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Reata Pharmaceuticals, Inc. (NASDAQ:RETA)
Q2 2020 Earnings Call
Aug 10, 2020, 8:30 a.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Hello and welcome to the Reata Pharmaceuticals' Second Quarter Financial Results and Update Development Programs Call. My name is Sheryl and I will be your operator for today's call. [Operator Instructions]

Before we begin, I'd like to go over a few housekeeping rules. An audio recording of today's webcast will be available shortly after the call today on Reata's website at reatapharma.com in the Investor section. Before the Company proceeds with its remarks, please note the forward-looking statement disclosure of the Company's press release. The Company will make forward-looking statements on today's call. There are many factors that could cause results to differ from expectations, including those noted in the Company's SEC filings. Today's statements are not guarantees of the future outcomes.

Please also note that any comments made on today's call speak only as of today, August 10, 2020, and may no longer be accurate at the time of any webcast replay or transcript rereading. Following the prepared remarks, we will open the call up for questions. We ask that you please limit yourself to one question so that we can accommodate as many questions as possible.

Please now welcome Mr. Vineet Jindal, Vice President of Strategy. You may begin.

Vineet Jindal -- Vice President of Corporate Communications and Strategy

Thank you. Good morning and welcome to Reata management's call to discuss our financial results for the second quarter of 2020 and to provide a review of our development programs. This morning, we issued a press release with a summary of these results and the press release can be found on the Investors section of our website at reatapharma.com.

I'm joined today by our Chief Executive Officer, Warren Huff; our Chief Operating Officer and Chief Financial Officer, Manmeet Soni; and Chief Research and Development Officer, Colin Meyer.

Before I turn the call over to Warren, I'd like to remind our callers that we're limiting questions to one per caller please, during the Q&A.

Warren, I'll now turn it over to you.

Warren Huff -- Founding Chief Executive Officer and President

Thanks, Vineet. Good morning, everyone. And thank you for joining us on our quarterly call. On today's call, I'll provide an update on a regulatory path for a lead products bardoxolone and omaveloxolone. Colin will summarize the status of our ongoing clinical programs and Manmeet will review the Company's financials. I'll begin with an update on the status of a regulatory interactions with the FDA, with respect to the potential approval of bardoxolone for the treatment of patients with Alport syndrome on slide 5.

So following the announcement of year one data from the Phase III CARDINAL study in November of 2019, we've been engaged with the FDA to discuss the year one efficacy and safety results. We've had a Type C meeting where the FDA expressed concern with basing an NDA for accelerated approval on the year one data alone and recommended that we consider submitting the NDA with the year two data. We believe that their recommendation was based in part on their assumption that there would not be much delay in NDA submission by waiting for the year two data.

The FDA invited us to address their questions and is provided suggestions for additional analyses of the year one data. Following the Type C meeting, we've had a series of interactions, including informal meetings and written submissions to the IND to address the FDAs questions and requested analyses raised at the meeting. We delayed requesting a pre-NDA meeting while we addressed the FDA's review question, we recently requested and were granted a pre-NDA meeting by the FDA to discuss the NDA submission, content and plans. One of the key questions to be resolved in the pre-NDA meeting is how the year two data should be handled during the NDA review process.

Our plan has been and continues to be to submit the NDA for bardoxolone in Alport syndrome during the fourth quarter of this year for accelerated approval based on the one year data from the Phase III portion of CARDINAL. If the second year results are available during an acceptable timeframe, we may be able to submit the second year data during the review process and before the FDA makes a determination about accelerated approval. This may extent the PDUFA date, but could also result in consideration of full approval rather than accelerated approval.

The FDA could recommend that we wait for the second year data from CARDINAL to file the NDA. This would permit us to file for full approval, but would delay the filing until the first quarter of 2021 compared to our current guidance of filing by the end of this year. Of course, this timing assumes that the year two data are positive and that we can complete the activities necessary to provide the year two data to the FDA on a timely basis. Colin will be providing more details on the steps we've undertaken to maintain data integrity and ensure timely database lock of the year two CARDINAL data.

Moving to slide 6, I'll provide an update on the regulatory pathway for omaveloxolone. After the announcement of the data from MOXIe Part 2 study in October 2019, we planned subject to discussion with regulatory authorities to proceed with the submission this year for marketing approval of Omav for the treatment of Friedreich's Ataxia in the United States. We've been engaged with the FDA to discuss our proposals to use the data from the MOXIe Part 2 study as a path to NDA submission.

Our proposals have been supported by the Friedreich's Ataxia Research Alliance or FARA and key opinion leaders in the FA Community. We recently completed a Type C meeting, in which the FDA provided us with guidance that it does not have any concerns with the reliability of the mFARS primary endpoint results in the MOXIe Part 2 study. Nevertheless, they're not convinced that the MOXIe Part 2 results will support approval based on a single study without additional evidence that lends persuasiveness to the results.

In preliminary comments for the meeting, the FDA stated that we'll need to conduct a second pivotal trial that confirms the mFARS results of the MOXIe Part 2 study with a similar magnitude of effect. In response to the preliminary comments FARA, key FA clinicians and we explained that it would be difficult to conduct an additional prospective clinical trial in FA because of the very slow progression rate of FA patients. The limited number of FA patients available for clinical research, the small number of clinical trial investigators who can conduct the mFARS exam and the impact of the COVID-19 pandemic on the ability to conduct neuroscience clinical trials.

We pointed out that conducting an additional pivotal study would result in a long delay in the availability of a potentially effective therapy to patients with a progressive life threatening disease with no treatment options. The FDA is acknowledged the unmet need of FA patients reiterated its commitment to facilitate the development of Omav within the constraints of the regulatory standards and emphasized its willingness to consider all available options to meet the regulatory standards.

It's an alternative to a second adequate and placebo controlled pivotal study FARA, key FA clinicians and we proposed the second study, the crossover study that could serve as additional evidence of effectiveness. The study would measure the effect of Omav on mFARS in patients who were previously randomized to placebo in the MOXIe Part 2 study and are being treated with Omav in the MOXIe open label extension study. The FDA acknowledged that launching a new clinical trial would be difficult now because of the COVID- 19 pandemic and that a study like the proposed crossover study could be a source of important additional information. The FDA asked the company to submit a description of the proposed design and agreed to review the proposal and determine whether the crossover study could provide additional evidence of effectiveness.

If the FDA accepts the proposal, we can have the completed data from the crossover study as early as the fourth quarter of this year assuming that the FDA views the crossover study data as sufficiently positive to provide confirmatory evidence. Our plan would be to submit an NDA during the first quarter of 2021. If the FDA rejects the proposal, or if the data are not supportive, we will evaluate whether it's feasible to conduct a second pivotal study in FA patients as suggested by the FDA. Regardless of the interaction with the FDA, we plan to pursue marketing approval outside of the United States. I just like to add, we only recently completed the Type C meeting and we're providing details of it without the benefit of having received minutes of the meeting from the FDA yet.

I'll now turn the call over to Colin to comment on the design of the proposed crossover study and to provide an update on the Company's ongoing development programs.

Colin Meyer -- Chief Research & Development Officer and Executive Vice President

Thanks, Warren. As Warren mentioned the crossover study would use patients as their own controls. Patients randomized to the placebo group in MOXIe Part 2 will be used in the analysis. Approximately 40 patients who were randomized to placebo, the MOXIe Part 2 entered the extension phase of the trial. We would measure their change in mFARS during MOXIe Part 2 and compare it to their change in mFARS on the open label extension study.

After patients completed the 48-week treatment duration in MOXIe Part 2, they stopped treatment for four weeks and had a safety visit at week 52. For the patients who continued in the extension phase of the trial, the week 52 mFARS value will be used as their baseline for analysis of the extension phase. Patients and investigators have remained blinded to treatment assignments from MOXIe Part 2 and therefore they do not know if they were receiving Omav or placebo.

Operationally the mFARS efficacy assessments have been conducted in the same rigorous manner during the extension as during MOXIe Part 2. We would like the analysis to be the most informative it can be and would like to have agreement with FDA before conducting the analysis. We are seeking guidance on the specific analysis methodology and many of the details will be finalized during our discussions with the FDA.

Moving to our CKD programs on slide 9 and as Warren mentioned earlier, we're in the process of completing the year two portion of our CARDINAL Phase III study. As COVID-19 emerged as a pandemic with serious public health implications during the first quarter of 2020, we undertook a series of measures to protect the health and safety of patients and healthcare workers involved in our ongoing clinical studies, while maintaining the conduct of our studies in accordance with guidance provided by the FDA and the EMA.

For example, we have implemented the use of at home visits as an alternative to in-clinic visits when necessary to collect blood draws and to assess patient safety. We also arrange for home delivery of the study drug to patients. At this time approximately 60% of 157 patients randomized to the CARDINAL Phase III cohort have completed the year two final off-treatment visit. The last study visits are anticipated to occur during the fourth quarter of 2020, which is consistent with our pre-COVID-19 timeline. Currently, almost all sites are allowing on site or remote monitoring as a result of the measures taken in response to the pandemic and based on current operational metrics.

At this time, we believe that the timeline for year two data availability is unlikely to be affected by COVID-19. In addition to the CARDINAL study, we are conducting the Phase III FALCON study of bardoxolone in ADPKD as described on slide 10. Similar to CARDINAL, FALCON is an international two year study enrolling patients with a wide range of kidney function and age with off-treatment eGFR assessments after one and two years of treatment that support approval.

In March 2020, we temporarily paused screening and enrollment of new patients in FALCON due to the emergence of COVID-19. We began to lift the screening hold in June 2020 and currently, all sites are able to screen patients and approximately half are able to randomize patients. The first few patients have now reached the second year of the trial. The measures we implemented to the conduct of FALCON in response to COVID-19 have been effective and we anticipate no meaningful impact on data integrity due to COVID-19.

During our first quarter earnings call, I described kidney code, a genetic testing program sponsored by Reata and Invitae to help nephrologists identify the genetic basis of various forms of CKD. Today, I'd like to briefly provide some background for this initiative.

Recent findings published in highly respective journals are consistent in suggesting that Alport syndrome may be more prevalent than currently estimated and patients with Alport syndrome are often misdiagnosed. In one study published last year in the New England Journal of Medicine, over 3000 patients with CKD were genotyped and 10% had a genetic form of CKD, of these 30% have mutations in the collagen genes that cause Alport syndrome, which was nearly identical to the proportion of patients who tested positive for mutations in the genes that cause ADPKD. More recently, the same research group assessed patients with IgA nephropathy and found that 20% of patients with familial IgA nephropathy tested positive for the collagen genes that cause Alport syndrome. Several other genetic studies have concluded that approximately 10% to 30% of patients with a clinical diagnosis of FSGS also test positive for these mutations and therefore have Alport syndrome as the underlying cause of the kidney disease.

Moving on to slide 12. As we previously announced, researchers at NYU are initiating an investigator sponsored trial to study the effects of bardoxolone in patients suffering from COVID-19. Serious complications of COVID-19 are caused by excessive systemic inflammation, which can result in dysfunction of the lungs, kidneys and other organs. Acute kidney injury has been reported to occur in up to 28% of all hospitalized COVID-19 patients, and then up to 72% of patients who do not survive COVID-19. Bardoxolone and its analogues have demonstrated anti-inflammatory activity in animal models of acute lung and kidney injury, have increased survival and models of systemic inflammation, suppress replication of several types of viruses, and have shown improvements in kidney function and multiple clinical trials that enrolled over 3000 patients with various forms of chronic kidney disease.

The Phase 2 BARCONA study is a randomized placebo controlled, double blind trial that will enroll 40 patients with a primary endpoint of safety and treatment duration of up to 29 days in hospitalized patients. Major exclusion criteria include patients who are intubated and on invasive mechanical ventilation for three or more days, prior hospitalization for heart failure, or eGFR less than 30 mL/min.

To further mitigate any safety risk, enrollment will be paused after enrollment of initial five patients to assess safety. As with all trials conducted at NYU, the trial will be overseen by the data safety monitoring board that meets every other week. Reata was involved in the design of the trial as a representative on the study's executive steering committee and is providing drug supplies requested by NYU, any further enrollment in a potential Phase 3 trial will be gated based on an assessment of Phase 2 safety and activity, as well as feasibility of conducting a Phase 3 trial.

I'll now turn the call over to Manmeet to provide an update on the Company's financial results.

Manmeet S. Soni -- Chief Operating Officer & Chief Financial Officer and Executive Vice President

Thanks, Colin and good morning, everyone. Thanks for joining us today. Please refer to our press release issued earlier today for a summary of our financial results for the second quarter of 2020. Before I walk through that summary, I want to highlight a few key financial developments from the second quarter, which are on slide 14.

First, we completed a $350 million strategic investment from Blackstone that strengthened Reata's balance sheet comprised of $300 million for future royalty payments and $50 million for common stock issued. Regarding the accounting for Blackstone investment, we accounted for future royalty payments as a liability due to our significant continued involvement. We allocated the total investment based on the relative fair value of the two components, resulting in $294.2 million in transaction consideration to the liability and $55.5 million to the common shares.

In connection with the payoff of our term loans, we recorded a loss on extinguishment of debt of $11.2 million. I would like to note that by paying off our term loans, we would save approximately $25 million of cash interest payments over the next three years related to the term loans.

Moving to the financial results on slide 15, we ended the second quarter of 2020 with approximately $610.4 million in cash and cash equivalents and we continue to expect our available cash to fund operations through 2023. The decreases in revenues in the three months ended June 30, 2020, were primarily due to the write-off of our remaining deferred balance related to our agreement with AbbVie to reacquire license rights for our Nrf2 activator programs, which occurred in last quarter of 2019 and which resulted in no revenue recorded during 2020.

Moving to expenses, our R&D expenses for the quarter were $36.8 million compared to $29.6 million for the second quarter of 2019. Our year-to-date R&D expenses were at $84.4 million compared to $55.7 million in 2019. Our G&A expenses for the quarter were $16.6 million, compared to $11.7 million for the second quarter of 2019. Our year-to-date, G&A expenses were $37.4 million compared to $21.7 million in 2019.

Our operating expenses for the quarter were $53.7 million compared to $41.5 million for the second quarter of 2019. Our net loss for the quarter was $67.6 million or $2.03 per share on both a basic and diluted basis. As compared to a net loss of $34.4 million or $1.14 per share on both a basic and diluted basis for the second quarter of 2019.

Moving to non-GAAP measures on slide 16. These non-GAAP measures exclude stock based compensation expenses, loss on extinguishment of debt and non-cash interest expense from liability related to sale of future royalties. Our non-GAAP R&D expenses were $29.3 million for the quarter as compared to $27.9 million for the second quarter of 2019. Our year-to-date non-GAAP R&D expenses were $65.4 million compared to $52.3 million for 2019.

Our non-GAAP G&A expenses were $9.3 million for the quarter as compared to $8.9 million for the second quarter of 2019. Our year-to-date non-GAAP expense were $22.3 million compared to $16.4 million for 2019. Our non-GAAP R&D and G&A expenses for the quarter increased primarily due to increased headcount to support the advancement in our pipeline to late stage clinical development programs. Our year-to-date non-GAAP R&D expenses increased due to increased development costs, primarily clinical studies and manufacturing expenses and higher personnel cost as we increased our headcount to support our expanded activities. Our non-GAAP G&A expenses also experienced increases in personnel to support growth in our development activities as well as increases in commercial readiness activities.

That concludes our prepared remarks. We will now open the line for questions.

Questions and Answers:

Operator

Thank you. We will now begin the question-and-answer session. [Operator Instructions] Our first question comes from Yigal Nochomovitz from Citigroup. Your line is now open.

Yigal Nochomovitz -- Citigroup -- Analyst

Hi, guys. Good morning. Thanks for taking the questions. Just a two part question, first on Omav, regarding the FDA feedback, emphasizing the willingness to consider all available options to meet the regulatory standards as well as acknowledging that a new trial may not be possible given COVID. Were those comments in subsequent to the written comments or in writing or were those also verbal comments? And then, regarding bardoxolone, I think Warren, you've mentioned that based on the Type C meeting that there was some additional analysis that were requested by the FDA on the Alport study, if you could potentially expand on what those additional analyses were? Thank you.

Warren Huff -- Founding Chief Executive Officer and President

Yes. I'll take the first half of the question. Yes, the comments about their willingness to consider all options and the discussion about the crossover study all occurred after the preliminary comments were sent to the meeting. It happened during the meeting.

Yigal Nochomovitz -- Citigroup -- Analyst

Okay, thank you.

Colin Meyer -- Chief Research & Development Officer and Executive Vice President

And I will answer your second question. So the FDA questions primarily about efficacy. They did not have questions about safety. In response to your questions, we provided pre-specified sensitivity analyses, as well as analyses they suggested. The review team was new to the program and we also provide a pre-clinical mechanism of action data, as well as data demonstrating the clinical pharmacodynamic profile. So we addressed these and informal meetings as well as a formal IND amendments that we believe comprehensively address their questions and comments. As we stated, we waited to submit a pre-NDA meeting request to I believe we had addressed the FDAs questions and comments. And as you know, we were recently granted to have that pre-NDA meeting.

Yigal Nochomovitz -- Citigroup -- Analyst

Got it. Thank you.

Operator

Thank you. Our next question comes from Maurice Raycroft from Jefferies. Your line is now open.

Maurice Raycroft -- Jefferies -- Analyst

Hi, good morning. Thanks for taking my questions. Thanks for providing the clarity and the regulatory path today. For FA just wondering, if you can say more about why FDA is not convinced MOXIe Part 2 single study results are supportive of approval. And when you'll find out and disclose to the public, if they view the crossover study as efficient.

Warren Huff -- Founding Chief Executive Officer and President

Sure, Maurice. So we believe the data are supportive of approval. MOXIe was the largest placebo controlled mFARS study conducted to-date. As you know, it involved approximately 100 patients. We hit the pre-specified primary endpoint with a p value of 0.014. The FDA could have wanted a lower p value. Our lead investigators believe the treatment effect was maximal for this duration of treatment and the variability was much lower than observed in the National History Study. We therefore unsure if the p value could have been much lower. Additional sensitivity analyses controlling for imbalances and baseline characteristics suggested that the primary analysis may be a conservative estimate of the treatment effects.

Importantly on that patients improved from baseline while placebos worsened, the treatment effect improved versus placebo at every time point all four sections of the mFARS and all pre-specified analysis populations favored Omav, major subgroups favored Omav including pediatric patients and those with risk factors for the most rapid progression, including age of onset and J1 repeat length. We reviewed the data with all of the MOXIe investigators who represent almost all of the global FDA clinical experts, as well as FARA and they agreed that the data should merit regulatory review.

The only real criticism of the data is that we've missed the secondary endpoints in the pre-specified hierarchy. We knew prior to conducting the trial, the secondary endpoints were not powered, but included them to provide descriptive data to support the conclusions of the primary analysis. The first secondary PGIC approach significance in the primary analysis population with a p value of 0.1 and was significant across all randomized patients.

CGIC and frequency of all favored Omav, most important to us and investigators is the patient reported activities of daily living or ADL result. The ADL had a nominally significant p value of 0.04, all my questions favored Omav and the different separate over time. So for those reasons, and we think the data, it should support approval. We're engaged right now with the FDA to discuss the crossover trial. As we stated, we believe that we could conduct that analysis in the fourth quarter, of course, pending FDA review of the design, we want to make sure that they're in agreement with design before we actually execute the analysis.

Maurice Raycroft -- Jefferies -- Analyst

Got it. Thank you.

Operator

Thank you. Our next question comes from Joseph Schwartz from SVB Leerink. Your line is now open.

Joseph Schwartz -- SVB Leerink -- Analyst

Thank you. What the FDA views are on Omav, could you walk us through what aspects of the one year CARDINAL data, the FDA questions the merits of and the scenario goes for the two year data that the FDA would like to see the scenario or scenarios.

Warren Huff -- Founding Chief Executive Officer and President

You were cutting out Joe, was your first question about the questions that FDA had about the CARDINAL one your data?

Joseph Schwartz -- SVB Leerink -- Analyst

Yes. Specifically like what aspects, it was helpful how you laid them out for Omav. So could you do the same thing for Bard? So that way we can understand, what aspects of the one year data they're not convinced by specifically? And then, what two year data would lead them to feel differently more positively?

Colin Meyer -- Chief Research & Development Officer and Executive Vice President

Yeah. So as I mentioned, we provided pre-specified sensitive analyses, as well as post hoc analyses which they recommended, which would address their specific questions. And that was all formally submitted in the IND amendment. And now, we have a pre-NDA meeting, where we're scheduled to discuss the actual mechanics of submission. And so as Warren mentioned, our plan is to file based upon the one year data in the fourth quarter of this year. We'll discuss with FDA how to handle the year two data, and that could influence the timing.

Joseph Schwartz -- SVB Leerink -- Analyst

Right. But what aspects of the one year data, was it the GFR? Was it proteinuria, was it something else?

Colin Meyer -- Chief Research & Development Officer and Executive Vice President

They were just standard questions that the FDA typically asks about the analysis of the trial, as well as pharmacodynamic effects so that they can better understand the results.

Joseph Schwartz -- SVB Leerink -- Analyst

And then, what data at two years with the FDA like to see, did they give you any insight into that?

Colin Meyer -- Chief Research & Development Officer and Executive Vice President

It's the same and so since our pre-IND meeting, FDA stated that they wanted two full years of data to support full approval.

Warren Huff -- Founding Chief Executive Officer and President

Okay. They commented in the context -- they commented that they didn't see much delay and waiting for the year two data.

Joseph Schwartz -- SVB Leerink -- Analyst

Yeah. That parts clear. Thanks.

Operator

Thank you. Our next question comes from Annabel Samimy from Stifel. Your line is now open.

Annabel Samimy -- Stifel -- Analyst

Hi. Thanks for taking the question. Just, I guess, from what it sounds like that regardless, the FDA is going to wait for that two year data, because it seems like they have some questions on that one year data. So can you please tell us first whether the Blackstone job is conducted before the Type C meeting? And if so, how does the delay impact the tiered royalties that you might see from that? And then, separately on Omav, I guess I wasn't clear exactly when we might know whether the FDA accepts the crossover study, will the 40 patients be sufficient to satisfy their needs to see additional data there? Thank you.

Warren Huff -- Founding Chief Executive Officer and President

I'll take the first part of that. The Blackstone diligence was conducted after the reference Type C meeting for bardoxolone.

Manmeet S. Soni -- Chief Operating Officer & Chief Financial Officer and Executive Vice President

There is no impact on the royalty from either of those, they remain same, in the Blackstone royalties are -- start at mid single digit and they can tier down to low single digit, or high mid single digit, but that's it. It doesn't change because of this.

Colin Meyer -- Chief Research & Development Officer and Executive Vice President

And just to address the first part of your question, so our current plan is to file on the basis of the one year data not to wait until the two year data. However, FDA in the pre-NDA meeting may provide additional guidance. And so that's why our current plan is to file on the one year data for accelerated approval.

Warren Huff -- Founding Chief Executive Officer and President

We believe we address their questions that were raised in the initial meetings. When we made the IND amendments submissions and the pre-NDA meeting requests, we made clear that our plan was to file before your end.

Annabel Samimy -- Stifel -- Analyst

And then, just on the Omav -- the clarity on the Omav?

Warren Huff -- Founding Chief Executive Officer and President

What was the question?

Annabel Samimy -- Stifel -- Analyst

It wasn't clear to me when we might hear whether the FDA is going to accept a crossover study design.

Colin Meyer -- Chief Research & Development Officer and Executive Vice President

There will be a process of working out the most informative analysis plan with them, which they offered to do informal meetings and make themselves aware for that, that'll take some period of time here. And then of course, ultimately they'll want to see the actual data before they make a final decision, I'm sure.

Annabel Samimy -- Stifel -- Analyst

Okay, great. Thank you.

Operator

Thank you. Our next question comes from Brian Skorney with Baird. Your line is now open.

Brian Skorney -- Robert W. Baird -- Analyst

Hey, good morning, guys. Thanks for taking my question. On the Omav regulatory update, can you talk about where the N1 division is coming down in terms of what they want in a single study for approval? I mean, it just seems like there's a lot of wiggle room here across divisions. And it's unclear, I mean, is their issue that they wanted -- that they normally want to lower p value on a primary that's deemed sufficient? Is it a matter of secondary analyses needing to support the primary with statistical significance or is it around an endpoint or a magnitude of endpoint? And how did the agency consider the MOXIe Part 1 data here? Would that not be considered sufficient confirmatory evidence?

Colin Meyer -- Chief Research & Development Officer and Executive Vice President

And so I think, they're just trying to follow the regulations they have for single study approvals. And so they told us that they wanted additional information. And so there's a few different ways to provide that, then discussions, they seem most receptive to the crossover design. So that's how we're proceeding to provide them with additional information to provide additional persuasiveness.

Brian Skorney -- Robert W. Baird -- Analyst

And then, in terms of the timing for the year two data from CARDINAL, can you just help me understand in terms of trial design, why wouldn't you expect the data to be available pretty much one year after the one year date was announced last year on November 11?

Colin Meyer -- Chief Research & Development Officer and Executive Vice President

Yes. That is the expectation. So our guidance is that we will have the year two data available in the fourth quarter of this year. We think its unlikely now to be affected by COVID-19 for the reasons I mentioned. And so obviously, in order to provide that to the NDA, there has to be analysis. We have to update the datasets and formally submit it. That being said, as we stated, our plan is to file by year end on the year one data, if the FDA requires the year two data and the initial submission that would delay the filing until the first quarter. And so there's potentially not a large difference in time. There's other potential mechanisms too to provide the data. And so we'll be discussing that with the agency at the pre-NDA meeting.

Brian Skorney -- Robert W. Baird -- Analyst

Great. Thanks, guys.

Operator

Thank you. [Operator Instructions] Our next question comes from Dae Gon Ha from BTIG. Your line is now open.

Dae Gon Ha -- BTIG -- Analyst

Great. Thanks for taking our questions. And appreciate the update as well. So just wondering, this might be extremely naive, but given the sort of timeline you've outlined for Alport, the expectation of the second year data and 4Q and the planned submission for the NDA and 4Q, just wondering, I mean, at this point, assuming positive data just comes out, I guess why wouldn't you just go for the full approval in the first quarter of '21 since that's the timeline you've laid out. And there's only seems to be a couple of months. If you do, I guess, supplement the second year data, I guess the three month delay would also kind of put you in that same timeline of review period anyway.

And the second part is, if we kind of look out into your FALCON trial, given the similar trial design, I mean, is there any read through as to what the FDA saying with regards to Alport requiring second year data for how we should think about the FALCON and ADPKD approval? Thank you

Warren Huff -- Founding Chief Executive Officer and President

Yeah. I think we agree with that. The options are to file and just seek accelerated or with the data coming, the two year data coming in the fourth quarter to supplement -- find a way to submit that data to the NDA. And there are multiple options for that. I just like to add that some of the thinking about this is evolved with the pandemic. I mean, a few months ago, it was not clear to us that we would be able to, for example, close the database on a timely basis, we didn't have concern about data integrity or the visits, but the timing, could have been impacted. And conceivably, it could still be impacted if the pandemic got much worse. Today, we don't see that. So we're stuck with some complexity, about timing, just based on the environment that we're currently operating in.

But it would probably, if things play out the way we believe today, we would have that data in time. And we should be able in the pre-NDA meeting, to have an open discussion with the FDA about how that data might be submitted if they let us proceed with the submission on the basis of the year one data. But of course, they may tell simply wait and submit on the year two data.

Operator

Thank you. I'm sorry, go ahead, sir. Dae Gon Ha, continue sir.

Warren Huff -- Founding Chief Executive Officer and President

Go ahead.

Dae Gon Ha -- BTIG -- Analyst

The question about the FALCON trial?

Operator

Go ahead. Go ahead.

Warren Huff -- Founding Chief Executive Officer and President

Yeah. I think it not necessarily does it read through the ADPKD, I think as all of you know, this design was given to us by the FDA. A similar design with a one year treatment duration or treatment period was given to a different company for the tolvaptan, REPRISE trial, which supported its approval. And so this is the first time the FDA is going through data, where there's one year data, but the trial is two years in duration. And so some of the questions was, again, as I mentioned, around analyses, that they recommended that we conduct which we provided and they've granted the pre-NDA meeting. And so, it's to be determined if there's any potential read through it. I'm not exactly sure what you would mean by read through the ADPKD.

Dae Gon Ha -- BTIG -- Analyst

Yeah. Okay. Well, thank you very much.

Operator

And presenters, we have no further questions in queue. At this time, I'd like to turn the call back to Mr. Vineet Jindal for closing comments.

Vineet Jindal -- Vice President of Corporate Communications and Strategy

Thank you so much. Thank you for joining us on today's call. That would be the end of the call today. Thank you.

Operator

[Operator Closing Remarks]

Duration: 40 minutes

Call participants:

Vineet Jindal -- Vice President of Corporate Communications and Strategy

Warren Huff -- Founding Chief Executive Officer and President

Colin Meyer -- Chief Research & Development Officer and Executive Vice President

Manmeet S. Soni -- Chief Operating Officer & Chief Financial Officer and Executive Vice President

Yigal Nochomovitz -- Citigroup -- Analyst

Maurice Raycroft -- Jefferies -- Analyst

Joseph Schwartz -- SVB Leerink -- Analyst

Annabel Samimy -- Stifel -- Analyst

Brian Skorney -- Robert W. Baird -- Analyst

Dae Gon Ha -- BTIG -- Analyst

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