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Reata Pharmaceuticals, Inc. (RETA)
Q1Â 2020 Earnings Call
May 11, 2020, 4:30 p.m. ET
Contents:
- Prepared Remarks
- Questions and Answers
- Call Participants
Prepared Remarks:
Operator
Ladies and gentlemen, thank you for standing by, and welcome to the Reata Pharmaceuticals First Quarter Financial Results and Update on Development Programs Conference Call. [Operator Instructions]. Please be advised, that today's conference is being recorded.[Operator Instructions]. 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 in the company's press release. The company will be making 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 future outcomes.
Please also note that any comments made on today's call speak only as of today, May 11, 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. [Operator Instructions].
I would now like to hand the conference over to your speaker today, Vineet Jindal, Vice President of Corporate Communications and Strategy. Please go ahead sir.
Vineet Jindal -- Vice President, Corporate Communications & Strategy.
Thank you, Chris.
Hello, and welcome to Reata Management's call to discuss our financial results for the first 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 Medical Officer, Colin Meyer; and our Chief Financial Officer, Manmeet Soni.
Turning to Slide 3, I'll now turn the call over to Warren.
Warren Huff -- Chief Executive Officer
Thanks, Vinny. Good afternoon, everyone, and thank you for joining us on our quarterly call. I'll start on Slide 4. As for many businesses worldwide, the first quarter of 2020 for Reata was defined by the emergence of COVID-19 as a global destabilizing pandemic. Early on, we recognized the disruptive potential of the pandemic, and we took steps during the quarter to mitigate its effect on our clinical programs, our drug supply chain and our business operations. In each case, the adjustments that we have made reflect our concern for the safety and well-being of the patients and healthcare workers participating in our clinical studies as well as our employees and partners.
With respect to our clinical programs, we evaluated each ongoing study to determine if it was possible to continue the study without imposing undue risk to the study participants. Based on this analysis and in consultation with the Data Safety Monitoring Board, we decided to stop the Phase III CATALYST study of bardoxolone in patients with connective tissue disease-associated pulmonary arterial hypertension. These patients have very compromised cardiopulmonary function, are often receiving immunosuppressants and are at an inherently high risk of adverse outcomes in the event of an infection. We decided the continued exposure of these high-risk patients to clinic or in-person visits presented an unacceptable risk.
With respect to our other ongoing clinical programs, we determined that we could continue the studies by implementing changes that mitigate risk to patients and caregivers, while maintaining the integrity of the studies. In our Phase III CARDINAL and FALCON studies, we're fortunate that study drug is self-administered and the key endpoints are blood based. Colin will provide more details on the steps we've taken to maintain the integrity of the studies. But in summary, we implemented the use of at-home visits to collect blood draws and to assess safety as an alternative to in-clinic visits when necessary. We also arranged for home delivery of the study drug to patients when a clinic visit was not possible. These measures have been working as planned. And at this time, we do not believe that the COVID-19 pandemic will have a significant impact on our ability to complete the studies.
For the CARDINAL study, the continuity of data collection is very important because we need to complete the second year of the study to have the data necessary for full approval of bardoxolone for Alport syndrome. For the FALCON study, we've been able to continue treatment of patients enrolled in the study, but because in-clinic visits are necessary to enroll new patients, we've had to pause enrollment of new patients into the study. Clinical trial sites are starting to reopen, and we're hopeful that we may be able to resume screening of patients for FALCON as early as this quarter at some sites.
As a reminder, the pivotal Part 2 of the MOXie study of omav in Friedreich's ataxia was completed before the emergence of COVID-19. And thankfully, the pandemic will have no impact on that study.
Regarding our regulatory path for bardoxolone and omav, our policy is to comment only when we have a major event to announce. And so as in our earlier calls, we'll not be answering questions regarding regulatory activities on this call. Having said that, I will take this opportunity to reiterate that our plan is to file NDAs for each of bardoxolone and omav this year, of course, subject to ongoing discussions with the FDA.
Finally, with respect to our business operations, we implemented work-from-home measures and additional safety protocols to protect our employees and to maintain business continuity. Our infrastructure investments have allowed us to continue to operate and, in particular, to continue to pursue our key goals for the year.
Moving to Slide 5, I'll turn the call over to Colin to provide an overview of our clinical programs and a look into our ongoing medical affairs activities.
Colin Meyer -- Chief Medical Officer, Executive Vice President, Product Development
Thank you, Warren. We'll turn now to Slide 6. As Warren mentioned, our top clinical priorities are to maintain the integrity up and complete the CARDINAL study of bardoxolone in CKD caused by Alport syndrome and for resume enrollment in FALCON. Early this year, and prior to COVID-19 becoming a global pandemic, our team recognized the potential negative impact the virus could have if it's spread globally, causing quarantines and affecting patients' ability to participate in our clinical trials, including conducting in-clinic visits to obtain efficacy and safety data and receive study drug. For many clinical studies, site visits are necessary to administer study drugs such as infusing biologics or gene therapies and to collect key efficacy data through performing sophisticated assessments, exams, imaging or other procedures. Closure of trial sites due to COVID-19 has presented a challenging set of obstacles for many of the ongoing clinical studies.
We are fortunate that the key efficacy endpoints for our CKD trials, including CARDINAL or blood-based markers of kidney function, and that our drug is a small molecule formulated in capsules that is self-administered orally and does not need to be infused at a medical facility, providing us options to complete our CKD studies. In prior trials, we have occasionally used home health nurses to conduct at-home visits for important study visits if patients were unable to intend an in-clinic visit. As COVID cases began to increase outside of China, we utilized our established relationships with these vendors to quickly mobilize their nurses to conduct CARDINAL visits in geographies that have now been affected by the pandemic, including the U.S. and Europe.
The first home-health visit occurred in March and to date, approximately 30 patients in the U.S., Spain and France have had a home health visit. We have observed no significant impact on data integrity during this period. As of today, more than half of the 157 patients, who are enrolled in the pivotal Phase III CARDINAL trial have now completed the study. We were also able to ensure that our patients were able to receive study drug if their sites were closed. Typically, drug supply is dispensed from clinic sites, while patients are conducting their regularly scheduled visits. We were able to work with our manufacturing vendor to have drug supply shipped directly to patients' homes to ensure a continuity of treatment. We were able to ship additional months of drug supply to most patients, so that they had sufficient supply to last until mid-summer. We will continue shipping drug supply directly to the homes of patients, who are affected by site closures throughout the duration of the trial.
During the pandemic, sites in Japan and Australia have remained open, and patients in those countries have been able to conduct in-clinic visits. While we will continue to use home health visits and direct shipment of drug supply as needed through the remainder of the trial, trial sites in less densely populated regions in the U.S., Spain and Germany have recently been able to conduct in-clinic visits. We hope this trend continues, but if sites remain closed indefinitely, we're prepared to complete the trial using the solutions I described.
Turning to Slide 7. The FALCON trial of bardoxolone in ADPKD was actively enrolling patients when COVID-19 turned into a pandemic. For patients, who are already enrolled, we implemented the same procedures that we have in the CARDINAL trial, including home health visits and direct shipment of drug supply to patients' homes. These solutions have allowed us to continue patients who are already in the trial, and we have observed no significant effect on data integrity. The screening process in any trial is fairly intensive. And as we previously disclosed, we paused screening and enrollment in FALCON in March, when sites were starting to close to research patients. As I mentioned during the CARDINAL discussion, some geographies have not been affected by COVID-19, some rural sites in the U.S. and Europe have remained open, and some of our sites that were previously closed are now starting to reopen. We have been communicating with our FALCON sites and are planning to restart screening soon. We will make decisions on a site-by-site basis, based on their individual capabilities to safely screen and enroll patients. As Warren said, we are hopeful that patient screening can begin this quarter.
Moving to Slide 8. In addition to trial execution and our NDA preparations, we are continuing to publish and present new data on our lead programs. The European Renal Association and European Dialysis and Transplant Association, also known as ERA-EDTA, has accepted three abstracts from our collaborators and us for presentation at its upcoming international congress, taking place virtually in early June. As many of you know, the ERA-EDTA meeting is the major European and second best globally attended nephrology conference of the year. These accepted abstracts include a poster entitled kidney effects in the MOXie trial, a study of omaveloxolone in patients with Friedreich's Ataxia. In our pivotal MOXie trial, we prospectively assess kidney function in FA patients over the course of a year. Kidney function in FA patients has not been well studied, in part because these patients do not have traditional risk factors for progression of CKD, such as high blood pressure or proteinuria. And end-stage kidney disease requiring dialysis or kidney transplant is uncommon in this very rare disease. FA is a disease caused by mutations in a mitochondrial protein, called frataxin, that lead to mitochondrial dysfunction. The hallmarks of mitochondrial dysfunction are impaired energy production and activation of inflammatory pathways. Clinically, these effects have been studied in several organs of FA patients, including the brain, spinal cord, heart, pancreas and liver.
Our MOXie data are the first to show that FA patients have rapidly progressive loss of kidney function. After 48 weeks of treatment, the mean decrease in eGFR for placebo patients was 4.4 mL/min. And in the pediatric patients who have more rapidly progressive neurological disease, it was 11.3 mL/min. The overall average loss of eGFR of 4.4 mL/min is higher than what is observed for many forms of CKD that are considered severe and highly progressive. In contemporary CKD trials of diabetics, hypertensives, ADPKD, IgA nephropathy, FSGS and other forms of CKD patients, on average, lose less than 4.4 mL/min. As mentioned, this loss occurred in patients in our MOXie trial without traditional risk factors for progression of CKD.
Because unfortunately, most FA patients will not survive long enough to reach end-stage kidney disease, this finding does not have direct relevance to the clinical management of FA patients. It does, however, highlight the importance of the role of mitochondrial dysfunction in CKD.
As we have extensively discussed in the context of the development of bardoxolone, for several forms of CKD, impairments of mitochondrial function have now been observed and are thought to be critical in the pathogenesis across many distinct forms of CKD, caused by very different insults that ultimately lead to a final common pathway of progression characterized by impaired metabolism, energy production and activation of inflammatory pathways. In addition to human biopsy studies of CKD patients that we have cited, these clinical data from patients with a pure form of mitochondrial disease are, in our view, the most persuasive evidence that mitochondria are key regulators of kidney function.
Beyond the conceptual insights that these data provide, they also demonstrate that like bardoxolone, omav can improve kidney function. The placebo-corrected on-treatment improvement in kidney function was 11.4 mL/min at week 48 across all patients. And in the pediatric patients, the magnitude was higher at 16.8 mL/min. We conducted a safety visit 28 days after patients discontinued drug, and as part of this visit, we assessed eGFR. At week 52, after wash-out of omav, the placebo-corrected off-treatment eGFR change was 5.4 mL/min, demonstrating that omav not only dynamically improved kidney function, but it also had a structural effect on the kidney and likely slowed fibrosis.
At ERA-EDTA, we'll also be presenting a poster entitled KIDNEY CODE, a genetic testing program for patients with chronic kidney disease, which describes an important aspect of our ongoing medical affairs activities.
As you can see on Slide 9, KIDNEY CODE is a genetic testing program, we are sponsoring in partnership with Invitae to help nephrologists identify the genetic basis of various forms of CKD. This initiative was launched in recognition of recent literature, which suggests that approximately 10% of patients with CKD have an underlying genetic cause. While Alport syndrome has been known to be the second most common hereditary form of CKD, recent data suggest it is more common than one's thought. And a large number of patients with Alport syndrome are either undiagnosed or misdiagnosed with other forms of CKD. Further, patients who are not diagnosed correctly, may be receiving a treatment that may not be relevant or helpful to their actual form of CKD.
The test consists of a panel of 17 genes that are linked to the most common causes of hereditary CKD, including ADPKD, Alport syndrome, FSGS and others, which provides broad interest to the nephrology community. It is available in the U.S. and has a rapid turnaround time. Blood or saliva that can be collected during a clinic visit, where a saliva kit can be directly shipped to a patient's home. Reata receives data from certain de-identified patients including mutation results, demographics and ordering position.
In the first several months of the pilot phase, we have had excellent uptake of the test in the nephrology community and received very positive feedback that the test is easy to order, has rapid turnaround time and is easy to interpret. Of the tests that have results that we can access, approximately half have been positive for Alport syndrome, and half of these patients were previously misdiagnosed with other forms of CKD. These include ADPKD, FSGS, hypertensive CKD, IgA nephropathy and several clinical diagnoses that have generally been considered to be benign.
While these patients are usually under the care of a nephrologist, they may be receiving incorrect care. For instance, an Alport syndrome patient should not receive tolvaptan or immunosuppressants, which would typically be given to patients with ADPKD or IgA nephropathy. These data allow nephrologists to appropriately diagnose and care for their patients, which is precision medicine in action.
Importantly, we have learned that identifying patients with Alport syndrome who are misdiagnosed or not yet diagnosed is straightforward. Based on prior literature from one of our CARDINAL investigators and his colleagues, 3 straightforward clinical criteria can be used to identify Alport syndrome patients. We have now prospectively shown that using these criteria of: one, a patient with CKD defined as an eGFR below normal; two, a family history of CKD; and three, the presence of hematuria or blood in the urine, has been effective. 78% of patients with all 3 risk factors haven't found to have Alport syndrome in the KIDNEY CODE program.
I'll now turn the call over to Manmeet to provide a summary of our business operations and financial results for the quarter.
Manmeet Soni -- Chief Financial Officer
Thanks, Colin, and good afternoon, everyone. Thanks for joining us today. We are on Slide 10. Please refer to our press release issued earlier today for a summary of our financial results for the first quarter of 2020.
Before I walk through that summary, I want to emphasize a few key points related to what Warren and Colin have described, specifically related to the practical aspects of ensuring the continuity of our ongoing trials. Our current inventory of investigational product is adequate to support these ongoing clinical trials. Based on current evaluations, we anticipate that our supply chains are adequate to meet our clinical, non-clinical and chemistry manufacturing and controlled supply demands across all programs. We have not experienced any significant disruptions in manufacturing to date for our planned commercial production for bard and omav. Additionally, we do not have supply chain exposure to China for either bard or omav.
Moving to the financial results, Slide 11. We maintained a strong balance sheet, ending the first quarter of 2020 with approximately $624.5 million in cash and cash equivalents. We continue to expect our available cash to fund operations through 2021. Collaboration revenues for the quarter were $1.4 million compared to $7.8 million in the first quarter of 2019. This reduction was due to the write-off our remaining deferred balance relating to our agreement with AbbVie to reacquire license rights for our Nrf2 activator programs, which occurred in 2019. Accordingly, in our current quarter, there is no revenue from our AbbVie agreement, and we do not anticipate any revenue from the adjuvant with AbbVie going forward.
Moving to expenses, our R&D expenses for the quarter were $47.7 million compared to $26.1 million for the first quarter of 2019. Our G&A expenses for the quarter were $20.8 million compared to $10 million for the first quarter of 2019. Our operating expenses for the quarter were $68.7 million compared to $36.3 million for the first quarter of 2019. Our net loss for the quarter was $48.9 million or $1.47 per share on both a basic and diluted basis as compared to a net loss of $29.2 million or $0.98 per share on both a basic and diluted basis for the first quarter of 2019.
Now moving to Slide 12. Looking at our non-GAAP measures, which exclude stock-based compensation expenses, non-GAAP R&D expenses were $36.1 million for the quarter as compared to $24.4 million for the first quarter of 2019. Non-GAAP G&A expenses were $13 million for the quarter as compared to $7.5 million for the first quarter of 2019. Our non-GAAP R&D expenses increased primarily due to increased development cost to advance our pipeline in late-stage clinical development programs and to higher personnel costs, 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 due to rent and commercial-readiness activities. Our non-GAAP operating expenses were $49.4 million for the quarter compared to $32.1 million for the first quarter of 2019. These increases are consistent with our development growth discussed earlier.
Looking at non-GAAP net loss, it was $29.6 million for the quarter or $0.89 per share on both a basic and diluted basis compared to a net loss of $24.9 million for the first quarter of 2019 or $0.84 per share on both a basic and a diluted basis. The increase in both GAAP and non-GAAP net loss measures reflect the change in revenue and expenses I just discussed with one additional change. During the first quarter of 2020, we were able to recognize a tax benefit of $22.1 million due to the enactment of the CARES Act that allowed us to recognize some prior year NOLs against our taxable income from a preceding year.
Now moving onto Slide 13. Looking at non-GAAP measures in the fourth quarter of 2019, these measures also exclude stock-based compensation expense and reacquired license rights expenses. Our non-GAAP net loss for the quarter was $29.6 million compared to a net loss of $50.3 million for the fourth quarter of 2019. This decrease in net loss during the first quarter primarily related to the recording of tax benefit of $22.1 million, as I mentioned above.
Finally, taking a look at the change in total non-GAAP operating expenses, which were $49.4 million for the first quarter of 2020, which resulted in a decrease of $1 million compared to a $50.4 million for the fourth quarter of 2019. This quarter-to-quarter decrease in our non-GAAP operating expenses highlights our financial discipline and efficient capital allocation.
Moving to Slide 14. I will now turn the call back over to Warren for concluding remarks.
Warren Huff -- Chief Executive Officer
Thanks, Manmeet. Moving to Slide 15, a few thoughts I want to make sure to convey before we close. Despite the disruption of the global coronavirus pandemic, Reata is in an excellent position to achieve substantial growth in the years ahead. Late last year, we generated positive pivotal data in each of our two lead programs, bardoxolone in Alport syndrome and omav in Friedreich's Ataxia. Subject to ongoing discussions with regulators, we plan to file for marketing approval for each program this year. Each therapy has several potential expansion opportunities in which we've already generated proof-of-concept data. We're well capitalized, and we've built a team capable of launching and commercializing these products worldwide.
That concludes our prepared remarks. I'd like to thank everyone who dialed in for listening, and we'll now open the line for questions.
Questions and Answers:
Operator
[Operator Instructions]. Our first question comes from the line of Yigal Nochomovitz with Citigroup.Your line is now open.
Yigal Nochomovitz -- Citigroup -- Analyst
Hi, great. Thanks very much for taking the question. Colin, the comments on the KIDNEY CODE test are interesting. I think previously, you'd referenced about a 30,000 to 60,000 U.S. population for Alport. Is it possible at this point, given the early data from the KIDNEY CODE test to potentially revise that estimate? Or can you extrapolate what the revised estimate might be at this point?
Colin Meyer -- Chief Medical Officer, Executive Vice President, Product Development
I think we could potentially revise our estimates. I mean, we aren't revising ours right now, but I think I'll reference New England Journal paper of glomerular that we probably discussed with you, it's published last year and showed that of patients who have hereditary cause ADPKD was the most common. I believe it was 31% of patients in that cohort, two large sets of patients in New York and Sweden had ADPKD and Alport syndrome, when you include all three type IV collagen genes accounted for 30% of patients who had hereditary CKD. And so we do think it's larger than our initial estimates, and the data from the literature suggests that it's likely approaching the ADPKD opportunity.
Yigal Nochomovitz -- Citigroup -- Analyst
Got it. And then with regard to omav and neurological diseases, you've obviously listed a variety of other avenues you could explore; Parkinson's, dementia, epilepsy, Huntington's and so forth. At this point, can you provide any more details as to which avenue you would be most likely to pursue next in a late-stage study?
Colin Meyer -- Chief Medical Officer, Executive Vice President, Product Development
Yes. So I think that, obviously, our approach as a company right now is to execute on our NDA submissions, restart FALCON and following behind would be initiating new trials with omav. And so we've already done a lot of work to determine what type of patient population we want to treat, and what the trial designs would entail. We've reached out to investigators. And so we have this down the list. And from our perspective, there's kind of two major categories. And so one is other movement disorders. And so FA-like diseases in that there's clear mitochondrial dysfunction that affect the patient's ability to move. We prefer to stay, obviously, in rare patient populations for the time being. And so as I mentioned before, familial Parkinson's disease is a clear setting where mitochondrial dysfunction caused by mutations in mitochondrial proteins causes the disease.
And we have evidence of activity from patient biopsy samples, just like with FA, that omav can restore mitochondrial function in those samples. We also have pre-clinical data and kind of broad PD models. There's a regulatory path forward with endpoints that have been used with other products that primarily treat symptoms. And so that's one setting that's of high interest to us, hereditary or familial Parkinson's disease accounts for about 15% of all PD cases. Another one is progressive supranuclear palsy. And so it's more common than FA, but less common than familial Parkinson's disease. It's on the Parkinsonian spectrum. And notably, if you search the literature, there's evidence that Nrf2 mutations that are -- that activate Nrf2 are protective. And mutations that suppress Nrf2's activity actually enhance the susceptibility to PSP.
And so those are two settings that are very high in the list. And then on a related set, we're interested in testing omav in non-movement disorders. And so frontotemporal dementia is a broad set of dementias, and there's a few subtypes that involve proteins that are mutated, and therefore, they're hereditary where mitochondrial dysfunction appears to play a key role. And so those are three settings that are higher on our list right now. The patients are readily identifiable, and there aren't a large number of ongoing competitive trials in those settings.
Yigal Nochomovitz -- Citigroup -- Analyst
Okay. That's super helpful. And if I could just squeeze in one more quickly. I know you may not be able to answer this given the pause of enrollment with FALCON given COVID. But can you say at this point, how far along you are with enrollment in FALCON? And if you have any rough idea, when you might be able to disclose the top-line data for that trial?
Colin Meyer -- Chief Medical Officer, Executive Vice President, Product Development
So we're well into enrollment. We can't disclose a specific number right now. As I mentioned, we've been in contact with our sites and many -- several are actually wanting to enroll patients now. And so that's a reason why we're considering reopening as long as sites can safely screen and see patients, especially during the titration phase, and we'll consider them for opening. But until we really understand the extent of the sites and the effect of COVID on our ability to screen, we're not going to give specific guidance.
Yigal Nochomovitz -- Citigroup -- Analyst
Understood. Alright, thank you very much Colin.
Operator
Thank you. And our next question comes from the line of Maury Raycroft with Jefferies. Your line is now open.
Maury Raycroft -- Jefferies -- Analyst
Hi, everyone. Thank for taking my questions. I think in the prepared remarks, you said 75% completed the Phase III Alport study. Just wondering if you can speak to the merits of potentially waiting to hit stat sig difference on two-year data and filing to get full approval? And if this could be one reason, why you're waiting to file for approval in Alport syndrome?
Colin Meyer -- Chief Medical Officer, Executive Vice President, Product Development
Yes. So first of all, we're not going to comment beyond what we have about the regulatory status and as Warren said, we're planning to file the NDA for Alport syndrome this year. I think secondly, to clarify, about half of patients have completed the full two-year treatment -- duration off-treatment period in CARDINAL.
Maury Raycroft -- Jefferies -- Analyst
Got it. Okay. And second question was just on omav and the ERA-EDTA data that you talked about. Just wondering if you've gotten any preliminary feedback from Friedreich's Ataxia KOLs and their views on the data? And I guess, could the kidney benefit make its way into the omav label?
Colin Meyer -- Chief Medical Officer, Executive Vice President, Product Development
So I think the view of the neurologists, who were involved in our FA trial is that the kidney data are intriguing. I mean they're not nephrologists. I think it points to another organ that is obviously affected. It's well described that FA patients have adverse effects in their heart, liver, pancreas, as I mentioned. And so this isn't really surprising to them. But it's actually really exciting to nephrologists. And so that's why we're having this data presented at a kidney meeting, because it's -- for some nephrologists, it's difficult to understand how patients could progress if they don't have hypertension and proteinuria. And so this is a setting where these patients had very normal blood pressure. They did not have proteinuria. Yet they progressed at a very rapid rate, as I mentioned, faster rate than almost all common forms of CKD.
And so I really think it helps to augment our understanding of how bardoxolone is likely affecting Alport syndrome patients, PKD patients and others where we see clear effects on kidney function. It just shows how important the mitochondria are to regulating metabolism and inflammation within the kidney. And so I think this is a much more interesting story to the nephrology community. And I'm not sure, I doubt this will make it on the FA label. It wasn't an efficacy endpoint. And as I said, it won't really affect clinical management of those patients because, unfortunately, they die before their kidney disease results in the need for transplant or dialysis. But I think it is a very exciting story for the nephrology community.
Maury Raycroft -- Jefferies -- Analyst
Got it. Okay. Thanks for taking my questions.
Colin Meyer -- Chief Medical Officer, Executive Vice President, Product Development
Yeah. You're welcome.
Operator
Thank you. And our next question comes from the line of Adam Walsh with Stifel. Your line is now open.
Adam Walsh -- Stifel -- Analyst
Good morning, guys. Thanks for taking my questions. Just the first one is a follow-up on the ADPKD FALCON trial. There's been a lot of talk about the potential for COVID-19 to return in the fall. And I'm just curious, as the clinical trial sites reopen and you are screening for new patients, are there any strategies that you can employ to potentially accelerate new patient enrollment in that trial during perhaps, what may be a window of opportunity to get all patients on board? That's the first. And then I have one follow-up.
Colin Meyer -- Chief Medical Officer, Executive Vice President, Product Development
Sure. So I would say that, yes, a reason to open enrollment soon is to get patients in before potential second wave. And as I discussed pretty extensively on the call, we're fortunate that our drug is administered orally, it can be shipped to patients' homes if needed. And once patients are on drug, they can be seen at home, and we can just draw blood. And so for the reopening of FALCON, and we're anticipating that this would occur at sites -- clinical trial sites that are open for patients to come. And so we have been exploring the possibility of doing screening enrollment more remotely. And so -- but I think one benefit of opening up soon is that we could get patients in quickly.
Adam Walsh -- Stifel -- Analyst
That's terrific. And then just could you give us an update on the commercial preparations for bardoxolone in Alport and potentially ultimately in ADPKD? And what have your learnings been from the JYNARQUE launch to date? And how might those be applied to your strategy? Thank you.
Warren Huff -- Chief Executive Officer
Manmeet, you want to take that?
Manmeet Soni -- Chief Financial Officer
Sure, sure. As you all know, we are actively preparing for the launch of our both drugs, obviously, pending approval from the FDA. We have already launched many disease awareness effects, including our disease awareness websites, which you have seen. We have initiated this KIDNEY CODE, which is helping us in identifying new patients, both on the CKD side for Alport syndrome and ADPKD. We have already deployed our medical affairs resources and performing a wide area of activities to support the launch. On the learnings from the JYNARQUE side, I think it has been very evident and clear that there is a big number of patients, right, off-label in the market. And obviously, based on the product profile, which we believe our product is -- will be much efficacious and safe. Once we have the clinical trial results readout, we will be able to capture a pretty significant market share out of that. Anything, Warren, you would like to add?
Colin Meyer -- Chief Medical Officer, Executive Vice President, Product Development
Yes. This is Colin. Just to, I guess, add to that. And so I think what the tolvaptan launch has taught us is that a drug that has modest efficacy, and it clearly works, but the treatment separation or analysis was 1.27 mL/min. And in the 1-year CARDINAL data, it's 4x larger. Tolvaptan has tolerability issues because of constant thirst and urination. And then there's a black-box warning for potential liver toxicity in the REMS Program. And so despite all of that, it's doing very well here in the U.S. And so we think that bardoxolone can be likely used without those tolerability issues. And the clinical trial data thus far shown us that it has been quite active and well tolerated. And so we think that, that bodes well for launch.
Warren Huff -- Chief Executive Officer
Yes, this is Warren. I'd just add, I think it just -- it's an exclamation point on how big the patient need is in these severe rare forms of CKD because the ADPKD patients are at high risk being on dialysis in their lifetime. That's different from many more common forms of CKD. And of course, this is also true for the Alport syndrome patients who are also at very high risk of being on dialysis in their lifetime. It tells you how much they desire a therapy.
Adam Walsh -- Stifel -- Analyst
Thanks very much.
Operator
Thank you. And our next question comes from the line of Joseph Schwartz with SVB Leerink. Your line is now open.
Joseph Schwartz -- SVB Leerink -- Analyst
Great, thanks so much. Congrats on all the progress. I was wondering sort of the follow-up on Adam's question. How prepared are you to adjust your clinical operations for CARDINAL or FALCON if we get a second wave that causes more disruption next year? Are you prepared to collect endpoint evaluations such as eGFR remotely, for example?
Colin Meyer -- Chief Medical Officer, Executive Vice President, Product Development
Yes. We're already doing that for CARDINAL. And so if the pandemic does not improve, we will be able to complete the trial. And as we stated today, we've had no meaningful impact on the integrity, the trial or data collection. And so we could continue with the home health visits, which allow for blood collection from home to assess eGFR, so efficacy as well as safety and direct shipment of drug supply to patients' homes. And so we've -- we don't anticipate at this point, any effect on CARDINAL.
And then for FALCON in ADPKD, we've employed the same measures for the patients already in the trial and don't anticipate any meaningful effect on the integrity of FALCON as well. For patients who are not yet enrolled, obviously, we're about to start reopening clinical trial sites. As I mentioned before, we'll be doing that at sites that are open for business and are able to see patients. If the pandemic gets worse, and we aren't able to do so, then we'll have to further adjust our operational strategy at countries that are impacted. But as I mentioned, right now, Japan has not been affected. Australia has not been affected in our CARDINAL trial. There are rural sides in the U.S. that have not been affected and are able to see patients. We even have patients in Spain and Germany recently who've been seen at their clinical trial sites. And so, I think we're going to be measured to make sure that we have the clinical trial sites, investigators, the site staff, the patients and their families and our employees in our best interest. But we do anticipate that we will be able to execute both trials.
Joseph Schwartz -- SVB Leerink -- Analyst
Okay. That's encouraging. And then I understand you won't comment on your regulatory interactions, but since there's so much investor interest around these NDA filings, I was wondering if you can give us some more insight into the bandwidth of your regulatory affairs team, such as how many people are working on these very important initiatives and how experienced are they and who is leading them? How are they being tasked and allocated by personnel, for example?
Warren Huff -- Chief Executive Officer
Yes, we have a significant in-house staff. I think it's about 15 or so people. Many of you may know that we recently added Andrea Loewen as our Head of Regulatory to our team. But for both programs, of course, there's substantial outside support to consulting groups and ex-FDA reviewers, who are very familiar with the divisions that we're working with. And so yeah, we're well staffed and resourced to do the job. Of course, we do have two filings that are running in parallel. But we believe that we're adequately resourced to advance them in the time frames that we've talked about.
Joseph Schwartz -- SVB Leerink -- Analyst
Great. Super helpful. Thanks for taking my questions.
Operator
Thank you. And our next question comes from the line of Brian Skorney with Baird. Your line is now open.
Jack Allen -- Robert W. Baird -- Analyst
Hi, thank you so much for taking that question. This is Jack dialling in for Brian. I just had two quick ones. Really exciting news about that KIDNEY CODE program. I was just wondering if you could give some more color as to how broadly the program has been rolled out and how many patients have been kind of enrolled in the program? And then I know you mentioned, I thought, three abstracts were being presented at the upcoming conference. I'm not sure if I caught too much about the third abstract, and I was wondering if you wanted to touch on that third abstract as well? Thank you so much.
Colin Meyer -- Chief Medical Officer, Executive Vice President, Product Development
Sure. So the program, as I mentioned, the KIDNEY CODE program, is U.S.-based, and I believe we've had patients from 48 states who've had their data submitted. I won't disclose the number of tests. But in the poster, I think we'll have a current cut of the data at the time when we finalize it. But it's been a really good uptake. It's not just investigators who we know most people, so we get the names of the physicians who order many of the tests. And most of them, we don't know. And so that it's not like it's just people involved in our clinical programs. Other investigators, once again, across the U.S. academic institutions as well as in private practice. And so I think because it's not just the Alport syndrome genes, we link the test to contemporary literature that has identified the most common causes of many forms of CKD. And as I was describing, if a patient has ADPKD, tolvaptan may be indicated. But if they don't have ADPKD, they should not be receiving tolvaptan.
We've had patients in KIDNEY CODE that were diagnosed as having Alport syndrome, and they were previously diagnosed as having ADPKD. And there's a list of misdiagnosed -- or misdiagnoses on the slide. And so we have patients who now are known to have Alport syndrome who had those diagnoses. And so I think because of that, it has been a broad interest in nephrology community. So we'll keep making updates over time but you should review our poster once it's publicly available. And the third, I'm actually blanking about what the third abstract is, but I can follow-up with you directly.
Jack Allen -- Robert W. Baird -- Analyst
Awesome. Thank you so much.
Operator
Thank you. [Operator Instructions] Our next question comes from the line of Matt Kaplan with Ladenburg Thalmann. Your line is now open.
Matt Kaplan -- Ladenburg Thalmann -- Analyst
Hi, good afternoon, guys. I wanted to follow up on Adam's question earlier on commercialization preparation. Can you tell us what your thinking is in terms of your -- what your commercial organization will look like when you're launching for Alport and FA, perhaps next year? And I guess, where are you in the build-out of it?
Warren Huff -- Chief Executive Officer
Manmeet, would you like to comment on that?
Manmeet Soni -- Chief Financial Officer
Sure. Sure, Warren. As you know, obviously, we are working on our customer targeting and segmentation, including sales force sizing, and territory alignment strategies, so that we can determine the optimal headcount and placement of the sales reps and the leadership team. We believe that very small efficient sales team will be deployed to reach and educate the identified nephrologists over here. And if you look at Alport syndrome, we expect that it could be in the range of 30 to 40 sales reps focusing on the nephrologists with current AS patients. And on top of that, I think we would also expect a pretty decent size of medical affairs team, who would be helping and educating on the disease awareness and disease -- early identification of the patients.
Matt Kaplan -- Ladenburg Thalmann -- Analyst
And a similar size in FA?
Manmeet Soni -- Chief Financial Officer
FA, we believe that will be even much more efficient sales team than Alport syndrome. We project on the FA side because, as you know, there are approximately 9 to 10 centers of excellence where you can find most of the patients and the patient population is 5,000 to 6,000 patients. We believe the sales team should be roughly consisting of around 15 to 20 sales reps, focusing on FA centers and selected MDA centers and some neurology practices, yes. But it will be -- again, as both are rare diseases, it will be a pretty efficient sales team.
Matt Kaplan -- Ladenburg Thalmann -- Analyst
Great. And then maybe a second question for you, Manmeet. You mentioned in your prepared remarks that the supply chain was intact to meet demand for your -- across all your programs. Can you comment on where you are in the preparation for the CMC sections of the NDAs in terms of stability batches, et cetera? And will those be affected at all by the COVID pandemic?
Manmeet Soni -- Chief Financial Officer
Sure. I could say that none of our operations, including both clinical or commercial supply readiness or validation batches have been impacted with -- due to COVID-19. So we are working on efficiently over there, but no impact as of now.
Matt Kaplan -- Ladenburg Thalmann -- Analyst
Great. Congrats on the progress and thanks for taking the question.
Manmeet Soni -- Chief Financial Officer
Sure. You are welcome.
Operator
Thank you. [Operator Instructions].
[Operator Closing Remarks]
Duration: 51 minutes
Call participants:
Vineet Jindal -- Vice President, Corporate Communications & Strategy.
Warren Huff -- Chief Executive Officer
Colin Meyer -- Chief Medical Officer, Executive Vice President, Product Development
Manmeet Soni -- Chief Financial Officer
Yigal Nochomovitz -- Citigroup -- Analyst
Maury Raycroft -- Jefferies -- Analyst
Adam Walsh -- Stifel -- Analyst
Joseph Schwartz -- SVB Leerink -- Analyst
Jack Allen -- Robert W. Baird -- Analyst
Matt Kaplan -- Ladenburg Thalmann -- Analyst
