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Aldeyra Therapeutics Inc (ALDX 1.81%)
Q1Â 2019 Earnings Call
May. 9, 2019, 8:00 a.m. ET
Contents:
- Prepared Remarks
- Questions and Answers
- Call Participants
Prepared Remarks:
Operator
Good morning and welcome to the Aldeyra Therapeutics First Quarter 2019 Financial Results and Corporate Update Conference Call. All participants will be in listen only mode. (Operator Instructions). After today's presentation there will be an opportunity to ask questions. (Operator Instructions). Please note, today's event is being recorded.
I would now like to turn the conference over to Joshua Reed, Chief Financial Officer. Please go ahead, sir.
Joshua Reed -- Chief Financial Officer
Good morning everyone. I'm Joshua Reed, Chief Financial Officer, Aldeyra Therapeutics and welcome to the Aldeyra Therapeutics conference call to discuss our first quarter 2019 financial results and corporate update. With me today is Dr. Todd Brady, Chief Executive Officer of Aldeyra.
This conference call contains forward-looking statements regarding future events and the future performance of Aldeyra. Forward-looking statements statements regarding 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, and Aldeyra assumes no obligation to update these statements as circumstances change. Future events and actual results could differ materially from those projected in the company's forward-looking statements.
Additional information concerning factors that could cause results to differ materially from our forward-looking statements are described in greater detail in the company's press release issued earlier this morning containing financial results for the first quarter of 2019, and the company's filings with the SEC.
Now, I would like to turn the call over to Dr. Todd Brady, President and Chief Executive Officer of Aldeyra. Dr. Brady?
Todd C. Brady -- President and Chief Executive Officer
Thank you, Joshua. Today we issued a press release which outlines our first quarter 2019 financial results, and which provided a corporate update. We encourage you to review the press release, as this contains information that is important to be considered in conjunction with today's call.
2019 is off to a remarkable start with the announcement of positive results from our Phase 3 ALLEVIATE Trial in allergic conjunctivitis. The initiation of our adaptive Phase 3 RENEW Trial in dry eye disease and the completion of dosing in our Phase 3 SOLACE trial in noninfectious anterior uveitis.
The ALLEVIATE results announced in March represent the first Phase 3 results from our late stage pipeline. Two concentrations of topical ocular reproxalap were tested in a challenged model of allergic conjunctivitis, and we were thrilled to report that both concentrations of drug achieved statistical significance versus vehicle for the primary and the key secondary endpoint of the trial.
As we have previously disclosed, we intend to complete ongoing environmental allergen exposure method development studies and subsequently discuss the ALLEVIATE results and methods development study results with regulatory authorities to determine the remaining clinical requirements for NDA submission in allergic conjunctivitis.
Allergic conjunctivitis is a persistently disturbing disease that diminishes quality of life for the estimated 30 million patients in the United States that are treated suboptimally with antihistamines. Many physicians resort to treatment with topical corticosteroids. But corticosteroids can be toxic, causing cataracts and glaucoma among other serious conditions in some patients, and are therefore generally limited to short term use.
In April, we announced the initiation of the Phase 3 RENEW trial in dry eye disease. RENEW is an adaptive trial. The objective of the first part of which is to confirm the design of the second part of the trial. In 2018, we announced results from a Phase 2b dry eye disease clinical trial, which demonstrated early onset and broad activity of reproxalap, relative to vehicle. In the moderate to severe patient groups to be tested in the RENEW trial, the Phase 2b p values were 0.0048 and 0.0007 for ocular dryness symptom score and fluorescein nasal region ocular staining respectively, which will comprise the co-primary endpoint of RENEW.
Following completion of the first part of RENEW assuming the results support advancement to further testing, we expect to report the endpoints dosing regimen and sample size for the remainder of the trial. We expect to report full clinical results following the completion of RENEW.
The two dry eye disease drugs available in the United States today are generally regarded by physicians and patients as inadequate, leaving many of the estimated 20 million dry eye disease patients suboptimally treated or untreated .Thus, new therapies for dry eye disease which is a chronic, and in some cases debilitating condition are in high demand.
Also in April we announced the completion of dosing and the Phase 3 solids trial in non-infectious anterior uveitis. The solids trial is the largest ever vehicle control trial in non-infectious anterior uveitis, a rare but severe disease that can lead to blindness. Nearly all cases are treated with topical corticosteroids, which as mentioned previously, can lead to serious ocular toxicity in some patients. If effective, reproxalap could represent a new and alternative approach in non-infectious anterior uveitis, and other ocular conditions responsive to corticosteroid therapy.
In 2016, we announced positive results from a Phase 2 clinical trial in non-infectious anterior uveitis, in which topical ocular reproxalap was statistically non-inferior to topical corticosteroid therapy, in reducing inflammatory cell count score in the anterior chamber of the eye. The primary endpoint of the Phase 3 solids trial is time to zero inflammatory cells in the anterior chamber versus that of vehicle. We look forward to announcing the results of the solids trial later this year.
In the second half of this year, we expect to complete Part 1 of the Phase 3 RESET trial in Sjogren-Larsson syndrome, an orphan condition characterized in part by ichthyosis, a severe and intractable skin disease, for which there is no FDA approved therapy, and which affects most of the body surface. The RESET trial is an adaptive trial. The objective of the first part of which is to design the second part of the trial, following completion of the first part of RESET assuming the results support advancement to further testing, we expect to report the endpoints dosing regimen and sample size for the remainder of the trial. We expect to report full clinical results following the completion of RESET.
In 2016, we announced that topical dermal reproxalap led to statistically significant and clinically meaningful reductions in ichthyosis over two months of treatment. The RESET trial will assess six months of treatment, of up to 90% of the body surface.
In January of this year, we announced the acquisition of Helio Vision and thereby expanded our retinal disease pipeline with the addition of ADX-2191 an intravitreal drug for the prevention of proliferative vitreoretinopathy are rare, but potentially blinding retinal disease that occurs following retinal detachment, and for which there is no therapy. We expect to initiate an adaptive phase III clinical trial of ADX-2191 in the second half of this year. Assuming initial results are sufficient, to warrant advancement, we expect to report the endpoints dosing regimen and sample size of subsequent clinical testing in 2020.
In 2019, for the first time, we intend to initiate clinical testing of our programs for systemic immune-mediated disease. A Phase 2 clinical trial of ADX-1612 and post-transplant lymphoproliferative syndrome and a Phase 1 clinical trial of ADX-629 for autoimmune disease are expected to be initiated in the second half of this year.
Based on the upcoming announcement from SOLACE and RESET, as well as the expected progress across the rest of our product pipeline, we hope the remainder of 2019 will be exciting. We look forward to continuing to update you, as we advance our pipeline toward commercialization and execute on our mission of improving the lives of patients suffering from immune-mediated disease.
Now I'd like to turn the call back over to Joshua to review our first quarter 2019 financials.
Joshua Reed -- Chief Financial Officer
Thank you, Todd. For the first quarter of 2019, we reported a net loss of approximately $15.6 million compared to a net loss of approximately $8.4 million for the first quarter of 2018. Basic and diluted net loss per share was $0.58 for the quarter compared to $0.43 per share the same period last year. Losses have resulted from the cost of our clinical trials, research and development programs, the January 2019 stock for stock acquisition of Helio Vision, as well as from our general and administrative expenses.
R&D expenses were $7.8 million for the first quarter of 2019, compared to $6.6 million for the same period in 2018. The increase of $1.2 million is primarily related to the increase in research and development expenditures, including manufacturing, preclinical and clinical development costs, and increase in personnel cost, and non-cash compensation costs related to a portion of the upfront consideration paid to the founders of Helio.
Acquired in-process research and development expenses were $6.6 million for the quarter ended March 31, 2019. There was no such expense for the three months ended March 31, 2018. The acquired in-process research and development expense during the quarter was comprised of a non-cash charge related to the fair value of consideration given to the Helio non founders, a cash charge related to the Helio acquisition transaction expenses, and a non-cash charge related to the deferred tax liability arising from the accounting differences for book and tax purposes, resulting from the Helio acquisition.
General and administrative expenses were $3 million for the first quarter of 2019 compared to $1.9 million for the same period last year. The increase of $1.1 million is primarily related to an increase in personnel costs and legal and patent related costs.
In the first quarter of 2019, total operating expenses were approximately $17.4 million compared to $8.5 million in the prior year. The first quarter 2019 total operating expenses include $6.6 million, primarily related to non-cash charges in connection with in-process research and development, as a result of the Helio acquisition. Cash, cash equivalents and marketable securities were $82.1 million as of the end of the first quarter of 2019.
In March 2019, we entered into a loan and security agreement that provides up to $60 million in non-dilutive financing. The facility advances capital at our option, based upon certain funding conditions. We elected not to draw-down capital from the initial term loan advance, which expired on April 15th, 2019. An additional term loan advance of $15 million is expected to be available at our option, through September 30th, 2019.
This concludes my comments on our first quarter 2019. Thank you for your participation. Operator, we would now like to open the call to questions.
Questions and Answers:
Operator
Absolutely, we will now begin our question and answer session. (Operator instructions). Today's first question comes from Yigal Nochomovitz from Citi. Please go ahead.
Samantha Semenkow -- Citigroup -- Analyst
Hi this is Samantha on for Yigal. Thanks very much for taking our question. First, I noticed on clinicaltrials.gov that you have initiated a Phase 2 in dry eye disease, testing and novel formulation of reproxalap, and the dosing bears the same QID to BID dosing that you have in Part 1 of RENEW. I wonder if you could just provide a little bit more context here. Details of the rationale for why you were developing the formulation in the first place, and what is different this and the reproxalaps, that you are using in the pivotal trials and what are your expectations going forward for the use of this novel formulation? Thanks. Hi Sam. Good morning and thanks for the question. Excellent question. Obviously we're very serious about dry eye disease. I think, yesterday's announcement regarding the purchase of Xiidra for $3.4 billion, sort of puts an exclamation point on the value and demand in this space. We've decided to allocate resources here at Aldeyra toward dry eye disease and there is never a perfect formulation. I think we're quite good at developing novel formulations. In this case the trial you reference on clinicaltrials.gov, I would characterize it as a minor formulation change, primarily designed to increase the residents time of drug. There may be other benefits as well. But you are correct, that the design of that trial mirrors what we're doing in the RESET trial and that's intentional obviously, for obvious reasons. We're very excited about this this trial. We're obviously very excited about RESET, and in a way the formulation trial gives us yet another shot on goal for dry disease, which as you mentioned previously, is a very high value program for Aldeyra and throughout the industry.
Thanks. That's helpful. And then just going a little bit more on the Novartis acquisition, does this change your commercial outlook or strategy at all for reproxalap?
Todd C. Brady -- President and Chief Executive Officer
I don't think so. We're committed as a company to taking products to market and the acquisition obviously of Xiidra, we view as a very good sign, given the size of the acquisition. I think Xiidra is about a $400 million run rate, so the premium placed on Xiidra was quite high, and we were glad to see that. Obviously, we know all the large companies quite well, that are interested in the eye space and we are actually interested in the large companies that didn't buy Xiidra. But all in all, I don't think it changes much for us. We're moving forward, as I previously mentioned. I think we have a superb chance to advance a molecule in dry eye disease, and we're thrilled about that.
Samantha Semenkow -- Citigroup -- Analyst
Got it. And just one more for me on the SOLACE trial for Noninfectious Anterior Uveitis. Could you remind us what the rationale was for using vehicle as a comparator, rather than corticosteroids? And what was the rationale for using the 0.5% dose in this setting?
Todd C. Brady -- President and Chief Executive Officer
Both excellent questions. I'll answer the latter one first. Noninfectious Anterior Uveitis is a very serious disease. This is a common cause of blindness. 0.5% reproxalap is our highest dose, our highest concentration of formulation. It is double the concentration that we are using in the Phase 3 trials for dry eye disease and allergic conjunctivitis, which is 0.25%. So that's the justification for the high concentration. Typically what's done in Noninfectious Anterior Uveitis is testing against other corticosteroids. Corticosteroids are the only approved class of drug for Noninfectious Anterior Uveitis, and typically approvals of subsequent corticosteroids have been based on non-inferiority trials. As you know, statistically, non-inferiority is a high bar. In fact it is a much higher bar, requiring much larger sample sizes than a superiority trial.
We were thrilled to be able to agree with the regulators that we could run a study against vehicle and thus aim for superiority. Again, which is a easier statistical hurdle than non-inferiority versus steroids. So for us, that was a real regulatory win.
Noninfectious Anterior Uveitis is a flaring disease, so patients get worse then they get better. The reason for time to response is very simple, and that is while patients on vehicle may get better eventually, our understanding of the time course is that, that may take a very long time, weeks to months. So our -- the SOLACE trial is four weeks of therapy, and the endpoint as they mentioned, is time to cure or time to zero cells in the anterior chamber of the eye, and that's precisely why we picked that endpoint, that is -- time to cure is important, the longer patients suffer with the inflammatory cells in the front of the eye, the more likely permanent vision damage is to result. And so, that's the reason why the trial is designed as it is.
Samantha Semenkow -- Citigroup -- Analyst
Thanks so much for taking the questions.
Todd C. Brady -- President and Chief Executive Officer
Thank you.
Operator
And the next question today comes from Adam Walsh at Stifel. Please go ahead.
Neil Carnahan -- Stifel Nicolaus -- Analyst
Good morning guys. It's Neil Carnahan on for Adam. Just following on the NAU question. For this Phase 3 trial, will these result along with the Phase 2b sufficient to support an NDA? And then can you talk a bit about the appetite for an alternative treatment to steroids in the treatment community for NAU? And I got one follow-up.
Todd C. Brady -- President and Chief Executive Officer
Sure, Neil. Yes, thanks for the question. You know corticosteroids have been approved for a long time for this disease, many of them are generic. Although the generic penetration in the ocular space for corticosteroids is not very strong. The branded presence of corticosteroids is generally the dominant usage for corticosteroids in this disease and other ocular inflammatory diseases. So I think with correct promotion and marketing, new entrants can compete and -- in a branded sense, very effectively.
The regulatory question you asked is interesting, and I think that obviously the standard for the FDA is two large well controlled trials to satisfy the clinical requirements of an NDA filing. I don't know that that standard is any different here. However, Noninfectious Anterior Uveitis is an extremely rare disease. There is high unmet need, considering the toxicity of steroids. Many of these patients will recur, in terms of their flares. They will relapse one to two to three times a year. Chronic, even episodic use of steroids can lead to glaucoma. Most of these patients will eventually develop cataracts, partially as a result of steroid therapy. So there may be some levers that we can pull with regulatory authorities, to argue for an accelerated course to approval. However our assumption at this point is that, the standard approval pathway applies.
Neil Carnahan -- Stifel Nicolaus -- Analyst
Okay. And then I got one follow-up on that same thought process. For the dry eye program, the Part 1 study -- Part 1 of the Phase 3 similar to the Phase 2b ran (ph) . If you see statistical significance in those results, I know the plan is for it inform on powering for Part 2 of the study, but if you see statistical significance on endpoints in that study, is there the possibility that that could be considered a stand-alone trial? Thanks.
Todd C. Brady -- President and Chief Executive Officer
Yeah. Thanks Neil. Thank you for asking that question. I think a brief description of adaptive trials is appropriate. The short answer to your question is, yes. But the long answer is, in any adaptive trial, not just our adaptive trial, there are sort of these initial phases of the trial, where certain parameters are tested. The results of the first phases of the trial are used to power the latter aspects of the trial and confirm that dosing and confirm the endpoints etcetera.
There is always a possibility in any adaptive trial, that if the first phases of the adaptive trial hit certain endpoints, with statistical significance, is that the trial can be terminated on grounds of early success, right. In other words, there is no reason to keep going, if the trial is statistically significant and so forth. However, that's obviously not the point of the initial phases of an adaptive trial. So there is an upside scenario, as you mentioned Neil, but that's certainly not how really any adaptive trial is designed. I think what I just said, applies not only to the RENEW trial in dry eye disease, potentially also the RESET trial in Sjogren-Larsson syndrome, and the adaptive Phase 3 trial that we intend to initiate later this year in proliferative vitreoretinopathy.
Neil Carnahan -- Stifel Nicolaus -- Analyst
Thank you.
Operator
And our next question today comes from Esther Hong of Janney. Please go ahead.
Esther Hong -- Janney -- Analyst
Hi, good morning. Congrats on another strong quarter of clinical execution. So just to follow-up on the uveitis study. So you do expect to complete another or have to complete another Phase 3 study and if another Phase 3 study is required, when can we expect that to initiate and then potentially read out, and then would you -- would this occur post allergic conjunctivitis in dry eye disease NDA filing or in parallel, any comment on that? Thanks.
Todd C. Brady -- President and Chief Executive Officer
Esther, thanks for the question. Your question is about uveitis?
Esther Hong -- Janney -- Analyst
Yes.
Todd C. Brady -- President and Chief Executive Officer
Yes. Well I think that -- as I mentioned previously, the standard is two trials for NDA filing. I think it depends on the results of the SOLACE trial, if they're tremendously strong. I do think that there may be some potential to argue for less clinical testing than is typically required, especially given the medical need that I highlighted and the severity of the disease.
In terms of sequencing, relative to other programs, that's an excellent question. I don't know that we're particularly concerned about the sequence of uveitis versus the programs in allergic conjunctivitis and dry disease. And the reason I say that, gets back to Sam's question earlier about the 0.5%. The concentration of the product in uveitis is different from the concentration of the product in dry eye disease and allergic conjunctivitis. And therefore, they are different products, different SKUs.
The uveitis product comes in a kit, right. And by that I mean, typically to treat a flare of uveitis, there is a frequent dosing administration that occurs initially, that's tapered down over time. That's precisely how steroids are given, although often steroids are given that way for safety reasons. That is different in theory from how allergic conjunctivitis and dry eye disease may be treated. Although as has been pointed out, in the RENEW trial, we are assessing a QID to BID taper throughout the 12 weeks of therapy.
Esther Hong -- Janney -- Analyst
Okay. All right, great. Thank you.
Todd C. Brady -- President and Chief Executive Officer
Thanks Esther.
Operator
And our next question comes from Matthew Cross of JonesTrading. Please go ahead.
Matthew Cross -- JonesTrading -- Analyst
Hey guys. Good morning and congrats on another quarter of progress and thanks for taking my questions. Wanted to start off here and clarify, that given your recent announcement that you have completed dosing for the SOLACE trial, does this mean that all patients have experienced treatable flares, and thus we can expect a pretty standard timeline to presentation of data in the second half, or is it still possible that patient flare cycles could lead this timing to vary in any way? And then could you also maybe clarify, what you're hoping to see from the secondary flare endpoints beyond the primary of bringing these these anterior chamber cell counts down to zero?
Todd C. Brady -- President and Chief Executive Officer
Yes, Matt. Thanks for the question. The last patient has completed the last visit and the last dose and what that means is, that flare has resolved. We are only looking at primary flares. So to be enrolled into the trial, not only does the subject have to have noninfectious anterior uveitis, but they have to be an active flare. So the drug is designed to treat active flares. So patients that are enrolled, are in flare, and based on our announcements in April, the last patient has completed dosing for that flare. So yes, I think a standard timeline to data announcement applied here you know across the industry, I typically see something like 90 days from last patient to last visit to the announcement of results for a Phase 3 trial. I don't expect we will differ materially from that, but you know, until we have the data on our hands, anything could happen. It is a Phase 3 trial, and the thus data queries and adjudication and confirmation of statistics and so forth is very important to us. We take all that very-very seriously and we certainly don't intend to rush results out prematurely. But given the guidance that I just gave, I think it's a fairly standard release process from here on out Matt.
Matthew Cross -- JonesTrading -- Analyst
Okay, great. Thank you for the clarification. And then we've had a lot of discussion about, you know what endpoints would look like for this second Phase 3 in allergic conjunctivitis based on these ongoing feasibility studies and FDA feedback. I was hoping to hear some of the same as far as SLS. You've noted you'll decide on endpoints and other design elements for Part 2, once Part 1 is completed. But is there anything you can say about, perhaps some of the possibilities for endpoints here? I guess, how validated or reliable would you say the visual assessment measures are, that are being employed in Part 1 and would you consider (inaudible) Part 2 or what are some other alternatives?
Todd C. Brady -- President and Chief Executive Officer
Right. Excellent question. SLS is unique in our portfolio, because it's an ultra rare condition, and endpoints for ultra rare condition are often or not validated. And in this case, there has been no large control trial ever in Sjogren-Larsson syndrome. And that's why there is some flexibility around endpoints. However, having said all that, I do think that the key clinical characteristic of ichthyosis, which is this severe intractable skin disease that I mentioned earlier in these patients. The key clinical characteristic is scaling. The skin is excessively dry, it flakes off, it does not have adequate moisture and blood supply. It putrefies, that leads to a foul odor and bacterial overgrowth and in some cases cracks and bleeds and gets infected. So this is a severely debilitating condition. But scaling, the scaling part of ichthyosis, which is actually what ichthyosis means, is a key clinical characteristic. So I suspect that the endpoint would focus around scaling.
And that's what we've released as part of Part 2. We have made some modifications to enhance the quality of the assessment of scaling. As you know, we have two different parameters. We have a investigator assessed scale and then we have a central reader that reviews digital photography of the patients over time. So I think, within that broad set of parameters, you'll see something in terms of endpoints, regarding scaling
Matthew Cross -- JonesTrading -- Analyst
Got it. Okay. That's helpful as well. If I can squeeze in just one more, quick housekeeping one, which was just -- as far as, could you give us an update in terms of your expectations for the timeline or setting for presentation of full details of ALLEVIATE in terms of, you know, the assessments over time, any effect size comparisons to prior trials, things of that nature?
Todd C. Brady -- President and Chief Executive Officer
Yes. The -- we expect to announce ALLEVIATE -- the full date of ALLEVIATE at a major medical conference. I'm sure you can guess which one might be a candidate for that. We are very interested in clinical relevance, effect sizes, and by that I mean (inaudible) the effect sizes and minimally important differences and so forth. Will be something you'll see more of, and a full disclosure of ALLEVIATE. But I would hope for that data -- those data to be released later this year.
Matthew Cross -- JonesTrading -- Analyst
Fair enough. I think that does it for me. Thanks guys.
Todd C. Brady -- President and Chief Executive Officer
Thanks Matt.
Operator
And ladies and gentlemen, this concludes question-and-answer session and today's conference. We thank you all for attending today's presentation. You may now disconnect your lines and have a wonderful day.
Duration: 34 minutes
Call participants:
Joshua Reed -- Chief Financial Officer
Todd C. Brady -- President and Chief Executive Officer
Samantha Semenkow -- Citigroup -- Analyst
Neil Carnahan -- Stifel Nicolaus -- Analyst
Esther Hong -- Janney -- Analyst
Matthew Cross -- JonesTrading -- Analyst
