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Operator
Good morning and welcome to the Aldeyra Therapeutics First Quarter 2020 Financial Results Conference Call. (Operator Instructions)
At this time, I would like to turn the call over to Mr. Joshua Reed, the company's Chief Financial Officer. Please go ahead, sir.
Joshua Reed - CFO
Thank you and good morning, everyone. On the call with me are Dr. Todd Brady, Aldeyra's President and Chief Executive Officer; and David McMullin, our Chief Commercial Officer. Todd will begin with an overview of our recent highlights and upcoming clinical milestones. I will discuss our first quarter financial results. Todd will make some concluding comments, and then we'll take your questions.
Please note that this morning's conference call contains forward-looking statements regarding future events and the future performance of Aldeyra. Forward-looking statements include statements regarding the timing of planned clinical trial initiations; Aldeyra's possible or assumed future results of operations, expenses and financial position; business strategies and plans; research, development and commercial plans or expectations; trends, market sizing, competitive position, industry environment and potential growth opportunities, among other things. These statements are based upon the information available to the company today.
As a result of the COVID-19 pandemic, clinical site availability, staffing and patient recruitment have been negatively affected, and the time lines 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-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 containing financial results for the quarter ended March 31, 2020, and the company's filings with the SEC.
And with that, I'll turn the call over to Todd.
Todd C. Brady - CEO, President & Director
Thank you, Josh. Good morning to everyone, and thank you for joining us today. In just a few short weeks, COVID-19 has affected virtually every aspect of our lives. On behalf of everyone at Aldeyra, I want to extend our thoughts to those that have been touched by this devastating illness.
Over the past 2 months, it's been inspiring to see the selfless commitment of doctors, nurses and other health care professionals working around the clock to extinguish the virus. And it's also been encouraging to witness the collaboration of companies across our industry as they attempt to solve this global health care crisis.
Along these lines, I want to thank our own employees for their tireless efforts over the past months regarding our initiatives to treat COVID-19 infection, which I'll discuss later in this call.
From Aldeyra's perspective, although the stay-at-home orders and other government-mandated measures have affected certain of our clinical enrollment time lines, we believe we remain well positioned to execute on our strategic objectives. As noted in this morning's press release, we concluded the first quarter with $61.4 million in cash, cash equivalents and marketable securities and are updating our guidance to extend our projected cash runway into 2022.
On our fourth quarter call, we discussed the strategic prioritization of our late-stage ocular disease programs, including our trials in dry eye disease, allergic conjunctivitis and proliferative vitreoretinopathy. Since our fourth quarter call, 2 events have prompted us to accelerate the development of our systemic disease programs with ADX-629, a first-in-class orally available and irreversible covalent inhibitor of pro-inflammatory RASP.
First was the potential applicability of ADX-629 to mitigate respiratory compromise in patients infected with COVID-19. In preclinical models, ADX-629 and structural analog reproxalap have demonstrated activity in cytokine release syndrome, which is thought to lead to acute respiratory distress and other forms of respiratory compromise that require mechanical intubation in COVID-19-infected patients.
Second, in April, we reported positive top line results from our Phase I clinical trial of ADX-629. To summarize those findings, ADX-629 was well-tolerated and no treatment adverse events were recorded in the trial at any of the doses tested. Clinically relevant plasma concentrations exceeding known levels of RASP were observed, suggesting that near-total RASP inhibition is theoretically possible in plasma. And relative to subjects treated with placebo, reduction in the commonly described pro-inflammatory RASP malondialdehyde was observed in drug-treated subjects, confirming target engagement.
With the success of ADX-629 in Phase I, we now plan to embark on a comprehensive systemic disease initiative to assess the activity of 629 in 3 types of severe inflammation, cytokine release syndrome, autoimmune disease and allergy. Our positive Phase I data, as mentioned above, is supported by strong preclinical evidence, demonstrating that ADX-629 reduced levels of TH1-, TH2- and TH17-related cytokines, suggesting potential activity across a broad array of inflammatory diseases.
Contingent on FDA review in the third quarter, we plan to initiate a Phase II clinical trial of ADX-629 in subjects with COVID-19-associated respiratory compromise. ADX-629, either as a single agent or as an adjunct to other therapies, has the potential to reduce levels, a broad array of inflammatory cytokines, thereby mitigating respiratory compromise and potentially improving patient outcomes.
We're also targeting 2 Phase IIa clinical trials of ADX-629 for the second half of this year to test the ADX-629 activity in autoimmune and allergic diseases. The first of these planned trials is in patients with psoriasis and autoimmune condition associated with TH1 cytokines. The other planned trial is in patients with atopic asthma, an allergic inflammatory disease associated with TH2 cytokines.
Regarding our ocular disease franchise, reproxalap continues to advance toward NDA filing in allergic conjunctivitis and dry eye disease. In dry eye disease, at midyear, we have a Type C meeting scheduled with the FDA to review the remaining NDA requirements for reproxalap. Dry eye disease affects approximately 34 million people in the United States and remains inadequately addressed by current therapies. Results from our trials with reproxalap, which include clinically relevant change from baseline in 2 well controlled trials, suggest potentially best-in-class rapid onset and broad symptomatic improvement. We plan to update on our clinical development plans in dry eye disease following receipt and review of the FDA feedback.
For allergic conjunctivitis, we now expect results from our Phase III INVIGORATE trial in the first half of 2021. The timing of trial completion is later than initially planned primarily due to delays associated with an extended allergy season. As many of you know, allergen chamber trials like INVIGORATE are conducted outside of allergy seasons to avoid the confounding effects of pollen in the environment. Based on the successful Phase III ALLEVIATE trial announced last year, and assuming continued clinical success and positive regulatory review, reproxalap has the potential to be the first new mechanistic approach in decades for the treatment of allergic conjunctivitis, which affects 66 million patients in the United States and, importantly, is often associated with dry eye disease.
As with dry eye disease, we think reproxalap could fill a significant gap in treatment. The current therapeutic landscape of allergic conjunctivitis is generally restricted to antihistamines and corticosteroids. The studies have shown that antihistamines are unsatisfactory for as many as 1/3 of patients, while chronic use of corticosteroids may lead to potentially serious adverse events.
Lack of clinical site availability and staffing due to COVID-19 has delayed patient enrollment in our Phase III GUARD trial of ADX-2191 for the prevention of proliferative vitreoretinopathy. We plan to update the enrollment and completion time lines by year-end. At the same time, we're exploring additional indications for ADX-2191, including primary intraocular lymphoma, a rare but serious ocular cancer.
With that, I'll hand it back over to Josh, who will cover our financial results in detail.
Joshua Reed - CFO
Thank you, Todd. For the 3 months ended March 31, 2020, we reported a net loss of $9.9 million compared with a net loss of $15.6 million for the quarter ended March 31, 2019. Net loss per share was $0.34 for the quarter ended March 31, 2020, compared with $0.58 for the same period last year. Losses have resulted from the cost of Aldeyra's clinical trials and research and development programs as well as from general and administrative expenses.
Research and development expenses were $6.6 million for the quarter ended March 31, 2020, compared with $7.8 million for the same period in 2019. The decrease of $1.2 million is primarily related to the decreases in clinical and preclinical development and manufacturing costs. Expenses for the 2019 period also included $6.6 million of in-process research and development expenses incurred in connection with the acquisition of Helio Vision.
General and administrative expenses were flat at $3 million for the quarter ended March 31, 2020, compared with March 31, 2019. Increases in personnel-related costs, including stock-based compensation, were offset by a decrease in legal and other miscellaneous administrative costs.
In Q1 of 2020, total operating expenses were $9.6 million compared with total operating expenses of $17.4 million for the same period in 2019.
As Todd noted, cash, cash equivalents and marketable securities were $61.4 million as of March 31, 2020. Based on current operating plans, we believe that our cash, cash equivalents and marketable securities at March 31 will be sufficient to fund currently anticipated operating expenses into 2022, including completion of the Phase III INVIGORATE trial for reproxalap; completion of the Phase II clinical trials of ADX-629 and COVID-19-associated respiratory compromise, atopic asthma and psoriasis; the commencement of one or more additional clinical trials in dry eye disease, subject to the outcome of the FDA meeting scheduled for mid-year 2020; and the continuation of Part 1 of the adaptive Phase III clinical trial in proliferative vitreoretinopathy contingent on patient enrollment.
Before concluding, I want to let you know that next month, we will be presenting and hosting one-on-one meetings at the Jefferies Virtual Health Care Conference. Details will be posted on the Investors and Media section of our website. For those investors who are participating, we look forward to meeting with you.
Now I'll hand the call back over to Todd for closing comments.
Todd C. Brady - CEO, President & Director
Thank you, Josh. From my perspective, a key takeaway from this morning's call is that we are ramping our systemic inflammatory disease program with a new comprehensive clinical initiative that complements our late-stage pipeline in ocular disease. The systemic disease initiative, stimulated by the opportunity to potentially address a major morbidity associated with COVID-19 infection and bolstered by Phase I data demonstrating safety, tolerability and target engagement, creates a number of new potential catalysts for Aldeyra in the coming quarters. And we're excited about the path forward for ADX-629.
As always, we remain committed to executing efficiently on our strategic plan and bringing to market novel therapies that improve the lives of patients with serious unmet medical needs.
With that, Joshua, Dave and I will be happy to take your questions. Operator?
Operator
(Operator Instructions) Your first question comes from Yigal Nochomovitz from Citi.
Samantha Lynn Semenkow - Senior Associate
This is Samantha on for Yigal. Just want to be sure. Can you hear me okay?
Todd C. Brady - CEO, President & Director
Yes, loud and clear, Samantha.
Samantha Lynn Semenkow - Senior Associate
Perfect. Okay. I just wanted to start with the cash runway extension into 2022. What cost-saving measures have you implemented that factor into the extension, especially given the announcement that you are going to have 3 new ADX-629 studies starting in the second half of this year?
Joshua Reed - CFO
Yes. Thank you, Samantha. As you might expect, we frequently look at our capital, and we're pretty fiscally responsible. What I would say is that, given some of the trial delays, we sort of looked at our portfolio and looked at the pace of spend over time. And so I think that contributes to sort of the extension of the runway, in addition to some changes from an infrastructure standpoint. With respect to ADX-629 and the development there, I think it's important to understand that the Phase II trials are not very expensive at all. So this is not a huge capital drain.
Samantha Lynn Semenkow - Senior Associate
Got it. That's helpful. And then sticking with 629, what are -- should we -- what are you envisioning for -- in terms of patient numbers and duration of treatment for these studies, particularly the autoimmune and allergy studies? And what would you think would be sufficient for you to gain proof of concept in those indications?
Todd C. Brady - CEO, President & Director
Great question, Samantha. I think our plan is, as the year progresses, to detail those trial designs. At this point, I think it's fair to assume that these would be Phase IIa-like proof-of-concept studies, generally including 30 patients or less. And the idea is to demonstrate activity of 629, not only from a clinical standpoint but also from a biomarker standpoint. So for example, in atopic asthma, a sputum analysis for cell counts would be an interesting biomarker. In psoriasis, transcription of inflammatory cytokines from biopsies would be an interesting example. In COVID-19-infected patients with respiratory compromise, not only clinical parameters, including time to mechanical ventilation or time on mechanical ventilation, but also levels of RASP in plasma and cytokine profiles in plasma. So these are the kinds of studies we're envisioning.
The idea is to more or less comprehensively test ADX-629 across those 3 different kinds of inflammation, which I think will guide us in terms of going forward into larger Phase II trials, which I hope we'll be in a position to announce early next year.
Operator
The next question will come from Louise Chen from Cantor.
Carvey Leung - Research Analyst
This is Carvey on for Louise. Just a few questions here. There are several dry eye programs we have seen. What differentiates your asset from the other? What -- in your trial design, which show the competitive advantages of the product versus others. Secondly, how do you think about the slowdown in ophthalmology due to COVID-19? Do you think the industry can adapt to telemedicine or other ways of treating new and existing patients if things persist here? And lastly, how should we think about OpEx in 2020?
Todd C. Brady - CEO, President & Director
Great. Why don't I turn the call over to Dave McMullin to comment on the competitive advantages in dry eye and the initial data that we're seeing regarding the impact of telemedicine on ophthalmology procedures and prescribing. Dave, are you on the line?
David B. McMullin - Chief Commercial Officer
Yes, I'm here, Todd. So with reproxalap, we're excited in our development thus far because we've seen a number of advantages versus existing treatments. Reproxalap has shown the ability to address symptoms very broadly. And that's exciting because we know that dry eye disease is largely a symptom-driven disease. That's what motivates the patients to go into the physician and talk with the physician. So on the sign front, we also see broad improvements in the eye with the treatment of reproxalap. And signs are important because they help you assess the health of the eye. But from a day-to-day clinical perspective, they don't take as prominent a role as the management of the symptoms. They're not the motivating factor that drives the patient into the doctor. And reproxalap has also shown a rapid effect on both of those. So it's symptoms and signs. And so it's that rapidity of improvement as well as the broadness of the effect that we believe will give reproxalap an advantage for the treatment of dry eye disease.
In terms of the impact of the current situation on the current patient-doctor dynamic, that's something that's obviously evolving. We do know that if you look at what's happened in the marketplace, which we've been following on a weekly basis, initially, one of the things that these chronic treatments have a benefit on is that they can be prescribed and refilled very easily, remotely. And in fact, prescriptions on some of these -- on the 2 existing chronic treatments went up in March when the disruption really started. Now in April, we do see that coming down, but we have seen also the AAO come out with some guidance on how eye care professionals can address the needs of patients through virtual visits. And if you think of dry eye disease, in particular, where the symptomatology is really that motivating factor, those things can be reported by the patient in a telemedicine setting very effectively. When you get into the signs of the disease, you will need to visit a doctor and have a test done. So I would expect that the management of dry eye disease may focus more on the symptoms in the short-term as the system tries to leverage and utilize telemedicine, and then manage the signs in a more spread out fashion that would allow for an appropriate type of approach given the pandemic.
Todd C. Brady - CEO, President & Director
Yes. And thank you, Dave. Before I turn the call over to -- the question over to Josh to talk about OpEx, I just want to reiterate a couple of things. First is we, as we said on the call, continue to believe that the symptom profile of our drug in dry eye disease is best-in-class. I think it would be difficult to find another therapeutic agent that demonstrates symptom control, like that we have depicted currently in our corporate deck, for example.
The second thing I want to say is that we're not a nasal spray. I don't think you will find in any rigorous market research that patients are clamoring for nasal sprays. We're a topical agent for relief of dry eye syndrome, topical ocular. And the second thing I would say is that we're not a steroid. Reproxalap is not a steroid, which, as I mentioned in the call, cannot be used chronically due to the risk of potentially very serious side effects. So I think in addition to the rapid onset of activity, to what we believe represents a best-in-class symptomatic profile, which is, by the way, what these very vast majority of patients and physicians care about, plus the novel mechanism of action relative to other late-stage assets in dry eye disease positions reproxalap quite nicely.
Josh, let me turn it over to you to comment on OpEx.
Joshua Reed - CFO
Yes. Just regarding OpEx, a slowdown in enrollment will lead to lower expenses, and that will give us the ability to fund some near term catalysts, specifically those items that we talked about earlier related to ADX-629.
Operator
(Operator Instructions) Your next question comes from Esther Hong from Janney.
Esther Lannie Hong - Director of Biotechnology
So ADX-629, there are multiple potential indications of psoriasis and atopic asthma. How will you prioritize which program moves forward, assuming that the Phase IIas are successful? Is there a way to streamline the programs? And then my second question is on ADX-2191. Can you discuss the potential of that for primary intraocular lymphoma?
Todd C. Brady - CEO, President & Director
Thanks, Esther. In terms of asthma and psoriasis, both of those diseases represent different flavors of inflammation. And the intent of the program we've initiated is to demonstrate activity of ADX-629 and, more broadly, RASP inhibition as a novel mechanism in those different types of inflammation. Whether we pursue psoriasis and asthma as indications, I think, depends on the strength of the data. In that, there are -- if there are signals that are generated from those clinical trials, then I think the company has considerable optionality in terms of moving forward in those particular diseases or moving forward in diseases that are TH1 or TH2 cytokine-related or autoimmune and allergy-related that are different from asthma and psoriasis.
Examples may include diseases such as chronic cough or alcoholic hepatitis, or minimal change disease, which is a rare form of renal inflammation that affects children and adolescents. There are many kinds of inflammation that relate to TH1 and TH2 diseases. I think most experts would agree that asthma and psoriasis are superb proof-of-concept indications to study in Phase IIa trials. But in terms of ultimate indications that we'll pursue internally, we're leaving our options open. They may include psoriasis and asthma, depending on the strength of the results, as I mentioned, but also may include related diseases that relate to the mechanisms in which we're attempting to demonstrate activity.
PVR is one of many indications that I think are addressable by ADX-2191. Ocular lymphoma, which we mentioned this morning, is a rare but serious form of cancer that generally affects the retina or the uvea and is treated almost exclusively with methotrexate, which is the active ingredient of ADX-2191. There is a very long history of the use of methotrexate for primary intraocular lymphoma. Unfortunately, today, that cancer is treated by compounding methotrexate. So the pharmacies at hospitals will essentially make up their own formulation of methotrexate for intravitreal injection into the eye, which as you can imagine, has many drawbacks.
So the intent would be to investigate our own novel formulation of methotrexate for intravitreal injection, ADX-2191, for use in ocular lymphoma. And one question is the extent of clinical data, if any, that Aldeyra would need to generate for filing, and that's something we're exploring over the next several months. So I expect you'll hear more from us regarding ocular lymphoma as an additional indication for ADX-2191 over the next quarter or 2.
Operator
The next question comes from Matthew Cross from JonesTrading.
Matthew David Cross - Research Analyst
Just wanted to ask a couple here. First off, could you kind of give us an update on what you're hoping to pitch to the FDA at this Type C meeting for dry eye and RENEW Part 2? I guess, there's been a little bit of discussion on this call, I think, about -- there's another competitor in the space that just submitted an NDA using ocular discomfort alone as the primary efficacy measure and hyperemia as a secondary sign endpoint. So do you think that the FDA will insist on the usage of fluorescein nasal staining as a co-primary going forward versus focusing on ocular dryness? Or what are the kind of tweaks to the staining time frame assessments, dosing schedule, et cetera, are you thinking right now you'll put forward to get the best clinical results and potential label?
Todd C. Brady - CEO, President & Director
Matt, that's something we've been thinking a great deal about, as you can imagine. Typically, the FDA has required symptoms and signs to be demonstrated for approval in dry eye disease. As you know, we have now demonstrated in 2 adequate and well controlled trials clear asymptomatic control, we would argue best-in-class symptomatic control in dry eye disease. And thus, we have requested and received a scheduling for a Type C meeting in the middle of this year with the agency to discuss our remaining NDA requirements.
One question is whether signs are required. One question is if signs are required, what kinds of signs are required. I will say I do not think -- I do not have any evidence that the agency has historically required a particular sign, such as staining or redness.
The other comment I'll make in terms of recent programs, I do think that ocular discomfort was a primary endpoint because the symptom had been missed on a prior trial. And if sponsors are required to achieve statistical significance twice on a symptom and a sign, one way to do that is to run more than 2 clinical trials in Phase III. And I think that was what was happening in the case that you referenced here.
Obviously, we're optimistic going into the FDA meeting. We wouldn't have requested the meeting otherwise. And we're positively surprised with the strength of our symptom data, which we have confirmed now in 2 trials. And we're eager to have that discussion. And as we mentioned, we'll be updating the Street on the remaining clinical requirements for NDA once we've reviewed feedback from that meeting.
Matthew David Cross - Research Analyst
Got it. Okay. And I'm looking forward to the feedback later in the year. And then just I have one more around the COVID program starting in the third quarter. I guess, I'm curious how much of a need do you anticipate in that time frame for an additional agent for COVID complications, again, in the third quarter? And do you have any kind of concerns about enrollment beginning in that time frame? I guess, currently, we're seeing some of these leading clinical trials report a shortage of patients in certain geographies as this kind of subsides due to preventative measures and natural immunity. So just kind of thoughts on the use of cash for this program in that time frame and any kind of enrollment challenges you might face.
Todd C. Brady - CEO, President & Director
Enrollment is always a question mark in any disease. I can tell you, we've been on the phone with representatives of government agencies this week, and they are, in general, predicting that COVID will not go away, that there will not be a long-term shortage of patients. And we would agree. I don't think we have a panacea for COVID in the pipeline as of yet. I think there are always -- there's always room for novel agents with novel mechanisms in any inflammatory disease, psoriasis, asthma and COVID included. So we -- at least based on the preclinical evidence that we have and have disclosed in the press release in March about broad-based cytokine reduction, which, by the way, seems to lead to respiratory compromise and the requirement for mechanical ventilation in COVID, and the fact that at least reproxalap, which is essentially a structural homolog of ADX-629, has shown clear evidence in animal models of acute respiratory distress syndrome of activity. We're optimistic about the potential for ADX-629 which, because it is orally administered, can be administered to patients immediately after hospital admission, could be administered via nasogastric tube to patients that are on ventilators and can be administered to patients after weaning off ventilators and even discharge. So our intent is to enroll patients at admission with evidence of respiratory compromise, which we would define as a hypoxia and pulmonary radiographic involvement, and treat them through the hospital stay up to about 28 days. And I think that for agents like that, there's still plenty of room. Enrollment, as you know, Matt, is always very difficult to predict, but I don't think anyone at Aldeyra or in terms of the government agencies we've been in touch with, are predicting that COVID is going to go away anytime soon.
Matthew David Cross - Research Analyst
Okay. No. Yes. That's great additional detail on kind of the program and the opportunity there. I tend to agree, and looking forward to seeing how all these new programs progress.
Operator
I have no further questions in queue. I turn the call back to Dr. Brady for closing remarks.
Todd C. Brady - CEO, President & Director
Thank you, operator. I'd like to thank you all again for joining us today. And as always, we look forward to continue to update you on our progress. Thank you.
Operator
Thank you, everyone. This will conclude today's conference call. You may now disconnect.