UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

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

Date of Report (Date of earliest event reported): August 8, 2019

 

Reata Pharmaceuticals, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

DELAWARE

001-37785

11-3651945

(State or Other Jurisdiction

of Incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

2801 Gateway Drive; Suite 150

Irving, TX 75063

(Address of Principal executive offices, including zip code)

(972) 865-2219

(Registrant’s telephone number, including area code)

 

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:

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange on which registered

Class A Common Stock, Par Value $0.001 Per Share

 

RETA

 

NASDAQ Global Market

 

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.

 

 


 

Item 2.02. Results of Operations and Financial Condition.

On August 8, 2019, Reata Pharmaceuticals, Inc. (“the Company”) issued a press release announcing its financial results for the six months ended June 30, 2019. A copy of the press release is furnished herewith as Exhibit 99.1.

The information set forth under Item 2.02 and in Exhibit 99.1 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, except as shall be expressly set forth by specific reference in such filing.

Item 8.01. Other Events.

On August 8, 2019, the Company issued a press release reporting updates to its registrational trials including, CARDINAL, FALCON, and MOXIe. The Company plans to hold a conference call on August 8, 2019, at 8:00 a.m. EDT to discuss these updates.  Information about how to access the conference call is in the press release attached as Exhibit 99.1.  The presentation slides that are to be used in connection with the conference call are attached as Exhibit 99.2 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 expected date of receipt of milestone payments, the success of our administrative protest with the IRS, the success, cost and timing of our product development activities and clinical trials, our plans to research, develop and commercialize our product candidates, 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) 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 (iv) 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, we undertake 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.

Exhibit

Number

 

Description

99.1*

 

Press release dated August 8, 2019 .

99.2

 

Company management presentation slides.

 

*

Furnished herewith.

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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.

 

 

 

Reata Pharmaceuticals, Inc.

 

 

 

 

Date: August 8, 2019

 

By:

/s/ Jason D. Wilson

 

 

 

Jason D. Wilson

 

 

 

Chief Financial Officer

 

3

Exhibit 99.1

 

 

REATA PHARMACEUTICALS, INC. ANNOUNCES SECOND QUARTER 2019 FINANCIAL RESULTS AND AN UPDATE ON DEVELOPMENT PROGRAMS

Conference call with management scheduled for today, August 8, 2019

IRVING, Texas—August 8, 2019 —Reata Pharmaceuticals, Inc. (Nasdaq: RETA), a clinical-stage biopharmaceutical company, today announced financial results for the second quarter ended June 30, 2019, and provided an update on the Company’s business and product development programs.

Product Development Updates

Phase 2/3 CARDINAL Trial of Bardoxolone in Alport Syndrome

The Phase 3 portion of CARDINAL is an international, multi-center, randomized, double-blind, placebo-controlled trial studying the safety and efficacy of bardoxolone methyl (bardoxolone) in patients with chronic kidney disease caused by Alport syndrome.  Enrollment in the pivotal Phase 3 portion of CARDINAL was completed last year with 157 patients.  We expect to announce one-year, top-line results from CARDINAL in the second half of 2019.  The U.S. Food and Drug Administration (FDA) has provided guidance that an improvement in retained estimated glomerular filtration rate (eGFR) versus placebo after 48 weeks of treatment and a four-week drug withdrawal period may support accelerated approval under subpart H.  Data demonstrating an improvement versus placebo in retained eGFR after two years may support full approval.  No safety concerns have been reported by the data monitoring committee.

MOXIe Trial of Omaveloxolone in Friedreich’s Ataxia

MOXIe is a two-part, international, multi-center, randomized, double-blind, placebo-controlled registrational trial studying the safety and efficacy of omaveloxolone in patients with Friedreich’s ataxia (FA).  Enrollment in the pivotal part 2 of MOXIe was completed last year with 103 patients, and we expect to announce top-line data in the second half of 2019.  The FDA has provided guidance that an analysis of modified Friedreich’s Ataxia Rating Scale (mFARS) scores demonstrating an improvement versus placebo after 48 weeks of omaveloxolone treatment may support submission of a New Drug Application for omaveloxolone for the treatment of FA.  No safety concerns have been reported by the data monitoring committee.

Phase 3 FALCON Trial of Bardoxolone in Autosomal Dominant Polycystic Kidney Disease

We announced in May 2019 that the first patient was enrolled in a registrational Phase 3 trial called FALCON, an international, multi-center, randomized, double-blind, placebo-controlled trial studying the safety and efficacy of bardoxolone in approximately 300 patients with autosomal dominant polycystic kidney disease.  The FDA has provided guidance that an improvement in retained eGFR versus placebo at one year may support accelerated approval under

1

 


 

 

subpart H, and that data demonstrating an improvement versus placebo in retained eGFR after two years may support full approval.

Phase 3 CATALYST Trial of Bardoxolone in Connective Tissue Disease-Associated Pulmonary Arterial Hypertension

We are conducting the pivotal Phase 3 CATALYST trial of bardoxolone in patients with pulmonary arterial hypertension associated with connective tissue disease, an often-fatal manifestation of many types of autoimmune disease, including systemic sclerosis (scleroderma) and systemic lupus erythematosus.  The trial will enroll approximately 200 patients, with top-line data expected in the first half of 2020.

Selected Clinical Milestones in 2019

 

Pivotal CARDINAL data in the second half of 2019

 

Pivotal MOXIe data in the second half of 2019

Financial Highlights

The Company incurred total expenses of $41.5 million for the quarter ended June 30, 2019, with research and development accounting for $29.6 million.  This compares to total expenses of $34.2 million for the same period of the year prior, when research and development accounted for $23.4 million.  We reported a net loss of $34.4 million or $1.14 per share for the quarter ended June 30, 2019.  This compares to a net loss of $28.2 million or $1.08 per share in the same period of the year prior.

The net loss for the three-month period compared to the year prior is primarily driven by an increase in expenses while revenue remained consistent to the year prior.  Higher expenses were driven by an increase in research and development expenses due to clinical, manufacturing, and medical affairs activities, and an increase in personnel expenses to support growth of our development activities.

We incurred total expenses of $77.8 million for the six month period ended June 30, 2019, with research and development accounting for $55.7 million.  This compares to total expenses of $62.4 million for the same period of the year prior, when research and development accounted for $44.8 million.  We reported a net loss of $63.5 million or $2.12 per share for the six month period ended June 30, 2019.  This compares to a net loss of $24.1 million or $0.92 per share in the same period of the year prior.  

The increase in net loss for the six month period is driven primarily by both an increase in expenses and a decrease in revenue.  Higher expenses were driven by an increase in research and development expenses due to clinical, manufacturing, and medical affairs activities, and an increase in personnel expenses to support expanded development activities.  Revenue to date has primarily been related to license and collaboration agreements entered into during 2009, 2010, and 2011.  The decrease in revenue was primarily due to an increase in revenue recognized in the first

2

 


 

 

quarter of 2018 from the portion of a $30 million milestone from K yowa K irin C ompany that was included in the transaction price for which we did not have a similar event du ri ng 2019.

Our cash-based operating expenses, a non-GAAP measure, were $36.8 million and $68.7 million for the three and six months ended June 30, 2019, respectively.  This compares to $31.6 million and $57.1 million for the same period of the year prior.  Cash-based operating expenses for the quarters ended June 30 and March 31, 2019, were $36.8 million and $31.9 million, respectively.   The increase in cash-based operating expenses for the three months ended June 30, 2019, were driven by increased manufacturing and clinical activities, as well as increased personnel costs to support growth in our development activities.  We expect our cash-based operating expenses to continue to increase in the future as we advance bardoxolone and omaveloxolone through ongoing and future clinical trials, scale manufacturing for registrational and validation purposes, advance other product candidates into mid- and later-stage clinical trials, expand our product candidate portfolio, increase both our research and development and administrative personnel, and plan for commercialization of our product candidates.

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

Non-GAAP Financial Measures

In addition to the U.S. generally accepted accounting principles (GAAP) financial highlights, this earnings release includes cash-based operating expenses, a non-GAAP financial measure, which the Company defines as total expenses excluding stock-based compensation expense and depreciation expense.  A reconciliation of this non-GAAP financial measure to its most directly comparable GAAP financial measure is presented in the table below in this earnings release.

We believe that this non-GAAP financial measure, in addition to GAAP financial measures, provides a meaningful measure of our ongoing business and operating performance by allowing investors to analyze our financial results similarly to how management analyzes our financial results by viewing period expense totals more indicative of effort directly expended to advance the business and our product candidates.  Non-GAAP financial measures should be considered in addition to, not in isolation or as a substitute for, GAAP financial measures.  In addition, our non-GAAP financial measure may differ from similarly named measures used by other companies.

 

CONFERENCE CALL INFORMATION

 

Date:

Wednesday, August 8, 2019

Time:

8:00 a.m. ET

Audience Dial-in (toll-free):

(844) 348-3946

Audience Dial-in (international):

(213) 358-0892

Conference ID:

7587139

Webcast Link:

https://edge.media-server.com/mmc/p/h8xmbyuj

 

 

3

 


 

 

 

 

Three Months Ended

 

 

Six Months Ended

 

 

 

June 30,

 

 

June 30

 

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Consolidated Statements of Operations

 

(Unaudited)

 

 

 

(in thousands, except share and per share data)

 

Collaboration revenue

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

License and milestone

 

$

7,813

 

 

$

7,519

 

 

$

15,539

 

 

$

39,686

 

Other revenue

 

 

20

 

 

 

52

 

 

 

64

 

 

 

276

 

Total collaboration revenue

 

 

7,833

 

 

 

7,571

 

 

 

15,603

 

 

 

39,962

 

Expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

29,554

 

 

 

23,429

 

 

 

55,668

 

 

 

44,835

 

General and administrative

 

 

11,706

 

 

 

10,689

 

 

 

21,744

 

 

 

17,317

 

Depreciation

 

 

232

 

 

 

105

 

 

 

401

 

 

 

206

 

Total expenses

 

 

41,492

 

 

 

34,223

 

 

 

77,813

 

 

 

62,358

 

Other income (expense)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Investment income

 

 

1,705

 

 

 

357

 

 

 

3,502

 

 

 

693

 

Interest expense

 

 

(2,413

)

 

 

(903

)

 

 

(4,810

)

 

 

(1,413

)

Loss on extinguishment of debt

 

 

-

 

 

 

(1,007

)

 

 

-

 

 

 

(1,007

)

Other income (expense)

 

 

7

 

 

 

-

 

 

 

7

 

 

 

-

 

Total other income (expense)

 

 

(701

)

 

 

(1,553

)

 

 

(1,301

)

 

 

(1,727

)

Loss before taxes on income

 

 

(34,360

)

 

 

(28,205

)

 

 

(63,511

)

 

 

(24,123

)

Provision for taxes on income

 

 

20

 

 

 

6

 

 

 

23

 

 

 

6

 

Net loss

 

$

(34,380

)

 

$

(28,211

)

 

$

(63,534

)

 

$

(24,129

)

Net loss per share—basic and diluted

 

$

(1.14

)

 

$

(1.08

)

 

$

(2.12

)

 

$

(0.92

)

Weighted-average number of common shares   

   used in net loss per share basic and diluted

 

 

30,069,048

 

 

 

26,178,793

 

 

 

29,950,241

 

 

 

26,167,033

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

June 30, 2019

(unaudited)

 

 

December 31,

2018

 

 

 

(in thousands)

 

Condensed Consolidated Balance Sheet Data

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

280,449

 

 

$

337,790

 

Working capital

 

 

219,502

 

 

 

286,353

 

Total assets

 

 

300,488

 

 

 

345,208

 

Term loan

 

 

79,897

 

 

 

79,219

 

Deferred revenue (including current portion)

 

 

210,182

 

 

 

225,721

 

Accumulated deficit

 

 

(483,857

)

 

 

(420,323

)

Total stockholders’ equity (deficit)

 

$

(33,473

)

 

$

15,159

 

 

 

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Reconciliation of GAAP to Non-GAAP Financial Measures

The following table presents results for the three months ending (in thousands) (unaudited):

 

 

2019

 

 

2018

 

 

June 30

 

 

March 31

 

 

December 31

 

 

September 30

 

 

June 30

 

 

March 31

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total expenses - GAAP

$

41,492

 

 

$

36,322

 

 

$

33,373

 

 

$

34,735

 

 

$

34,223

 

 

$

28,136

 

Stock-based compensation expense

 

(4,483

)

 

 

(4,227

)

 

 

(2,768

)

 

 

(2,745

)

 

 

(2,552

)

 

 

(2,485

)

Depreciation

 

(232

)

 

 

(170

)

 

 

(120

)

 

 

(105

)

 

 

(105

)

 

 

(101

)

Cash-based operating

   expenses - Non-GAAP

$

36,777

 

 

$

31,925

 

 

$

30,485

 

 

$

31,885

 

 

$

31,566

 

 

$

25,550

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Change from previous quarter

$

4,852

 

 

$

1,440

 

 

$

(1,400

)

 

$

319

 

 

$

6,016

 

 

$

961

 

Percentage change from previous

   quarter

 

15

%

 

 

5

%

 

 

-4

%

 

 

1

%

 

 

24

%

 

 

4

%

 

About Reata Pharmaceuticals, Inc.

Reata is a clinical-stage biopharmaceutical company that develops 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 two most advanced clinical candidates, bardoxolone and omaveloxolone, target the important transcription factor Nrf2 that promotes restoration of mitochondrial function, reduction of oxidative stress, and inhibition of pro-inflammatory signaling.   Bardoxolone and omaveloxolone are investigational drugs, and their safety and efficacy have not been established by any agency.

Forward-Looking Statements

This press release includes 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, 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 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 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) 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 (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, under the caption “Risk Factors.”  The forward-looking statements speak

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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.

 

Contact:

Reata Pharmaceuticals, Inc.

(972) 865-2219

http://reatapharma.com

 

Investors:

Vinny Jindal

Vice President, Strategy

(469) 374-8721

ir@reatapharma.com

http://reatapharma.com/contact-us/

 

Media:

Matt Middleman, M.D.

LifeSci Public Relations

(646) 627-8384

matt.middleman@lifescipublicrelations.com

 

6

 

SLIDE 1

Second quarter 2019 earnings call August 8, 2019 Exhibit 99.2

SLIDE 2

Forward-Looking Statements 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, business strategy, and plans and objectives of management for future operations. In some cases, you can identify forward-looking statements by terminology such as “believe,” “will,” “may,” “estimate,” “continue,” “aim,” “assume,” “anticipate,” “contemplate,” “model,” “intend,” “target,” “project,” “should,” “plan,” “expect,” “predict,” “could,” “possible,” “seek,” “goal”, “potential,” “hypothesize,” “likely” 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, 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 forecast in these statements. Any differences could be caused by a number of factors including but not limited to: the success, cost, and timing of our product development activities and clinical trials; our ability to advance our Nrf2 activators and other technologies; our ability to obtain and maintain regulatory approval of our product candidates, and limitations and warnings in the label of an approved product candidate; 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 commercialization of our product candidates, if approved; the rate and degree of market acceptance of our product candidates; the size and growth potential of the markets for our product candidates, and our ability to identify target patient populations and serve those markets, especially for diseases with small patient populations; the success of competing therapies that are or may become available; 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 contract with third-party suppliers and manufacturers and their ability to perform adequately; our ability to attract 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; and regulatory developments in the United States and foreign countries. 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 omaveloxolone are investigational drugs, and their safety and efficacy have not been established by any agency.

SLIDE 3

Strong financial position Cash of $280M, lasting through 3 pivotal readouts Franchise building Expansion into other rare forms of CKD2 and neurological diseases Addressing unmet needs Deadly rare diseases No approved therapy Little to no competition Two pivotal trials fully enrolled and reading out this year Alport syndrome Friedreich’s ataxia Pathway to potential approval Strong Phase 2 outcomes Conservative pivotal clinical trial designs Clear formal FDA1 guidance on the path to approval Reata at a Glance 1FDA: U.S. Food and Drug Administration; 2CKD: Chronic Kidney Disease.

SLIDE 4

US Rare CKD Patients ADPKD T1D CKD FSGS IgAN Alport Syndrome ~400,000 ~160,000 ~120,000 ~40,000 ~30,000-60,000 Significant opportunity for Bard1 in rare forms of CKD Few or no effective therapies currently approved Aggregate prevalence exceeds 700,000 patients CARDINAL Phase 3 study in Alport syndrome Fully enrolled at 157 patients Potential to be first therapy approved for AS FALCON Phase 3 study in ADPKD2 PHOENIX Phase 2 demonstrated significant eGFR improvement at 12 weeks FALCON design and endpoints similar to CARDINAL Phase 3 study Study is enrolling patients Positive data from PHOENIX in ADPKD, IgAN3, FSGS4, and T1D CKD5 1Bard: bardoxolone methyl; 2ADPKD: autosomal dominant polycystic kidney disease; 3IgAN: IgA nephropathy; 4FSGS: focal segmental glomerulosclerosis; 5T1D CKD: type 1 diabetic CKD. Bard Development for Rare Forms of CKD

SLIDE 5

CARDINAL: Data in Alport Syndrome Expected this Year Pivotal Phase 3 enrolled 157 patients Randomized, double-blind, placebo-controlled international study Two-year total treatment duration Enrolled patients across approximately 50 sites in the U.S., Europe, Australia, and Japan Broad eligibility criteria eGFR1 30-90 mL/min 2 Age 12-70 years old Key endpoints at one and two years are eGFR-based Retained eGFR benefit at Week 52 after withdrawal of drug for 4 weeks may support accelerated approval Retained eGFR benefit at Week 104 after withdrawal of drug for 4 weeks may support full approval One-year data will be reported this year Trial is ongoing and will be completed in 2H20 1eGFR: estimated glomerular filtration rate; 2Units of mL/min/1.73m2 are represented as mL/min.

SLIDE 6

CARDINAL Phase 3 Analysis Plans Adjusted the statistical analysis plan based on recent FDA review of tolvaptan Phase 3 study, REPRISE REPRISE used ANCOVA1 analysis method to support approval in ADPKD ANCOVA allows inclusion of patients who discontinued early, minimizing missing data Accordingly, CARDINAL Phase 3 will use ANCOVA, not MMRM2, to calculate retained benefit Using ANCOVA, the placebo-corrected detectable difference in retained eGFR benefit is approximately 2.5 mL/min CARDINAL is conservatively powered based on observed Phase 2 results 1ANCOVA: Analysis of covariance; 2MMRM: Mixed effect Model Repeat Measurement

SLIDE 7

Pivotal Phase 3 is enrolling approximately 300 patients Randomized, double-blind, placebo-controlled international study Two-year total treatment duration Broad eligibility criteria eGFR 30-90 mL/min Age 18-70 years old Retained eGFR after drug withdrawal can support approval Potential accelerated approval on retained eGFR after one year of treatment and drug withdrawal Potential full approval on retained eGFR after two years of treatment and drug withdrawal Enrollment began during May 2019 Phase 3 Trial of Bard for the Treatment of ADPKD: FALCON

SLIDE 8

NDA1 preparations are underway Large safety database with over 2,000 people having been exposed to Bard Reata has conducted all pivotal preclinical toxicology studies and clinical pharmacology studies required for NDA submission for Alport syndrome Commercial preparations are underway Supply chain readiness on track for planned NDA and product launch Marketing, operations, and sales commercial leadership team is onboard Disease awareness campaigns have launched to educate physicians about Alport syndrome 1NDA: new drug application Bard CKD Program: Summary and Next Steps

SLIDE 9

MOXIe: Data in Friedreich’s Ataxia Expected this Year Pivotal portion enrolled 103 patients Randomized, double-blind, placebo-controlled international study of Omav1 in FA2 48-week total treatment duration Enrolled patients across 11 sites in the U.S., Europe, and Australia Broad eligibility criteria mFARS3 20-80 Age 16-40 years old Patients with pes cavus foot deformity limited to 20 total patients mFARS endpoint may support approval Potential full approval on mFARS after 48 weeks of treatment Key secondary endpoint is Patient Global Impression of Change Battery of other secondary endpoints is being assessed In 2H19, trial will be completed and data will be reported 1Omav: omaveloxolone; 2FA: Friedreich‘s ataxia; 3mFARS: modified Friedreich's Ataxia Rating Scale

SLIDE 10

Pes cavus foot deformity likely interferes with the ability to perform assessments that require standing, walking or pedaling FDA recently published draft guidance “Enhancing Diversity of Clinical Trial Populations1” Encourages sponsors to study broader participant groups as part of secondary analyses Allows sponsor to implement a “predictive enrichment strategy” or narrowing population for primary analysis to enrich treatment effect Consistent with the guidance, we narrowed the primary analysis population for Part 2 efficacy to the patients enrolled without pes cavus The minimum detectable placebo-corrected difference in mFARS is approximately 1.3 points assuming similar variability to that observed in part 1 of MOXIe Safety and efficacy will be assessed descriptively for the broader participant group that includes all patients enrolled FDA has reviewed the revised analysis plan MOXIe Part 2 Analysis Plans 1https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhancing-diversity-clinical-trial-populations-eligibility-criteria-enrollment-practices-and-trial

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Omav FA Program: Summary and Next Steps NDA preparations are underway FDA has provided written guidance that mFARS is an acceptable endpoint for approval for Omav in FA No major safety signals detected in completed trials Few remaining clinical pharmacology studies required for NDA submission are underway Few remaining nonclinical toxicology studies required for NDA submission are nearing completion Commercial preparations are underway Supply chain readiness on track for planned NDA and product launch Marketing, operations, and sales commercial leadership team is onboard Disease awareness campaigns have launched to educate about Friedreich’s ataxia

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Phase 3 Trial of Bard for Treatment of CTD-PAH: CATALYST Phase 3 enrolling 200 patients Randomized, double-blind, placebo-controlled international study of Bard in CTD-PAH1 24-week treatment duration Enrolling patients across approximately 100 sites in North America, Europe, Australia, South America, and Asia Broad eligibility criteria 6MWD2 ≥ 150 meters Age 18-75 years old WHO3 Functional Class II and III on up to two background therapies 6MWD endpoint supports approval Potential full approval on 6MWD after 24 weeks of treatment Conservatively powered Data expected 1H20 1CTD-PAH: connective tissue disease-associated pulmonary arterial hypertension; 26MWD: Six-minute walk distance; 3WHO: World Health Organization

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Condensed Statements of Operations Three Months Ended June 30 Six Months Ended June 30 (unaudited; in thousands, except share and per share data) 2019 2018 2019 2018 Total Revenue $7,833 $7,571 $15,603 $39,962 Expenses Research and development $29,554 $23,429 $55,668 $44,835 General and administrative $11,706 $10,689 $21,744 $17,317 Depreciation $232 $105 $401 $206 Total Expenses $41,492 $34,223 $77,813 $62,358 Net loss $(34,380) $(28,211) $(63,534) $ (24,129) Weighted-average number of common shares used in net loss per share (basic) 30,069,048 26,178,793 29,950,241 26,167,033 Net loss per share (basic) $(1.14) $(1.08) $(2.12) $(0.92) We expect our current cash to fund our operations through data readouts for CARDINAL, MOXIe, and CATALYST June 30, 2019 (unaudited) December 31, 2018 (in thousands) Cash and Cash Equivalents $280,449 $337,790 Financial Highlights

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Bard in Alport syndrome Pivotal Phase 3 fully enrolled with data available in 2H19 Bard in ADPKD Pivotal Phase 3 trial in ADPKD initiated in May 2019 Omav in Friedreich’s ataxia Pivotal Phase 2, part 2 fully enrolled with data available in 2H19 Bard in CTD-PAH Phase 3 CATALYST pivotal data available in 1H20 Partner Program: Bard in diabetic CKD Phase 3 AYAME trial fully enrolled, data available in 1H22 Sponsored by Kyowa Kirin Co., Reata’s licensee in Asia Recent Highlights and Key Upcoming Milestones

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Q&A