UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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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) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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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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Name of each exchange on which registered |
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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. ☐
Item 2.02. Results of Operations and Financial Condition.
On May 10, 2022, Reata Pharmaceuticals, Inc. (“the Company”) issued a press release announcing its financial results for the three months ended March 31, 2022. 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 7.01. Regulation FD Disclosure.
The Company will utilize slides to make a presentation regarding the Company’s business on the Company’s earnings call scheduled for 8:30 a.m. ET, on May 10, 2022. A copy of the slides is furnished as Exhibit 99.2 attached hereto 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 99.2 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.
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.
Exhibit Number |
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Description |
99.1* |
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99.2* |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document). |
* 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.
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Reata Pharmaceuticals, Inc. |
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Date: May 10, 2022 |
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By: |
/s/ Manmeet S. Soni |
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Manmeet S. Soni |
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Chief Operating Officer, Chief Financial Officer and President |
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Exhibit 99.1 |
REATA PHARMACEUTICALS, INC. ANNOUNCES FIRST QUARTER 2022 FINANCIAL RESULTS AND PROVIDES AN UPDATE ON CLINICAL DEVELOPMENT PROGRAMS
COMPLETED ROLLING SUBMISSION OF NDA FOR OMAVELOXOLONE FOR TREATMENT OF PATIENTS WITH FRIEDREICH’S ATAXIA; ACTIVELY PREPARING FOR COMMERCIAL LAUNCH
UPDATES OUTCOME OF TYPE A MEETING WITH THE FDA ON THE PROTOCOL AMENDMENT FOR FALCON; FDA CONFIRMS WEEK 108 AS PRIMARY ENDPOINT
REAFFIRMS CASH RUNWAY THROUGH END OF 2024
CONFERENCE CALL WITH MANAGEMENT ON MAY 10, 2022, AT 8:30 A.M. ET
PLANO, Texas—May 10, 2022 (BUSINESS WIRE)—Reata Pharmaceuticals, Inc. (Nasdaq: RETA) (“Reata,” the company,” “our,” “us,” or “we”), a clinical-stage biopharmaceutical company, today announced financial results for the first quarter of 2022 and provided an update on the Company’s business operations and clinical development programs.
“We are pleased to have recently completed rolling submission of a New Drug Application (“NDA”) for omaveloxolone for the treatment of patients with Friedreich’s ataxia in the United States” said Warren Huff, Reata’s Chief Executive Officer. “Friedreich’s ataxia is a rare, genetic, debilitating, and degenerative neuromuscular disorder with no approved therapies, and we are looking forward to working with the U.S. Food and Drug Administration (“FDA”) on its review of our NDA throughout this year. If approved, we are preparing to be in a position to launch this important drug by early 2023.”
Recent Company Highlights
Neurology
Omaveloxolone in Patients with Friedreich’s Ataxia
The FDA has granted Fast Track Designation, Orphan Drug Designation, and Rare Pediatric Disease Designation to omaveloxolone for the treatment of Friedreich’s ataxia. In March 2022, we completed the rolling submission of an NDA to the FDA for omaveloxolone for the treatment of patients with Friedreich’s ataxia. This NDA is supported by the efficacy and safety data from the MOXIe Part 2 trial and additional supporting data from the MOXIe Part 1 and MOXIe Extension trials.
We have secured an agreement on our Pediatric Investigation Plan with the European Medicines Agency (“EMA”) Pediatric Committee, and we are continuing to complete the regulatory procedures and submissions required prior to filing a Marketing Authorization Application ("MAA") in Europe for approval for of omaveloxolone for the treatment of patients with Friedreich’s ataxia. We plan to submit an MAA to the EMA in the fourth quarter of 2022.
Chronic Kidney Disease
Bardoxolone Methyl in Autosomal Dominant Polycystic Kidney Disease
We are currently enrolling patients in FALCON, a Phase 3, international, multi-center, randomized, double-blind, placebo-controlled trial studying the safety and efficacy of bardoxolone methyl (“bardoxolone”) in patients with autosomal dominant polycystic kidney disease (“ADPKD”) randomized one-to-one to active drug or placebo. FALCON is enrolling patients in a broad range of ages with an estimated glomerular filtration rate ("eGFR") between 30 and 90 mL/min/1.73 m2. More than 550 patients are currently enrolled in the trial.
In the first quarter of 2022, we submitted a protocol amendment to the FALCON Phase 3 trial of bardoxolone in patients with ADPKD with the FDA and other relevant health authorities. We recently met with the FDA in a Type A meeting to discuss our protocol amendment. Based on the discussion during the meeting and the meeting minutes, the Division stated that the proposed primary endpoint of eGFR change from baseline at Week 108 (8 weeks after planned drug discontinuation at Week 100) was reasonable because bardoxolone’s acute pharmacodynamic effect on eGFR should be largely resolved. The FDA also confirmed that, if the FALCON trial is positive, it could support registration of bardoxolone in ADPKD.
First Quarter Financial Highlights
Cash and Cash Equivalents
On March 31, 2022 we had cash and cash equivalents of $532.0 million, as compared to $590.3 million on December 31, 2021.
GAAP and Non-GAAP Research and Development (“R&D”) Expenses
R&D expenses according to generally accepted accounting principles in the U.S. (“GAAP”) were$39.8 million for the first quarter of 2022, as compared to $34.9 million for the same period of the year prior. The increase is primarily due to personnel and personnel-related costs to support the product development activities.
Non-GAAP R&D expenses were $32.2 million for the first quarter of 2022, as compared to $28.1 million, for the same period of the year prior.1
GAAP and Non-GAAP General and Administrative (“G&A”) Expenses
GAAP G&A expenses were $24.8 million for the first quarter of 2022, as compared to$20.7 million, for the same period of the year prior. The increase is primarily due to rent expense related to the new headquarters building lease that commenced in December 2021.
Non-GAAP G&A expenses were $17.0 million for the first quarter of 2022, as compared to $12.8 million for the same period of the year prior.1
[1] See “Non-GAAP Financial Measures” below for a description of non-GAAP financial measures and a reconciliation between GAAP and non-GAAP R&D expenses, GAAP and non-GAAP G&A expenses, and GAAP and non-GAAP net loss, respectively, appearing later in the press release.
GAAP and Non-GAAP Net Loss
The GAAP net loss for the first quarter of 2022, was $73.8 million, or $2.03 per share, on both a basic and diluted basis, as compared to a GAAP net loss of $67.5 million, or$1.86 per share, on both a basic and diluted basis, for the same period of the year prior.
The non-GAAP net loss for first quarter of 2022, was $48.5 million, or $1.33 per share on both a basic and diluted basis, as compared to a non-GAAP net loss of $41.9 million, or $1.16 per share, on both a basic and diluted basis, for the same period of the year prior.1
Updated Cash Guidance
The Company reaffirms its existing cash and cash equivalents will be sufficient to enable it to fund operations through the end of 2024.
Non-GAAP Financial Measures
This press release contains non-GAAP financial measures, including non-GAAP R&D expenses, non-GAAP G&A expenses, non-GAAP operating expenses, non-GAAP net loss and non-GAAP net loss per common share – basic and diluted. These measures are not in accordance with, or an alternative to, GAAP, and may be different from non-GAAP financial measures used by other companies.
The Company defines non-GAAP R&D expenses as GAAP R&D expenses, which exclude stock-based compensation expense; non-GAAP G&A expenses as GAAP G&A expenses, which exclude stock-based compensation expense; non-GAAP operating expenses as GAAP operating expenses, which exclude stock-based compensation expense; non-GAAP net loss as GAAP net loss, which excludes stock-based compensation expense and non-cash interest expense from liability related to sale of future royalties; and non-GAAP net loss per common share – basic and diluted as GAAP net loss per common share – basic and diluted, which excludes stock-based compensation expense and non-cash interest expense from liability related to sale of future royalties. The Company has excluded the impact of stock-based compensation expense, which may fluctuate from period to period based on factors including the variability associated with performance-based grants for stock options and restricted stock units and changes in the Company’s stock price, which impacts the fair value of these awards. The Company has excluded the impact of accreted non-cash interest expense from liability related to sale of future royalties as it may be calculated differently from, and therefore may not be comparable to, peer companies who also provide non-GAAP disclosures. The Company has excluded the impact of stock-based compensation expense and non-cash interest expense from liability related to sale of future royalties because the Company believes its impact makes it difficult to compare its results to prior periods and anticipated future periods.
Because management believes certain items, such as stock-based compensation expense and non-cash interest expense from liability related to sales of future royalties, can distort the trends associated with the Company’s ongoing performance, the following measures are often provided, excluding special items, and utilized by the Company’s management, analysts, and investors to enhance consistency and comparability of year-over-year results, as well as to industry trends, and to provide a basis for evaluating operating results in future periods: non-GAAP net loss; non-GAAP net loss per common share – basic and diluted; non-GAAP R&D expenses; non-GAAP G&A expenses; and non-GAAP operating expenses.
The Company believes the presentation of these non-GAAP financial measures provides useful information to management and investors regarding the Company’s financial condition and results of operations. When GAAP financial measures are viewed in conjunction with these non-GAAP financial measures, investors are provided with a more meaningful understanding of the Company’s ongoing operating performance and are better able to compare the Company’s performance between periods. In addition, these non-GAAP financial measures are among those indicators the Company uses as a basis for evaluating performance, allocating resources, and planning and forecasting future periods. These non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP financial measures. A reconciliation between these non-GAAP measures and the most directly comparable GAAP measures is provided later in this press release.
Conference Call Information
Reata’s management will host a conference call on May 10, 2022, at 8:30 am ET. The conference call will be accessible by dialing (844) 200-6205 (toll-free domestic) or (929) 526-1599 (international) using the access code 488160.The webcast link is https://services.choruscall.com/mediaframe/webcast.html?webcastid=MTgDXzgf.
First quarter 2022 financial results to be discussed during the call will be included in an earnings press release that will be available on the Company’s website shortly before the call at https://www.reatapharma.com/investors/ and will be available for 12 months after the call. The audio recording and webcast of the conference call will be accessible for at least 90 days after the event at https://www.reatapharma.com/investors/.
About Reata
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, omaveloxolone and bardoxolone, target the important transcription factor Nrf2 that promotes the resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, and inhibiting pro-inflammatory signaling. Omaveloxolone and bardoxolone 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 for the fiscal year ended December 31, 2021, 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
https://www.reatapharma.com/
Investor Relations & Media Relations:
John Hunter ir@reatapharma.com
Wendy Segal media@reatapharma.com
https://www.reatapharma.com/contact-us/
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Three Months Ended |
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March 31 |
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2022 |
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2021 |
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Consolidated Statements of Operations |
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(unaudited) |
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(in thousands, except share and per share data) |
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Collaboration revenue |
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License and milestone |
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$ |
893 |
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$ |
795 |
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Other revenue |
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21 |
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149 |
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Total collaboration revenue |
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914 |
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944 |
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Expenses |
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Research and development |
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39,804 |
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34,880 |
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General and administrative |
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24,841 |
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20,704 |
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Depreciation |
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308 |
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274 |
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Total expenses |
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64,953 |
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55,858 |
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Other income (expense), net |
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(9,772 |
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(12,556 |
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Loss before taxes on income |
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(73,811 |
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(67,470 |
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Benefit from (provision for) taxes on income |
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(31 |
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15 |
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Net loss |
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$ |
(73,842 |
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$ |
(67,455 |
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Net loss per share—basic and diluted |
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$ |
(2.03 |
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$ |
(1.86 |
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Weighted-average number of common shares |
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36,412,621 |
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36,203,631 |
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As of |
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As of |
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March 31, 2022 |
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December 31, 2021 |
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(in thousands) |
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Condensed Consolidated Balance Sheet Data |
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Cash and cash equivalents |
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$ |
531,979 |
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$ |
590,258 |
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Working capital |
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493,716 |
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542,481 |
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Operating lease right-of-use assets |
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131,178 |
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126,777 |
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Total assets |
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679,868 |
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735,016 |
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Liability related to sale of future royalties, net |
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372,013 |
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362,142 |
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Operating lease liabilities |
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141,587 |
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136,033 |
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Deferred revenue |
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755 |
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1,648 |
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Accumulated deficit |
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(1,329,473 |
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(1,255,631 |
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Total stockholders’ equity |
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$ |
127,785 |
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$ |
185,989 |
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Reconciliation of GAAP to Non-GAAP Financial Measures
The following table presents reconciliations of non-GAAP financial measures to the most directly comparable GAAP financial measures (in thousands, except for per share data):
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Three Months Ended |
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March 31 |
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2022 |
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2021 |
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Reconciliation of GAAP to Non-GAAP Research and development: |
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(unaudited) |
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GAAP Research and development |
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$ |
39,804 |
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$ |
34,880 |
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Less: Stock-based compensation expense |
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(7,606 |
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(6,808 |
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Non-GAAP Research and development |
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$ |
32,198 |
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$ |
28,072 |
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Reconciliation of GAAP to Non-GAAP General and administrative: |
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GAAP General and administrative |
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$ |
24,841 |
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$ |
20,704 |
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Less: Stock-based compensation expense |
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(7,838 |
) |
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(7,871 |
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Non-GAAP General and administrative |
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$ |
17,003 |
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$ |
12,833 |
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Reconciliation of GAAP to Non-GAAP Operating expenses: |
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GAAP Operating expense |
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$ |
64,953 |
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$ |
55,858 |
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Less: Stock-based compensation expense |
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(15,444 |
) |
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(14,679 |
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Non-GAAP Operating expense |
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$ |
49,509 |
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$ |
41,179 |
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Reconciliation of GAAP to Non-GAAP Net loss: |
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GAAP Net loss |
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$ |
(73,842 |
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$ |
(67,455 |
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Add: Stock-based compensation expense |
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15,444 |
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14,679 |
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Add: Non-cash interest expense from liability |
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9,871 |
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10,925 |
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Non-GAAP Net loss |
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$ |
(48,527 |
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$ |
(41,851 |
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Reconciliation of GAAP to Non-GAAP Net loss per common share- |
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GAAP Net loss per common share-basic and diluted |
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$ |
(2.03 |
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$ |
(1.86 |
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Add: Stock-based compensation expense |
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0.42 |
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0.41 |
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Add: Non-cash interest expense from liability |
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0.28 |
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0.29 |
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Non-GAAP Net loss per common share-basic and diluted |
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$ |
(1.33 |
) |
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$ |
(1.16 |
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Three Months Ended |
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March 31, 2022 |
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December 31, 2021 |
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September 30, 2021 |
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June 30, 2021 |
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Reconciliation of GAAP to Non-GAAP Operating expenses |
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(unaudited) |
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GAAP Operating expenses |
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$ |
64,953 |
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$ |
72,503 |
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$ |
65,486 |
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$ |
62,351 |
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Less: Stock-based compensation expense |
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(15,444 |
) |
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(15,226 |
) |
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(13,657 |
) |
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|
(13,244 |
) |
Non - GAAP Operating expenses |
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$ |
49,509 |
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$ |
57,277 |
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$ |
51,829 |
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|
$ |
49,107 |
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Reconciliation of GAAP to Non-GAAP Net loss |
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GAAP Net loss |
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$ |
(73,842 |
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$ |
(85,385 |
) |
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$ |
(71,846 |
) |
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$ |
(72,700 |
) |
Add: Stock-based compensation expense |
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|
15,444 |
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15,226 |
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|
13,657 |
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|
13,244 |
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Add: Non-cash interest expense from liability |
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|
9,871 |
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|
12,376 |
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11,958 |
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|
|
11,429 |
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Non-GAAP Net loss |
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$ |
(66,866 |
) |
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$ |
(57,783 |
) |
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$ |
(46,231 |
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$ |
(48,027 |
) |
1st Quarter 2022 Financial Results and Update on Clinical Development Programs May 10, 2022 Exhibit 99.2
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, 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 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, 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, 2021, filed with the U.S. Securities and Exchange Commission (SEC) on February 28, 2022. 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. Omaveloxolone, bardoxolone methyl, and RTA 901 are investigational drugs, and their safety and efficacy have not been established by any agency.
Today’s Agenda Opening Remarks | Warren Huff, CEO Development Update | Colin Meyer, MD, Chief Innovation Officer Development Update | Seemi Khan, MD, Chief Medical Officer Commercial Update | Dawn Bir, Chief Commercial Officer Financial & Operational Update | Manmeet Soni, President Concluding Remarks | Warren Huff, CEO
NDA: New Drug Application; FDA: United States Food & Drug Administration; MAA: Marketing Authorization Application; PDUFA: Prescription Drug User Fee Act Update on Omaveloxolone Program in Friedreich’s Ataxia U.S. Launch preparation efforts underway MAA filing in Europe planned for 4Q 2022 3Q21 Pre-NDA meeting with FDA 4Q21 FDA granted Rolling NDA Submission/ Review 2Q22 FDA granted Rare Pediatric Disease Designation 4Q22 Anticipated FDA PDUFA date if under Priority Review 4Q21 FDA granted Fast Track Designation 1Q22 Rolling NDA Submission initiated and completed 2Q22 Anticipated FDA decision on NDA acceptance 1Q23 Anticipated FDA PDUFA date if under Standard Review
eGFR: estimated glomerular filtration rate We continue to work with the FDA to confirm our next steps on our Alport syndrome program FALCON protocol amended Type A meeting completed Kyowa Kirin’s Phase 3 AYAME Outcomes Trial Last patient visit expected 2H 2022 FDA stated primary endpoint of eGFR change from baseline at Week 108 was reasonable Update on Bardoxolone Program in Chronic Kidney Disease
Omaveloxolone inFriedreich’s Ataxia
Friedreich’s Ataxia – Rare, Progressive, Life-Shortening, Neuromuscular Disease 1Poburski D., Biology Open 2016; 2D’Oria V., Int. J. Mol. Sci. 2013; 3Paupe V., PLoS ONE 2009; 4Tsou A.Y., J Neurol Sci 2011;5Rummey C., Neurol Genet 2019; 6Rummey C., EClinicalMedicine. 2020; 72020 IQVIA claims data and projected diagnosed; 8Estimated by Reata and the Friedreich’s Ataxia Research Alliance (FARA) based on publicly available data and from Vankan P, J Neurochem 2013 Caused by epigenetic silencing of frataxin Impaired mitochondrial function, suppressed Nrf2 expression, which impairs energy production1-3 Mean survival in mid-thirties4 Typically diagnosed in teens,5 wheelchair-dependent in twenties6 Numerous failed trials No approved therapies that can delay functional deterioration Rare recessive form of ataxiaIn U.S., an estimated 4,000 patients are diagnosed7 with Friedreich’s ataxia out of 5,000 total8
Clinical Trials in FA Challenging Due to Limited Number of Patients Available for Clinical Research Limited number of patients available for clinical trials since FA is a rare disease ~5,000 patients in the US1 with FA with ~4,000 diagnosed2 At the time of MOXIe conduct, only 7 specialty centers trained to conduct FA clinical research3 MOXIe is one of the largest interventional international trials completed to date and the only trial to demonstrate a significant effect on a functional endpoint that could support approval Relatively small number of patients available for future trials with design similar to MOXIe 1,200 patients have volunteered for clinical research4 Over 250 patients screened over 3 years to enroll 172 patients in MOXIe Part 1 and Part 2 1Estimated by Reata and the Friedreich’s Ataxia Research Alliance (FARA) based on publicly available data and from Vankan P, J Neurochem 2013; 22020 IQVIA claims data and projected diagnosed; 3From the FARA “Clinical Network & Trials” website, consulted in October 2017; 4Personal communication from the FA-COMS PI, Dr. David Lynch, MD PhD, Children's Hospital of Philadelphia, Philadelphia, PA,U.S.; FA: Friedreich’s ataxia
Clinical Trials in FA Challenging Due to Very Slow Rate of Progression Despite relentless progression and early mortality, patients progress over four decades Progression over one year is clinically meaningful to patients yet relatively small versus the course of the disease Outcome measures have been developed and validated to be able to measure progression over one year Friedreich's Ataxia Research Alliance (FARA) worked with FDA to define sensitive, clinically meaningful endpoint for FA Adapted FARS exam, which was previously developed by FA researchers Removed neurological signs that are not clinically meaningful Total score of four sections range from 0 to 99 Higher scores associated with worsening of neurological function FARS: Friedreich’s Ataxia Rating Scale; mFARS: modified Friedreich’s Ataxia Rating Scale Bulbar Upper Limb Lower Limb Upright Stability mFARS Sections
mFARS: Clinical Impact of 1 Point Worsening Subramony S., Neurology 2005; Patel M., Ann. Clin. Transl. Neurol. 2016 Section Representative Assessment Examples of 1-Point Worsening Clinical Impact Upper Limb Coordination Finger taps (15 times in 6 seconds) Score 1 misses 1-3 taps Score 2 misses 4-9 taps Deterioration may mean loss of ability to type Upright Stability Time maintaining stance on dominant foot (3 attmepts) Score 3 >15 to < 30 sec Score 4 <15 sec or needs assistance Shortened stance may preclude activities such as standing at sink to wash dishes Lower Limb Coordination Heel to shin taps(8 times) Score 2 misses shin 3-5 times Score 3 misses shin > 5 times Increasing spasticity or weakness with impaired ambulation Bulbar Function Spontaneous speech (read or repeat specific sentences) Score 1 all or most words understandable Score 2 most words not understandable Impaired ability to communicate
Friedreich’s Ataxia Clinical Outcome Measures (FA-COMS)Longitudinal Natural History Study Global, multicenter network of clinical research centers specializing in FA1 Enrolling up to 2,000 patients with FA Collecting quantitative serial clinical data including mFARS Patients are assessed annually and followed for up to 25 years Interim results show that patients with FA worsen by an average of approximately two mFARS points per year2 Cohort of patients aged 16 to 40 years mFARS scores had meaningful changes within one year Other outcome measures move at a slower pace and require more than one year to show progression 1ClinicalTrials.gov Identifier: NCT03090789; 2Patel M., Ann Clin Transl Neurol. 2016, data from 812 patients and 426 patients at baseline in the overall and 16-40 year old baseline age cohorts respectively; SD: Standard Deviation Mean (SD) Change from Baseline in mFARS2 Years from Baseline 16-40 y Baseline Age Cohort 1 2 3 4 5 Overall Cohort 1.91 (6.34) 4.24 (7.14) 5.85 (7.27) 8.22 (8.49) 9.62 (8.30) 16-40 Years Baseline Age Cohort 1.04 (5.31) 3.83 (6.32) 5.12 (6.96) 7.92 (7.27) 9.06 (7.55) Change in mFARS Over Time in FA-COMS Natural History Study2
MOXIe Part 2 Met the Primary Endpoint One of the largest completed global interventional studies in patients with FA Prespecified full analysis set (FAS) included patients without pes cavus and with at least one post-baseline measurement MMRM used for primary endpoint Site and baseline mFARS used as covariates All mFARS values at all time points included in analysis No imputation for missing data in the primary analysis mFARS Change from Baseline (FAS) Worsened Improved 2 1 0 -1 -2 -3 0 12 24 36 48 Placebo (n=42) Omav (n=40) +0.85 pts -1.55 pts Difference = 2.40 (p=0.014) Change from Baseline in mFARS Study Week
Omav Placebo Treatment Difference (95% CI) p-value Primary Endpoint (FAS) 40 42 -2.40 (-4.31, -0.50) 0.014 ANCOVA (FAS)1 34 41 -2.83 (-4.85, -0.81) 0.0068 Treatment-Based Imputation (FAS) 40 42 -2.38 (-4.41, -0.35) 0.022 Control-Based Imputation (FAS) 40 42 -2.14 (-4.18, -0.10) 0.040 Pes Cavus Population 10 10 -1.19 (-5.19, 2.82) 0.5379 All Randomized Population 51 52 -1.93 (-3.70, -0.15) 0.034 MOXIe Part 2: Prespecified Sensitivity Analyses Support Robustness of Primary Endpoint All analyses conducted using MMRM unless otherwise noted. 1Post-hoc analysis conducted using ANCOVA; CI: Confidence Interval Favors Placebo Favors Omaveloxolone All sensitivity analyses favored omaveloxolone
MOXIe Extension Trial Update 1As of August 2021 data cut-off MOXIe Extension is an ongoing, long-term extension trial Assessing the safety and tolerability of omaveloxolone in patients with FA Patients that completed MOXIe Part 1 or Part 2 were eligible to enroll No new safety signals have been identified in the MOXIe Extension trial Part 2 Full Analysis Set (FAS) Part 2 All Randomized (ARP) Part 1 Intent-to-Treat (ITT) Enrolled in MOXIe Part 2 or Part 1 82 103 69 Completed Week 48 of MOXIe Part 2 or Week 12 of MOXIe Part 1 75 (91%) 94 (91%) 67 (97%) Completers Enrolled in MOXIe Extension 73 (97%) 92 (98%) 57 (85%) Continuing in MOXIe Extension 64 (88%) 80 (87%) 45 (79%) MOXIe Part 2, Part 1, and Extension Patient Disposition1
Delayed Start Analysis of mFARS Data Demonstrates Persistent Effect on Disease Course Delayed-Start Analysis of mFARS data demonstrates that separation observed at Week 48 of MOXIe Part 2 is maintained at Extension Week 72 Similar magnitude of separation observed at all time points beyond Extension Week 72 Extension Week 120 completers analysis demonstrates low rate of progression for patients with ~2.5 years of treatment in the extension LS mean changes are estimated from a mixed model repeated measures analysis using all available data from scheduled MOXIe Part 2 and MOXIe Extension visits (through Extension Week 120); Data from August 2021 Data Cut-off (same as used in NDA); Week 120 Completers are patients with an mFARS assessment at Extension Week 120; SE: Standard Error Change from Baseline in mFARS Change from Baseline in mFARS Ext. Week 120 Completers Ext. 72 (Δ2) Week 48 (Δ1)
Parallel Trajectories between Treatment Groups andLow Progression Rates are Consistent with Altered Disease Course All extension data from FAS patients through Extension Week 120 used to calculate annualized progression rates Mean treatment duration of approximately 2 years with 12% drop-out rate Total of 257 mFARS assessments from 73 patients 1Extension data as of August 2021 (Part 2 Full Analysis Set); 252 weeks after entry in MOXIe Part 2 = Extension baseline; 3 Change at Year 3 divided by 3, from Patel M., Ann Clin Transl Neurol. 2016 mFARS Change Per Year MOXIe Part 2 placebo-treated patients Week 52 (n=39)2 1.42 FA-COMS Natural History average change over 3 years3 Overall cohort 1.95 Age 16-40 cohort 1.71 MOXIe Extension Annualized mFARS Change per Year (± SE)1 Average mFARS Change per Year mFARS Change per Year Omav-to-Omav (n=34) 0.27 ± 0.59 Placebo-to-Omav (n=39) 0.45 ± 0.38 Difference -0.18 ± 0.67 p=0.79
Chronic Kidney Disease Program Updates
FALCON Phase 3 Study of Bardoxolone in Patients with ADPKD ADPKD: Autosomal dominant polycystic kidney disease; CKD: Chronic kidney disease ADPKD is the most common hereditary form of CKD International, multi-center, randomized, double-blind, placebo-controlled Phase 3 trial of bardoxolone in patients with ADPKD Recently filed protocol amendment and completed a Type A meeting with FDA Division stated that proposed primary endpoint of eGFR change from baseline at Week 108 (eight weeks after planned drug discontinuation) was reasonable FDA agreed with addition of pediatric patients (12-17 years) FDA confirmed that if the FALCON trial is positive, it could support registration of bardoxolone in ADPKD More than 550 patients are currently enrolled in the trial with planned enrollment of 850 patients
RTA 901HSP90 Modulator forDiabetic Neuropathy
RTA 901: Phase 2 Study in Patients with Diabetic Peripheral Neuropathic Pain (DPNP) RTA 901 is a novel, small-molecule, orally bioavailable C-terminal Hsp90 inhibitor and Hsp70 inducer1 DPNP is a serious complication of diabetes mellitus2-4 Associated with substantial morbidity, including often debilitating peripheral neuropathic pain Approximately 4 million patients in the U.S. are affected with moderate or severe DPNP 1Burlison J.A., J Am Chem Soc. 2006; 2Xu L., Anesth Analg. 2022; 3Price R., Neurology. 2022; 4U.S. Food and Drug Administration. The Voice of the Patient Neuropathic Pain Associated with Peripheral Neuropathy. February 2017; PK: Pharmacokinetic; AAN: American Academy of Neurology; Hsp90: Heat shock protein 90; Hsp70: Heat shock protein 70; HSF1: Heat shock factor 1; SAE: Serious Adverse Event Phase 1 study in healthy volunteers is complete Well tolerated with no safety signals, drug discontinuations, or SAEs Favorable PK profile Phase 1 clinical pharmacology studies including a drug-drug interaction study have been initiated Phase 2 randomized, placebo-controlled study to evaluate safety and efficacy in patients with DPNP- expected to begin enrolling in the fourth quarter of 2022
Commercial Update
Listening to and Learning From the FA Community Commercial Readiness Efforts-Completed New ICD-10 claims data analysis complete Patient chart audit conducted to evaluate FA treatment dynamics Draft label testing research with HCPs currently treating FA US Friedreich’s ataxia patients identified and linked to treating HCPs HCP Disease Awareness developed HCP Disease Awareness Campaign Under Development HCP, Patient and Payer landscape analysis complete. Launch strategy development is underway. FA patient disease education continues through social, digital and web platforms HCP: Health Care Provider
Preparing for Launch Execution - Now and Next Launch Operations-Completed Launch Operations- Underway Patient access and adherence program development Sales force sizing and territory alignment Messaging, materials and tactical launch plan development underway Core commercial functions are in place. Field sales force and additional commercial hiring this year. Health economic and value work initiated Data, systems & infrastructure designed and ready for implementation Payer mix determined for addressable market Payer engagement initiated in March, communicating FA disease severity and need for treatment Product distribution services-Limited specialty pharmacy network designed. Partners selected Patient access services partner selected Launch readiness review process ensures internal cross-department preparedness Brand name and logo selected
Financial & Operational Update
Financial Summary – 1Q 2022 vs 4Q 2021 vs 1Q 2021 1Excludes stock-based compensation expenses; 2Excludes various adjustments, including stock-based compensation expenses, non-cash interest expense from liability related to sale of future royalties; see the next slide for a reconciliation between GAAP and non-GAAP measures. GAAP: Generally Accepted Accounting Principles; M: Million Updated Cash Guidance: Based on our operational plans, we reaffirm our cash guidance runway through the end of 2024 Key Items at March 31, 2022 Cash and cash equivalent $532.0M Total shares outstanding 36.4M 31.5M class A shares outstanding 4.9M class B shares outstanding
Reconciliation of GAAP to Non-GAAP Financial Measures - 1Q 2022 vs 4Q 2021 vs 1Q 2021
Concluding Remarks
Reata at a Glance Completed rolling submission of NDA for omaveloxolone in FA in first quarter of 2022 Plan to submit MAA for omaveloxolone in the fourth quarter of 2022 Plan to initiate Phase 2 study of RTA 901 in DPNP in fourth quarter of 2022 FDA stated primary endpoint of eGFR change from baseline at Week 108 was reasonable >550 patients enrolled in FALCON Received CRL and will work with FDA to confirm next steps on Alport program Strong cash position Worldwide commercial rights to all pipeline assets1 Robust IP protection for omaveloxolone, RTA 901, and bardoxolone Neurology Pipeline CKD Pipeline Global Opportunity 1Ex-Asia for bardoxolone IP: Intellectual Property
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