# EDGAR Filing Document

**Accession Number:** 0001358762
**File Stem:** 0000950170-23-005219
**Filing Date:** 2023-2
**Character Count:** 85295
**Document Hash:** a5d8e335e1bf0edce64e74878deebf95
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0000950170-23-005219.hdr.sgml**: 20230228

**ACCESSION NUMBER**: 0000950170-23-005219

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 51

**CONFORMED PERIOD OF REPORT**: 20230228

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230228

**DATE AS OF CHANGE**: 20230228

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** REATA PHARMACEUTICALS INC
- **CENTRAL INDEX KEY:** 0001358762
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **IRS NUMBER:** 113651945
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-37785
- **FILM NUMBER:** 23687592

**BUSINESS ADDRESS:**
- **STREET 1:** 5320 LEGACY DRIVE
- **CITY:** PLANO
- **STATE:** TX
- **ZIP:** 75024
- **BUSINESS PHONE:** 972-865-2219

**MAIL ADDRESS:**
- **STREET 1:** 5320 LEGACY DRIVE
- **CITY:** PLANO
- **STATE:** TX
- **ZIP:** 75024

?xml version="1.0" encoding="ASCII"? 8-K

**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**WASHINGTON, D.C. 20549** 

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**FORM** 8-K

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**CURRENT REPORT** 

**Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934** 

**Date of Report (Date of earliest event reported):** February 28, 2023

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Reata Pharmaceuticals, Inc.

**(Exact name of Registrant as Specified in Its Charter)** 

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| | | |
|:---|:---|:---|
| Delaware | 001-37785 | 11-3651945 |
| **(State or Other Jurisdiction**<br>**of Incorporation)** | **(Commission File Number)** | **(IRS Employer**<br>**Identification No.)** |

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5320 Legacy Drive

Plano**,** TX 75024

(Address of Principal executive offices, including zip code)

**(**972**)** 865-2219

(Registrant's telephone number, including area code)

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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) 

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) 

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) 

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) 

Securities registered pursuant to Section 12(b) of the Securities Exchange Act of 1934:

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| | | |
|:---|:---|:---|
| **Title of each class** | **Trading**<br>**Symbol(s)** | **Name of each exchange on which registered** |
| Class A Common Stock, Par Value $0.001 Per Share | RETA | Nasdaq Global Market |

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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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**Item 7.01. Regulation FD Disclosure.**

The Company announced the marketing approval of SKYCLARYS (omaveloxolone) by the FDA for the treatment of patients with Friedreich's ataxia. The script, that will be utilized during the management call to discuss the approval and which is scheduled for 5:00 pm ET today, February 28, 2023, is attached as Exhibit 99.1 and incorporated herein by reference.

In accordance with General Instruction B.2 of Form 8-K, the information set forth under Item 7.01 and in Exhibit 99.1 shall not be deemed "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth in such filing.

**Item 8.01. Other Events.**

The press release announcing the approval and a management call to discuss the approval scheduled for 5:00 p.m. ET today, February 28, 2023, is attached as Exhibit 99.2 hereto and incorporated herein by reference. The Company will utilize slides to make a presentation regarding the approval on the call. A copy of the slides is attached as Exhibit 99.3 hereto and incorporated herein by reference.

Cautionary Note Regarding Forward-Looking Statements

This Current Report on Form 8-K and oral statements made with respect to information contained in this report may contain certain disclosures that contain "forward-looking statements," including, without limitation, statements regarding the success, cost and timing of our product development activities and clinical trials, our plans to research, develop and commercialize our product candidates, our plans to submit regulatory filings, and our ability to obtain and retain regulatory approval of our product candidates. You can identify forward-looking statements because they contain words such as "believes," "will," "may," "aims," "plans," "model," and "expects." Forward-looking statements are based on the Company's current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, (i) the timing, costs, conduct, and outcome of our clinical trials and future preclinical studies and clinical trials, including the timing of the initiation and availability of data from such trials; (ii) the timing and likelihood of regulatory filings and approvals for our product candidates; (iii) whether regulatory authorities determine that additional trials or data are necessary in order to obtain approval; (iv) the potential market size and the size of the patient populations for our product candidates, if approved for commercial use, and the market opportunities for our product candidates; and (v) other factors set forth in the Company's filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K, under the caption "Risk Factors." The forward-looking statements speak only as of the date made and, other than as required by law, the Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

**Item 9.01. Financial Statements and Exhibits.**

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| | |
|:---|:---|
| &nbsp;&nbsp;**Exhibit**<br>**Number** | &nbsp;&nbsp;**Description** |
| &nbsp;&nbsp;99.1 | &nbsp;&nbsp;[<u>Call Script.</u>](reta-ex99_1.htm) |
| &nbsp;&nbsp;99.2 | &nbsp;&nbsp;[<u>Press Release.</u>](reta-ex99_2.htm) |
| &nbsp;&nbsp;99.3 | &nbsp;&nbsp;[<u>Company slides.</u>](reta-ex99_3.htm) |
| &nbsp;&nbsp;104 | &nbsp;&nbsp;Cover Page Interactive Data File (embedded within the Inline XBRL document). |

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**SIGNATURES**

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

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| | | |
|:---|:---|:---|
|  | Reata Pharmaceuticals, Inc. | Reata Pharmaceuticals, Inc. |
| Date: February 28, 2023 | By: | /s/ Manmeet S. Soni |
|  |  | **Manmeet S. Soni** |
|  |  | **Chief Operating Officer, Chief Financial Officer and President** |

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## Ex-99

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| | |
|:---|:---|
| &nbsp;&nbsp; <br>![img141630853_0.jpg](img141630853_0.jpg)  | &nbsp;&nbsp;**Exhibit 99.1** |

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**Reata Pharmaceuticals SKYCLARYS™ (Omaveloxolone) Approval Conference Call Script**

February 28, 2023

**Company Participants**

Warren Huff – Chief Executive Officer

Manmeet Soni – President, COO, CFO

Colin Meyer – Chief Innovation Officer

Seemi Khan – Chief Medical Officer

Dawn Bir – Chief Commercial Officer

**Operator Script**

Thank you for standing by, and welcome to the Reata Pharmaceuticals SKYCLARYS FDA Approval 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,

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February 28, 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. We ask that you please limit yourself to one question and one follow-up so that we can accommodate as many questions as possible.

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 and Seemi Khan, Chief Medical Officer.

At this time, I would like to turn the call over to Warren Huff.

**Warren Huff**

**Slide 3: Today's Agenda**

Good afternoon, everyone. This is a very exciting day, and we thank you for joining us.

I'll begin on slide 4.

**Slide 4: SKYCLARYS™ First and Only FDA Approved Therapy Indicated for Patients with Friedreich's Ataxia**

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Since Reata's founding in 2002, our mission has been to change patients' lives for the better by developing therapeutics with novel mechanisms of action and the potential to have high clinical impact on life-threatening diseases that have few or no approved therapies. Earlier today, we announced that the FDA has approved SKYCLARYS as the first and only FDA approved drug indicated for the treatment of Friedreich's ataxia, or FA, in adults and adolescents aged 16 years and older. For these FA patients, treatment with SKYCLARYS demonstrated significantly less impairment over time and represents a major step forward for those living with this devastating and progressive neuromuscular disease that until today had no treatments.

With this approval, we are pleased to announce that the FDA also granted a rare pediatric disease priority review voucher.

The approval of SKYCLARYS is a historic milestone for FA patients and their families as well as the FA support community. It is also an important milestone for Reata because it is the culmination of more than 15 years of scientific research and clinical development on our Nrf2 platform conducted by our team and our collaborators to bring this important, first therapy to FA patients.

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It is gratifying to have received this approval on Rare Disease Day. That underscores the progress that has been made by many patient groups, researchers, investigators, regulators, and others in the development of therapeutics for rare diseases. In that regard, I would like to thank the Friedreich's Ataxia Research Alliance, FARA, for their critical help with our development program. FARA and its researchers identified Nrf2 as an important therapeutic target in FA. They did ground-breaking work on FA clinical endpoints and collected critical natural history data on the disease. They helped us design and conduct our FA clinical trials, aided us in data interpretation, and provided important patient and investigator perspectives to us and to the FDA.

I would also like to thank the FDA. The FDA played an important role in the development of SKYCLARYS by working with FARA to develop clinical endpoints for FA clinical studies, providing us with important guidance regarding the design of our pivotal study as well as the design and data analysis of our long-term extension study, and performing a thoughtful review of our NDA.

Finally, I would like to thank the patients and their families for participating in our clinical trials and the FA-COMs natural history study. We know that participation in these clinical programs places a heavy burden on FA patients and their families often with no expectation of direct benefit to the participant.

Next slide.

**Slide 5: Looking Forward**

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Looking ahead, over the past several months we have been actively preparing for the commercial launch of SKYCLARYS. We are very pleased with the SKYCLARYS label, which provides that SKYCLARYS is indicated for patients with Friedreich's ataxia that are 16 years old or older. We believe that the prescribing information provides physicians the safety and efficacy information they need to prescribe SKYCLARYS. There are no contraindications or limitations based on pes cavus status, cardiovascular status, ambulation status, high or low mFARS score, or older age. There are no boxed warnings. Colin Meyer, our Chief Innovation Officer, will provide more detail concerning the prescriber information in a moment.

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 our top priority, and we are planning to engage with the FDA about possible label expansion for pediatric patients younger than 16 years of age.

As Seemi Khan, our Chief Medical Officer, will discuss, we received full approval for SKYCLARYS in FA, and we have finalized our post-marketing commitments and are preparing to meet those commitments on a timely basis. Also, our Medical Affairs team is in place and prepared for the launch of SKYCLARYS.

As Dawn Bir, our Chief Commercial Officer, will discuss, our commercial team is hired, and they are prepared for the launch of SKYCLARYS. This includes our sales leadership team, the field sales team, the payer team, and the field reimbursement managers.

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Importantly, we are committed to ensuring that patients have access to our therapies. Patient access is fundamental to our SKYCLARYS launch strategy as Dawn will discuss in a moment.

Regarding our plans outside the United States, I am pleased to announce that we submitted our Marketing Authorization Application for Omav for the treatment of patients with FA to the European Medicines Agency in the fourth quarter of 2022. We look forward to working with the European agency during their review of our application.

Reata's commitment to patients is to bring life-changing medicine to those who need them the most. We plan to continue to focus our Nrf2 activator platform on devastating neurological diseases with limited or no therapeutic options and to pursue programs that have the potential to produce a meaningful clinical impact for these patients.

Finally, Manmeet Soni, our President, Chief Operating, and Chief Financial Officer, will provide an overview of our operations, strong balance sheet and non-dilutive financing options.

I will now turn the call over to Colin Meyer to review the now approved SKYCLARYS label.

**Colin Meyer: SKYCLARYS Label**

**Slide 7: Friedreich's Ataxia: Ultra-Rare, Progressive, Neuromuscular Disease**

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Thanks Warren. I'll begin on slide 7. FA is a relentlessly progressive and debilitating neuromuscular disorder, which affects approximately 5,000 diagnosed patients in the United States. FA is a hereditary disease caused by the silencing of frataxin, which leads to impaired mitochondrial function and energy production. Patients with FA typically become dependent on walkers and then wheelchairs in their mid-twenties and, unfortunately, pass away from the disease in their mid-thirties. However, as of today, SKYCLARYS is the first approved drug for these patients.

**Slide 8: SKYCLARYS: Prescribing Information**

Slide 8 provides an overview of the prescribing information. SKYCLARYS is the first and only drug indicated for the treatment of Friedreich's ataxia in adults and adolescents aged 16 and older.

The label is very informative, will help guide healthcare providers to treat patients with FA, and we are very pleased with it.

The recommended dosage of SKYCLARYS is 150 mg taken orally once daily. The label contains recommended dosing adjustments for patients with hepatic impairment and those taking CYP3A4 inhibitors and inducers.

There are only three warnings and precautions: elevation of aminotransferases, elevation of B-type Natriuretic Peptide, or BNP, and lipid abnormalities. They each provide healthcare providers with clear monitoring instructions, which are not burdensome. I will discuss the details on the next slide.

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The most common adverse reactions with SKYCLARYS treatment with an incidence of at least 20% and greater than placebo are elevated liver enzymes, headache, nausea, abdominal pain, fatigue, diarrhea, and musculoskeletal pain.

Contraindications can be included on the label if the FDA determines that certain patients should not have access to a drug because the risk from use clearly outweighs any possible therapeutic benefit. Our label has no contraindications, meaning health care providers are not prevented from prescribing SKYCLARYS to patients due to their underlying disease characteristics or comorbidities. For instance, patients with or without pes cavus, or high arched feet, will be able to access SKYCLARYS. Patients who are ambulatory or wheelchair bound will be able to access SKYCLARYS. Patients who have pre-existing cardiovascular disease, including cardiomyopathy, which is common in FA patients, will also be able to access the drug. Lastly, there are no restrictions for older patients, such as those older than 40 years, or mFARS scores, including high and low scores.

Our label does not include a boxed warning, which is the FDA's most stringent and highest safety-related warning for drugs. It is used to alert health care providers and patients to serious or life-threatening side effects.

Additionally, the SKYCLARYS label does not include a Risk Evaluation and Mitigation Strategy, or REMS. A REMS is a drug safety program that the FDA can require for medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.

**Slide 9: SKYCLARYS: Warnings and Precautions**

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Slide 9 highlights the warnings and precautions on the label, which as I mentioned include elevation of aminotransferases, elevation of BNP, and lipid abnormalities.

ALT, AST, and total bilirubin should be monitored prior to initiation of SKYCLARYS, every month for the first three months of treatment, and periodically thereafter. If transaminases increase to levels greater than five times the upper limit of normal, or greater than three times the upper limit of normal with evidence of liver dysfunction, SKYCLARYS should be discontinued, and liver function tests repeated as soon as possible. If transaminase levels stabilize or resolve, SKYCLARYS may be reinitiated with an appropriate increased frequency of monitoring of liver function.

BNP should also be evaluated prior to initiation of SKYCLARYS, and patients should be monitored for signs and symptoms of fluid overload. Management of fluid overload and heart failure may require discontinuation of SKYCLARYS. If signs and symptoms of fluid overload develop, evaluate BNP and cardiac function, and manage appropriately.

Finally, lipid parameters should be assessed prior to initiation of SKYCLARYS and monitored periodically during treatment. Any lipid abnormalities should be managed according to clinical guidelines.

**Slide 10: Safety Evaluation and MOXIe Part 2 Adverse Events**

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Regarding safety on slide 10, SKYCLARYS has been evaluated in 165 patients with FA, including 137 patients who were exposed to SKYCLARYS for at least 48 weeks and 125 patients who were exposed for at least 96 weeks, including during the open-label extension. Generally, SKYCLARYS was well tolerated in the MOXIe Part 2 study. AEs were generally mild to moderate in intensity. Four, or 8%, of SKYCLARYS patients and two, or 4%, of placebo patients discontinued the study due to AEs. The table on the right of the slide shows the adverse reactions that occurred in at least 10% of patients treated with SKYCLARYS and more frequently than in placebo-treated patients.

Next slide.

**Slide 11: MOXIe Part 2 Study Design**

On the next few slides, I will review the clinical efficacy and safety data from the pivotal study, MOXIe Part 2, which was the primary evidence supporting the approval of SKYCLARYS. I will also discuss the extension data, which also supported approval.

MOXIe Part 2 was a double-blind, placebo-controlled, randomized international study and was one of the largest global interventional studies ever conducted in FA. The study enrolled 103 FA patients aged 16 to 40 years across a wide range of disease severity. Patients were randomized 1:1 to either 150 mg of SKYCLARYS or placebo for a duration of 48 weeks.

The pre-specified primary analysis population, or full analysis set, included the 82 patients who did not have severe pes cavus. As I mentioned earlier, pes cavus is the medical term for a high arched foot, and most FA patients have some form of pes cavus. The primary analysis patients included

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patients with pes cavus, yet we excluded patients who had severe manifestations leading to complete loss of lateral support of the feet. We prospectively defined and analyzed the primary analysis population of 82 patients, as well as the all randomized population of 103 patients.

The status of FA patients over time is measured in clinical studies by the modified Friedreich's Ataxia Rating Scale, or mFARS, a physician-assessed neurological exam, and this was the primary endpoint of the trial at Week 48. The mFARS consists of 4 domains to evaluate bulbar function, or speech and swallowing, upper limb coordination, lower limb coordination, and upright stability. A lower score on the mFARS score signifies lesser physical impairment. Based on the FA-COMS natural history study, a two-point difference in mFARS represents one to two years of progression.

**Slide 12: MOXIe Part 2 Placebo-Controlled Trial Results**

Moving to slide 12, SKYCLARYS is the first drug to demonstrate a clinical benefit in patients with FA. MOXIe Part 2 met its primary endpoint, and treatment with SKYCLARYS resulted in statistically significant lower, or improved, mFARS scores compared to placebo at Week 48. Patients treated with SKYCLARYS experienced on average an improvement compared to baseline, whereas patients who received placebo worsened. Overall, the placebo-corrected difference between the two groups was -2.41 points with a p-value of 0.0138. Additionally, the all-randomized population, which included patients with severe pes cavus, demonstrated a statistically significant placebo-corrected improvement in mFARS favoring patients who received SKYCLARYS. Treatment with SKYCLARYS resulted in less physical impairment over time.

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Next slide.

**Slide 13: MOXIe Extension: Post Hoc Propensity-Matched Analysis**

To provide additional clinical evidence in support of SKYCLARYS' approval, we performed a post-hoc propensity-matched analysis of the MOXIe Extension data compared to the largest, most robust FA natural history study, FA-COMS.

FA-COMS is a global multi-center longitudinal prospective observational study that has enrolled more than 1,250 patients. Clinical outcome measures, including mFARS, are assessed annually, and patients are followed for up to 25 years. Patients from FA-COMS were matched to MOXIe Extension patients using propensity scores based on five covariates, including sex, baseline age, age of FA onset, baseline mFARS score, and baseline gait score. Selection of these covariates was made in collaboration with the principal investigator and statistician for FA-COMS, based on clinical relevance, the relevance as prognostic indicators for disease progression and availability in both studies.

In this post hoc, propensity-matched analysis, lower or improved mFARS scores were observed in patients treated with SKYCLARYS after 3 years relative to a matched set of untreated patients from a natural history study. These exploratory analyses should be interpreted cautiously given the limitations of data collected outside of a controlled study, which may be subject to confounding.

In summary, the data from MOXIe Part 2 and the extension study showed that treatment with SKYCLARYS resulted in less physical impairment over

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time for patients in this relentlessly progressive disease, which now has its first available FDA approved therapy.

With that I will now turn the call over to Seemi.

**Seemi Khan: SKYCLARYS Post-Marketing Requirements & Registry Study**

Thanks Colin. I'll continue on slide 15.

**Slide 15: Post Marketing Requirements**

The FDA granted full approval to SKYCLARYS and so a post-marketing confirmatory efficacy study is not required. We have agreed to several post-marketing requirements. The first is to conduct a clinical drug-drug interaction study to determine the effect of concomitant administration of a moderate CYP3A4 inducer on the pharmacokinetics of SKYCLARYS in healthy volunteers. Secondly, we will conduct a thorough QT study to assess the risk of QT prolongation with SKYCLARYS. Third, we will conduct a study to assess the concentration of SKYCLARYS in breast milk. Fourth, we will conduct a global descriptive study to collect prospective and retrospective data in women exposed to SKYCLARYS during pregnancy and lactation to assess risk of maternal and fetal/neonate complications. Finally, we have agreed to conduct additional non-clinical studies.

Next slide.

**Slide 16: SKYCLARYS: Post-Approval Registry Study**

Beyond our post-marketing requirements, we will be sponsoring a voluntary, post-marketing, prospective, observational, multinational registry

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study of patients treated commercially with SKYCLARYS. The primary objective of the registry is to evaluate the long-term safety of SKYCLARYS in FA patients in the real-world setting.

Next slide.

**Slide 17: Pharmacovigilance and Medical Affairs**

Turning to our pharmacovigilance and medical affairs activities, we have established the infrastructure necessary to support our pharmacovigilance and safety obligations for SKYCLARYS in the United States. We have a medical information call center that has been established and is now active.

We have optimized our medical affairs group structure and strengthened our medical science liaison team to support SKYCLARYS launch. We have expanded and refined our medical affairs strategic and tactical plans, and our data generation, dissemination, and publication programs.

I will now turn the call over to Dawn.

**Dawn Bir: SKYCLARYS Commercial Launch Plans**

Thank you, Seemi. Good afternoon, everyone. I'll begin on slide 19.

**Slide 19: Friedreich's Ataxia is a Serious, Devastating, Ultra-Rare Disease**

Friedreich's ataxia is an ultra-rare debilitating, neuromuscular disease impacting a very small patient population. Like many other diseases without therapeutic options and limited drug development, FA is a disease that many outside of neurology have never heard of.

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FA strikes the young and vulnerable, at a time when kids are just kids, enjoying sports, friends, school, and perhaps thinking about college. This serious and devastating disease slowly robs patients of full independence, their ability to walk, speak, perform normal daily activities, and all too soon their lives. Until today, only palliative, and symptomatic treatment was available.

Next slide.

**Slide 20: Friedreich's Ataxia: Patients and HCPs Waiting for a Treatment**

FA represents a significant commercial opportunity. In the United States, there are approximately 5,000 diagnosed FA patients today that can be linked to healthcare providers, of which an estimated 4,500 or 90%, represent our total on-label addressable market. This number excludes the approximately 10% of diagnosed patients under the age of 16.

Additionally, we see that about 2,500 unique patients with FA were seen by a neurologist or other HCP in the last two years. Much of the FA patient community is engaged, connected, well-informed, and motivated. Now, with the first approved drug indicated for patients with Friedreich's ataxia, we expect that many patients will return to their physicians for treatment.

Next slide.

**Slide 21: Commercial Launch Strategy**

We are pleased to introduce SKYCLARYS, the first and only approved drug for FA in adults and adolescents 16 years of age and older. Our Commercial launch strategy engages our 3 key launch stakeholders: HCPs

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currently treating Friedreich's ataxia, on-label patients diagnosed with FA, and the Payer community.

With our attention on physicians currently treating patients with FA, our objective is 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.

FA patients and caregivers have created a well-connected community. Because SKYCLARYS is the first and only drug approved for Friedreich's ataxia, we will work to inform and educate patients and their families on this approval and encourage them to see their healthcare provider.

Lastly, and core to our promise to patients, we will facilitate coverage, access, and affordability through payer education and our robust programs designed to minimize or eliminate patient out of pocket cost burden.

**Slide 22: HCPs Treating FA Patients Identified**

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Turning to slide 22. Because there has been no FDA approved drug for Friedreich's ataxia until now, most patients today seek routine care by their local neurologist or primary care physician. We expect that, with the approval of SKYCLARYS, many patients will return to their FA specialists and treatment centers over time. Important commercial launch targets include CCRN centers, or Collaborative Clinical Research Network sites, ataxia centers, and HCPs with FA patients linked to their practices. Through the evaluation of ICD-10 claims data, we've identified approximately 2,500 target healthcare providers treating patients with Friedreich's ataxia today. About 1,200 FA patients are linked to approximately 200 highest target physicians. Several hundred of these patients can be tied to 14 ataxia centers and 9 CCRN sites, recognized as centers of excellence by FARA. We are prepared to reach these providers at their local practice or clinic. This targeted approach will allow us to reach the majority of the United States FA market efficiently. Additionally, our marketing outreach efforts through digital, social, email, and print have been developed to reach up to an additional 9,300 practicing neurologists, driving the awareness of SKYCLARYS' approval as newly diagnosed patients are identified and others return to their neurologists for treatment.

Next slide.

**Slide 23: Neurologists Anticipate Prescribing SKYCLARYS for FA**

In September 2022, we conducted market research with HCPs currently treating FA. When presented with the SKYCLARYS product profile and pivotal data, neurologists shared their willingness to prescribe following approval, with approximately 85% indicating that they anticipate prescribing within 6-months, and about 95% indicating within the first year.

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Furthermore, PCPs treating FA are also likely to prescribe, with over 75% stating that they would do so within the first year. Many HCPs expressed their dissatisfaction with the lack of treatment options available and indicated their likelihood to prescribe quickly.

**Slide 24: Reaching and Educating Patients, HCPs, and Payers**

Turning to slide 24, an experienced commercial team is hired, trained, and prepared to launch SKYCLARYS. This team includes seasoned brand marketers, a team of veteran biotech sales professionals, training, market access, product distribution, and commercial operations. Go-to-market plans are in place and ready to execute.

With SKYCLARYS approval, we now begin to inform the FA network of patients, caregivers, and healthcare providers. Omni-channel outreach efforts are wide-reaching, and we start immediately with the launch of our brand websites, online search, social media, and digital campaigns that go live today.

Our sales organization consists of a team of Region Business Directors and Neurology Account Managers responsible for educating HCPs. Each member of the sales team has years in the industry and experience across neurology or rare diseases. All have worked with specialty therapeutics. Most have launched first products with emerging commercial companies. The sales team is completing their final training this week and will be in the field on Monday morning, March 6, educating physicians on the efficacy and safety of SKYCLARYS.

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Lastly, 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 support practice-level access needs. Together, this team's primary responsibility is to facilitate patient access to the drug by working to minimize and navigate payer criteria. Coverage by most national and regional payers is expected to take approximately 4-8 weeks via medical exception while formulary review progresses over the next 3-6 months. We anticipate that most plans will place SKYCLARYS on their specialty tier along with most rare specialty therapeutics. SKYCLARYS will be shipped directly to the patient's home through a single specialty pharmacy. The Reata REACH program is at the center of these services. I'll introduce this program on the next slide.

**Slide 25: The Responsibility of Patient Access & Affordability**

We believe that every eligible person with Friedreich's ataxia should have access to the only approved drug available, and we offer programs to help make this happen. Reata REACH, or the Reata Education, Access, and Care Helpline, is an integrated, exclusive specialty pharmacy and patient services program. It will serve as the single point of contact for HCPs prescribing SKYCLARYS, FA patients receiving drug, and their caregivers. REACH is designed to create a simple and positive experience through the new patient start process, insurance navigation, therapy adherence, access, and commercial copay support.

Through claims data analysis we believe that today approximately 60% of currently diagnosed FA patients have commercial insurance. The remainder have coverage through Medicare Part D or Medicaid, with a very small portion uninsured. This mix could change slightly, and more

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uninsured patients may be identified with a new therapeutic coming to the market. We've designed our access programs with this knowledge, offering specific programs where possible to bring down the patient's potential out of pocket cost. Regardless of coverage, no Friedreich's ataxia patient will face more than a nominal copay for SKYCLARYS treatment.

Next slide.

**Slide 26: Pricing SKYCLARYS**

The ultra-rare disease ecosystem stimulates innovation and development for serious diseases impacting very small populations. Because of this environment there has been much success in recent years bringing new drugs forward.

We considered several factors and constraints in setting the SKYCLARYS price.

First, the price reflects the small size of the patient population. The current estimated total addressable market in the United States is approximately 4,500 diagnosed patients.

Second, there is an urgent need for a treatment. Friedreich's ataxia is a progressive, debilitating, and life-threatening disease, that robs patients of their ability to function, impacting their independence and shortening their expected lifespan.

Third, SKYCLARYS is the only FA drug approved by the FDA which has demonstrated significantly less impairment over time in a well-controlled clinical trial. Before today, there were no FDA-approved drugs for Friedreich's ataxia.

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And fourth, SKYCLARYS has a novel mechanism of action that required 15 years of research and development with our Nrf2 platform to bring SKYCLARYS to market.

We evaluated recent ultra-rare disease drug launches between 2016-2022 and established a peer group of products approved for diseases with very small patient populations like Friedreich's ataxia. SKYCLARYS is priced below the mid-point of these peer analogue disease therapies. An annual WAC price point of $370,000 will support sustainability, our commitment to advancing ground-breaking science and developing new, novel therapies.

Next slide

 **Slide 27: Beginning Treatment with SKYCLARYS**

Our SKYCLARYS launch efforts begin today. Patient access services are now active and operational. New Patient Start Forms are available for download on the REACH website at ReataREACH.com, and Care Navigators are available to answer questions Monday through Friday at the REACH call center. FA patients or their caregivers seeking SKYCLARYS treatment should see their healthcare provider.

Since payer coverage may take several weeks, HCPs can submit new patient start forms immediately to initiate the benefit verification process and coverage through medical exception. SKYCLARYS will ship to patients as soon as it is in the channel. With that, I will now turn the call over to Manmeet. He will provide our operational and financial updates.

**Manmeet Soni: Operational and Financial Update**

**Slide 29: Operational Update**

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Thank you, Dawn. I'll continue on slide 29.

First of all, let me start by adding that we are thrilled to be at this stage of our company's journey. Becoming a commercial company has always been our plan. We have been working hard to prepare for this day. And so, I speak for our entire Reata team when I say how excited we are to reach this important milestone of getting SKYCLARYS approved to help patients who had no current approved therapy.

SKYCLARYS' approval represents a culmination of the perseverance and commitment over the last 15 years for our research and development team for our Nrf2 activator platform.

Moving on to the update on operations, we are working diligently to ensure we get the drug to the market as soon as possible.

Currently, we are in the final stages of SKYCLARYS manufacturing, which includes encapsulation, packaging, and labeling. We expect to complete these manufacturing activities by the end of April 2023.

Recently, a process-related drug substance impurity above the reporting threshold was observed. This impurity had been observed previously below the reporting threshold. Based on the chemical characteristics of the impurity and testing results, there are no expected safety concerns. An update to the drug substance specification with this new information will be submitted to the FDA as soon as the required data and documentation are available. The

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change will become effective 30 days after submission, absent further action required by the FDA, which we do not expect.

We believe SKYCLARYS commercial drug product will be available to our specialty pharmacy in May 2023 or early June 2023. We continue to work diligently on the last steps of production and to shorten the timelines, and currently don't expect any further delays.

Regarding our operations in Europe, following submission of our MAA in the fourth quarter of last year, we have accelerated build out of our European infrastructure to support the potential commercial launch of omav in the European region by early 2024, if approved. Additionally, we are working to setup Early Access Programs in certain European countries to provide early access to omav for patients in need, where possible.

Moving to our intellectual property, composition of matter of patents claiming SKYCLARYS have been granted in the United States, Europe, Japan, China, and more than 20 other territories. We anticipate that the composition of matter patent protection for SKYCLARYS could be extended to 2037 in the United States and 2038 in Europe.

Next slide.

**Slide 30: Financial update**

I will now provide color on our cash position and funding options.

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As of December 31, 2022, we maintained a solid balance sheet, with approximately $387.5 million in cash, cash equivalents, and marketable debt securities. We currently have no outstanding funded debt on our balance sheet.

I wanted to remind everyone of a few items:

We have multiple options to raise additional funding to strengthen further our cash balance and future investments into the pipeline and fuel the growth of SKYCLARYS beyond the United States.

The granted rare pediatric disease priority review voucher will provide us with future optionality to monetize the voucher.

Additionally, if you recall, we previously had a debt facility of $155 M with Silicon Valley Bank and Oxford in mid-2020 prior to entering into a royalty agreement with Blackstone. We prepaid that debt post-financing from Blackstone. Under our royalty agreement with Blackstone, we have the right to obtain secured debt with a first lien on our assets to replace our previous debt of $155 M.

Our agreement with Blackstone only requires us to pay royalty from the revenues generated from bardoxolone. We do not owe any royalty on SKYCLARYS revenue to Blackstone.

Based on our current plan, our cash balance will enable us to fund operations through the end of 2024. Additionally, with the option to monetize the priority review voucher and raise non-dilutive debt financing, we believe we can further extend our cash runway and get

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to the point of self-sustainability and breakeven with our financial discipline. We will continue to invest appropriately in our product pipeline and expansion of omav into Europe and Brazil, which could have significant revenue potential.

Please note that on today's call, we will not provide any guidance on market assumptions or sales potential. We'll continue to evaluate the possibility of providing guidance over the next few quarters, once we gain comfort with the ramp of the launch, market dynamics and key metrics.

We plan to do an R&D Day later this year to provide more details on our programs including our Nrf2 activators.

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

**Warren Huff**

**Slide 32: Reata Looking Ahead in 2023**

Thanks, Manmeet. Continuing on slide 32, the approval of SKYCLARYS is a transformative moment for Reata as a company as we work to bring SKYCLARYS to patients as a commercial enterprise. We would like to again thank FARA, FA scientists and researchers, the FDA, and, most of all, FA patients and their families for their help with our FA development program.

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We are well prepared for the commercial launch of SKYCLARYS in the United States. Importantly, we are committed to ensuring that eligible FA patients have access to SKYCLARYS, and to continued development to address the group of FA patients that are younger than 16 years of age. We have submitted our Marketing Authorization Application for Omav for the treatment of patients with FA to the European Medicines Agency, and we will be working throughout this year to support the European agency during their review of our application.

Reata's promise to patients is to bring life-changing medicine to those who need them the most. We plan to continue to focus our Nrf2 activator platform on devastating neurological diseases with limited or no therapeutic options and to pursue programs that have the potential to produce a meaningful clinical impact for these patients.

That concludes our prepared remarks. We'd like to thank, everyone, who dialed in. I'll now turn the call over to the operator for questions.

**Operator**

Ladies and gentlemen, at this time, we will begin the question-and-answer session.

Please keep your questions to one question and one follow-up.

**Operator**

Thank you. And I'm showing no further questions in the queue. 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.

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## Ex-99

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|:---|:---|
| &nbsp;&nbsp; <br>![img142554374_0.jpg](img142554374_0.jpg)  | &nbsp;&nbsp;**Exhibit 99.2** |

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**REATA PHARMACEUTICALS ANNOUNCES FDA APPROVAL OF SKYCLARYS™ (OMAVALOXOLONE), THE FIRST AND ONLY DRUG INDICATED FOR PATIENTS WITH FRIEDREICH'S ATAXIA**

**Friedreich's Ataxia is an Ultra-Rare, Progressive, Neuromuscular disease that affects approximately 5,000 diagnosed patients in the United States**

**SKYCLARYS is indicated for the treatment of Friedreich's ataxia in adults and adolescents aged 16 years and older**

**Rare Pediatric disease priority review voucher granted**

**MANAGEMENT TO HOST CONFERENCE CALL today, february 28, 2023, at 6:00 pm ET**

**PLANO, Texas—February 28, 2023 (BUSINESS WIRE)—**Reata Pharmaceuticals, Inc. (Nasdaq: RETA) ("Reata," the "Company," "our," "us," or "we"), a biopharmaceutical company focused on developing and commercializing novel therapies for patients with severe diseases, announced that the U.S. Food and Drug Administration ("FDA") has approved SKYCLARYS™ (omaveloxolone) for the treatment of Friedreich's ataxia in adults and adolescents aged 16 years and older. With this approval, the FDA granted a rare pediatric disease priority review voucher.

"The approval of SKYCLARYS, the first therapy specifically indicated for the treatment of Friedreich's ataxia, is an important milestone for patients affected by this disease as well as their families and caregivers," said Warren Huff, Reata's Chief Executive Officer. "We are grateful to Friedreich's ataxia patients, investigators, U.S. regulators, and our scientists and employees who made this approval possible. As a company, this is a transformative milestone that highlights our commitment to developing and commercializing novel therapies for patients with severe diseases with few or no approved therapies. We look forward to delivering SKYCLARYS to eligible patients as quickly as possible."

Friedreich's ataxia is an ultra-rare, inherited neurodegenerative disorder that is typically diagnosed during adolescence. Patients with Friedreich's ataxia experience progressive loss of coordination, muscle weakness, and fatigue, which commonly progresses to motor incapacitation and wheelchair reliance by their teens or early twenties, and eventually death. Friedreich's ataxia affects approximately 5,000 diagnosed patients in the U.S.

"Friedreich's ataxia is a debilitating neuromuscular disease that progressively robs patients of their mobility and independence," said Susan Perlman, MD, Clinical Professor, Department of Neurology, David Geffen School of Medicine, UCLA. "The approval of SKYCLARYS represents an important step forward in the treatment of Friedreich's ataxia, providing physicians with the first disease-specific treatment option approved for patients living with this ultra-rare and progressive disease."

"Today's approval of SKYCLARYS represents a significant milestone in our effort to advance research and achieve treatments for Friedreich's ataxia," said Jen Farmer, Chief Executive Officer at Friedreich's Ataxia Research Alliance.

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"The entire Friedreich's ataxia community including patients, clinicians, scientists, pharmaceutical companies, government agencies, and others have worked collaboratively for decades to enable therapeutic development for this debilitating disease. Today, we celebrate the impact of an engaged patient community, and we are grateful to the FDA and Reata for working together on the approval of SKYCLARYS, the first therapy approved in the United States for adult and adolescent patients aged 16 years and older with Friedreich's ataxia."

The approval of SKYCLARYS is supported by the efficacy and safety data from the MOXIe Part 2 trial and a post hoc Propensity-Matched Analysis of the open-label MOXIe Extension trial.

MOXIe Part 2 was a randomized, double-blind, placebo-controlled study. Patients with genetically confirmed Friedreich's ataxia and baseline modified Friedreich's Ataxia Rating Scale ("mFARS") scores between 20 and 80 were randomized 1:1 to receive placebo or 150 mg of SKYCLARYS daily. The primary endpoint was change from baseline in mFARS score compared to placebo at Week 48 in the Full Analysis Population of patients without severe pes cavus (n=82). The mFARS is a clinical assessment tool to assess patient function and is used in clinical trials to assess the efficacy of investigational products for use in Friedreich's ataxia. Treatment with SKYCLARYS resulted in statistically significant lower mFARS scores (less impairment) relative to placebo at Week 48. The placebo-corrected difference between the two groups was -2.41 points with a p-value of 0.0138. The most common adverse reactions in MOXIe Part 2 (≥20% and greater than placebo) were elevated liver enzymes (AST/ALT), headache, nausea, abdominal pain, fatigue, diarrhea, and musculoskeletal pain.

Further, in a post hoc Propensity-Matched Analysis, mFARS progression of patients treated with 150 mg of SKYCLARYS daily in the open-label MOXIe Extension trial was compared to the progression of propensity score-matched untreated patients in the largest natural history study of Friedreich's ataxia, Clinical Outcome Measures in Friedreich's ataxia ("FA-COMS"). All patients enrolled in the MOXIe Extension study with at least one post-baseline assessment (n=136) were matched one to one with patients from the FA-COMS study (n=136). Lower (improved) mFARS scores were observed in patients treated with SKYCLARYS after 3 years relative to the matched set of untreated patients from the FA-COMS natural history study. These exploratory analyses should be interpreted cautiously given the limitations of data collected outside of a controlled study, which may be subject to confounding.

**Reata REACH Offers Personalized Access Support for Patients**

Today, the Company also announced the launch of the Reata Education, Access, and Care Helpline (REACH), an integrated specialty pharmacy and patient services program, designed to help eligible patients access prescribed Reata medicines. For additional information about REACH programs call 1-844-98-REACH or visit www.reataREACH.com. Reata Pharmaceuticals has partnered with an independent specialty pharmacy specializing in rare disease services to serve as the exclusive SKYCLARYS pharmacy.

We are completing the commercial drug product manufacturing and anticipate commercial drug supply of SKYCLARYS to be available in the second quarter of 2023.

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**Conference Call Information**

Reata's management will host a conference call on February 28, 2023, at 6:00 pm ET. The conference call will be accessible by dialing (844) 200-6205 (toll-free domestic) or (929) 526-1599 (international) using access code 827526. The webcast link is https://events.q4inc.com/attendee/939887927.

**About SKYCLARYS™ (omaveloxolone)**

SKYCLARYS™ (omaveloxolone) is an oral, once-daily medication indicated for the treatment of Friedreich's ataxia in adults and adolescents aged 16 years and older in the U.S. SKYCLARYS has received Orphan Drug, Fast Track, and Rare Pediatric Disease Designations from the FDA. Additionally, the company's Marketing Authorization Application for omaveloxolone is under review in Europe by the European Medicines Agency (EMA). The European Commission has granted Orphan Drug designation in Europe to omaveloxolone for the treatment of Friedreich's ataxia.

**INDICATION AND IMPORTANT SAFETY INFORMATION FOR SKYCLARYS (omaveloxolone)**

**Indication**

SKYCLARYS is indicated for the treatment of Friedreich's ataxia in adults and adolescents aged 16 years and older.

**IMPORTANT SAFETY INFORMATION**

**WARNINGS AND PRECAUTIONS**

**Elevation of Aminotransferases:** Treatment with SKYCLARYS can cause an elevation in hepatic transaminases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]). The incidence of elevations of ALT or AST above 5 times and 3 times the upper limit of normal (ULN) was 16% and 31%, respectively, in patients treated with SKYCLARYS. There were no cases of concomitant elevation of transaminases and total bilirubin observed. Maximum increases in ALT and AST occurred within 12 weeks after starting SKYCLARYS. Increases in serum aminotransferases were generally asymptomatic and reversible following discontinuation of SKYCLARYS. Patients with clinically significant liver disease were excluded from the pivotal study.

Monitor ALT, AST, and total bilirubin prior to initiation of SKYCLARYS, every month for the first 3 months of treatment, and periodically thereafter. If transaminases increase to levels greater than 5 times the ULN, or greater than 3 times the ULN with evidence of liver dysfunction (e.g., elevated bilirubin), immediately discontinue SKYCLARYS and repeat liver function tests as soon as possible. If transaminase levels stabilize or resolve, SKYCLARYS may be reinitiated with an appropriate increased frequency of monitoring of liver function.

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**Elevation of B-Type Natriuretic Peptide:** Treatment with SKYCLARYS can cause an increase in B-type natriuretic peptide (BNP), a marker of cardiac function. A total of 14% of patients treated with SKYCLARYS had an increase from baseline in BNP value above the ULN (100 pg/mL), compared to 4% of patients who received placebo. The incidence of elevation of BNP above 200 pg/mL was 4% in patients treated with SKYCLARYS. Cardiomyopathy and cardiac failure are common in patients with Friedreich's ataxia. Patients were excluded from the pivotal study if they had BNP levels > 200 pg/mL prior to study entry, or a history of clinically significant left-sided heart disease and/or clinically significant cardiac disease, with the exception of mild to moderate cardiomyopathy associated with Friedreich's ataxia. Whether the elevations in BNP are related to SKYCLARYS or cardiac disease associated with Friedreich's ataxia is unclear.

Elevations in BNP may indicate cardiac failure and should prompt an evaluation of cardiac function. Check BNP prior to initiation of SKYCLARYS. Monitor patients for the signs and symptoms of fluid overload, such as sudden weight gain (3 pounds or more of weight gain in one day, or 5 pounds or more of weight gain in a week), peripheral edema, palpitations, and shortness of breath. If signs and symptoms of fluid overload develop, worsen, or require hospitalization, evaluate BNP and cardiac function, and manage appropriately. Management of fluid overload and heart failure may require discontinuation of SKYCLARYS.

**Lipid Abnormalities:** Treatment with SKYCLARYS can cause changes in cholesterol. In the pivotal study, 29% of patients treated with SKYCLARYS reported elevated cholesterol above ULN at one or more time points. Mean increases were observed within 2 weeks of initiation of SKYCLARYS and returned to baseline within 4 weeks of discontinuing treatment. A total of 16% of patients treated with SKYCLARYS had an increase in low-density lipoprotein cholesterol (LDL-C) from baseline, compared to 8% of patients who received placebo. The mean increase in LDL-C for all SKYCLARYS-treated patients was 23.5 mg/dL at 48 weeks. A total of 6% of patients treated with SKYCLARYS had decreases in high-density lipoprotein cholesterol (HDL-C) from baseline compared to 4% of patients who received placebo. The mean decrease in HDL-C for all SKYCLARYS-treated patients was 5.3 mg/dL at 48 weeks.

Assess lipid parameters prior to initiation of SKYCLARYS and monitor periodically during treatment. Manage lipid abnormalities according to clinical guidelines.

**CONTRAINDICATIONS**

None.

**ADVERSE REACTIONS**

Adverse reactions reported in 10% or more of patients and greater than placebo were elevated liver enzymes (AST/ALT) (37%), headache (37%), nausea (33%), abdominal pain (29%), fatigue (24%), diarrhea (20%), musculoskeletal pain (20%), oropharyngeal pain (18%), influenza (16%), vomiting (16%), muscle spasms (14%), back pain (13%), decreased appetite (12%), rash (10%).

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**DRUG INTERACTIONS**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;·Moderate or Strong CYP3A4 Inhibitors: Avoid concomitant use. Consider SKYCLARYS dosage reduction with monitoring if use is unavoidable.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;·Moderate or Strong CYP3A4 Inducers: Avoid concomitant use.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;·Hormonal Contraceptives: Counsel females to use an alternative contraceptive method (e.g., non-hormonal intrauterine system) or additional non-hormonal contraceptive (e.g., condoms) during concomitant use and for 28 days after discontinuation of SKYCLARYS.

This is not a complete list of potential drug interactions.

**Specific Population:** Due to the uncertainty of any potential adverse effects on the breastfed infant, women are advised not to breastfeed during treatment with SKYCLARYS.

**To report SUSPECTED ADVERSE REACTIONS, contact Reata Pharmaceuticals, Inc. at 1-800-314-3934 or FDA at 1-800-FDA-1088 or** www.fda.gov/medwatch.

**For more information about SKYCLARYS, please see the full Prescribing Information**

US-SKY-2300055 v2.0

**About Friedreich's Ataxia**

Friedreich's ataxia is an ultra-rare, genetic, life-shortening, debilitating, and degenerative neuromuscular disorder typically caused by a trinucleotide repeat expansion in the first intron of the frataxin gene, which encodes the mitochondrial protein frataxin. Pathogenic repeat expansions can lead to impaired transcription and reduced frataxin expression, which can result in mitochondrial iron overload and poor cellular iron regulation, increased sensitivity to oxidative stress, and impaired mitochondrial ATP production. Patients with Friedreich's ataxia typically experience symptoms in childhood, including progressive loss of coordination, muscle weakness, and fatigue that commonly results in motor incapacitation with patients requiring a wheelchair in their 20s. Based on an insurance claim analysis, we believe there are approximately 5,000 patients diagnosed with Friedreich's ataxia in the United States.

**About Reata**

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Reata is biopharmaceutical company committed to developing and commercializing novel therapeutics for patients with serious or life-threatening diseases by targeting molecular pathways involved in the regulation of cellular metabolism and inflammation. Reata's first product, SKYCLARYS™ (omaveloxolone) has been approved by the FDA for the treatment of FA and is under review in Europe by the EMA. In addition, Reata is developing bardoxolone methyl ("bardoxolone") for the treatment of patients with chronic kidney disease and cemdomespib for the treatment of patients with diabetic neuropathic pain. **Bardoxolone and cemdomespib are investigational drugs, and their safety and efficacy have not been established by any regulatory agency.**

**Forward-Looking Statements**

This press release includes certain disclosures that contain "forward-looking statements," including, without limitation, our plans and objectives for the commercialization of SKYCLARYS and the timing thereof, our expectations regarding the size of the patient population for SKYCLARYS, and our plans to research, develop, and commercialize our other product candidates. You can identify forward-looking statements because they contain words such as "believes," "will," "may," "aims," "plans," "model," and "expects." Forward-looking statements are based on Reata's current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, (i) the potential market size and the size of the patient population for SKYCLARYS and the market opportunities for SKYCLARYS; (ii) our ability to successfully build our commercial infrastructure to manufacture, market and sell SKYCLARYS, including the successful development and implementation of our sales and marketing campaigns for SKYCLARYS; (iii) the ability of our third-party suppliers and contract manufacturers to manufacture SKYCLARYS at the required quality and quantities and in compliance with applicable laws and regulations; and (iv) other factors set forth in Reata's filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2022, under the caption "Risk Factors." The forward-looking statements speak only as of the date made and, other than as required by law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

![img142554374_1.jpg](img142554374_1.jpg)# # #

**Contact:**

Reata Pharmaceuticals, Inc.

(972) 865-2219

https://www.reatapharma.com/

**Investor Relations & Media Relations:**

John Hunter ir@reatapharma.com

Wendy Segal media@reatapharma.com

<u>https://www.reatapharma.com/contact-us/</u>

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## Ex-99

![Slide 1](reta-ex99_3s1.jpg)

SKYCLARYS™ Approval Call February 28, 2023 Exhibit 99.3

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![Slide 2](reta-ex99_3s2.jpg)

This presentation contains certain "forward-looking" statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical or present facts, are forward-looking statements, including statements regarding our future financial condition, future revenues, projected costs, prospects, business strategy, and plans and objectives of management for future operations, including our plans to submit for regulatory filings, and plans and objectives of management for the commercialization of SKYCLARYS, including anticipated pricing and reimbursement, marketing costs, revenues, licenses (if any) and the production, manufacture and distribution of SKYCLARYS. In some cases, you can identify forward-looking statements by terminology such as "believe," "will," "may," "might," "estimate," "continue," "anticipate," "intend," "target," "project," "model," "should," "would," "plan," "expect," "predict," "could," "seek," "goal," "potential," or the negative of these terms or other similar terms or expressions that concern our expectations, strategy, plans, or intentions. These statements are based on our intentions, beliefs, projections, outlook, analyses, or current expectations using currently available information, and are not guarantees of future performance, and involve certain risks and uncertainties. Although we believe that the expectations reflected in these forward-looking statements are reasonable, we cannot assure you that our expectations will prove to be correct. Therefore, actual outcomes and results could materially differ from what is expressed, implied, or forecasted in these statements. Any differences could be caused by a number of factors including but not limited to: our expectations regarding the timing, costs, conduct, and outcome of our clinical trials, including statements regarding the timing of the initiation and availability of data from such trials; the timing and likelihood of regulatory filings and approvals for our product candidates; whether regulatory authorities determine that additional trials or data are necessary in order to obtain approval; our ability to obtain funding for our operations, including funding necessary to complete further development and commercialization of our product candidates; our plans to research, develop, and commercialize our product candidates; the success of our launch and commercialization of SKYCLARYS as well as the commercialization of our other product candidates, if approved; our ability to successfully build our commercial infrastructure to manufacture, market and sell our products, including the successful development and implementation of our sales and marketing campaigns for SKYCLARYS; the rate and degree of market acceptance of SKYCLARYS and our other product candidates; our expectations regarding the potential market size and the size of the patient populations for SKYCLARYS and our other product candidates, if approved, for commercial use, and the potential market opportunities for commercializing SKYCLARYS and our other product candidates; our ability to obtain or maintain coverage and reimbursement for SKYCLARYS from third-party payors, such as Medicare, Medicaid, insurance companies, health maintenance organizations and other plan administrators, including whether such payors will reimburse for SKYCLARYS at a price that is profitable to us; product quality, efficacy or safety concerns relating to SKYCLARYS resulting in complaints, adverse events, product recalls or regulatory action; the adequacy of our pharmacovigilance and drug safety reporting processes; the ability of our third-party suppliers and contract manufacturers to manufacture SKYCLARYS at the required quality and quantities and in compliance with applicable laws and regulations; the effect of increased scrutiny by federal, state and foreign national governments on the pricing of pharmaceutical products, including government price controls or other changes in pricing regulation that would restrict the amount we are able to charge for SKYCLARYS and our other product candidates, if approved; our ability to successfully manufacture, market and distribute SKYCLARYS while maintaining compliance with applicable federal and state laws, rules and regulations; our ability to comply with ongoing regulatory requirements with respect to SKYCLARYS (or any product candidate for which we obtain approval in the future) by the FDA, the EMA and other comparable international regulatory authorities; the success of competing therapies that are or may become available, including competing therapies for SKYCLARYS in the treatment of Friedreich's ataxia; our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates; the ability to license additional intellectual property relating to our product candidates and to comply with our existing license agreements; our ability to maintain and establish relationships with third parties, such as contract research organizations, contract manufacturing organizations, suppliers, and distributors; our ability to maintain and establish collaborators with development, regulatory, and commercialization expertise; our ability to attract and retain key scientific or management personnel; our ability to grow our organization and increase the size of our facilities to meet our anticipated growth; the accuracy of our estimates regarding expenses, future revenue, capital requirements, and needs for additional financing; our expectations related to the use of our available cash; our ability to develop, acquire, and advance product candidates into, and successfully complete, clinical trials; the initiation, timing, progress, and results of future preclinical studies and developments and projections relating to our competitors and our industry; the impact of governmental laws and regulations and regulatory development in the United States and foreign countries; the impact of the coronavirus disease (COVID-19) on our clinical trials, our supply chain, and our operations; and other risks and uncertainties, including those described under the heading "Risk Factors" included in our most recent Annual Report on Form 10-K for the year ended December 31, 2022, filed with the U.S. Securities and Exchange Commission (SEC) on February 24, 2023. Additional factors that could cause actual results to differ materially from our expectations can be found in our Securities and Exchange Commission filings. Moreover, we operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time, and it is not possible for our management to predict all risk factors, nor can we assess the effects of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements. All forward- looking statements included in this presentation are expressly qualified in their entirety by these cautionary statements. The forward-looking statements speak only as of the date made and, other than as required by law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Bardoxolone methyl and Cemdomespib are investigational drugs, and their safety and efficacy have not been established by any agency.

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![Slide 3](reta-ex99_3s3.jpg)

Today's Agenda Opening Remarks \| Warren Huff, Chief Executive Officer SKYCLARYS Label \| Colin Meyer, MD, Chief Innovation Officer SKYCLARYS PMR & Registry \| Seemi Khan, MD, Chief Medical Officer SKYCLARYS Commercial Launch \| Dawn Bir, Chief Commercial Officer Operational & Financial Update \| Manmeet Soni, President, COO, CFO Concluding Remarks \| Warren Huff, Chief Executive Officer

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![Slide 4](reta-ex99_3s4.jpg)

SKYCLARYSTM First and Only FDA Approved Therapy Indicated for Patients with Friedreich's Ataxia 1Please see full Prescribing Information at SKYCLARYS.com; FDA: U.S. Food and Drug Administration; FA: Friedreich's ataxia

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![Slide 5](reta-ex99_3s5.jpg)

Looking Forward mFARS: modified Friedreich's Ataxia Rating Scale; MAA: Marketing Authorization Application SKYCLARYS is indicated for the treatment of FA in patients aged 16 years and older No contraindications or limitations based on pes cavus, cardiovascular status, ambulation, mFARS score, or older age Planning to engage with the FDA about possible label expansion for pediatric patients younger than 16 years of age We are prepared for SKYCLARYS launch Medical affairs and pharmacovigilance infrastructure is in place Commercial team is hired and trained Access to therapy is an important responsibility MAA for omaveloxolone submitted in fourth quarter of 2022 Strong balance sheet and no outstanding funded debt Our commitment to patients is to bring life-changing medicine to those who need them the most

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SKYCLARYS Label

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Friedreich's Ataxia: Ultra-Rare, Progressive, Neuromuscular Disease 1Cook A., Br Med Bull. 2017; 2Poburski D., Biology Open 2016; 3D'Oria V., Int. J. Mol. Sci. 2013; 4Paupe V., PLoS ONE 2009; 5U.S. claims data and projected diagnosed, 6Rummey C., Neurol Genet 2019; 7Rummey C., E Clinical Medicine. 2020; 8Tsou A.Y., J Neurol Sci 2011 Caused by silencing of frataxin1 Impaired mitochondrial function, suppressed Nrf2 expression, which impairs energy production2-4 Ultra-rare genetic diseaseAn estimated 5,000 patients are diagnosed in the U.S.5 Relentlessly progressive loss of motor function Typically diagnosed in teens6, requires mobility aids in twenties7, mean survival is mid-thirties8 No approved therapies before today

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SKYCLARYS: Prescribing Information ALT: Alanine aminotransferase; AST: Aspartate aminotransferase; BNP: B-type natriuretic peptide No contraindications or restrictions based on pes cavus, ambulatory, or cardiovascular status No upper age limit or mFARS score restriction Overview of Prescribing Information Indication Statement SKYCLARYS is indicated for the treatment of Friedreich's ataxia in adults and adolescents aged 16 years and older Contraindications None Boxed Warning None Risk Evaluation and Mitigation Strategy None Dosing and Administration Obtain ALT, AST, bilirubin, BNP, and lipid parameters prior to initiating SKYCLARYS and during treatment Recommended dosage of SKYCLARYS is 150 mg (3 capsules) taken orally once daily Warnings and Precautions Elevation of Aminotransferases Elevation of B-type Natriuretic Peptide (BNP) Lipid Abnormalities Adverse Reactions Most common adverse reactions (incidence ≥20% and greater than placebo) are elevated liver enzymes (AST/ALT), headache, nausea, abdominal pain, fatigue, diarrhea, and musculoskeletal pain Not actual product picture

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SKYCLARYS: Warnings and Precautions Elevation of Aminotransferases Monitor ALT, AST, and total bilirubin prior to and monthly for 3 months after initiation of treatment, and periodically thereafter If transaminases increase to levels greater than 5 times the ULN, or greater than 3 times the ULN with evidence of liver dysfunction, immediately discontinue SKYCLARYS and repeat liver function tests If transaminase levels stabilize or resolve, SKYCLARYS may be reinitiated with appropriate monitoring of liver function Elevation of B-type Natriuretic Peptide (BNP) Check BNP prior to initiation of SKYCLARYS Monitor patients for signs and symptoms of fluid overload If signs and symptoms of fluid overload develop, evaluate BNP and cardiac function, and manage appropriately Lipid Abnormalities Assess lipid parameters prior to initiation of SKYCLARYS and monitor periodically during treatment Manage lipid abnormalities according to clinical guidelines

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Adverse Reactions Reported in 10% or More of Patients Treated with SKYCLARYS and Greater than Placebo Safety Evaluation and MOXIe Part 2 Adverse Events The safety of SKYCLARYS 150 mg once daily has been evaluated in 165 patients with FA 137 patients exposed for at least 48 weeks 125 patients exposed for at least 96 weeks Adverse Reactions SKYCLARYS 150 mg(n=51) % Placebo (n=52) % Elevated liver enzymes (AST/ALT) 37 2 Headache 37 25 Nausea 33 13 Abdominal pain 29 6 Fatigue 24 14 Diarrhea 20 10 Musculoskeletal pain 20 15 Oropharyngeal pain 18 6 Influenza 16 6 Vomiting 16 12 Muscle spasms 14 6 Back Pain 13 8 Decreased appetite 12 4 Rash 10 4

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MOXIe Part 2 Study Design Scr: screening Double-blind, placebo-controlled, randomized trial (n=103) Enrolled a wide range of patients with FA aged 16 to 40 years Patients randomized 1:1 to 150 mg SKYCLARYS or placebo Primary endpoint: change from baseline in mFARS at Week 48 103 Patients Scr D1 WK12 WK18 WK24 WK36 WK48 Placebo (n=52) SKYCLARYS 150 mg (n=51) 4-WK Follow-Up 4-WK Follow-Up WK52

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Treatment with SKYCLARYS resulted in statistically significant lower (improved) mFARS scores relative to placebo at Week 48 MOXIe Part 2 Placebo-Controlled Trial Results Data plotted are LS mean changes from baseline estimated from mixed model repeated measures (MMRM) analysis for patients randomized to SKYCLARYS (n=40) or placebo (n=42). LS: least squares; pts: points; SE: Standard error; Lynch et al. Ann Neur (2021) 40 42 40 42 36 41 35 41 34 41 40 42 38 41 Placebo SKYCLARYS Group Difference -2.41 points (p=0.0138) LS Mean Change from Baseline in mFARS ± SE 18 4 Study Week Number of patients SKYCLARYS Placebo mFARS Change from Baseline +0.85 pts -1.56 pts Worsened Improved

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MOXIe Extension: Post Hoc Propensity-Matched Analysis FA-COMS: Friedreich's Ataxia Clinical Outcome Measures Study A post hoc Propensity-Matched Analysis was conducted using data from the open-label MOXIe Extension study and external natural history data from FA-COMS as a comparator FA-COMS is a global, multi-center, longitudinal, prospective, observational study Enrolled more than 1,250 patients Clinical outcome measures, including mFARS, assessed annually Patients followed for up to 25 years Lower mFARS scores were observed in patients treated with SKYCLARYS after 3 years relative to a matched set of untreated patients in FA-COMS These exploratory analyses should be interpreted cautiously given the limitations of data collected outside of a controlled study, which may be subject to confounding

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SKYCLARYS Post-Marketing Requirements & Registry Study

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Post-Marketing Requirements Drug-drug interaction study Thorough QT study Lactation study (milk only) Pregnancy and lactation surveillance study Additional nonclinical studies

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SKYCLARYS: Post-Approval Registry Study In addition to the post-marketing requirements, Reata will sponsor a post-marketing registry study Prospective, observational, multinational study Patients with FA treated with SKYCLARYS commercially Objective is to evaluate long-term safety in the real-world setting

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Pharmacovigilance and Medical Affairs Established infrastructure to support pharmacovigilance and safety obligations for SKYCLARYS in the U.S. Medical Information call center has been established Medical affairs team hired and trained to support SKYCLARYS launch

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SKYCLARYS Commercial Launch Plans

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Friedreich's ataxia is an ultra-rare disease Only symptomatic treatment has been available FA strikes the young and vulnerable Patients progress from independence to reliance on others Often, mobility requires wheelchair dependence within 10 years of diagnosis Friedreich's Ataxia is a Serious, Devastating, Ultra-Rare Disease No approved therapies. High unmet medical need 1Internal publication analysis; 2What you need to know about Gaucher Disease, Pfizer (Accessed 1/2023); 3NIH Friedreich's Ataxia Fact Sheet (Accessed 10/2022)

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Friedreich's Ataxia: Patients and HCPs Waiting for a Treatment 1NIH Friedreich Ataxia Fact Sheet (Accessed 2/2023); 22023 Claims Analysis; 3Estimated addressable market; HCP: Healthcare provider US claims data indicates about 5,000 unique, diagnosed FA patients The initial estimate of the Total Addressable Market (TAM) at launch is ~4,500 patients The HCPs treating diagnosed patients have been identified FA patients are motivated. Highly engaged patients are expected to seek treatment early UPDATED FA Patient Population-U.S. Est. U.S. Prevalence1 Diagnosed and Linked to HCP2 U.S. Total Addressable Market: ~4,500 Patients ~5,000 ~6,000 Total Addressable Market (TAM)3 ~4,500

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Communicate the value of SKYCLARYS to HCPs who treat FA Activate FA patients to proactively seek SKYCLARYS treatment Facilitate coverage, access and affordability Commercial Launch Strategy First and only FDA approved treatment for FA in adults and adolescents aged 16 years and older Establish SKYCLARYS as the first effective and safe treatment approved for Friedreich's ataxia 1 2 3

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HCPs Treating FA Patients IdentifiedCommercial efforts to focus on neurology and HCPs with diagnosed patients 1CCRN: Collaborative Clinical Research Network in Friedreich's ataxia, https://curefa.org/network; ; 2https://www.ataxia.org/neurologists-and-specialty-clinics/; 32023 FA Claims analysis A Targeted Approach Covering the Majority of the U.S. FA Market ~2,500 HCPs 9 CCRN Centers1 14 Ataxia Centers2 ~2,500 HCP targets treating FA patients as identified through claims data3 9 CCRN FA Centers are considered centers of excellence for FA patient care 14 Ataxia Centers with diagnosed FA patients will be prioritized through launch 200 Highest Target HCPs 200 Highest FA patient volume target HCPs

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Approximately 95% of neurologists surveyed anticipate prescribing SKYCLARYS within 1 year of approval FA-treating PCPs also communicated that they are likely to prescribe within the first year HCPs are dissatisfied with lack of treatment options currently available to FA patients HCPs indicated that SKYCLARYS addresses many of their unmet needs related to FA treatment Neurologists Anticipate Prescribing SKYCLARYS for FA OMAV in FA HCP Demand Research September 2022 with 124 HCPs, 77 neurologists, 47 PCPs; PCP: Primary care physician % of Neurologists Surveyed Anticipate Prescribing SKYCLARYS

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Reaching and Educating Patients, HCPs and Payers Patient & HCP Education Sales Force Efforts Patient Access Neurology Sales Team National Account Directors Patient Access Liaisons Practice-Level Access Support Centralized Hub Services HCP & Key Account Targets Neurology Sales Experience Rare Disease Experience Average 19 Years Biotech Sales Social & Digital Brand Campaigns Patient & HCP Websites National HCP & Patient Webcasts 2023 Neurology Conferences Field Access Team U.S. Commercial Team of ~50 Employees: Hired, Trained, and Prepared to Launch Communication and Outreach A seasoned and experienced commercial team will execute Reata's first launch

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www.ReataREACH.com 1-844-98-REACH No FA patient will face more than a nominal copay for SKYCLARYS treatment The Responsibility of Patient Access & Affordability 12022 claims analysis; PAP: Patient assistance program; OOP: Out of pocket Commercial Copay Support Product Distribution Insurance & Access Therapy Adherence Resource Referrals New Patient Start Payer Mix and Cost to the Patient1 Patient Access Services-REACH Commercial Effective Patient OOP with Copay Card: $0 Medicare/Medicaid Nominal OOP or Qualify for PAP Uninsured Qualify for PAP (~2%) ~60% ~38%

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Pricing SKYCLARYS SKYCLARYS Pricing Prioritizes Patient Access and Delivering Value to Payers and Physicians Pricing Principles Size of FA Patient Population Urgent Unmet Need for FA Patients SKYCLARYS Efficacy & Safety Profile Novel Mechanism of Action in FA Time and Financial Investment Patient Access is an Important Responsibility and the foundation of our commercial launch Patient Out-of-Pocket Cost will be Nominal Pricing reflects the Value and Benefit brought to Friedreich's ataxia patients Commitment to the Friedreich's Ataxia community

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Beginning Treatment with SKYCLARYS REACH Patient Access Services now active New Patient Start Forms available on the REACH website: www.reataREACH.com 1-844-98-REACH Find information about SKYCLARYS through the brand website: www.SKYCLARYS.com (Websites active within 24 hours) SKYCLARYS Commercial Product Available in Q2 2023 SKYCLARYS New Patient Start Form Not actual product picture

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Operational and Financial Update

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Operational Update Anticipate commercial drug supply to be available in the second quarter of 2023 Accelerating build up of our EU infrastructure following submission of MAA SKYCLARYS intellectual property Composition of Matter patents granted in U.S., Europe, Japan, China, and more than 20 other territories Could be extended 14 years post approval to 2037 in U.S. Could be extended as late as 2038 in Europe Not actual product picture

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Financial Update Strong balance sheet Cash and marketable securities $387.5 million as of December 31, 2022 Option to monetize rare pediatric disease priority review voucher No outstanding funded debt Cash guidance Based on our operational plans, we reaffirm our cash guidance runway through the end of 2024

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Closing Thoughts

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Reata Looking Ahead in 2023 With SKYCLARYS approval Reata is transitioning into a commercial enterprise Planning to engage with FDA about possible label expansion for pediatric patients younger than 16 years of age MAA for omaveloxolone in FA submitted in 4Q22 Plan to pursue development of our Nrf2 activator platform in additional neurological diseases Phase 2 trial of cemdomespib (RTA 901) anticipated to begin in 3Q23 AYAME Phase 3 trial results expected in 1H23 Strong balance sheet Worldwide commercial rights to all pipeline assets1 Robust IP protection for SYKCLARYS, cemdomespib, and bardoxolone 1Ex-Asia for bardoxolone IP: Intellectual Property SKYCLARYSTM Pipeline Global Opportunity

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Q&A