Reata Pharmaceuticals, Inc. (NASDAQ:RETA) Q1 2023 Earnings Call Transcript

Reata Pharmaceuticals, Inc. (NASDAQ:RETA) Q1 2023 Earnings Call Transcript May 11, 2023

Operator: Thank you for standing by, and welcome to the Reata Pharmaceuticals First Quarter Financial Results Update on Operational Progress and Development Programs Conference Call. An audio recording of today’s webcast will be available shortly after the call in the Investor section of Reata’s website at reatapharma.com. Before the Company proceeds with its remarks, please note the forward-looking statements disclosure in the Company’s press release. 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 apply only as of today, May 10, 2023, 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] We are joined today by Warren Huff, Reata’s Chief Executive Officer; Manmeet Soni, President; Colin Meyer, Chief Innovation Officer; Dawn Bir, Chief Commercial Officer; Seemi Khan, Chief Medical Officer; and Andrea Loewen, Senior Vice President, Regulatory Affairs. At this time, I would like to turn the call over to Warren Huff.

Warren Huff: Good morning, everyone. We thank you for joining us today. I’ll begin on Slide 4. On February the 28th, we announced that the FDA approved SKYCLARYS as the first and only FDA approved drug indicated for the treatment of Friedreich’s ataxia or FA, an adults and adolescents aged 16 years and older. As Dawn Bir will share later in the call, our experienced and fully trained teams began engaging customers immediately following approval. We are pleased to share that we have seen strong initial demand for SKYCLARYS from patients and their healthcare providers. We’ve received approximately 500 patient start forms through early May. The patient start forms were submitted by over 250 prescribing physicians, including neurologists, primary care physicians, and other healthcare providers providing a broad initial prescriber base.

We’ve been working diligently to ensure we can get drug to the market as quickly as possible. We’ve completed the final stages of SKYCLARYS drug product manufacturing and packaging. As we shared on the approval call in February, we observed a process-related drug substance impurity above the reporting threshold, which required us to update the drug substance specification prior to releasing final product. We are working collaboratively with the FDA to obtain an approval of the revised drug substance specification for the process impurity as quickly as possible. We now anticipate SKYCLARYS commercial drug availability to be available no later than mid-August. Andrea Loewen, our SVP of Regulatory Affairs, will provide an update on this process.

We understand that in some patients, symptoms of FA manifest early in life and SKYCLARYS is not currently indicated for patients younger than 16 years of age. Addressing this is a top priority for us and we are evaluating strategies to support label expansion for pediatric patients younger than 16 years of age. We are planning to request a meeting this quarter with the FDA to discuss our possible strategies. We are also planning to initiate a study to evaluate the safety, tolerability and pharmacokinetics of Omaveloxolone or Omav in pediatric patients in the fourth quarter of this year. Seemi will provide additional details on our plans later in the call. Next slide. We submitted a marketing authorization application for Omav for patients with FA in Europe in the fourth quarter of last year and the application is currently under review.

We recently received the day 120 list of questions and, as Andrea will outline later, we believe that we can adequately respond to the questions that have been raised. We are on track to provide the responses in the third quarter of this year. Beyond Omav, we continue to pursue development of our Nrf2 activator platform and are advancing additional preclinical drug candidates. As Colin will discuss, we anticipate IND filings for two additional molecules in 2024. Moving to our Hsp90 program, we are developing RTA 901 for patients with diabetic peripheral neuropathic pain or DPNP. We finalized the design for a randomized, double-blind, placebo controlled two part 12-week Phase 2 trial of RTA 901 in patients with DPNP and plan to initiate that study during the third quarter of this year.

Next slide. Earlier today, Kyowa Kirin reported results from AYAME, Kirin’s Phase 3 trial of bardoxolone in patients with diabetic kidney disease. As Colin will discuss, the study met the primary and key secondary endpoints and there were no significant safety issues identified in patients receiving bardoxolone. However, there was no separation in end-stage renal disease or ESRD events between the active drug and placebo groups after three years of treatment. Because there was no improvement in ESRD events and the regulatory implications of that, we and KKC have decided to discontinue our bardoxolone development activities and we’ve decided to refocus our capital and resources on our other programs. Lastly, we are pleased to announce this morning, a new non-dilutive $275 million debt facility, with funds managed by Pharmakon Advisors.

As Manmeet will discuss, this new facility extends our cash runway to the end of 2026. And with the commercial launch of SKYCLARYS, puts us on a path to self sustainability. With that summary, I’d now like to turn the call over to Dawn Bir, who will provide an update on our commercial launch for SKYCLARYS.

Dawn Bir: Thank you, Warren. Good morning. I’ll continue on Slide 8. Friedreich’s ataxia represents a significant commercial opportunity and we believe that there are approximately 6,000 patients in the United States living with FA today. Through ICD-10 claims data analyses, we see approximately 5,000 unique diagnosed FA patients that can be linked to healthcare providers, excluding approximately 10% of those diagnosed under the age of 18, the remaining 4,500 or approximately 90% represent our total on-label addressable market. Most patients seek routine care by their local neurologist or primary care physician. Important commercial launch targets include CCRN centers or collaborative clinical research network sites, ataxia centers and HCP is currently treating FA patients.

Through the evaluation of claims data, we’ve identified approximately 2,500 healthcare target providers treating patients with Friedreich’s ataxia. These HCPs and the diagnosed FA patients they treat are the primary focus of our commercial launch efforts this year. Next slide, please. Patients and healthcare providers have long awaited and approved treatment for Friedreich’s ataxia. And this is evident through the demand we see for SKYCLARYS in only two months following approval. Reata REACH is our single point of contact for our patient services program and serves as the intake center for all SKYCLARYS patient start forms. Start forms received by REACH are an early indicator of our launch progress. Through early May, we’ve received approximately 500 SKYCLARYS patient start forms submitted by over 250 prescribing physicians, including neurologists, PCPs and other healthcare providers.

500 FA patients represents over 10% of our current total addressable market. We are pleased with this quick uptake, which reflects strong demand. Patients are actively seeking treatment and healthcare providers are willing to prescribe SKYCLARYS. Next slide. Our 2023 launch objective remains unchanged. Our goal is simple to establish SKYCLARYS as the first and only effective and safe treatment approved for Friedreich’s ataxia. Our commercial launch activities engage our three important stakeholders. This includes HCPs currently treating Friedreich’s ataxia with patients in their practice today, on-label patients diagnosed with FA and the payer community. With our attention on physicians currently treating patients with FA, we continue to communicate the value of SKYCLARYS, the significance of our clinical data, and how this data translates to a clinically meaningful impact on the disease.

Additionally, we are working to ensure all HCPs understand how to access SKYCLARYS for their patients and the programs we offer to support utilization. FA patients and their caregivers are also important stakeholders because SKYCLARYS is the first and only drug approved for Friedreich’s ataxia. We continue to inform and educate patients and their families on this approval, and we encourage them to see their healthcare provider for treatment. To support these educational efforts, we recently launched our branded patient and HCP campaigns, highlighting the recent approval and communicating that Friedreich’s ataxia previously untreatable is now a treatable disease. Immediately following approval, Reata created a strong market presence and engaged the FA community with our first branded booth at important Neurology Conferences, including the Muscular Dystrophy Association, the National Ataxia Foundation and the American Academy of Neurology.

Now approved digital, social, paid search and patient webcast were launched in March and April to drive the awareness of SKYCLARYS and provide clarity on how to access treatment. Lastly, critical to our launch success and quarter, our patient promise, we continue to facilitate payer coverage, access and affordability through payer education and robust programs designed to minimize or eliminate patient out-of-pocket cost burden. Continuing on Slide number 11. Reata’s field sales and market access teams are executing on our branded launch strategy, working to drive demand and facilitate payer coverage. Our experienced and fully trained teams began engaging customers immediately following approval on Monday, March 6. The sales organization is working to reach and educate approximately 2,500 healthcare providers, who treat most of the diagnosed FA patients in the United States.

They have also engaged FA treatment centers driving early utilization at each of the nine U.S. Centers of Excellence and implementing plans to support the needs of these highly important accounts. Our field access team consists of national account directors focused on SKYCLARYS coverage by top national and regional payers, and a patient access liaison team, hired to educate practices on access requirements. Together, this team’s primary responsibility is to facilitate patient access to the drug by working to minimize and navigate payer criteria. Since FDA approval of SKYCLARYS, the payer team has engaged all of the top U.S. payers representing 90% of covered lives. We anticipate that most commercial payer policies will be established during the second half of 2023 and that plans will place SKYCLARYS on their specialty tier along with most rare specialty therapeutics.

Our patient access liaison team has worked with local practices to educate on access requirements and facilitate rapid payer approvals through medical exception and prior authorization while awaiting payer policies. We are pleased with early payer coverage of SKYCLARYS tracking as we expected for a rare, progressive and devastating disease with no other approved treatment options. I will now turn the call over to Andrea Loewen, our Senior VP and Head of Global Regulatory Affairs, for the regulatory update on drug availability and Omaveloxolone MAA status.

Andrea Loewen: Thank you, Dawn. I’ll continue on Slide 13 to provide an update on SKYCLARYS availability. We are working collaboratively with the FDA to revise the drug substance impurity specification that is required for SKYCLARYS distribution to the market. We submitted a supplement to the NDA, which is being reviewed as a prior approval supplement referred to as a PAS or PAS, under expedited priority review. As a PAS, FDA approval is needed before we can release finished our product to the commercial market and not within 30 days after submission as previously guided with respect to the CB-30 prior to its conversion by the FDA to a PAS. While the FDA’s approval target action date is in mid-August, for standard review timelines, the FDA stated that its review of the PAS is prioritized and approval should come before the goal date.

The approval and its timing are, of course, subject to FDA’s review of the supplement provided. There were no major deficiencies in the content of this mission, which we expect to know by mid-June. We believe that the information provided in the NDA supplement is sufficient to support the proposed updated specification limit for the process impurity. We developed the submission content based on FDA and International Harmonized Regulatory Guidance as well as FDA’s internal review procedures and engaged with multiple experts to confirm the adequacy of the information to support the change. Next slide. For more context, the FDA reviews each impurity limit on a case by case basis to determine its impact on product safety and known product characteristics.

FDA guidance documents outline key elements required for this determination, which we believe we have provided. For example, safety is of utmost importance. The limit for the proposed process impurity was set at the qualification threshold, which, per guidance, should not require toxicology qualification testing based upon the known characteristics of the identified impurity and patient dosages. While not specifically required, we conducted multiple evaluations, including gene toxicology studies and In Silico Structural Analysis, which demonstrate no mutagenic potential. We’ve also been able to identify the impurity and its structure and it’s highly detectable with our validated analytical method. Further, there is no meaningful impact on the total impurities and there are no observed changes to any other properties of the drug substance.

We believe we have provided a complete package to the FDA and anticipate that SKYCLARYS will be available to our specialty pharmacy no later than mid-August 2023. Next slide. I would now like to share an update on our ongoing marketing authorization application in Europe. As you know, we submitted the MAA in the last quarter of 2022. We recently received the European Medicine Agency’s day 120 list of questions, which is the primary mechanism for questions and responses to be exchanged during the MAA review. The EMA separates their questions into major and other categories. We are pleased that we should be able to provide thorough responses and requested information back to the EMA within a standard response period. With respect to major questions on clinical efficacy, the EMA invited us to discuss the robustness of the totality of efficacy results and suggested that the discussion could include the impact of imbalances in baseline characteristics on the pivotal study results and extrapolation of these results to patients with advanced disease and patient groups not included in the pivotal trial.

If you recall, in the pivotal Omav trial imbalances in baseline characteristics, such as history of cardiomyopathy and longer GAA1 Repeat Length, favored placebo patients with less sick and had less advanced disease. Since the imbalance favored placebo, the statistically significant results of the primary analysis favoring Omav treatment despite these imbalances indicate a robust efficacy outcome. The EMA also asked us to justify inclusion of [indiscernible] in the proposed labeled indication. With respect to major questions on clinical safety, the EMA asked us to discuss the similarities between Nrf2 activators with respect to chemical structure and safety and to discuss suitable contraindications and warnings in the label for cardiac, renal, diabetic and other conditions, taking into account the population studied.

We believe that the recent bardoxolone AYAME safety data in Japanese patients with diabetic CKD will be very helpful to address potential bardoxolone and Nrf2 carryover safety questions for Omav. These data will also be helpful to discuss suitable warnings and precautions, which the EMA asked us to discuss in relation to the summary of product characteristics, which is the EU label. With respect to major questions regarding drug product quality, the EMA requested us to provide additional clarification regarding the potential for neuroinflammation and to provide further information and justification for our active substance control strategies. A GMP certificate is also required for the quality control side used to provide microbiological testing of the drug product.

Again, we believe that we can provide the EMA with required responses for the questions and are on track to do so in the third quarter of this year. I will now turn the call over to Seemi.

Seemi Khan: Thanks, Andrea. Label expansion to pediatric patients with FA is of prime importance to us. As Warren mentioned, we have been evaluating various strategies to support the expansion of the Omaveloxolone label for pediatric patients younger than 16 years of age. Last year in Europe, we received a positive opinion from pediatric committee on a proposed pediatric investigation plan. And as agreed in this plan, we have submitted a request for scientific advice for additional input on the design of a clinical study in pediatric patients between two and 16 years of age. With respect to the U.S., we are completing briefing documents to submit this quarter to the FDA with a request for a meeting to discuss label expansion for younger pediatric patients who are not included in the approved SKYCLARYS label.

We are also finalizing a protocol for a pediatrics study of Omaveloxolone to evaluate the safety, tolerability and pharmacokinetics of a single ascending dose of Omaveloxolone in pediatric patients between two and 16 years of age. We expect to submit this study protocol to the FDA this quarter and plan to initiate this study in the fourth quarter of 2023. Based on feedback from the EMA and FDA, we will determine what additional pediatric studies will be required. With that, I will now turn the call over to Colin.

Colin Meyer: Thank you, Seemi. Moving to Slide 19. Mitochondrial dysfunction, neuroinflammation and neurodegeneration are common features across a range of neurological diseases. While mitochondrial dysfunction may not be the initiating event, it appears to be a common downstream pathway that results in subsequent loss of function and regeneration in areas that are affected. This specific area of the brain that is affected results in the clinical symptomology, whether it be movement, balance or memory disturbances. Genetic and pharmacologic activation of Nrf2 have demonstrated activity in multiple preclinical models that demonstrate effects a mitochondrial function, neuroinflammation, neurodegeneration and fibrosis, movement and coordination, memory and survival.

Perhaps more importantly recent evidence from genetic studies in people have linked Nrf2 to susceptibility and/or progression of several diseases, including movement disorders and Alzheimer’s disease. Next slide. We have advanced two next-generation Nrf2 activators, RTA 145 and RTA 417 to IND-directed studies based on our extensive in-house library of over 800 molecules and understanding of the structure activity relationship. The non-clinical profiles support advancement to clinical studies. We have shown broad activity and systemic and CNS models of inflammation, autoimmune disease and neurodegeneration with appropriate ADME/PK properties. Our dose ranging toxicology studies demonstrate an expected profile based on our knowledge of the class and our late-stage IND-directed studies are underway or planned.

We anticipate IND filings for both molecules in 2024. Next slide. Cemdomespib also known as RTA 901 is a highly potent and selective, oral, small-molecule modulator of Hsp90. It is differentiated from m N-terminal Hsp90 inhibitors and that it binds at the C-terminus and promotes mitochondrial function. It affects mitochondrial function by promoting proper protein folding and reducing ROS-mediated inflammatory signaling. The drug is active in preclinical models of painful and insensate diabetic neuropathy. It is differentiated from other molecules and that it not only reduces pain, but it also restores sensation and models associated with loss of sensation. Diabetic neuropathy is a serious complication of diabetes associated with substantial morbidity.

Approximately, 4 million patients in the U.S. are affected with moderate or severe DPNP. Phase 1 studies in healthy volunteers are complete and demonstrate an acceptable profile. Cemdomespib was well tolerated with no safety signals, drug discontinuations or SAEs. Moving to Slide 22. The Phase 2 trial that we are initiating is a randomized, double-blind, placebo controlled two-part, 12-week Phase 2 trial of Cemdomespib in patients with DPNP. The objective is to assess pain using the numeric pain rating scale or NPRS. We plan to enroll 192 patients randomized evenly across three arms in each part for a total of 384 patients. Patients are allowed to take up to one standard of care medication. In order for patients to enroll, they must not have achieved adequate pain control upon entry with a NPRS pain intensity score of at least 4 on a 0 to 10-point scale at screening.

We will conduct an Exposure Response Analysis using Part 1 data to select doses for Part 2. The primary endpoint is the change in average pain intensity assessed by NPRS at week 12. We plan to dose patients in the third quarter of this year. Moving to our CKD programs and as shown on Slide 24, the AYAME trial was conducted to determine if eGFR improvements observed with bardoxolone could translate to reductions in ESRD. AYAME was a Phase 3, randomized, double-blind, placebo controlled trial in diabetic kidney disease patients conducted in Japan. Patients who had advanced CKD defined by eGFR values between 15 to 59 mill per minute were allowed to enroll. The minimum treatment duration was three years and the maximum was four years. Upon completion of treatment, patients then participated in a 16-week observational period.

The primary endpoint was time to onset of confirmed 30% decrease in eGFR from baseline or adjudicated ESRD. In an important secondary event was timed to ESRD, even though the trial was not powered for this endpoint. Next slide. As Warren mentioned, the primary and key secondary composite endpoints of AYAME demonstrated statistical significance favoring Bardoxolone. These endpoints were driven by reductions in eGFR decline events. However, no separation in ESRD events was observed. This result appears to be explained by initial eGFR increases that were not maintained in patients who reached ESRD. In regard to the impact of AYAME on our CKD programs, a major challenge for bardoxolone CK development program has been the use of eGFR as a surrogate that is intended to predict ESRD.

The AYAME data show a disconnect in that eGFR improvements were observed, but they were not associated with reduced ESRD events. This poses a significant regulatory challenge. As a consequence, we and KKC are terminating our CKD programs. We will be communicating these plans with regulators and our clinical trial sites immediately. Next slide. Despite the disappointing outcome of our CKD program, the safety data from AYAME provide important data for the broader Nrf2 activator class. From a safety perspective, there was no evidence of adverse renal safety, including hyper filtration or other adverse findings. There was also no evidence of adverse cardiovascular safety with no imbalances in deaths, adjudicated cardiovascular events or SAEs, fluid overload events or blood pressure.

There was also no evidence of drug-induced liver injury and the AE profile was consistent with the established safety profile. I’ll now turn the presentation over to Manmeet.

Manmeet Soni: Thanks, Colin. Good morning, everyone. Today, I will provide an update on the following key topics. First, operational progress on the SKYCLARYS manufacturing; second, European commercial readiness activities; third, amendment on the Blackstone equipment; fourth, brief update on the $275 million non-diluted financing; and finally, first quarter 2023 financial update, including our updated cash guidance, which provides funding through the end of 2026 and allows the path to self sustainability. I will continue on Slide 28 to provide update on SKYCLARYS manufacturing activities. As Andrea mentioned earlier, subject to regulatory approval, we anticipate SKYCLARYS bottles to be available through our specialty pharmacy for shipment to patients during August of 2023 or earlier.

From an operation standpoint, we have completed manufacturing and packaging of SKYCLARYS capsules. To remind everyone, in 2019, we reacquired ex-U.S. rights for Omav from AbbVie. Accordingly, we currently own the global commercial rights for Omav. In line with our plans to prepare for the potential label expansion in U.S. and global expansion opportunity for Omav, we have ramped up our production for re-supply of SKYCLARYS commercial drug supply. Next slide. Following the submission of our MAA for Omav in Europe last year, we accelerated our build out of our European infrastructure outside the U. S. We have hired an European leadership team overseeing commercial, marketing, market access, medical affairs and supply chain activities in anticipation of Omav launch in the European countries.

Further, we initiated marketing activities, global value messaging and health technology assessment work screens for European countries. We have selected a third-party logistics or 3PL partner or product distribution in the Europe. If approved in Europe, we will be prepared for our European commercial launch for Omav during the second quarter of 2024. Next slide. As we announced this morning, based on the results of AYAME and our decision to discontinue development of our Bard CKD programs, we have amended our development and commercialization funding agreement with Blackstone. Under the terms of the amended agreement, Blackstone has removed all obligations for Bard development and commercialization, removed all restrictions on any new debt and released all prior security interest.

Additionally, we have granted a low single-digit royalty on worldwide net sales of Omav for Friedreich’s ataxia. Our total royalty obligation on Omav, including our academic institutions, Blackstone and AbbVie, will be in the range of 5.5% to 7.5% of net product revenues based on the tiered product revenues. While we are disappointed with AYAME results, our decision to discontinue by bardoxolone development and enter into the amended agreement with Blackstone allows us to refocus our resources and over $100 million in capital towards our future pipeline and programs that were previously planned for CKD development. Next slide. This morning, we also announced a $275 million debt facility with funds managed by Pharmakon Advisors, LP. The aggregate $275 million in new non-dilutive funding will be advanced in four tranches.

The first tranche of $75 million will be funded this week. This new non-dilutive debt facility of $275 million bolsters our strong balance sheet, which will enable us to extend our cash runway through the end of 2026. Along with the savings from the firms previously planned for Bard development and our anticipated SKYCLARYS revenues, we believe that we are on a path to sell sustainability. I would also like to remind you that with the approval of SKYCLARYS, the FDA granted us a rare pediatric disease priority review voucher and we have the option to do nonverbal financing by monetizing this voucher in the future. Next slide. We announced our financials and filed our 10-Q earlier this morning. I would like to highlight a few financial items this quarter, including our strong cash position and our operating expenses.

Let me start with our cash balance. As of march 31, 2023, we maintained a solid balance sheet with approximately $321 million in cash, cash equivalents and marketable debt securities. I would like to remind everyone the above $321 million as of March end excludes the $275 million debt financing announced this morning. And based on our current operational plan with the anticipated commercial launch of SKYCLARYS and our cash balance will enable us to fund operations through the end of 2026. We expect that this debt funding may allow us to reach the path of self sustainability barring any new pipeline expansion or in-licensing activity. Moving to the first quarter of 2023 financial update. R&D expenses increased by $15.7 million for the three months ended March 31, 2023, as compared to the three months ended March 31, 2022.

This increases due to an increase in certain ongoing clinical study cost and in stock-based compensation due to the vesting of certain performance-based equity grants upon FDA approval of SKYCLARYS. SG&A expenses increased by $30 million for the three months ended March 31, 2023, compared to three months ended March 31, 2022. This increase was primarily due to increased commercial activities and increase in stock-based compensation due to vesting of certain performance-based equity grants upon FDA approval of SKYCLARYS. On next slide, we have a reconciliation of GAAP to non-GAAP financial measures for the first quarter of 2023 compared to the first quarter of 2022. Non-GAAP R&D expenses increased by $9 million for the three months ended March 2023 compared to three months ended March 2022.

This increases due to certain ongoing clinical study cost. An ongoing SG&A expenses increased by $14.1 million as compared to the three months ended March 2022. This increase is due to an increase in commercial activities for SKYCLARYS. With that, I will turn the call back over to Warren.

Warren Huff: Thank you, Manmeet. In closing, we are pleased with the approval of SKYCLARYS, the first and only drug to treat patients with FA. We are encouraged by the significant interest from patients and healthcare providers to begin SKYCLARYS treatment and are working to have commercial drug in the channel as expedition as possible. Further, we’re cooperating with the EMA and their review of our marketing application seeking approval for Omav in Europe. Of course, we’re disappointed with the results of the AYAME study and the need discontinued development of bardoxolone for the treatment of patients with CKD. We put a lot of effort over the years in an attempt to produce a novel drug with a very meaningful clinical benefit to patients with CKD, who have seen little progress in the treatment of their disease.

But the AYAME data made the decision straightforward and it permits us to focus our resources and future development on our neurology programs. The Pharmakon debt facility of $275 million bolsters our strong balance sheet, which will enable us to extend our cash run rate through the end of 2026. Along with the savings from the funds planned for bardoxolone development and our anticipated SKYCLARYS revenues, we believe that we’re on a path to self sustainability. These resources will permit us to relentlessly pursue our mission to bring life-changing medicine to patients with severe diseases. That concludes our prepared remarks. We’d like to thank everyone who dialed in. And I’ll now turn the call over to the operator for questions.

Q&A Session

Operator: Thank you. Ladies and gentlemen, at this time, we will begin the question-and-answer session. [Operator Instructions] Our first question today comes from Yigal Nochomovitz with Citi. Please go ahead.

Operator: Our next question comes from Madhu Kumar with Goldman Sachs. Please go ahead. Your line is open.

Operator: The next question comes from Yatin Suneja with Guggenheim. Yatin, please go ahead.

Operator: Our next question comes from Charles Duncan with Cantor Fitzgerald. Please go ahead, Charles. Your line is open.

Operator: Our next question comes from Carter Gould with Barclays. Carter, please go ahead.

Operator: Our next question comes from Annabel Samimy with Stifel. Annabel, please go ahead.

Operator: Our next question comes from Maury Raycroft with Jefferies. Maury, please go ahead.

Operator: Our next question comes from Brian Skorney with Baird. Brian, please go ahead.

Operator: Our next question comes from Matt Kaplan with Ladenburg. Please go ahead, Matt.

Operator: Thank you. Those are all the questions we have time for today. Again, thanks for your participation on today’s conference call. As a reminder, an audio recording of the call will be available shortly after the call on Reata’s website at reatapharma.com in the Investors section. Thank you very much for your participation. You may now disconnect.