous retinal detachments, which typically happen spontaneously for the first time, and patients with open globe injuries who have experienced trauma to the eye. These patients face a higher risk of PBR if a retinal detachment occurs alongside the injury. In the group with rhegmatogenous detachments, the risk of PBR significantly rises with the number of recurrent detachments. There are additional risk factors, but in the GUARD Trial, we primarily focused on patients in the rhegmatogenous group where PBR was present. The data we presented in GUARD were compelling, particularly the safety data. We will highlight dose safety data for both PVR and the lymphoma NDA submission. Overall, the market for PBR looks promising, as there are currently no approved drugs for this condition. We have received orphan and fast track designations, and it will be interesting to observe how the drug is utilized commercially if it receives approval. It could be used in a wide variety of patients, even those who have had recurrent retinal detachments without PBR, essentially as a preventive measure. In fact, our orphan designation specifically focuses on the prevention of PBR. I’m eager to see how ADX-2191, if approved, will be integrated into clinical practice concerning PBR.

Unidentified Analyst, Analyst

Great. Thanks for the color.

Todd Brady, President and CEO

Thank you, Sung.

Operator, Operator

Thank you. There are no additional questions waiting at this time. So, I'd like to pass the conference back over to Todd Brady for any closing remarks.

Todd Brady, President and CEO

Thank you for your time this morning, and it's always we look forward to keeping you updated on our progress as we continue to endeavor to improve the lives of patients with significant unmet medical need.

Operator, Operator

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