RETA Reata Pharmaceuticals Inc.

102.21
-2.21  -2%
Previous Close 104.42
Open 103.2
52 Week Low 70
52 Week High 257.965
Market Cap $3,434,699,489
Shares 33,604,339
Float 20,991,131
Enterprise Value $2,861,245,261
Volume 553,154
Av. Daily Volume 460,166
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Upcoming Catalysts

Drug Stage Catalyst Date
Omaveloxolone
Friedreich’s ataxia (FA)
Phase 2
Phase 2
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Bardoxolone methyl - CARDINAL
Chronic Kidney Disease Caused by Alport Syndrome
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Bardoxolone - FALCON
Chronic Kidney Disease
Phase 3
Phase 3
Phase 3 enrollment has recommenced following pause due to COVID-19.
Bardoxolone (BARCONA)
COVID-19
Phase 2
Phase 2
Phase 2 initiation announced July 28, 2020.
Bardoxolone methyl - CATALYST
Pulmonary arterial hypertension associated with connective tissue disease - CTD-PAH
Phase 3
Phase 3
Phase 3 trial stopped following DSMB recommendation. Primary endpoint unlikely to be met.
RTA 1701
Healthy Volunteers
Phase 1
Phase 1
Phase 1 initiation announced June 20, 2018.
Omaveloxolone - MOTOR
Mitochondrial myopathies (MM)
Phase 2
Phase 2
Phase 2 initial data released March 1, 2018 - endpoints not met.

Latest News

  1. PRE-NDA (NEW DRUG APPLICATION) MEETING GRANTED FOR BARDOXOLONE

    REGULATORY UPDATE ON OMAVELOXOLONE

    YEAR 2 DATA FROM CARDINAL TRIAL EXPECTED IN FOURTH QUARTER 2020

    ENROLLMENT RESUMED IN FALCON TRIAL

    PLANO, Texas, Aug. 10, 2020 (GLOBE NEWSWIRE) -- Reata Pharmaceuticals, Inc. (NASDAQ:RETA) ("Reata," the "Company," or "we"), a clinical-stage biopharmaceutical company, today announced financial results for the quarter ended June 30, 2020, and provided an update on the Company's business operations and clinical development programs.

    Regulatory Update

    Bardoxolone Methyl ("Bardoxolone") for Alport Syndrome

    Since the announcement of positive, Year 1 data from the Phase 3 CARDINAL study, we have been engaged in discussions…

    PRE-NDA (NEW DRUG APPLICATION) MEETING GRANTED FOR BARDOXOLONE

    REGULATORY UPDATE ON OMAVELOXOLONE

    YEAR 2 DATA FROM CARDINAL TRIAL EXPECTED IN FOURTH QUARTER 2020

    ENROLLMENT RESUMED IN FALCON TRIAL

    PLANO, Texas, Aug. 10, 2020 (GLOBE NEWSWIRE) -- Reata Pharmaceuticals, Inc. (NASDAQ:RETA) ("Reata," the "Company," or "we"), a clinical-stage biopharmaceutical company, today announced financial results for the quarter ended June 30, 2020, and provided an update on the Company's business operations and clinical development programs.

    Regulatory Update

    Bardoxolone Methyl ("Bardoxolone") for Alport Syndrome

    Since the announcement of positive, Year 1 data from the Phase 3 CARDINAL study, we have been engaged in discussions with the U.S. Food and Drug Administration ("FDA") regarding the Year 1 efficacy and safety results.  We have had a Type C meeting and have provided written responses to the FDA's questions and comments.  We believe that we have addressed the FDA's questions and comments regarding the Year 1 results, and, accordingly, we recently requested and were granted a pre-NDA meeting by the FDA to discuss the NDA submission content and plans.

    One of the key questions to be resolved in the pre-NDA meeting is how the data from Year 2 of the CARDINAL study should be handled during the NDA review process.  Our plan has been, and continues to be, to submit the NDA for bardoxolone in Alport syndrome during fourth quarter of 2020 for accelerated approval based on the one-year data from the Phase 3 portion of CARDINAL.  If the second-year results are available during an acceptable time frame, we may be able to submit the second-year data to the NDA during the review process and before the FDA makes a determination about accelerated approval.  This may extend the PDUFA date, but could also result in consideration of full approval, rather than accelerated approval.  The FDA could recommend that we wait for the second-year data from CARDINAL to file the NDA.  This would permit us to file for full approval but would delay the filing until the first quarter of 2021, compared to our current guidance of filing by the end of this year.

    Omaveloxolone for Friedreich's Ataxia

    Following the announcement of the positive data from the MOXIe Part 2 study in October 2019, we have planned, subject to discussion with regulatory authorities, to proceed with a submission for marketing approval of omaveloxolone for the treatment of Friedreich's ataxia ("FA") in the United States.  We recently completed a Type C meeting in which the FDA provided us with guidance that it does not have any concerns with the reliability of the mFARS primary endpoint results in the MOXIe Part 2 study.  Nevertheless, the FDA is not convinced that the MOXIe Part 2 results will support a single study approval without additional evidence that lends persuasiveness to the results.  In preliminary comments for the meeting, the FDA stated that we will need to conduct a second pivotal trial that confirms the mFARS results of the MOXIe Part 2 study with a similar magnitude of effect.

    In response to the preliminary comments, the Friedreich's Ataxia Research Alliance ("FARA"), key FA clinicians, and we provided the FDA with information to demonstrate that it will be difficult to conduct an additional, prospective clinical trial in FA because of the very slow progression rate of FA, the limited number of FA patients available for clinical research, the small number of clinical trial investigators who can conduct the mFARS exam, and the impact of the COVID-19 pandemic on the ability to conduct neuroscience clinical trials.  Thus, conducting an additional pivotal study would result in a long delay in the availability of a potentially effective therapy to patients with a progressive, life-threatening disease with no treatment options.  The FDA acknowledged the unmet need of patients with FA, reiterated its commitment to facilitate the development of omaveloxolone within the constraints of the regulatory standards, and emphasized its willingness to consider all available options to meet the regulatory standards.  The FDA also acknowledged that launching a new, neuroscience clinical trial now may not be possible because of the COVID-19 pandemic.

    At the Type C meeting, to address the FDA's requirement, FARA, key opinion leaders, and Reata proposed a second study (the "crossover study") to provide additional evidence of effectiveness.  The study would measure the effect of omaveloxolone on mFARS in patients who were previously randomized to placebo in the MOXIe Part 2 study and are being treated with omaveloxolone in the MOXIe open-label extension study.  The FDA acknowledged that a study like the proposed crossover study could provide important additional information and asked us to submit a design for the crossover study for their consideration.

    If the FDA accepts this approach, we expect to complete the crossover study as early as the fourth quarter of this year.  Assuming that the FDA views the crossover study data as sufficiently positive to provide confirmatory evidence, our plan would be to submit an NDA during the first quarter of 2021.  If the FDA rejects the proposal or if the data are not supportive, we will evaluate whether it is feasible to conduct a second pivotal study in FA patients as suggested by the FDA.  Regardless of the interaction with the FDA, we plan to pursue marketing approval outside of the United States.

    Clinical Development Update

    CARDINAL Phase 3 Study of Bardoxolone in Alport Syndrome

    We are in the process of completing the second year of CARDINAL and anticipate that the study will be completed this year.  The last study visits are anticipated to occur during the fourth quarter of 2020, which is consistent with our pre-COVID-19 trial timeline.  As a result of the measures taken in response to the pandemic, at this time we believe that the timeline for Year 2 data availability is unlikely to be affected by COVID-19.

    FALCON Phase 3 Study of Bardoxolone in Autosomal Dominant Polycystic Kidney Disease ("ADPKD")

    In March 2020, we temporarily paused screening and enrollment of new patients in the FALCON Phase 3 study due to the emergence of COVID-19.  We began to lift the screening hold in June 2020, and currently all sites are able to screen patients and approximately one-half of all sites are able to randomize patients.  The measures we implemented to the conduct of FALCON in response to COVID-19 have been effective, and we anticipate no meaningful impact on data integrity due to COVID-19. 

    BARCONA Study of Bardoxolone in Patients with COVID-19

    Reata recently announced the start of an investigator-sponsored trial, led by researchers at New York University's ("NYU") Grossman School of Medicine, to study the effect of bardoxolone in patients with COVID-19.  The Phase 2 BARCONA study is a randomized, placebo-controlled, double-blind trial that will enroll 40 patients with a primary endpoint of safety and a treatment duration of up to 29 days.  Reata was involved in the design of the trial, has a representative on the study's executive steering committee, and is providing drug supply for the study, as requested by NYU.

    Second Quarter Financial Highlights

    Reata recently announced a strategic investment from Blackstone Life Sciences ("BXLS") of $350 million, which includes $300 million in return for various percentage royalty payments by the Company on worldwide net sales of bardoxolone by the Company and its licensees, other than Kyowa Kirin Co., Ltd ("KKC"), and a $50 million investment in 340,793 shares of Reata's Class A common stock at $146.72 per share.  The royalty percentage will initially be in the mid-single digits and in future years can vary between higher-mid single digit percentages to low-single digit percentages depending on various milestones, including indication approval dates, cumulative royalty payments, and cumulative net sales.

    In connection with the closing of the BXLS investment, the Company paid off in full its senior loan with Oxford Finance LLC and Silicon Valley Bank, which included $155.0 million in principal and $12.1 million in exit and prepayment fees, and which resulted in a charge for extinguishment of debt of $11.2 million.

    Cash and Cash Equivalents

    On June 30, 2020, we had cash and cash equivalents of $610.4 million, as compared to $664.3 million at December 31, 2019.

    Collaboration Revenue

    Collaboration Revenue was $3.1 million in the second quarter of 2020, as compared to $7.8 million for the same period of the year prior.  Revenue for the second quarter of 2020 included $1.2 million from the KKC license agreement and $1.9 million in reimbursements of expenses from KKC.

    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 $36.8 million for the second quarter of 2020, as compared to $29.6 million for the same period of the year prior.

    Non-GAAP R&D expenses were $29.3 million for the second quarter of 2020, as compared to $27.9 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 $16.6 million for the second quarter of 2020, as compared to $11.7 million for the same period of the year prior.

    Non-GAAP G&A expenses were $9.3 million for the second quarter of 2020, as compared to $8.9 million for the same period of the year prior.1

    GAAP and Non-GAAP Net Loss

    The GAAP net loss for the second quarter of 2020 was $67.6 million, or $2.03 per share, on both a basic and diluted basis, as compared to a GAAP net loss of $34.4 million, or $1.14 per share, on both a basic and diluted basis, for the same period of the year prior.

    The increase in GAAP net loss for the second quarter of 2020 is driven primarily by the loss on extinguishment of debt related to the payoff of our loan to Oxford Finance LLC and Silicon Valley Bank, higher stock-based compensation expense, and decreased collaboration revenue related to AbbVie since the reacquisition of licensing rights.

    The non-GAAP net loss for the second quarter of 2020 was $40.9 million, or $1.23 per share on both a basic and diluted basis, as compared to a non-GAAP net loss of $29.9 million, or $0.99 per share, on both a basic and diluted basis, for the same period of the year prior.1

    Reiterates Cash Guidance

    The Company reiterated that it expects existing cash and cash equivalents will be sufficient to enable it to fund operations through the end of 2023.

    ___________________________

    1 See "Use of 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.

    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 less stock-based compensation expense; non-GAAP G&A expenses as GAAP G&A expenses less stock-based compensation expense; non-GAAP operating expenses as GAAP operating expenses less stock-based compensation expense; non-GAAP net loss as GAAP net loss plus stock-based compensation expense, loss on extinguishment of debt, 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 plus stock-based compensation expense, loss on extinguishment of debt, and non-cash interest expense from liability related to sale of future royalties.  During the three and six months ended June 30, 2020 and 2019, the Company did not incur any reacquired license rights expense; therefore, this expense is not included in the reconciliations below for the measures for non-GAAP operating expenses, non-GAAP net loss, and non-GAAP net loss per common share – basic and diluted for these periods.  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 loss on extinguishment of debt in connection with the Term Loan payoff because the Company has no other similar loan obligation and we believe it is a non-recurring transaction, that makes it difficult to compare its results to peer companies who also provide non-GAAP disclosures.  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, loss on extinguishment of debt, non-cash interest expense from liability related to sale of future royalties, and reacquired license rights expense 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, loss on extinguishment of debt, non-cash interest expense from liability related to sales of future royalties, and reacquired license rights expense 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 August 10, 2020 at 8:30 a.m. ET.  The conference call will be accessible by dialing (800) 708-4539 (toll-free domestic) or (847) 619-6396 (international) using the access code: 49873533.  The webcast link is https://edge.media-server.com/mmc/p/hr8ew88f.

    Second quarter 2020 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 http://reatapharma.com/investors/ and will be available for 12 months after the call.  The audio recording and webcast will be accessible for at least 90 days after the event at http://reatapharma.com/investors/.

    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 the resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, and inhibiting pro-inflammatory signaling.  Bardoxolone and omaveloxolone are investigational drugs, and their safety and efficacy have not been established by any agency.

    Contact:

    Reata Pharmaceuticals, Inc.

    (972) 865-2219

    http://reatapharma.com

    Investors:

    Vinny Jindal

    Vice President, Corporate Communications and Strategy

    (469) 374-8721



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

    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 the detailed factors discussed under the caption "Risk Factors." in its Annual Report on Form 10-K for the fiscal year ended December 31, 2019.  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.

           
      Three Months Ended  Six Months Ended 
      June 30,  June 30, 
      2020  2019  2020  2019 
                 
    Consolidated Statements of Operations (unaudited) 
      (in thousands, except share and per share data) 
    Collaboration revenue                
    License and milestone $1,169  $7,813  $2,338  $15,539 
    Other revenue  1,904   20   2,088   64 
    Total collaboration revenue  3,073   7,833   4,426   15,603 
    Expenses                
    Research and development  36,783   29,554   84,436   55,668 
    General and administrative  16,600   11,706   37,387   21,744 
    Depreciation  284   232   562   401 
    Total expenses  53,667   41,492   122,385   77,813 
    Other income (expense), net  (16,990)  (701)  (20,804)  (1,301)
    Loss before taxes on income  (67,584)  (34,360)  (138,763)  (63,511)
    (Benefit from) provision for taxes on income  (3)  20   (22,243)  23 
    Net loss $(67,581) $(34,380) $(116,520) $(63,534)
    Net loss per share—basic and diluted $(2.03) $(1.14) $(3.51) $(2.12)
    Weighted-average number of common shares



     used in net loss per share basic and diluted
      33,265,778   30,069,048   33,243,931   29,950,241 
                     



      As of

    June 30, 2020

    (unaudited)
      As of

    December 31, 2019
     
      (in thousands) 
    Condensed Consolidated Balance Sheet Data        
    Cash and cash equivalents $610,419  $664,324 
    Working capital  593,282   477,262 
    Total assets  652,404   682,420 
    Term loan (including current portion, net of issuance cost)  -   155,017 
    Liability related to sale of future royalties, net  294,234   - 
    Payable to collaborators  70,055   216,862 
    Deferred revenue (including current portion)  7,051   9,389 
    Accumulated deficit  (827,013)  (710,493)
    Total stockholders' equity $231,627  $256,857 



    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) (unaudited):

      Three Months Ended  Six Months Ended 
      June 30,  June 30, 
      2020  2019  2020  2019 
    Reconciliation of GAAP to Non-GAAP Research and development:                
    GAAP Research and development $36,783  $29,554  $84,436  $55,668 
    Less: Stock-based compensation expense  (7,527)  (1,659)  (19,044)  (3,350)
    Non-GAAP Research and development $29,256  $27,895  $65,392  $52,318 
                     
    Reconciliation of GAAP to Non-GAAP General and administrative:                
    GAAP General and administrative $16,600  $11,706  $37,387  $21,744 
    Less: Stock-based compensation expense  (7,269)  (2,824)  (15,060)  (5,360)
    Non-GAAP General and administrative $9,331  $8,882  $22,327  $16,384 
                     
    Reconciliation of GAAP to Non-GAAP Operating expenses:                
    GAAP Operating expenses $53,667  $41,492  $122,385  $77,813 
    Less: Stock-based compensation expense  (14,796)  (4,483)  (34,104)  (8,710)
    Non-GAAP Operating expenses $38,871  $37,009  $88,281  $69,103 
                     
    Reconciliation of GAAP to Non-GAAP Net loss:                
    GAAP Net loss $(67,581) $(34,380) $(116,520) $(63,534)
    Add: Stock-based compensation expense  14,796   4,483   34,104   8,710 
    Add: Loss on extinguishment of debt  11,183   -   11,183   - 
    Add: Non-cash interest expense from liability related to sale of

      future royalties
      664   -   664   - 
    Non-GAAP Net loss $(40,938) $(29,897) $(70,569) $(54,824)
                     
    Reconciliation of GAAP to Non-GAAP Net loss per common share-basic

      and diluted:
                    
    GAAP Net loss per common share-basic and diluted $(2.03) $(1.14) $(3.51) $(2.12)
    Add: Stock-based compensation expense  0.44   0.15   1.03   0.29 
    Add: Loss on extinguishment of debt  0.34   -   0.34   - 
    Add: Non-cash interest expense from liability related to sale of

      future royalties
      0.02   -   0.02   - 
    Non-GAAP Net loss per common share-basic and diluted $(1.23) $(0.99) $(2.12) $(1.83)
                     



      Three Months Ended 
    Reconciliation of GAAP to Non-GAAP Operating

      expenses
     June 30, 2020  March 31, 2020  December 31, 2019 
    GAAP - Operating expenses $53,667  $68,718  $187,103 
    Less: Stock-based compensation expense  (14,796)  (19,307)  (12,291)
    Less: Reacquired license rights expense  -   -   (124,398)
    Non - GAAP - Operating expenses $38,871  $49,411  $50,414 
                 
    Reconciliation of GAAP to Non-GAAP Net loss            
    GAAP - Net loss $(67,581) $(48,939) $(186,942)
    Add: Stock-based compensation expense  14,796   19,307   12,291 
    Add: Loss on extinguishment of debt  11,183   -   - 
    Add: Non-cash interest expense from liability related

      to sale of future royalties
      664   -   - 
    Add: Reacquired license rights expense  -   -   124,398 
    Non-GAAP Net loss $(40,938) $(29,632) $(50,253)
                 

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  2. PLANO, Texas, Aug. 03, 2020 (GLOBE NEWSWIRE) -- Reata Pharmaceuticals, Inc. (NASDAQ:RETA) ("Reata," the "Company," or "we"), a clinical-stage biopharmaceutical company, today announced that it will report financial results and provide an update on its development programs pre-market on August 10, 2020.

    Reata's management will host a conference call on August 10, 2020 at 8:30 a.m. ET.  The conference call will be accessible by dialing (800) 708-4539 (toll-free domestic) or (847) 619-6396 (international) using the access code: 49873533.  The webcast link is https://edge.media-server.com/mmc/p/hr8ew88f.

    Second quarter 2020 financial results to be discussed during the call will be included in an earnings press release that will be available…

    PLANO, Texas, Aug. 03, 2020 (GLOBE NEWSWIRE) -- Reata Pharmaceuticals, Inc. (NASDAQ:RETA) ("Reata," the "Company," or "we"), a clinical-stage biopharmaceutical company, today announced that it will report financial results and provide an update on its development programs pre-market on August 10, 2020.

    Reata's management will host a conference call on August 10, 2020 at 8:30 a.m. ET.  The conference call will be accessible by dialing (800) 708-4539 (toll-free domestic) or (847) 619-6396 (international) using the access code: 49873533.  The webcast link is https://edge.media-server.com/mmc/p/hr8ew88f.

    Second quarter 2020 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 http://reatapharma.com/investors/ and which will be available for 12 months after the call.  The audio recording and webcast will be accessible for at least 90 days after the event at http://reatapharma.com/investors/.

    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 methyl ("bardoxolone") and omaveloxolone, target the important transcription factor Nrf2 that promotes the resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, and inhibiting pro-inflammatory signaling.  Bardoxolone and omaveloxolone are investigational drugs, and their safety and efficacy have not been established by any agency.

    Contact:

    Reata Pharmaceuticals, Inc.

    (972) 865-2219

    http://reatapharma.com

    Investors:

    Vinny Jindal

    Vice President, Corporate Communications and Strategy

    (469) 374-8721



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

    Primary Logo

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  3. PLANO, Texas, July 30, 2020 (GLOBE NEWSWIRE) -- Reata Pharmaceuticals, Inc. (NASDAQ:RETA) ("Reata," the "Company," or "we"), a clinical-stage biopharmaceutical company, today announced the appointment of Martin W. Edwards, M.D. to its Board of Directors, effective August 3, 2020. 

    Since 2003, Dr. Edwards has held various positions at Novo Holdings, a life sciences investment firm, and most recently, he has served as a part-time Senior Partner.  Earlier in his career, he was Corporate VP and Global Head of Drug Development for Novo Nordisk, where he led all aspects of pre-clinical and clinical drug development.  Dr. Edwards currently serves on the board of directors of three publicly traded pharmaceutical companies, Inozyme Pharma, Inc., Kalvista…

    PLANO, Texas, July 30, 2020 (GLOBE NEWSWIRE) -- Reata Pharmaceuticals, Inc. (NASDAQ:RETA) ("Reata," the "Company," or "we"), a clinical-stage biopharmaceutical company, today announced the appointment of Martin W. Edwards, M.D. to its Board of Directors, effective August 3, 2020. 

    Since 2003, Dr. Edwards has held various positions at Novo Holdings, a life sciences investment firm, and most recently, he has served as a part-time Senior Partner.  Earlier in his career, he was Corporate VP and Global Head of Drug Development for Novo Nordisk, where he led all aspects of pre-clinical and clinical drug development.  Dr. Edwards currently serves on the board of directors of three publicly traded pharmaceutical companies, Inozyme Pharma, Inc., Kalvista Pharmaceuticals, Inc., and Verona Pharma plc.  He previously served on the board of directors of CoLucid Pharmaceuticals, Inc., which was a publicly traded pharmaceutical company.  Dr. Edwards trained in physiology and medicine at the University of Manchester, where he obtained his M.D.  He is a Member of the Royal College of Physicians, a Member with distinction of the Royal College of General Practitioners, a Fellow of the Faculty of Pharmaceutical Medicine, and holds an M.B.A. from the University of Warwick.

    "I'm honored to join Reata's Board, and I look forward to the opportunity to help oversee the Company's important work," said Dr. Edwards.  "I'm excited to be part of realizing Reata's mission to improve the lives of people facing serious and life-threatening diseases."

    "I'm very pleased to welcome Dr. Edwards to Reata's Board," said Warren Huff, Reata's Chairman, Chief Executive Officer and President.  "He is a highly respected leader in our industry, with valuable experience across many organizations and therapeutic areas.  Our Board and Company will benefit from his insights and counsel as Reata continues to make progress toward becoming a fully integrated, global, commercial enterprise."

    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 methyl ("bardoxolone") and omaveloxolone, target the important transcription factor Nrf2 that promotes the resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, and inhibiting pro-inflammatory signaling.  Bardoxolone and omaveloxolone are investigational drugs, and their safety and efficacy have not been established by any agency.

    Contact:

    Reata Pharmaceuticals, Inc.

    (972) 865-2219

    http://reatapharma.com

    Investors:

    Vinny Jindal

    Vice President, Corporate Communications and Strategy

    (469) 374-8721



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

    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 the detailed factors discussed under the caption "Risk Factors" in its Annual Report on Form 10-K for the fiscal year ended December 31, 2019.  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.

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  4. PLANO, Texas, July 28, 2020 (GLOBE NEWSWIRE) -- Reata Pharmaceuticals, Inc. (NASDAQ:RETA) ("Reata," the "Company," or "we"), a clinical-stage biopharmaceutical company, today announced that researchers at NYU Grossman School of Medicine ("NYU"), led by Sripal Bangalore, MD, interventional cardiologist and professor of Medicine, are initiating an Investigator-Sponsored Trial ("IST"), known as BARCONA, to study the effect of bardoxolone methyl ("bardoxolone") in patients suffering from COVID-19.  At NYU's request, Reata is providing drug supply for the trial.  NYU will be initiating the Phase 2 BARCONA study with a primary endpoint of safety.

    The severity of COVID-19 and the development of systemic complications is associated with excessive…

    PLANO, Texas, July 28, 2020 (GLOBE NEWSWIRE) -- Reata Pharmaceuticals, Inc. (NASDAQ:RETA) ("Reata," the "Company," or "we"), a clinical-stage biopharmaceutical company, today announced that researchers at NYU Grossman School of Medicine ("NYU"), led by Sripal Bangalore, MD, interventional cardiologist and professor of Medicine, are initiating an Investigator-Sponsored Trial ("IST"), known as BARCONA, to study the effect of bardoxolone methyl ("bardoxolone") in patients suffering from COVID-19.  At NYU's request, Reata is providing drug supply for the trial.  NYU will be initiating the Phase 2 BARCONA study with a primary endpoint of safety.

    The severity of COVID-19 and the development of systemic complications is associated with excessive, systemic inflammation, which can result in dysfunction of the lungs, kidneys, and other organs.  Acute kidney injury ("AKI") has been reported to occur in up to 28% of all hospitalized COVID-19 patients and up to 72% of patients who do not survive COVID-19.  Bardoxolone and its analogs have demonstrated anti-inflammatory activity in animal models of acute lung and kidney injury and have shown improvements in kidney function in multiple clinical trials that enrolled over 3,000 patients with various forms of chronic kidney disease.

    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 the resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, and inhibiting pro-inflammatory signaling.  Bardoxolone and omaveloxolone are investigational drugs, and their safety and efficacy have not been established by any agency.

    Contact:

    Reata Pharmaceuticals, Inc.

    (972) 865-2219

    http://reatapharma.com

    Investors:

    Vinny Jindal

    Vice President, Corporate Communications and Strategy

    (469) 374-8721



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

    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 the detailed factors discussed under the caption "Risk Factors" in its Annual Report on Form 10-K for the fiscal year ended December 31, 2019.  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.

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  5. PLANO, Texas, July 07, 2020 (GLOBE NEWSWIRE) -- Reata Pharmaceuticals, Inc. (NASDAQ:RETA) ("Reata," the "Company," or "we"), a clinical-stage biopharmaceutical company, today announced the expansion of its leadership team and the appointment of several experienced industry leaders to key management roles. 

    Colin J. Meyer, MD has been promoted to the newly created position of Chief Research and Development Officer and Executive Vice President.  In this role, Dr. Meyer will be responsible for the strategic direction of the Company's research, development, and clinical functions, with a focus on advancing the development of Reata's robust product pipeline.  Dr. Meyer will lead the Company's efforts to explore additional indications for bardoxolone…

    PLANO, Texas, July 07, 2020 (GLOBE NEWSWIRE) -- Reata Pharmaceuticals, Inc. (NASDAQ:RETA) ("Reata," the "Company," or "we"), a clinical-stage biopharmaceutical company, today announced the expansion of its leadership team and the appointment of several experienced industry leaders to key management roles. 

    Colin J. Meyer, MD has been promoted to the newly created position of Chief Research and Development Officer and Executive Vice President.  In this role, Dr. Meyer will be responsible for the strategic direction of the Company's research, development, and clinical functions, with a focus on advancing the development of Reata's robust product pipeline.  Dr. Meyer will lead the Company's efforts to explore additional indications for bardoxolone methyl ("bardoxolone") and omaveloxolone and to advance the Phase 2-ready molecules RTA 901 and RTA 1701.  Dr. Meyer joined Reata in 2003.  He was involved with the initial in-licensing activities that resulted in the acquisition of several of Reata's technologies, including its Nrf2 activators.  Dr. Meyer held various roles of increasing responsibility in Clinical, Regulatory, and Product Development before being appointed to the role of Chief Medical Officer in 2013.

    In addition, Reata welcomes the following new hires—all of whom have significant industry and commercial experience—to key leadership positions within the Company:

    • Seemi Khan, MD has been named Chief Medical Officer at Reata.  Dr. Khan, a U.S. trained internist and nephrologist, will have responsibility for all clinical development programs, from late preclinical to pivotal Phase 3 trials, as well as completion of post-approval commitments and medical affairs activities across the Company's therapeutic areas.  Dr. Khan served as a nephrology faculty member at Tufts University, Boston.  Her prior industry experience includes leadership roles at Mitsubishi Tanabe, Quark Pharma, and AbbVie.
    • Andrea Loewen has joined Reata as Vice President, Global Regulatory Affairs.  Her career in the biopharmaceutical industry spans more than 30 years at Shire, Biogen, Baxter Healthcare, and a number of smaller biopharmaceutical companies.  She has significant leadership experience developing and implementing innovative regulatory strategies, building out global regulatory organizations and capabilities,  engaging and negotiating with health authorities, and preparing and filing development and registration dossiers, including New Drug Applications (NDAs), Biologics License Applications, and EU Marketing Authorisation Applications (MAAs).
    • Kevin Johnston joins Reata as Vice President and Chief Technical Officer.  In this role, Mr. Johnston will be responsible for establishing and leading the Company's manufacturing and supply chain organization.  Mr. Johnston has over 20 years of global pharmaceutical management and leadership experience in small-molecule development and manufacturing.  Most recently, he served as Vice President of Supply Chain & Logistics at TESARO, Inc., where he built and led a late-stage clinical and commercial manufacturing and supply chain organization that enabled multiple, small-molecule NDA and MAA approvals and launches, in addition to supporting global clinical supply management.

    "We are delighted to make these key additions to our leadership team," said Warren Huff, Reata's Chief Executive Officer and President.  "Each of these individuals brings a critical set of skills to the organization as we transition from a late-stage research and development company to a multi-product, commercial-stage company with a robust and sustainable pipeline of innovative medicines."

    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 the resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, and inhibiting pro-inflammatory signaling.  Bardoxolone and omaveloxolone are investigational drugs, and their safety and efficacy have not been established by any agency.

    Contact:

    Reata Pharmaceuticals, Inc.

    (972) 865-2219

    http://reatapharma.com

    Investors:

    Vinny Jindal

    Vice President, Corporate Communications and Strategy

    (469) 374-8721



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

    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 the detailed factors discussed under the caption "Risk Factors" in its Annual Report on Form 10-K for the fiscal year ended December 31, 2019.  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.

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