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Healthcare - Biotechnology - NASDAQ - US
$ 4.21
-1.41 %
$ 251 M
Market Cap
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P/E
EARNINGS CALL TRANSCRIPT
EARNINGS CALL TRANSCRIPT 2015 - Q3
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Executives

David Burke – Investor Relations, The Ruth Group Todd Brady – President, Chief Executive Officer and Director Stephen Tulipano – Chief Financial Officer and Treasurer.

Analysts

Ritu Baral – Cowen and Company Yale Jen – Laidlaw and Company.

Operator

Greetings and welcome to the Aldeyra Therapeutics’ Third Quarter 2015 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions]. As a reminder, this conference is being recorded.

I’d now like to turn the conference over to your host Mr. David Burke of the Ruth Group. Thank you, sir, you may begin..

David Burke Head of Investor Relations

Yes, thank you, Melisa. Good morning everyone and welcome to the Aldeyra Therapeutics’ third quarter conference call and audio webcast. With me today are Dr. Todd Brady, President and Chief Executive Officer; and Stephen Tulipano, Chief Financial Officer of Aldeyra Therapeutics.

Earlier this morning, Aldeyra issued a press release announcing the Company’s financial and operating results for the third quarter of 2015. We encourage everyone to read today’s press release which is available on Aldeyra’s website at www.aldeyra.com.

In addition, this conference call is being webcast through the Company’s website and will be archived there for future reference.

Please note that various statements we make during this call about the Company’s business, financial position, business strategy and plans and objectives for Aldeyra’s future operations are considered forward-looking statements within the meaning of the federal securities laws.

Actual results could differ materially from those stated or implied by these forward-looking statements due to risks, changes in circumstance, assumptions and uncertainties associated with the Company’s business.

These risks are described in the Risk Factors and Management Discussion and Analysis of Financial Condition sections of Aldeyra’s Annual Report on Form 10-K for the year ended December 31, 2014, which is on file with the SEC and available on the SEC and Aldeyra websites.

Additional factors may also be set forth in those sections of Aldeyra’s quarterly report on Form 10-Q for the quarter ended September 30, 2015 which is expected to be filed with the SEC later this week. We encourage all investors to read these reports and our other SEC filings.

This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, November 12, 2015. Aldeyra undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call. With that, I would now like to turn the call over to Dr.

Todd Brady.

Todd?.

Todd Brady Chief Executive Officer, President & Director

Thank you, David. And thank you all for joining us this morning for our third quarter 2015 conference call. I hope you had a chance to read our press release this morning, as we’ve provided financial and development updates, all of which we’ll discuss in more detail on today’s call.

We have been very active over the past few quarters, making significant progress in the clinical developments of our lead compound NS2, with the announcement of the initiation of enrollment in our allergic conjunctivitis clinical trial in September. We now have three active phase 2 clinical trials ongoing in different indications.

Consistent with our belief that Aldehyde trapping represents a broad therapeutic platform that applied to numerous rare and common diseases. We are committed to testing NS2 and other Aldehyde traps in multiple indications, particularly those that related to inflammation and certain inborn errors of metabolism.

We expect enrollment to conclude for all of our active clinical trials in the first half of 2016 and based on the initial enrollments in the allergic conjunctivitis trial, we are projecting completion of enrollment for that trial in the second quarter of 2016.

For our trial Sjögren-Larsson syndrome or SLS and Noninfectious Anterior Uveitis, we are pleased to report that in response to a multi factorial plan of action that we implemented last quarter, enrollment has accelerated in both trials and we are confident maintaining our previous guidance for completion of enrollment.

Specifically, we continue to expect SLS to complete enrollments in the first quarter of 2016 and Noninfectious Anterior Uveitis to complete enrollments in the second quarter of 2016. Trials synopsis is including endpoints, design, enrollment criteria and clinical sites are all now available on clinicaltrial.gov for all of our active phase 2 studies.

In addition to our current clinical trials we are testing, where we are testing topical administration of NS2.

We’ve been active in planning for clinical trials of systemically administered NS2, which has the potential to treat a broader variety of symptoms and diseases and to that end we’re reiterating our intent to advance a systemic formulation of NS2 to the clinic in 2016.

Potential clinical indications for a systemic Aldehyde trap include SLS and inflammatory or autoimmune crises where patients are treated acutely with systemic medications and an inborn error of Aldehyde metabolism called Succinic Semi-Aldehyde Dehydrogenase deficiency or SSADH deficiency for short.

SSADH deficiency is a particular entrance to Aldeyra because like at the last the disease is caused by rare genetic mutations and it enzyme the metabolize as Aldehydes, the leading elevated levels of toxic Aldehydes that are thought to be responsible for the symptoms of the disease.

In addition although SSADH deficiency is characterized by serious manifestation such as cognitive delay and seizures, there is no FDA approved treatment for this disease.

By trapping Succinic Semi-Aldehyde, which is a key toxic Aldehyde in SSADH deficiency and NS2 another Aldehyde trap have the potential to address the core passive physiological cause of the disease.

During the third quarter at the 2015 American Society of Human Genetics Annual meeting we were pleased to present data from a knock-out mouse model of SSADH deficiency showing that a single dose of NS2 when administered systemically trapped Succinic Semi-Aldehyde in key tissues, these data supports the therapeutic potential of Aldehyde traps in this disease and form the basis of a development plan that we hope we’ll lead to the clinical testing of Aldehyde traps in patients with SSADH deficiency.

Of course, we look forward to continuing to update you on our progress on SSADH deficiency as well as our current phase 2 trials in SLS Noninfectious Anterior Uveitis and Allergic Conjunctivitis over the next two quarters.

I’d now like to turn the call over to Steve to a [indiscernible] for a view of the financials before providing closing remarks and opening the floor for questions.

Steve?.

Stephen Tulipano

Thanks Todd, good morning everyone. In Q3 we have a net loss from operations of $3.3 million compared to a loss of $2 million for the same period in 2014. For the nine month period, we had a loss of operations of $7.7 million versus $4.9 million.

Research and development expenses totaled approximately $2.1 million for Q3 2015 compared to approximately $1.2 million last year. For the year-to-date period R&D was $4.5 million compared to $2.3 million. The increases are due to our three active phase 2 trials and increased headcounts compared to the period year the prior year.

G&As for Q3 2015 were $1.3 million versus $772,000 for last year, for the year-to-date period G&A was $3.2 million versus $2.6 million. The increases are related to increased legal, insurance, personnel and other cost related to being a public company.

In Q3, we had a net loss attributable to common stockholders of $3.4 million or $0.35 per share compared to a loss of $2 million or $0.36 per share for the same period in 2014.

For the nine month periods we had a loss attributable to common stockholders of $7.7 million or $0.94 per share versus $7.1 million or $2.21 per basic share and $2.89 per diluted share for the prior period. The current year-to-date loss includes $1.6 million in non-cash stock based compensation.

At the end of September we had $30.6 million in cash and we used $6.3 million for the nine months ended September 30, 2015 through fund operating activities. With that Todd would like to have closing remarks..

Todd Brady Chief Executive Officer, President & Director

Yes, thank you Steve. As I mentioned earlier this is an exciting time for Aldeyra and its shareholders.

Over the past quarter, we continue to execute on our growth strategy with the initiation of our phase 2 trial on allergic conjunctivitis and we are able to provide data that highlights the potential for a systemic formulation of NS2 and a rare inborn error of metabolism.

As Steve mentioned earlier, we are well capitalized following several financings this year that we believe not only to support our program expansion efforts but also speak to the support of our investors and the confidence they have in Aldeyra.

Now looking ahead, we see significant near-term catalyst with data from all three of our clinical trials that we expect to read out in the first half of 2016 and we look forward to providing you with these results.

Now with that we’d like to open the floor to questions and operator?.

Operator

Thank you. [Operator Instructions] Our first question comes from the line of Ritu Baral with Cowen and Company. Please proceed with your question..

Ritu Baral

Hi guys, thank you for taking the question.

I just wanted to get a little more detail on the steps that you took to increase the enrollment in the NIAU [ph] study, where there are any changes for the protocol or screening or enrollment criteria for patients?.

Todd Brady Chief Executive Officer, President & Director

Hi Ritu, good morning and thanks for the question.

We touched a bit on this last quarter, I think most of the activities that Aldeyra undertook are standard for companies that desired to boost enrollment, classic approaches include increasing the number of sites modifying the enrollment criteria that make them more acceptable to a broader variety of patients.

All of those have been done and we’ve reflected that publically in the clinicaltrials.gov synopsis of that trial you can see all the sites now as well as the current protocol.

I think though - when it comes to protocol modification the differences are not significant I think the primary boostin enrollment was due to increasing our sites and in the end I think the trial remains consistent with what we’ve started out, when we started enrolling in April..

Ritu Baral

Got it, and then what remains to be done for the systemic delivery IND, do you have any toxicities that, that still need to be executed?.

Todd Brady Chief Executive Officer, President & Director

Yes, we haven’t provided specific guidance on that Ritu, but as is standard anytime you have a systemic formulation it could involve other toxicities studies different from the kind you would run to exam [ph] topical formulation to the clinic, and depending on the diseases that you are attending to test it may involve a difference, the decision of the FDA.

So I would look towards IND filling next year, we said we’ve been the clinic, I think there are few more boxes to check, but obviously we feel confident enough to reiterate our 2016 guidance, based on what we have to do at this point..

Ritu Baral

Got it. Thanks for taking the questions..

Operator

Thank you. [Operator Instructions]. Our next question comes from the line of Yale Jen with Laidlaw & Company. Please proceed with your questions..

Yale Jen

Good morning guys and congrats on the progress..

Todd Brady Chief Executive Officer, President & Director

Thanks Yale, good morning..

Yale Jen

Just try to get little bit details in terms of the data release of three studies I know FAIS completed enrollment in first quarter, so do we anticipate anything in the second quarter versus the other two study would that be in third quarter or maybe in the fourth – or the second half of 2016?.

Todd Brady Chief Executive Officer, President & Director

Yes, so that’s an excellent question Yale and thank you for asking. We have not guided as you note on the timing of data, I think that, it’s obviously much easier to predict when enrollment will complete.

But I think you can look on the trial synopsis that are online and probably not too difficult to surmise that the timing of data won’t be an unreasonably long period of time after enrollment completes, relative to other clinical trials.

And I’d say that for two reasons, one is two of our trials have low numbers of patients, so SLS has 12 patients, Uveitis has 45 patients, so it’s not a ton of data to analyze.

And the second reason I’d say that is because if you look at the endpoints that we are measuring, in Uveitis these are standard endpoints that are generally done by slit-lamp exam and then in SLS you’ve got a visual score of the skin and then exam and some biomarker.

So, it’s not like we are having to reinvent the wheel or undertake some sort of complex endpoint analysis to report top-line data, but allergic conjunctivitis is a little more complicated just because there is a 100 patients in that trial.

And so, locking the database and cleaning up the CRS and all the kinds of things that you have to do in any standard trial may take a little longer in that case just given the volume..

Yale Jen

Okay, great that’s very helpful.

And if we can go back to the SLS for a second that given the endpoint you have, let’s just assume if the data is robust, what might be the possible scenario for you guys to have the discussion with the FDA that’s against end of phase 2, would that be something you’d potentially seek for accelerated profile with a full approval after another study or you need to go to, if you are thinking, you have to go through a second or pivotal study before binding [ph] for approval?.

Todd Brady Chief Executive Officer, President & Director

Yes, that’s a good point Yale. I think there is two questions there, one is what kind of regulatory approaches can we take to the filings and I think obviously orphan designation is something that may apply, that something else that may apply as breakthrough therapy we’re the only company were aware off is testing Aldehyde trapping in a clinic.

I think accelerated approval relates to biomarkers and in SLS dermatology, we really have – we don’t really need biomarkers of course for measuring the clinical effects on the skin directly.

As to whether the FDA how they will respond to the Phase II data, I think that depends on the Phase II data, it’s obviously hard to predict what the data will look like, it’s also hard to predict how the FDA will respond to that data, it just simply depends on I think the strengths of the data and how the FDA interprets that data, as to whether more trials will be needed..

Yale Jen

Okay, great. And the last question here is the follow-up of the previous one which is that would the systemic deliver in the Aldehyde traps.

Do you have a look in more refined timeline in terms of when you guys may be started IND, would that be the second half of next year or the first half or is it just too early to tell?.

Todd Brady Chief Executive Officer, President & Director

Well, I think it gets the Ritu’s question also which is what’s left to do, we haven’t narrowed that down, first half, second half which tells you something I guess and by reiterating our 2015 guidance as I said to Ritu’s question, clearly, we have some optimism here.

We’ve maintained for years now that NS2 has minimal biologic activity right, NS2 traps Aldehydes, it’s a small molecule to small molecule that covalent reaction and that’s chemistry not biology, and what we found is we’ve disclosed numerous times is that NS2 seems to have minimal effects on anything relating to cell to receptors to iron channels to enzymes.

So we are confident in filing in IND systemically in 2016. The exact timing I think depends on a lot of things that are too hard to predict at this point, but that’s a good question..

Yale Jen

Okay, thanks a lot again and congrats on the progress..

Todd Brady Chief Executive Officer, President & Director

Thanks Yale..

Operator

Thank you. Thank you for participating in today’s call. This concludes our teleconference for this morning. You may disconnect your lines..

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