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Reata Pharmaceuticals, Inc. (RETA) Q2 2019 Earnings Call Transcript

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Reata Pharmaceuticals, Inc.  (NASDAQ: RETA)
Q2 2019 Earnings Call
Aug. 08, 2019, 8:00 a.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good day, ladies and gentlemen, and welcome to Reata Pharmaceuticals' Second Quarter Financial Results and Update on Development Programs.

[Operator Instructions]

As a reminder, this conference is being recorded. An audio recording of today's webcast would be available shortly after the call today on Reata's website at reatapharma.com in the Investors section.

Before the Company proceeds with its remarks, please note the forward-looking statements 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, August 8th 2019, and may no longer be accurate at the time of any webcast, replay or transcript rereading.

I would now like to introduce your host, Vinny Jindal, Vice President of Strategy. You may begin.

Vineet Jindal -- Vice President, Strategy

Thank you. Hello, and welcome to Reata management's call to discuss our financial results for the second quarter of 2019 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; Chief Medical Officer, Colin Meyer; and Chief Financial Officer, Jason Wilson.

I'll now turn the call over to Warren.

Warren Huff -- Founding Chief Executive Officer and President

Thanks, Vinny. Good morning, everyone, and thank you for joining us on our quarterly call. I'd like to begin our call today by reviewing the significant progress the Reato team has made in advancing our development pipeline. Over the past few years, we've reported proof-of-concept data in eight different diseases and we've advanced four programs into registrational studies. We're poised to report data before the end of this year from two of these pivotal studies, the Cardinal Study in Alport syndrome, and the MOXIe Study in Friedreich's Ataxia. Preparations for regulatory submissions and commercial launch for these programs are well under way and the entire Reata team is working to create a seamless transition from a development stage to a commercial biopharmaceutical company.

As many of you know, we're studying bardoxolone in five rare forms of chronic kidney disease with an aggregate population of over 700,000 patients who have no or few effective therapies currently approved. Our lead program is the pivotal CARDINAL trial of bard in CKD caused by Alport Syndrome, which is fully enrolled with 157 patients.

As we announced in May, enrollment is now under way in FALCON, a pivotal study for bardoxolone in Autosomal Dominant Polycystic Kidney Disease or ADPKD. In addition to ADPKD, we reported positive data from our PHOENIX Study in patients with IgA neprhopathy, focal segmental glomerulosclerosis, and Type 1 diabetic CKD. And as we commented previously, we intend to pursue these indications commercially as well.

The Phase 3 portion of CARDINAL enrolled 157 patients across a range of ages and baseline kidney function that we believe represents the broad population of patients with progressive Alport syndrome. The FDA has provided us with guidance that an improvement in retained estimated glomerular filtration rate or eGFR versus placebo after one year of bard treatment may support accelerated approval in this indication and an improvement in retained eGFR versus placebo after two years of bard treatment may support full approval. We expect to announce top line one year efficacy and safety data from CARDINAL before the end of the year.

We recently modified the Statistical Analysis Plan, or SAP, for CARDINAL to benefit from what we learned from the FDA review of data from the REPRISE Study, which served as the basis for approval of Otsuka's tolvaptan for ADPKD. This was the first drug to gain FDA approval using retained eGFR as an endpoint. The REPRISE SAP assessed retained eGFR benefit using an analysis of covariance or the ANCOVA statistical method. To align with this FDA precedent, we incorporated the use of ANCOVA into the SAP for CARDINAL for the assessment of the retained eGFR benefit. Compared to the mixed effect model repeat measurement or MMRM method selected previously, the ANCOVA method allows for the inclusion of patients who discontinued early and this minimizes missing data.

With 157 patients enrolled, the study can detect the placebo corrected difference and change from baseline eGFR of approximately 2.5 milliliters per minute. Last year, we reported long-term results from the Phase 2 portion of CARDINAL demonstrating that patients treated daily with bardoxolone experienced an improvement in retained eGFR of approximately 4 milliliters per minute that was observed in patients that were actively declining by an average of over 4 milliliters per minute annually prior to the study.

Using these patients as their own control group, in our statistical modeling, we estimated the potential treatment effect is approximately 6 milliliters per minute to 8 milliliters per minute. As a result, we believe the study remains very conservatively powered for success.

In the second quarter, we announced the enrollment of the first patient in FALCON, a pivotal Phase 3 study of bardoxolone and ADPKD. Similar to CARDINAL, an improvement in retained eGFR benefit versus placebo after one year bard treatment may support accelerated approval and an improvement in retained eGFR benefit versus placebo after two years of bard treatment may support full approval.

We're actively opening new clinical trial sites and enrolling patients and we expect to provide guidance on timing for the completion of enrollment of the study in the near future.

In summary, our CKD development programs are making excellent progress and we're in active preparation for NDA submission and commercial launch in the event that the CARDINAL data are positive. We've conducted all pivotal pre-clinical toxicology studies and clinical pharmacology studies required for NDA submission. We're making significant investments in supply chain readiness. We've put our marketing, commercial operations and sales leadership in place and we've initiated a first disease awareness campaigns for Alport Syndrome.

Following Alport Syndrome, we believe that ADPKD represents a significant label expansion opportunity for bardoxolone in CKD because over 140,000 patients are currently diagnosed with the disease in the United States alone. Additionally, the AYAME study in diabetic CKD being conducted by Kyowa Kirin is expected to read out in the first half of 2022, adding meaningful safety and efficacy data for bardoxolone's clinical profile.

Turning to Omav , the pivotal part 2 of the MOXIe study in patients with Friedreich's ataxia, enrolled 103 patients across a range of ages and baseline mFARS scores that we believe represents the broad population of patients with Friedreich's ataxia.

The FDA has provided us with guidance that an analysis of the modified Friedreich's ataxia rating scale or mFARS scores demonstrating an improvement versus placebo after 48 weeks of Omav treatment may support an NDA submission for Omav for the treatment of FA. We expect to announce top line efficacy and safety data from this trial before the end of this year.

Pes cavus is a musculoskeletal foot deformity that interferes with patient's ability to perform assessments that require standing, walking or pedaling, including components of the mFARS exam like lower limb coordination and upright stability. Because these comprise two of the four components of the mFARS, patients with pes cavus ay be less likely to have a measurable response on the mFARS exam. For this reason, we limited the enrollment of patients with pes cavus in part 2 of MOXie and we stratified these patients between active drug and placebo based on pes cavus status.

The FDA recently published draft guidance titled 'Enhancing the Diversity of Clinical Trial Populations' that encourages sponsors to study broader participant groups as part of the secondary efficacy and safety analyses, even when the primary efficacy analysis population is narrowed. Consistent with the guidance, we've included a predictive enrichment strategy in part 2 of MOXIe. The primary analysis population has been narrowed to the 83 patients enrolled in part 2 of MOXIe without pes cavus. The minimum detectable placebo corrected difference in mFARS is approximately 1.3 points, assuming similar variability to that observed in part 1 of MOXIe.

You may recall that in part 1 of MOXIe, excluding the pes cavus patients,we observed a statistically significant improvement in mFARS scores of 4.4 points relative to placebo. Several secondary endpoints are also included in MOXIe to provide descriptive data that we hope will support approval of Omav if we hit the primary endpoint. Though the study is not powered to achieve statistical significance for any of these secondary endpoints, they may provide additional evidence that Omav has important activity in patients with FA, including the patients with pes cavus. The FDA has reviewed and provided guidance on our revised statistical analysis plan and the predictive enrichment strategy.

In summary, the MOXIe study is proceeding as expected, and we are in active preparation for NDA submission and commercial launch in the event that the data are positive. The few clinical pharmacology and non-clinical toxicology studies required for NDA submission are under way and are nearing completion. We're making significant investments in supply chain readiness. We've put our marketing, commercial operations and sales leadership in place, and we've initiated our first disease awareness campaigns for Friedreich's ataxia.

In addition to these three ongoing pivotal trials, we're currently enrolling a fourth pivotal study, the CATALYST trial of bardoxolone in patients with connective tissue disease-associated pulmonary arterial hypertension. Patients with CTDPAH generally have a worse prognosis than patients with other forms of PAH and despite treatment with vasodilator therapies, these patients have a five-year survival rate of only approximately 44%. Based on the results observed in our Phase 2 LARIAT trial and the design of the CATALYST trial, we're optimistic that bardoxolone has the potential to become the first therapy approved specifically for patients with CTDPAH. We expect top line data to be available in the first half of 2020.

I'll now turn the call over to Jason to provide a summary of our financials for the quarter.

Jason Wilson -- Chief Financial Officer and Executive Vice President, Strategy

Thanks, Warren. As noted earlier this morning, we reported financial results for the second quarter of 2019. Net loss for the quarter was $34.4 million or $1.14 per share compared to a net loss of $28.2 million or $1.08 per share for the same period last year. The increased net loss for the three-month period was driven by an increase in expenses, while revenue remained consistent. Higher expenses were driven primarily by an increase in research and development expenses due to clinical manufacturing and medical affairs activities and an increase in personnel expenses to support growth of our development activities.

The Company incurred total expenses of $41.5 million for the quarter, with research and development accounting for $29.6 million, and this compares to total expenses of $34.2 million for the same period last year when research and development was $23.4 million.

Our cash-based operating expenses, a non GAAP measure we define as total expenses, excluding stock-based compensation expense and depreciation expense, were $36.8 million for the quarter. This compares to $31.6 million for the same period last year. A reconciliation of this non-GAAP measure to total expenses can be found attached to the press release filing this morning. We expect our cash-based operating expenses will continue to increase in the future as we advance bard and Omav with their ongoing and future clinical trials, continue to scale manufacturing for registration and validation purposes, advance additional product candidates, and increase both R&D and administrative personnel, as we move forward and plan for commercialization for our product candidates.

At June 30th 2019, we had $280.4 million in cash and cash equivalents, and we expect our current cash to fund our operations through data readouts for CARDINAL, MOXIe, and CATALYST.

With that, I'll turn the call back over to Warren.

Warren Huff -- Founding Chief Executive Officer and President

Thanks, Jason. As our presentation today indicates, Reata has developed a significant late-stage pipeline, which will yield three pivotal data readouts over the coming year, including potentially registrational data from CARDINAL and MOXIe this year.

This concludes our prepared remarks, and I'd like to thank everyone who dialed in for listening. We'll now open the line up for questions.

Questions and Answers:

Operator

[Operator Instructions] And our first question comes from Maury Raycroft with Jefferies. Your line is open.

Maury Raycroft -- Jefferies -- Analyst

Hi, everyone, good morning, and thanks for taking my questions.

First question is just on the SAP changed to use ANCOVA. I'm just wondering if you can provide any specifics on our early discontinuation rates? Are you seeing any major differences from the control arm? And then any other context on what drove the statistical change?

Warren Huff -- Founding Chief Executive Officer and President

Sure, and so we haven't commented on the discontinuation rate in the trial. I will say that the primary analysis at week 48, we'll continue to use MMRM, and all available patients will be included in the analysis including those who discontinue early. For the ANCOVA analysis at week 52, obviously, as we've discussed multiple times, that is the registrational endpoint. The FDA will use to determine efficacy with bardoxolone and that was the endpoint that was used in REPRISE trial with tolvaptan. In that analysis, a benefit of that analysis is that it allows us to use all patients in the analysis and so drop-outs don't really affect the numbers. If patients discontinue early before the week 52 time point, if they have a week 4 value after they discontinue treatment, that value is used in the analysis and there is effectively a time adjustment to that particular patient's value, so it's a time-based covariate, and that was the methodology that was used with REPRISE analysis, and that is the major benefit, it allows those patients to be included IN the analysis. If the patient doesn't happen to have a week 4 value after they terminate study drug early, drug early, the values will be imputed using multiple imputation based on an assumption of missing at random and so therefore all available patients will be included in the analysis.

Maury Raycroft -- Jefferies -- Analyst

Got it. Thank you. And just a quick one on Friedreich's ataxia, for the trial adjustment there, just clarifying, is that revised plan finalized or is it still an ongoing discussion with FDA?

Warren Huff -- Founding Chief Executive Officer and President

It's finalized, we've submitted to FDA and we received minor comments --

Colin Meyer -- Chief Medical Officer and Executive Vice President, Product Development

-- back from the FDA, slightly turning up the calculation.

Maury Raycroft -- Jefferies -- Analyst

Got it. Okay. Quick question on ADPKD. I'm assuming you can't comment much on the enrollment that you're seeing so far, but I'm just wondering if you talk about the site rollout for the study. You currently have 82 sites listed on clinicaltrials.gov. Would you anticipate needing more or less sites based on what you're seeing?

Warren Huff -- Founding Chief Executive Officer and President

We obviously don't comment on ongoing enrollment for ongoing studies, but as I'm sure you can appreciate, it's much quicker to roll out sites in the US first and so when we announced the first enrollment that occurred in the US. And so all those sites are either active or being activated. The next sites typically are from Australia for this trial and then Europe and then Japan after that. And so it's ongoing.

Maury Raycroft -- Jefferies -- Analyst

Got it. Thank you. Thanks for taking my questions and I hope I can do.

Operator

Thank you. Our next question comes from Yigal Dov Nochomovitz with Citigroup. Your line is open.

Yigal Nochomovitz -- Citigroup -- Analyst

Hi, guys. Thank you very much for taking the questions. I just had a few clarifying questions on the powering. So I believe that previously the powering for CARDINAL was 2.2 and now if I understand correctly, with the switch to ANCOVA, it's now 2.5. Can you just confirm that or clarify?

Colin Meyer -- Chief Medical Officer and Executive Vice President, Product Development

Yes. We can clarify that or confirm that it is 2.5. It was 2.2. Can point out that, you know, in the Phase 2 data, we saw a pretty full -- pretty meaningful treatment effect. The increase above baseline half withdrawal was about 4.1 milliliters per minute. Those patients were progressing at a rate of 4.1. And so that estimated treatment effect based upon the Phase 2 data is 8.3. And so we view the change of 2.2 to 2.5 as very small and hopefully meaningless. We have a large margin, 3.3-fold margin, we believe, to detect significant P value.

Yigal Nochomovitz -- Citigroup -- Analyst

Okay, thanks. And just so I understand, when you say 2.5 milliliters per minute, is that the minimum delta that you need for significance or is that the the way the study is powered such that if you had a lower down below that you would still hit a P-value?

Colin Meyer -- Chief Medical Officer and Executive Vice President, Product Development

Depends upon the variability and so based upon the observed variability that we've seen in this trial and our large historical database of CKD trials, if we hit that assumed variability at 2.5, the P-value is under 0.05. If the variability happens to be lower, then we could detect a smaller difference. And by the way, if that, excuse me, if that very small delta would be frankly noise inside of the variability changes.

Yigal Nochomovitz -- Citigroup -- Analyst

Okay. And then are you making the same adjustments on this using ANCOVA week 52 for FALCON as well, or just CARDINAL?

Colin Meyer -- Chief Medical Officer and Executive Vice President, Product Development

Yes, yes, for FALCON as well. So there may be a very small difference with that minimal treatment, detectable effect of 1.6. And so we may decide to slightly boost up the sample size, but it should be very small in part because there are more patients being enrolled in FALCON.

Yigal Nochomovitz -- Citigroup -- Analyst

Okay. And then you, Warren, you referenced year-end -- before year-end '19 for both CARDINAL Friedreich's ataxia, so is it fair to assume that this is more likely now going to be a 4Q '19 event, as previously communicated it was second half?

Warren Huff -- Founding Chief Executive Officer and President

No, we're still not just -- we're not going to provide any additional guidance on timing other than what we've provided before, which is the second half of this year.

Yigal Nochomovitz -- Citigroup -- Analyst

Okay. All right. Understood. Thank you very much.

Operator

Thank you. Our next question comes from Adam Walsh with Stifel. Your line is open.

Neil -- Stifel -- Analyst

Good morning, guys, it's Neil on for Adam. Otsuka;s tolvaptan has seen success in the early stages of their launch, despite the difference in the size of patient population, can you talk about any read-through that you think this may have here to bard in Alport's should the CARDINAL ultimately read out positively and gain approval?

And then in ADPKD, specifically, do you have any initial thoughts on positioning bard versus tolvaptan? I know it's a larger patient population, but do you have any thoughts there, should the FALCON trial read out positively and bard gain approval in ADPKD as well? Thanks.

Warren Huff -- Founding Chief Executive Officer and President

Yes, we're obviously really encouraged by the response, you know, to the tolvaptan launch. I mean, I think it confirms the research that we had done, which suggests that patients with these diseases, these rare forms of CKD have an extremely high unmet need and are very willing to adopt a new therapy. They just haven't had anything available to them. We don't think that the ADPKD that tolvaptan will have an impact frankly on bardoxolone, and there's a very simple way to distinguish the two. Historically, in the other rare forms of CKD, we've produced clinical data showing that patients actually recover on average function, in the tolvaptan studies, both the placebo and active groups were meaningfully declining from baseline. And so I think that obviously will be a significant distinguishing factor. Said another way, because patients are still declining on tolvaptan and there's need for additional therapy.

Neil -- Stifel -- Analyst

Congratulations on the progress, guys. Thank you.

Operator

[Operator Instructions] And our next question comes from Charles Duncan with Cantor Fitzgerald. Your line is open.

Maria -- Cantor Fitzgerald -- Analyst

Hi, good morning, everybody. This is Maria on for Charles Duncan. Thank you for taking my question. As we all know, we're looking forward to the readouts for both MOXIe and CARDINAL in the second half of this year. Assuming they're both positive, could you please provide a little bit more color regarding next steps? I know you mentioned that commercial preparations are both under way for both MOXIe and CARDINAL, but maybe a little bit more granularity in terms of sales force size, you know, specific positions you're targeting early payor interactions and also an update on how the disease awareness campaigns for both are going? Thanks.

Warren Huff -- Founding Chief Executive Officer and President

Yeah, sure, there's obviously a lot of activity -- a lot of activity, because we could be moving forward with two novel products in two completely different disease areas, as you mentioned, both are in rare diseases with no approved therapy, with specialty physicians as the target population. So, we have significant work streams taking place in terms of ramping up our manufacturing, as I mentioned. You know, we've put our commercial leadership team in place. You all may know that's led by Dawn Bir. Her senior team is all in place and doing the sales force sizing and market development work that's necessary to position us for successful launch.

We've launched our initial disease awareness campaigns for both Alport Syndrome and Friedreich's ataxia. We've done preliminary sizing work for Alport Syndrome. It's obviously the nephrology, primarily the nephrology community. And I don't think we've given any estimates, but there's nothing unusual. It's, you know, specialty -- we targeted specialty in the United States. So a very reasonable size of sales force to address those positions. And we actually have a well worked out plan to have our regional leadership in place and available to scale, frankly, you know, for the demand after launch. This is similar in Friedreich's ataxia. So there are approximately a dozen key centers treating Friedreich's ataxia patients and virtually all of them are actually in the study. And then there's also a relatively small number, I think 20 to 30 additional centers that are focused almost exclusively on neuromuscular diseases. So it's a -- it's again, a very addressable target group for our commercial activities. We'd have, again, a very manageable sales force for launch. And so, yes, there's just a lot of activity now to prepare ourselves for a potential success in both studies.

Maria -- Cantor Fitzgerald -- Analyst

Sure. Thank you. And I have a quick question about MOXIe. Given the prior failures, and I'd say, it seems that you guys are taking a much more conservative approach with longer duration size and limiting the enrollment of pes cavus, and last time the placebo perhaps had difference in mFARS, I guess my question would be what type of result do you think will be clinically meaningful to drive patient interest? And also, are you guys measuring biomarkers in the secondary and what type? Thank you.

Colin Meyer -- Chief Medical Officer and Executive Vice President, Product Development

Sure, so we think that any significant difference is likely to be very clinically meaningful. As you may know, there's a national history registry that is led by Dave Lynch, the P.I. of our trial, sponsored by the main patient advocacy groups there. And they've demonstrated in this registry that's enrolled over 2,000 people and followed them for up to 10 years that the annual rate of progression is 1 point to 2 points. And so that may seem like a small number, but that's just the scale that's used. And so if we see a significant difference at the minimum detectable difference of 1.3, that would be one year's difference in the rate of progression. And so we think that would be very clinically meaningful. As you know, there are no approved therapies for these patients, they're unfortunately on a predefined course to significant disability and premature death. And so we think there would be a high demand for the drug if FDA deems it to be efficacious and safe. We're conducting a battery of secondary endpoints. The key second secondary endpoint is the patient global impression of change. It's simply a question to the patient if they're doing better than they think they were when they started the trial. There are seven gradations.

And so in the middle, no change, and 3 for improvement, and 3 for worsening. And so it's important endpoint in the trial to generally understand if the patients think they're doing better. There's also a clinical global impression of change and then a series of other endpoints, including nine-hole peg test, false diary, activities of daily living, passing a five-foot walk test, and a few others. Importantly, the trial's power to show a difference in the modified [Indecipherable] test. The trial is not powered to show significant difference in the secondary endpoints. We hope that we see a lean in several of these to support the change the mFARS, but we think that the overall data should obviously tell us if the drug is working and we believe that if it's mFARS is significant and we would proceed to discussions with FDA and hopeful NDA submission.

Maria -- Cantor Fitzgerald -- Analyst

Thank you for taking the questions.

Operator

Thank you. And we have a follow-up from Yigal Nochomovitz with Citigroup. Your line is open.

Yigal Nochomovitz -- Citigroup -- Analyst

Thanks. I was just wondering, on FALCON, the old powering was [Indecipherable] benefit. Given the change on the stats plan, what is the new number? Or is there any number?

Colin Meyer -- Chief Medical Officer and Executive Vice President, Product Development

There isn't a new number yet, it might be modestly higher. If we keep the sample size to 300, but we may increase the sample size slightly to make up for that small difference. But obviously with the CARDINAL trial, we have enrolled 157 patients, the difference goes from 2.2 to 2.5. So 0.3. We've enrolled -- we plan to enroll double the patients approximately with FALCON. So we think that that delta would likely be smaller and much less and probably if we wanted to, I'm sure we can easily bridge it with a small increase in the sample size.

Yigal Nochomovitz -- Citigroup -- Analyst

Got it. Okay. And then, Colin, just going back to the basic science. I know that there were some experimental work that you were working -- one of your collaborators was working on with the multi-photon imaging to explore vascular flow with bardoxolone at the single nephron level. Where does that work stand and do you have any updates there?

Colin Meyer -- Chief Medical Officer and Executive Vice President, Product Development

So, yeah, as you may recall, that physician investigator, Prof. Kashihara is the President of the Japanese Society of Nephrology, and per our Kirin colleagues, the most important nephrologist in Japan, he published data in circulation a prominent journal a few months ago, demonstrating that the mechanism of acute reduction in GFR with empagliflozin, an SGLT2 inhibitor reduction in diameter of the blood vessel going into glomerulus, and so just to remind you, all the work that he's doing with bardoxolone similar to that work he's able to in living animals, so not some contrived artificial system Image the glomeruli, he is able to determine if there's any change to the diameter of the blood vessel going in and out, he's able to measure blood pressure to determine if there is any change in pressure or to potentially rule out hyperfiltration, he's able to measure the size of the glomerulus, as well as the permeability of the glomerulus to protein as well as dextrans and so this work has been ongoing and will be presented at a official medical meeting. And we think it will be very enlightening and put to rest any question about the mechanism of acute increase in GFR with bardoxolone.

Yigal Nochomovitz -- Citigroup -- Analyst

Got it. Thank you.

Operator

[Operator Closing Remarks]

Duration: 33 minutes

Call participants:

Vineet Jindal -- Vice President, Strategy

Warren Huff -- Founding Chief Executive Officer and President

Jason Wilson -- Chief Financial Officer and Executive Vice President, Strategy

Maury Raycroft -- Jefferies -- Analyst

Colin Meyer -- Chief Medical Officer and Executive Vice President, Product Development

Yigal Nochomovitz -- Citigroup -- Analyst

Neil -- Stifel -- Analyst

Maria -- Cantor Fitzgerald -- Analyst

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