Aldeyra Therapeutics, Inc. (ALDX) Earnings Call Transcript & Summary

Hello, everyone, and thank you for joining us today for the Aldeyra Therapeutics Regulatory Update Conference Call. My name is Sammy, and I'll be coordinating your call today. [Operator Instructions] I'll now hand over to your host, Laura Nichols, Associate Director of Investor Relations at Aldeyra Therapeutics to begin. Please go ahead, Laura.

Thank you, and good morning, everyone. Today, we issued a press release announcing a PDUFA target action date extension for the new drug application of reproxalap for the treatment of dry eye disease. A copy of the press release is available on the Investor and Media section of our website, www.aldeyra.com. The press release contains important information and should be read and considered in conjunction with the prepared remarks on today's call. With me today to discuss the PDUFA extension is Dr. Todd Brady, President and Chief Executive Officer of Aldeyra. This presentation contains forward-looking statements regarding Aldeyra in the investigational drug candidate, reproxalap, and Aldeyra's plans, expectations and opportunities, including regulatory activities regarding reproxalap. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Aldeyra's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These statements are based upon the information available to Aldeyra today and reflect Aldeyra's current views with respect to the future events and are based on assumptions and subject to risks, uncertainties, including the outcome and timing of the FDA's review and approval of the new drug application for reproxalap in the adequacy of the data contained therein. Aldeyra assumes no obligation to update oral or written statements made today as circumstances change. Future events and actual results could differ materially from those projected in the company's forward-looking statements, including the 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 press release issued last night and in our filings with the Securities and Exchange Commission. I would now like to introduce Dr. Brady.

Thank you, Laura. Thank you all for joining us. I want to first say that my comments today represent only our understanding of the FDA's decision to extend the PDUFA target action date for the reproxalap dry eye disease New Drug Application or NDA because we're not party to internal FDA discussions, and my comments may not accurately reflect the FDA's rationale discussions or decisions, and our understanding is strictly limited to only those discussions that we've had with the division of Ophthalmology, which sits under the office of Specialty Medicine. During the NDA review, we've had no direct conversation with the office of Specialty Medicine nor have we had any conversation with the FDA administration above the office of Specialty Medicine. Finally, I'm going to restrict my comments to what we believe to be facts based on our understanding of what's been told to us by the FDA. As we disclosed in the press release issued last night, on June 16, 2025, we resubmitted an NDA for reproxalap for the treatment of dry eye disease. Approximately 30 days later, on July 16, the FDA accepted the NDA as "a Complete Class II Response" to the Complete Response letter previously received. At the time of the NDA acceptance, the target PDUFA action date was December 16, 2025. At a meeting with the division of Ophthalmology on Friday, December 12, the division requested the submission to the NDA of a Clinical Study Report or CSR for the field trial announced on May 5, 2025. The field trial, which was supportive of the activity of reproxalap relative to vehicle did not meet the primary endpoint of reducing symptoms relative to vehicle. But I want to note that prior to submitting the NDA in June, the field trial was specifically discussed with the FDA and written agreement was reached not to submit the trial to the NDA, consistent with our prior disclosures. The field trial CSR has been previously submitted to the IND and the CSR has been reviewed by the FDA under the IND. And during the review of the NDA, the division also requested submission of the field trial safety data, which was submitted to the NDA on August 21. The FDA has considered the submission of the CSR to the NDA, which occurred on Friday as a major amendment triggering a 90-day PDUFA extension. During the meeting last Friday, the division made no other requests and identified no other specific issues associated with the review. Based on our understanding of the meeting, the division appeared to represent the following: Number one, the division's review, which includes review of the field trial CSR from the IND is substantively complete. Number two, on Thursday, December 11, 3 business days before the original PDUFA date, the request to submit the CSR to the NDA came from the office of Specialty Medicine, which is the signatory on any NDA action for reproxalap because reproxalap is a new chemical entity. We understand from the division that the office's rationale for the CSR submission is that all completed trials need to be included in the NDA. Importantly, in early December, a draft label was sent by the FDA to Aldeyra, and Aldeyra has responded with comments on the draft label. In the formal communication of the review extension, the FDA noted that if no major deficiencies are identified during the extended review, labeling requests and potential post-marketing requirements, if any, will be communicated by February 16, 2026. With that, operator, I'd now like to open the call for questions.

[Operator Instructions] Our first question comes from Catherine Novack from Jones.

I was wondering if you can comment on turnover at the FDA in the Ophthalmology division this year and specifically in the reproxalap review team. Any changes between the personnel who were there at the time of NDA acceptance versus at the December 12 meeting?

Catherine, and thanks for your note this morning as well. I am not aware of any turnover within the division of Ophthalmology. At least the FDA employees with whom we interface on a regular basis at the division have been the same throughout this review and throughout other reviews. I am aware that the Director of the Office of Specialty Medicine retired this summer and a new Director of the Office of Specialty Medicine has been in place, I believe, since late summer.

Got it. And then is it -- looking through some FDA industry guidance and it seems that it is standard to submit all CSRs regardless of therapeutic impact with an NDA. So is this -- has their guidance changed? Or what was the rationale behind admitting some of the -- admitting the CSR?

I agree with your assessment of the guidance, Catherine. Typically, in an NDA, all completed trials are submitted. Our discussion with the division in June prior to the submission of the NDA revolved around satisfaction of the Complete Response letter, which identified a single deficiency, namely a clinical trial to assess symptoms. Because we had a positive clinical trial in the dry eye chamber, we spoke with the division about submitting that trial alone. We were quite clear with the division that the field trial, while supportive of reproxalap, did not meet statistical significance. And at that time, the division agreed in writing that only the chamber trial need to be submitted in the NDA. As I said in my prepared comments, what appears to have happened is that the Director of the Office of Specialty Medicine decided that the protocol should be followed in the standard sense that all completed trials should be submitted to the NDA and made the request that the CSR be submitted on Friday.

Got it. And then -- is there -- have you seen a label, a draft label prior to the one that was shared in the beginning of December?

No. Labeling discussions were initiated with the division at -- in the beginning of December.

Our next question comes from Matthew Caufield from H.C. Wainwright.

I appreciate the updates. Has the announced extension impacted the terms of the AbbVie option agreement, if at all, for going forward here?

Thanks for the question. Per the terms of the option agreement with AbbVie, AbbVie has 10 business days to exercise the option following approval of the NDA. There are other terms attached to that agreement and the actual option is to a co-promote, co-development agreement with AbbVie, which we've disclosed elsewhere and is in our corporate deck.

Got it. So the same time frames and same optionality exists going forward for now?

Correct.

Our next question comes from Clara Dong from Jefferies.

This is Angie online for Clara. So how should we think of the commercialization time line or any potential events between today and the next PDUFA day? What will the company be focused on during this time?

I think that the -- first of all, the launch dates have not been set for reproxalap and would depend on when the product is approved, if it is approved. My guess is that typically companies launch within a quarter or 2 of the approval. The original target PDUFA action date, which was today, would have suggested that a launch might have occurred at the end of Q1 or sometime in Q2, typically for a drug product launch. And I don't know that those time lines change very much depending on when the reproxalap is approved, again, if it's approved. The 90-day extension doesn't mean necessarily that the PDUFA is 90 days from now, it means that the FDA has 90 days to issue an action letter on the application.

Our next question comes from Marc Goodman from Leerink Partners.

This is Basma for Marc. Again, Todd, just to confirm, was there a discussion at any point on December 12 or earlier that either field trials will be used as confirmatory or supportive evidence for the package and for the -- especially for the resubmission package. So basically, one of the field trials had to be positive on the symptoms. Was there any agreement with the FDA that one of them has to be positive. And again, regarding the request on the August 12 for safety data from the field trial, is that request normal given that you had an agreement not to submit the field trial at all in the package? That's it, that's it for us.

Yes, thanks for the question. Let me take the second one first. The safety data request is normal. So during NDA reviews, the FDA updates or requests an update of the safety database as safety data come in, I think it was more or less standard for the FDA to ask for the field trial safety data to be submitted. Regarding the discussions about the field trial. As I mentioned in my prepared comments, before we submitted the NDA in June, we discussed both the positive chamber trial as well as the field trial with the FDA, the division decided that the dry eye chamber trial would be sufficient for submission, and so that's why we submitted only the chamber trial.

Our next question comes from Tom Shrader from BTIG.

To reask a previous question, is there an expiration date on the AbbVie option that you can disclose?

No, if the drug is approved and when the drug is approved, AbbVie has 10 business days to exercise. So whenever that occurs, there will be a 10-business day period during which AbbVie can decide whether or not to exercise.

And then the second question is remedial. Could you clarify what the distinction submit to the IND versus submit to the NDA? Don't they both go to the FDA? I'm just a little unclear what that means.

That also is an excellent question. On the face of it, if the CSR has been reviewed, the CSR has been reviewed. I did pose that question to the division. It seems that the review itself, as I mentioned in my prepared comments is substantively complete, but what needs to happen I believe, based on my conversations with the division is that more detail on the field trial needs to be added to the NDA review. I assume that the division has a very thorough understanding of the field trial. I don't think that understanding or impression will change. What may change to your question is more detail added to the NDA review.

Our next question comes from Yale Jen from Laidlaw & Company.

In terms of the label discussion you mentioned in the press release that in February of next year, if that happens, you will -- and my question is, would you guys report that after the discussion with the FDA or you will have communicated street once the PDUFA day has done?

Unlike other companies, we do not report on day-to-day interactions with the FDA during the NDA review until we receive an action letter such as the one we received last night regarding the extension. I certainly hope that label discussions occur well before February 16, 2026, especially given, as I mentioned in my prepared comments that we've already responded to a draft label. I do not expect at this point substantive changes to the label based on what we've seen so far. But until we receive an action letter, you wouldn't expect to hear from us any updates on our interactions with the FDA.

Okay. Great. Maybe just one follow-up. For the last communication you have with the FDA or the FDA request seems kind of delay to the PDUFA date. Was this something you anticipate or something that was just a surprise?

In general, I think these kinds of extensions are surprising to companies. I don't think Aldeyra is any different. It is true that the request from the office came in 3 business days before the PDUFA. On the other hand, I think towards the end of the review, both the division and the office go through a series of checklists to make sure that the application is complete. And as I mentioned, clearly, the new Director of the Office of Specialty Medicine disagreed with the division that the field trial didn't need to be in the NDA, hence, the request.

We currently have no further questions. And with that, this concludes today's call. We thank everyone for joining. You may now disconnect your lines.