8-K

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): November 12, 2019 (November 11, 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.)

5320 Legacy Drive

Plano, TX 75024

(Address of Principal executive offices, including zip code)

(972) 865-2219

(Registrant’s telephone number, including area code)

2801 Gateway Drive, Suite 150

Irving, Texas 75063

(Former name, former address and former fiscal year, if changes since last report)

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 November 12, 2019, Reata Pharmaceuticals, Inc. (“the Company”) issued a press release announcing its financial results for the nine months ended September 30, 2019. A copy of the press release is attached as Exhibit 99.1 and incorporated herein by reference.

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 November 11, 2019, the Company issued a press release reporting top-line data from the Company’s Phase 3 trial (CARDINAL) of bardoxolone methyl in patients with chronic kidney disease (CKD) caused by Alport syndrome. A copy of the press release is attached as Exhibit 99.2 and incorporated herein by reference.

The Company plans to discuss these results on its previously announced conference call on November 12, 2019, at 8:00 a.m. EDT. Information about how to access the conference call is in the press release attached as Exhibit 99.2. The presentation slides that are to be used in connection with the conference call are attached as Exhibit 99.3 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 for the year ended December 31, 2018 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2019, 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.

Exhibit Number	Description
99.1*	Earnings release press release dated November 12, 2019.
99.2	Cardinal top-line data results press release dated November 11, 2019
99.3	Company management presentation slides.
104	Cover Page Interactive Data File (embedded within the Inline XBRL document).

* Furnished herewith.

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: November 12, 2019	By:	/s/ Manmeet S. Soni
		Manmeet S. Soni
		Chief Financial Officer

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EX-99.1

Exhibit 99.1

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

Conference call with management scheduled for today, November 12, 2019 at 8:00 AM ET

PLANO, Texas—November 12, 2019—Reata Pharmaceuticals, Inc. (Nasdaq: RETA) (“Reata” or the “Company”), a clinical-stage biopharmaceutical company, today announced financial results for the third quarter ended September 30, 2019, and provided an update on the Company’s business and product development programs.

Recent Company Highlights

• Reported positive, topline one-year data from the pivotal CARDINAL study of bardoxolone methyl in patients with chronic kidney disease caused by Alport syndrome

• Reported positive topline data from the pivotal MOXIe study of omaveloxolone in patients with Friedreich’s ataxia

Third Quarter Financial Highlights

The Company incurred total expenses of $46.8 million for the quarter ended September 30, 2019, with research and development accounting for $32.3 million.  This compares to total expenses of $34.7 million for the same period of the year prior, when research and development accounted for $27.1 million.  We reported a net loss of $39.7 million or $1.32 per share for the quarter ended September 30, 2019.  This compares to a net loss of $30.8 million or $1.07 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 offset with an increase 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 growth of our development activities.

We incurred total expenses of $124.6 million for the nine month period ended September 30, 2019, with research and development accounting for $87.9 million.  This compares to total expenses of $97.1 million for the same period of the year prior, when research and development accounted for $72.0 million.  We reported a net loss of $103.2 million or $3.44 per share for the nine month period ended September 30, 2019.  This compares to a net loss of $55.0 million or $2.03 per share in the same period of the year prior.  

The increase in net loss for the nine month period ended September 30, 2019 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 growth of our development activities.  Revenue to date has primarily been related to license and collaboration

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agreements entered into during 2009, 2010, and 2011.  Additional revenue related to variable consideration that was included in the transaction price under the KKC Agreement was recognized in the prior year period. Since we did not have a similar event in the current period, the revenue decreased by comparison.

Our cash-based operating expenses, a non-GAAP measure, were $41.2 million and $109.9 million for the three and nine months ended September 30, 2019, respectively.  This compares to $31.9 million and $89.0 million for the same periods of the year prior.  The increase in cash-based operating expenses for the three and nine months ended September 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 methyl 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 September 30, 2019, we had $240.1 million in cash and cash equivalents.  We expect our current cash, along with our access to additional equity or debt funding, will enable us to meet our current obligations through December 31, 2020.

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:	November 12, 2019
Time:	8:00 a.m. ET
Audience Dial-in (toll-free):	(844) 348-3946
Audience Dial-in (international):	(213) 358-0892
Conference ID:	4159656
Webcast Link:	https://edge.media-server.com/mmc/p/ofwujzj9

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	Three Months Ended						Nine Months Ended
	September 30,						September 30,
	2019			2018			2019			2018
Consolidated Statements of Operations	(Unaudited)
	(in thousands, except share and per share data)
Collaboration revenue
License and milestone	$	7,898		$	4,766		$	23,437		$	44,452
Other revenue		344			409			409			685
Total collaboration revenue		8,242			5,175			23,846			45,137
Expenses
Research and development		32,279			27,144			87,948			71,979
General and administrative		14,283			7,486			36,027			24,802
Depreciation		258			105			659			311
Total expenses		46,820			34,735			124,634			97,092
Other income (expense)
Investment income		1,311			1,094			4,812			1,787
Interest expense		(2,389	)		(2,360	)		(7,199	)		(3,773	)
Loss on extinguishment of debt		-			-			-			(1,007	)
Other income (expense)		-			-			7			-
Total other income (expense)		(1,078	)		(1,266	)		(2,380	)		(2,993	)
Loss before taxes on income		(39,656	)		(30,826	)		(103,168	)		(54,948	)
Provision for taxes on income		38			9			60			15
Net loss	$	(39,694	)	$	(30,835	)	$	(103,228	)	$	(54,963	)
Net loss per share—basic and diluted	$	(1.32	)	$	(1.07	)	$	(3.44	)	$	(2.03	)
Weighted-average number of common shares used in net loss per share basic and diluted		30,110,391			28,704,853			30,004,211			27,022,269

	As of September 30, 2019 (unaudited)			As of December 31, 2018
	(in thousands)
Condensed Consolidated Balance Sheet Data
Cash and cash equivalents	$	240,149		$	337,790
Working capital		171,969			286,353
Total assets		259,123			345,208
Term loan (including current portion, net of issuance cost)		80,236			79,219
Deferred revenue (including current portion)		202,284			225,721
Accumulated deficit		(523,551	)		(420,323	)
Total stockholders’ equity (deficit)	$	(67,423	)	$	15,159

Reconciliation of GAAP to Non-GAAP Financial Measures

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

	Three Months Ended						Nine Months Ended
	September 30,						September 30,
	2019			2018			2019			2018
	(Unaudited)
Total expenses - GAAP	$	46,820		$	34,735		$	124,634		$	97,092
Stock-based compensation expense		(5,380	)		(2,745	)		(14,090	)		(7,783	)
Depreciation		(258	)		(105	)		(659	)		(311	)
Cash-based operating expenses - Non-GAAP	$	41,182		$	31,885		$	109,885		$	88,998

About Reata Pharmaceuticals, Inc.

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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 methyl (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, 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 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) 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 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 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/

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Media:

Matt Middleman, M.D.

LifeSci Public Relations

(646) 627-8384

matt.middleman@lifescipublicrelations.com

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EX-99.2

Exhibit 99.2

Reata Announces Positive topline year one results from pivotal Phase 3 cardinal study of Bardoxolone Methyl in PaTIENTS WITH Alport Syndrome

achieved primary endpoint of Statistically Significant Improvement in eGFR compared to placebo After 48 Weeks of Treatment

achieved key secondary endpoint of statistically significant improvement in Retained egFR compared to placebo after 48 Weeks of Treatment and Withdrawal of drug for 4 Weeks

Conference Call With Management Scheduled for November  12, 2019 at 8:00 AM ET

PLANO, Texas—November 11, 2019—Reata Pharmaceuticals, Inc. (Nasdaq:RETA) (“Reata” or the “Company”), a clinical-stage biopharmaceutical company, announced today that the Phase 3 portion of the CARDINAL study of bardoxolone methyl (bardoxolone) in patients with chronic kidney disease (CKD) caused by Alport syndrome met its primary and key secondary endpoints.  After 48 weeks of treatment, patients treated with bardoxolone had a statistically significant improvement compared to placebo in mean estimated glomerular filtration rate (eGFR) of 9.50 mL/min/1.73 m² (p<0.0001). After 48 weeks of treatment and a four-week withdrawal period, patients treated with bardoxolone had a statistically significant improvement compared to placebo in mean retained eGFR of 5.14 mL/min/1.73 m² (p=0.0012). Bardoxolone treatment was generally reported to be well-tolerated and showed a similar safety profile to the Phase 2 portion of the CARDINAL study.  Based on these positive results, and subject to discussions with regulatory authorities, the Company plans to proceed with the submission of regulatory filings for marketing approval in the United States and internationally.

“The first year results from the CARDINAL study are very promising. This provides hope to the entire Alport syndrome community that we could finally have the first therapy to treat this rare, genetic kidney disease,” said Lisa Bonebrake, Executive Director of the Alport Syndrome Foundation. “The Alport Syndrome Foundation is grateful to the patients who participated in the study.  Their willingness to contribute to our understanding of bardoxolone is a gift to all patients facing the devastating impact that Alport syndrome can have on their lives, others with the disease in their family, and those who care about them. We also extend our deepest gratitude to the clinicians and their institutions for conducting this study and caring for these patients through the process, and to Reata Pharmaceuticals for investing their scientific expertise in the search to find a therapy for Alport syndrome.”

“Patients living with Alport syndrome experience a severe and progressive loss of kidney function that can lead to the need for chronic dialysis treatment or a kidney transplant in the prime of their lives.  The CARDINAL trial of bardoxolone is the first study in which a therapy halted the progression of chronic kidney disease in patients with Alport syndrome,”

said Warren Huff, Reata’s President and Chief Executive Officer. “On behalf of everyone at Reata, I would like to express my sincere appreciation to all of the patients, families, and investigators who are participating in the ongoing CARDINAL study.”

Trial Overview and Results

The Phase 3 portion of CARDINAL is an international, multi-center, double-blind, placebo-controlled, randomized registrational trial that enrolled 157 patients with Alport syndrome at approximately 50 study sites in the United States, Europe, Japan, and Australia.  Pediatric patients represented approximately 15% of enrolled patients.  Patients were randomized 1:1 to bardoxolone or placebo.  The primary endpoint for the study was the change in eGFR, an important measure of the ability of the kidney to filter waste products out of the blood, after 48 weeks of treatment.  The key secondary endpoint for the study was the change in the retained eGFR after 48 weeks of treatment and four weeks of drug withdrawal.  After 52 weeks, patients who completed the first 48 weeks of treatment are restarted on study drug with their original treatment assignments and continue on study drug for a second year.  The second-year on-treatment eGFR will be measured after 100 weeks of treatment and the retained eGFR will be measured at Week 104 after withdrawal of drug for four weeks.  The FDA has provided the Company with written guidance that, in patients with CKD caused by Alport syndrome, an analysis of retained eGFR demonstrating an improvement versus placebo after one year of bardoxolone treatment may support accelerated approval and an improvement versus placebo after two years of treatment may support full approval.

After 48 weeks of treatment, patients treated with bardoxolone had a statistically significant improvement compared to placebo in mean eGFR of 9.50 mL/min/1.73 m² (p<0.0001).  Patients treated with bardoxolone experienced a statistically significant increase from baseline in mean eGFR of 4.72 mL/min/1.73 m², while patients treated with placebo experienced a statistically significant decline from baseline in mean eGFR of -4.78 mL/min/1.73 m².  Patients’ retained eGFR was also assessed at Week 52, after 48 weeks of treatment and four weeks of drug withdrawal.  At Week 52, patients treated with bardoxolone had a statistically significant improvement compared to placebo in mean retained eGFR of 5.14 mL/min/1.73 m² (p=0.0012).  Patients treated with bardoxolone experienced a nonsignificant decline from baseline in mean retained eGFR of -0.96 mL/min/1.73 m², while patients treated with placebo experienced a statistically significant decline from baseline in mean retained eGFR of -6.11 mL/min/1.73 m².  Similar efficacy at Week 48 and Week 52 was observed across multiple subgroups, including among pediatric patients.

Bardoxolone was generally reported to be well tolerated in this study and showed a similar safety profile to the Phase 2 portion of the CARDINAL study.  Seventy-five patients (97%) receiving bardoxolone and 73 patients (91%) receiving placebo experienced an adverse event (AE).  Nine patients (12%) receiving bardoxolone and four patients (5%) receiving placebo discontinued study drug due to an AE, and no individual AE contributed to more than two discontinuations in either group.

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Four patients (5%) receiving bardoxolone and 10 patients (13%) receiving placebo experienced a treatment-emergent serious adverse event (SAE).  No fluid overload or major adverse cardiac events were reported in patients treated with bardoxolone. Blood pressure was reduced relative to baseline in the bardoxolone group, and the between group difference was not significant.  The reported AEs were generally mild to moderate in intensity, and the most common AEs observed more frequently in patients treated with bardoxolone compared to patients treated with placebo were increases in aminotransferases and muscle spasms.  Increases in aminotransferases are a pharmacological effect of bardoxolone, which increases production of aminotransferases in vitro.  The aminotransferase increases observed in CARDINAL were associated with improvements (reductions) in total bilirubin and were not associated with liver injury, and we believe they are related to restoration of mitochondrial function.  Laboratory markers associated with pharmacodynamic activity, including urinary albumin to creatinine ratio and aminotransferases, were unchanged relative to placebo at Week 52 following withdrawal of drug for four weeks.

Reata management will host a call to discuss these results as well as the financial results for the third quarter of 2019 tomorrow, November 12, 2019 at 8:00 a.m. ET.

CONFERENCE CALL INFORMATION

Date:	November 12, 2019
Time:	8:00 a.m. ET
Audience Dial-in (toll-free):	(844) 348-3946
Audience Dial-in (international):	(213) 358-0892
Conference ID:	4159656
Webcast Link:	https://edge.media-server.com/mmc/p/ofwujzj9

About the Retained eGFR Analysis

CKD is characterized by a progressive worsening in the rate at which the kidney filters waste products from the blood called the glomerular filtration rate or GFR.  When GFR falls too low, patients require dialysis or a kidney transplant to survive.  Dialysis leads to a reduced quality of life and increases the likelihood of serious and life-threatening complications.  The five-year survival rate for hemodialysis patients is only approximately 42%.  eGFR is an estimate of GFR that nephrologists use to track the decline in kidney function and progression of CKD.

The FDA has accepted for approval in rare forms of CKD the placebo-corrected “retained eGFR” after withdrawal of drug. Withdrawal of drug after long-term treatment provides evidence whether a drug either protected or harmed the kidney during treatment. If retained eGFR is higher than placebo, this is evidence that the drug protected the kidney during treatment, and, if retained eGFR is lower than placebo, this is evidence that the drug harmed the kidney during treatment. A positive retained eGFR benefit provides evidence that drug treatment may delay kidney failure.

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About Alport Syndrome

Alport syndrome is a rare, genetic form of CKD caused by mutations in the genes encoding type IV collagen, which is a major structural component of the glomerular basement membrane in the kidney. Alport syndrome patients experience a progressive loss in the kidney’s capacity to filter waste products out of the blood that can lead to end stage kidney failure (ESKD) and the need for chronic dialysis treatment or a kidney transplant.  A majority of patients with Alport syndrome develop ESKD, and approximately 50% of patients with the most severe form of the disease require dialysis or a kidney transplant by the age of 25.  According to the Alport Syndrome Foundation, Alport syndrome affects approximately 30,000 to 60,000 people in the United States. There are currently no approved therapies to treat Alport syndrome.

About Bardoxolone Methyl

Bardoxolone methyl is an experimental, oral, once-daily activator of Nrf2, a transcription factor that induces molecular pathways that promote the resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, and inhibiting pro-inflammatory signaling. The FDA has granted Orphan Drug designation to bardoxolone for the treatment of Alport syndrome. The European Commission has granted Orphan Drug designation in Europe to bardoxolone for the treatment of Alport syndrome.

Bardoxolone is currently being studied in CARDINAL, a Phase 3 study for the treatment of Alport syndrome, FALCON, a Phase 3 study for the treatment of autosomal dominant polycystic kidney disease, AYAME, a Phase 3 study for the treatment of diabetic kidney disease that is being conducted by our licensee, Kyowa Kirin Co., Ltd., in Japan, and CATALYST, a Phase 3 study for the treatment of connective tissue disease associated with pulmonary arterial hypertension.  Bardoxolone treatment has produced positive results in Phase 2 studies in patients with IgA nephropathy, focal segmental glomerulosclerosis, and CKD associated with type 1 diabetes.

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.

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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, 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 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) 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 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 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

info@reatapharma.com

http://news.reatapharma.com

Investor Relations:

Vinny Jindal

Vice President, Strategy

(469) 374-8721

ir@reatapharma.com

Media:

Matt Middleman, M.D.

LifeSci Public Relations

(646) 627-8384

matt.middleman@lifescipublicrelations.com

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EX-99.3

Management call to discuss Positive topline pivotal Year 1 CARDINAL Data Exhibit 99.3

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, future revenues, projected costs, prospects, business strategy, and plans and objectives of management for future operations, including our plans to submit for regulatory filings. 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, 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: 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 commercialization of our product candidates, if approved; the rate and degree of market acceptance of our product candidates; our expectations regarding the potential market size and the size of the patient populations for our product candidates, if approved for commercial use, and the potential market opportunities for commercializing our product candidates; 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 maintain and establish relationships with third parties, such as contract research 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 clinical trials, and our research and development programs; the impact of governmental laws and regulations and regulatory developments in the United States and foreign countries; and developments and projections relating to our competitors and our industry. 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.

Alport Syndrome is a Severe, Inherited Form of CKD Estimated Prevalence Alport syndrome is the second most common inherited cause of kidney failure1,2 Collagen mutations drive mitochondrial dysfunction, inflammation, and fibrosis3,4 In most severe forms of disease, median age for kidney failure is 25 years1 Progressive loss of kidney function leads to need for dialysis or kidney transplant 1Jais et al., JASN (2000); 2Kashtan et al., Kidney Int (2018); 3Suh et al., Nat Rev Nephrol (2013); 4Gomez et al., JCI (2015); 5Estimated based on Persson Clin Nephrol (2005); USRDS Report; Hasstedt Am J Hum Genet. (1983); Temme, Kidney Int. (2012)   30,000-60,000 in US 32,000-64,0005 in the EU5 Very severe form of CKD with no approved therapies

Alport Syndrome Patients Rapidly Progress to ESKD Diabetic CKD1 Hypertensive CKD2 ADPKD3 Alport4 Syndrome Average Annual Kidney Function Decline on Standard of Care 1Perkovic et al. 2018 CANVAS; 2Wright et al. 2002 AASK; 3Torres et al. 2017 REPRISE; 4CARDINAL Phase 3 placebo arm  5Assuming baseline eGFR=60 mL/min and ESKD occurs at 15 mL/min Estimated Years to ESKD5 25 23 19 7

Approved and Widely Used CKD Drugs Slow the Rate of eGFR Decline Standard of care treatments for CKD include ACE inhibitors (ACEi), angiotensin receptor blockers (ARBs) and SGLT2 inhibitors In registrational studies, these drugs slow, but do not stop eGFR decline eGFR over time in both the placebo and active drug arms declines The treatment effect is measured by comparing the active treatment group to the placebo group When compared to baseline, both the active and placebo groups’ eGFR change is negative The therapeutic benefit is the delay in the rate of decline which delays the need for dialysis/transplant RENAAL: ARB in Diabetic CKD1 CREDENCE: SGLT2i in Diabetic CKD2 1Brenner, NEJM (2001), 2Perkovic (2019)

Tolvaptan Also Only Slows the Rate of eGFR Decline 1.27 mL/min Tolvaptan in ADPKD Retained eGFR Benefit1 Tolvaptan recently approved for ADPKD using eGFR change after withdrawal of drug, the retained eGFR benefit Same registrational endpoint as CARDINAL Phase 3 study In its registrational REPRISE study, tolvaptan slowed, but did not stop eGFR decline eGFR in both tolvaptan and placebo groups declined The tolvaptan group eGFR declined by 2.34 mL/min The placebo group eGFR declined by 3.61 mL/min Tolvaptan was approved based on the 1.27 mL/min improvement compared to placebo 1Torres, NEJM (2017)

CARDINAL Endpoints: eGFR Improvement On and Off Treatment FDA guided Reata that retained eGFR benefit versus placebo at one year of treatment may support accelerated approval and after two years may support full approval Consistent with tolvaptan precedent FDA provided us with similar guidance for our FALCON study in ADPKD Has provided this design to other sponsors CARDINAL Primary: change from baseline in eGFR versus placebo at Week 48 Key Secondary: change from baseline in eGFR versus placebo at Week 52 after withdrawal of drug for 4 weeks Retained eGFR benefit versus placebo is strong evidence treatment may delay or prevent the need for dialysis or a transplant 

CARDINAL Phase 3: Pivotal Study Design International, double-blind, placebo-controlled, randomized, registrational trial Largest interventional study in patients with AS Enrolled a wide and representative range of patients with AS eGFR: 30 to 90 ml/min Age: 12 to 70 years After 52 weeks, patients restart study drug with original treatment assignments and continue for the second year R Bard Placebo Bard Placebo Year 1 On-Treatment Year 2 On-Treatment W/D W/D Off Study Drug Off Study Drug 1:1

Demographics and Baseline Disease Characteristics Characteristic (Mean ± SD) Placebo (n=80) Bard (n=77) Male (n,%) 32 (40%) 34 (44%) Age 39.6 ± 16.0 38.8 ± 14.6      <18 (n,%) 12 (15%) 11 (14%) eGFR (mL/min/1.73 m2) 62.6  ± 18.2 62.7 ± 17.7      ≤60 (n,%) 33 (41%) 33 (43%)      >60 (n,%) 47 (59%) 44 (57%) Albumin to Creatinine Ratio (mg/g)  (Geometric Mean ± SE) 134.5 ± 33.4 148.1 ± 34.3      ≤ 300 mg/g (n,%) 43 (54%) 42 (55%)      > 300 (n,%) 37 (46%) 35 (46%) SBP (mmHg) 119.6 ± 13.2 119.7 ± 11.9 DBP (mmHg) 72.6 ± 10.5 73.8 ± 9.4 ACEi and/or ARB Use (n, %) 60 (75%) 62 (81%)

CARDINAL Met the Primary Endpoint Bard treatment significantly improved on-treatment eGFR at Week 48 by 9.50 ml/min relative to placebo (p<0.0001) Placebo patients had significant kidney function loss versus baseline (p=0.0002)*  Bard significantly improved eGFR (p=0.0004)* versus baseline  p<0.0001 Primary Endpoint: eGFR Change at Week 48 *p-value estimated comparing the mean changes to zero.

CARDINAL Met Key Secondary Endpoint Bard treatment significantly improved off-treatment eGFR at Week 52 by 5.14 ml/min relative to placebo (p=0.0012) Placebo patients had significant kidney function loss relative to baseline (p<0.0001)*  Bard patients had a slight, non-significant decline relative to baseline (p=0.45)* Similar efficacy observed across multiple subgroups, including males versus females, pediatric population, and baseline ACR p=0.0012 Key Secondary Endpoint: eGFR Change at Week 52 *p-value estimated comparing the mean changes to zero. ANCOVA analyses include off-treatment eGFR values from patients that discontinued treatment early

Bard Treatment Produced Benefit Across All Quartiles of Response Week 48 eGFR Change Mean ± SD Week 52 eGFR Change Mean ± SD ∆eGFR Quartile Placebo Bard Placebo Bard 1 4.2 ± 2.4 20.9 ± 11.5 5.0 ± 4.2 12.9 ± 8.1 2 -1.3 ± 1.4 9.2 ± 2.4 -2.5 ± 1.4 2.5 ± 1.6 3 -5.7 ± 1.5 1.7 ± 2.2 -7.4 ± 2.3 -3.2 ± 1.7 4 -16.1 ± 6.4 -10.5 ± 6.4 -17.3 ± 5.0 -12.7 ± 5.6 eGFR change measured as mL/min

Summary of Safety Fewer SAEs reported in Bard patients No fluid overload or major adverse cardiac events in patients treated with Bard Blood pressure decreased relative to baseline in the Bard group but was not significantly different between groups Overall low rate of cardiac and vascular AEs that was reduced in the Bard arm Most common AEs included muscle spasms and increased ALT or AST Albuminuria increased with Bard at Week 48 but was unchanged when adjusted for eGFR and unchanged from baseline at Week 52 Placebo (n=80) Bard (n=77) Number of Patients with AE 73 (91%) 75 (97%) Number of Patients with SAE 10 (13%) 4 (5%) Number of Patients with AE Leading to Permanent  Treatment Discontinuation 4 (5%) 9 (12%)

Summary and Next Steps The Phase 3 portion of CARDINAL met its primary endpoint (p<0.0001) The Phase 3 portion of CARDINAL met its precedented, registrational key secondary endpoint (p=0.0012) Bard treatment effectively slowed or halted decline in eGFR in patients with rapidly progressing CKD Approximately 75% of bardoxolone treated patients had an improvement in eGFR while on treatment Approximately 75% of placebo patients had worsening eGFR Reported to be well tolerated with numerically fewer SAEs on Bard (5%) versus placebo (13%) Potential for Bard to be the first approved treatment for AS Planning to meet with FDA and other regulatory agencies to discuss marketing application submission plans Beginning to plan for ex-US launch as a result of recent reacquisition of global rights

Q&A

An Eventful Q4 On October 10, we announced that we had reacquired the rights to develop Bard, Omav and our other Nrf2 activators On October 11, we announced the presentation at ASN of several important studies, including the Kashihara work demonstrating the precise mechanism of GFR improvement from Nrf2 activation On October 14, we announced positive data from the MOXIe study of Omav in patients with Friedreich’s ataxia And yesterday we announced positive data from the CARDINAL Phase 3 study of Bard in patients with Alport syndrome

Poised to Develop Franchises in CKD and Neurological Disease Global Opportunity Reata possesses WW commercial rights to all pipeline assets* Few or no effective therapies currently approved for lead indications Bardoxolone in Rare Forms of CKD Positive pivotal data in Alport syndrome Pipeline in rare forms of CKD Pivotal ADPKD study ongoing Positive proof-of-concept data in FSGS, IgAN, and T1D-CKD Omaveloxolone in Neurology Positive pivotal data in FA Proof-of-concept in other neurological diseases Plan to study Omav in additional neurological indications *ex-Asia for Bardoxolone

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Document and Entity Information	Nov. 11, 2019
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Document Period End Date	Nov. 11, 2019
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